VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1518054
Sex: F
Age:
State:

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: the patient experienced event of COVID-19; for a blood transfusion to get her blood counts up; water retention; Red blood cell count low; suspected; is not herself; low iron; sleeping a lot; had no appetite; had nose bleed recently from oxygen; lost her hearing/ has tubes in her ears; infected ear; was not able to do anything; knocked her down; This is a spontaneous report from a non-contactable consumer and contactable Other-HCP. A 79-year-old female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection), via an unspecified route in 2021, as a single dose for covid-19 immunization. Medical history included primary pulmonary arterial hypertension, ongoing, transfusion procedure in May2021 and ear tube insertion procedure in 2021. Concomitant medications included ambrisentan and tadalafil. Co-suspect medications included treprostinil diethanolamine (ORENITRAM) extended-release tablet, unk mg (Lot number: 2101840, Exp. Date: 28Feb2022), extended-release tablet, 1 mg (Lot number: 2101841, Exp. Date: 28Feb2022), extended-release tablet, 2.5 mg (Lot number: 2101810, Exp. Date: 31Jan2023), extended-release tablet, unk mg (Lot number: 2101646, Exp. Date: 31Jan2022), extended-release tablet, 5 mg (Lot number: 2101811, Exp. Date: 31Jan2023) and additional dosage regimen of 5.25 mg TID, oral for primary pulmonary arterial hypertension, tadalafil resulted red blood cell count decreased, fluid retention and oxygen which was drug withdrawn on an unreported date in 2021 due to the event of epistaxis. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection), via an unspecified route in 2021, as a single dose for covid-19 immunization. On 01Apr2021, the patient experienced event of COVID-19 (COVID-19, hospitalization). On an unreported date in 2021, the patient experienced event of lost her hearing, has tubes in her ears, patients one of the tubes placed in ears fell out and one got infected, infected ear (device related infection, medically significant, device dislocation, medically significant and ear infection), So, her physician gave drops for her ears. She was sleeping a lot, low iron and she was now on an iron pill. On an unreported date in 2021, the patients second COVID vaccine knocked her down, was not able to do anything and had nose bleed recently (in Jun2021) from oxygen, while she was able to stop it (oxygen) on her own (previously reported epistaxis) about a week and half ago (from the time of reporting) and had a hard time getting it to stop. On 01Jul2021, the patient almost went to the hospital in night because she was not doing well (previously reported malaise), and they thought it was because of the PO Orenitram dose increases. It was also reported that the patient had no appetite, and she was not herself. On 01Apr2021, 1 year 3 months 15 days after initiating PO Orenitram, the patient was hospitalized due to COVID-19, and was discharged from the hospital on 07Apr2021. The patient was again hospitalized from 25May2021 to 27May2021 for a blood transfusion to get her blood counts up. On 18May2021, patient experienced red blood cell count decreased and fluid retention. The reporter assessed the causal relationship between PO Orenitram and the event of malaise as possible. The reporter did not provide causality for the events of device related infection, device dislocation, ear infection, decreased appetite, and feeling abnormal. The company has assessed the serious adverse events of red blood cell count decreased, fluid retention, COVID-19, deafness, device related infection, device dislocation, and malaise as not related to Orenitram. The event red blood cell count decreased was likely related to iron deficiency anemia, which is common in the elderly, in view of the treatment with iron and blood transfusion. The event fluid retention was likely related to cardiac dysfunction associated with the underlying chronic and progressive PAH. The event COVID-19 was related to the current SARS-CoV-2 virus pandemic with the event malaise possibly being symptomatic of the COVID-19 infection; however, it is also noted that the patient had received co-suspect COVID-19 vaccine, therefore it is plausible COVID-19 vaccine was possibly causal for the event malaise. The event deafness was possibly related to COVID-19 infection and managed with tympanostomy tube placement, which is a rather unusual procedure for adults with deafness. However, additional confounding factors for deafness in this patient include advanced age in which deafness is common, and treatment with co-suspect medication tadalafil, which was possibly causal in view of its safety profile, and as such cannot be excluded. The events device related infection and device dislocation were related to the tympanostomy tubes dislodging, which is typical for this device, with the device related infection likely referring to infection and/or fluid collection the middle ear itself as the purpose of the tympanostomy tube itself is to aid drainage of fluid from the middle ear. The patient underwent lab test and procedure which included blood count abnormal on 25May2021, blood iron low, Red blood cell count and weight measurements 133 lbs and 134 lbs. The clinical outcome of events COVID-19, deafness, hypersomnia, blood iron decreased, malaise and epistaxis were unknown at the time of this report. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds: AMBRISENTAN; TADALAFIL

Current Illness: Ear tube insertion; Pulmonary arterial hypertension; Transfusion

ID: 1518055
Sex: M
Age:
State: MI

Vax Date: 07/08/2021
Onset Date: 07/08/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: stated the patient was in a wheelchair on 08Jul2021; Patients vaccinated with expired use; the 4 patients that received the COVID-19 Vaccine involved in the temperature excursion.; the 4 patients that received the COVID-19 Vaccine involved in the temperature excursion.; This is a spontaneous report from a contactable other hcp. This other HCP reported similar events for 4 patients. This report is for 4th of 4 report. A 18-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0196; Expiration Date: 30Sep2021), dose 1 via an unspecified route of administration, administered in Deltoid Left on 08Jul2021(at the age of 18 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced stated the patient was in a wheelchair on 08Jul2021 on an unspecified date, patients vaccinated with expired use on 08Jul2021, the 4 patients that received the covid-19 vaccine involved in the temperature excursion. on 08Jul2021.Patient stated, 4 patients vaccinated with the Pfizer Covid vaccine which was stored in the freezer since 08Jun2021. Reporter is looking for guidance on how to proceed. office manager reported their practice had kept the COVID-19 Vaccine in the freezer since 08Jun2021, past the allowed extended freezer time, and then the COVID-19 Vaccine was then given to 4 patients. said the COVID-19 Vaccine can only be kept in the freezer for 3 weeks. a temperature excursion had occurred on the practice's COVID-19 Vaccine, and the practice's office manager was being transferred to report on the 4 patients that received the COVID-19 Vaccine involved in the temperature excursion. Reported the patient was unaware the COVID-19 Vaccine was involved in a temperature excursion, and the patient had not reported any adverse events to their office since the COVID-19 Vaccine was administered. Patient not received treatment for reported events. The outcome of events was unknown.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event disability cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202100922637 same reporter/product/event, different patient

Other Meds:

Current Illness:

ID: 1518056
Sex: F
Age:
State: FL

Vax Date: 07/03/2021
Onset Date: 07/03/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Bruises on shins appeared symmetrically; muscle/body pain; stiffness; nausea; weight loss; my temp raised slightly to 99; cold sweat; shaking chills; cold extremities; heart palpitations; extremely painful squeezing buzzing; hot/cold feeling in both calves.; hot/cold feeling in both calves.; restless sleep; thumping in ears; muscle twitches; upset stomach; ankle which swelled and became so sore; ankle which swelled and became so sore; unable to walk; I had a tingling sensation in my left ring finger on the left side of finger tip.; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ew0196), via an unspecified route of administration, administered in Arm Left on 03Jul2021 17:00 as dose 1, single (age at vaccination 35-year-old) for Covid-19 immunisation. Medical history included Hashimoto's thyroiditis (autoimmune), known allergies to Penicillin, amoxicillin sulfa from an unknown date. Concomitant medication(s) included bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]); levothyroxine sodium (SYNTHROID); vitamin d nos (VITAMIN D NOS); omeprazole (OMEG) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug known allergies: amoxicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The other medications in two weeks includes Synthroid, multi vitamin, vitamin d, probiotic, omeg. On 04Jul2021, the patient experienced heart palpitations, extremely painful squeezing buzzing, hot/cold feeling in both calves, restless sleep, thumping in ears, muscle twitches, upset stomach, ankle which swelled and became so sore, unable to walk. Reported that she had a tingling sensation in left ring finger on the left side of fingertip on 03Jul2021 and temp raised slightly to 99, cold sweat, shaking chills, cold extremities on 05Jul2021 while muscle/body pain, stiffness, nausea, weight loss on 06Jul2021. On 16Jul2021, the patient experienced bruises on shins appeared symmetrically. It was reported that adverse event immediately after injection patient had a tingling sensation in her left ring finger on the left side of fingertip. This has been present the entire time and after 17 days post vaccination. 8-12 hours after vaccination patient experienced extremely painful squeezing buzzing and hot/cold feeling in both calves. This lasted until day 14. Bruises on shins appeared symmetrically on day14.12-24 hours after vaccination patient had restless sleep heart palpitations thumping in ears and muscle twitches. 24 hours after vaccination patient experienced upset stomach heart palpitations and an ankle which swelled and became so sore patient was unable to walk. 48 hours after vaccination my temp raised slightly to 99 but patient felt ok, and her ankle pain resolved. That night patient awoke in a cold sweat with shaking chills and cold extremities. Patient took an oral temp which registered at 95.6. Patient took it 3 times with 3 different thermometers. From day 4 on patient experienced heart palpitations, muscle/body pain stiffness twitches, nausea, weight loss. On 05Jul2021, the patient underwent lab tests and procedures which included body temperature: 99 (temp raised slightly to 99), body temperature: 95.6. The clinical outcome for all events was resolving.

Other Meds: PROBIOTIC [BIFIDOBACTERIUM LACTIS]; SYNTHROID; VITAMIN D NOS; OMEG

Current Illness:

ID: 1518057
Sex: M
Age:
State: KY

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Sjogren's; aches; fatigue; dryer than usual eyes; anemia; low iron; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Age at Vaccination was 56 years. Medical history included suspected history of Sjogren's. The patient's concomitant medications were not reported. Previously patient bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation and no events reported. The patient experienced general aches, pains, fatigue, dryer than usual eyes 24hrs after the 2nd COVID shot. Blood tests report anemia and low iron. He has a suspected history of Sjogren's. Tests were inconclusive for the diagnosis but doctor's assume from the symptoms it is Sjogren's. Optional Information was reported as previously mention, he was suspected of having Sjogren's. Several doctors were in agreement based on tests and physical presentation. It was asked could Sjogren's exacerbate the side effects and cause the anemia and low iron. The outcome of the events was unknown. Information about Lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518058
Sex: F
Age:
State: SD

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: expired since 15Jul2021/3 doses were administered; This is a spontaneous report from a contactable other hcp. This HCP reported similar events for three patients. This report is for 2nd of 3 patients. A 62-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW0186; Expiration Date: 15Jul2021), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jul2021 as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot EW0186 and Expiration date 30Aug2021), via an unspecified route of administration Administered in the Left arm on 28Jun2021 as single dose for COVID-19 immunization. The patient experienced expired since 15jul2021/3 doses were administered (medically significant) on 20Jul2021. Reporter stated that they received Covid-19 vials from a different office and realized that they were already expired since 15Jul2021, and 3 doses were administered today to patients. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100924541 Same reporter/SD/AE, different patient;US-PFIZER INC-202100924476 Same reporter/SD/AE, different patient

Other Meds:

Current Illness:

ID: 1518060
Sex: M
Age:
State: SD

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: 3 doses were administered; This is a spontaneous report from a Pfizer-sponsored program. A contactable Other-HCP reported similar event for 3 patient. This is 1st of 3 reports. This Other-HCP reported for a 48-year-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0186 and expiry date: 30Aug2021) via an unspecified route of administration on 20Jul2021 as dose 1, 0.3 ml single on left arm for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. It was mentioned that no other products were received, patient had no history and no investigation assessment was done. The transferring agent stated that she has a HCP on the line that reported that they received Covid-19 vials from a different office and realized that they were already expired since 15Jul2021. On 20Jul2021 the patient was administered 3 doses (overdose). The event outcome was unknown. The caller verified the information provided by the transferring agent.; Sender's Comments: As there is limited information in the case provided, the causal association between the event overdose and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-202100924476 Same reporter/SD/AE, different patient;US-PFIZER INC-202100924472 Same reporter/SD/AE, different patient

Other Meds:

Current Illness:

ID: 1518061
Sex: F
Age:
State: IN

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: feeling movement in my left arm, up my neck, in my left ear; felt tingling across my face; could taste the vaccine; numbness; nerve damage is still around my left eye; causing pain and constant stiffness in my cranial nerve/ jaw; causing pain and constant stiffness in my cranial nerve/ jaw; Laying down on my left side puts pressure on my face; I never sleep well; This is a spontaneous report from a non-contactable consumer (patient herself). A 38-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number; unknown, expiry date: unknown) via unknown via unspecified route of administration, in left arm on 02Apr2021 14:30 (age at vaccination: 38-years) as dose 1, single for Covid-19 immunization. Patients medical history and concomitant medications were not reported. Facility type vaccine was Pharmacy or Drug Store. Patient took no other vaccine in four weeks and no other medications in two weeks of covid vaccine. On 02Apr2021 15:30 after she sat for 15 minutes she left the (name)pharmacy and drove in her car for another 15 minutes before she started feeling movement in left arm, up her neck, in left ear, and then felt tingling across her face for the next 40 minutes. She thought that was part of the vaccine until she got home and spoke with family members about her experience. Also, she could taste the vaccine. She did go to the er, then to her doctor who prescribed prednisone and Valtrex. Previously she had never had an allergy to anything before taking this vaccine. Her doctor told not to get the second shot. The numbness did not go away, and the nerve damage was still around her left eye, causing pain and constant stiffness in cranial nerve/ jaw. Laying down on her left side puts pressure on her face so she never slept well. Next week she was scheduled to get an MRI from the neurologist. She had already reported side effects to VAERS. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Patient did not have covid prior vaccination and was not covid tested post vaccination also. The outcome of the events was not recovered when reported. Information about lot/batch has been requested.

Other Meds:

Current Illness:

ID: 1518062
Sex: F
Age:
State:

Vax Date: 07/16/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: had mild anaphylactic/an allergic reaction to the Covid vaccine; felt like she had a lump in her throat; tongue felt weird; or an adverse reaction; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 16Jul2021 as dose 1, single for COVID-19 immunization. Medical history included COVID-19 infection from Mar2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced had mild anaphylactic, felt like she had a lump in her throat, tongue felt weird. Caller is reporting an allergic reaction to the Covid vaccine. She had the vaccine Friday, and it was the first dose. After the vaccine, it felt like she had a lump in her throat and her tongue felt weird. She called the doctor the next day and he said that she had mild anaphylactic or an adverse reaction and was recommended to not get the second dose. She is not an anti vaxxer or anything but, she definitely likes to read about everything. Caller states that before her son was born, she read the vaccine book and chose to do the vaccines for him. But with the Covid, she was nervous because it felt like she didn't know enough, like she couldn't get enough information. It felt like the pros outweighed the cons. She is a schoolteacher and is getting ready to go back to full capacity. In the fall, it is going to change. The same with her son, they both had Covid last Mar2020, and had no symptoms but both tested positive. Her son had the fever. States that her students are coming back but, wanted to ask if she did have a reaction, would that warrant not getting the second dose; if she would it be like just going in and taking Benadryl or bring an Epi Pen. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive in Mar2020. The clinical outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518063
Sex: F
Age:
State: NY

Vax Date: 04/16/2021
Onset Date: 06/20/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: her deltoid is pulling from the back all the way to the armpit ever since the injection/ her arm was fatigued and a pulling under her arm like the back of her breast; Rash was reported as worsened.; Rash/This rash started on the side of her arm like towards the front of her breast; the caller's skin broke out to something that like eczema, psoriasis, or a diaper rash; the caller's skin broke out to something that like eczema, psoriasis, or a diaper rash.; the caller's skin broke out to something that like eczema, psoriasis, or a diaper rash.; The break out started on the left side where the caller got the injection; It was like the caller had sunburn that had breaks and blisters.; The things under the caller's arms are so painful; The rash got so bad and the pain was so excruciating because it felt like a sunburn; skin is becoming scarred; the discoloration of African Americans, skin is becoming scarred and discolored from this event; The caller's doctor said the rash was some sort of antifungal or bacteria thing; Once the contusion went away; muscle is sore and fatigued; but the muscle is sore and fatigued/ her arm is fatigued; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot/batch no: unspecified) via unspecified route in the left arm, on 16Apr2021 as dose 2, single for COVID-19 immunization (at the age of 51-years). Medical history included that the patient is a cancer survivor, sun-burn from 2019 to 2019 and the patient has been like a hermit since the pandemic. The patient's concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection); Lot/batch no: ER8730) via unspecified route on 26Mar2021 as dose 1, single for COVID-19 immunization (at the age of 51-years) and experienced worst pain, fever and severe soreness at injection site. Patient reported that, she got the Pfizer shots, and never had any issues previously with her skin, and then on 20Jun2021, she realized she had a reaction on her skin. This rash started on the side of her arm like towards the front of her breast. Once the contusion went away her skin broke out to something that like eczema, psoriasis, or a diaper rash. The patient applied cortisone, ointments, and everything and it was still horrible. The rash got so bad and the pain was so excruciating because it felt like a sunburn. She went to Urgent care and was prescribed clotrimazole and betamethasone dipropionate cream. The break out started on the left side where she got the injection. It would go right near the hip by the side and down as far as the thigh, right above the knee, and then it went under her armpit. It was like she had sunburn that had breaks and blisters. The patient started using that medication from the Urgent Care and the rash would dry up within a day then one would pop up next to where the rash just was. Her doctor said the rash was some sort of antifungal or bacteria thing. She took showers like crazy and was a neat freak so she knows that she was not dirty. She was using the medication but they are popping up on different sites but they mostly start on the left side. Then the patient had the discoloration of African Americans, like when they have diabetes, she was getting something like that under her arm. The medication cream was working but was not killing whatever this virus was. The vaccine was a virus that was going to help kill the covid 19 virus and now the patient thinks this virus is causing this rash. The patient had been experiencing this rash the last 4 weeks and it she been 5-6 weeks after the second dose. She doesn't want people to not get the virus because of this event so she doesn't want to say anything about this event. The dermatologist was full until the end of September so she hasn't seen them yet. She further stated that, the things under the caller's arms were so painful she was not wearing tank tops anymore. She was willing to take photos of it and send them in if Pfizer needs that. She was researching it and nothing looks like what she had on her skin, she can't identify with any-thing. The rash looks like maybe eczema at first, she thought it was hives and the doctor said it was more like a virus, bacteria, or fungus. The cream was not killing it for it to go away completely. What-ever it was it was trying to leave the caller's body. She on the second refill of the medicated cream and can't wait to see the dermatologist. She went to the urgent care because the pain was so bad, her skin was becoming scarred and discolored from this event. She felt like that was becoming a chronic condition. She just started using the second tube of the clotrimazole and betamethasone dipropionate cream, first box that the caller started on 20Jun2021- lot 342279, expiration date Sep2022, NDC un-known and second box- lot, the font was tiny and blurred, it almost looked like an AC12555, expiration date Dec2022, NDC unknown. Patient also stated that arm was not weak but the muscle was sore and fatigued like she went to the gym. When she lifts her arm now its like her deltoid was pulling from the back all the way to the armpit ever since the injection and while sitting down and she felt like her arm was fatigued and a pulling under her arm like the back of her breast and also went to the doctor for this. The events resulted in emergency room and physician office visit. The clinical outcome for events was not recovered for all events except for event, the rash got so bad and the pain was so excruciating because it felt like a sunburn/It was like the caller had sunburn, the discoloration of African Americans, like when they have diabetes, she is getting something like that under her arm/caller's skin is becoming scarred and discolored from this event, muscle is sore and fatigued and When the caller lifts her arm now its like her deltoid is pulling from the back all the way to the armpit ever since the injection was unknown and for contusion was recovered on an unspecified date. Information about Lot/Batch number has been requested.

Other Meds:

Current Illness:

ID: 1518064
Sex: M
Age:
State:

Vax Date: 03/30/2021
Onset Date: 04/02/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Pulsatile tinnitus; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration on 30Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: ER8732), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. It was reported that on 02Apr2021, Pulsatile tinnitus occurred 2 days after the 2nd dose on 30Mar2021. The tinnitus does not go away and the symptom persists. Patient visited physician office. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518065
Sex: F
Age:
State: OH

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: After the second shot she felt even better; Caller states that her last labs were very very good other than her A1c which was high.; but that she coughed 24/7; This is a spontaneous report from a contactable consumer or other non hcp. A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EN0150; Expiration Date: 20Jul2021), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 (Age at Vaccination 71-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing type 1 diabetes mellitus Verbatim: Type 1 Diabetes, ongoing chronic obstructive pulmonary disease Verbatim: COPD, ongoing emphysema Verbatim: Emphysema, ongoing asthma Verbatim: Asthma, fatigue from an unknown date and unknown if ongoing. Concomitant medications included prednisone (PREDNISONE) taken for an unspecified indication from an unspecified start date to Mar2021; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported; benzonatate (TESSALON) taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 12Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced after the second shot she felt even better, on unspecified date, patient experienced caller states that her last labs were very good other than her a1c which was high and but that she coughed 24/7. It was reported that After the second shot she felt even better. Her doctor took her off of her nebulizers. She barely uses her inhalers. She was taken off a lot of her medications. Her stamina and energy was through the roof. States she feels like a new person. Before the shot she used to cough 24 hours a day 7 days a week. States she needs Pfizer to know how much the shot has changed her life. States she was a whole different person. Caller states that her last labs were very very good other than her A1c which was high. States that was because she had been taking Prednisone as mentioned. Caller needs to know who to talk to, states in Mar2021, she got a shot, and in APR she got a shot, clarifies that this is the Pfizer Covid vaccine, states prior to the vaccines for years and years and years she has been sick and she still exercises, but she has asthma, COPD, and she has never smoked, but that she coughed 24/7, states she was on nebulizers, inhalers, was on stuff for cough, states once she got the shot she got better. States she got entirely better, no coughing, not on nebulizer anymore, still does the inhalers sometimes, states this lasted for months and now it was all starting to come back. Therapeutic measures were taken as a result of caller states that her last labs were very very good other than her a1c which was high and but that she coughed 24/7. The patient underwent lab tests and procedures which included blood test: unknown in 2021. The outcome of event After the second shot she felt even better was Unknown, outcome for Caller states that her last labs were very very good other than her A1c which was high was Not recovered, but that she coughed 24/7 was recovering

Other Meds: PREDNISONE; MONTELUKAST; TESSALON

Current Illness: Asthma (Verbatim: Asthma); COPD (Verbatim: COPD); Emphysema (Verbatim: Emphysema); Type 1 diabetes mellitus (Verbatim: Type 1 Diabetes)

ID: 1518066
Sex: F
Age:
State: CO

Vax Date: 07/20/2021
Onset Date: 07/20/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: High fever; body chills; sensitive skin; appetite loss; dizziness; weak muscles; sore body; emotional; drowsy; This is a spontaneous report from a non-contactable consumer (Patient). A 19-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 20Jul2021 09:30 (at the age of 19-year-old) as dose 2, single for COVID-19 immunization. Medical history included asthma and had no allergies. Concomitant medication(s) included acetaminophen. Historical vaccine included BNT162B2 (Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 01Jul2021 09:00 as dose 1, single for COVID-19 immunization. Facility type was pharmacy or drug Store. The patient did not received any other vaccine in four weeks. Patient did not tested for covid prior or post vaccination. The patient experienced high fever, body chills, sensitive skin, appetite loss, dizziness, weak muscles, sore body, emotional and drowsy on 20Jul2021 13:45. The event high fever was serious (medically significant). The patient did not received any treatment for the events. The outcome of the events was not recovered. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Other Meds: ACETAMINOPHEN

Current Illness:

ID: 1518067
Sex: M
Age:
State: AR

Vax Date: 05/02/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: positive bands for Lyme; brain fog; trouble concentrating; depression; forget where he was driving; increased anxiety; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 36-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02May2021 11:00 (age at vaccination: 36-years-old) as single dose for COVID-19 immunization. (Vaccination Facility: nursing home building). Vaccine was not administered in Military Facility. medical history was reported as none. No concomitant medications were reported. patient also received first dose of bnt162b2 on 11Apr2021(at age a vaccination: 36-years-old) for covid-19 immunization and experienced shaking, confusion, upset stomach, freezing cold, his temperature was like 96 degrees and he can't remember his temperature which was 96.5 or 96.3 degrees at that time. Patient did not receive any other vaccine within 4 weeks. It was reported that patient wanted to know if I could join the trial for treating lyme. had my ass kicked this year with Covid/Strep but what takes the cake is he thought he was having a reaction to the Pfizer vaccine, now after a test shows positive bands for Lyme, he was rethinking everything. he would appreciate info on this. Upon date 21Jul2021 it was reported that after the vaccine had tests that showed positive bands for Lyme. Stated states the date of that test was about 4 weeks ago and he is technically not positive and technically not negative but the test just showed a couple of bands that were positive for Lyme. he had the 1st dose of the Pfizer COVID Vaccine exactly three weeks earlier than his 2nd dose which was on 02May2021. he started experiencing symptoms the night before his 2nd dose of the Pfizer COVID Vaccine and did not attribute anything to anything at that point but the symptoms he had he thought he had food poisoning and he had had home made pizza and his grandmother told him she tried to cut off the bad parts of the peppers so when he woke up he was shaking and had confusion and upset stomach and they were the kind of symptoms he had not had before. his feet and hands were freezing cold and his temperature was like 96 degrees and he can't remember his temperature which was 96.5 or 96.3 degrees at that time. he had not been shaking and went ahead and got the 2nd dose of the Pfizer COVID vaccine the next day because he thought it was food poisoning and no one else had gotten food poisoning after eating the pizza. he told the nurse he did not have symptoms and had not had symptoms to shots before like to any vaccines. the next three weeks after that were extremely difficult and ongoing and he is having what he thinks was brain fog and trouble concentrating, increased anxiety and increased depression and he would try to walk that off and drive and would forget where he was driving and not even know he was driving. he thinks he went to the emergency room three times and to the walk in one time and that was originally what brought him to his primary care physician which would be the 5th time he saw a HCP. Stated up to that point he was pretty healthy and is a body builder and carries a lot of mass on him which is both muscle and fat and he was always pretty healthy. Adverse event resulted in ER and physician office visit. The patient underwent lab tests and procedures which included investigation: test shows positive bands for Lyme/test just showed a couple of bands that were positive for Lyme, investigation: he is technically not positive stated the date of that test was about 4 weeks ago and he is technically not positive and technically not negative. The outcome for the events was reported as unknown at the time of this report. Information on the batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1518068
Sex: M
Age:
State: CO

Vax Date: 02/21/2021
Onset Date: 02/01/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: ulcerative colitis/the flare started again very aggressively/t was the longest flare I have ever had in my life; I had blood in my stools/blood in my feces; diarrhea; I had a very bad time; This is a spontaneous report from a contactable Pharmacist (patient). A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 21Feb2021 at 12:30 (at the age of 38-year-old), as single dose for COVID-19 immunization at the Hospital. Medical history of the patient included Colitis ulcerosa. Patient did not receive any other medications in two weeks or any other vaccine in four weeks of suspect vaccine. Patient had no known allergies. Patient did not have covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9266) via an unspecified route of administration on 31Jan2021 at 13:00, as single dose for COVID-19 immunization and experienced a flare up of ulcerative colitis. On an unspecified date in 2021, patient had blood in feces and diarrhea every day, 7-10 times a day and three days after second dose on an unspecified date in Feb2021, patient experienced that flare started again very aggressively (ulcerative colitis). The second flare lasted 4 months until it went away, it was the longest flare that patient have ever had in his life. Patient had to take mesalamine, high two prednisone, dicyclomine and had a very bad time. Events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. On 01Mar2021, patient underwent lab test for COVID-19 (PCR-nasal swab test) which came negative. Treatment received for the adverse event included Mesalamine, prednisone and dicyclomine. Outcome of the event ulcerative colitis was resolved with sequel on an unspecified date in 2021 and for other events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events of ulcerative colitis ,haematochezia and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Other Meds:

Current Illness:

ID: 1518069
Sex: F
Age:
State: NY

Vax Date: 04/18/2021
Onset Date: 07/16/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: I got my second shot and I got Covid; I got the rapid test and I also had home PCR test and my report came positive; I got my second shot and I got Covid; I got the rapid test and I also had home PCR test and my report came positive; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Batch/Lot Number: EW0162; Expiration Date: 31Jul2021, age at vaccination: 29-year-old), dose 2 via an unspecified route of administration, administered in upper Arm Left on 18Apr2021 at 14:30 as dose 2, single for covid-19 immunization. The patient previously took BNT162B2 dose 1 via an unspecified route of administration, administered in upper Arm Left on 28Mar2021 at around 1-2 PM (Batch/Lot Number: EC8730) as dose 1, single for covid-19 immunization. Medical history was not reported and concomitant medication was none. The vaccine was not administered at facility. No family Medical History Relevant to AE. The patient started feeling body ache, slight sore throat on Thursday (15Jul2021) around like 3:30 pm and then the next day, still had the same symptoms like body ache and minor sore throat. So, on Thursday, she got the rapid test and she tested positive on 16Jul2021 with rapid test and and it wasn't until Saturday (17Jul2021) that she got the fever around the afternoon and then Sunday (18Jul2021) whole day fever as well and she just took a lots of Tylenol, 'stuck to thousands milligrams' like every six hours and so and then on Sunday, she took almost '1800 grams' to break the fever. She also had it confirmed with a PCR test that was sent in on Thursday and results received on 18Jul2021. Yesterday, Monday (19Jul2021) fever was gone all day and she just had a really bad congestion and couldn't smell or taste because of the congestion. No treatment was received for the events. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No vaccines additional Vaccines Administered on Same Date of the Pfizer Suspect. No Emergency Room and Physician Office visit due to events. The patient did not receive any prior vaccination within 4 weeks of Pfizer vaccination. Conclusion of Previously Completed Investigation. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EW0162 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0162, fill lot EP8695, and the bulk formulated drug product EP8592. Manufacturing and packaging batch records were reviewed for the reported complaint lot. A complaint:# When more than one investigation is found in the family, the Conclusion field could result in repeating rows for the CR in the table. If the Conclusion is blank in the table above, then the investigation record is likely and the conclusion must be obtained directly from the child investigation record(s) of the linked Complaint Record. Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot EW0162. The final scope was expanded to include the reported finished goods lot EW0162, fill lot EP8695, and the bulk formulated drug product EP8592. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0162 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0162, fill lot EP8695, and the bulk formulated drug product EP8592. Manufacturing and packaging batch records were reviewed for the reported complaint lot. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518070
Sex: M
Age:
State: NY

Vax Date: 06/18/2021
Onset Date: 06/01/2021
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Got hospitalized for my injury for my back; This is a spontaneous report from Pfizer Sponsored Program COVAX Support from a contactable consumer or other non-healthcare professional. A 43-years-old male patient received the first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection) via an unspecified route of administration, administered in Arm Right on 18Jun2021 (at the age of 43-years-old) (Batch/Lot Number: EW0181, Expiry date was not reported) as a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications reported. On an unspecified date in Jun2021, the patient experienced got hospitalized for injury for his back. It was reported that the patient received his first dose of the vaccine last 18Jun2021. He was scheduled to have the second dose last 10Jul2021. However, he missed his shot because he was in the hospital. He called in to know how to get the second dose of the vaccine. He stated that he got hospitalized for his back injury which was not related to the vaccination. The patient was hospitalized for got hospitalized my injury for my back from Jun2021 to an unknown date. Laboratory tests on an unspecified date in Jul2021 included sars-cov-2 test: negative (COVID test 5-6 days ago. The COVID-19 negative. Everything was negative). The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the available information, it cannot be ascertained with reasonable possibility that suspect therapy BNT162B2 has caused or contributed to the reported event back injury.

Other Meds:

Current Illness:

ID: 1518071
Sex: F
Age:
State: TX

Vax Date: 07/20/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: My stomach must full, started cramping up and I started passing out and I counted it, I kept 5 times.; My arm started hurting, right after shot, first about an hour, later it did not hurt.; My stomach must full, started cramping up and I started passing out and I counted it, I kept 5 times.; My back started sweating from my neck, down to my middle, it was like a cold sweat.; I have a nausea and I threw up.; I got sick.; I have a nausea and I threw up.; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was FA7484, Expiry date: Unknown) via an unspecified route of administration on 20Jul2021, 12:45 in right arm at dose 1, single for COVID-19 immunization. No medical history reported. No concomitant medications reported. Patient stated her arm started hurting, right after shot, first about an hour, later it did not hurt, stomach must full, started cramping up and started passing out and counted it, patient kept 5 times, back started sweating from my neck, down to my middle, it was like a cold sweat, nausea, got sick. She was just using a cold bath to keep her mind, from hurting. It makes her feel better, cold bath on her head. Little wash part with cold water. Patient started take things, Saline Salt (intent treatment) for sweating. The outcome of events was unknown. Follow-up (26Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518072
Sex: M
Age:
State: TX

Vax Date: 06/14/2021
Onset Date: 05/25/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Narcolepsy; Headaches; Brain Fog; Extreme Tiredness; Dizziness; Slight chest discomfort/pain; Slight chest discomfort/pain; Nausea; Is affecting my ability to work as before and perform daily activities at times; This is a spontaneous report from a contactable consumer or other non hcp. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0186) via an unspecified route of administration, administered in Arm Right on 24May2021 at 17:00 (Age at Vaccination: 50 years) as dose 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 14Jun2021 at 17:00 (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported.The patient previously took codeine and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. On 25May2021, the patient experienced narcolepsy, headaches, brain fog, tiredness, dizziness, slight chest discomfort/pain, nausea and was affecting my ability to work as before and perform daily activities at times. He had taken doctor or other healthcare professional office/clinic visit for events. He had not taken treatment. The outcome of the events were not recovered

Other Meds:

Current Illness:

ID: 1518074
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: optic neuritis; Photophobia; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 54-years-old female patient received BNT162B2 (Pfizer/BioNtech COVID-19 vaccine, formulation solution for injection, lot Number unknown, expiration date unknown) via an unspecified route of administration on an unspecified date, dose number unknown as single dose for covid-19 immunization. The patient medical history was not reported. There was no concomitant medication list. It was reported that after receiving the dose of Pfizer-BioNTech vaccine on an unspecified date the patient suffered from photophobia and optic neuritis. Enquiry received in writing, therefore logged with limited information. There was no product complaint associated with this case. The outcome was not recovered for the events at the time of reporting. The sender noted in their email: As the case reports described in this signal have been transmitted to (withheld) we kindly request you not to resubmit them to the correspondent Regulatory Authority as this is where they originate from. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518076
Sex: F
Age:
State: MI

Vax Date: 06/01/2021
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: Friend's daughter was feeling fine one day and the next day she was very ill. They took her to ER and liver and kidneys were failing.; Friend's daughter was feeling fine one day and the next day she was very ill. They took her to ER and liver and kidneys were failing.; This is a spontaneous report from a contactable consumer. A 16-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date in Jun2021 as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient was not pregnant at time of vaccination. Stated that, on an unspecified date in Jul2021, friend's daughter was feeling fine one day and the next day she was very ill. They took her to the emergency room, her liver and kidneys were failing. Stated that, she was stabilized and was back to normal in a few days. Stated that, friend told the reporter that, she had received her COVID-19 shot a week or so before this incident, so the reporter wanted to report it. The patient was hospitalized for the duration of 5 days. The AEs resulted in emergency room/department or urgent care, hospitalization, Life-threatening illness (immediate risk of death from the event). Treatment medication included unknown steroids. The device timestamp was on 21Jul2021. The outcome of the events was recovered on an unspecified date in 2021.

Other Meds:

Current Illness:

ID: 1518077
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: After the first shot her joints and muscles hurt; After the first shot her joints and muscles hurt; This is a spontaneous report from a non-contactable consumer reported for a female patient (daughter). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as Dose 1, single for COVID-19 immunization. The patient medical history was not reported. There is no Concomitant list reported. It was reported that patient received Pfizer vaccine. The dates of vaccination and lot numbers are unavailable. On an unspecified date after the first shot her joints and muscles hurt. The same doctor as his put her on steroid pills, and within the next day, all her symptoms went away. The doctor tried to refer her a rheumatologist, but they have to wait a year to get an appointment. The patient states that he received another referral, but it is very hard to get a hold of the doctor. Therapeutic measures were taken as a result of events and treatment included prescribed steroid pills which made her symptoms go away. The outcome of the events was recovered on an unspecified date. Product Complaint: There is no product complaint associated with this case. No follow-up attempts are possible, information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100929337 Same patient, drug, reporter and different dose and event.

Other Meds:

Current Illness:

ID: 1518078
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: This is a spontaneous report from a non-contactable consumer (parent). A female patient (daughter) of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history of the patient was not reported. Patient was not taking any concomitant medication [no concomitant list]. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and experienced joints and muscles hurt. On an unspecified date, after receiving second dose of vaccination, patient condition got worsened and her Joints swelled up-feet, hands, ankles. Reporter stated it was not muscle it was more joints. Doctor put her on steroid pills, and within the next day, all her symptoms went away. When she got off the steroid, everything came back just the way it was. The doctor tried to refer her a rheumatologist but have to wait a year to get an appointment. Reporter assessed the event as non-serious. Treatment received included steroid pills. Outcome of the events were unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100929336

Other Meds:

Current Illness:

ID: 1518079
Sex: F
Age:
State: MI

Vax Date: 02/10/2021
Onset Date: 05/10/2021
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: Heart failure; Kidney failure; Difficulty breathing; lymphedema in the right arm; she has low vision and has trouble seeing things; test showed that she had no antibodies against COVID19; This is a spontaneous report from a contactable consumer, the patient. A 76 years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9267, Expiry Date: unknown), via an unspecified route of administration on arm left on 10-FEB-2021 08:50 (age at vaccination: 76 years) as DOSE 2, 0.3 ML SINGLE for COVID-19 immunization. The reported verbatim indication was reported as She was 76 years old and she does not want to die of Covid. The patient medical history included kidney disease, COPD, Asthma, Fibromyalgia, A- Fib, Cholesterol, Spinal stenosis, GERD (Gastrooesophageal reflux disease), heart damage and blood pressure, congestive heart failure to deal with edema, sleep. Historical vaccines included Pneumonia vaccine, Flu vaccine. Prior Vaccinations (within 4 weeks)or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Adverse events following prior vaccinations was reported as none. Family Medical History Relevant to Adverse events was reported as none and family members have had Covid and has 2 friends that have died of Covid. The patient Concomitant medications included Carvedilol(Generic for Coreg) taken for heart damage and blood pressure from an unknown date, Lisinopril taken for heart damage and blood pressure from an unknown date, Furosemide taken for congestive heart failure to deal with edema from an unknown date, Atorvastatin taken for Cholesterol from an unknown date, salbutamol(ALBUTEROL HFA) taken for unspecified indication from an unknown date, Alprazolam taken for sleep from an unknown date, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY ELLIPTA) taken for unspecified indication from an unknown date, Duloxetine (which is also Cymbalta) taken for Fibromyalgia from an unknown date, Diclofenac sodium taken for Spinal stenosis from an unknown date, Omeprazole taken for GERD from an unknown date, colecalciferol(VIT D3) taken for unspecified indication from an unknown date, Fluticasone taken for unspecified indication from an unknown date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), via an unspecified route of administration on arm left on 20Jan2021 (at the age of 76 years) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunization. On 10May2021, the patient experienced Difficulty breathing, Kidney failure, Heart failure. On an unspecified date, the patient experienced lymphedema in the right arm. It was reported that Caller states she has low vision and has trouble seeing things. The patient was hospitalized from 10May2021 to Unspecified as a result of Difficulty breathing, Kidney failure, Heart failure. The events Difficulty breathing, kidney failure, heart failure resulted in Emergency Room (admitted for 39 days) and physician office (many times). The lab tests included test: Blood test: Unknown result, Investigation: Unknown result, Urine analysis: Unknown result on an unknown date; Test: SARS-CoV-2 antibody test, result: Negative on 10May2021; Test: SARS-CoV-2 antibody test (Sars-Cov-2 anti spike) was collected 28May2021, result: negative (with no serological evidence) on 01Jun2021. It was reported that she had several tests because she just spent 39 days in the hospital. They did blood work pretty much every day. They did urinalyses, bladder scans, all those kind of things. Was brought in to the ER 10May2021 and was admitted to the hospital for 39 days. She spent part of the time in rehab and then was re-admitted to the hospital and then back home after 39 days. Was admitted for congestive heart failure, kidney failure and difficulty breathing. The breathing was exacerbated that day, she has COPD and asthma. All of those thing worsened to the point where she was in serious trouble and needed to be admitted to the hospital. It was reported as there was product complaint. Therapeutic measures were taken as a result of Heart failure, kidney disease, lymphedema in the right arm and treatment included They put her on IV Lasix to get rid of the fluid build up and take the burden off of her heart and kidneys. The clinical outcome of the events was unknown.

Other Meds: CARVEDILOL; LISINOPRIL; FUROSEMIDE; ATORVASTATIN; ALBUTEROL HFA; ALPRAZOLAM; TRELEGY ELLIPTA; DULOXETINE; DICLOFENAC SODIUM; OMEPRAZOLE; VIT D3; FLUTICASONE

Current Illness:

ID: 1518080
Sex: F
Age:
State:

Vax Date: 06/11/2021
Onset Date: 06/01/2021
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Fatigue; red rash; Diarrhea; aches and pains; cancer through the liver; This is a spontaneous report from a contactable consumer (patient's husband). A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration on 11Jun2021 18:27 (age at vaccination: 62 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unknown route on 21May2021 as Dose 1, 0.3ml, SINGLE for COVID-19 immunisation. There were no prior vaccinations within 4 weeks. It was reported that the patient got the second shot on 11Jun2021. The patient experienced fatigue, diarrhea, rashes starting to form on her body that looked like prickly heat a red rash and bumps, aches and pains. On 20Jun2021, the patient experienced fatigue and diarrhea. On an unknown date in June2021, the patient had rashes starting to form on her body that looked like prickly heat a red rash and bumps, cancer through the liver, aches and pains. The patient was hospitalized for fatigue (fatigue) from an unknown date to 09Jul2021. The patient required emergency and physician's office visit. Therapeutic measures were taken as a result of fatigue, red rash and diarrhea. The patient was treated in the nursing home put her in rehab facility under prednisone 60mg for rash, unspecified treatment for fatigue and Mucilex for diarrhea. The patient was hospitalized for red rash from an unknown date to 09Jul2021. On 12Jul2021, the patient underwent biopsy but results were unknown on an unknown date, magnetic resonance imaging showed cancer through the liver. They are saying this is in relation to a malignancy in the body. They do not feel it has to do with what happen. It all came up within a week of getting shot. The outcome of the events hepatic cancer, aches and pain was unknown; fatigue, diarrhoea was not recovered, rash erythematous was recovering. Information about lot and batch number was requested.

Other Meds:

Current Illness:

ID: 1518081
Sex: F
Age:
State: FL

Vax Date: 03/10/2021
Onset Date: 07/19/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: On Monday 19Jul2021 I tested positive for Covid.; On Monday 19Jul2021 I tested positive for Covid.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, Lot Number: En6199) via an unspecified route of administration, administered in Arm Right on 10Mar2021 as DOSE 1, SINGLE and dose 2 (Lot Number: En6208) via an unspecified route of administration, administered in Arm Left on 31Mar2021 (Age at Vaccination 42-years-old) as DOSE 2, SINGLE both for covid-19 immunisation. Medical history included chronic vitamin b12 deficiency, vitamin d deficiency and Known allergies: Sulpha from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient started sneezing and congested on sunday 18Jul2021 at 08:30. On Monday 19Jul2021, she tested positive for Covid. She experienced severe headaches, incessant sneezing, mild to moderate congestion, moderate to severe body aches. While she understood that there was a chance of this with the vaccine, she wanted to report her experience as she was a healthy individual, but she had a chronic B12 deficiency and vitamin D deficiency. She taken doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included Covid-19 test was positive on 19Jul2021 (On Monday 19Jul2021 I tested positive for Covid), covic 19 home test was positive on 20Jul2021 (Nasal Swab), Sofia 2 rapid COVID-19 antigen test was positive on 18Jul2021 (Nasal Swab). Therapeutic measures were taken as a result of on monday 19Jul2021, i tested positive for covid with prescriptions of zpack, dexamthasone, fluticasone. The outcome of the events were not recovered.

Other Meds:

Current Illness:

ID: 1518082
Sex: M
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Covid-19 vaccine in March, then got Covid; Covid-19 vaccine in March, then got Covid; This is a spontaneous report from a contactable pharmacist. A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), via an unspecified route of administration on Mar2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient got COVID-19 vaccine in March, then got COVID. The outcome of events was unknown. No follow-up attempts are possible. No further information was expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the event of drug ineffective and COVID-19 cannot be ruled out.

Other Meds:

Current Illness:

ID: 1518083
Sex: U
Age:
State:

Vax Date: 04/18/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Difficulty breathing; Swelling; Rash; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration on 18Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation; and ziprasidone hcl (GEODON), via an unspecified route of administration, from an unspecified date, at an unknown dose and frequency for an unspecified indication. Medical history included ongoing chronic arthritis. The patient had an arthritis related illness and was receiving biologic treatment. Concomitant medications included unspecified biologic treatment for chronic arthritis. On 18Apr2021, the patient received the first dose of the BNT162B2 vaccine. On an unspecified date, after vaccination, the patient developed a rash, followed by difficult breathing and swelling. The patient was hospitalized for the adverse events. The action taken in response to the events for ziprasidone hcl was unknown and for the BNT162B2 vaccine was not applicable. The outcome of events rash, difficulty breathing and swelling was unknown. Information about lot/batch number has been requested.

Other Meds: GEODON

Current Illness: Chronic arthritis (receiving biologic treatment)

ID: 1518084
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: optic neuritis; photophobia; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) (Batch/Lot number and Expiry date was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient suffered photophobia and optic neuritis after receiving the Pfizer-BioNTech vaccine. The clinical outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518086
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Photophobia; Optic neuritis; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced photophobia and optic neuritis after receiving the Pfizer-BioNTech vaccine. The event photophobia intervention/medically important reported as yes. The outcome of the events was not recovered at the time of the report. Follow-up attempts completed. No further information expected.

Other Meds:

Current Illness:

ID: 1518087
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Optic neuritis; photophobia; This is a spontaneous report from a contactable consumer. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration, on an unspecified date as dose number unknown, single (age at vaccination: 54 years), for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that, on unspecified dates, after receiving the Pfizer-BioNTech vaccine, the patient suffered photophobia and optic neuritis. The seriousness criteria for the events were reported as Intervention/Medically Important (Intervention/Medically Important: Yes) and the rest of the criteria: life threatening, death, hospitalization prolonged disabling/incapacitating, congenital anomaly/birth defect and hospitalization required were denied. No abstracts have been assigned to this case. The outcome of the events were reported as not recovered, at the time of reporting. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1518088
Sex: M
Age:
State: VA

Vax Date: 04/06/2021
Onset Date: 04/07/2021
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: I hallucinated and could see images with my eyes closed.; I developed an open sore inside my upper esophagus; Upper chest muscles ached.; my blood sugars have been uncontrollable.; poor balance, inability to concentrate; poor balance, inability to concentrate; Very weak; I began to vomit violently, with 12 episodes during the overnight and morning hours.; headache; Upper chest muscles ached.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: DR8 729), via an unspecified route of administration in right arm on 06Apr2021 at 11:30 (at the age of 62-years-old) as second dose, single for COVID-19 immunization. Medical history included diabetes type 2. Concomitant medications included Metformin and Glipizide. Patient had no known allergies. Patient did not have COVID prior vaccination. The patient previously took first bnt162b2 (Lot number: ENU 207) in right arm on 16Mar2021 (at the age of 62-years-old) as first dose, single for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. On 07Apr2021 at 01:00, the patient began to vomit violently, with 12 episodes during the overnight and morning hours. Patient had a terrible headache, as if the skull would explode. He was hallucinating and could see images with eyes closed. He developed an open sore inside his upper esophagus that would not allow food or liquids to pass down his throat without irritating and causing possible additional vomiting. He went without food or water for more than a week. His upper chest muscles ached. Patient was taken by ambulance to the hospital, as soon as his sister came in from out of town to care for his aged mother on the 3rd day. Patient was hospitalized for 1 week. During the next 90 days his blood sugars had been uncontrollable. Vomiting, he was admitted to hospital for 4 days, discharged, then re-admitted 36 hours later for 4 more days in Jul2021. Uncontrolled high blood sugars unrelated to diet during all 3 hospitalizations. Patient felt very weak, brain fog, poor balance and inability to concentrate. The events resulted in emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized for total 15 days. The patient underwent lab tests and procedures which included blood sugar: during the next 90 days her blood sugars have been uncontrollable on an unknown date in 2021, Covid test type post vaccination: Blood test: negative on 10Apr2021 and 01Jul2021. Therapeutic measures were taken as a result of events included insulin/Metoprolol/Amlodipine and other drugs. Outcome of events was recovering.

Other Meds: METFORMIN; GLIPIZIDE

Current Illness:

ID: 1518089
Sex: M
Age:
State: NV

Vax Date: 02/01/2021
Onset Date: 06/30/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Bells Palsy, left side of face and mouth; This is a spontaneous report from a contactable consumer (patient). A 48-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot number: unknown) via an unspecified route of administration in right arm on 01Feb2021 at 12:00 (at the age of 48-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's historical vaccine included first dose of bnt162b2 (COVID Pfizer vaccine; lot number: unknown) on 12Jan2021 at 12:00 in right arm for covid-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccine in four weeks. Patient had no allergies. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medications received in two weeks included nebivolol hydrochloride (BYSTOLIC) and flecainide (FLECAINIDE) both taken for an unspecified indication, start and stop date were not reported. The patient experienced bells palsy, left side of face and mouth on 30Jun2021 at 19:00. The adverse event resulted in doctor or other healthcare professional office/clinic visit, disability, or permanent damage. The patient was treated with steroids, anti-viral. The outcome of the event was resolving. Information about lot/batch has been requested.

Other Meds: BYSTOLIC; FLECAINIDE

Current Illness:

ID: 1518090
Sex: F
Age:
State:

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Patient had both doses of the Pfizer Covid Vaccine and tested positive for Covid; Patient had both doses of the Pfizer Covid Vaccine and tested positive for Covid; congestion; sore throat; loss of smell; This is a spontaneous report from a contactable consumer (patient) via Pfizer Sales Representative. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on an unspecified date as single dose for COVID-19 immunization. The patient experienced patient had both doses of the pfizer covid vaccine and tested positive for covid (medically significant) on an unspecified date, congestion, sore throat, loss of smell on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518091
Sex: M
Age:
State:

Vax Date: 03/09/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Tested Positive for Covid 19; Tested Positive for Covid 19; Dose 1 on 09Mar2021 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE, and dose 2 on 09Mar2021 (Batch/Lot Number: ER8732) as DOSE 2, SINGLE; This is a spontaneous report from a non-contactable consumer (Patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE, and dose 2 via an unspecified route of administration on 09Mar2021 (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient did not have other vaccine in four weeks. Patient did not had covid prior vaccination. Patient tested covid post vaccination. The patient tested positive for covid 19 on an unspecified date, Patient received Dose 1 on 09Mar2021 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE, and dose 2 on 09Mar2021 (Batch/Lot Number: ER8732) as DOSE 2, SINGLE (Inappropriate schedule of vaccine administered). Lab test included Covid 19: Positive on unspecified date. The outcome of the event was unknown. Conclusion of Previously Completed Investigation stated that the complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot EN6199 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6199, fill lot EN5331, and the formulated drug product lot EN5320. A complaint sample was not returned, and photographs were not received. No related quality issues were identified. QA Review and Rationale included that the complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect of lot EN6199 of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE. The initial scope of this investigation is limited to the reported finished goods lot EN6199 pending review of lot genealogy. The investigation will include a review of the returned complaint sample (if received) and reserve samples, if necessary. Summary of Investigation stated that the initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EN6199, fill lot EN5331, and the formulated drug product lot EN5320. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (Site name) did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. The product requires storage in ultra-low temperature freezers. A review of the temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. Other Conclusion was that the complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6199 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6199, fill lot EN5331, and the formulated drug product lot EN5320. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The scope of this investigation included the reported finished goods lot EN6199, fill lot EN5331, and the bulk formulated drug product EN5320. Acceptable review of related documentation, including manufacturing and packaging batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature. The bulk manufacturing and fill batch records for the complaint batch were reviewed as part of this investigation and were found to be acceptable. All processing steps were performed within pre-established parameters. The review of the manufacturing record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. All raw materials used in the complaint batch were of the correct weight and identity. All the manufacturing temperatures mix speeds and mixing times were within acceptable ranges. In-process appearance and specific gravity test results were all within acceptable ranges. A review of the solution filtration documentation confirmed that all materials, filters and Water for Injection (WFI) were used within their expiration dates, and that all the filtration times, pH results, and pressure specifications were met. The manufacturing processes of raw material usage, solution formulation and filtration were all found to be acceptable. All manufacturing parameters met established requirements. A log is maintained throughout the manufacturing process of the amount of elapsed time that the product is out of refrigeration. A review of the elapsed time tracking logs confirmed that all times were within allowable limits. The review of the packaging record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. Audits are performed on the finished packaged units by Packaging Operations personnel at regular intervals throughout the final packaging process. This is done in order to ensure that all required labeling and packaging is present, complete, and meets all establishments requirements. During the audits, inspectors visually check the appearance of the finished product for defects. The Pfizer-BioNTech COVID-19 Vaccine vials are loaded into trays containing 195 vials each. Five trays are then banded together into a bundle. The vaccine requires ultra-low temperature freezer storage. Prior to loading, freezer temperatures were verified to between -67C and -73C. Freezer shelves were then loaded with bundles of product. During the freezing phase, which occurs 60 hours after loading, the temperature of the freezers is monitored. If the temperature is warmer than the previously recorded temperature, supervision is notified. Additionally, after the freezer temperature drops below -60C, the temperature recorded may be warmer due to the freezer operation caused by the freezer cycling. This is acceptable. A review of the log for the reported batch confirmed that all freezer temperatures acceptable. Samples are then stored until the product is released for distribution. A reserve sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months of the release date of the involved batch. The results of all analytical tests performed at the time of lot release were confirmed to be within registered specifications. All available stability results for this product were within registered specification and stability studies (including accelerated studies) are ongoing for this product. The complaint history for the reported PFIZER-BIONTECH CO

Other Meds:

Current Illness:

ID: 1518092
Sex: F
Age:
State: MO

Vax Date: 01/15/2021
Onset Date: 07/20/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: tested postiive for Covid virus; tested postiive for Covid virus; First Dose, 15Jan2021, Second Dose 03Feb2021,; This is a spontaneous report from a contactable consumer (patient herself). A 40-years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: EL1284, expiry date: unknown) on 15Jan2021 4:45PM (age at vaccination: 40 -years) as single dose and second dose (lot number: EL9263, expiry date: unknown) on 03Feb2021 9:15AM (age at vaccination: 40 -years) via unspecified route of administration in left arm as single dose for covid-19 immunisation. Vaccination facility type was hospital. Patient's medical history and concomitant medications were not reported. Patient was diagnosed with Covid yesterday 20Jul2021, and she was trying to find a way to report the breakthrough COVID diagnosis, had not seen anywhere on the website that they are tracking this information, could only find that they have tracked it through the end of Apr2021. She wanted to know if Pfizer was tracking this information. Patient had physician office visit due to adverse event. She went to respiratory clinic yesterday, doctor had her regen-cov infusion today for treatment, 21Jul2021. Prior Vaccinations (within 4 weeks) no other vaccinations within four weeks prior to the first administration date of the suspect vaccine was given. Patient was on the phone with one of their colleague and was reporting that she had the Pfizer vaccine in January and February but yesterday was diagnosed with COVID-19. So, she was reporting the breakthrough and had just about finished the report, the voluntary report but they were unfortunately disconnected. So, she doesnt know what else she needs to do to answer remaining questions but just wanted to complete that form. The outcome of event was not recovered, when reported. Follow-Up (26Jul2021): Follow-up attempts are completed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518093
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: has tested positive for COVID 19 after being fully vaccinated (2 doses) with PFE vaccine several months ago; has tested positive for COVID 19 after being fully vaccinated (2 doses) with PFE vaccine several months ago; This is a spontaneous report from a non-contactable consumer. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch number/Lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 26-year-old) as a dose 2, single and the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch number/Lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 26-year-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that by patient family member, patient who was a 26-year-old male has tested positive for COVID-19 after being fully vaccinated (2 doses) with PFE vaccine several months ago. Stated that, he was a healthcare worker. On an unspecified date, the patient underwent lab tests and procedures which included SARS-CoV-2 test resulted as positive. for COVID-19. The outcome of the events was unknown. No follow up attempts are possible, information about lot/batch no cannot be obtained.

Other Meds:

Current Illness:

ID: 1518094
Sex: M
Age:
State: VA

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: after the first vaccine he had a headache for a few days also but it was not bad at all; This is a spontaneous report from a contactable consumer or other non-HCP (patient's mother). A 14-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EWO177), via an unspecified route of administration, in Arm Right on 01Jun2021 (age at the time of vaccination 14-years-old), as a single dose for COVID-19 immunization. The patient's medical history included allergies. The patient's concomitant medications included Cetirizine Hydrochloride (Zyrtec Allergy) for allergies, one tablet, 10 mg, as needed, He has been taking it since he was six about; and Ferrous Fumarate, Vitamins Nos (Flintstone Vitamins with Iron), 2 gummies once a day, He started taking last year for health. On an unspecified date the patient experienced after the first vaccine he had a headache for a few days also, but it was not bad at all. On an unspecified date, the patient underwent lab tests and procedures which included clotting, Coagulation time: Unknown result; took some blood they are checking, Investigation: Unknown result; and Platelet count: Unknown result. The patient visited to physician office. Caller stated, when the headaches got bad, he would take Tylenol the first few days and then he took Motrin. Caller corrects this and states he took Ibuprofen, not Motrin. The outcome of the event was unknown. VACCINE SUPPLEMENTAL FORM 1.: Patient details, dose details, concomitant, adverse events, visited to Physician Office, patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine, Patient's Medical History, and Relevant Tests was included. The information about lot umber was provided. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021868617 similar report from same reporter

Other Meds: ZYRTEC ALLERGY; FLINTSTONE VITAMINS WITH IRON

Current Illness:

ID: 1518095
Sex: F
Age:
State: PA

Vax Date: 05/14/2021
Onset Date: 05/15/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: bleeding; burning; itching; sores; raised patches; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 14May2021 12:30 PM (Batch/Lot Number: EW0177) as single dose for COVID-19 immunisation, administered at church. Medical history included psoriasis on her scalp since childhood and ongoing, C-sections in 1997 and 2001, hypothyroidism from 2005 and ongoing, Lupus anticoagulant from 2012 and ongoing, hysterectomy from 2012 to Dec2020 (as reported), hernia repair from 2012 to Dec2020 (as reported), anxiety, gastrooesophageal reflux disease (GERD). Concomitant medication(s) included levothyroxine sodium (SYNTHROID) at 50 mcg taken for hypothyroidism from an unspecified start date and ongoing; rivaroxaban (XARELTO) at 10 mg taken for lupus anticoagulant from an unspecified start date and ongoing; pantoprazole (PANTOPRAZOLE) at 20 mg taken for gastrooesophageal reflux disease from an unspecified start date and ongoing; escitalopram (ESCITALOPRAM) at 10 mg taken for anxiety from an unspecified start date and ongoing. The patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 16Apr2021 12:30 PM (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation, administered at church, and on 17Apr2021 her scalp started to itch significantly (no treatment received). On 15May2021 the patient experienced bleeding (medically significant) with outcome of not recovered, burning (non-serious) with outcome of not recovered, itching (non-serious) with outcome of not recovered, sores (non-serious) with outcome of not recovered, raised patches (non-serious) with outcome of not recovered. The course of events was as follows: The patient had psoriasis on her scalp since she was a child. It went into remission on her 20's and returned in mild form in her late 40's. After her first COVID vaccine her scalp started to itch significantly. After her second shot her scalp has gotten significantly worse with raised patches, bleeding, sores, and burning and itching. She saw a dermatologist and then prescribed clobetasol. The patient underwent lab tests and procedures which included chest X-ray: normal on 17Mar2021, echocardiogram: normal in Mar2021, electrocardiogram ambulatory: normal on 25Mar2021, mammogram: normal on 17Mar2021. New med clobetasol for scalp was given as treatment.

Other Meds: SYNTHROID; XARELTO; PANTOPRAZOLE; ESCITALOPRAM

Current Illness: Hypothyroidism; Lupus anticoagulant (Lupus anticoagulant); Psoriasis (on her scalp since childhood)

ID: 1518096
Sex: U
Age:
State:

Vax Date: 07/15/2021
Onset Date: 07/16/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: I started having simple partial seizures the day after I got the first vaccine; This is a spontaneous report from a contactable consumer (patient). A 32-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EWO198) via an unspecified route of administration, administered in Arm Right on 15Jul2021 15:00 (at the age of 32-year-old) as dose 1, single for covid-19 immunisation. Medical history included epilepsy. The patient concomitant medications were not reported. It was reported that patient did not receive other vaccine in four weeks. Patient had no COVID prior vaccination and patient had not tested COVID post vaccination. On 16Jul2021 16:00, the patient reported that this might be just a HUGE coincidence but, patient started having simple partial seizures the day after patient got the first vaccine. Patient said HUGE coincidence because patient have not had a single issue with seizures in over 5 years. No treatment received for event. The outcome of event was recovering. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1518097
Sex: F
Age:
State: LA

Vax Date: 02/26/2021
Onset Date: 03/01/2021
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: very disoriented; neurologically and cognitively there has been a continuous decline; neurologically and cognitively there has been a continuous decline; bed confined; unable to talk; forgetful; lightheartedness; unable to sleep; diarrhea; fell; colitis; anemia; dehydration; PE in lungs; DVT right leg; Decrease level of consciousness; Could not walk without assistance; This is a spontaneous report received from a contactable consumer via a consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: El9265), via an unspecified route of administration, administered in Arm Left on 26Feb2021 at age of 75-year-old as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was doctor's office/ urgent care. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination. The patient previously received first dose of bnt162b2 (Batch/Lot Number: El9265), via an unspecified route of administration, administered in Arm Left on 05Feb2021 at age of 75-year-old as single dose for covid-19 immunisation. Medical history included High blood pressure, high cholesterol. No known allergies. Concomitant medications included lisinopril, ranolazine (RANEXA), simvastatin, ubidecarenone (COQ10), calcium. On Mar2021, two weeks after 2nd vaccine, the patient started being very forgetful, lightheartedness. 4 weeks following 2nd vaccine, patient was unable to sleep, diarrhea and fell on 3 different occasions. By Apr2021 became very disoriented, diarrhea continued. Was taken to emergency room and was diagnosed colitis, anemia, dehydration, pulmonary embolism (PE) in lungs and deep venous thrombosis (DVT) right leg. Patient was admitted into hospital for 3 days. Discharged 3 days later, could not walk without assistance and experience decrease level of consciousness. Hospital discharge doctor stated that Physical therapy and hydration will offer her a full recovery. Since the beginning of Apr2021 neurologically and cognitively there had been a continuous decline. Before Apr2021 patient was independent, living on her own, paying Bill's, driving, and preparing her own meals. Now she was bed confined, unable to talk. In early Jun2021, while she was still able to move via walker assistance she was referred to neurologist, MD. He performed MRI, EEG, and MR venagram. He ruled out stroke, and blood clot to brain. The patient received pednisone as treatment. The adverse events result in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Seriousness criteria were reported as life threatening, caused/ prolonged hospitalization and disabling/ incapacitating. COVID test (Nasal Swab) post vaccination on 05Apr2021 with result negative. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Other Meds: LISINOPRIL; RANEXA; SIMVASTATIN; COQ10 [UBIDECARENONE]; CALCIUM

Current Illness:

ID: 1518098
Sex: F
Age:
State: MO

Vax Date: 07/17/2021
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: not able to breathe at night/had trouble breathing, however that trouble breathing was different and not like night time; she was dizzy/dizziness; Caller also adds that her arm did get red and had swollen up when she got the vaccine; Caller also adds that her arm did get red and had swollen up when she got the vaccine; it also itched terribly; If the first one was doing this then it's really scary for her/panicked some; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FA6780, Expiration date: Unknown), via an unspecified route, administered in Right Arm on 17Jul2021 at 15:00 (67-year-old vaccination) as a Dose 1, single for Covid-19 immunization.The patient's medical history included asthma and blood pressure.Concomitant medications included Blood pressure medication but that was nothing new for her.The patient had her first dose on 17Jul2021, between 2:30 to 3PM.On 20Jul2021 (Tuesday Night) she first woke up from her sleep not being able to breathe and again on Wednesday night 21Jul2021. The last 2 nights she had woke up not being able to breathe, her husband called the ambulance for her the past 2 nights. The reporter clarifies that she already had asthma prior to the Covid vaccine but she had never woke up not being able to breathe, this never happened before. She was not able to breathe again last night.The reporter stated that she probably also panicked some, but because of this experience she was not sure about getting the second vaccine. She would like to know with the first dose making her not able to breathe at night was it okay for her to get the second dose. If the first one was doing this then it's really scary for her.Stated that she ended up waking up at night. The outcome was unknown to her because it only happened at night and she won't know until she went to bed tonight. She added that after she got the shot, she was dizzy and had trouble breathing, however that trouble breathing was different and not like night time, she described it as she couldn't breathe. For the trouble breathing she experienced within 15 minutes of getting the vaccine, it went away after using her inhaler. The dizziness was also experienced within 15 minutes of getting the first dose of the vaccine, but it didn't last long and went away on that same day Saturday 17Jul2021. She also clarified that when her husband called the Ambulance Tuesday night, by then she able to breathe and they checked her lungs and saw she had air flow going through. Last night when her husband called the ambulance, again she was able to breathe and so they cancelled the ambulance. She stated that both time she did not have to go to the hospital and confirmed she was not admitted. She stated that she did not want to go to the hospital due to Covid in the area. She also added that her arm did get red and had swollen up when she got the vaccine, it's better now, and it also itched terribly starting on Sunday 18Jul2021 or Monday 19Jul2021. She stated that there was no Expiry Date written on the card, and said she got the vaccine at 3PM. The outcome of the event dizzy was resolved on 17Jul2021 and event arm did get red and had swollen up was recovering and the outcome of other events was unknown. Follow-up attempts are completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1518099
Sex: F
Age:
State: NC

Vax Date: 03/04/2021
Onset Date: 03/01/2021
Rec V Date: 07/31/2021
Hospital: Y

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: neurological complication with her eyes that the doctor's thought might be a stroke; initially thought she had a TIA (transient ischemic attack); neurological palsy; a pain that she describes as "lightening bolts" throughout her body but mainly in her big toe, both hands, and scalp; did not get the second dose; sore left arm/intense lightning bolt pain in her big toes/between her thumb and fore finger; blisters in her mouth; intense lightning bolt pain that was in her skull area right along her scalp; Maybe her immune system went crazy; nerve issues came up from her sore left arm, up the left side of her neck, and the left side of her head; shingles on the face; lost feeling in different parts of her body that started on the left side and then moved to the right side /numbness and weakness in right foot/ right leg/right hand; weakness /numbness and weakness in right foot / weakness and numbness on the left side of her body; doctor's thought might be a stroke; she might have had Guillian-Barre Syndrome; This is a spontaneous report from a contactable consumer or other non hcp. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration in left arm on 04Mar2021 (at the age of 47-years-old) as single dose for COVID-19 immunization. Medical history included autoimmune disorder, interstitial cystitis and father's side has a lot of heart problems like arrhythmias, heart attacks, and strokes. The patient's concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). The patient experienced neurological complication with her eyes that the doctor's thought might be a stroke, initially thought she had a tia, doctor's thought might be a stroke and she might have had guillian-barre syndrome, nerve issues came up from her sore left arm, up the left side of her neck, and the left side of her head, shingles on the face, lost feeling in different parts of her body that started on the left side and then moved to the right side /numbness and weakness in right foot /numbness and weakness in lower part of her right leg /numbness and weakness in her right hand, a pain that she describes as lightening bolts throughout her body but mainly in her big toe, both hands, and scalp on an unspecified date, did not get the second dose on an unspecified date, sore left arm/intense lightning bolt pain in her big toes/between her thumb and fore finger, blisters in her on, intense lightning bolt pain that was in her skull area right along her scalp, maybe her immune system went crazy on Mar2021 and neurological palsy on an unspecified date. AE resulted in both emergency room and physician's office. The patient was hospitalized for neurological complication with her eyes that the doctor's thought might be a stroke and initially thought she had a tia from Mar2021 to an unknown date for 1 days. Seriousness criteria for the events Guillian-Barre Syndrome and cerebro vascular accident was medically significant and remaining events assess as non-serious. She started losing feeling in different parts of her body. It was really bad for about 3 to 4 weeks. She still struggled with it. She tried to avoid certain foods that she had found make her symptoms worse. She tried to keep her symptoms at bay. The shingles progressed and maybe 3 to 4 days into the shingles she had the strange event that happened with her eyes. She called the rescue squad to take her to the hospital. At the hospital, she had MRI scans out the wazoo. Relayed to caller that since she did experience what was considered to be a severe reaction to the first dose of the vaccine that it was considered to be contraindicated for her to receive the second dose. The patient was an educator and having kids around so took COVID-19 vaccine. She could not take pain relievers because it made the numbness worse. She had tried to take Ibuprofen, she only took one and realized it was not going to be the solution. She did not have the bottle or package for the Ibuprofen. After that she tried ice and Epsom salt and anything else over the counter for treatment. She thought she was going to die, like her heart was not working properly. When she went to the urgent care she had an EKG and the EKG did show her heart was skipping beats and not doing beats right. The doctor told her she was not having a heart attack but it was very scary. The shingles started in her mouth and came up the left side of her face, cheek, it followed a little nerve path. The shingles missed her eye and instead was on her eyelid and in her ear and the left side of her scalp. Only a little in her hair. Patient reported that she got her flu vaccine every year and has had all her vaccines as a child and never had anything like this happen before and reported she does have a family history of autoimmune disorders and her mother had nerve problems when she got older. Her fathers side has a lot of heart problems like arrhythmias, heart attacks, and strokes. Maybe her immune system went crazy because it was naturally responding to the Covid 19 vaccine and triggered some problems early. It was hard for her to call Pfizer today. She had not been vocal because she wanted people who want to get the Covid 19 vaccine to get it and did not want to be a negative influence. She felt like Pfizer needs to know what happened to her and did not know if other people have experienced this. Her daughter wanted to get the Pfizer Covid 19 vaccine but she was terrified for her daughter to get it. She was asking for information on what she experienced and if there was any information for her daughter for guidance. The patient underwent lab tests and procedures which included blood test, electrocardiogram and magnetic resonance imaging wnl on Mar2021 within normal Limits. The outcome of the events doctor's thought might be a stroke, shingles on the face was not recovered and neurological palsy, she might have had Guillian-Barre Syndrome, lost feeling in different parts of her body that started on the left side and then moved to the right side /numbness and weakness in right foot/ numbness and weakness in lower part of her right leg /numbness and weakness in her right hand, maybe her nerves are not quite back to normal was recovering and outcome for all remaining events was unknown.

Other Meds:

Current Illness:

ID: 1518100
Sex: F
Age:
State: WA

Vax Date: 01/22/2021
Onset Date: 07/06/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: The date of PCR COVID test was 06Jul2021 and she was positive for COVID; The date of PCR COVID test was 06Jul2021 and she was positive for COVID/ she had no symptoms at all; This is a spontaneous report from a contactable consumer, the patient. This report is for the reporter herself (wife). A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm deltoid area on 12Feb2021 (at the age of 57-years-old) (Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) as dose 2, 0.3 ml single and dose 1 via an unspecified route of administration, administered in left arm deltoid area on 22Jan2021 (at the age of 57-years-old) (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as DOSE 1, 0.3 ML SINGLE for covid-19 immunization. Vaccine administered at Military Facility reported as no. Medical history reported as none. There were no concomitant medications. Family Medical History Relevant to AE: Not Provided. Prior Vaccinations (within 4 weeks): none. AE following prior vaccinations: Not Provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Caller was reporting side effect to Pfizer COVID Vaccine. Caller and her husband both travelled to (privacy) where they got COVID19 infection and they both had received both doses of COVID19 Vaccine, wife (patient) said she had no symptoms at all after getting the infection. The caller was pleased that the vaccine worked with her not having symptoms and she just wanted to make sure it got documented because they got COVID19 infection when in the (privacy). The date of PCR COVID test was 06Jul2021 and she was positive for COVID. She stayed in quarantine for 10 days. Stop date would be the 16Jul2021 and she recovered completely. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 06Jul2021. Description of Product Complaint: Traveled to (privacy) where she got COVID19 infection. She had received both doses of COVID19 Vaccine. she had no symptoms at all after getting the infection. The caller is pleased that the vaccine worked with her not having symptoms. She just wanted to make sure it got documented because she got COVID19 infection when in the (privacy). The date of PCR COVID test was 06Jul2021 and she was positive for COVID. The events had not resulted in emergency room/ physician office visit. The outcome of the event Asymptomatic COVID-19 was recovered on 16Jul2021 and vaccination failure was unknown. Information on the lot/ batch number is available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1518101
Sex: U
Age:
State: IL

Vax Date: 07/03/2021
Onset Date: 07/03/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: I just wanted to report that, after receiving the Covid vaccine, I got the Bell's palsy so, that was the reaction I received.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included Cancer. There were no concomitant medications. The patient previously received first dose of bnt162b2 (BNT162B2, formulation: Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported), as single dose for covid-19 immunisation. On 03Jul2021, the after the vaccination, the patient experienced bell's palsy. Patient just wanted to report that, after receiving the Covid vaccine, patient got the Bell's palsy so, that was the reaction received. Patient stated just wanted to report that, after receiving the Covid vaccine, patient got the Bell's palsy so, that was the reaction received. The patient did not receive treatment for the event. It was reported that the patient has to take medications after the vaccine because of the side effect (Not further clarify). The patient underwent lab tests and procedures which included unknown investigation with unknown results on an unspecified date in 2021. It was reported that the patient was basically being treated by the doctor. The outcome of the event was unknown at the time of this report.

Other Meds:

Current Illness:

ID: 1518102
Sex: F
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: blood clot in her leg; severe leg pain and cramps; severe leg pain and cramps; she can't even stand long enough to brush her teeth; my sister continually cries from pain and frustration; This is a spontaneous report from a contactable consumer. A female patient of unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration at unknown dose single for COVID-19 immunization. No medical history reported. No concomitant medication reported. The patient start experiencing blood clot in her leg, then severe leg pain and cramps, continually cries from pain and frustration. The outcome of Events was unknown. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1518103
Sex: F
Age:
State: LA

Vax Date: 03/02/2021
Onset Date: 07/13/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: She contracted COVID on 15 July 2021 and tested positive.; She contracted COVID on 15 July 2021 and tested positive.; fluid in her ears; Dizzy/she is falling sometimes; Coughing; severely dehydrated; gas coming from her stomach that creeps her out; she couldn't go back to sleep; horrible stomach ache; her blood pressure was down to 52; low level of oxygen; her brain can't focus; Sunday the caller couldn't get out of bed; hasn't had a meal in 10 days; gagging; broke out in a rash from her pelvis to her breasts; Sweating; felt awful; Nauseated; didn't have any taste or smell; didn't have any taste or smell; Diarrhea; Headache/her head is so heavy; temperature; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EN6198) via unspecified route of administration in the arm on 02Mar2021 as dose 2, single for COVID-19 immunization (at the age of 68-years). Medical history was not reported. Concomitant medication(s) included naproxen sodium (ALEVE) one tablet at night, and loratadine (CLARITIN [LORATADINE]). The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: FL9267 or EL9267) via unspecified route of administration in the arm on 09Feb2021 as dose 1, single for COVID-19 immunization (at the age of 68-years). Patient stated that she received her first dose last 09Feb2021 and second dose 02Mar2021. She went fine after the vaccine. She contracted COVID on 15Jul2021 and tested positive. She wanted to know why was she so susceptible for COVID and she wants to know how long she will have her COVID symptoms and side effects last. She had fever, can't taste nor smell, diarrhea, headache, felt awful, sweating, has rash, nausea and dizziness. She also mentioned that she went to the hospital and no cases of people who had the shot that had been severe, "It must have bad serum". "I shouldn't be feeling this bad. She mentioned that she had no primary doctor and no related medical condition. Patient also wanted to know if there were handling issues with the product itself, it could have been the syringe. Patient further stated that, a week ago from Sunday she felt under the weather. By Tuesday she did not feel well and Wednesday, she was pushing herself getting stuff ready for a vacation. The patient went to bed and woke up with a temperature (13Jul2021). The patient called urgent care and wanted an antibiotic but they told her they had to have a covid test. The patient was positive for covid and said that was not accurate so she called another place for a delta test and they said there was no such thing. 4 hours later, the patient didn't have any taste or smell (15Jul2021). The patient started treating with diarrhea (15Jul2021), headache (15Jul2021), and felt awful (16Jul2021), so she cancelled her trip. She was given a Z pack in case she had any infection and she progressively got worse. Yesterday, she could hardly lift her head off the pillow and she was so nauseated (16Jul2021) and hasn't had a meal in 10 days. The patient felt so bad she made herself eat before she takes Tylenol (lot and NDC unknown, expiration date Mar2022) but kept on running a high fever. She had a fever and it would break and she had to change her sheets and shirt 3 times because she was sweating (17Jul2021) so much. Tuesday she went to an ENT and they said she had fluid in her ears. The ENT told the patient to go to the hospital if she got worse. The patient had another bad night and was getting weaker and weaker and went to the hospital yesterday. The hospital kept the patient on IVs for about 7-8 hours and wanted to put her on the BAM but didn't have it so they gave her the Region. She was given nausea medicine in the drip because she was gagging. The patient was sent home with some of that nausea medicine. She was so dizzy, she was afraid she was going to fall. She went to bed and woke up like someone was killing her and she woke up and survives it was like her fever broke and she couldn't go back to sleep. She ate soup and stayed up 4 hours. She woke up with a horrible stomach ache and her head was so heavy. The doctor said people who are vaccinated aren't on ventilators. Patient wanted to know if it was possible that something happened to the vials of medication that something may have slipped through like a box of cookies or meat with lead in it, if there was a possibility that this could have happened. The patient had a severe case of covid. She was coughing. She was not sure if Pfizer was familiar with the Regal or the Bam which was concoction of medications for the treatment of COVID. She was severely dehydrated, her blood pressure was down to 52 and the other number was higher. She was drinking A hydration drink but she couldn't taste it and kept it down. She can't taste and there's a gas coming from her stomach that creeps her out because it was that horrible inner body stuff. The patient felt like she was falling sometimes. She was healthy otherwise. Patient also stated that, she couldn't taste or smell, it could have started Wednesday night but she didn't notice until Thursday when she couldn't taste her smoothie or chili. She could taste salt and sweet tastes like a piece of fruit, she can't taste butter. The diarrhea was severe. The doctor thought her kidneys could be compromised. They did an x-ray and her lungs look okay they put her on heart monitor because of her low level of oxygen. That Saturday the patient felt like she had cement in her nose, she felt like she could really smell. Sunday she couldn't get out of bed. The first two days she put clothes on, other than that she stayed in her pajamas. She can't watch TV because her brain can't focus and the sound hurts her head. Two hours after she was sleeping her head was wet and she thought she wet the bed, you could see the sweat dripping down her body, she put a towel on the bed and went back to bed and the same thing happened an hour and half later. Sunday morning she finally slept. The fever kept going up and she had the sweats but only had to change once. The night before last, she thought she was on the mend, the ENT gave her more medicine but the sweating did the same thing 3 times. The patient broke out in a rash from her pelvis to her breasts (18Jul2021), its likes whelps but she thinks its from heat and moisture. She had not taken her temperature that morning because she was scared. On 15Jul2021, the patient underwent lab tests and procedures which included covid-19: positive, hypotension: 52, hypoxia: low and x-ray: okay, her lungs looked okay. Therapeutic measures were taken as a result of temperature, nauseated and gagging. The clinical outcome events, temperature, didn't have any taste or smell, headache, felt awful, sweating, broke out in a rash from her pelvis to her breasts, nauseated was not recovered, recovering for diarrhea while for the other events was unknown.

Other Meds: ALEVE; CLARITIN [LORATADINE]

Current Illness:

ID: 1518104
Sex: M
Age:
State: WA

Vax Date: 02/12/2021
Onset Date: 07/05/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: positive for COVID; he had mild symptoms; breakthrough of COVID infection; This is a spontaneous report from a contactable consumer. This report is for caller's husband. This consumer (patient's wife) reported for patient (Reporter's husband) that a 67-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN6201, expiration date: 30Jun2021) via an unspecified route of administration, administered in arm right on 12Feb2021 as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EL3302, expiration date: 31May2021) (Age at vaccination 67 years) via an unspecified route of administration, administered in arm right on 22Jan2021 as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. The patient did not have medical history. No concomitant medications. On an unknown date, the patient experienced positive for COVID. On 05Jul2021, breakthrough of COVID infection and on an unknown date, he had mild symptoms. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 05Jul2021. It was reported that the reporter was calling to report that my husband and I both had two doses of my Pfizer COVID-19 vaccine. We both had a breakthrough of COVID infection while traveling to the UK. My husband had mild symptoms. I had no symptoms after the infection so the vaccine did it's job. I saw the doctor in UK and not in the US. I wanted to make sure it's reported in the United States. Caller and her husband both traveled to UK where they got COVID19 infection and they both had received both doses of COVID19 Vaccine. Husband said he had mild symptoms where as the wife said she had no symptoms at all after getting the infection. The caller was pleased that the vaccine worked with her not having symptoms and she just wanted to make sure it got documented because they got COVID19 infection when in the UK. It was reported that COVID19 infection: he was diagnosed on 05Jul2021. He quarantined for 10 days. Stop date would be 15Jul2021 and he recovered completely. Patient did not administered additional vaccine on same date of the Pfizer suspect. Patient was not visited to emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The clinical outcome of event breakthrough of COVID infection was recovered on 15Jul2021, while other events were unknown. Follow-up attempts are completed. No further information was expected.

Other Meds:

Current Illness:

ID: 1518105
Sex: M
Age:
State:

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: COVID-19 diagnosed by rapid testing after COVID vaccine; COVID-19 diagnosed by rapid testing after COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot Number: EN6208) as single dose, dose 2 via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included no underlying conditions; 45 y/o male in good health who was likely exposed at an outdoor dinner in (withheld) where others tested positive. The patient's concomitant medications were not reported. The patient reported that he had COVID-19 diagnosed by rapid testing after COVID vaccine in 2021. Outcome of the events was unknown. Summary of product quality Investigation for the lot Number: EN6208 was reported as follows: The initial scope of the investigation was limited to the reported finished goods lot EN6208, fill lot EN5338, and the bulk formulated drug product lot EN5329. Based on the results of the investigation, the scope was not expanded. Manufacturing and packaging batch records were examined for the reported complaint batch. Pfizer did not receive photographs or a complaint sample for examination. The complaint was not confirmed. No probable root cause for the complaint related to the manufacturing process of the reported lot was identified. There were no corrective actions taken as a result of this complaint investigation. No related quality issues were identified during the investigation. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product was stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch meets potency specifications. There was no impact to the quality of the lot. It was unknown how the product was handled, stored, or administered after it left the site. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EN6208 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EN6208, fill lot EN5338, and the formulated drug product lot EN5329. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The lot number for the vaccine, [BNT162B2], for Dose-2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1518106
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Chest pain 1 week after first dose; This is a spontaneous report from a contactable consumer. A 43-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 2021(Age at vaccination 43-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Pregnancy at time of Vaccination was reported as unknown. Medical history included ehlers-danlos syndrome, autonomic nervous system imbalance from an unknown date and unknown if ongoing Dysautonomia and Ehlers Danlos syndrome, Concomitant medications included hydroxyzine (HYDROXYZINE), diphenhydramine hydrochloride (BENADRYL), thyroid (ARMOUR THYROID), clonazepam (KLONOPIN), curcuma longa (TURMERIC [CURCUMA LONGA], ginger [zingiber officinale rhizome] (GINGER [ZINGIBER OFFICINALE RHIZOME]), ibuprofen taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, serious no for Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect. patient was not diagnosed with COVID-19. On 2021 the patient experienced chest pain 1 week after first dose. Therapeutic measures were taken as a result of chest pain 1 week after first dose (chest pain). The adverse event result in Emergency room/department or urgent care and also reported no hospitalization prolonged. Outcome of events was recovered on unspecified date of 2021. Information on the lot/batch number has been requested.

Other Meds: HYDROXYZINE; BENADRYL; ARMOUR THYROID; KLONOPIN; TURMERIC [CURCUMA LONGA]; GINGER [ZINGIBER OFFICINALE RHIZOME]; IBUPROFEN

Current Illness:

ID: 1518107
Sex: F
Age:
State:

Vax Date: 07/19/2021
Onset Date: 07/01/2021
Rec V Date: 07/31/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: has a bad rash on the front of her face and behind both ears that "looks like measles."; has a bad rash on the front of her face and behind both ears that "looks like measles."; This is a spontaneous report from a contactable consumer or other non hcp. A 15-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 19Jul2021 16:00 as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller states her daughter has a bad rash on the front of her face and behind both ears that "looks like measles." on Jul2021. The outcome of events was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm