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: 1278497
Sex: M
Age:
State: NY

Vax Date: 04/01/2021
Onset Date: 04/15/2021
Rec V Date: 05/01/2021
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: Pulmonary embolism with pulmonary infarction; Pulmonary embolism with pulmonary infarction; This is a spontaneous report from a contactable physician. A 38-year-old male patient received second dose of BNT162B2 (Batch/Lot number was not reported), intramuscular on Apr2021, at 38 years old, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 intramuscular on Mar2021 at 38 years old as single dose for COVID-19 immunisation. On 15Apr2021, the patient experienced pulmonary embolism with pulmonary infarction and patient was hospitalized for 1 day. The events resulted in Emergency room/department or urgent care and Hospitalization. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination and medications within two weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 15Apr2021. Therapeutic measures were taken as a result of pulmonary embolism with pulmonary infarction which included anticoagulation. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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 Committees, and Investigators, as appropriate

Other Meds:

Current Illness:

ID: 1278499
Sex: F
Age:
State:

Vax Date: 04/15/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: her arm was a little sore; This is a spontaneous report from a contactable consumer (patient) from Pfizer sponsored program and Medical Information Team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient's arm was little sore in Apr2021 from receiving the vaccine. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278500
Sex: M
Age:
State: MI

Vax Date: 03/12/2021
Onset Date: 03/13/2021
Rec V Date: 05/01/2021
Hospital: Y

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: stroke; he could not speak; diarrhea; vomiting; This is a spontaneous report from a contactable physician. A 63-years-old male patient received bnt162b2 (BNT162B2), intramuscular on 12Mar2021 as single dose for COVID-19 immunization at a workplace clinic. Medical history was reported as none. There was no known allergies. There was no vaccine administered in four weeks. There were no concomitant medications. On 13Mar2021, the patient experienced diarrhea and vomiting for 8 hours and 2 days later on 15Mar2021, he could not speak so patient went to the hospital and was told he had a stroke. The patient underwent lab tests and procedures which included SARS-COV-2 test, pcr swab test: negative on 14Mar2021. Therapeutic measures were taken as a result of the events which included aspirin, clopidogrel (PLAVIX), atorvastatin calcium (LIPITOR), evolocumab (RAPATHA). The events caused hospitalization. The patient recovered from the events on an unknown date. Information on batch/lot number has been requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 (BNT162B2) to the reported events of diarrhea, vomiting, could not speak and stroke cannot be excluded. The case will be reassessed once more information become 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.

Other Meds:

Current Illness:

ID: 1278501
Sex: F
Age:
State:

Vax Date: 04/13/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: hearing disability and a broken foot; hearing disability and a broken foot; she woke up at 1:30 am to her knee caps aching and pounding like no tomorrow; About 8 hours later, she experienced a sore arm; very tired; chills worse than the one she got from the 1st dose; low grade fever; her face was red and hot as well as her legs; her face was red and hot as well as her legs; Had a bad reaction to both of my shots; This is a spontaneous report from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular on 13Apr2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history was not reported. Concomitant medication included polyethylene glycol 3350. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 21Mar2021 and experienced faint, stroke, meningitis, diarrhea, could not swallow, menstrual cramps, getting sick, extreme fatigue, felt hands to be freezing, severe headache, flu-like chills, body ache, sore throat, feeling dehydrated, sinus pain, face and eyebrows hurt, throw up viscously, not understood well, profusely sweating, ice-cold ends, painful arm, neck pain, losing her mind, sheer panic, and swollen glands under her jaw. The patient experienced hearing disability and a broken foot. On 13Apr2021, about 8 hours after vaccination, she experienced a sore arm, she was very tired, chills worse than the one she got from the 1st dose, a low grade fever which felt like her whole body was on fire, her face was red and hot as well as her legs, she woke up at 1:30 am to her knee caps aching (14Apr2021) and pounding like no tomorrow. The patient had a bad reaction to both of the shots in Apr2021. The outcome of the events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds: POLYETHYLENE GLYCOL 3350

Current Illness:

ID: 1278502
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: noticed has swelling underneath the armpit on the side of the injection site and it's hurting; noticed has swelling underneath the armpit on the side of the injection site and it's hurting; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient noticed swelling underneath the armpit on the side of the injection site and it's hurting. The patient did not have anything after 1st dose. The patient asked whether she could take anything or should go to the ER. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278503
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: very severe COVID symptoms starting 8 days after my second vaccine shot; seven days later I am bedridden; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported. A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, 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. The patient medical history and concomitant medications were not reported. The patient stated to experience very severe COVID symptoms starting 8 days after my second vaccine shot. I have all symptoms except for loss of taste & swell, and still seven days later I am bedridden. My question is what is the time spread post shot where symptoms can show. My dr follows 2-3 days but I believe this is the norm and that I may be an outlier. The 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: 1278504
Sex: M
Age:
State:

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 05/01/2021
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: swollen lymph nodes on his right arm; This is a spontaneous report from a contactable consumer (patient's wife). A 55-year-old male patient (reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection), via an unspecified route of administration in right arm on 13Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Reporter stated that his husband had experienced swollen lymph nodes on his right arm, the same site as the vaccine was administered. She was just wondering if this is a normal side effect of the vaccine. She mentioned she had this reported to safety already. The outcome of the event was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278505
Sex: F
Age:
State: VA

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 05/01/2021
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: body is responding to food, water and medicine like it is foreign; she is frustrated; elevated heart rate/rapid heart rate; Angioedema; having a hard time finding food to eat; water makes tongue swell and tingle; lip swelling; respiration changes from clothing; extreme hypersensitivity; heart racing; tongue tingling; rapid breathing/rapid respirations; nervousness; chills; burning sensation in her body; skin itches; bumps on back and abdomen; lock jaw at night; skin feels like it is thinning out; breathing stops and starts at night; electrical charges that were prickly in her body; warm flush; high blood pressure/blood pressure went up; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. On an unspecified date, the patient experienced body is responding to food, water and medicine like it is foreign and she is frustrated. On 17Mar2021, the patient experienced high blood pressure/blood pressure went up (which required an emergency room visit), electrical charges that were prickly in her body, and warm flush. On 18Mar2021, the patient experienced angioedema, extreme hypersensitivity, heart racing, tongue tingling (which required an emergency room visit), rapid breathing/rapid respirations (which required an emergency room visit), nervousness, chills, burning sensation in her body, skin itches, bumps on back and abdomen, lock jaw at night, skin feels like it is thinning out, breathing stops and starts at night, having a hard time finding food to eat, water makes tongue swell and tingle, lip swelling (which required an emergency room visit), and respiration changes from clothing, elevated heart rate/rapid heart rate (which required an emergency room visit). The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date, blood pressure measurement: had gone down on 17Mar2021, blood pressure measurement: 164/100 on 17Mar2021, blood pressure measurement: 176/100 on 17Mar2021, blood pressure measurement: went up on 17Mar2021, heart rate: rapid on 18Mar2021, heart rate: elevated on 18Mar2021, respiratory rate: rapid on 18Mar2021. Therapeutic measures were taken as a result of high blood pressure/blood pressure went up (hypertension). The outcome of electrical charges that were prickly in her body, body is responding to food, water and medicine like it is foreign, warm flush and frustrated was unknown. The outcome of the other events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427769 Pfizer

Other Meds:

Current Illness:

ID: 1278506
Sex: U
Age:
State: MA

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: Severe headache; Fever; Chills; Soreness at injection site; Malaise; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 at an unspecified date. Patient took Advil for symptoms after receiving the second dose of the COVID-19 vaccine and reported the Advil helped to reduce discomfort. Patient takes low dose oral contraceptives but reports taking no other medications. The patient experienced severe headache, fever, chills, soreness at injection site and malaise on an unspecified date. The 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: 1278507
Sex: F
Age:
State: MA

Vax Date: 03/01/2021
Onset Date: 04/10/2021
Rec V Date: 05/01/2021
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: muscle weakness to the right eye; can feel a slight droop but not visually; muscle weakness right corner of mouth; right side did seem to be decreased (sensation) compared to left; tongue started to swell; mouth pain; muscle weakness; numbness in her right arm; Pain in the jaw, radiating to the right arm; some jaw pain on the right; This is a spontaneous report received from a contactable nurse based on the information received by Pfizer from Allergan (manufacturer control number: AGN261930). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, in Mar2021 (reported as two weeks prior to her Botox injections), as single dose, for COVID-19 immunisation; and botulinum toxin type A (BOTOX COSMETIC Injection, lot number: C6548AC4; expiration date: Jul2023), via an unspecified route of administration, from 09Apr2021, for Glabella, frontalis and crow's feet, at dose "for glabella -12U total (3 injection locations), frontalis- 8 units , and crow's feet - 4 units in each side (2 injection sites of 2 units each on both sides)". Medical history included birth control. The patient was not pregnant and was not breastfeeding at the time of vaccination. Concomitant medication included ethinylestradiol, norethisterone (ALYACEN) taken for birth control, from 2011 (reported as 10 years ago) and ongoing. The patient previously took clindamycin and was allergic. The patient received her first dose of BNT162B2 two weeks prior to her Botox injections (Mar2021). On an unspecified date, the patient started having symptoms of muscle weakness, which she can feel but isn't visual, to the right eye and then a few days later in her right corner of her mouth which progressed into some jaw pain on the right. The patient's neuro assessment was her sensation on the side she was having all her symptoms, her right side did seem to be decreased compared to left. It was also reported that the patient received her first ever Botox treatment on 09Apr2021. On 10Apr2021, she experienced numbness in her right arm, pain in the jaw, radiating to the right arm, this was ongoing and progressing. The patient called her PCP went to the emergency room (ER) on an unspecified date because her tongue started to swell. ER did her blood work on an unspecified date (unknown result) and said to monitory the patent. The patient was given ibuprofen every 8 hours for the events "some jaw pain on the right", "pain in the jaw, radiating to the right arm" and "mouth pain". It was reported that the patient has less arm, mouth and jaw pain probably due to ibuprofen. It was also reported that the patient can feel a slight droop but not visually and experienced muscle weakness on an unspecified date. The muscle weakness was minimal during the neuro assessment. The events did not result to hospitalization. The nurse wanted to know if the numbness in right arm; pain in the jaw, radiating to the right arm; and swelling of tongue has been experienced in the past. The patient was recovering from the events "some jaw pain on the right", "numbness in her right arm", "pain in the jaw, radiating to the right arm", and "mouth pain". The outcome of the event "can feel a slight droop but not visually" was unknown, while the outcome of the remaining events was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the limited information in the case report, a possible causal relationship between events Extraocular muscle paresis, facial paralysis 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: ALYACEN, BOTOX (cosmetic) lot # C6548AC4

Current Illness:

ID: 1278508
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: swollen uvula; This is a spontaneous report from a contactable consumer reported for his wife (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter mentioned that he and his wife, already received their 1st dose of the Pfizer COVID Vaccine 3 weeks ago and have been doing well. He mentioned that they have completed the side effect text tracker things. They were due for their 2nd dose on Monday and he mentioned that his wife came down with a swollen uvula the morning after getting vaccinated with their 1st dose. According to him, it might not be related to the vaccine and maybe caused by her snoring or other things. He is asking if this is going to be contraindicated for the 2nd dose. The clinical outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278509
Sex: F
Age:
State: LA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr; received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr; having been miserable the last week; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on an unspecified date and received the second dose on 16Mar2021; both dose via an unspecified route of administration at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received both doses of the Pfizer Covid vaccine (2nd dose rec'd 16Mar), and tested positive on 8Apr after symptoms began 6Apr. The patient also reported that she completely understood that the vaccine would not prevent her from contracting, rather protect against serious illness. The patient also mentioned that her purpose in reaching out was that she was very willing to participate in any research to help further understand breakthrough cases. If she could even provide a small amount info to further science, it out weighs having been miserable the last week. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1278510
Sex: F
Age:
State:

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 05/01/2021
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: facial tingling and numbness; facial tingling and numbness; This is a spontaneous report received from contactable consumer (patient) reported for herself. A female patient (unknown age) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 05Apr2021 (age at vaccination was unknown) at a single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. Caller reported that she received her first vaccine dose 1 week ago on April 5th, and afterwards she experienced facial tingling and numbness which went away but then came back on Wednesday. She reported that she had no other symptoms but went to see her Primary doctor who considered this to be a reaction to the vaccine and advised her to call Pfizer for guidance on getting the second vaccine dose given her symptoms. The patient stated that she had a side effect after the first dose of the vaccine. She asked whether she should get the second dose. She asked if there was any guidance available for delaying the second vaccine dose after having a reaction to the first vaccine dose. Caller reports that she already spoke with safety, no reference number was provided. They informed her that as noted in the Fact Sheet for Recipients, she should not get the Pfizer-BioNTech COVID-19 Vaccine if she had a severe allergic reaction after a previous dose of the vaccine or if she had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They referred her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Her healthcare provider knew her health situation and had access to information that can better help inform this decision. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278511
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
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: eye was "really swollen on the bottom" and it "looked like a sty"; eye was "really swollen on the bottom" and it "looked like a sty"; "hurt to blink", and the inner corner of eye start to hurt; "hurt to blink", and the inner corner of eye start to hurt; felt pressure and headache at the left upper side of the face or head area; felt pressure and headache at the left upper side of the face or head area; This is a spontaneous report received from a contactable consumer (reporting on herself). A 43-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration Date was not reported), via an un-specified route of administration on 14Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 14Apr2021, patient received the first dose of the BNT162B2. By the evening, patient reported to have felt pressure and headache at the left upper side of the face or head area. When patient woke up on 15Apr2021, her eye was really swollen on the bottom and it looks like a sty. Eventually, patient mentioned that it hurts to blink, and the inner corner of eye start to hurts. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278512
Sex: F
Age:
State: DC

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 05/01/2021
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: fatigue; This is a spontaneous report from Eliquis Patient Ambassador Program. This contactable year-old female consumer (patient) received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. On an unspecified date, the patient experienced fatigue. The outcome of event was unknown. No follow-up attempts are needed. No further information is expected

Other Meds:

Current Illness:

ID: 1278513
Sex: M
Age:
State: MI

Vax Date:
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
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: Patient diagnosed with COVID-19, confirmed by PCR; Patient diagnosed with COVID-19, confirmed by PCR/ Vaccine Failure; This is a spontaneous report from a contactable physician. A 74-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on an unspecified date as single dose, then second dose on 19Feb2021 (lot number and expiration date not provided) intramuscular, administered in right arm on as single dose for Covid-19 immunisation. Medical history and concomitant medications were not reported. On 14Apr2021, the patient was diagnosed with COVID-19, confirmed by PCR. The patient was hospitalized for four days and received steroids and Remdesivir as treatment medication. The outcome of the events was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation.

Other Meds:

Current Illness:

ID: 1278514
Sex: F
Age:
State: CA

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 05/01/2021
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: both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; both my doses of vaccine led to facial tightening, twitching, and slightly more paralysis; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE)), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 11:30 (Batch/Lot Number: EP7533) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left on 13Apr2021 11:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation . Medical history included high blood pressure (HBP) from an unknown date and unknown if ongoing , supraventricular tachycardia (PAT) from an unknown date and unknown if ongoing, had Bell's palsy from 2001 to an unknown date. No known allergies. Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; enalapril taken for an unspecified indication, start and stop date were not reported. The patient did not have any vaccines in four weeks and did not have covid prior to vaccination. In 2001, the patient had Bell s palsy (Medical history). Her left side paralysis never fully went away. Now, both of her doses of vaccine led to facial tightening, twitching, and slightly more paralysis on 23Mar2021 11:30 with outcome of unknown. She did not regret taking the vaccine and would do it again. Her mainly reason for reporting this was that she wanted to know if the vaccine was still effective. No treatment was received. No covid test post vaccination.

Other Meds: AMLODIPINE; ENALAPRIL

Current Illness:

ID: 1278515
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: neck to her fingertips are numb and she can't move it; cold; Runny nose; Congestion; Watering eyes; This is a spontaneous report received from a contactable consumer. A 87-years-old female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The consumer talked to nurse about mom, she had the Pfizer shot yesterday. Her neck to her fingertips were numb and she can't move it. She had cold, congestion, runny eyes, and a running nose. They haven't gone there yet because they were waiting to talk to see what to do. The outcome of the event was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278516
Sex: M
Age:
State:

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/01/2021
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: Chills; Headache; Body sore; hot; This is a spontaneous report from a contactable consumer (Patient reported). A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, as a single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. It was reported that patient received Pfizer Covid first dose yesterday and experienced chills, headache, body sore, hot, and he still has headache and body sore today. The patient further wanted to know if its ok to drink Theraflu. Patient had already spoke to the safety department but did not have any reference number to provide. The outcome of the events chills, hot was unknown and outcome for headache and body sore was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278517
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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: Pain to the injection; can't lift or use my arm; headache; This is a spontaneous report from contactable consumer. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection) (Lot Number: EL3247, Expiry date: May2021), via unspecified route of administration on unspecified date as single dose for COVID-19 Immunization. Patient medical history and concomitant medication were not reported. Patient experienced pain to the injection site, can not lift or use my arm and headache. She stated that no fever at this time. Was fine after getting the shot yesterday and by the evening my arm started to really hurt and now in the morning it was worse with a headache on unspecified date. Treatment received to event she took Tylenol. Outcome of event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278518
Sex: F
Age:
State:

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 05/01/2021
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: Drug ineffective; and on Monday she tested positive for Covid; and is experiencing fever; and is experiencing fever and fatigue; This is a spontaneous report from a contactable consumer(Patient herself). A female patient of unspecified age had received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 02-APR-2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, Caller reports that she got her first dose 2 weeks ago today and she tested positive for Covid and was experiencing fever and fatigue. She is supposed to go back for her second dose on April 26th but reported that her Quarantine ends by April 25th and she wasn't sure if she was supposed to go or delay her second dose. Caller also reports that her husband also had the same situation. She reports that he received his first dose, tested positive but had more severe symptoms with congestion, fever and fatigue and he is also supposed to go for his second dose on April 26th. Caller reports that she already spoke with safety, no reference number for that encounter. E-transmitting. Survey offered. The outcome of the events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278519
Sex: F
Age:
State:

Vax Date: 04/13/2021
Onset Date:
Rec V Date: 05/01/2021
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: she is now having "pretty severe" diarrhea; This is a spontaneous report from a contactable Other Health Professional (Nurse, self-reported). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 13Apr2021 as SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced she is now having "pretty severe" diarrhea. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278520
Sex: F
Age:
State: VA

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/01/2021
Hospital:

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: period became heavy 8 hours after the shot/passed several golf ball size blood clots; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EWO153), via an unspecified route of administration, administered in arm left on 15Apr2021 10:45 (at the age of 40-years-old) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient had no known allergies. The patient had no covid-19 prior vaccination. The patient previously received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), administered in arm left on 24Mar2021 11:00 AM (at the age of 40-years-old) for covid-19 immunization. There were no concomitant medications. It was reported that the patient's period became heavy 8 hours after the shot (15Apr2021 08:00 PM) and she passed several golf ball size blood clots. The clots and heavy bleeding subsided by 6am. This has never happened to her before in her life so it was most likely vaccine related. She contacted her PCP who told her to see her OBGYN ASAP. She was waiting for her OBGYN to call her back. The patient did not received any treatment for the event. The outcome of the event was recovered. The patient did not covid-19 tested post vaccination.

Other Meds:

Current Illness:

ID: 1278521
Sex: F
Age:
State:

Vax Date: 03/21/2021
Onset Date:
Rec V Date: 05/01/2021
Hospital:

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: Caller received the Pfizer Covid vaccine on 21Mar2021 and subsequently tested positive for Covid 19.; Caller received the Pfizer Covid vaccine on 21Mar2021 and subsequently tested positive for Covid 19.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the Pfizer covid vaccine on 21Mar2021 and subsequently tested positive for COVID-19. She was scheduled for the 2nd dose, more than 21 days apart, she also asked if she is still recommended to get the 2nd dose of covid-19 vaccine after. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive for COVID 19 on an unknown date. The outcome of the events was unknown. Information on lot number/batch number has been requested.

Other Meds:

Current Illness:

ID: 1278522
Sex: F
Age:
State: NY

Vax Date: 04/14/2021
Onset Date: 04/16/2021
Rec V Date: 05/01/2021
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: Appendicitis symptoms; Acute stomach pain; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 14Apr2021 13:15 (at the age of 30years) as single dose for Covid-19 immunization. There were no medical history and concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Apr2021 12:00PM, the patient experienced appendicitis symptoms and acute stomach pain. There was no treatment received for the adverse events. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered. Information about lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1278523
Sex: M
Age:
State: NC

Vax Date: 04/14/2021
Onset Date: 04/16/2021
Rec V Date: 05/01/2021
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: diverticulitis aggravated by added bile in digestive tract.; diverticulitis aggravated by added bile in digestive tract.; agonizing pain; dehydration; constipation; sweating profusely; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 14Apr2021 13:15 (Batch/Lot Number: ew0169) as SINGLE DOSE for covid-19 immunisation, at 60 years old. Medical history included diverticulitis and recurring atypical pneumonia from an unknown date. No other vaccine in four weeks and no other medications in two weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient has no known allergies. There were no concomitant medications. On 16Apr2021 23:45, the patient experienced diverticulitis aggravated by added bile in digestive tract. Spent entire night in agonizing pain and sweating profusely. Perhaps aggravated by dehydration/constipation. Reporter stated he suggests that people with this condition completely avoid nuts or other lipid/fatty acid foods as much as possible. Treatment was not given for the events. The events recovered on an unspecified date in Apr2021.

Other Meds:

Current Illness:

ID: 1278524
Sex: F
Age:
State: NY

Vax Date: 04/09/2021
Onset Date: 04/16/2021
Rec V Date: 05/01/2021
Hospital:

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: angioedema of left lower lip; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729, expiration date not reported), via an unspecified route of administration, administered in the left arm on 09Apr2021 17:00 at single dose for covid-19 immunisation. Medical history included asthma, degenerative disc disease, migraines, allergies: shellfish intolerance, nickel allergy, skin allergy to some kind of plastic/foam. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); sertraline; ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE); fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); minocycline. The patient experienced angioedema of left lower lip on 16Apr2021 01:00. The patient was given methylprednisolone 4 mg dose pack as treatment for the event. The patient has no prior vaccination and no covid test post vaccination. The patient had not recovered from the event at the time of the report.

Other Meds: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; SERTRALINE; BLISOVI 24 FE; BREO ELLIPTA; MINOCYCLINE

Current Illness:

ID: 1278525
Sex: U
Age:
State: GA

Vax Date: 01/26/2021
Onset Date: 01/30/2021
Rec V Date: 05/01/2021
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: deep pain in left shoulder; not be able to go back to sleep; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246), via intramuscular route of administration on 26Jan2021 at 19:30 as single dose in left deltoid, and second dose of BNT162B2 (Lot Number: EN6201), via unspecified route of administration, on 16Feb2021 18:30, as single dose in left deltoid for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 30Jan2021, the patient experienced deep pain in left shoulder. Pain was not muscular as much as seemingly in the shoulder socket. Not as noticeable when active in the day but makes it difficult to sleep well or will wake him up hurting and not be able to go back to sleep. Patient don't know if it was a nerve issue of the joint but does not feel like the muscle itself. Pain seems to be constant, but more pronounced on times. There was no treatment received for the events. Outcome of the event was not recovered for deep pain in left shoulder and unknown for sleep disorder. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278526
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date:
Rec V Date: 05/01/2021
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: She has chronic urticaria; she had extreme nausea and pain and broke out into full hives; she had extreme nausea and pain and broke out into full hives; she had extreme nausea and pain and broke out into full hives; She threw up for the first time; She is is extremely tired; stomach cramping/stomach was hurting; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration for COVID-19 immunization as a single dose on 08Apr2021. The patient's medical history and concomitant medications were not reported. She stated she had a reaction to her second dose of the vaccine that she received on Thursday, 08Apr2021. She has chronic urticaria so her allergist expected she would have some kind of reaction. Friday her stomach was hurting, she had extreme nausea and pain and broke out into full hives. She took a Benadryl and then took another and the hives subsided in an hour and a half. She has had stomach cramping, diarrhea and nausea since last Friday. She threw up for the first time about an hour and a half ago. She is extremely tired. She stated she called the doctor and the doctor told her to call Pfizer and we would tell her what to do. The caller asked if these symptoms are normal and asked for treatment recommendations. The outcome of event hives was recovered and outcome of event for vomiting was unknown. The outcome of other events were not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278527
Sex: F
Age:
State: TN

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.

Other Meds:

Current Illness: Arthritis (Diagnosed over 20 years ago); Complex regional pain syndrome (Diagnosed over 20 years ago); Fibromyalgia (Diagnosed over 20 years ago)

ID: 1278528
Sex: F
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: Injection site pain

Symptoms: they are both experiencing sharp pain in the lower abdomen.; it kind of feel like cramps on my arms; This is a spontaneous report received via Medical Information Team and from a contactable consumer (patient). This 28-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiry date- UNKNOWN) via an unspecified route of administration (at the age of 28-years-old) on an unspecified date as single dose for covid-19 immunization. Relevant medical history and concomitant medications were not reported. On an unknown date, the patient had sharp abdominal pain on my right side and then now it started to basically spread and feel like cramps on my arms and abdominal side. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278529
Sex: F
Age:
State:

Vax Date: 04/05/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: neck ache; headache with intermittent nausea; headache with intermittent nausea; muscle spasms and muscle twitches that did not start until after she got home a few hours later.; muscle spasms and muscle twitches that did not start until after she got home a few hours later.; the muscle twitches have become worse and are "more intense" and "more often."; her eyeballs feel like "they're shaking in my head"; she has fatigue in her quads; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: EW0150; Expiration Date: Jul2021) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter states she received the first dose of vaccine on 05Apr2021 and reports afterwards approximately on an unknown date in Apr2021, the patient experiencing neck ache and headache with intermittent nausea and muscle spasms and muscle twitches that did not start until after she got home a few hours later. She reported that the muscle twitches had become worse and were more intense and more often. Her eyeballs felt like they were shaking in head and had fatigue in her quads. She wanted to know what to do to make these side effects go away. She was curious if Pfizer has any products that could be used to treat her symptoms and what were the reported side effects there are with the Pfizer BioNTech COVID-19 vaccine. She asked if you were in a situation where you were worried about side effects, what questions would you ask. She reported that she was scheduled to receive her second dose of the Pfizer BioNTech COVID-19 vaccine on 26APR2021 but does not know if she should get it or wait on it due to her lingering side effects. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278530
Sex: F
Age:
State: WA

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 05/01/2021
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: brain felt like it wasn't working; Dizziness; mental fog; exhaustion; weak; shaky; upper back neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; neck shoulders and head all hurt; Non-stop pressure behind her neck, forehead, eyes; Injection site arm throbbing really bad; This is a spontaneous report from a contactable patient. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 10:15 (Batch/Lot number was not reported), at the age of 35-years-old as a single dose for COVID-19 immunization. The patient is not pregnant. Medical history included poly cystic ovary syndrome. The patient had no known allergies. Concomitant medication included ethinylestradiol, etynodiol diacetate (KELNOR) for birth control; metformin; ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL); all start and stop date were not reported. The patient had side effects which started within 45 minutes (also reported as within 30 minutes) of injection. Dizziness, mental fog, she felt like she was looking in through someone else's body. She doesn't know how she drove home from appointment. Her brain felt like it wasn't working, chronic exhaustion, weak, shaky, upper back neck shoulders and head all hurt severely. Non-stop pressure behind her neck, forehead, eyes with headache. Injection site arm was throbbing really bad at night. Symptoms lasted 8 days. The events occurred on 26Mar2021 11:00. No treatment was received. The patient had no other vaccine in four weeks. The patient had no prior vaccination and was not tested for COVID post vaccination. The outcome of the events was recovered with sequel. Information on the lot/batch number has been requested.

Other Meds: KELNOR; METFORMIN; NUTRAFOL

Current Illness:

ID: 1278531
Sex: M
Age:
State: ME

Vax Date: 03/18/2021
Onset Date:
Rec V Date: 05/01/2021
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: I WAS SICK; chills; shortness of breath; loss of apetite; Muscular aches and pains; diarrhea; constipation; dry cough; nausea; hoarse voice; extream fatigue; Generalized prickle sensation; Walking difficulty; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613) intramuscularly route of administration in left shoulder on 18Mar2021 at noontime as single dose for and patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6198) via an unspecified route of administration in right shoulder on 25Feb2021 at noontime as single dose for covid-19 immunization. Patient medical history was not reported. The concomitant medication(s) included lisinopril, amlodipine, evolocumab (REPATHA), rosuvastatin calcium (CRESTON) taken for an unspecified indication, start and stop date were not reported. The patient experienced with both vaccination, i was sick with typical COVID-19 Symptoms chills, shortness of breath, loss of apetite, muscular aches and pains, diarrhea, constipation, dry, nausea, hoarse voice, extream fatigue, generalized prickle sensation, walking difficulty. Patient had expected some slight discomfort at the injection sites, however that did not occur. The patient did not require medical intervention, the patient was not seen in the emergency department, the patient was not hospitalized and was not admitted to an Intensive care. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient receive recent (2 Vaccination) vaccines for SARS-Cov2 other than PFIZER-BIONTECH COVID-19 mRNA VACCINE prior to the event being reported. The patient has not receive any other vaccines around the time of PFIZER-BIONTECH COVID-19 mRNA VACCINE vaccination. The patient underwent lab tests and procedures and diagnosed positive for COVID-19 on 27May 2020. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds: LISINOPRIL; AMLODIPINE; REPATHA; CRESTON

Current Illness:

ID: 1278532
Sex: M
Age:
State: CA

Vax Date: 04/05/2021
Onset Date: 04/06/2021
Rec V Date: 05/01/2021
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: severe gout attack in right foot - I'm on day 11 with no end in sight; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 16Apr2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received second dose of bnt162b2 (Lot Number: ew0150), via an unspecified route of administration, administered in arm left on 05Apr2021 12:15 as single dose for covid-19 immunisation. The patient medical history included penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: en6208) on 15mar2021 12:30 PM in left arm for covid-19 immunisation. The patient experienced severe gout attack in right foot - I'm on day 11 with no end in sight on 06Apr2021 20:00. The patient reported she had pretty severe, she just got 2nd shot Monday last week ago, and 2 days later (as reported) she got a very severe gout reaction and she never had that in her life, she wanted to know that was the known side effect of the Covid vaccine. No fever. Repeated as she got a very severe gout reaction in her foot, was in the red skin cause, its more than a rash, it's incredibly painful and her entire foot get swollen. And she had been to the doctor, they diagnosed her for the gout. She never had a gout previously in her life, she did not have any other food trigger or anything else that they think and cause, so she just wondering was that, It was known reaction that continually determined. She was just trying to figure out, why this was happening? She couldn't walk. The adverse event result in Doctor or other healthcare professional office/clinic visit Emergency room/department or urgent care. Treatment received for the adverse event included Indomethacine- Prednisone. The outcome of event goat was not recovered. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278533
Sex: M
Age:
State: NY

Vax Date: 04/14/2021
Onset Date: 04/15/2021
Rec V Date: 05/01/2021
Hospital: Y

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: syncope; Soreness overnight in left arm; expanding pain to left shoulder; Strong Fever/low fever; body pain; headache; felt uneasy; nausea/Felt like throwing up; dizzy/lightheaded; Profuse sweating; EKG showed low heart rate, blood pressure; EKG showed low heart rate, blood pressure; feeling weak; could not stand; Feeling worse; This is a spontaneous report from a contactable consumer. A 48-year-old male patient received second dose of BNT162B2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included Cholesterol (blood cholesterol abnormal) from an unknown date. There were no concomitant medications. The patient previously received first dose of BNT162B2 for covid-19 immunisation on 24Mar2021. The patient also previously received naproxen and experienced allergies. The patient experienced syncope, soreness overnight in left arm, expanding pain to left shoulder, strong fever/low fever, body pain, headache, felt uneasy, nausea/felt like throwing up, dizzy/lightheaded, profuse sweating, ekg showed low heart rate, blood pressure, feeling weak, could not stand and feeling worse all on 15Apr2021 at 13:00. All the reported events caused hospitalization for 1 day. It was reported that After receiving Pfizer vaccine at 4pm developed Soreness overnight in left arm, expanding pain to left shoulder. Strong Fever and body pain in morning. Feeling worse throughout morning after breakfast of tea and fruits. While having lunch at 1.30 pm felt uneasy and nausea and could not complete lunch. Felt like throwing up and got up feeling dizzy and lightheaded. Experienced syncope and had to lie down on kitchen floor. Tried to get up with help from family members but could not stand and had to lie down again on floor. Profuse sweating. Wife called 911 and ambulance who arrived and checked pulse, EKG showed low heart rate, blood pressure. Taken by ambulance and paramedics to hospital Emergency where IV fluids were given to stabilize and discharged after 4 hours of observation. Still feeling weak, headache, low fever. Taking Tylenol and fluids while recovering. Adverse event start date: 15Apr2021. Adverse event start time: 01:00 PM. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): low on 15Apr2021, EKG (electrocardiogram): showed low heart rate, blood pressure on 15Apr2021 and pulse/heart rate (heart rate): low on 15Apr2021. Therapeutic measures were taken as a result of all the events which includes IV fluids and Tylenol. Outcome of all the events was recovering Information on batch/lot number was requested.

Other Meds:

Current Illness:

ID: 1278534
Sex: F
Age:
State:

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 05/01/2021
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: body ache; chills; fever; bad Headache; This is a spontaneous report from a contactable reporter (patient's husband). A 41-year-old female patient (wife) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration on 15Apr2021, as single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. On 15Apr2021, the patient experienced body ache, chills, fever, a bad headache. Caller stated that his wife received the second dose of the Pfizer Covid-19 vaccine yesterday morning and by noon until now she has felt like she was run over with a truck, she has a strong body ache, chills, fever, a bad headache and it has been going back and forth. Would like to consult when will these side effects will pass. Outcome of the events were unknown. No follow up activities required as no further information can be expected.

Other Meds:

Current Illness:

ID: 1278535
Sex: F
Age:
State:

Vax Date: 04/08/2021
Onset Date: 04/10/2021
Rec V Date: 05/01/2021
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: very delusional; Can't remember; Severe headache; Double vision; Still not feeling right; Cold chills; This is a spontaneous report from a contactable consumer (patient's daughter). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Apr2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a severe reaction 2 days later on 10Apr2021 and was still not feeling right. The patient was experiencing cold chills, severe headache, she's like out of her head, she can't remember, especially at nighttime it's worse, double vision and she's very delusional. The reporter wanted to know what to do. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278536
Sex: F
Age:
State:

Vax Date: 04/14/2021
Onset Date: 04/01/2021
Rec V Date: 05/01/2021
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: severe nausea; she is having a hard time drinking tea or anything; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry dates: unknown), via an unspecified route of administration, on 14Apr2021, as single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient reported that on an unknown date in Apr2021, after receiving the first dose of the vaccine, patient had severe nausea. Patient stated that, this was the third day, and she was having a hard time drinking tea or anything. The outcome of the events was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278537
Sex: F
Age:
State: TX

Vax Date: 01/20/2021
Onset Date: 02/01/2021
Rec V Date: 05/01/2021
Hospital:

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: received her first dose on 21Jan2021/contracted Covid illness/tested positive for COVID; This is a spontaneous report from a contactable other healthcare professional (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided) via an unspecified route of administration, administered in the left arm on 20Jan2021 as a single dose for COVID-19 immunisation. The patient has no medical history and there were no concomitant medications. The patient did not receive any other vaccine within 4 weeks and no adverse events following prior vaccinations. The patient stated that she got the COVID vaccine in the middle of Jan (20Jan2021) and later got COVID. She stated a couple days after getting COVID, she got the monoclonal antibody infusion and was told to wait until the first of May to get the vaccine but they did not tell her if she should start over again. She stated that she tested positive on 01Feb2021 and 2 to 3 weeks later, on an unspecified date in Feb2021, she tested negative. She stated that symptoms she had was mainly fatigue and a wet productive cough when she was positive with COVID. She stated that fatigue and wet productive cough started around 01Feb2021 and lasted about 3 weeks so probably ended on 21Feb2021 but she has recovered completely from the symptoms. She received a monoclonal antibody infusion and the medications she tooks were Zpack and Ivermectin. The outcome of the event was recovered on an unspecified date in Feb2021.

Other Meds:

Current Illness:

ID: 1278539
Sex: F
Age:
State: OH

Vax Date: 04/13/2021
Onset Date: 04/13/2021
Rec V Date: 05/01/2021
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: sore arm; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program . A female patient of unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unknown route of administration on 13Apr2021 as a single dose for Covid-19 immunization. Medical history and concomitant medications were not reported. On 13Apr2021, the patient had sore arm. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278540
Sex: M
Age:
State: WI

Vax Date: 04/12/2021
Onset Date: 04/12/2021
Rec V Date: 05/01/2021
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: Loss of consciousness; Seizure; Drowsiness, couldn't stay awake; Vomiting; This is a spontaneous report from a contactable consumer (patient). An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 12Apr2021 (11:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included peanut and penicillin allergy. The patient's concomitant medications were not reported. On12Apr2021 (11:45), the patient had loss of consciousness; seizure; drowsiness/could not stay awake; and vomiting. The events had resulted in an emergency room/department for urgent care, and were assessed as serious (medically significant). The patient was hospitalized in Apr2021 due to loss of consciousness. The patient had received epinephrine (EPIPEN) as treatment for the reported events. The outcome of the events was recovered in Apr2021. The patient did no have COVID-19 prior to the vaccination, and had not been tested post-vaccination. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1278541
Sex: F
Age:
State:

Vax Date: 04/06/2021
Onset Date:
Rec V Date: 05/01/2021
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: Her arm at the injection site is still swollen; Her arm at the injection hot and itchy.; injection site is red; This is a spontaneous report from a contactable consumer (patient).. A 22-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided), via an unspecified route of administration, in arm, on 06Apr2021 (at the age of 22-years-old) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had experienced the injection site is still swollen, red, hot and itchy. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278542
Sex: F
Age:
State: MI

Vax Date: 04/09/2021
Onset Date: 04/09/2021
Rec V Date: 05/01/2021
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: arm soreness; fever; chills; felty achy; she felt tired; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an 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 09Apr2021 as single dose for covid-19 immunization. Medical history included covid-19 from 13Jan2021 to an unknown date. The patient's concomitant medications were not reported. The patient waited 90 days before getting the first dose because she got Covid-19 last 13Jan2021. She experienced side effects after the first dose. First, she experienced arm soreness and took Tylenol. She also had fever, chills, felty achy and the following day she felt tired. She was not scheduled for her second dose yet. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278543
Sex: F
Age:
State: MI

Vax Date: 04/07/2021
Onset Date: 04/07/2021
Rec V Date: 05/01/2021
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: swollen joints; her back condition and may have "pinched a nerve or something; describes it as the worst pain; the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot; leg pain; also has some tingling on the skin; It feels like a Charley's horse; had a horrible flu; Her every muscles and every joint hurt, and her head hurt; Fever; body aches; chills; joint pain; Her every muscles and every joint hurt, and her head hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 07Apr2021 at 14:00 (Batch/Lot number was not unknown; Expiration Date: 31Jul2021), at age of 53 year-old, as 0.3 mL single, for Covid-19 immunisation. Medical history included liver disease from 2016 and ongoing. There were no concomitant medications. The patient previously took the first dose on 17Mar2021 for Covid-19 immunization and experienced fever. The patient received her second dose of the Pfizer BioNTech COVID-19 vaccine on 07Apr2021 and reports having side effects after. She is specifically worried about the leg pain that she is experiencing and would like to know if it is possible that it could be related to a blood clot and if she needs to be worried about it. She stated that with the "swollen joints" and everything from the vaccine, it is possible that it worsened her back condition and may have "pinched a nerve or something." She describes it as the worst pain she's ever felt in her life and states it "comes out of the blue" so she does not have time to prepare for it. She likens it to a "Charley horse" but a "really bad one" that goes away and has no pain afterwards. She states she is scheduled for an MRI next week of her lower back to investigate. The patient also mentions that she thinks she had COVID-19 at the time of her vaccine because "when I got the shot, I had a super strong response." On 07Apr2021, the patient had body aches, chills, she was on the couch for quite a while. The joint pain was incredible, even in her toes. She felt like she had a horrible flu. Her every muscles and every joint hurt, and her head hurt. She was on the couch for like 4 days. On day 3 or 4 she developed intermittent pain in the leg and shin on 08Apr2021. It feels like someone is drilling a jackhammer in it. It feels like a Charley's horse, but not, more like it's in the bone. She didn't associate it with the vaccine at first, even though she had never had this pain before until she got the vaccine. She said that she has had some back problems and scheduled a MRI to see if she had pinched nerve or something. On 08Apr2021, she also has some tingling on the skin. She read about side effects of blood clots and doesn't know if this leg pain could be related to a blood clot. She assumed it could be from her back. She read that with blood clots there is usually an ache and discoloration, which she does not have now. She also read that intermittent Charley's horse could have something to do with blood clots. She has pins and needles on the skin. She also had a headache after the vaccine, but she does not have it now. She said that the pain in her leg that shoots on and bangs in her tibia hurts when bending over, lifting her leg to her chest, squatting to pick up something, and going up and down the stairs. She said that the pain is horrible and it is worse than leg pain, it is worse than a charley horse, it is the worst pain she has ever felt in her life. She cannot stop screaming when it happens. States with the joint pain that she had, there may be a nerve that's being pressed on her back. She said that with all of the information being reported in the news about blood clots, she asked is that something she needs to be concerned about. She said that she did a virtual visit with her doctor and notified her of the leg pain and asked the doctor to schedule her for an MRI because of the pain. She stated her hemoglobin and hematocrit, MCV are high. She also said that the clotting is affecting her red blood cells. She ran a fever with the first vaccine, but she had a high fever between 103-104 degrees Fahrenheit after the second vaccine that stopped on 12Apr2021 or 13Apr2021. Her high fever lasted for about 3 days. She had a low grade fever that lasted for about a week. Her body aches resolved completely on 12Apr2021 or 13Apr2021. Her joint pain is in her back and elbows. She also had lot of joint pain in her shoulder and arm and radiates to her neck on the left side. She still has some muscle pain in her leg, but overall her muscle pain is gone. For treatment she used Ibuprofen 600 mg by mouth and fluids. The day before her shot, her son called and told her he tested positive for covid. She got a PCR test immediately on 07Apr2021 and the next day she was told it was negative. She thinks she might have tested too soon. She also says her response to it was so strong, she must have been getting covid and didn't know it. She might have tested negative because she had the first shot already. She wasn't worried about exposing others and went to get her second shot, but she got really sick after that and it kicked her butt pretty hard. The outcome of the events for leg pain and tingling on skin was not recovered, fever, body aches and headache recovered in Apr2021, chills on 11Apr2021, muscle hurt/pain on 12Apr2011, joint pain was recovering, and outcome of other events was unknown.

Other Meds:

Current Illness: Liver disorder

ID: 1278544
Sex: F
Age:
State:

Vax Date: 03/13/2021
Onset Date: 03/13/2021
Rec V Date: 05/01/2021
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: cold painful stuff in my arm; feeling chills; fever; nauseated; began feeling sick; Headache; felt very weak and tired; felt very weak and tired; I've been constipated since; burning painful; all that night hard time sleep; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration on 13Mar2021 at 07:50 (Lot number : not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included historical vaccine received first dose of bnt162b2,Inoperable lung cancer from 2010 to an unknown date stage 3B lung cancer, metastases to lymph nodes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The reporter stated that she felt the second one "immediately, like the solution hit a nerve or something. I said out loud, "ouch", felt like a cold painful stuff in my arm and immediately my arm started to get pain, and during the time we had to wait afterward, my arm got very sore, hard to pick up my arm. When I got home, I began feeling sick, chills, fever, legs felt like 100 pound weights on them. nauseated felt like lumps in the back of my head. Headache, fever, chills, nauseated, ached all over. I don't know if this is part of it, but my bowels, she have been constipated since, and normally have no issue having bowel movements. she felt very weak and tired. She states that she could feel it Immediately going in my arm, she told the nurse after first, you were good. After the second, It was burning painful, going in on the second dose. (the vaccination provider) " she have never felt an injection to feel that solution to feel painful going in." Caller states, We had gotten ours 7:50am 13Mar2021, I immediately felt it, as soon as she got home, started getting sick, all that night hard time sleep, next day 14Mar2021 all day all night, same feeling, Yesterday, when she got awake it was better. The events were considered as non-serious. The outcome of the event all that night hard time sleep was reported as recovered on 14Mar2021 and other events were reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278545
Sex: F
Age:
State: NY

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 05/01/2021
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: bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements. The patient previously took amoxicillin and experienced allergies. The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. Information on the lot/batch number has been requested.

Other Meds: BUPROPION; BENADRYL

Current Illness:

ID: 1278546
Sex: F
Age:
State: OH

Vax Date: 04/08/2021
Onset Date: 04/10/2021
Rec V Date: 05/01/2021
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: confused/When talking to her she is talking out of her head/hought her condo was turned completely around; She is having headaches; muscle pain; chills; double vision; dizziness; her arm, and joint pain; her arm, and joint pain; extremely exhausted; This is a spontaneous report from a contactable consumer. A 68-year-old female patient (consumer's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 08Apr2021 (Batch/Lot number unknown as complainant does not have the product with them at the time of call) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling about her mother. The patient was fine before she got this shot and no one can seem to help her. They had the vaccine on 08Apr2021 and her mom (patient) started having severe reactions to it on 10Apr2021. Patient had the chills, muscle aches, muscle pain, headache, dizziness, her arm, and joint pain. She did not have fever, but had chills. She had double vision now. The symptoms are not going away. They are getting worse. They took her mom to the ER. The patient was confused. When talking to her she was talking out of her head. The severity of confusion is she thought her condo was turned completely around. Patient was not getting better. Went to the doctor and the doctor was at a lost. Patient was extremely exhausted. Caller stated they all took the same shot on the same day and her mom was the only one to have a reaction. Patient was literally out of her mind. Caller's dad had to take patient to the store with him because he didn't want to leave her by herself. They live in a condo on the second floor. Her mom thought the condo was reversed. Her dad was worried to leave her mom by herself because he didn't want her to go out the wrong door and go over the balcony. Her mom was not like that prior to receiving COVID19 Vaccine. Reporter was asked if there was an antidote. They were told patient should see her doctor and that she need treatment but no one could give they something to antidote the vaccine. The outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Other Meds:

Current Illness:

ID: 1278547
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: feeling achy in shoulders back and legs.; feeling achy in shoulders back and legs.; feeling achy in shoulders back and legs.; This is a spontaneous report from a contactable consumer(patient). A 72-years-old male patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) second dose via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Reported that he has had the second dose 2 weeks ago and is feeling achy in shoulders back and legs. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Other Meds:

Current Illness:

ID: 1278548
Sex: F
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 05/01/2021
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: sneezing and tasting the after vaccine.; sneezing and tasting the after vaccine.; This is a spontaneous report received from a contactable consumer (patient) via Pfizer-sponsored Program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced symptoms like sneezing and tasting the after vaccine. She would like to get the guidance on whether she should receive the second dose after experiencing these symptoms. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown. No follow-up attempts are needed; Information related to batch/Lot number could not be obtained.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm