VAERS 2021 Database www.vaers.hhs.gov

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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: 1387827
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
Hospital:

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: My arm is itching all over; This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: Unknown; expiry date: unknown), via an unspecified route of administration on an unspecified date in 2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took a shot earlier today at Pfizer BioNTech shot and now the arm was itching all over. On an unspecified date in 2021 and when got too low left (Not sure as voice was not clear hence not captured as event) on each hour. The patient reported it was not on all the arm, not gonna itching bad under skin it is an hour ago. The clinical outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

Other Meds:

Current Illness:

ID: 1387828
Sex: F
Age:
State:

Vax Date: 05/28/2021
Onset Date: 06/02/2021
Rec V Date: 06/10/2021
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: itching; shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm on 28May2021 (Batch/Lot number was not reported) as 1st Dose, Single Dose for covid-19 immunization. The patient's medical history was reported as itch in her back (sometimes get this same itch back in the past). The patient's concomitant medications were not reported. On Wednesday, 02Jun2021,the patient experienced itching, no rash, shortness of breath. The case was assessed as non-serious by the reporter. The outcome for the events was Unknown. Information on the lot/batch number has been requested

Other Meds:

Current Illness:

ID: 1387829
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Small fiber neuropathy; worsening neuropathy; she has experienced increased pain and numbness over her body. This has been ongoing for six plus weeks; she has experienced increased pain and numbness over her body. This has been ongoing for six plus weeks; This is a spontaneous report from a contactable physician. A 64-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported treating for small fiber neuropathy. Subsequently after the vaccine she had experienced increased pain and numbness over her body. This had been ongoing for six plus weeks. Patient had taken a 72-hour 5-day course of Ibuprofen, with no benefit. She had a skin biopsy to check for worsening neuropathy. Test results were pending at this time. The patient was asked to complete the biopsy prior to the vaccine; however, she was reluctant about coming out during the Pandemic. It was stated that there may be a possibility of a 5-day Medrol dose pack. Caller asked if there were reports of individuals with similar diagnosis who had experienced the same symptoms, if so, were there any treatment recommendations. Physician voiced he has had a couple patients with the same diagnosis that had been vaccinated report worsening symptoms also. The outcome of the events was unknown. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1387830
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
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: Vomiting; Constipation; Headache; Nausea; This is a spontaneous report from a contactable consumer(patient). A 55-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), 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. The patient constipated and also experienced headache, nausea and vomiting. Patient reported she can not use bathroom. The outcome of events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1387831
Sex: F
Age:
State: KS

Vax Date: 06/02/2021
Onset Date: 06/03/2021
Rec V Date: 06/10/2021
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: This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0169), via an unspecified route of administration, administered in Arm Right on 02Jun2021 (at the age of 67-year-old) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, high cholesterol from 1980, irregular heartbeats started this year ago but had not been told by a doctor. The patient stated she was in her 40s and going through menopause when they diagnosed her. The patient's family history was reported as none. The patient's concomitant medications included metoprolol ER 25 mg every day taken for Blood Pressure abnormal, Duloxetine 30 mg a day and 60 mg a day, olanzapine 10 mg a day at bedtime, amlodipine besylate 5 mg day taken for Blood Pressure abnormal, Potassium 20 mg, acetylsalicylic acid (ASPIRIN) 81 mg and atorvastatin 80 mg taken for cholesterol abnormal. No AEs was reported prior vaccinations. The patient was not administered with vaccine at Military facility. The patient was not administered with any other vaccine on same date of the Pfizer suspect. The patient was not administered with any other vaccine 4 weeks prior to suspect vaccine. The patient stated that after receiving the Pfizer COVID-19 vaccine on 02Jun2021 (Wednesday) she was experiencing an elevated heart rate /noticed her heart rate was elevated this morning. She would like to know if this was a normal side effect. The patient stated her heart races when she gets up and when she sits it goes back down. She stated it has not worsened but it's scary. On 04Jun2021, the patient's heart rate a little faster than normal. After the COVID-19 vaccine her pulse was too low to take her blood pressure medication. The reporter stated this was yesterday (03Jun2021). She stated she does not know when she started taking any of her medications. She stated that, she didn't take her blood pressure medication yesterday as she can't take it if her pulse was below 60. This morning it was in the 90s. The patient had not visited emergency room/physician office. The patient's relevant medical tests were reported as none. The reporter stated that her next vaccine was scheduled for 26Jun2021. She stated that, she cannot find her card for the vaccine and it was in her purse and now she can't find it. She later clarifies that she found the card. The outcome of the events was unknown. Information on Lot/Batch number is available; Further information has been requested.

Other Meds: METOPROLOL; DULOXETINE; OLANZAPINE; AMLODIPINE BESYLATE; POTASSIUM; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN

Current Illness:

ID: 1387832
Sex: M
Age:
State:

Vax Date: 04/22/2021
Onset Date: 04/01/2021
Rec V Date: 06/10/2021
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: cramps in his legs in weird places; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 70-year-old male patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on 22Apr2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date of Apr2021 (reported as a day or two later), the patient experienced cramps in his legs in weird places. The outcome of the event was not recovered. Information about batch no/lot no has been requested.

Other Meds:

Current Illness:

ID: 1387833
Sex: F
Age:
State: NY

Vax Date: 06/01/2021
Onset Date: 06/03/2021
Rec V Date: 06/10/2021
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: Mild chills; Feel tired; This is a spontaneous report from a contactable consumer or other non hcp. A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Jun2021 (at the age of 87-years-old) (Batch/Lot Number: EW0185) as single dose for covid-19 immunisation. Medical history included ongoing high blood pressure (10 years ago), ongoing anxiety (2 years ago), ongoing atrial fibrillation and hip surgery from an unknown date and unknown if ongoing (few years ago). The patient did not emergency room and physician office visit. Prior Vaccinations (within 4 weeks): None. Concomitant medication included warfarin taken for atrial fibrillation, start and stop date were not reported; olmesartan medoxomil (BENICAR) taken for blood pressure, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken for blood pressure start and stop date were not reported; diltiazem hydrochloride (DILTIAZEM CD) taken for blood pressure, start and stop date were not reported; clonazepam taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 on 04May2021 (Batch/lot number EW017) administered in, Left arm for covid-19 immunisation and experienced tired. The patient previously took Flu shot and experienced Sort of bothered my face (40-50 years ago). The reporter stated that second dose received 28 days after first dose. she had her second dose of the Pfizer COVID-19 vaccine 01Jun2021 and on 03Jun2021 started to feel tired she is stating to feel better. she didn't have a sore arm or anything and that the Covid-19 vaccine didn't seem to bother her. She stated she did notice having chills but realized it was because she had her air conditioning too high and was cold from the air temperature, does not think she had a fever. The patient experienced mild chills on 04Jun2021, but she was no longer having. Relevant tests was none. The outcome of the events feel tired was reported as recovering and mild chills was reported as recovered on 04Jun2021. Follow-up attempts are completed. No further information is expected.

Other Meds: WARFARIN; BENICAR; BYSTOLIC; DILTIAZEM CD; CLONAZEPAM

Current Illness: Anxiety (2 years ago); Atrial fibrillation; Blood pressure (10 years ago)

ID: 1387834
Sex: F
Age:
State: CT

Vax Date: 05/22/2021
Onset Date: 05/23/2021
Rec V Date: 06/10/2021
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: A fast heartbeat; Dizziness; Weakness; This is a spontaneous report from Medical information team. A contactable consumer (patient) reported that a 55-year-old (same age at vaccination) female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot: EW0191) intramuscularly on 22May2021 as single dose in arm left for COVID-19 immunization/ preventative. Medical history reported was ongoing knee disability, she does not take any prescription medication for this, once in a while takes ibuprofen for pain. Diagnosed when she was 2 years old, ongoing thyroid developed as an adult (her mother had a thyroid condition), at least 20 years ago or so, ongoing allergies, breathing difficulties and sarcoidosis in her lungs. Concomitant medications reported was levothyroxine sodium (SYNTHROID, Tablet) orally and ongoing at 25mcg daily for thyroid and fexofenadine hydrochloride (ALLEGRA) for allergies in the morning. She will sneeze a lot if she does not take it. There were none additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks were reported. She explained since then, she has been experiencing a fast heartbeat, dizziness, and weakness. She asked if her symptoms, should continue for that long, now that it has been 13 days. Patient asked if she should get the second dose of the Pfizer-BioNTech COVID-19 vaccine if the side effects from the first dose persist. Around the day after the first dose, she thinks all the symptoms started, clarified all symptoms started Sunday 23May2021. It is not as much, but still enough that she can tell. For the first few days, almost first week even at night she was having it, at night she will still have the fast heartbeat. And now she was able to sleep through the night and when she wakes up the fast heartbeat will happen, it was not continuous but frequent enough during the day. She confirmed all the symptoms have slightly improved. Patient declined any treatment, she kept thinking it will go away. She takes two medications other supplements like vitamin b. In 2009 she was diagnosed with sarcoidosis in her lungs but was not given active treatment. They did tests and told her it was almost in remission and she would go in for check-ups. Two years ago, they told her she did not need any more check-ups, it is not active. The first year when she had breathing difficulties, she was given a medication and she was to take one puff of it and that was it. Stated it was not an inhaler or spray. It was a minimal dose that had a steroid in it, and she was concerned about the steroid. It was oral and she only used it as a precaution and to help with breathing. Her breathing issue went away as soon as she lost weight, so not sure if breathing issue was sarcoidosis or being overweight. The reporter assessed seriousness as non-serious. Outcome of the events was recovering. No follow-up attempts possible. No further information expected.

Other Meds: SYNTHROID; ALLEGRA

Current Illness: Allergy; Knee deformity (Verbatim: knee disability Diagnosed when she was 2 years old.); Thyroid disorder (Verbatim: thyroid developed as an adult, at least 20 years ago or so,)

ID: 1387835
Sex: F
Age:
State: CT

Vax Date: 06/02/2021
Onset Date: 06/03/2021
Rec V Date: 06/10/2021
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: palpable node on her left collar bone; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age (age: 61, unit: unknown) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration administered in left arm on 02Jun2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received her second dose of the Pfizer Covid 19 Vaccine on Wednesday 02June2021. On Thursday 03June2021, she experienced a palpable node on her left collar bone. The patient was asking if the symptom has been reported. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1387836
Sex: M
Age:
State: NY

Vax Date: 05/17/2021
Onset Date: 05/31/2021
Rec V Date: 06/10/2021
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: felt a little weird; feeling foggy; couldn't walk/felt like a drunken sailor, that's how bad the walking and gait pattern were; couldn't do any of his work, couldn't take phone calls; couldn't concentrate; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0182, Expiration Date: not reported) via an unspecified route of administration in upper left arm on 17May2021 09:30 (at the age of 68-year-old) as 1st dose, single dose for COVID-19 immunization. Patient did not received any other vaccinations within four weeks prior to the first dose. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and was not administered with additional vaccines on same date. Medical history included ongoing spinal stenosis diagnosed 5 years ago. Concomitant medication(s) included codeine phosphate, paracetamol (TYLENOL WITH CODEINE) taken for spinal stenosis. The patient experienced feeling foggy, couldn't walk/felt like a drunken sailor, that's how bad the walking and gait pattern were, couldn't do any of his work, couldn't take phone calls, couldn't concentrate on 31May2021, 2 weeks after first shot and felt a little weird on an unspecified date. AE(s) did not required a visit to emergency room or physician office. The patient underwent lab tests and procedures which included magnetic resonance imaging: spinal stenosis on an unspecified date diagnosed 5 years ago. It was reported, according to the MRI 5 years ago, had supposedly been suffering for over 30 years and they just discovered it 5 years ago. It was reported that, his second dose was scheduled this coming Monday, 07Jun2021. He stated the first 2 weeks between 17May2021 and 31May2021, he was fine and had no side effects, not even a pain at the injection site in his left arm, until 31 May. He suddenly started feeling foggy, couldn't walk- he was walking "like a drunken sailor", couldn't do any of his work, couldn't take phone calls, and couldn't concentrate. He was getting a little better- still had a little trouble walking and still feeling a little foggy. He have spinal stenosis and wasn't sure if that had anything to do with it but said the nurse he spoke to before said she didn't think it had anything to do with it. He wanted to know if anyone else reported that. He also had concerned about the two week delay in side effects. He stated his 29 year old son took the vaccine the same day and had no reaction what so ever. He did not said if his son had concerned about efficacy because of that or not. Patient enquired if he should go ahead and take the second dose. Patient stated at the moment, he didn't had a primary care doctor and he hadn't been to a doctor in over 5 years. He suffered or had debilitating condition, spinal stenosis and he never discussed it by the nurse and it didn't come up on the questionnaire. He still had a problem walking, he can't walk a straight line, it was very strange. He improved slightly, it was all terrible on Monday, he was like a drunken sailor, that's how bad the walking and gait pattern were and he had gotten a little bit better, but it was still a problem. Patient was curious and have concerned about his second dose as he has heard stories from people that the side effects are worse. His concern was as he got a reaction to the first shot, he going to experience on his second shot. The outcome of the event felt a little weird was unknown and for rest of the events it was resolving.

Other Meds: TYLENOL WITH CODEINE

Current Illness: Spinal stenosis (Diagnosed 5 years ago)

ID: 1387837
Sex: M
Age:
State:

Vax Date: 06/03/2021
Onset Date: 06/03/2021
Rec V Date: 06/10/2021
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: severe nose bleed; This is a spontaneous report received from a contactable consumer (patient's fiance). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 03Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. She stated patient got the second dose of Pfizer on 03Jun2021. It was almost 2 hours ago. Now he was having a severe nosebleed. It was not stopping. She states this never happened before. It didn't happen the first time he got a dose and he has never had a problem with bleeding through the nose. The outcome of the event was unknown. Follow-up needed. Information about batch/lot number has been requested.

Other Meds:

Current Illness:

ID: 1387838
Sex: M
Age:
State:

Vax Date: 02/13/2021
Onset Date:
Rec V Date: 06/10/2021
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: pain in the arm that he received the injection in; This is a spontaneous report from a contactable consumer (patient's wife). A 95-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm on 13Feb2021 (Batch/Lot number was not reported) as second dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that on an unspecified date in 2021, the patient was still complaining of pain in the arm that he received the injection in. Outcome of event was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1387839
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 06/10/2021
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: slight headache that never went away/ lot worse headache and had become a persistent.; This is a spontaneous report from a contactable Nurse (patient). A 72-year-old female Patient vaccine BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), first dose via an unspecified route of administration on an unspecified date in Mar2021 as single dose and second dose via an unspecified route of administration on 11Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Post vaccination of her first dose on an unspecified date in Mar2021, she experienced slight headache that never went away. And then post vaccination of her second dose on 11Apr2021, she experienced a lot worse headache and had become a persistent. Additionally, her doctor did some brain scans which came back with negative results indicating absence of abnormalities. And that he is scheduled to see his neurologist in 2 months. Patient was concerned about what to expect about this, or if there were any reports about this and how long this lasts and what she should do about this. The patient underwent lab tests and procedures which included magnetic resonance imaging head: negative on 2021 absence of abnormalities. Outcome of the event was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1387840
Sex: F
Age:
State:

Vax Date: 06/01/2021
Onset Date: 06/04/2021
Rec V Date: 06/10/2021
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: She lost the sense of taste this morning; This is a spontaneous report received from a contactable consumer (Patient mother) via medical information team. A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Jun2021 as 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 (solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. No adverse events reported with the first dose. On 04Jun2021, the patient had lost the sense of taste. The consumer stated that "My adult daughter received the second dose of the Pfizer COVID-19 vaccine two days ago. She lost the sense of taste this morning. I have seen people reported a loss of taste but along with a metallic taste in the mouth. But my daughter doesn't have a metallic taste in her mouth". The reporter has been reading some of the questions and articles and none of them talk about a loss of a sense of taste. They talk about a metallic taste, but her daughter doesn't have a metallic taste. The reporter wanted to know that if loss of a sense of taste was common after the Covid vaccine and if this was a side effect reported. Information on lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1387841
Sex: F
Age:
State: VA

Vax Date: 03/02/2021
Onset Date: 03/03/2021
Rec V Date: 06/10/2021
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: Fever (100F); This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. Follow-up (04Jun2021) was processed together with initial information. A 71-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 (at age of 71-year-old) as single dose for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient's historical vaccine included Methotrexate as immunosuppressant back in Dec2020 and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 (at age of 70-year-old), as single dose for covid-19 immunization. On 03Mar2021, the patient reported that experienced fever (100F) on the second day, after her 2nd dose of vaccination. Patient did experience a mild fever the second night of her second dose. She had a question about Methotrexate that was covered by Medical Information. she was just calling because she has been on Methotrexate for a year and gave it up in December. She didn't have the vaccine until February and March. Pfizer's research didn't begin with identifying immunosuppressed people. She may not be covered, so she called to find out what's new. Mild fever patient had the second dose of the vaccine on 02Mar2021, and it was 03Mar2021 in the evening that she had a fever. She took 2 Aspirin and went to bed. She was probably getting it as the evening wore on from earlier. It was only for a few hours that she was conscious of it and then she went to bed. She is trying to get out before traffic starts and she can't drive. Caller states that she would like to go now and that Pfizer can follow up with her and call any other time. The patient underwent laboratory tests and procedures which included body temperature showed 100 Fahrenheit (Mild fever), on 03Mar2021. The patient received treatment with Aspirin for fever. The outcome of the reported events was unknown. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1387842
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Could not walk for a week; was like limping like from one place to another; Severe pain in both leg and the arm was like sore; could not really walk normally; arm was like sore; This is a spontaneous report received from a contactable consumer or other non hcp. A 14-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Batch/Lot Number: EW0167), dose 1 via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included covid-19 in Apr2018 and recovered. The patient's concomitant medications were not reported. Patient did not had vaccination prior 4 weeks. The patient got the first shot and then he could not walk for a week, he was like he can walk but he was like limping like from one place to another, he had like severe pain in both leg and the arm was like sore a little bit at the first day, for hours then the next day and he was like he could not really walk normally he was like jumping with thorns for a whole week. The outcome of the events was unknown. Information on lot/batch number was available. Additional information has been requested.

Other Meds:

Current Illness:

ID: 1387843
Sex: F
Age:
State: NC

Vax Date: 04/22/2021
Onset Date: 04/01/2021
Rec V Date: 06/10/2021
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: Back pain (a thousand times worse)/severe pain/Pain starting on back and wrapping around; Couldn't hardly move; Couldn't hardly take a breath; It's hurting down into her stomach.; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration, on 22Apr2021 as single dose, for covid-19 immunisation. Medical history of patient included Type 2 diabetic and small herniated disc. Concomitant product included medicine for diabetes (Not specified). Patient received first dose of vaccination on 01Apr2021 at the age of 66 years. There was no family medical history. The patient had no prior vaccinations (within 4 weeks). The patient experienced Back pain (a thousand times worse)/severe pain/Pain starting on back and wrapping around, couldn't hardly move, Couldn't hardly take a breath and It's hurting down into her stomach on Apr2021. The reporter was calling on behalf of sister in law. Prior to receiving vaccine had already experienced back pain. The patient received first vaccine dose on 01Apr2022, back pain felt was different than previous pain. Patient received second dose on 22Apr2021 and back pain was described as "a thousand times worse". Reporter learned of this information approximately 01May2021. Her sister in law got the vaccine because she stays with her wife and her wife just had triple bypass. So she signed her sister-in-law up and got her the vaccine and she and her wife had already had the vaccine and they did not have any issues. Prior to her sister in law getting the vaccine she had a little bit of a back issue which they knew was a small herniated disc. She had some issues off and on. The patient got the second booster and from there it was down hill. It was like it amplified a thousand times. She thinks it's a side effect or some type of combination between the vaccine. Somehow the vaccine has done something, but she can't figure out what. She knows it has done something to cause her immune system to make it worse. She thinks it was initiated by the vaccine. She states hopefully this does not impact her job at all. She does not think it will, but she is concerned for her sister-in-law. The vaccine seems to correlate with the back pain. She didn't say anything until probably the second week or so after she got the second one. The first, she was kind of like, I think it's doing something, but she wasn't sure. Then when she got the second one, it amplified it and then she was like yeah, it's got something to do with it. It's bad. She states her sister-in-law is a very strong lady. This morning she went in to see her and she couldn't even hardly move or take a breath. She's trying to move around. She wants to know if this is going to effect her job. She states the pain is starting in the back and wrapping all the way around. It's hurting down into her stomach. The events were persisting and she's not sure how much worse it can get. Her doctor suggested that she get it. She feels bad now because she kind of talked her into getting it as well because she is a type 2 diabetic. Her diabetes is controlled with medicine. She had a test prior to vaccine about the back problem. She has a very high pain tolerance. She was now hurting to a point where she is about ready to go to the emergency room. There was no previous immunization with the Pfizer vaccine considered and no vaccines administered on same date of the Pfizer suspect. The patient had no relevant tests. There was no investigation assessment. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Other Meds:

Current Illness:

ID: 1387844
Sex: F
Age: 0
State: VA

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 06/10/2021
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: 4 month old received Pentacel and Acthib at the same time, no AE; Initial information received on 17-May-2021 regarding an unsolicited valid non-serious case from a pharmacist. This case involves a 4 months old female patient who received 0.5 ml first dose of HIB (PRP/T) VACCINE [Act-HIB] (lot SO21458 and expiration date not reported) via intramuscular route in the right vastus lateralis and 0.5 ml first dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (lot UJ412AA and expiration date not reported) via intramuscular route in the left vastus lateralis for prophylactic vaccination on 12-May-2021 (that is at the same time). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (lot numbers, expiration date and other dosing details were not reported) for prophylactic vaccination. It was a case of medication error due to extra dose administered (same day). It was also reported that caller wanted to know if there was any data on patient receiving too much medication or receiving the products at the same time. On 17-May-2021 - Confirmed pharmacist's questions about PENTACEL and ACTHIB being given at the same time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. No further information was provided.

Other Meds:

Current Illness:

ID: 1387845
Sex: F
Age: 0
State: OH

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 06/10/2021
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: 7 month old female patient inadvertently administered an expired dose of Pentacel intramuscularly with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer via Agency (Reference number- 00609761) and transmitted to Sanofi on 20-May-2021. This case involves a 7 month old female patient who was inadvertently administered an expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation. On 18-May-2021, the patient received a 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ262AAA and expiry date: 14-May-2021) (Suspect formulation: single dose vials) via an intramuscular route in the right leg for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (latency on same day). It was also reported that expire Pentacel was given to a baby and the vaccine was 4 days past the expiry date. Caller would like to know if they need to re-vaccinate. Reporter relationship: health care professional (HCP) Product used: used still using product: no At the time of report no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1387846
Sex: M
Age:
State: HI

Vax Date: 05/18/2021
Onset Date: 05/18/2021
Rec V Date: 06/10/2021
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: An expired Act-Hib was administered to a patient/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Agency (Reference number- 00609798) and transmitted to Sanofi on 20-May-2021. This case involves a 3 years old male patient who received fourth dose 0.5 mL HAEMOPHILUS TYPE B (HIB) VACCINE [ACT-HIB] (frequency: once, batch number: UJ207AA and expiry date : 30-Apr-2021 via an intramuscular route at an right thigh administration site) (expired product administered) on 18-May-2021 for prophylactic vaccination. The patient's medical history, past medical treatment, vaccination and family history were not provided. It was an actual medication error case due to expired vaccine used (latency: same day). Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS A VACCINE (HEPATITIS A) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for prophylactic vaccination. Reporter want to know what need to know and which actions to take for the affected donors. Caller requested information to provide to mother of patient. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1387847
Sex: F
Age: 13
State:

Vax Date: 05/20/2021
Onset Date: 05/20/2021
Rec V Date: 06/10/2021
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: 13 year old patient had recieved MENACTRA vaccine 5 years early with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 20-May-2021 from other health care professional via Medical Information (Reference number- 00610012) and transmitted to Sanofi on 20-May-2021. This case involves a 13 year-old female patient who was vaccinated with 0.5 mL MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 5 years too early (batch number and expiry date not reported) via an intramuscular route at left deltoid on 20-May-2021 for prophylactic vaccination (inappropriate schedule of product administration) The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE for prophylactic vaccination. It was also a case of an actual medication error due to inappropriate age at vaccine administration (latency was on same day). It was reported that, would the patient be harmed, what should they do, would the patient need a booster? Result of assessment was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on batch number for this case.

Other Meds: HPV VACCINE

Current Illness:

ID: 1387849
Sex: F
Age: 6
State: TX

Vax Date: 03/18/2021
Onset Date: 03/18/2021
Rec V Date: 06/10/2021
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: temperature that product was out of range at 9 C time exposed to temperature was30 minutes or less/ NO AE; Initial information received on 26-May-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information. This case involves a 6-years-old female patient who received 0.5 mL (VERO) [IPOL] (frequency: once, strength: standard, batch number: R1F801M and expiry date: 28-Sep-2021 via intramuscular route in left deltoid) which was exposed to 9 degree Celsius for 30 minutes and less was given post a temperature excursion that made the vaccine not useable (product storage error) on 18-Mar-2021 for prophylactic vaccination The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. No other vaccines received by patient. It was potential medication error case due to incorrect product storage. Excursion occurred on 09-Mar-2021. that the excursion was spotted during an audit of temperatures from a data logger; that three consumers received the vaccine; and that with further verifying dates and times of vaccine administration only two consumers received the vaccine. The clinic calling the manufacturer for guidance. Caller is requesting temperature excursion information for the vaccine. At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1387850
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
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: patient only received a 0.3 ml dose due to a defective syringe with no AE; patient only received a 0.3 ml dose due to a defective syringe with no AE; Initial information regarding an unsolicited valid non-serious was received from a Pharmacist via Medical Information (Reference number- 00618533) and transmitted to Sanofi on 27-May-2021. This case involves a patient with unknown gender received a 0.3 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date were not reported) via unknown route at an unknown administration site (underdose) for prophylactic vaccination due to a defective syringe (syringe issue) on an unknown date. The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. The reporter asked should the patient be revaccinated. It was an actual medication error case due to vaccine underdose and syringe issue (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information on the batch number for this case.

Other Meds:

Current Illness:

ID: 1387851
Sex: M
Age: 7
State: NC

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/10/2021
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: expired Ipol dose was given to a child with no ae; Initial information regarding an unsolicited valid non-serious was received from a Physician via Medical Information (Reference number- 00620475) and transmitted to Sanofi on 28-May-2021. This case involves a 7 years old male patient who received a expired dose of suspect IPV (VERO) [IPOL] (lot R1B251M and expiry date: 12-Mar-2021) via unknown route at an unknown administration site (expired product administered) for prophylactic vaccination on 28-May-2021. The patient's medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided. The reporter asked how to proceed. It was an actual medication error case due to expired vaccine used (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds:

Current Illness:

ID: 1387852
Sex: M
Age: 62
State: MN

Vax Date: 04/12/2021
Onset Date: 05/03/2021
Rec V Date: 06/10/2021
Hospital: Y

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

Lab Data:

Allergies: statin pills

Symptom List: Injection site pain, Menorrhagia

Symptoms: After my first and second Moderna shots my heart raced and 3 weeks after the second shot I started to retain body fluid from heart failure and Edema. also my mother died 3 weeks after her first Moderna shot and also my aunt (her sister) died 3 weeks after her Moderna shot.

Other Meds: levothyroxine 1.25mg. , clopidogrel 75mg. , tamsulosin 0.4mg. , asprin tab ec 81mg.

Current Illness:

ID: 1387853
Sex: F
Age: 29
State: CA

Vax Date: 05/27/2021
Onset Date: 05/27/2021
Rec V Date: 06/10/2021
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: N/A

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

Symptoms: Chills and shaking 05/27/2021 Cough, fatigue, pain in legs 05/27/2021-05/30/21 I slept nearly all day 05/31/21- 06/02/21 Difficulty breathing + coughing 06/05/21-06/07/21 Fever, pounding headache, Shortness of breath, pain in arms 06/08/2021 Shortness of breath, pain in abdomen, headache, nose feels like it?s underwater, nauseous 06/09/2021

Other Meds: N/A

Current Illness: N/A I had an arm injury but that was it. The injury was in my left arm so I got the vaccine in my right arm.

ID: 1387854
Sex: M
Age: 41
State: MA

Vax Date: 05/27/2021
Onset Date: 05/28/2021
Rec V Date: 06/10/2021
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: None known

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Proteinuria about 0.5g/L. Hematuria about 200 ery/uL. Fever of 100.5F oral. Malaise. Patient has had similar proteinuria and hematuria in response to viral infections (influenza) before but it had resolved and not been seen in the last year prior to the vaccination. Suspected mild IgA nephropathy but not confirmed. Fever and malaise resolved in 36 hours. Hematuria resolved in about 4 days and proteinuria in about 6 days. No treatment other than tylenol for fever.

Other Meds: Sertraline, Famotidine, Omeprazole, Loratidine, Vitamin D

Current Illness: None

ID: 1387855
Sex: F
Age: 39
State:

Vax Date: 05/26/2021
Onset Date: 05/26/2021
Rec V Date: 06/10/2021
Hospital:

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

Lab Data:

Allergies: None

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Tight throat developed within minutes of shot. When eating later in the day, chest pain as food might have been having difficulty going down. Both symptoms lasted all day but were better the next day.

Other Meds: None

Current Illness: None

ID: 1387856
Sex: F
Age: 39
State: CO

Vax Date: 06/01/2021
Onset Date: 06/08/2021
Rec V Date: 06/10/2021
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: Codeine

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

Symptoms: 7 days after vaccine around where injection was given is now red, swollen, itchy and hot to the touch

Other Meds: Sertraline, buspirone and dicyclomine

Current Illness:

ID: 1387857
Sex: F
Age: 34
State: CA

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 06/10/2021
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: Headache, myalgia, elevated heart rate up to 55 bpm above baseline

Other Meds: Montelukast, Alvesco

Current Illness:

ID: 1387858
Sex: F
Age: 40
State: MN

Vax Date: 05/15/2021
Onset Date: 05/23/2021
Rec V Date: 06/10/2021
Hospital:

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

Lab Data:

Allergies: Penicillin

Symptom List: Injection site pain

Symptoms: Increased frequency of seizures

Other Meds: Anti epileptic meds: vimpat and briviact

Current Illness: None

ID: 1387859
Sex: M
Age: 48
State: CA

Vax Date: 05/07/2021
Onset Date: 05/09/2021
Rec V Date: 06/10/2021
Hospital:

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

Lab Data:

Allergies: N/A

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

Symptoms: Roughly two days after the second Pfizer shot my arm muscle was sore, but then I started having lightheadedness and dizzy spells along with severe fatigue. I've been to several doctors since.

Other Meds: Ambien, Doxycycline

Current Illness: N/A

ID: 1387860
Sex: M
Age: 14
State: MD

Vax Date: 06/08/2021
Onset Date: 06/09/2021
Rec V Date: 06/10/2021
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: None

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

Symptoms: Arm hurt, could barely move it. Then he got the chills and a fever, and really tired. Hours later, he said his tongue started to hurt. I tried to log this on the daily check in but by the time I clicked on the link it said it expired - 12 hours after receiving - why wouldn't they give you 24 hours?

Other Meds: None

Current Illness: None

ID: 1387861
Sex: M
Age: 31
State: TX

Vax Date: 05/12/2021
Onset Date: 05/18/2021
Rec V Date: 06/10/2021
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: Possibility of allergic reaction to penicillin, Bactrim, latex.

Symptom List: Tremor

Symptoms: Injection site swollen around my back arm and armpit, small hive left inner elbow, increased heart rate, blood pressure was 183/110. Was hard to breathe, clammy, faint, confused, and panicky. Left arm went numb. I went to hospital twice, and clinic twice due to the symptoms coming and going.

Other Meds: None

Current Illness: None

ID: 1387891
Sex: F
Age:
State: NC

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
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: Hashimoto's disease; missed for second dose; This spontaneous report was received from a physician referring to a 20 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with 1 out of the 2 required doses of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) 0.5 milliliter for prophylaxis. On an unknown date, the patient was diagnosed with Hashimoto's disease and had never had her second dose of varicella virus vaccine live (oka/merck) (VARIVAX). The outcome of Hashimoto's disease was not recovered. The causality between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was not provided. Upon internal review, Hashimoto's disease was determined to be medically significant.

Other Meds:

Current Illness:

ID: 1387892
Sex: F
Age:
State: TX

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 06/10/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Seizure; This case was received via VAERS (Reference number: 1151220) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SEIZURE (Seizure) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. There was no treatment medication reported. There was no concomitant medication reported. The patient had a seizure about 10 minutes after the vaccine was given. She had reported to us ahead of time that she has a seizure disorder. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's underlying condition of seizure disorder remains a confounder. Further information can't be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's underlying condition of seizure disorder remains a confounder. Further information can't be requested.

Other Meds:

Current Illness:

ID: 1387893
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
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: Got shingles vaccine / my arms are in pain since then; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine. Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingles vaccine few months ago and experienced pain in arm. The follow up would not be possible as no contact details available.

Other Meds:

Current Illness:

ID: 1387894
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
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: the maladministration of Infanrix in a 7 year old male patient.; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Sales representative that maladministration of Infanrix in a 7 year old male patient which led to inappropriate age at vaccine administration. No further details were provided at the time of the call. No more details about the vaccine or the patient were provided at the time of the call. The reporter mentioned the health care professional (HCP) who told her about the adverse event consented to follow-up by email.

Other Meds:

Current Illness:

ID: 1387896
Sex: M
Age: 66
State: MN

Vax Date: 05/01/2021
Onset Date: 05/01/2021
Rec V Date: 06/10/2021
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: received only the liquid component of Menveo vaccine; received only the liquid component of Menveo vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 66-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA380A, expiry date unknown) for prophylaxis. On 1st May 2021, the patient received Menveo. On 1st May 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The patient received only the liquid component of Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The batch number was reported as AMXA38OA and was updated to AMVA380A, as per sales data sheet. The reporter consented to follow up.

Other Meds:

Current Illness:

ID: 1387900
Sex: U
Age:
State: NC

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 06/10/2021
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: TIREDNESS/INTENSE FATIGUE; moderate flu symptoms; HOT FLASHES; SWEATS THROUGHOUT THE NIGHT; light sinus pain and pressure; slight joint pain; CHILLS/CHATTERING TEETH; light muscle pain; LIGHT PAIN IN MY ARM FROM THE INJECTION; moderate headache; moderate nausea; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy season. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced moderate flu symptoms. On MAR-2021, the subject experienced hot flashes. On MAR-2021, the subject experienced sweats throughout the night. On MAR-2021, the subject experienced light sinus pain and pressure. On MAR-2021, the subject experienced slight joint pain. On MAR-2021, the subject experienced chills/chattering teeth. On MAR-2021, the subject experienced light muscle pain. On MAR-2021, the subject experienced light pain in my arm from the injection. On MAR-2021, the subject experienced moderate headache. On MAR-2021, the subject experienced moderate nausea. On 13-MAR-2021, the subject experienced tiredness/intense fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue on MAR-2021. The reporter causality and company causality between JNJ-78436735 and events moderate flu symptoms, hot flashes, sweats throughout the night, light sinus pain and pressure, slight joint pain, chills/chattering teeth, light muscle pain, light pain in my arm from the injection, moderate headache, moderate nausea, and tiredness/intense fatigue was possible. This report was non-serious.

Other Meds:

Current Illness: Seasonal allergy

ID: 1387901
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
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: BREAKTHROUGH BLEEDING; INCREASED FLOW; This spontaneous report received from a consumer concerned multiple patients. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced breakthrough bleeding, and increased flow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased flow and breakthrough bleeding was not reported. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard procedure as the case was assessed as non -serious

Other Meds:

Current Illness:

ID: 1387902
Sex: F
Age:
State: NV

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 06/10/2021
Hospital:

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: EAR PAIN IN RIGHT EAR THAT COMES AS A STRONG AND QUICK PINCH, LIKE A NERVE PAIN, IT COMES IN TINY SHOCKS AND AFFECTS THE WHOLE AREA AROUND THE RIGHT EAR, AND THROUGH THE RIGHT TEMPLE; CHILLS; A STRONG HEADACHE; GOOSEBUMPS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUN-2021, the subject experienced goosebumps. On 01-JUN-2021, the subject experienced chills. On 01-JUN-2021, the subject experienced a strong headache. On 03-JUN-2021, the subject experienced ear pain in right ear that comes as a strong and quick pinch, like a nerve pain, it comes in tiny shocks and affects the whole area around the right ear, and through the right temple. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear pain in right ear that comes as a strong and quick pinch, like a nerve pain, it comes in tiny shocks and affects the whole area around the right ear, and through the right temple, and the outcome of a strong headache, chills and goosebumps was not reported. This report was non-serious. This case, from the same reporter is linked to 20210612255.

Other Meds:

Current Illness:

ID: 1387903
Sex: F
Age: 45
State: AR

Vax Date: 03/06/2021
Onset Date: 05/27/2021
Rec V Date: 06/10/2021
Hospital: Y

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: its ischemic stroke; I was at store and passed out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (its ischemic stroke) and LOSS OF CONSCIOUSNESS (I was at store and passed out) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 020B21A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included AMLODIPINE, ROSUVASTATIN CALCIUM (CRESTOR), ROPINIROLE, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]), FUROSEMIDE (LASIX [FUROSEMIDE]), QUETIAPINE FUMARATE (SEROQUEL), BUSPIRONE HYDROCHLORIDE (BUSPAR), ESTRADIOL and TRAZODONE for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced ISCHAEMIC STROKE (its ischemic stroke) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (I was at store and passed out) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 27-May-2021 due to ISCHAEMIC STROKE. The patient was treated with ALTEPLASE ongoing since an unknown date at a dose of Activase Alteplase. At the time of the report, ISCHAEMIC STROKE (its ischemic stroke) and LOSS OF CONSCIOUSNESS (I was at store and passed out) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Computerised tomogram: abnormal (abnormal) ischemic stroke.. On 27-May-2021, Magnetic resonance imaging: abnormal (abnormal) ischemic stroke.. Patient was in Emergency room for 3 days and 2 days in ICU. patient was shifted to room and 1 day in regular room. In emergency room patient was prescribed with Activase Alteplase for treatment along with her daily medication. Company comment: Very limited information regarding this events has been provided at this time. Further information can't be requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information can't be requested.

Other Meds: AMLODIPINE; CRESTOR; ROPINIROLE; CELEXA [CITALOPRAM HYDROBROMIDE]; LASIX [FUROSEMIDE]; SEROQUEL; BUSPAR; ESTRADIOL; TRAZODONE

Current Illness:

ID: 1387904
Sex: F
Age: 71
State: OH

Vax Date: 03/05/2021
Onset Date: 05/12/2021
Rec V Date: 06/10/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Blood clots in her leg and lungs; She is black and blue; She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle; She also felt pain midway between her knee and ankle; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots in her leg and lungs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dyslipidaemia. Concurrent medical conditions included Blood pressure high, Depression, Acid reflux (oesophageal) and Allergy. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced GROIN PAIN (She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle) and ARTHRALGIA (She also felt pain midway between her knee and ankle). On 18-May-2021, the patient experienced THROMBOSIS (Blood clots in her leg and lungs) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CONTUSION (She is black and blue). The patient was hospitalized from 21-May-2021 to 22-May-2021 due to THROMBOSIS. The patient was treated with APIXABAN (ELIQUIS) on 22-May-2021 at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in her leg and lungs), CONTUSION (She is black and blue), GROIN PAIN (She felt pain above her knee and on the inside of her thigh toward the groin that felt like she had been wearing a tight sock. Also felt pain midway between her knee and ankle) and ARTHRALGIA (She also felt pain midway between her knee and ankle) outcome was unknown. The patient thought there were bug bites on her leg on 12-May-2021. Treatment also included IV blood thinner while she was hospitalized. The action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.

Other Meds:

Current Illness: Acid reflux (oesophageal); Allergy; Blood pressure high; Depression

ID: 1387905
Sex: F
Age: 42
State: TX

Vax Date: 02/26/2021
Onset Date: 03/01/2021
Rec V Date: 06/10/2021
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: out of the range of time for the second dose; Staph Infection in the nose; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (Staph Infection in the nose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced STAPHYLOCOCCAL INFECTION (Staph Infection in the nose) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (out of the range of time for the second dose). On 01-Apr-2021, STAPHYLOCOCCAL INFECTION (Staph Infection in the nose) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (out of the range of time for the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment with anti-biotic therapy was provided by the patient pertained to the events experienced. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1387906
Sex: F
Age: 74
State: LA

Vax Date: 01/08/2021
Onset Date: 02/04/2021
Rec V Date: 06/10/2021
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: lost the hearing in her right ear; This spontaneous case was reported by an other health care professional and describes the occurrence of DEAFNESS (lost the hearing in her right ear) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEAFNESS (lost the hearing in her right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS (lost the hearing in her right ear) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1387907
Sex: U
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 06/10/2021
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: 73 year old patient taking Adacel with no reported adverse event; Initial information was received on 24-May-2021 regarding an unsolicited valid non-serious case received from a consumer or other non-professional. This case involves a 73 year old (unknown gender) patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age). It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment, vaccination, family history and concomitant medications were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. (latency same day) It was unknown if there were laboratory data/results available. At the time of report, no adverse event was reported. It was unknown if the patient experienced any additional symptoms/events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.

Other Meds:

Current Illness:

ID: 1387908
Sex: M
Age: 0
State: TX

Vax Date: 05/24/2021
Onset Date: 05/24/2021
Rec V Date: 06/10/2021
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: Patient was given PENTACEL and a separate DTAP vaccine (INFANRIX) with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from Physician via Medical Information (Reference number- 00613527) and transmitted to Sanofi on 24-May-2021. This case involves a 6 months old male patient who received a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ390AAA and expiration date: 12-Oct-2021) via intramuscular route in the right thigh and a separate dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] (lot number and expiry date were not reported) via unknown route at an unknown administration site (extra dose administered) for prophylactic vaccination on 24-May-2021. The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) for Immunisation. The reporter asked for what to look out for and if the patient will be ok. They also questioned on the duplicate DTAP dose and what they need to do and what to expect. It was an actual medication error case due to extra dose administered (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: HEPATITIS B [HEPATITIS B VACCINE]

Current Illness:

ID: 1387909
Sex: F
Age:
State: OH

Vax Date: 05/28/2021
Onset Date: 05/28/2021
Rec V Date: 06/10/2021
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: HCP accidentally grabbed Pentacel instead of Daptacel by mistake and administered to patient with no adverse event; Initial information regarding an unsolicited valid non-serious was received from other healthcare professional via Medical Information (Reference number- 00620295) and transmitted to Sanofi on 28-May-2021. This case involves an 18 months old female patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ389ABA and expiry date: 09-Oct-2021) via intramuscular route in the right thigh instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date were not reported) (wrong product administered) for prophylactic vaccination as administrator accidentally grabbed wrong vaccine by mistake on 28-May-2021. The patient's medical history, past medical treatments, past vaccinations and family history were not provided. Concomitant vaccinations included HEPATITIS A VACCINE (HEPATITIS A VACCINE); PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation. The reporter asked if receiving the extra Ipol and ActHIB will harm the patient. Reporter also asked what side effects she should look out for. As it turned out it was also time for the ActHIB, however the next Ipol vaccine is not due until ages 4-6 years of age. They stated that Stated that a patient was given pentacel but the patient only needed the dTap. It was an actual medication error case due to wrong vaccine administered (latency: same day). At the time of reporting, the patient experienced no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.

Other Meds: HEPATITIS A VACCINE; PNEUMOCOCCAL VACCINE

Current Illness:

ID: 1387910
Sex: F
Age: 59
State: VA

Vax Date: 06/03/2021
Onset Date: 06/09/1921
Rec V Date: 06/10/2021
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: None

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

Symptoms: Head hurts to touch getting itchy on arms legs and Buttocks also arems sweeling

Other Meds: Swelling of arms . Head to touch hurts. And itching on arms and hand and buttocks and legs

Current Illness: None

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm