chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Bone pain, Chest pain, Dizziness
Clinical narrative: bedridden; extreme nausea; headache; bodyache; stiffness; chest pain; dizzy whenever I try and stand/ light headed; can't focus on screen very long without feeling like throwing up; can barely turn neck; bones/joints hurt; bones/joints hurt; no energy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0191) via unspecified route of administration, administered in arm left on 01Jun2021 at 06:15 (at the age of 32-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included allergy to peanuts and shellfish. Concomitant medication was not reported. The patient previously took bnt162b2 (lot number: EW0185) in arm left on 07May2021 at 07:15 as 1st dose, single dose for COVID-19 immunization and experienced bed ridden and fatigue. No other vaccines within 4 weeks prior to the COVID vaccine. On 02Jun2021 at 10:00 (AM), the patient experienced lightheaded, extreme nausea, physical weakness, headache and body ache. It was reported that the patient also experienced stiffness, chest pain, dizzy on same day. Whenever the patient was trying and stand, could not focus on screen very long without feeling like throwing up, always lightheaded, could barely turn neck, bones and joints hurt and no energy. The patient stated he received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. The patient also stated he did not know if this was a permanent condition caused by the vaccine nor did he know what the extent of any permanent damage was. This was the worst body he had ever felt. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. Patient was not tested COVID post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Nausea, Nuchal rigidity, Pain
Clinical narrative: bedridden; extreme nausea; headache; bodyache; stiffness; chest pain; dizzy whenever I try and stand/ light headed; can't focus on screen very long without feeling like throwing up; can barely turn neck; bones/joints hurt; bones/joints hurt; no energy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0191) via unspecified route of administration, administered in arm left on 01Jun2021 at 06:15 (at the age of 32-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included allergy to peanuts and shellfish. Concomitant medication was not reported. The patient previously took bnt162b2 (lot number: EW0185) in arm left on 07May2021 at 07:15 as 1st dose, single dose for COVID-19 immunization and experienced bed ridden and fatigue. No other vaccines within 4 weeks prior to the COVID vaccine. On 02Jun2021 at 10:00 (AM), the patient experienced lightheaded, extreme nausea, physical weakness, headache and body ache. It was reported that the patient also experienced stiffness, chest pain, dizzy on same day. Whenever the patient was trying and stand, could not focus on screen very long without feeling like throwing up, always lightheaded, could barely turn neck, bones and joints hurt and no energy. The patient stated he received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. The patient also stated he did not know if this was a permanent condition caused by the vaccine nor did he know what the extent of any permanent damage was. This was the worst body he had ever felt. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. Patient was not tested COVID post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: bedridden; extreme nausea; headache; bodyache; stiffness; chest pain; dizzy whenever I try and stand/ light headed; can't focus on screen very long without feeling like throwing up; can barely turn neck; bones/joints hurt; bones/joints hurt; no energy; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0191) via unspecified route of administration, administered in arm left on 01Jun2021 at 06:15 (at the age of 32-year-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included allergy to peanuts and shellfish. Concomitant medication was not reported. The patient previously took bnt162b2 (lot number: EW0185) in arm left on 07May2021 at 07:15 as 1st dose, single dose for COVID-19 immunization and experienced bed ridden and fatigue. No other vaccines within 4 weeks prior to the COVID vaccine. On 02Jun2021 at 10:00 (AM), the patient experienced lightheaded, extreme nausea, physical weakness, headache and body ache. It was reported that the patient also experienced stiffness, chest pain, dizzy on same day. Whenever the patient was trying and stand, could not focus on screen very long without feeling like throwing up, always lightheaded, could barely turn neck, bones and joints hurt and no energy. The patient stated he received full-time care while bedridden first day and a half from his partner and continue to receive care daily as he was not able to accomplish much on his own at this point. The patient also stated he did not know if this was a permanent condition caused by the vaccine nor did he know what the extent of any permanent damage was. This was the worst body he had ever felt. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination. Patient was not tested COVID post vaccination. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Eating disorder, Gastrointestinal disorder, Illness
Clinical narrative: vomiting; sick; lost 20+ pounds; have trouble with sleep; barely eat anything; GI flare up; got eh chest pressure; insomnia; nausea; diarrhea; This is a spontaneous report from a contactable consumer (Patient herself). A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Right on 15-APR-2021 (at the age of 35-year-old non-pregnant) 10:30 A.M as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection for COVID-19 immunization. The patient previously took cephalexine, mucinex, nasonex. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had not received other medications within 2 weeks of vaccination. It was reported that, on 28Apr2021 patient had experienced chest pressure and insomnia a few days after. Then, GI flare up. She was so sick and could not keep fluids down and ended up in the ER. She started to feel better week 3, then had to get my second dose. She got eh chest pressure and insomnia the first night. The nausea and diarrhea on on 28Apr2021 and vomiting came back a week and a half later, and now she was still so sick. She had lost 20 plus pounds and was only 145 to start. She still had trouble with sleep some nights like she jolt awake. She could barely eat anything. She was having an endoscopy and colonoscopy on Monday and a cardiology appointment on Wednesday. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had received treatment as all sorts of stomach medications. The patient's lab test included SARS-COV-2 test which was negative on 06May2021. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events, eh chest pressure, insomnia, nausea and diarrhea was not recovered while for other events was unknown.  information on batch and lot number is requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, SARS-CoV-2 test, Sleep disorder, Vomiting
Clinical narrative: vomiting; sick; lost 20+ pounds; have trouble with sleep; barely eat anything; GI flare up; got eh chest pressure; insomnia; nausea; diarrhea; This is a spontaneous report from a contactable consumer (Patient herself). A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Right on 15-APR-2021 (at the age of 35-year-old non-pregnant) 10:30 A.M as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection for COVID-19 immunization. The patient previously took cephalexine, mucinex, nasonex. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had not received other medications within 2 weeks of vaccination. It was reported that, on 28Apr2021 patient had experienced chest pressure and insomnia a few days after. Then, GI flare up. She was so sick and could not keep fluids down and ended up in the ER. She started to feel better week 3, then had to get my second dose. She got eh chest pressure and insomnia the first night. The nausea and diarrhea on on 28Apr2021 and vomiting came back a week and a half later, and now she was still so sick. She had lost 20 plus pounds and was only 145 to start. She still had trouble with sleep some nights like she jolt awake. She could barely eat anything. She was having an endoscopy and colonoscopy on Monday and a cardiology appointment on Wednesday. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had received treatment as all sorts of stomach medications. The patient's lab test included SARS-COV-2 test which was negative on 06May2021. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events, eh chest pressure, insomnia, nausea and diarrhea was not recovered while for other events was unknown.  information on batch and lot number is requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: vomiting; sick; lost 20+ pounds; have trouble with sleep; barely eat anything; GI flare up; got eh chest pressure; insomnia; nausea; diarrhea; This is a spontaneous report from a contactable consumer (Patient herself). A 35-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration, administered in Arm Right on 15-APR-2021 (at the age of 35-year-old non-pregnant) 10:30 A.M as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection for COVID-19 immunization. The patient previously took cephalexine, mucinex, nasonex. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had not received other medications within 2 weeks of vaccination. It was reported that, on 28Apr2021 patient had experienced chest pressure and insomnia a few days after. Then, GI flare up. She was so sick and could not keep fluids down and ended up in the ER. She started to feel better week 3, then had to get my second dose. She got eh chest pressure and insomnia the first night. The nausea and diarrhea on on 28Apr2021 and vomiting came back a week and a half later, and now she was still so sick. She had lost 20 plus pounds and was only 145 to start. She still had trouble with sleep some nights like she jolt awake. She could barely eat anything. She was having an endoscopy and colonoscopy on Monday and a cardiology appointment on Wednesday. The adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had received treatment as all sorts of stomach medications. The patient's lab test included SARS-COV-2 test which was negative on 06May2021. The patient was not diagnosed prior and since the vaccination with COVID-19. The outcome of events, eh chest pressure, insomnia, nausea and diarrhea was not recovered while for other events was unknown.  information on batch and lot number is requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Incorrect route of product administration, Rash
Clinical narrative: Severe allergic reaction; I broke out with rash; BNT162B2 intravenously; This is a spontaneous report from a contactable consumer. A 34-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, lot: EW0182) intravenously on 16May2021 14:00 (34-year-old at the time of the vaccination) as single dose in left arm COVID-19 immunization. Medical history and concomitant medications were not reported. Patient reported to be allergic to Amoxicillin and Penicillin, other than that no related allergy. No prior vaccination was reported within 4 weeks. Consumer stated to report some basically a severe allergic reaction that she had to the COVID-19 Pfizer Vaccine and that was administered on 16May2021. Only they did lab testing and blood work when she broke out with rash that was it but other than that no. she has been at the ER (emergency room). They had given antihistamine and steroids but the rash, it only spread, and it's been prevalent for a week now today and it's probably getting worse. Outcome of the events unknown.  Follow-up attempts are needed. Further information is requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased
Clinical narrative: a spike in blood pressure; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at an unknown dose, single dose for COVID-19 immunization. The patient's medical and concomitant medications were not reported. On an unspecified date, the patient experienced a spike in blood pressure after getting the COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: mild headache; left arm soreness; This is a spontaneous report from a non-contactable consumer (Patients brother). A 38-year-old male 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 an unspecified date as single dose for Cvoid-19 immunisation. He was administered his first vaccination of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE on an unspecified date with no AE. Medical history and concomitant medications were not reported. After vaccination, the patient experienced mild headache and left arm soreness on an unspecified date in second day after taking second dose. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer. This consumer  reported for a 12 year old female patient (reporter daughter). A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date (at age of 12-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unknown date, the reporter stated her 12-year-old got the vaccination and she was fine except a sore arm. Now the patient is due for second one next week. Hoping she doesn't have same reaction as her sister. All four of them in the family had sore arm. Everybody said that was to be expected. Reporter's youngest goes to have the second one next week and if she has something happen caller will calls back. The Outcome of the event was reported as unknown.  The report is cross referenced to report ID: 8W2QO95A  Information about batch/ lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in his feet and pain in his hand; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program.   A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: ER8736, Expiration date: unknown), dose 2 via an unspecified route of administration on 04Jun2021 as 2nd dose, single dose COVID-19 immunization. patient previously took first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: EW0167, Expiration date: unknown) via an unspecified route of administration on an unspecified date as first dose single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 04Jun2021 after second vaccine, the patient experienced pain in his feet and pain in his hand. Patient is still experiencing a pain in his feet and pain in his hand. The outcome of event was unknown.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: She had a high fever; This is a spontaneous report from a non-contactable consumer or other non hcp patient's mother).  A 13-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 right on 02Jun2021 (Batch/Lot Number: EW0177) as a Single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously took BNT162B2 on 12May2021 for COVID-19 Immunization (Dose: 1st, Batch/lot number: EW0179, anatomical site of injection for first vaccination: Left arm). On 03Jun2021, She had a high fever and the fever recorded 24 hours after the shot. The patient mother was interesting to patient about the fever was recorded 24 hours after the shot. So first she thought the patient didn't go to have any side effects at all but then she did get side effects 24 hours after the shot." The patient did not take any vaccination prior to second vaccination. The patient took Ibuprofen for fever reducing medicine. The outcome of the event was recovered in Jun2021.   No follow-up attempts are possible. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; Sore arm; This is a spontaneous report from a A contactable consumer (patient neighbour) reported that a 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC, lot, Expiry Date: Not provided), via an unspecified route of administration, on an unknown date (age at vaccination 90-year-old) as unknown, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced diarrhea and sore arm. Reporter states as, her old neighbour said she got Pfizer and she had diarrhea too. the patient had diarrhea and sore arm. The patient got hers, so patient was the first round of people. she doesn't think she has enough information to complete a report for her. The patient told her that she barely made it home in time before the symptoms started. Outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from contactable consumer a Pfizer sponsored program. A male patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, 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. Patient previously took first dose of BNT162b2 for COVID-19 immunization. It was reported that I had a caller on the other line, and she was calling for his son (consumer) because his son experienced fever after getting the second dose vaccine. That's the only concern, he was calling about. In response, reporter stated, I was only interested what I can do about, I was not interested about the Drug (Safety) Report. I was just concern about his fever and I am not concern about reporting. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site mass, Vaccination site pain
Clinical narrative: Soreness and quarter-sized bump at injection site; Soreness and quarter-sized bump at injection site; Slight fever; minor headache; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness and quarter-sized bump at injection site, slight fever and minor headache. It was reported that the events took place after the vaccination. The outcome of events was unknown.   Follow up needed; Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Went to the doctor for aches; Muscle ache and it says joint pain on the paper; Muscle ache and it says joint pain on the paper; This is a spontaneous report from a contactable consumer (patient, self-reported). A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 01Jun2021, as a single dose for COVID-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date, she went to the doctor for aches. She had muscle ache and it says joint pain on the paper. It was only on her right leg. The patient stated that she had her second dose and then she took her mom to the pharmacist. She gave her paper with all the side effects. She was currently feeling like muscle ache and it says joint pain on the paper, and she knew there was something that could cause. The patient did not have laboratory test. She thought she did one last year. Right now, she was taking medication which included muscle relaxant Orphenadrine citrate and Diclofenac sodium, and she was not taking any medications before. Outcome of the events was unknown.  Reason for no lot number: of COVID Vaccine: Other: Is it EW0217 that is for the second dose, I am not sure if this 2 or 0. they kind of went over the number. I think so because They also have like 2 over 0 or 0 over 2. I am not too sure.  Information about lot/batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Cystitis, Pyrexia
Clinical narrative: Bladder infection; High fever; Cough; This is a spontaneous report received from a contactable consumer (patient) reported for himself. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0177), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. He stated that the reason he called was he supposed to get a second shot on Monday and he have a bladder infection, high fever 2 days ago and cough. He is not sure if I should get the second shot right now. The patient received treatment due to the bladder infection with Cephalexin. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non-health care professional. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date in 2021. Caller stated that all four of them in the family had sore arm. Everybody said that was to be expected. Her husband gets second one next week. The outcome of the event was reported as unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging head, Muscle twitching, Neck pain, Pain in extremity
Clinical narrative: Pain from elbows to neck/shoulder pain; had a twitch in her head; Pain from elbows to neck/shoulder pain; left arm hurt when lifting; This is a spontaneous report from a contactable consumer (the patient). A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EM6198), intramuscularly in the left arm on 18Feb2021 10:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included: hypertension, gastroesophageal reflux disease, allergies, and arthritis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9262), intramuscularly in the right arm on 28Jan2021 12:00 as a single dose for COVID-19 immunization and experienced right arm wasn't lifting and in pain, and weakness in her right arm. On 02Mar2021, the patient experienced left arm hurt when lifting. On 23Mar2021, the patient experienced pain from elbows to neck and had a twitch in her head. The clinical course was as follows: vaccine was put in left shoulder (arm) resulting in unable to lift arm. Pain from elbow upwards to neck. The patient had a twitching in her head that was scary. She was unable to do normal chores-clean mirrors, take down dishes, lift things. After seeing her primary doctor, she was sent to a specialist. Seriousness was reported as disability. For treatment, the patient took pain medicines and started doing PT exercise for her shoulders and arms at home. Treatment also included Extra Strength paracetamol (TYLENOL) from 02Mar2021 to 15Mar2021, ibuprofen from 15Mar2021 and ongoing, and tizanidine 4mg from 14Apr2021 to 16Apr2021, all for pain in limb/ arm/ shoulder/arm. For left arm hurt when lifting, X-ray and MRI was done. Cervical spine X-ray on 15Mar2021: mild cervical degeneration; comments: X-ray for neck pain and twitch after vaccine. MRI brain on 22Mar2021: no abnormal restricted diffusion; comments: right arm weakness, fatigue. After 3 months since the vaccine, pain was bearable, and the patient was able to lift her arms more. The patient was presently recovering and doing better but not back to normal.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021210910 same patient/ different events and dose
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Pain from elbows to neck/shoulder pain; had a twitch in her head; Pain from elbows to neck/shoulder pain; left arm hurt when lifting; This is a spontaneous report from a contactable consumer (the patient). A 71-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EM6198), intramuscularly in the left arm on 18Feb2021 10:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included: hypertension, gastroesophageal reflux disease, allergies, and arthritis. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9262), intramuscularly in the right arm on 28Jan2021 12:00 as a single dose for COVID-19 immunization and experienced right arm wasn't lifting and in pain, and weakness in her right arm. On 02Mar2021, the patient experienced left arm hurt when lifting. On 23Mar2021, the patient experienced pain from elbows to neck and had a twitch in her head. The clinical course was as follows: vaccine was put in left shoulder (arm) resulting in unable to lift arm. Pain from elbow upwards to neck. The patient had a twitching in her head that was scary. She was unable to do normal chores-clean mirrors, take down dishes, lift things. After seeing her primary doctor, she was sent to a specialist. Seriousness was reported as disability. For treatment, the patient took pain medicines and started doing PT exercise for her shoulders and arms at home. Treatment also included Extra Strength paracetamol (TYLENOL) from 02Mar2021 to 15Mar2021, ibuprofen from 15Mar2021 and ongoing, and tizanidine 4mg from 14Apr2021 to 16Apr2021, all for pain in limb/ arm/ shoulder/arm. For left arm hurt when lifting, X-ray and MRI was done. Cervical spine X-ray on 15Mar2021: mild cervical degeneration; comments: X-ray for neck pain and twitch after vaccine. MRI brain on 22Mar2021: no abnormal restricted diffusion; comments: right arm weakness, fatigue. After 3 months since the vaccine, pain was bearable, and the patient was able to lift her arms more. The patient was presently recovering and doing better but not back to normal.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021210910 same patient/ different events and dose
Age: 53.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: medical assistant gave TUBERSOL as an Intramuscular injection instead of a TDAP vaccine with no reported adverse event; Initial information received on 24-May-2021 regarding an unsolicited valid  non-serious case from a other health professional (office manager).  This case involves a 53 years old male patient who was tested with 0.1 ml total TUBERCULIN TEST [TUBERSOL] (once, solution for injection, lot - C5751AA, expiration date: 19-Sep-2022) as an intramuscular injection in the left arm instead of a DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE for tuberculin test on 24-May-2021 by medical assistant (wrong product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given to the patient.  It was an actual medication error due to wrong vaccine administered (same day latency).It was reported that consumer was coming in for a physical and was supposed to receive TDAP.   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.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Inflammation, Nausea, Pain in extremity
Clinical narrative: arm was really red, painful, swollen and on fire; nauseated; sleepy;Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00585546) and transmitted to Sanofi on 03-May-2021.   This case involves a 64 years old female patient whose arm was really red, painful, swollen and on fire (inflammation), was nauseated (nausea) and sleepy (somnolence) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] and while being treated with DIPHENHYDRAMINE HYDROCHLORIDE [BENADRYL].  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 19-Oct-2010, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot U3734AA, Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patients arm was really red, painful, swollen and on fire (inflammation) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE.   The patient took 2 (ADVIL [IBUPROFEN]), however the swelling increased for 2 hours, until it was so bad that she was scared, and had to go to the emergency room (ER). In the ER, her arm was really swollen, red, and on fire.   The patient thought she received Benadryl (date unspecified) and then she was nauseated (nausea), she thought that they inserted an intravenous (IV) but she was not sure because she was so sleepy (somnolence) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE and being treated with DIPHENHYDRAMINE HYDROCHLORIDE.  She was then discharged (date unspecified). The health care professional (HCP) that discharged her stated that she should not receive any more flu shots because they now contain the avian bird flu H1N1 and she had a reaction and her next reaction could be much worse. She asked if it was a specific batch that landed her in the ER after her Fluzone injection on 19-Oct-2010. There was difficulty reading the Lot and what was on the vial, due to the writing being small.  The events were non-serious  The reporter stated that she wanted to visit her mother in the nursing home but the management was insisting that she receive the coronavirus (COVID) vaccine in order to see her mother. The patient stated that she had a reaction to the H1N1 portion of the 2010 Fluzone vaccine and she believed that the COVID vaccines have the H1N1 in them and will make her sick  One of the HCP's in a white lab coat stated to the patient that it must be why so many people are having reactions to the COVID vaccines because so many people got sick after getting the Flu vaccines with the added H1N1.   It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available  At time of reporting, the outcome of events was unknown.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Somnolence
Clinical narrative: arm was really red, painful, swollen and on fire; nauseated; sleepy;Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00585546) and transmitted to Sanofi on 03-May-2021.   This case involves a 64 years old female patient whose arm was really red, painful, swollen and on fire (inflammation), was nauseated (nausea) and sleepy (somnolence) after receiving INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE] and while being treated with DIPHENHYDRAMINE HYDROCHLORIDE [BENADRYL].  It is unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 19-Oct-2010, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot U3734AA, Suspension for injection) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patients arm was really red, painful, swollen and on fire (inflammation) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE.   The patient took 2 (ADVIL [IBUPROFEN]), however the swelling increased for 2 hours, until it was so bad that she was scared, and had to go to the emergency room (ER). In the ER, her arm was really swollen, red, and on fire.   The patient thought she received Benadryl (date unspecified) and then she was nauseated (nausea), she thought that they inserted an intravenous (IV) but she was not sure because she was so sleepy (somnolence) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE and being treated with DIPHENHYDRAMINE HYDROCHLORIDE.  She was then discharged (date unspecified). The health care professional (HCP) that discharged her stated that she should not receive any more flu shots because they now contain the avian bird flu H1N1 and she had a reaction and her next reaction could be much worse. She asked if it was a specific batch that landed her in the ER after her Fluzone injection on 19-Oct-2010. There was difficulty reading the Lot and what was on the vial, due to the writing being small.  The events were non-serious  The reporter stated that she wanted to visit her mother in the nursing home but the management was insisting that she receive the coronavirus (COVID) vaccine in order to see her mother. The patient stated that she had a reaction to the H1N1 portion of the 2010 Fluzone vaccine and she believed that the COVID vaccines have the H1N1 in them and will make her sick  One of the HCP's in a white lab coat stated to the patient that it must be why so many people are having reactions to the COVID vaccines because so many people got sick after getting the Flu vaccines with the added H1N1.   It is unknown if the patient experienced any additional symptoms/events  It is unknown if there were lab data/results available  At time of reporting, the outcome of events was unknown.
Age: 69.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: consumer did not get Imovax at all on day 3 but another manufacturers rabies vaccine with no reported adverse event; Initial information received on 21-May-2021 regarding an unsolicited valid non-serious case from a pharmacists.  This case involves a 69-year-old female patient who received first day zero dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date not reported) but on day 3 received another manufacturers RABIES VACCINE INACT (CHICK EMBRYO) [RABAVERT] (lot ARBA651B, expiry date-01-Mar-2023) via unknown route in unknown administration site for post exposure immunization on 17-May-2021 (interchange of vaccine products).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of interchange of vaccine products (same day).  It was reported that, the patient is scheduled for a 4-series vaccination. Also, the reporter had query if the entire post exposure series of Imovax needs to be performed if the consumer did not receive a dose on Day 3.  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.  There will be no information available on the lot number for this case.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Blood test normal, Muscle twitching, Musculoskeletal stiffness
Clinical narrative: Bell's Palsy.  Prednisone, Antiviral medication and artificial tear eye drops.  Left Ear Pain on 6/1/2021 in the evening.  Twitching on the left side of my mouth.  Woke up on 6/2/2021 with the left side of my face very stiff.  Went to ER.  They said it was the early stages of Bell's Palsy.  Followed up with my Primary Care Physician on 6/8/2021 and confirmed Bell's Palsy.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abnormal behaviour, Anxiety, Hyperventilation, Hyporesponsive to stimuli
Clinical narrative: Pt received Covid #1 at out of office vaccine clinic on 5/27/21. Seen at ER 5/30/21 for behavior change (decreased level of responsiveness, staring off into space, vomiting & nausea, hyperventilation, anxiety Please see enclosed ER note. Spoke with Mom on 6/1/21 is improved History of Present Illness HPI Narrative: 14-year-old boy with history of autism presents with behavior changes, nausea, vomiting.  Patient and his mother provide the history.  He was in his usual state of health last night, had a normal dinner.  Did not answer his door this morning.  Parents found him staring off into space with decreased level of responsiveness.  He was able to drink fluids.  Patient reported having a few episodes of vomiting and abdominal pain earlier.  They were concerned that he could be having a reaction to his COVID-19 vaccine which was given 4 days ago.  Mom gave 25 mg of Benadryl at home.  They were driving to Hospital for evaluation when the patient started looking worse.  He has been hyperventilating but also has now clenching of hands and reports that his feet feel funny.  Mom reports that he is not at his behavioral baseline currently.  No prior abdominal surgeries or additional issues.  Not currently take any medications.  Patient denies taking any Illicit medications/substances.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Joint contracture, Limb discomfort, Nausea, Staring, Vomiting
Clinical narrative: Pt received Covid #1 at out of office vaccine clinic on 5/27/21. Seen at ER 5/30/21 for behavior change (decreased level of responsiveness, staring off into space, vomiting & nausea, hyperventilation, anxiety Please see enclosed ER note. Spoke with Mom on 6/1/21 is improved History of Present Illness HPI Narrative: 14-year-old boy with history of autism presents with behavior changes, nausea, vomiting.  Patient and his mother provide the history.  He was in his usual state of health last night, had a normal dinner.  Did not answer his door this morning.  Parents found him staring off into space with decreased level of responsiveness.  He was able to drink fluids.  Patient reported having a few episodes of vomiting and abdominal pain earlier.  They were concerned that he could be having a reaction to his COVID-19 vaccine which was given 4 days ago.  Mom gave 25 mg of Benadryl at home.  They were driving to Hospital for evaluation when the patient started looking worse.  He has been hyperventilating but also has now clenching of hands and reports that his feet feel funny.  Mom reports that he is not at his behavioral baseline currently.  No prior abdominal surgeries or additional issues.  Not currently take any medications.  Patient denies taking any Illicit medications/substances.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, HIBV, PNC13, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; incorrect product storage; This spontaneous report has been received from a licensed practical nurse and an office manager referring to a 5 months old (also reported as 6 months old) male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported.    On 22-APR-2021, the patient was vaccinated with the second dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml, orally (strength not provided, lot number 1691302 has been verified to be a valid lot number, expiration date reported as 28-SEP-2021, but upon internal validation established as 23-JAN-2022) as prophylaxis; with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (dose and strength not provided; lot number T001206 has been verified to be a valid lot number, expiration date reported as 03-JUN-2022) intramuscularly (IM) on left anterolateral thigh (LAT) as prophylaxis; with the second dose of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (indication, strength and dose were not provided, lot number LY4777, expiration date reported as 22-AUG-2022) IM at right anterolateral thigh (RAT); with the second dose of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX) (indication, strength and dose were not provided, lot number 23YL4, expiration date reported as 04-APR-2022) IM at LAT; and with hib vaccine conj (tet tox) (HIBERIX) (indication, strength, dose, route of administration, lot numbers and dates of expiration were not provided). All vaccines underwent temperature excursion of 35.2 Fahrenheit (F) for 480 hours and 0 minutes (product storage error). It was reported that there were no previous temperature excursions. The digital data logger was involved in recording excursion details. No additional adverse events (AEs) were reported.