chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: left shoulder and upper arm pain; left shoulder and upper arm pain; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left (left shoulder) on 29Mar2021 (Batch/Lot Number: ER8730) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 01Mar2021, with lot number EL3302, in his left shoulder and experienced pain in his left shoulder. The patient received the second dose at the end of Mar 2021, on 29Mar2021. Since the second dose (29Mar2021), he experienced left shoulder and upper arm pain for two months and the pain has not gone away. Caller states that he received the injection in his left arm. He had consulted with his HCP in which they advised him to perform stretching exercises and states that the exercises have not helped. Caller states his doctor said the pain must be from him having a strong immune system. It was reported that after the second dose, he had less pain in his shoulder, but it hasn't gone away. He did not have a prescribing doctor. He had not received treatment. He didn't go to the doctor or ER. He did talk to his doctor, and his doctor said people are reporting all kinds of weird stuff. He did ask him if he was working it out. The caller was stretching every morning, and that was when he felt it. Patient wanted to know if he should be concerned about this side effect, what he should do and there is any treatment recommendations to provide. He also asked if anyone else has experienced this side effect and what could cause this pain in his arm and shoulder. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pains to our elbows for 5 weeks; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age 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 as a 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient received historical vaccine of BNT162B2 (COVID 19 Vaccine) as first dose on an unspecified date. The patient's concomitant medications were not reported. On an unspecified date the patient experienced joint pains in elbows for 5 weeks (arthralgia) (non-serious). The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021592717 Same reporter/drug/AE, different patient
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Right side facial numbness; Arms is sore; This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 22May2021 (Batch/Lot Number: EW0187/Expiry date: unknown) (at the age of 28-year-old) as 1st dose, single dose for covid-19 immunisation. The patient had no medical history. Concomitant medication included LESSINA taken for birth control. Nurse stated, on 22May2021 (yesterday) she got her Pfizer Vaccine, the first dose and today, on 23May2021 just randomly she had right side facial numbness and arms was sore. Nurse wanted to know was this common side effect that happen with Pfizer vaccine. The outcome of the events was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: was tired a little; This is a spontaneous report from a contactable consumer or other non hcp for herself. This is the first of two reports (report 2 was for her husband). This is a split case of another report with same patient, different dose number (first dose) and event. An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EN6200; Expiration date was not reported), via an unspecified route of administration, administered in right arm on 24Feb2021 as single dose for COVID-19 immunisation. Medical history included tachycardia, benign with a regular rhythm and panic attacks from an unspecified date and unknown if ongoing which she has had for 40 years. The patient stated she is anxious person. Patient stated that her tachycardia started when she was 43 years old, and usually gets them periodically. The patient also states she had a routine with different medications and only takes three, but no she didn't have anything out of the ordinary. No further details provided for concomitant medications. The patient experienced little bit tiredness on 24Feb2021. She wasn't quite sure if she should call and report this, but her husband said that she should. The patient really didn't have any aftereffects from the first dose of COVID vaccine. Her arm wasn't sore. She was tired a little bit and thought that it began probably within an hour or two after her first dose of COVID vaccine in the afternoon. She stated that it lasted fairly long, for several hours. The patient was reluctant at first because she used to work for a doctor's business office for 20 years and had observed too much and not being a medical person, she put a lot of fear into her mind. This was so quick and fast, but her cardiologist and primary care provider said to get it, so she did. Her husband was reluctant also but at their age they knew that they needed to be protected. They had the fear more out of the quickness on everything and how all at once they had the vaccine but not being a medical people, they listened to their doctors. Patient didn't remember but tend to think it was in her right arm she got vaccinated. No history of vaccinations with in 4 weeks prior to the first dose of COVID vaccine. No relevant tests were done. She remembered reading articles while waiting for her first dose and tachycardia jumped out at her as a side effect and her husband's first thought was that seeing that triggered her, but she didn't have anything after the first dose, so she dismissed it. The outcome of the evet was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gout, Movement disorder
Clinical narrative: Made her gout flare up in her whole right leg and she couldn't move it so she had to go to the emergency room; Made her gout flare up in her whole right leg and she couldn't move it so she had to go to the emergency room; Ankle pain; This is a spontaneous report received from a contactable consumer (reporting on herself). A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0161; Expiration Date was not reported) via an unspecified route of administration in Arm Left on 14Apr2021, as 1st dose, single dose for COVID-19 immunization. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications.  On 16Apr2021 she was in the emergency room be-cause they were checking to be sure that she had no blood clots or a stroke. The COVID vaccine caused a reaction to her gout. Caller clarifies that the COVID vaccine made her gout flare up in her whole right leg and she couldnt move it so she had to go to the emergency room. She used to see Dr. but he retired so now she sees another Dr. She had called her doctor on 16Apr2021 about what she was experiencing and the doctor told the caller that she needed to go to the emergency room so that they could rule out a blood clot and whatever else they do in the emergency room. Probed for when this ended and caller says it ended shortly after they gave her some Tylenol. That was how she knew it was a reaction to the COVID vaccine because gout medicine takes 3 to 4 days to work but they gave her Tylenol and a prescription for ibuprofen therefore she knew what she was experiencing didnt have anything to do with gout. When she was rolled out she saw that they put that she was in there for ankle pain and they didnt put anything about gout. They also did a survey on her and said not to take the second COVID vaccine. Also the COVID nurse said for the caller to not take the second dose, too. Her doctor told her to take it because otherwise she wasnt going to get it because she knows that everyone was just a guinea pig right now. But her doctor suggested that she get it, so she did. She just wants this DSU agent to put in her report she was getting sick from it. She was allergic to penicillin and it will kill her. That was her question before going and having the COVID vaccine. But when they show you the ingredients, no one can read , no one can read those ingredients. Probed for NDC, lot number and expiry date for the previous penicillin and caller declined to provide and said that this was when she was a baby and she hasnt been able to take it since then, they put on her medical records for her to not have it or she will die. The out-come for event ankle pain  was unknown and for events The patient experienced made her gout flare up in her whole right leg and she couldn't move it so she had to go to the emergency room was recovered on 16Apr2021.   Follow up needed, further information has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swollen since 19May; This is a spontaneous report from a contactable consumer (Patient).   A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) dose 1 via an unspecified route of administration in Arm Left on 18May2021 17:15 (Batch/Lot Number: EW0162; 12-years-old age at time of vaccination) as single dose for covid-19 immunisation. Medical history included asthma and seasonal allergies. Concomitant medications included montelukast and cetirizine hydrochloride (ZYRTEC) and Smarty Pants Vitamins. The patient previously took Tamiflu and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19May2021 at 07:30 PM, patient had lymph node swelling. No treatment was received for event. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not resolved.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in left arm and leg/tingling in right arm and leg; This is a spontaneous report from a non-contactable consumer (patient). A 39-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; lot number: ER8730, Expiration date: Unknown), via an unspecified route of administration in the left arm, on 12May2021 18:45 as single dose for COVID-19 immunization. The patient's medical history was known allergies from sulfa. Concomitant medications (other medications the patient received within 2 weeks of vaccination) included multivitamin, Vitamin D, Biotin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. It was reported that after administration, the patient experienced tingling in left arm and leg approx. 8 hours after shot, tingling in right arm and leg approx.36 hours after shot on 13May2021 03:00. No treatment was received for the adverse events. Patient reported no for seriousness criteria-Results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: we had very mild (drowsy/arm pain) symptoms; we had very mild (drowsy/arm pain) symptoms; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and Expiration date was not reported) as 1st dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced very mild (drowsy/arm pain) symptoms. The outcome of the events was unknown.  Information about batch/lot number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021595764 Same reporter/drug/AE and different patients.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: We had very mild (drowsy/arm pain) symptoms; We had very mild (drowsy/arm pain) symptoms; This is a spontaneous report received from a contactable consumer (patients wife). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient's wife reported that, we had very mild (drowsy/arm pain) symptoms. We supported each other for the 3 days it took to pull it together. We campaign for others to get their vaccines. She also asked can we please consider our son for your child study. She have been anxiously following articles about possible roll out in September. Would like to help with that in any way. The outcome of the events was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021595672 Master case, same reporter, product, adverse event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm for 3 days at the site of injection; This is a spontaneous report from a contactable consumer. A 14-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21May2021 as single dose for COVID-19 immunisation. Medical history not reported. Concomitant medication included methylphenidate taken from 21May2021 to 23May2021. Past drug included that patient was received methylphenidate 36 mg tablets (PO, QD) for two years for ADHD without reported problems. On 21-May-2021, the patient received his first Pfizer COVID-19 vaccine. It was reported that the reporter had asked the patient physician about recommendations on interactions with methylphenidate and the COVID-19 vaccine and the physician had no information to provide to the reporter. Therefore, the patient held his methylphenidate doses starting 21-May-2021 to 23-May-2021. It was reported that patient only experienced a sore arm for 3 days at the site of injection. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: I have like a big swelling underneath my arms and it is on the same arm that I got the shot in; This is spontaneous report received from contactable consumer (Patient). An unspecified age and gender patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on an unspecified date in May2021 (on Friday) at 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In May2021, the patient had like a big swelling underneath arms and it was on the same arm that the patient got the shot in. Reporter seriousness for the patient had like a big swelling underneath arms and it was on the same arm that the patient got the shot in was unspecified. The outcome of the event was unknown.  Consumer was informed about Pfizer Medical Information department and provided with the number Limited information was available over the call as consumer hung up abruptly.  Information on the Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Hyperhidrosis, Pain in extremity
Clinical narrative: Lot of pain in arm; Bit woozy; Hot/cold sweats; Sore back; This is a spontaneous report from a non-contactable consumer or other non hcp. A 57-years-old non-pregnant female consumer (patient) reported for herself that who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscular on 22May2021 11:00 (Batch/Lot number unknown) (Age at Vaccination: 57 years) as unknown, single dose for covid-19 immunization. Medical history included allergic to salmonids and juniper. The patient's concomitant medications were not reported. Any other vaccines within 4 weeks prior to the COVID vaccine as unknown. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient developed lot of pain in arm, bit woozy, hot/cold sweats and sore back for which she did not received any treatment. The outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Sneezing
Clinical narrative: slight headache; sneezing; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced slight headache and sneezing on an unspecified date. The reporter stated that patient also in week 3 and patient felt like slight headache and sneezing. No fever." Could it be related to the pollen in the air. Patient use NASONEX every day and have been using it every day. Patient was sneezing. Maybe it's the vaccination completing the process. Patient was supposed to get my 2nd dose but now that it's authorized for kids, patient waited 20-25 minutes. The pharmacist said, "pharmacist was actually thawing it" (pharmacist felt like they were rushed). Pharmacist enquired do they need to be thawed within 30 minutes pharmacist didn't feel comfortable. Pharmacist felt like the pharmacy was rushing. " Therapeutic measures were taken as a result of sneezing and treatment included NASONEX. The outcome of the events was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm after first dose of Covid Vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EW0176, expiry date: unknown) dose 1 via an unspecified route of administration, administered in right arm on 29Apr2021 as single dose for COVID-19 immunisation. The patient took Covid Pfizer Vaccine because she wanted to travel. The patient medical history and concomitant medication were not reported. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as none. Additional Vaccines administered on same date of the Pfizer Suspect was reported as none. Any adverse events following prior vaccinations was reported as none. Any illness at the time of vaccination was reported as none. On 30Apr2021, the patient experienced sore arm the next day after the first dose of the vaccine, but then it was gone. The outcome of the event was recovered on 01May2021.  No follow-up attempts possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient friend). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on an unspecified date for covid-19 immunisation. On an unspecified date, after vaccination the patient experienced flu like symptoms. The outcome of the event was unknown.  Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Polymerase chain reaction
Clinical narrative: Sore throat; This is a spontaneous report from a Pfizer sponsored program . A non-contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that caller mother got a pcr test because she had a sore throat, but tested negative on an unspecified date in 2021. She got her first dose 29Apr2021. She wants to know when her mom can get second dose now. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site reaction
Clinical narrative: rash on his site of admin; he saw redness and flare at his site of admin; he saw redness and flare at his site of admin; This is a spontaneous report from a contactable HCP (parent) reporting on behalf of son(patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/Batch number and Expiration date not reported), via an unspecified route of administration on 16May2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. He was not reported for history of any allergies. The patient experienced rash on his site of admin and he saw redness and flare at his site of admin on an unspecified date of May2021. The outcome of the events was reported as unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm Hurt; This is a spontaneous report via Pfizer Sponsored Program from a non-contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) 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. On an unspecified date the patient experienced arm hurt. patient was about to receive the second dose. patient was asking if she can take Tylenol before or after the second dose because the last time her arm hurt. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nausea
Clinical narrative: changes in breathing; it just feels different; a little nauseous; a little achy/body aches; headache in the top of her neck; tiredness/extremely tired; chills; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 05May2021 at 15:45 (Batch/Lot Number: EW0167) as, single dose for covid-19 immunization. Medical history included ongoing hyperthyroidism, seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 25May2021, morning she woke up, 20 days after receiving her first vaccine and patient was extremely tired, she had to lay back down. She was a little nauseous, a little achy, had a headache in the top of her neck and changes in her breathing stated that it just felt different. She does think it was related to the Covid 19 vaccine because her husband woke up with the same symptoms last week on 19May2021. She took a powernap this morning and she felt better. She also had chills, not shivering, just kind of like a chill and then she was fine. That was this morning also. She had a sweatshirt on. She started blaming her symptoms on seasonal allergies. She still had a little headache at the top of her neck. She was still tired, she could lay down and go to sleep. She has hyperthyroidism so being tired is not normal for her. She was leery over getting the second Covid 19 vaccine because she was heard that people get sicker after the second dose. The outcome of the events nausea, changes in breathing was unknown and other events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiration abnormal
Clinical narrative: changes in breathing; it just feels different; a little nauseous; a little achy/body aches; headache in the top of her neck; tiredness/extremely tired; chills; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on 05May2021 at 15:45 (Batch/Lot Number: EW0167) as, single dose for covid-19 immunization. Medical history included ongoing hyperthyroidism, seasonal allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 25May2021, morning she woke up, 20 days after receiving her first vaccine and patient was extremely tired, she had to lay back down. She was a little nauseous, a little achy, had a headache in the top of her neck and changes in her breathing stated that it just felt different. She does think it was related to the Covid 19 vaccine because her husband woke up with the same symptoms last week on 19May2021. She took a powernap this morning and she felt better. She also had chills, not shivering, just kind of like a chill and then she was fine. That was this morning also. She had a sweatshirt on. She started blaming her symptoms on seasonal allergies. She still had a little headache at the top of her neck. She was still tired, she could lay down and go to sleep. She has hyperthyroidism so being tired is not normal for her. She was leery over getting the second Covid 19 vaccine because she was heard that people get sicker after the second dose. The outcome of the events nausea, changes in breathing was unknown and other events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have had no congestion, itchy eyes, shortness of breath while exercising or a running nose. Nothing has changed other than the vaccinations.; This is a spontaneous report from a contactable consumer. This 66-year-old male consumer (patient) reported that he received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on unspecified dates in 2021 as 1st dose, single and 2nd dose, single for COVID-19 immunization. The patient medical history included ongoing allergies, hay fever; and congestion and stuffy nose during pollen season (since childhood). The concomitant medications for patient were not reported. The patient reported that he had history of allergies, hay fever, congestion and stuffy nose during pollen season since childhood. He completed the two doses of Pfizer COVID vaccination along with his wife in 2021. This spring, despite of very heavy pollen, the patient had no congestion, itchy eyes, shortness of breath while exercising or a running nose. Nothing had changed other than the vaccinations. The patient wanted to make aware of this in the event this was a possible positive vaccination side effect. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: my second Covid vaccine has left me ill for over one week.; This is a spontaneous report from a Pfizer sponsored program Pfizer Rx Pathways. A contactable consumer (patient) reported that a 56-year-old patient of an unspecified gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as second dose single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. On an unspecified date it was reported that my second Covid vaccine has left me ill for over one week. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: he felt dizzy; This is a spontaneous report from a contactable consumer (patient himself). A 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, after first COVID-19 Vaccine, he felt dizzy on an unspecified date. The outcome of the event was unknown.   Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: a little stomach ache; This is a spontaneous report from a non-contactable consumer (patient) via medical information team. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on 21May2021 as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a little stomach ache on 23May2021. The patient received treatment with TYLENOL (Paracetamol). The outcome of event was not recovered as the patient had this event at the time of report.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second 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 unknown date in 2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took 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 a single dose for COVID-19 immunization and experienced few chills on 2nd day. On an unspecified date in 2021, the patient experienced sore arm the day after the second shot. The clinical outcome of the event was unknown.  Follow-up needed. Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm was sore; This is a spontaneous report received from a non-contactable consumer identified during social media monitoring.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patients arm was sore after receiving the vaccine but was otherwise felt fine. Patient took covid-19 vaccine after it was approved for children ages 12-15. Outcome of the events was reported as unknown.  No follow-up attempts are possible,information about lot/batch number cannot be obtained
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Malaise, Pain, Pyrexia
Clinical narrative: fever; doesn't feel well; body aches; headaches; coughing; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer, the male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history included severe allergies and susceptible to getting seasonal problems. The patient's concomitant medications were not reported. On an unspecified date, the patient did not want to do report and has a scheduled second dose of Pfizer's COVID vaccine on 27May2021. Last night the developed a fever and doesn't feel well and doesn't know if he should reschedule his appointment or not. He is feeling body aches and stated, "I cant go through another round of fever and headache. I have fever, body aches, and headaches from my coughing, but usually during the April time, I get severe allergies and I'm pretty susceptible to getting seasonal problems. I'm not sure exactly what's going on with me." Seriousness criteria was reported as non-serious. The outcome of the events was unknown.  Information about lot/batch number have been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Sleep disorder
Clinical narrative: Headache; Fever; Cannot get to sleep at night; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A patient of an unspecified age and gender (children) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had headache, fever, and cannot get to sleep at night. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cyst
Clinical narrative: ovarian cysts; This is a spontaneous report from a contactable consumer, the patient. A 31-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 06May2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose on 06May2021, a week after the patient had ovarian cysts. She indicated the only thing that was changed, she has been working from home.  The outcome of the event was unknown  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 100.8F fever; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) at an unknown dose number, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he was vaccinated on previous day and was still experiencing the fever in May2021 and had temperature of 100.8 Fahrenheit. The reporter wanted to know how long the fever usually lasts after the administration of the Pfizer BioNTech Covid-19 Vaccine. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Loss of personal independence in daily activities, Pain in extremity, Vaccination site pain
Clinical narrative: burn feeling on her arm; pain at the injection site; shoulder and arm have been hurting; shoulder and arm have been hurting; having a hard time getting dressed and lift her arm; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 62-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date: unknown) via an unspecified route of administration on 30Apr2021 (at the age of 62-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccines included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) on 13Apr2021 as single dose for COVID-19 immunization. She stated that the nurse who administered the 2nd dose asked her to pull her arm down and had burn feeling on her arm when she received the shot on 30Apr2021. She had pain at the injection site. Her shoulder and arm have been hurting ever since she got the 2nd dose. She was having a hard time getting dressed and lift her arm in 2021. She wanted to know recommendations to manage the symptoms and how long usually the symptoms last. The outcome of events is unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from contactable consumer (patient) from a Pfizer sponsored program support. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 21May2021 as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in May 2021, after her shot, her arm really hurts. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; This is a spontaneous report from a contactable consumer or other non hcp. A 20-years-old male patient received BNT162B2 (: PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as a Single dose for covid-19 immunization. The patient past medical history and concomitant medications were not reported.  The patient experienced runny nose 10 days but was fine after on Mar2021. However, 4 days later he woke up with an incredible ringing in my ears and a spike headache that he has never experienced that in his life. He also reported a rash under one of his eyes that later spread to the other eye, as well as insomnia. He has seen his HCP and was referred to an Audiologist, who he has visited 3 times since then. He was diagnosed with 50% loss of hearing and 10500 Hertz tinnitus, which the Audiologist mentioned is high. He was prescribed with high dose Prednisone for 7 days, but caller mentioned it did not help and had no effect whatsoever. His HCP wanted to be super cautious and recommended a brain scan this week just to make sure he didn't develop a blood clot. He has reached out to CDC and asked for medical advice, but he stated that everyone is giving him the same answers - there is not enough data. He is on the verge of suicide and said, I can't live with this for the rest of my life. I can't sleep and can't think, its driving me crazy. The event outcome was recovered on Apr2021.  He is desperate for answers and even tried reporting to VAERS but there was no way to submit it.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I need to know,I had the COVID 20days ago, if it's okay I have the second dose.; This is a spontaneous report received from a non-contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on a IVR call, the patient wanted to know that, he had the COVID 20 days ago and whether it was okay, if the patient have the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Fever; Headache; This is a spontaneous report received from Pfizer-Sponsored Program. A non-contactable consumer (patient) reported for himself that a male patient of an unspecified age received 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 05May2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, the patient received Pfizer Covid-19 vaccine first dose on 05May2021 and experienced fever and headache for 3 days on an unspecified date in May2021. He was confused if he would take the 2nd dose of the vaccine because of the side effects he experienced. The 2nd dose would be on the 27May, which is 22 days prior to 1st dose. Outcome of the events was recovered on an unspecified date in May2021.  Medical Information: No: Customer and/or medical inquiry was not forwarded or referred to MI  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Catheterisation cardiac, Coronary artery occlusion, Hypertension, SARS-CoV-2 test
Clinical narrative: high blood pressure; blockage / two cardiac stents placed; This is a spontaneous report from a non-contactable consumer (patient). This 57 years old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 at 05:00 (at 57 years of age) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced high blood pressure on 11Feb2021. The event required ER visit on 11Feb2021, physician office visit and was reported as serious per hospitalization for 3 days and as life-threatening. Cardiac cath lab was performed on 12Feb2021 and blockage was found, resulting in two cardiac stents placed. Device date: 25May2021. High blood pressure resolved with sequel on an unspecified date in 2021. Blockage outcome was unknown. On 25Feb2021 at 05:30 the patient received the second vaccination. On 15Apr2021, the patient had another emergency trip to ER, another blockage in the left anterior descending artery. This blockage was only 40% blocked in Feb2021 and suddenly in Apr2021 became 99% blocked. Dr suspected a blook clot when symptoms of shortness of breath appeared suddenly. Since the vaccination, the patient had been tested for COVID-19 (on an unknown date in 2021, with unknown results).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021601862 same patient, different vaccine dose/events
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: She felt extreme soreness after 1st dose; This is a spontaneous report from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported, she felt extreme soreness after 1st dose. She is taking antibiotics and is scheduled to get 2nd dose of covid vaccine today and on the antibiotic bottle it says not to get any vaccines while taking. Wanted to know if she should reschedule- provided number for as they are not open yet. Caller then mentioned that she didn't want to take any chances. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Malaise, Oropharyngeal pain
Clinical narrative: cough; not feeling wel; sore throat; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient developed a bad cough today and patient supposed to get second dose today at 5:00 and patient coughing and not feeling well and also patient developed sore throat on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Immune system disorder
Clinical narrative: immune system's reaction; flare ups after vaccination; This is a spontaneous report received from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as 1st dose, single, dose 2 via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient reported that he was experiencing flare ups after vaccination. The patient stated that his doctor stated that this normal and was immune system's reaction and will go away in about a month. The patient stated that it was getting better over time. Pharmacist informed the patient that it will get better with the more doses of Dupixent given and symptoms should be resolved eventually, but as far as a time frame couldn't tell exactly. The outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.