chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin reaction
Clinical narrative: Skin reaction; Itchy; Chills; Got a little bloated in the area where the shot was administered; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient). A 50-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8732, Expiry date: unknown), via an unspecified route of administration in left arm on 01Apr2021 09:30 (at age of 50-years-old) as dose 2, single for covid-19 immunisation. Medical history included hysterectomy, kidney donor from 2006 to an unknown date, maxillofacial surgery. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6206, Expiry date: unknown), via an unspecified route of administration on 11Mar2021 (at noon) as dose 1, single for covid-19 immunisation. History of all previous immunization with the bnt162b2 vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available and additional vaccines administered on same date of the bnt162b2 suspect were none. The patient had not received any other vaccine within 4 weeks. Adverse events following prior vaccinations were none. Patient had no family medical history relevant to adverse events. On an unspecified date in 2021, the patient experienced skin reaction, itchy, chills and got a little bloated in the area where the shot was administered. The patient received the second dose of the bnt162b2 covid vaccine in Apr2021 and for about three months afterwards she had a skin reaction to it. She wanted to know if she should get the third shot. She went to a specialist doctor and she was told that the skin reaction looked something like a spider bite that continued again and again. They did not know what it was. It was itchy each time. She went to a dermatologist as well. Reports the skin reaction was no more than 3 bites at a time and then they would disappear and come back again. When she got the first dose she had one bite on her chest and then it disappeared. When she got her second dose on 01Apr2021 at 9:30, the next day three bites appeared. She had one big one on her forehead and two on her right hand. It was itchy each time. Her son came on the line and described that his mother would get itchy, get chills and got a little bloated in the area where the shot was administered, these symptoms occurred after the second dose. She did not have any of the described symptoms right now. The last time she had the skin reaction was about two weeks ago. The adverse events resulted in Physician's office visit. No relevant tests were performed. She was given anti itch cream. Therapeutic measures were taken as a result of the events. The outcome of all the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pruritus, Skin reaction, Vaccination site swelling
Clinical narrative: Skin reaction; Itchy; Chills; Got a little bloated in the area where the shot was administered; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer (patient). A 50-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8732, Expiry date: unknown), via an unspecified route of administration in left arm on 01Apr2021 09:30 (at age of 50-years-old) as dose 2, single for covid-19 immunisation. Medical history included hysterectomy, kidney donor from 2006 to an unknown date, maxillofacial surgery. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6206, Expiry date: unknown), via an unspecified route of administration on 11Mar2021 (at noon) as dose 1, single for covid-19 immunisation. History of all previous immunization with the bnt162b2 vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available and additional vaccines administered on same date of the bnt162b2 suspect were none. The patient had not received any other vaccine within 4 weeks. Adverse events following prior vaccinations were none. Patient had no family medical history relevant to adverse events. On an unspecified date in 2021, the patient experienced skin reaction, itchy, chills and got a little bloated in the area where the shot was administered. The patient received the second dose of the bnt162b2 covid vaccine in Apr2021 and for about three months afterwards she had a skin reaction to it. She wanted to know if she should get the third shot. She went to a specialist doctor and she was told that the skin reaction looked something like a spider bite that continued again and again. They did not know what it was. It was itchy each time. She went to a dermatologist as well. Reports the skin reaction was no more than 3 bites at a time and then they would disappear and come back again. When she got the first dose she had one bite on her chest and then it disappeared. When she got her second dose on 01Apr2021 at 9:30, the next day three bites appeared. She had one big one on her forehead and two on her right hand. It was itchy each time. Her son came on the line and described that his mother would get itchy, get chills and got a little bloated in the area where the shot was administered, these symptoms occurred after the second dose. She did not have any of the described symptoms right now. The last time she had the skin reaction was about two weeks ago. The adverse events resulted in Physician's office visit. No relevant tests were performed. She was given anti itch cream. Therapeutic measures were taken as a result of the events. The outcome of all the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: I have not been feeling good; congestion; cough; head; body aches; severe diarrhea; Shingles; felt like she had the flu; Severe chronic fatigue; cant think or concentrate; has never been so sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0164), via an unspecified route of administration in arm left on 27Jul2021 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included degenerative disc disease from Jul1991 and ongoing, patient medical continuing. The concomitant medications of the patient included she takes blood thinners, but nothing that would make her feel like that. The History of all previous immunization with the Pfizer vaccine considered as suspect and the list all vaccines administered on same date with the Pfizer vaccine considered as suspect were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. The patient experienced I have not been feeling good, congestion, cough, head, body aches, severe diarrhea, shingles, felt like she had the flu, severe chronic fatigue, cant think or concentrate, has never been so sick on an unspecified date. the patient said she was caregiver, and she was not able to do her job. She said that she was going back to the urgent care. She stated that 3 days after she received the first dose of the Covid-19 Vaccine she had severe congestion and cough, headache, and body aches. She felt like she had the flu. She went to urgent care and was negative for Covid. She was told it was the flu and was provided antibiotics for treatment. She said that she had been tested at least 14 times for Covid and they have all been negative. She said that she got shingles and Saturday and Sunday she had severe diarrhea and had never been so sick. She was going back to urgent care to see what they can give her so she could work. She said that she also experienced chronic fatigue. Her body and head felt like she cant think or concentrate because she hurts so bad. She was so exhausted and something was wrong and she was not getting the second shot. She does not think that she was supposed to felt like that. In hindsight she wished she had never got it. The patient underwent lab tests and procedures which included sars-cov-2 test: all been negative on an unspecified date. Therapeutic measures were taken as a result of, felt like she had the flu that included antibiotics. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Herpes zoster, Illness, Influenza, Nasal congestion
Clinical narrative: I have not been feeling good; congestion; cough; head; body aches; severe diarrhea; Shingles; felt like she had the flu; Severe chronic fatigue; cant think or concentrate; has never been so sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0164), via an unspecified route of administration in arm left on 27Jul2021 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included degenerative disc disease from Jul1991 and ongoing, patient medical continuing. The concomitant medications of the patient included she takes blood thinners, but nothing that would make her feel like that. The History of all previous immunization with the Pfizer vaccine considered as suspect and the list all vaccines administered on same date with the Pfizer vaccine considered as suspect were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. The patient experienced I have not been feeling good, congestion, cough, head, body aches, severe diarrhea, shingles, felt like she had the flu, severe chronic fatigue, cant think or concentrate, has never been so sick on an unspecified date. the patient said she was caregiver, and she was not able to do her job. She said that she was going back to the urgent care. She stated that 3 days after she received the first dose of the Covid-19 Vaccine she had severe congestion and cough, headache, and body aches. She felt like she had the flu. She went to urgent care and was negative for Covid. She was told it was the flu and was provided antibiotics for treatment. She said that she had been tested at least 14 times for Covid and they have all been negative. She said that she got shingles and Saturday and Sunday she had severe diarrhea and had never been so sick. She was going back to urgent care to see what they can give her so she could work. She said that she also experienced chronic fatigue. Her body and head felt like she cant think or concentrate because she hurts so bad. She was so exhausted and something was wrong and she was not getting the second shot. She does not think that she was supposed to felt like that. In hindsight she wished she had never got it. The patient underwent lab tests and procedures which included sars-cov-2 test: all been negative on an unspecified date. Therapeutic measures were taken as a result of, felt like she had the flu that included antibiotics. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: I have not been feeling good; congestion; cough; head; body aches; severe diarrhea; Shingles; felt like she had the flu; Severe chronic fatigue; cant think or concentrate; has never been so sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0164), via an unspecified route of administration in arm left on 27Jul2021 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included degenerative disc disease from Jul1991 and ongoing, patient medical continuing. The concomitant medications of the patient included she takes blood thinners, but nothing that would make her feel like that. The History of all previous immunization with the Pfizer vaccine considered as suspect and the list all vaccines administered on same date with the Pfizer vaccine considered as suspect were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. The patient experienced I have not been feeling good, congestion, cough, head, body aches, severe diarrhea, shingles, felt like she had the flu, severe chronic fatigue, cant think or concentrate, has never been so sick on an unspecified date. the patient said she was caregiver, and she was not able to do her job. She said that she was going back to the urgent care. She stated that 3 days after she received the first dose of the Covid-19 Vaccine she had severe congestion and cough, headache, and body aches. She felt like she had the flu. She went to urgent care and was negative for Covid. She was told it was the flu and was provided antibiotics for treatment. She said that she had been tested at least 14 times for Covid and they have all been negative. She said that she got shingles and Saturday and Sunday she had severe diarrhea and had never been so sick. She was going back to urgent care to see what they can give her so she could work. She said that she also experienced chronic fatigue. Her body and head felt like she cant think or concentrate because she hurts so bad. She was so exhausted and something was wrong and she was not getting the second shot. She does not think that she was supposed to felt like that. In hindsight she wished she had never got it. The patient underwent lab tests and procedures which included sars-cov-2 test: all been negative on an unspecified date. Therapeutic measures were taken as a result of, felt like she had the flu that included antibiotics. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: My brothers wife had the Pfizer vaccine and had a rash after the second shot; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's brothers wife) that:  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient stated that his sister-in-law had the pfizer vaccine and had a rash after the second shot on an unspecified date. He was not sure which vaccine she got. There were 50/50 chance she had the Pfizer vaccine. Patient stated do I had to report it without confirming it was a Pfizer Product. The patient did not state when he became aware of the adverse events and the MI agent did not inquire. The outcome of event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101076604 same drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Musculoskeletal chest pain, Vaccination site discolouration, Vaccination site pain
Clinical narrative: Skin turned brown around the injection site and it burns/Has dark pigmentation around injection site; Skin turned brown around the injection site and it burns; Occasional pain in armpit, under rib, and that side of the arm where the shot was; Occasional pain in armpit, under rib, and that side of the arm where the shot was; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported for herself 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, administered in Arm Right on 13Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergic to every antibiotic from an unknown date and unknown if ongoing, Fell from an unknown date and unknown if ongoing and allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced skin turned brown around the injection site and it burns/has dark pigmentation around injection site, skin turned brown around the injection site and it burns and occasional pain in armpit, under rib, and that side of the arm where the shot was. The patient had dark pigmentation around injection site. Saturday or Sunday experienced pain under her rib and armpit. The patient would not be getting second dose. She Does not want more side effects. The patient was allergic to every antibiotic under the sun and doesn't know if that has anything to do with this. Her skin turned brown around the injection site and it burns. Having occasional pain in armpit and that side of the arm where the shot was. Confirmed is having pain in under the rib. Fell a few years ago and hit the left side of her rib cage, but this was on the right side. She was allergic to everything. She went to the doctor and was told she can't be treated. The patient doesn't want to give too personal information like her social security, and She doesn't want anyone coming to her house about this. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable nurse. A 66-year-old male patient received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN solution for injection; Batch/Lot number and expiration date were not reported) via unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was healthy. The patient experienced second one kicked his butt and had fever on an unspecified date. Event was assessed as not serious by the reporter. The reporter's causality assessment was yes, caused by the vaccine.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: I have had constant tone tinnitus for 46 years/It had steadily/3 weeks after second dose the volume steadily increased; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FW0172) via an unspecified route, administered in Right Arm on 26Apr2021 at 09:30 (64-year-old at vaccination) as a Dose 2, Single for COVID-19 immunization. The most recent facility of COVID-19 vaccine administration was reported facility. The patient's medical history included essential hypertension and he have had constant tone tinnitus for 46 years as a result of noise exposure. The patient had no known allergies. The patient's concomitant medication(s) included Valsartan, Omeprazole within 2 weeks of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: LR8733) via an unspecified route, administered in Left Arm on 05Apr2021 at 09:30 (64-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. On 29May2021 at 11:45 PM, the reporter stated that he had constant tone tinnitus for 46 years as a result of noise exposure. It had steadily dissipated over decades from a volume of 10 (on a 0 to 10 scale) to around 3. About 3 weeks after his second dose the volume steadily increased (same tone) to around 7 and was now hovering there with some modulation in intensity, kind of like a slow sine wave, sometimes down to 4 or 5. He cannot attribute this to any other event. Since the vaccination the patient had not been tested for COVID-19. No treatment medications received for resulted events. The seriousness of the event was reported as non-serious by the reporter. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information was expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Erythema, Feeling hot, Nausea
Clinical narrative: Body ached Bad; Chills; Nauseated; Weak; Vaccine shot area sore; Arm Hurting bad within hours.; Red; swollen; Hot to touch; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included myalgia Other medical history: Polymyalgia. HBP. Thyroid, hypertension Other medical history: Polymyalgia. HBP. Thyroid, thyroid disorder Polymyalgia. HBP. Thyroid, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Sulfa. 0n 26Jul2021 Historical Vaccine BNT162B2 for COVID-19 immunisation Other vaccine 4 weeks details: other vaccine 4 weeks product: Covid Pfizer Other vaccine 4 weeks vaccine date: 26Jul2021 Other vaccine 4 weeks lot number: FA7485 A7485, Other vaccine 4 weeks vaccine location Left arm. covid prior vaccination No If Covid tested post vaccination No. On 17Aug2021 15:00 the patient experienced Body ached Bad. Chills. Nauseated. Weak. Vaccine shot area sore. Arm Hurting bad within hours. Couldn't lay on it. Red, swollen. Hot to touch. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Swelling, Vaccination site pain
Clinical narrative: Body ached Bad; Chills; Nauseated; Weak; Vaccine shot area sore; Arm Hurting bad within hours.; Red; swollen; Hot to touch; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 16Aug2021 16:00 (Batch/Lot Number: FC3182) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included myalgia Other medical history: Polymyalgia. HBP. Thyroid, hypertension Other medical history: Polymyalgia. HBP. Thyroid, thyroid disorder Polymyalgia. HBP. Thyroid, drug hypersensitivity from an unknown date and unknown if ongoing Known allergies: Sulfa. 0n 26Jul2021 Historical Vaccine BNT162B2 for COVID-19 immunisation Other vaccine 4 weeks details: other vaccine 4 weeks product: Covid Pfizer Other vaccine 4 weeks vaccine date: 26Jul2021 Other vaccine 4 weeks lot number: FA7485 A7485, Other vaccine 4 weeks vaccine location Left arm. covid prior vaccination No If Covid tested post vaccination No. On 17Aug2021 15:00 the patient experienced Body ached Bad. Chills. Nauseated. Weak. Vaccine shot area sore. Arm Hurting bad within hours. Couldn't lay on it. Red, swollen. Hot to touch. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: not feeling very well; heavy headache/feel like my head is being cut up in half; This is a spontaneous report from a contactable consumer (reported herself). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration, administered in arm left on 16Aug2021 (age at the vaccination was 47-year-old) as dose 1, single for covid-19 immunisation. The vaccine was not administered at military facility. The patient medical history included COVID (patient had COVID a week prior to receiving the vaccine) from an unknown date and unknown if ongoing. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Prior to the vaccination adverse reaction was none. Prior Vaccinations (within 4 weeks) list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Additional vaccines administered on same date of the Pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. The patient denies any other medical conditions, medications, labs, testing, or treatments relevant to symptoms. The patient experienced heavy headache/feel like my head is being cut up in half on 17Aug2021. On an unknown dated the patient was not felling very well. The patient started a heavy headache that's getting worst. The patient asked if the side effect was normal. The patient was asked what can to take to calm the pain. Response provided was spoke from the attached document under side effects/ adverse reaction. "If asked how to manage potential adverse reaction/experience and no information found in approved resources". The patient stated that since patient had real heavy headaches and patient was not feeling very well. The patient had not visited emergency room and physician office. The outcome of the event heavy headache/feel like my head is being cut up in half was not resolved. The outcome of the event not felling very well was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site swelling
Clinical narrative: itchy; site was swollen and red; site was swollen and red; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 11Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller is a consumer who received the first dose of the Pfizer Biontech COVID19 vaccine on 11Aug2021 and stated that after 8 days, she was itchy and swollen. Caller wants to know if it is normal to have the side effect after 8 days since the usual is 1-3 days after. Caller wants to know if she still experiences the side effect, if she should get the second dose of the Pfizer Biontech COVID19 vaccine. Caller states she is calling to check about the Pfizer covid 19 vaccine and states she took the 1st dose on 11Aug2021 and in the first 1-2 days she did not feel anything and after the 8th day she started feeling itchy and the site was swollen and red and states she knows this may be part of the side effects of the vaccine but after 8 days is this normal because it continues. Caller declined to complete the full report at this time and states right now her main concern is that she wants to speak with somebody about her question. The outcome of the events unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: he had a sore arm for a couple of days after the first Pfizer Covid 19 injection.; This is a spontaneous report from a contactable consumer (other non-HCP) who reported for friend. A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration, on an unspecified date (age at the time of vaccination was 62-year-old) as a single dose for COVID-19 immunization. Medical history included chronic ankle pain from a boating accident in Aug2010. Concomitant medication included Oxycodone. The patient had no known allergies. The patient had no other vaccines in 4 weeks. The patient was not tested for COVID prior to vaccination but was tested for COVID post the vaccination. On 07Apr2021, the patient experienced he had a sore arm for a couple of days after the first Pfizer COVID 19 injection. No treatment was received for the event. The patient underwent lab and medical procedure of SARS-CoV-2 test on an unspecified date, with negative result. The clinical outcome of the event was recovered on an unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This is a spontaneous report from a contactable consumer (Parent). An unspecified age of male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not provided), via an unspecified route of administration on an unknown date Aug2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Aug2021, the patient experienced Shortness of breath. It was reported that My son just had the vaccination conducted on Saturday and he is now experiencing shortness of breath and I am sure you could find out if there is any advise you can give us what can we expect in terms of the shortness of breath, what can we expect and how long it's usually last, so forth and so on. Reporter was informed about the role of Pfizer drug safety and Pfizer Medical Information and provided with the number as # and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday as per EST. Product details and pharmacy details could not be probed as the reporter was unwilling to complete the report. Hence limited information available over the call.The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2], F/UP closure to be managed as significant
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Off label use, Product use issue, Pruritus
Clinical narrative: Itchy; Trouble staying asleep; I'm breastfeeding; I'm breastfeeding; This is a spontaneous report received from a contactable consumer (Patient). A 34-year-old female patient received BNT162B2 (PIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7485), Solution for injection, via an unspecified route of administration, administered in Arm Left on 11Aug2021 (at the age of A 34-year-old) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 11ug2021, the patient experienced itchy, trouble staying asleep and she was breastfeeding. The seriousness was reported as non-serious by the reporter. No treatment was received to treat adverse events. The event itchy, trouble staying asleep was recovered on an unspecified date in Aug2021 and outcome of other events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Body aches; Fatigue; Fever; Chills; Headache; Sweats; Coughing; This is a spontaneous report from a contactable consumer Patient reported that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced body aches, fatigue, fever, chills, headache, sweats and coughing. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; Fatigue; Fever; Chills; Headache; Sweats; Coughing; This is a spontaneous report from a contactable consumer Patient reported that. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced body aches, fatigue, fever, chills, headache, sweats and coughing. The event outcome was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Coagulopathy, Fatigue, Headache, Heavy menstrual bleeding
Clinical narrative: Get heavy flow on what would normally be my 'time of the month'; It affects my daily life to detrimental proportions.; Tired; Headache; Bloating throughout every month; My menstrual cycle is now 3 weeks+ long flow and never really stops.; Cramps, spotting, clotting; Cramps, spotting, clotting; Cramps, spotting, clotting; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported for herself that.  A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 13:45 as (At the age of 44-years) dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included acetaminophen taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of Vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. The patient previously took Erythromycin, penicillin and all derivatives, Epinephrine shot (the way it is prepared) and experienced drug hypersensitivity (Allergies). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 01:30 PM as (At the age of 44-years) dose 1, single for covid-19 immunisation and experienced intermenstrual bleeding. On 29Apr2021 12:00 patient experienced menstrual cycle is now 3 weeks long flow and never really stops. Cramps, spotting, clotting, the whole nine yards almost all month, every month since his second dose. First dose had made spot some between periods, too. It was reported that patient still get heavy flow on what would normally be his 'time of the month'. If patient lucky, might get up to a week after his 'time' flow-free, but never more and often less. Patient cannot go even one day without wearing a pad at least or I'll bleed through clothing. Tired, headache, cramps, even a bit of bloating throughout every month since vaccination. This suck, it affects his daily life to detrimental proportions. Patient did not receive any Treatment for events. No Prolonged Hospitalization for events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Loss of personal independence in daily activities, Menstrual disorder, Muscle spasms
Clinical narrative: Get heavy flow on what would normally be my 'time of the month'; It affects my daily life to detrimental proportions.; Tired; Headache; Bloating throughout every month; My menstrual cycle is now 3 weeks+ long flow and never really stops.; Cramps, spotting, clotting; Cramps, spotting, clotting; Cramps, spotting, clotting; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported for herself that.  A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 13:45 as (At the age of 44-years) dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included acetaminophen taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of Vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. The patient previously took Erythromycin, penicillin and all derivatives, Epinephrine shot (the way it is prepared) and experienced drug hypersensitivity (Allergies). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 01:30 PM as (At the age of 44-years) dose 1, single for covid-19 immunisation and experienced intermenstrual bleeding. On 29Apr2021 12:00 patient experienced menstrual cycle is now 3 weeks long flow and never really stops. Cramps, spotting, clotting, the whole nine yards almost all month, every month since his second dose. First dose had made spot some between periods, too. It was reported that patient still get heavy flow on what would normally be his 'time of the month'. If patient lucky, might get up to a week after his 'time' flow-free, but never more and often less. Patient cannot go even one day without wearing a pad at least or I'll bleed through clothing. Tired, headache, cramps, even a bit of bloating throughout every month since vaccination. This suck, it affects his daily life to detrimental proportions. Patient did not receive any Treatment for events. No Prolonged Hospitalization for events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable Nurse. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown) via an unspecified route of administration as dose number unknown, single on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Nurse reported that the patient had shingles after the vaccine on an unspecified date. The reporter assessed the event as non-serious. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084524 Same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable other health care professional (registered nurse). A contactable Registered Nurse reported similar events for 3 patients. This is 2 of 3 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection ,batch/Lot number was not reported, expiry date: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller was listening to the radio, and they said people are reporting an uptick of shingles after getting the COVID 19 vaccine. She had shingles after the vaccine as well as 3 other people she knows. It was out of the blue. On an unspecified date, One of the people she works with was going through shingles now after the vaccine. His happened within 6 months of the shot. The person was going to be terminated if he didn't get the vaccine. She doesn't have his information to do a report. The outcome of event was not recovered. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084524 Same reporter/drug/AE, different patient
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Gait disturbance, Muscle spasms, Peripheral swelling, Premenstrual syndrome
Clinical narrative: I have leg cramp, cramps in my calf.; I have swelling below my knee.; I have a bruise that after seven days is now going away; 24 hours after my vaccine I could not walk up up a hill. I barely could walk and definitely could not walk up a hill; I have red dots on my thigh; I have red spots in my thighs; I have PMS symptoms. So, like perimenopause symptoms. It is not like I had my period again but I have all those symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 56 years), (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported, I was going to go on Pfizer website just trying to figure out the safety one, I have had side effects from the Pfizer Covid first vaccine, and I wanted to report it, but I thought to speak to somebody verbally. I have leg cramp, cramps in my calf. I have swelling below my knee. I have a bruise that after seven days is now going away. I never bruise and I had Bruise. 24 hours after my vaccine I could not walk up a hill. I barely could walk and definitely could not walk up a hill. I had, I did not know how to put this, I had PMS symptoms. So, like perimenopause symptoms. It was not like I had my period again, but I had all those symptoms and now I had red spots in my thighs. The clinical outcome of the event I have a bruise that after seven days is now going away was recovering, and remaining all other events was unknown at the time of report. Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: I have leg cramp, cramps in my calf.; I have swelling below my knee.; I have a bruise that after seven days is now going away; 24 hours after my vaccine I could not walk up up a hill. I barely could walk and definitely could not walk up a hill; I have red dots on my thigh; I have red spots in my thighs; I have PMS symptoms. So, like perimenopause symptoms. It is not like I had my period again but I have all those symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date (at the age of 56 years), (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported, I was going to go on Pfizer website just trying to figure out the safety one, I have had side effects from the Pfizer Covid first vaccine, and I wanted to report it, but I thought to speak to somebody verbally. I have leg cramp, cramps in my calf. I have swelling below my knee. I have a bruise that after seven days is now going away. I never bruise and I had Bruise. 24 hours after my vaccine I could not walk up a hill. I barely could walk and definitely could not walk up a hill. I had, I did not know how to put this, I had PMS symptoms. So, like perimenopause symptoms. It was not like I had my period again, but I had all those symptoms and now I had red spots in my thighs. The clinical outcome of the event I have a bruise that after seven days is now going away was recovering, and remaining all other events was unknown at the time of report. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nerve injury
Clinical narrative: Painful nerve issue in her neck and arm for 6 weeks; This is a spontaneous report from a contactable consumer reported for a female patient (twin sister). A female patient of unspecified age received second dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection), via an unspecified route on an unspecified date in Dec2020 (age at vaccination: 62-year-old), as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection), as a single dose for covid-19 immunization. On an unknown date, after the second dose patient experienced a painful nerve issue in her neck and arm for 6 weeks. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.