chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Alopecia areata
Clinical narrative: 1 week after my second dose I start developing hair loss, specifically alopecia Areta; 1 week after my second dose I start developing hair loss, specifically alopecia Areta; This is a spontaneous report received from a contactable 28-year-old female nurse reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: El1284, dose number=2) via an unspecified route of administration on 06Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: Ej1685, dose number=1) via an unspecified route of administration on 18Dec2020 10:30 AM at single dose for Covid-19 immunization. As per the adverse event description, one week after her second dose on 15Jan2021, she started developing hair loss, specifically alopecia Areta resulted in doctor or other healthcare professional office/clinic visit. She took unspecified steroid injections to scalp. The outcome of events was not recovered.  No follow-up attempts are possible. No further information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood sodium, Chills, Fatigue
Clinical narrative: muscle pain; she did not feel good; tiredness; joint pain (thigh/hip/went down to her both legs)/all over body; pain in her back/pain right side of her back; injection site pain; chills; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A 82-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: EL322/9, Expiration date: Not provided, NDC number: Not provided), via unspecified routed of administration (Anatomical location: Arm Right) on 27Jan2021 12.10 as single dose for Covid-19 immunisation. The patient medical history included on May2020 she had emergency gallbladder surgery and she had a severe low sodium level. Adds she is still taking gatorade for the sodium level (still low sodium level; doesn't even come to the bottom range) and her doctor told her not to take free water, on 9Mar2020 she had a total knee replacement, she had a hysterectomy 10 years ago She had ongoing Urinary incontinence, ongoing urinary tract infection in Jun2020 or Jul2020, patient family history includes husband passes and she is alone. The patient had no Prior Vaccinations within 4 weeks. The patient concomitant medications included vitamin d3 at 50 mcg orally once a day, oxybutynin orally 5mg twice a day, diphenhydramine hydrochloride orally 25mg once a day for allergy, cephalexin orally 250mg once a day, amitriptyline 10 mg thrice a day orally for urinary incontinence all concomitant medications are ongoing. It was reported that on 27Jan2021 2 hours later patient experienced pain in her back, injection site pain, tiredness, chills, muscle pain, and joint pain ("upper joint of both legs, 1st one leg, then 2nd leg, then both"), also stated that almost two hours to the date she felt pain 7 inches by 9 inches on the right side of her back. Eventually it went away, she also had injection site pain, tiredness; muscle pain really really bad chills; joint pain; but she had no fever; Adds she did not feel good and these effects just came one after the other. Adds she was so cold besides four sweaters and her heating blankets she was still so cold, she does get chilled a lot but this was so obvious, States she had the joint pain all over her body but especially in the joint of her thigh/hip and it went down to her legs. She is not sure when went away because she took two extra strength tylenol and it got better. Adds she lives alone because her husband passes, and she had to use a cane and it was really difficult. The outcome of the event back pain recovered on 31Jan2021, injection site pain recovered on 28Jan2021, chills recovered on 30Jan2021, Fatigue, muscle pain, Arthralgia, she did not feel good recovered on 01Feb2021.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Vaccination site pain
Clinical narrative: muscle pain; she did not feel good; tiredness; joint pain (thigh/hip/went down to her both legs)/all over body; pain in her back/pain right side of her back; injection site pain; chills; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A 82-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: EL322/9, Expiration date: Not provided, NDC number: Not provided), via unspecified routed of administration (Anatomical location: Arm Right) on 27Jan2021 12.10 as single dose for Covid-19 immunisation. The patient medical history included on May2020 she had emergency gallbladder surgery and she had a severe low sodium level. Adds she is still taking gatorade for the sodium level (still low sodium level; doesn't even come to the bottom range) and her doctor told her not to take free water, on 9Mar2020 she had a total knee replacement, she had a hysterectomy 10 years ago She had ongoing Urinary incontinence, ongoing urinary tract infection in Jun2020 or Jul2020, patient family history includes husband passes and she is alone. The patient had no Prior Vaccinations within 4 weeks. The patient concomitant medications included vitamin d3 at 50 mcg orally once a day, oxybutynin orally 5mg twice a day, diphenhydramine hydrochloride orally 25mg once a day for allergy, cephalexin orally 250mg once a day, amitriptyline 10 mg thrice a day orally for urinary incontinence all concomitant medications are ongoing. It was reported that on 27Jan2021 2 hours later patient experienced pain in her back, injection site pain, tiredness, chills, muscle pain, and joint pain ("upper joint of both legs, 1st one leg, then 2nd leg, then both"), also stated that almost two hours to the date she felt pain 7 inches by 9 inches on the right side of her back. Eventually it went away, she also had injection site pain, tiredness; muscle pain really really bad chills; joint pain; but she had no fever; Adds she did not feel good and these effects just came one after the other. Adds she was so cold besides four sweaters and her heating blankets she was still so cold, she does get chilled a lot but this was so obvious, States she had the joint pain all over her body but especially in the joint of her thigh/hip and it went down to her legs. She is not sure when went away because she took two extra strength tylenol and it got better. Adds she lives alone because her husband passes, and she had to use a cane and it was really difficult. The outcome of the event back pain recovered on 31Jan2021, injection site pain recovered on 28Jan2021, chills recovered on 30Jan2021, Fatigue, muscle pain, Arthralgia, she did not feel good recovered on 01Feb2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia, SARS-CoV-2 test
Clinical narrative: pins and needles in the left arm/pins and needles feeling right arm; pain in left arm; numbness in face; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: unknown, Formulation: Solution for injection, Lot number: EL3302, Expiration date: unknown), via an unspecified route of administration in left arm at the age of 64-years, on 20Jan2021, at single dose (dose number: 1) for COVID-19 immunisation. The patient's medical history included positive Covid test (tested positive is either 03Jan2021 or 07Jan2021, does not remember exact date. Got positive test on a Sunday and retested on Tuesday). Concomitant medications were none. Caller states she is a veterinarian, had Covid blow through the office, states during that time she got a positive Covid test but it was an inconclusive thing, states she got tested 4 days later and it came back negative, so she went ahead and got the Pfizer vaccine on 20Jan2021, states since she got the vaccine she has felt pretty bad pins and needles in the arm that she got it in (in 2021), clarifies her left arm, states it has moved up into her face, makes her feel like she wants to drool, states the feeling in her face is more numbness than the pins and needles feeling, states it is not drooping or she is not seeing a Bell's palsy kind of thing, just that she is not really talking properly out of the left side of her mouth because of it. States she also had the pins and needles feeling in her right arm but that has improved some. I still have some soreness in my left arm. Caller states she thought she may just get the second booster shot (booster scheduled on the 10Feb2021) in the opposite arm, but that she cannot afford to have both arms feeling like this as she performs surgeries and stuff. Caller states that maybe the positive test she thought was a false positive was actually a real positive and this could be why she is reacting this way. Caller states the symptoms started maybe a couple of days after the vaccine, unknown exact dates. The pins and needles in her hands on the left side where vaccine was given was worse than other side, no longer experiencing this symptom. It's now on left side of her face, numbness that has been persistent a couple of days after the vaccine. The events were reported as non-serious. The outcome of the events was not recovered.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal discomfort, Neck pain, Pain assessment
Clinical narrative: had shoulder pain moved into left neck\pain in neck (both sides) nearly unbearable with movement of neck/head; shoulder pain moved into left neck; minor shoulder discomfort; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on left arm on 27Jan2021 15:30 as SINGLE DOSE for covid-19 immunisation. Medical history was None. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. If covid prior vaccination: No. If covid tested post vaccination: No. There was no Allergies to medications, food, or other products. The patient experienced minor shoulder discomfort (musculoskeletal discomfort) on 29Jan2021 16:00, had shoulder pain moved into left neck\pain in neck (both sides) nearly unbearable with movement of neck/head (neck pain) (non-serious) on 30Jan2021, shoulder pain moved into left neck and (arthralgia) (non-serious) on 30Jan2021. It was reported that injection received on 27Jan2021. felt minor shoulder discomfort evening of 29Jan2021. Morning of 30Jan2021 had shoulder pain moved into left neck. pain in neck increased during 30Jan2021. Pain progressed/increase on 31Jan2021 and contacted Pfizer manufacturing site. morning of 01Feb2021 pain in neck (both sides) nearly unbearable with movement of neck/head and contacted Pfizer manufacturing site. recommended alternating heating/cooling to neck and use Advil. By afternoon pain reduced from 10 to 4 with described methods. Contacted Pfizer manufacturing site to report progress and recommended this be reported as side affect to vaccine received. The outcome of events was recovering.  Information on the lot/batch number has been requested
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: I tested positive for Covid yesterday; I tested positive for Covid yesterday; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech; Solution for injection), via an unspecified route of administration on 06Jan2021, as single dose for covid-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were unknown. The patient historical vaccine included bnt162b2 for covid-19 immunisation. On an unspecified, it was reported that, I am a registered nurse, and have already received two vaccines, last one on 06Jan2021. I tested positive for Covid yesterday via rapid nasal swab. I am asymptomatic at this time. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jan2021. Outcome events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back ache; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 29Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jan2021, the patient experienced back ache. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: got covid positive; got covid positive; sore throat; runny nose; This is a spontaneous report from a Pfizer via a contactable consumer.  A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced got covid positive, sore throat (oropharyngeal pain) (non-serious) on an unspecified date, runny nose (rhinorrhoea) (non-serious) on an unspecified date.   The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unknown date. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events were reported as unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: and felt a little bit sore; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot: Number: Unknown) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced and felt a little bit sore on an unspecified date and mentioned that her daughter got the first dose of vaccine with Moderna and tested positive, they wanted to know if how many days before they can take the second shot and are they still eligible for the 2nd dose. The clinical outcome of the event was reported as unknown.   Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They are supposed to take the 2nd dose of the vaccine tomorrow. However, they tested positive last Saturday; They are supposed to take the 2nd dose of the vaccine tomorrow. However, they tested positive last Saturday; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for 2 patients. This is the second of two reports. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported "They were supposed to take the 2nd dose of the vaccine tomorrow (in Jan 2021). However, they tested positive last Saturday. Asking if they should still take the 2nd dose of the vaccine." The patient underwent lab tests and procedures which included test (sars-cov-2 test): positive in Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106614 Same reporter, same product. same event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain
Clinical narrative: feeling sick at 11pm/ he has been sick since 11:00PM; pain all over the body at 11pm/ he has been sick since 11:00PM last night (02Feb2021) with pains/ hurting allover; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 02Feb2021 13:00 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE yesterday 02Feb2021 at 13:00. On the same day since 23:00, he was feeling sick and with pains. He said it's hurting allover. Asking if this was a normal reaction, he never experienced side effects when he had the first dose. He asked if that is normal for someone to experience after receiving the second COVID-19 Vaccine. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive to COVID-19 after getting the first dose of the COVID-19 vaccine; tested positive to COVID-19 after getting the first dose of the COVID-19 vaccine; This is a spontaneous report from a contactable consumer(patient). A 29 year old female patient of unspecified age received first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot: unknown), via an unspecified route of administration at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. On unspecified date, the patient tested positive to COVID-19 after getting the first dose of the COVID-19 vaccine and she would be out of quarantine by the time she should receive the second dose of the vaccine. the reporter wanted to know whether it is recommended to receive the vaccine after testing positive to COVID-19. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Jan2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient took the 1st dose of Covid 19 Vaccine 2nd of Jan. and then 2 weeks later, tested positive for Covid. He was quarantined at the (Department name) that's why he didn't take the 2nd dose of Covid 19 Vaccine. Now, he was feeling good. They're asking if he can take the 2nd dose now. The patient underwent lab tests and procedures which included sars-cov-2 test: he was confirmed to have covid on 05Jan2021.  Outcome of the events was unknown.    Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Jan2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient took the 1st dose of Covid 19 Vaccine 2nd of Jan. and then 2 weeks later, tested positive for Covid. He was quarantined at the (Department name) that's why he didn't take the 2nd dose of Covid 19 Vaccine. Now, he was feeling good. They're asking if he can take the 2nd dose now. The patient underwent lab tests and procedures which included sars-cov-2 test: he was confirmed to have covid on 05Jan2021.  Outcome of the events was unknown.    Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Jan2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that patient took the 1st dose of Covid 19 Vaccine 2nd of Jan. and then 2 weeks later, tested positive for Covid. He was quarantined at the (Department name) that's why he didn't take the 2nd dose of Covid 19 Vaccine. Now, he was feeling good. They're asking if he can take the 2nd dose now. The patient underwent lab tests and procedures which included sars-cov-2 test: he was confirmed to have covid on 05Jan2021.  Outcome of the events was unknown.    Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 14 days later he tested positive for COVID; 14 days later he tested positive for COVID; He does have some lingering nerve pain; brain fog; tiredness and fatigue; then he just had kind of achy flu type symptoms; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, dose 1), via an unspecified route of administration on 02Jan2021 as single dose for covid-19 immunization. The patient medical and concomitant medications were not reported. The report received as, the patient says had first shot on 02Jan2021 and about 2 weeks, 14 days later he tested positive for COVID. He is way out of quarantine now. He does have some lingering nerve pain, brain fog, tiredness and fatigue stuff but outside of that, that part of it has been worse than the actual COVID was for him, he didn't get very sick with the actual virus. The health department has contacted him to come get his second vaccine, he is actually in route now to get that, but he thought he would call and see if Pfizer had any input, to see if they even have any stats or history to look at quickly to see if you should get the vaccine when you have had COVID between the doses. As far as he knows the nerve pain, brain fog, tiredness and fatigue had nothing to do with the vaccine and everything to do with him having the virus. He didn't really have any of those problems during the actual virus which now he knows pf 8-10 more people that had it like that, so it is not totally uncommon. No further information provided. He didn't feel bad until he was almost out of quarantine then he just had kind of achy flu type symptoms is what he would compare it to. Like the stuff you have when you have the flu. He says he is kind of on a timeline. He held for 30 minutes and he is about 20 minutes from the place to get the second dose, so he is trying to make a knee jerk decision on whether to get it today. The patient underwent lab tests and procedures which included COVID: positive on an unknown date in Jan2021. Outcome of the events was unknown. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: 14 days later he tested positive for COVID; 14 days later he tested positive for COVID; He does have some lingering nerve pain; brain fog; tiredness and fatigue; then he just had kind of achy flu type symptoms; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, dose 1), via an unspecified route of administration on 02Jan2021 as single dose for covid-19 immunization. The patient medical and concomitant medications were not reported. The report received as, the patient says had first shot on 02Jan2021 and about 2 weeks, 14 days later he tested positive for COVID. He is way out of quarantine now. He does have some lingering nerve pain, brain fog, tiredness and fatigue stuff but outside of that, that part of it has been worse than the actual COVID was for him, he didn't get very sick with the actual virus. The health department has contacted him to come get his second vaccine, he is actually in route now to get that, but he thought he would call and see if Pfizer had any input, to see if they even have any stats or history to look at quickly to see if you should get the vaccine when you have had COVID between the doses. As far as he knows the nerve pain, brain fog, tiredness and fatigue had nothing to do with the vaccine and everything to do with him having the virus. He didn't really have any of those problems during the actual virus which now he knows pf 8-10 more people that had it like that, so it is not totally uncommon. No further information provided. He didn't feel bad until he was almost out of quarantine then he just had kind of achy flu type symptoms is what he would compare it to. Like the stuff you have when you have the flu. He says he is kind of on a timeline. He held for 30 minutes and he is about 20 minutes from the place to get the second dose, so he is trying to make a knee jerk decision on whether to get it today. The patient underwent lab tests and procedures which included COVID: positive on an unknown date in Jan2021. Outcome of the events was unknown. Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neuralgia, SARS-CoV-2 test
Clinical narrative: 14 days later he tested positive for COVID; 14 days later he tested positive for COVID; He does have some lingering nerve pain; brain fog; tiredness and fatigue; then he just had kind of achy flu type symptoms; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, dose 1), via an unspecified route of administration on 02Jan2021 as single dose for covid-19 immunization. The patient medical and concomitant medications were not reported. The report received as, the patient says had first shot on 02Jan2021 and about 2 weeks, 14 days later he tested positive for COVID. He is way out of quarantine now. He does have some lingering nerve pain, brain fog, tiredness and fatigue stuff but outside of that, that part of it has been worse than the actual COVID was for him, he didn't get very sick with the actual virus. The health department has contacted him to come get his second vaccine, he is actually in route now to get that, but he thought he would call and see if Pfizer had any input, to see if they even have any stats or history to look at quickly to see if you should get the vaccine when you have had COVID between the doses. As far as he knows the nerve pain, brain fog, tiredness and fatigue had nothing to do with the vaccine and everything to do with him having the virus. He didn't really have any of those problems during the actual virus which now he knows pf 8-10 more people that had it like that, so it is not totally uncommon. No further information provided. He didn't feel bad until he was almost out of quarantine then he just had kind of achy flu type symptoms is what he would compare it to. Like the stuff you have when you have the flu. He says he is kind of on a timeline. He held for 30 minutes and he is about 20 minutes from the place to get the second dose, so he is trying to make a knee jerk decision on whether to get it today. The patient underwent lab tests and procedures which included COVID: positive on an unknown date in Jan2021. Outcome of the events was unknown. Information about lot/batch number has been requested.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Insomnia, Personality change
Clinical narrative: 24-48 he's post vaccine Acute Insomnia with severe anxiety component; 24-48 he's post vaccine Acute Insomnia with severe anxiety component/Anxiety worsening; Completely out of character with no preceding symptoms; very debilitated; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EH9899), via an unspecified route of administration, administered in left arm on 17Dec2020 8:00 as single dose, second dose via an unspecified route of administration, administered in left arm on 07Jan2021 (Batch/Lot Number: EL3246) as single dose for covid-19 immunisation. Medical history included hypertension and Increased cholesterol. Concomitant medication included atorvastatin (LIPITOR); lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. other medications the patient received within 2 weeks of vaccination were Lipitor and Lisinopril. It was reported 24-48 hours post vaccine (18Dec2020 22:00) patient had Acute Insomnia with severe anxiety component. Completely out of character with no preceding symptoms. No prior history of any recent event to explain acute change in personality and character. Insomnia has now persisted for seven weeks. Was better two weeks after 1st dose then worsened again after the 2nd dose was given. Same timeline. Anxiety worsening. Never suffered form any psych issues. Highly functional Interventional Cardiologist now very debilitated. the adverse event result in doctor or other healthcare professional office/clinic visit; The patient received treatment with Psych therapy, Benzos, Ambien, Trazadone, Melatoni. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The reported seriousness was non serious. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Coronavirus test positive, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for covid on 1Feb2021; Tested positive for covid on 1Feb2021; This is a spontaneous report from a contactable consumer (Reporter's husband). An unspecified age 70-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Patient's medical history was not reported. The patient's concomitant medications were not reported. The patient reported Caller, female, calling about her husband, aged 70, who received first dose on 21Jan2021. He developed symptoms on 30Jan2021 and tested positive for covid on 01Feb2021. Her husband is due to get vaccine on 11Feb2021. Can he still receive it?. The outcome of the events was "Unknown".  Information about Batch/Lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: covid infection; covid infection; This is a spontaneous report from a contactable consumer reporting for herself  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection),dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported.The patient's concomitant medications were not reported. The patient experienced covid infection (drug ineffective) on an unspecified date with outcome of unknown ,covid infection (sars-cov-2 test positive) on an unspecified date with outcome of unknown.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Caller is looking for guidance on administering the covid vaccine in a patient with a history of covid infection between both doses. DSU: E-transmitting AE noted after call. A patient confirmed covid positive post 1st dose of the covid vaccine  The events were considered as non-serious by the other healthcare professional.The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Both contracted covid virus after vaccine; Both contracted covid virus after vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported similar events for two patient (herself and her husband). This is a 1st of 2 reports. This 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 13Jan2021 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient and her husband 1st dose of covid vaccine on 13Jan2021. Both contracted covid virus after vaccine. Supposed to get 2nd dose 03Feb2021. They were in quarantine. Wondering if and when they should get 2nd dose of vaccine. The patient experienced both contracted covid virus after vaccine in 2021. Outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021111978 different patient, different event and drug
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer (patient reported himself). A 70-year-old male patient received first dose BNT162B2 (COVID 19, Pfizer, Formulation: Solution for injection, Lot number: EL8982) via an unspecified route of administration at left arm on 28Jan2021 07:00 PM at single dose for covid-19 immunization. The patient's medical history included hypertension, high cholesterol and osteoarthritis. Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Allergies to medications, food, or other products was none. Concomitant medications included meloxicam, hydrochlorothiazide, triamterene (TRIAMTERENE/HCTZ), losartan and atorvastatin. On 30Jan2021 02:00 AM, the patient experienced dizziness approximately 36 hours after injection. Multiple episodes over an 8 hour period. Had not re-occurred since then. The patient did not receive any treatment in response to the event. Outcome of the event was recovered on an unspecified date in 2021. Vaccine Facility information, ethnicity information and race information was available.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid 19 one week following vaccination; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injectioN, Lot Number: UNKNOWN), via an unspecified route of administration on 22Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient's concomitant medications were not reported. On 29Jan2021 the patient tested positive for Covid 19 one week following vaccination by nasal swab test. No treatment was received for the COVID-19. Outcome of the event was recovering.  Information on the lot/batch number has been requested
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, in left arm on 02Feb2021, at 16:30 (at the age of 73-year-old) as single dose for COVID-19 immunisation. Medical history included High BP and stage 3 kidney disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient concomitant medication included valsartan at the dose of 160 mg and levothyroxine at the dose of 88ug. The patient didn't receive any vaccine within 4 weeks prior to the vaccine. The patient experienced chills and tiredness on 03Feb2021 at 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Feb2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Got covid the next day; Sick; This is a spontaneous report received from contactable consumer (patient herself). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL1284) via intramuscular on 30Dec2020 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient received 1st dose of vaccine on 30Dec2020. Patient "caught COVID right after and didn't get the 2nd dose". She was due back to get the second dose of the vaccine on 20Jan2021. After she got the first dose of the vaccine she got COVID the next day. She heard she is supposed to wait 90 days till she is supposed to get the vaccine. She was not diagnosed with COVID till 02Feb2021 since she was sick and could not get into to get the test. Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: tested positive for COVID-19 three days; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gen-der received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of ad-ministration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.The patient's medical history and concomitant medications were not reported. The patient took Dose 1 but tested positive for COVID-19 three days after getting the shot. Caller is asking about the patient's eligibility for the Dose 2 and about the dosing interval that is beyond the 3 weeks recommended.The patient underwent lab tests and procedures which included sars-cov-1 test: positive on unspecified date. The outcome of the event was unknown.  Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid test result=Positive; Covid test result=Positive; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) first dose on 18Dec2020 04:45 PM (Lot number: EK5730) and second dose on 08Jan2021 (Lot number: EL3246) both via unknown route of administration at single dose in right arm for COVID-19 immunisation at Hospital. Medical history was not reported. No covid prior vaccination. Concomitant medication included sertraline. The patient previously took bactrim and had allergies. It was reported as Covid test result was Positive on 31Jan2021 and also reported as not sure if this was considered an adverse event but I did end up getting sick with COVID-19 about a month after my second vaccine after my child was exposed. I did have symptoms from the virus. I really did not have any symptoms after each vaccine. No treatment received for adverse events. No other vaccine in four weeks. Covid was tested post vaccination. The patient underwent labs and procedures included PCR Covid 19: negative on 26Jan2021 and PCR Covid 19: positive on 31Jan2021. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "COVID test result=Positive".
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Nausea
Clinical narrative: feeling lethargic, tired, like wanting to take a nap very often; feeling lethargic, tired, like wanting to take a nap very often; some nausea; This is a spontaneous report from a contactable other health professional (patient). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261), via an unknown route of administration on Left arm on 03Feb2021 17:00 at single dose for covid-19 immunisation administered by healthcare worker. Medical history was none. Concomitant medications were not reported. The patient stated she received her first dose of Pfizer-BioNTech COVID-19 Vaccine yesterday at 5 o'clock (03Feb2021). She wanted to know if the following two are common side effects: "some nausea" and "feeling lethargic, tired, like wanting to take a nap very often". Has been experiencing nausea this morning before getting out of bed and just a little bit before noon was when she felt it. Had an appointment about 4:45pm and had shot about 5pm. Adverse events reported prior to vaccination was none. Vaccine was not administered at Military Facility. Previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The seriousness was reported as non-serious. The outcome of the event nausea was recovering and for the other events it was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: Pfizer's COVID vaccine on 16Jan2021 with his second dose scheduled 06Feb2021. Caller stated he had taken the COVID test on 02Feb2021 and tested positive for COVID 19 an hour ago; This is a spontaneous report from a contactable consumer (patient). A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration on 16Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had second dose scheduled on 06Feb2021. Patient had taken the COVID test on 02Feb2021 and tested positive for COVID 19 an hour ago. He had family members that just came out of quarantine 3 days ago and he got tested when his family members just came out of quarantine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report from a contactable Nurse (Patient herself) via medical information team. A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, expiry dates UDC and NDC not provided), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that she got the COVID shot, then got headache and fever after taking it and she had COVID. Reported that she took the vaccine and reacted to the shot five days later ended up having fever and headache and other stuffs but then they went away." The outcome of the events was recovered.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reevaluated should additional information become available.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Illness
Clinical narrative: fever; chills; fatigue; headache; stomach upset; aches; illness; This is a spontaneous report from a contactable pharmacist (patient herself). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283) intramuscularly on 21Jan2021 08:15 PM at single dose in right arm for COVID-19 immunization at Hospital. Medical history included hypertension. Known allergies included walnuts and penicillin. It was unknown if covid prior vaccination. Concomitant medications in two weeks included lisinopril, colecalciferol (VITAMIN D) and multivitamin. The patient previously took first dose (at 59-year-old) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) intramuscularly on 31Dec2020 06:45 AM in right arm for COVID-19 immunization. It was reported that 12 hours post vaccination symptoms started, fever, chills, fatigue, headache, stomach upset, aches and 48 hours of illness on 22Jan2021 08:30 AM. Treatment for adverse events included Tylenol and Motrin. No covid tested post vaccination. The outcome of events was recovered on unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; chills; fatigue; headache; stomach upset; aches; illness; This is a spontaneous report from a contactable pharmacist (patient herself). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283) intramuscularly on 21Jan2021 08:15 PM at single dose in right arm for COVID-19 immunization at Hospital. Medical history included hypertension. Known allergies included walnuts and penicillin. It was unknown if covid prior vaccination. Concomitant medications in two weeks included lisinopril, colecalciferol (VITAMIN D) and multivitamin. The patient previously took first dose (at 59-year-old) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) intramuscularly on 31Dec2020 06:45 AM in right arm for COVID-19 immunization. It was reported that 12 hours post vaccination symptoms started, fever, chills, fatigue, headache, stomach upset, aches and 48 hours of illness on 22Jan2021 08:30 AM. Treatment for adverse events included Tylenol and Motrin. No covid tested post vaccination. The outcome of events was recovered on unknown date in 2021.  No follow-up attempts are possible. No further information is expected.