chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Intermenstrual bleeding, Myalgia, Nausea, Pyrexia
Clinical narrative: she had her period and non stop bleeding for 21 days with no end in sight; shaking; dizziness; nausea; sick; dry heaving; headache; Every muscle felt that I did a total body work out; Low grade fever of 96.8; weakness; loose stools; Slept 5-6 post inoculation/slept most of the day; tiredness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 12Mar2021 08:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, for covid-19 immunization.  Medical history included concussion from Sep2019. The patient received birth control within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient slept 5-6 post inoculation. On 12Mar2021 03:15, patient experienced loose stools. On Saturday morning 13Mar2021 at 3am, patient woke to shaking, dizziness, nausea, so much so that she did get sick twice, dry heaving followed for the next three hours. Extreme constant headache during the day and slept most of the day. She tried her best to stay hydrated. Every muscle felt that she did a total body work out, works than she had experienced with the flu. She had a low grade fever of 96.8. Continued weakness, tiredness, and headache Monday and Tuesday. It was also reported that on 13Mar2021 at 04:00 she had her period and non stop bleeding for 21 days with no end in sight. The outcome of event "she had her period and non stop bleeding for 21 days with no end in sight" was not recovered. The outcome of all other events was reported as Recovered/Resolved with Sequel. The patient did not receive treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Retching, Somnolence, Tremor
Clinical narrative: she had her period and non stop bleeding for 21 days with no end in sight; shaking; dizziness; nausea; sick; dry heaving; headache; Every muscle felt that I did a total body work out; Low grade fever of 96.8; weakness; loose stools; Slept 5-6 post inoculation/slept most of the day; tiredness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 12Mar2021 08:30 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE, for covid-19 immunization.  Medical history included concussion from Sep2019. The patient received birth control within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient slept 5-6 post inoculation. On 12Mar2021 03:15, patient experienced loose stools. On Saturday morning 13Mar2021 at 3am, patient woke to shaking, dizziness, nausea, so much so that she did get sick twice, dry heaving followed for the next three hours. Extreme constant headache during the day and slept most of the day. She tried her best to stay hydrated. Every muscle felt that she did a total body work out, works than she had experienced with the flu. She had a low grade fever of 96.8. Continued weakness, tiredness, and headache Monday and Tuesday. It was also reported that on 13Mar2021 at 04:00 she had her period and non stop bleeding for 21 days with no end in sight. The outcome of event "she had her period and non stop bleeding for 21 days with no end in sight" was not recovered. The outcome of all other events was reported as Recovered/Resolved with Sequel. The patient did not receive treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood iron, COVID-19, Dehydration, SARS-CoV-2 test
Clinical narrative: dehydrated; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), fist dose at the age of 57-years-old via an unspecified route of administration, administered in arm left on 04Mar2021 (Batch/Lot Number: EN6205) as 1st dose, single for covid-19 immunisation.  Medical history included cholesterol from an unknown date and unknown if ongoing. Concomitant medication included simvastatin taken for cholesterol, start and stop date were not reported.  The patient reported that he had lingering effects from all week long mostly fatigue and dizziness and so just to rule it out, he had a covid test on 11Mar2021 and it came back; he found out today, 13Mar2021 that it came back positive. He further reported that he was a little bit of tired before the vaccine but didn't really had the dizziness and fatigue. The patient underwent lab tests and procedures which included blood iron: unknown results, blood test for sugar: unknown results, urine test: unknown results (was dehydrated); all on 12Mar2021, sars-cov-2 test: positive on 11Mar2021. The patient was recovering from COVID-19 while the outcome of dehydrated was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis
Clinical narrative: dehydrated; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), fist dose at the age of 57-years-old via an unspecified route of administration, administered in arm left on 04Mar2021 (Batch/Lot Number: EN6205) as 1st dose, single for covid-19 immunisation.  Medical history included cholesterol from an unknown date and unknown if ongoing. Concomitant medication included simvastatin taken for cholesterol, start and stop date were not reported.  The patient reported that he had lingering effects from all week long mostly fatigue and dizziness and so just to rule it out, he had a covid test on 11Mar2021 and it came back; he found out today, 13Mar2021 that it came back positive. He further reported that he was a little bit of tired before the vaccine but didn't really had the dizziness and fatigue. The patient underwent lab tests and procedures which included blood iron: unknown results, blood test for sugar: unknown results, urine test: unknown results (was dehydrated); all on 12Mar2021, sars-cov-2 test: positive on 11Mar2021. The patient was recovering from COVID-19 while the outcome of dehydrated was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity, Polymerase chain reaction, Pyrexia
Clinical narrative: Fever; Nausea; Aches; Arm Pain; This is a spontaneous report from a contactable, consumer. A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021 at 15:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient medical history included celiac disease, asthma, HBP- high blood pressure, SVT- Supraventricular tachycardia from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested negative for COVID-19. Concomitant medications included Bupropion (WELBUTRIN) , oestrogens, conjugated (PREMARIN), furosemide (MANUFACTURER UNKNOWN), ditiazem (MANUFACTURER UNKNOWN), omepraz (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021 at 06:00, the patient experienced fever, nausea, aches and arm pain. On 12Mar2021, the patient underwent nasal swab test (test name reported as IDnow) and test result showed negative. On 16Mar2021, the patient underwent COVID-19 nasal swab test again and rapid RT-PCR (Reverse transcription polymerase chain reaction) test and both test result showed negative. The patient did not receive any treatment for the events. The clinical outcome of the event fever, nausea, aches and arm pain was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; Nausea; Aches; Arm Pain; This is a spontaneous report from a contactable, consumer. A 59-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021 at 15:00 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. The patient medical history included celiac disease, asthma, HBP- high blood pressure, SVT- Supraventricular tachycardia from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested negative for COVID-19. Concomitant medications included Bupropion (WELBUTRIN) , oestrogens, conjugated (PREMARIN), furosemide (MANUFACTURER UNKNOWN), ditiazem (MANUFACTURER UNKNOWN), omepraz (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021 at 06:00, the patient experienced fever, nausea, aches and arm pain. On 12Mar2021, the patient underwent nasal swab test (test name reported as IDnow) and test result showed negative. On 16Mar2021, the patient underwent COVID-19 nasal swab test again and rapid RT-PCR (Reverse transcription polymerase chain reaction) test and both test result showed negative. The patient did not receive any treatment for the events. The clinical outcome of the event fever, nausea, aches and arm pain was recovered on an unknown date. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Swelling
Clinical narrative: The rash is back and itchy and very swollen. There is a bump; After 8 days rash is back and itchy; Had a slight rash when I got the shot; This is a spontaneous report from a contactable consumer (patient). An adult, non-pregnant female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Solution for injection, Lot number: EN6199 and expiration date not provided) via an unspecified route of administration, in left arm on 08Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medication details were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On the day of vaccination (08Mar2021), after the shot the patient had a slight rash and that went away. 8 days after the shot, on 16Mar2021 the rash was back and itchy and very swollen. There was a bump. The patient was not treated for the events. The patient recovered from the event rash on 08Mar2021 and the clinical outcome of the events itchy rash and swelling was not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated suspect vaccine details (suspect vaccine recoded as BNT162B2, added stop date as same date; 08Mar2021 00:00), treatment as no for the events and leading sentence updated to a contactable consumer.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid/lost his sense of taste and sense of smell/really tired/lost appetite/upset stomach/body aches/had a low grade fever; This is a spontaneous report from a contactable consumer via a Pfizer. A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 03Mar2021 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included hypertension from an unknown date diagnosed ten years ago. The patient's concomitant medications were not reported. On 06Mar2021, patient tested positive for COVID and experienced symptoms reported as lost his sense of taste and sense of smell, was really tired, lost appetite, upset stomach, body aches and had a low grade fever. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Mar2021. Outcome of event was not recovered.   Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache immediately after; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age who reported for herself received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 12Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history included antiphospholipid syndrome, cutaneous lupus erythematosus, systemic lupus erythematosus, sjogren's syndrome and chronic obstructive pulmonary disease (start date and ongoing status unknown for all). The patient's concomitant medications were not reported. The patient previously took immunosuppressants. Unspecified time later the patient experienced headache immediately after vaccination with outcome of unknown.    No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; Soreness; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 12Mar2021 10:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced headache and soreness on an unspecified date. It was reported as, "She had her first dose yesterday, 03/12/2021 at 10 am, her next dose will be on 04/02/2021.She experienced soreness yesterday for awhile but she's okay now however she still has headache and she's asking if she can take any drug for it. She is also asking if she can go to her appointment for the mammogram on Tuesday, 03/16/2021. Her follow-up question for this was, how long does she have to wait before rescheduling her appointment for her mammogram. On 03/23/2021, she will have a doctor's appointment and every time she visits her doctor does an echogram, so she was also asking if she can go or she has to reschedule. For how long does she have to wait as well before going for the appointment. The Outcome of the event soreness was recovered and unknown for headache.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Arm rash on injection arm; This is a spontaneous report received from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: lot/batch number: EN 6198) via an unspecified route of administration in the left arm on 21Feb2021 at 18:00 (at the age of 36-year-old) and her second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA VACCINE; Lot/batch number: EN 6206) via an unspecified route of administration in the left arm on 14Mar2021 at 18:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included juvenile idiopathic arthritis, uveitis, sjogrens and pituitary adenoma. She was allergic to penicillin, erythromycin, Ceclor, Keflex, naproxen, doxycycline and Valtrex. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medications included multivitamins was taken for an unknown indication 02 days before the vaccination. On 17Mar2021 at 07:00, the patient had experienced arm rash on injection arm. It was reported that the patient did not receive treatment for the event. The clinical outcome of the event arm rash on injection arm was not resolved. No follow up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Nasal congestion
Clinical narrative: can't smell or taste; can't smell or taste; nose congestion; tested for COVID-19, which came back positive; real fatigued; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) administered in the arm as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included hypertension from 2011 and ongoing; and high blood pressure. Concomitant medication included High Blood Pressure Pills (unspecified) 20 mg from 2011 for hypertension. She reported that on 05Mar2021 she felt real fatigued but did not think the vaccine could cause this. She thinks she had the symptoms of COVID-19 before getting her first dose of the vaccine. On 06Mar2021, three days after the patient was vaccinated, she tested for covid-19, which came back positive. The patient did not get any nose congestion until Sunday (07Mar2021), she had nose congestion; she had it until Tuesday and that only thing she have left is that now (unspecified date) she cannot smell or taste. She further stated that she have no other symptoms just fatigue, congestion but off course she lost my sense of taste and smell, since then and do not have anything after that, "it is very little smell". She would now like to know if it is safe to take her second dose of the vaccine which was due on 24Mar2021. She was concerned that because she had COVID-19, she may need to restart the vaccination series. The outcome of events " can't smell or taste" was not recovered; the patient recovered from nose congestion on 09Mar2021 and recovered from fatigued from unspecified date; and outcome of COVID-19 was unknown. Patient took OTC for the nasal congestion.   Information regarding Lot/Batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: can't smell or taste; can't smell or taste; nose congestion; tested for COVID-19, which came back positive; real fatigued; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) administered in the arm as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included hypertension from 2011 and ongoing; and high blood pressure. Concomitant medication included High Blood Pressure Pills (unspecified) 20 mg from 2011 for hypertension. She reported that on 05Mar2021 she felt real fatigued but did not think the vaccine could cause this. She thinks she had the symptoms of COVID-19 before getting her first dose of the vaccine. On 06Mar2021, three days after the patient was vaccinated, she tested for covid-19, which came back positive. The patient did not get any nose congestion until Sunday (07Mar2021), she had nose congestion; she had it until Tuesday and that only thing she have left is that now (unspecified date) she cannot smell or taste. She further stated that she have no other symptoms just fatigue, congestion but off course she lost my sense of taste and smell, since then and do not have anything after that, "it is very little smell". She would now like to know if it is safe to take her second dose of the vaccine which was due on 24Mar2021. She was concerned that because she had COVID-19, she may need to restart the vaccination series. The outcome of events " can't smell or taste" was not recovered; the patient recovered from nose congestion on 09Mar2021 and recovered from fatigued from unspecified date; and outcome of COVID-19 was unknown. Patient took OTC for the nasal congestion.   Information regarding Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from contactable consumer(patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that he had a headache for just one day and didn't take anything. It was reported that, On Sunday he was getting the second dose. Patient filled this big sheet out at the facility and put that he had a headache, it was at the facility. Patient got a letter from the facility, and they really handled the vaccination process well. Even the bosses were there. Patient queried for If Tylenol, never worked on him. Can you take anything stronger If I get a headache. The outcome of the event was unknown.   Information on the lot/batch number has been requested  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Heart rate, Heart rate increased, Insomnia, Lymphadenopathy
Clinical narrative: rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation.  Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported.  The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021.  He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again.  His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing".  The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Rash, Restlessness, Suspected COVID-19
Clinical narrative: rash on arms; little restless; noticed how sore his arm was/pain in his arm; trouble sleeping/problems with sleep; felt movements in his chest at times; felt like he had COVID all over again/ if he possibly has COVID-19 again; soreness; heart rate accelerated; some swollen in lymph nodes; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer sponsored program. A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 at around 13:00 or 13:30 (at the age of 44 years old) (Lot Number: EP7534, unknown expiration) as 1st dose, single for COVID-19 immunisation.  Medical history included COVID-19 in Nov2020; sneezing and runny nose both on 21Mar2021. The patient's concomitant medications were not reported.  The patient reported that he received his first dose of Pfizer COVID vaccine on 22Mar2021. He felt fine after receiving the vaccine, but there was little bit rash on arms just afterwards and felt maybe a little restless but felt fine and went for a walk on 22Mar2021. As the night went on, he really noticed how sore his arm was/pain in his arm and when he was sleeping, he had trouble sleeping/problems with sleep (Mar2021) and felt movements in his chest at times (Mar2021). It felt like he had COVID all over again and had chills, soreness, and his smell was kind of gone in Mar2021. He was previously feeling pretty good. He had COVID-19 in Nov2020, and his symptoms feel very similar including loss of sense of smell but no coughing. He had a fever but that has gone away in Mar2021 and he did not take aspirin or anything for it. He also had fatigue, some swollen in lymph nodes, and his heart rate accelerated in Mar2021.  He had sneezing and runny nose the day prior to receiving the vaccine. The patient would like to know if his symptoms are related to the vaccine or if he possibly has COVID-19 again.  His symptoms are the same as COVID as far as what he can see, and his symptoms are really high. He would like to know if he can still receive the second dose of the vaccine if he has a positive COVID test after the first dose of the vaccine. The patient mentioned that there was very pretty high percentage of people having the symptoms after having the vaccine, kind of virus "causing".  The patient asked if he needs to be tested to see if he had the virus before he was vaccinated and to know if these are one of the side effects or one of the symptoms of the virus, and to make sure that these are not actually corona virus. The patient recovered from fever in Mar2021, while unknown outcome for the remaining events.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: "very infected" with COVID-19 after receiving the first dose; "very infected" with COVID-19 after receiving the first dose; This is a spontaneous report received from a contactable consumer (patient's son-in law). This consumer reported same events for three patients. This is the third of three reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Mar2021 (lot number and expiry date unknown) as 1st dose, single for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The reporter himself, his wife and his wife's mother received the first dose of Pfizer's COVID-19 vaccine on 04Mar2021. At the time of the report, they were due to get the second dose and wanted to know what to do, since three of them were very infected with COVID-19 after receiving the first dose. This patient was delicate because she was in bed, because of her age and because she was diabetic. He would like to know when they would get the second dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021329502 same reporter/drug/events, different patients;US-PFIZER INC-2021333614 same reporter/drug/events, different patients
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis
Clinical narrative: Heavy chill headache; Heavy chill headache; sweetness; This is spontaneous report from a contactable consumer (patient, self-reported).   A 51-year-old male patient (age at vaccination: 51 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Right, on 13Mar2021 at 07:15 AM, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that on 17Mar2021 at 05:00 PM, he had heavy chill headache and sweetness. The events were resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the adverse event. Outcome of the events was unknown.  Information about the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Lip disorder, Lymphadenopathy, Odynophagia
Clinical narrative: headache; sore throat; red bumps on the upper roof of my mouth; problems with swallowing; my glands were also swollen; scratchy throat; problems with swallowing (hurt); This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 07:00 (Batch/Lot Number: EN6203) as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and experienced drug hypersensitivity. No other vaccine in four weeks was given to patient. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 25Mar2021, the patient started with a headache, in which she took tylenol then shortly thereafter she had a scratchy throat, sore throat and problems with swallowing (hurt), this continued throughout the day and into the evening. The next day same thing but she also noticed red bumps on the upper roof of my mouth, and noticed her glands were also swollen. Therapeutic measures were taken as a result of headache (headache). The outcome of the events was reported as not recovered. Information on lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Throat irritation
Clinical narrative: headache; sore throat; red bumps on the upper roof of my mouth; problems with swallowing; my glands were also swollen; scratchy throat; problems with swallowing (hurt); This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 07:00 (Batch/Lot Number: EN6203) as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took codeine and experienced drug hypersensitivity. No other vaccine in four weeks was given to patient. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. It was reported that on 25Mar2021, the patient started with a headache, in which she took tylenol then shortly thereafter she had a scratchy throat, sore throat and problems with swallowing (hurt), this continued throughout the day and into the evening. The next day same thing but she also noticed red bumps on the upper roof of my mouth, and noticed her glands were also swollen. Therapeutic measures were taken as a result of headache (headache). The outcome of the events was reported as not recovered. Information on lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report from a contactable physician. A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration, administered in arm left on 26Mar2021(at the age of 59 years old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history included cardiac disorder from an unknown date and unknown if ongoing. The patient received other medications within 2 weeks of vaccination. 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 was not tested for COVID-19 since the vaccination. The patient does not have any allergies to medications, food, or other products. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: Unknown) via unspecified route of administration in left arm, administered on 05Mar2021 at 12:00 for covid-19 immunisation. On 27Mar2021 at 13:00, the patient experienced headache and fatigue. No treatment was received for the adverse events. The reporter classified the events as non-serious. The outcome of the events was resolving.  Follow-up (11May2021) was processed as non-significant: No new information was reported.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pain in extremity, Suspected COVID-19
Clinical narrative: I had a little soreness but I was fine/soreness in her arm; they both quarantined. She reports that they came out of quarantine this past Thursday and were told they were fine to get the vaccine. Now she worries she has covid; body aches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER COVID 19 VACCINE), via an unspecified route of administration, administered in Arm Left (left upper arm) on 27Mar2021 (Batch/Lot Number: ER0733; Expiration Date: 31Jul2021) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported that she had her first covid vaccine on Saturday (27Mar2021) and reported that she felt great, she had a little soreness but she was fine, she exercised yesterday, but last night (28Mar2021) she had a temperature and body aches. She asked if this is from the first vaccine dose or could she have covid? Patient reported that her husband had covid about 1 week ago, they were able to distance in the house, she didn't have any symptoms but they both quarantined. She stated her husband had Covid and came off quarantine on last Thursday 25Mar2021. She clarifies the state Health Department called and told him he was out of quarantine. She confirms she stayed quarantined from her husband those 10 days. She slept upstairs.  She did not provide further details on her husband for report. She reports that they came out of quarantine this past Thursday and were told they were fine to get the vaccine. Now she worries she has covid. She stated her father was in memory care and she was waiting for the day she could get her vaccine so she could see her father again. She stated she felt fine, she just had some soreness in her arm (unspecified date), just a little bit. She exercised and felt great. Last night, 28Mar2021, it hit her and she started running a temperature of like a 102.She asked if this was normal for the first vaccine? She cried all morning because she was worried and wanted to know if this was normal with your first shot? She wanted to know if this is a side effect? She would rather it be a side effect than think she could have COVID. She declined to fill out a safety report and wanted to speak with someone in MI to know if this could be a side effect so she can go on about her day. While looking for information off of her vaccine record card, the She makes the comment "oh my goodness I can't see nothing" and mentions something about her contacts. The outcome of the events was unknown.  No follow-up attempts are possible. No further information expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Her legs got extremely sore/Legs got so sore; both legs; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 82-year-old female patient received bnt162b2 first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in right arm on 21Mar2021 at 12:00 (at the age of 81-year-old) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing high blood pressure (Diagnosed a long time ago), Crippled leg from an unknown date and unknown if ongoing (she is dragging one and trying to walk on the other one and she can't hardly get around on it), eyesight is not that good from an unknown date and unknown if ongoing (she can't see that well), ongoing pain in a disc in her back from an unknown date and unknown if ongoing. Concomitant medication(s) included tramadol (MANUFACTURER UNKNOWN) taken for pain in a disc in her back from an unspecified start date and ongoing at a dose of 50mg twice a day; gabapentin (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified start date and ongoing at a dose of 300mg twice a day; lorazepam (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified start date and ongoing at a dose of 2mg once a day at night; nifedipine (MANUFACTURER UNKNOWN) taken for blood pressure increased from an unspecified start date and ongoing at a dose of 60mg once a day. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took IV iron for the indication of iron falls low; Furosemide and experienced cramp (Dose: 20mg, she is also on a water pill, Furosemide but it was not taken in the two weeks). The patient experienced Her legs got extremely sore/Legs got so sore; both legs, fever and chills. Fever and chills lasted only one day but is still experiencing sore legs but it has it improved slightly. It was reported that it hurts to get up, she already has a crippled leg, she is dragging one and trying to walk on the other one and she can't hardly get around on it. Caller clarifies it hurts from her butt down on her legs. The reporter states she can't take aspirin, codeine, penicillin or could not have strawberries. The patient did not visit emergency room or physician office. The outcome of the events Her legs got extremely sore/Legs got so sore; both legs was recovering while for fever and chills was recovered on 21Mar2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Malaise
Clinical narrative: she is not feeling well today; headache; numbness; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: unknown), via an unspecified route of administration on 06Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. After vaccination the patient experienced headache and numbness in Mar2021 and on 27Mar2021 she was not feeling well. The patient was request for a reschedule of her 2nd dose (due 27Mar2021) because she was not feeling well. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Headaches; 37-38oC fever; Dizziness; pain in the arm where the vaccine was administrated (left); This is a spontaneous report from a non-contactable other health care professional (patient herself). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Lot Number: ER8733) via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 16:00 as 1st dose, single for COVID-19 immunization. Medical history included depression, ulcerative gastritis and shrimps Shrimps Allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline and lansoprazole within 2 weeks of vaccination. COVID-19 vaccine was administered in hospital. On 01Apr2021 at 12:00 the patient experienced headaches, 37-38 degree c fever, dizziness and pain in the arm where the vaccine was administrated. Headaches, 37-38oC fever and Dizziness lasted for one day and more than 48hrs of pain in the arm where the vaccine was administrated (left). Paracetamol was given as treatment. The events were not serious as none of the events were meeting the seriousness criteria. Since the vaccination, the patient has not been tested for COVID-19. Upon follow up 06Apr2021, translation spontaneous report was received about the anatomical location and the outcome of the events. The patient underwent lab tests and procedures which included body temperature: 37-38 centigrade on an unspecified date. Treatment received was update das yes for all the events. Outcome of the events was recovering.   On 14May2021, follow-up attempts completed. No further information expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; On the day after my first dose, I had the following side-effects / symptoms: Strong headache, muscle aches, fatigue.; This is a spontaneous report received from a contactable consumer (patient), who reported for herself. A 28-year-old female patient received the first dose of Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534), via unspecified route of administration in left arm on 01Apr2021 at 08:00 AM (at the age of 28 years) as single dose for covid-19 immunization. The patient medical history included asthma and allergies to penicillin and cephalosporin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. On 02Apr2021, (on the day following her first dose of covid vaccine), the patient experienced the side-effects / symptoms including strong headache, muscle aches and fatigue. The patient did not receive treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymph node pain, Oral herpes, Vaccination site pain
Clinical narrative: New oral herpes simplex lesion (on lip); Headache; fatigue; right arm pain; painful lymph nodes on right side of neck; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient (Non-pregnant) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP6955, expiry date was not reported), via an unspecified route of administration, administered in arm right on 30Mar2021 13:15 single dose for covid-19 immunisation. Patient's medical history was not reported. Concomitant medication(s) included levothyroxine, famotidine, Colecalciferol taken for an unspecified indication, (within 2 weeks of vaccination) start and stop date were not reported. Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient previously took vaccine included BNT162B2 on 10Mar2021 13:15 single dose for covid-19 immunisation. The patient experienced right arm pain on 30Mar2021, painful lymph nodes on right side of neck, On 31Mar2021 headache, fatigue, new oral herpes simplex lesion (on lip) on 06Apr2021 10:00. The patient received treatment for the event new oral herpex simplex lesion that included One dose Valacyclovir 2g. No Covid Prior Vaccination. No Covid tested Post vaccination. The outcome of all the events are recovering except the event "new oral herpes simplex lesion (on lip)" was not recovered.    No Follow-up Attempts are needed.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Intermittent headaches; In the beginning 7/10 pain and then 2/10; This is a spontaneous report from a contactable physician. A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 20Mar2021 at 11:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included poststreptococcal uveitis. Concomitant medications were not reported. Family history included penicillin allergy. Allergies to medications, food, or other products: Familial history of penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient refers intermittent headaches 24 hours after the vaccine on 21Mar2021 until 01Apr2021. In the beginning 7/10 pain and then 2/10 on 21Mar2021. The patient was treated with ibuprofen at 600 mg one time. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.