chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin, Heart rate, Hepatitis A antibody, Hepatitis B antibody, Hepatitis C antibody
Clinical narrative: covid test result Positive; covid test result Positive; joint inflammation; joint inflammation and swelling; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 1st single dose via an unspecified route of administration in the arm left on 14Jan2021 at 12:15 PM (LOT number: EL3248, expiration date unknown) and 2nd single dose via an unspecified route of administration in the arm left on 10Feb2021 at 12:00 PM (LOT/Batch number and expiration date unknown) for COVID-19 immunization. Patient was 69-year-old at time of vaccination. Patient was not pregnant at time of vaccination and events onset. Medical history included previous breast CA from 1993. Concomitant medications the patient received within 2 weeks of vaccination included losartan, hydrochlorothiazide.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, patient had joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days then extreme hairloss, severe reaction to bee sting and amoxicillin, severe allergic response to foods, histamine and any sugar, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue; on 19Jan2021 at 12:00 and were still ongoing. Patient received treatment for above events. Patient had previous covid test (Blood test) on 28Sep2021 which was positive. Test to R/O other things (Blood test) on 28Sep2021 was negative. The events resulted in doctor or other healthcare professional office/clinic visit. "US lower extremities, steroid rash, many visits" was reported as treatment for the events. Outcome of event COVID test result Positive was unknown, of the other events was not recovered.  Information on the lot/batch number of 2nd dose has been requested.; Sender's Comments: The possibility of COVID-19, Vaccination failure being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Illness, Investigation, Joint stiffness, Joint swelling
Clinical narrative: covid test result Positive; covid test result Positive; joint inflammation; joint inflammation and swelling; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 1st single dose via an unspecified route of administration in the arm left on 14Jan2021 at 12:15 PM (LOT number: EL3248, expiration date unknown) and 2nd single dose via an unspecified route of administration in the arm left on 10Feb2021 at 12:00 PM (LOT/Batch number and expiration date unknown) for COVID-19 immunization. Patient was 69-year-old at time of vaccination. Patient was not pregnant at time of vaccination and events onset. Medical history included previous breast CA from 1993. Concomitant medications the patient received within 2 weeks of vaccination included losartan, hydrochlorothiazide.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, patient had joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days then extreme hairloss, severe reaction to bee sting and amoxicillin, severe allergic response to foods, histamine and any sugar, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue; on 19Jan2021 at 12:00 and were still ongoing. Patient received treatment for above events. Patient had previous covid test (Blood test) on 28Sep2021 which was positive. Test to R/O other things (Blood test) on 28Sep2021 was negative. The events resulted in doctor or other healthcare professional office/clinic visit. "US lower extremities, steroid rash, many visits" was reported as treatment for the events. Outcome of event COVID test result Positive was unknown, of the other events was not recovered.  Information on the lot/batch number of 2nd dose has been requested.; Sender's Comments: The possibility of COVID-19, Vaccination failure being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Myalgia, Pain
Clinical narrative: covid test result Positive; covid test result Positive; joint inflammation; joint inflammation and swelling; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 1st single dose via an unspecified route of administration in the arm left on 14Jan2021 at 12:15 PM (LOT number: EL3248, expiration date unknown) and 2nd single dose via an unspecified route of administration in the arm left on 10Feb2021 at 12:00 PM (LOT/Batch number and expiration date unknown) for COVID-19 immunization. Patient was 69-year-old at time of vaccination. Patient was not pregnant at time of vaccination and events onset. Medical history included previous breast CA from 1993. Concomitant medications the patient received within 2 weeks of vaccination included losartan, hydrochlorothiazide.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, patient had joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days then extreme hairloss, severe reaction to bee sting and amoxicillin, severe allergic response to foods, histamine and any sugar, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue; on 19Jan2021 at 12:00 and were still ongoing. Patient received treatment for above events. Patient had previous covid test (Blood test) on 28Sep2021 which was positive. Test to R/O other things (Blood test) on 28Sep2021 was negative. The events resulted in doctor or other healthcare professional office/clinic visit. "US lower extremities, steroid rash, many visits" was reported as treatment for the events. Outcome of event COVID test result Positive was unknown, of the other events was not recovered.  Information on the lot/batch number of 2nd dose has been requested.; Sender's Comments: The possibility of COVID-19, Vaccination failure being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Platelet count, Protein total normal, Pruritus, Pyrexia
Clinical narrative: covid test result Positive; covid test result Positive; joint inflammation; joint inflammation and swelling; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 1st single dose via an unspecified route of administration in the arm left on 14Jan2021 at 12:15 PM (LOT number: EL3248, expiration date unknown) and 2nd single dose via an unspecified route of administration in the arm left on 10Feb2021 at 12:00 PM (LOT/Batch number and expiration date unknown) for COVID-19 immunization. Patient was 69-year-old at time of vaccination. Patient was not pregnant at time of vaccination and events onset. Medical history included previous breast CA from 1993. Concomitant medications the patient received within 2 weeks of vaccination included losartan, hydrochlorothiazide.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, patient had joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days then extreme hairloss, severe reaction to bee sting and amoxicillin, severe allergic response to foods, histamine and any sugar, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue; on 19Jan2021 at 12:00 and were still ongoing. Patient received treatment for above events. Patient had previous covid test (Blood test) on 28Sep2021 which was positive. Test to R/O other things (Blood test) on 28Sep2021 was negative. The events resulted in doctor or other healthcare professional office/clinic visit. "US lower extremities, steroid rash, many visits" was reported as treatment for the events. Outcome of event COVID test result Positive was unknown, of the other events was not recovered.  Information on the lot/batch number of 2nd dose has been requested.; Sender's Comments: The possibility of COVID-19, Vaccination failure being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Red blood cell count, Rheumatoid factor, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: covid test result Positive; covid test result Positive; joint inflammation; joint inflammation and swelling; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 1st single dose via an unspecified route of administration in the arm left on 14Jan2021 at 12:15 PM (LOT number: EL3248, expiration date unknown) and 2nd single dose via an unspecified route of administration in the arm left on 10Feb2021 at 12:00 PM (LOT/Batch number and expiration date unknown) for COVID-19 immunization. Patient was 69-year-old at time of vaccination. Patient was not pregnant at time of vaccination and events onset. Medical history included previous breast CA from 1993. Concomitant medications the patient received within 2 weeks of vaccination included losartan, hydrochlorothiazide.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, patient had joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days then extreme hairloss, severe reaction to bee sting and amoxicillin, severe allergic response to foods, histamine and any sugar, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue; on 19Jan2021 at 12:00 and were still ongoing. Patient received treatment for above events. Patient had previous covid test (Blood test) on 28Sep2021 which was positive. Test to R/O other things (Blood test) on 28Sep2021 was negative. The events resulted in doctor or other healthcare professional office/clinic visit. "US lower extremities, steroid rash, many visits" was reported as treatment for the events. Outcome of event COVID test result Positive was unknown, of the other events was not recovered.  Information on the lot/batch number of 2nd dose has been requested.; Sender's Comments: The possibility of COVID-19, Vaccination failure being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Serum sickness, Skin burning sensation, Skin swelling, Tearfulness, Urticaria
Clinical narrative: covid test result Positive; covid test result Positive; joint inflammation; joint inflammation and swelling; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 1st single dose via an unspecified route of administration in the arm left on 14Jan2021 at 12:15 PM (LOT number: EL3248, expiration date unknown) and 2nd single dose via an unspecified route of administration in the arm left on 10Feb2021 at 12:00 PM (LOT/Batch number and expiration date unknown) for COVID-19 immunization. Patient was 69-year-old at time of vaccination. Patient was not pregnant at time of vaccination and events onset. Medical history included previous breast CA from 1993. Concomitant medications the patient received within 2 weeks of vaccination included losartan, hydrochlorothiazide.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, patient had joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days then extreme hairloss, severe reaction to bee sting and amoxicillin, severe allergic response to foods, histamine and any sugar, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue; on 19Jan2021 at 12:00 and were still ongoing. Patient received treatment for above events. Patient had previous covid test (Blood test) on 28Sep2021 which was positive. Test to R/O other things (Blood test) on 28Sep2021 was negative. The events resulted in doctor or other healthcare professional office/clinic visit. "US lower extremities, steroid rash, many visits" was reported as treatment for the events. Outcome of event COVID test result Positive was unknown, of the other events was not recovered.  Information on the lot/batch number of 2nd dose has been requested.; Sender's Comments: The possibility of COVID-19, Vaccination failure being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vein disorder, Vomiting
Clinical narrative: covid test result Positive; covid test result Positive; joint inflammation; joint inflammation and swelling; extreme hairloss; hemoglobin leakage under skin; intermittent fever; intermittent body rash; extreme itching and/or burning of skin; burning of skin; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), 1st single dose via an unspecified route of administration in the arm left on 14Jan2021 at 12:15 PM (LOT number: EL3248, expiration date unknown) and 2nd single dose via an unspecified route of administration in the arm left on 10Feb2021 at 12:00 PM (LOT/Batch number and expiration date unknown) for COVID-19 immunization. Patient was 69-year-old at time of vaccination. Patient was not pregnant at time of vaccination and events onset. Medical history included previous breast CA from 1993. Concomitant medications the patient received within 2 weeks of vaccination included losartan, hydrochlorothiazide.  The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. After dose 1, patient had joint inflammation leading to severe joint inflammation and swelling for 12 wks/5 days then extreme hairloss, severe reaction to bee sting and amoxicillin, severe allergic response to foods, histamine and any sugar, hemoglobin leakage under skin, intermittent fever, intermittent body rash, extreme itching and/or burning of skin, fatigue; on 19Jan2021 at 12:00 and were still ongoing. Patient received treatment for above events. Patient had previous covid test (Blood test) on 28Sep2021 which was positive. Test to R/O other things (Blood test) on 28Sep2021 was negative. The events resulted in doctor or other healthcare professional office/clinic visit. "US lower extremities, steroid rash, many visits" was reported as treatment for the events. Outcome of event COVID test result Positive was unknown, of the other events was not recovered.  Information on the lot/batch number of 2nd dose has been requested.; Sender's Comments: The possibility of COVID-19, Vaccination failure being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot, Inflammation, Nausea
Clinical narrative: Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; fever at 104 F; severe chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in arm left on 30Sep2021 at 19:30 at 31-year-old (Lot Number: Ff8839) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included COVID-19 (not ongoing). Patient was not pregnant and was not pregnant at time of vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks. The patient experienced excessive hives all over body red hot inflamed and irritated (medically significant) on 01Oct2021 with outcome of not recovered, fever at 104 F (medically significant) on 01Oct2021 with outcome of not recovered, severe chills (non-serious) on 01Oct2021 with outcome of not recovered, nausea (non-serious) on 01Oct2021 with outcome of not recovered. The events did not require therapeutic measures. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on 01Oct2021. It was reported that the patient have been breaking out in excessive hives all over her body red hot inflamed and irritated since the day after vaccination, she also had 104 F fever with severe chills and nausea. Patient did not test for COVID-19 post vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Skin irritation, Urticaria
Clinical narrative: Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; fever at 104 F; severe chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in arm left on 30Sep2021 at 19:30 at 31-year-old (Lot Number: Ff8839) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included COVID-19 (not ongoing). Patient was not pregnant and was not pregnant at time of vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks. The patient experienced excessive hives all over body red hot inflamed and irritated (medically significant) on 01Oct2021 with outcome of not recovered, fever at 104 F (medically significant) on 01Oct2021 with outcome of not recovered, severe chills (non-serious) on 01Oct2021 with outcome of not recovered, nausea (non-serious) on 01Oct2021 with outcome of not recovered. The events did not require therapeutic measures. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on 01Oct2021. It was reported that the patient have been breaking out in excessive hives all over her body red hot inflamed and irritated since the day after vaccination, she also had 104 F fever with severe chills and nausea. Patient did not test for COVID-19 post vaccination.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Depression, Dyspnoea
Clinical narrative: depressed feeling/had before but then it enhanced; had before but then it enhanced; Lack of energy; Hard to breathe; This is a spontaneous report by a contactable consumer (patient) from a Pfizer-sponsored program. This 56-year-old male patient received dose 1 of BNT162B2 (lot number EN6202) via an unspecified route of administration on 24Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included depressed feeling, lack of energy, hard to breathe, suicidal thoughts and blood clot in lungs. Concomitant medications were none. On an unspecified date the patient experienced having depressed feeling, lack of energy, and hard to breathe. He had before but then it enhanced after he got his first shot. The patient did not receive any treatment for the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101366714 same patient, different dose/events
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Depression, Dyspnoea, Suicidal ideation
Clinical narrative: Started to have suicidal thoughts; I had suicidal thought prior but it enhance it.; Hard to breath; Depression; Lack of energy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 56-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 (lot number: EN6206) at the age of 55 years old as single dose for COVID-19 immunization. Medical history included had blood clot in lungs, had suicidal thought before this vaccine. Concomitant medications were reported as none. Historical Vaccine included first dose of BNT162B2 on 24Feb2021 at the age of 55 years old for COVID-19 immunization and experienced depressed feeling, lack of energy, hard to breath. After his second dose he started to have suicidal thoughts in 2021 and he had checked himself into a hospital. He did mentioned that he had these thoughts before this vaccine but they just got worse when he got vaccinated. Patient stated, "I had suicidal thought prior but it enhance it." When probed if patient experienced any adverse event after taking COVID-19 Vaccine, patient stated, "Depression, suicide (incomplete word), lack of energy, hard to breath and I think that is because of medical (Further clarification was unknown) because I had blood clot in my lungs (Intent: history)." Patient also stated "I (incomprehensible voice) for suicide and breathing in hospital for 3 days (Further details were not clarified over the call)." No treatment was received for the events. The outcome of the events were not resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: After both 2nd & 3rd dose my period came the next day after several months of not getting a period; This is a spontaneous report from a contactable consumer.  A 53-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 12Oct2021 11:00 (at the age of 53 years) (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient had no medical history. Concomitant medication included estradiol cipionate; progesterone (PROGESTIN). The patient previously took BNT162B2 DOSE 1 on 17Feb2021 16:30 (lot: EN6201) and DOSE 2 on 10Mar2021 16:30 (lot number: EN6206); at the age of 52 years both in the right arm for COVID-19 immunization; Flu vaccine on 23Sep2021 (at the age of 53 years) for immunization. It was reported that the patient's period came the next day after several months of not getting a period (postmenopausal haemorrhage) on 13Oct2021 04:00. The event was assessed as serious (medically significant). The patient did not received treatment for the event. The outcome of the event was recovered on an unspecified date.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Tremor, Vaccination site erythema
Clinical narrative: chills really bad; he was shaking all over; Muscle pain across two shoulders and arms; tired; Injection site redness; injection site pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in the left arm, on 12Oct2021 (Lot number: EW0179), at age 82 years old, as dose 3 (booster), single, for COVID-19 immunisation. Relevant medical history included diabetic, heart problems, and lymphoedema all from unknown date, not reported if ongoing or not, and flu on an unknown date. Concomitant medications included unspecified products. Historical vaccines included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on 21Feb2021 (lot number: EN6203), at age 81 years old, as dose 1, single; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on 14Mar2021 (lot number: EN6204), at age 81 years old, as dose 2, single, for COVID-19 immunisation. The patient did not receive prior vaccinations within 4 weeks. On 12Oct2021, the patient experienced injection site pain and injection site redness. On 13Oct2021 at 08:00, the patient started to have chills really bad, he was shaking all over. On 13Oct2021, the patient experienced muscle pain across two shoulders and arms and was tired. The patient had the shot on 12Oct2021 at noon and had no problems with it from noon until this morning. This morning at about 8:00 the caller started to have chills really bad, he was shaking all over. The caller put a heating pad on this body to warm himself up. The patient's injection site had pain but not too bad, but there was pain. The patient has taken 2 Tylenols in order to ease the pain a little bit. The caller was tired and fell asleep once he put the heating pad on him and woke up about 5 minutes ago and slept for 3 hours. The patient also had muscle pain across his two shoulders and arms. The patient had injection site redness. The patient stated it was nothing is too serious except the chills and the patient has never had anything like that not even when he had the flu. The events did not result to emergency room and physician's room visits. The outcome of the event injection site redness was not resolved. The patient was recovering from the remaining events.  No follow-up attempts are needed. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: chills really bad; he was shaking all over; Muscle pain across two shoulders and arms; tired; Injection site redness; injection site pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in the left arm, on 12Oct2021 (Lot number: EW0179), at age 82 years old, as dose 3 (booster), single, for COVID-19 immunisation. Relevant medical history included diabetic, heart problems, and lymphoedema all from unknown date, not reported if ongoing or not, and flu on an unknown date. Concomitant medications included unspecified products. Historical vaccines included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on 21Feb2021 (lot number: EN6203), at age 81 years old, as dose 1, single; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on 14Mar2021 (lot number: EN6204), at age 81 years old, as dose 2, single, for COVID-19 immunisation. The patient did not receive prior vaccinations within 4 weeks. On 12Oct2021, the patient experienced injection site pain and injection site redness. On 13Oct2021 at 08:00, the patient started to have chills really bad, he was shaking all over. On 13Oct2021, the patient experienced muscle pain across two shoulders and arms and was tired. The patient had the shot on 12Oct2021 at noon and had no problems with it from noon until this morning. This morning at about 8:00 the caller started to have chills really bad, he was shaking all over. The caller put a heating pad on this body to warm himself up. The patient's injection site had pain but not too bad, but there was pain. The patient has taken 2 Tylenols in order to ease the pain a little bit. The caller was tired and fell asleep once he put the heating pad on him and woke up about 5 minutes ago and slept for 3 hours. The patient also had muscle pain across his two shoulders and arms. The patient had injection site redness. The patient stated it was nothing is too serious except the chills and the patient has never had anything like that not even when he had the flu. The events did not result to emergency room and physician's room visits. The outcome of the event injection site redness was not resolved. The patient was recovering from the remaining events.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Crohn's disease, Immunisation, Off label use
Clinical narrative: Patient with case of regional ileitis starting the day after his 3rd booster.; DOSE 3 (BOOSTER), SINGLE; DOSE 3 (BOOSTER), SINGLE; This is a spontaneous report from a contactable physician. A 53-years-old male patient received BNT162B2 dose 3 via an unspecified route of administration on 27Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single, at the age of 53-years-old, for COVID-19 immunisation. Medical history included hypertension (HTN). No Known allergy. The patient previously received the first dose of BNT162B2 on 23Dec2020 and second dose of BNT162B2 on 13Jan2021, both at the age of 53-years-old, for COVID-19 immunization. Concomitant medication included lisinopril. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination. The patient had not had covid tested post vaccination. The patient with case of regional ileitis starting the day after his 3rd booster. Event (regional ileitis) onset date reported as 28Sep2021. Treatment received for the event (regional ileitis) that included antibiotics. Event (regional ileitis) resulted in physician office visit. The event (regional ileitis) was resolved in 2021. The patient underwent lab tests and procedures which included CT scan: ileitis on 28Sep2021.    The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on temporal relationship the possibility of causal association between the events Crohn's disease and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Hyperhidrosis, Loss of consciousness, Nausea
Clinical narrative: managed to make it to bed to lay under A/C and passed out; all of a sudden my Body broke out into a real bad sweat that soaked clothes; felt real nauseous like I was going to vigorously vomit; was light headed; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 27Sep2021 19:45 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy. The patient's medical history was not reported. The patient previously took clindamycin and azithromycin and experienced drug allergies. No other vaccines in four weeks and no other medications in two weeks. No COVID prior to vaccination. On 28Sep2021 12:45, the patient reported that she was folding clothes and felt fine when all of a sudden her body broke out into a real bad sweat that soaked clothes, felt real nauseous like she was going to vigorously vomit, was light headed, managed to make it to bed to lay under A/C and passed out. The patient had a doctor or other healthcare professional office/clinic visit. The patient received an unspecified treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results and COVID Nasal Swab: negative on unspecified date. The blood work was used to determine if she can receive the 2nd dose. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: managed to make it to bed to lay under A/C and passed out; all of a sudden my Body broke out into a real bad sweat that soaked clothes; felt real nauseous like I was going to vigorously vomit; was light headed; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 27Sep2021 19:45 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization at a pharmacy. The patient's medical history was not reported. The patient previously took clindamycin and azithromycin and experienced drug allergies. No other vaccines in four weeks and no other medications in two weeks. No COVID prior to vaccination. On 28Sep2021 12:45, the patient reported that she was folding clothes and felt fine when all of a sudden her body broke out into a real bad sweat that soaked clothes, felt real nauseous like she was going to vigorously vomit, was light headed, managed to make it to bed to lay under A/C and passed out. The patient had a doctor or other healthcare professional office/clinic visit. The patient received an unspecified treatment for the events. The patient underwent lab tests and procedures which included blood test: unknown results and COVID Nasal Swab: negative on unspecified date. The blood work was used to determine if she can receive the 2nd dose. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: found on the floor by his wife/passed out; This is a spontaneous report from a contactable nurse (patient's daughter). A 79-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FF8839), via an unspecified route of administration on 08Oct2021 (at the age of 79 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient previously received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 20Feb2021 (at the age of 78 years old; lot number: EL9269) as dose 1, single and via an unspecified route of administration on 13Mar2021 (at the age of 78 years old; lot number: EL3302, expiry date: 30May2021) as dose 2, single for COVID-19 immunization. The patient was found on the floor by his wife/passed out, weak on the floor and couldn't get up on 09Oct2021. The patient's daughter clarified this was her father's booster shot. He took the injection on 08Oct2021. On Saturday, 09Oct2021, his wife found him and said he was passed out, weak on the floor, he couldn't get up. On 10Oct2021, her father went to the bathroom on himself which was totally unlike her father. On 11Oct2021, he started coming back to his normal self. For the causality, the reporter stated she doesn't know, it could possibly be related but she doesn't know. She confirmed her father started no new medications; he has no other medical conditions. The events did not require ER visit or physician office visit. The patient's daughter also confirmed her father has not been to the doctor's. She highly encouraged her parents to take him to the doctor and tell the doctor exactly what happened. She informed them they should have brought her father to the ER immediately. The outcome of the events found on the floor by his wife/passed out and weak on the floor was recovering.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Freezer was set to a temperature that was a little too low/temperature excursion; Freezer was set to a temperature that was a little too low/temperature excursion; icky feeling; Fever; Chills; Headache; This is a spontaneous report from a contactable other nurse (patient). A 30-year-old female patient received the third dose of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on 06Oct2021 (at the age of 30 years old) (Lot Number: FF8841; Expiration Date: 31Mar2022) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient took her first dose of the vaccine on an unspecified date had lot EJ1685 (not involved in the temperature excursion) for COVID-19 immunization; her second dose on an unspecified date has lot EK9231 for COVID-19 immunisation (not involved in the temperature excursion) and experienced fever, chills for a day, icky feeling and headache. Patient wanted stability information on a temperature excursion that they have with the undiluted Pfizer COVID-19 vaccines which were administered to an unknown number of patients for their 1st, 2nd and booster doses, and patient (also reporter) was one of the patients who received the booster dose of this vaccine. Patient (nurse) stated that the freezer was set a little too low for the last couple of months and were keeping it at negative 28 degrees Celsius and had raised the temperature to negative 25 to negative 15 degrees Celsius about a day ago; states the freezer never went below negative 30 degrees Celsius and kept it the standard frozen temperature between negative 30 to negative 15 degrees Celsius. The vaccines were stored in the freezer "never longer than 2 weeks". Patient stated that for seriousness criteria for the temperature excursion she would say it is a near miss potential and medically significant and she also had the same reaction for the booster dose as she had for her second dose of the vaccine and that was fever, chills for a day, icky feeling and headache and those symptoms have resolved but began on 07Oct2021 and resolved that evening. Patient reported symptoms were caused by the vaccine but she thinks this is normal for side effects. The outcome of the events was recovered on 07Oct2021. Event relatedness reported for Pfizer COVID Vaccine: icky feeling - Related.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Freezer was set to a temperature that was a little too low/temperature excursion; Freezer was set to a temperature that was a little too low/temperature excursion; icky feeling; Fever; Chills; Headache; This is a spontaneous report from a contactable other nurse (patient). A 30-year-old female patient received the third dose of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on 06Oct2021 (at the age of 30 years old) (Lot Number: FF8841; Expiration Date: 31Mar2022) as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient took her first dose of the vaccine on an unspecified date had lot EJ1685 (not involved in the temperature excursion) for COVID-19 immunization; her second dose on an unspecified date has lot EK9231 for COVID-19 immunisation (not involved in the temperature excursion) and experienced fever, chills for a day, icky feeling and headache. Patient wanted stability information on a temperature excursion that they have with the undiluted Pfizer COVID-19 vaccines which were administered to an unknown number of patients for their 1st, 2nd and booster doses, and patient (also reporter) was one of the patients who received the booster dose of this vaccine. Patient (nurse) stated that the freezer was set a little too low for the last couple of months and were keeping it at negative 28 degrees Celsius and had raised the temperature to negative 25 to negative 15 degrees Celsius about a day ago; states the freezer never went below negative 30 degrees Celsius and kept it the standard frozen temperature between negative 30 to negative 15 degrees Celsius. The vaccines were stored in the freezer "never longer than 2 weeks". Patient stated that for seriousness criteria for the temperature excursion she would say it is a near miss potential and medically significant and she also had the same reaction for the booster dose as she had for her second dose of the vaccine and that was fever, chills for a day, icky feeling and headache and those symptoms have resolved but began on 07Oct2021 and resolved that evening. Patient reported symptoms were caused by the vaccine but she thinks this is normal for side effects. The outcome of the events was recovered on 07Oct2021. Event relatedness reported for Pfizer COVID Vaccine: icky feeling - Related.
Sex: F
Vaccine: COVID19
Symptoms: Skin laceration, Urinary tract infection, Vaccination site nodule
Clinical narrative: Laceration of finger; Urinary tract infection; Vaccination site nodule/ Knot in arm; This is a solicited report from a Non-Interventional Study based on information received by Pfizer from AbbVie, MFR Control No. 21K-163-4114081-00). A contactable consumer (patient) reported that a 58-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE and dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE, both vaccination site was arm and for covid-19 immunisation; upadacitinib (RINVOQ), oral from an unspecified date (Batch/Lot number was not reported) and no information about ongoing, at unknown dose and frequency for moderate to severe rheumatoid arthritis.  The patient's medical history and concomitant medications was not reported. Patient with events of knee replacement surgery and urinary tract infection, patient cut knuckles and got second covid vaccine and had knot in arm with Rinvoq (upadacitinib). Events onset date was in 2021.The action taken in response to the event(s) for upadacitinib was unknown.  Therapeutic measures were taken as a result of urinary tract infection and cut knuckles included antibiotics. The outcome of Vaccination site nodule/ Knot in arm was recovered in 2021 with duration 4 dyas. The outcome of other events was not recovered. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.    The reporter's causality for the event(s) of knee replacement surgery, urinary tract infection, patient cut Knuckles and got second covid vaccine and had knot in arm was not provided.   AbbVie's opinion is that there is no reasonable possibility that the events of knee replacement surgery, Patient cut knuckles and got second covid vaccine and had knot in arm are related to Rinvoq (upadacitinib).  AbbVie's opinion is that the event of urinary tract infection is not assessable.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Laceration of finger, Urinary tract infection and Vaccination site nodule. The case will be reassessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Condition aggravated
Clinical narrative: spike in his blood pressure readings from his normal of 130/80/48 to 152/85/58; spike in his blood pressure readings from his normal of 130/80/48 to 152/85/58; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received booster (third dose) of BNT162B2 (brand=Pfizer), via an unspecified route of administration (right arm) on 11Oct2021 14:45 as single dose for COVID-19 immunization. Facility type vaccine: military base. The patient previously received the first dose on 24Jan2021 09:15 AM (lot number: EL9263) and second dose on 14Feb2021 09:30 AM (lot number: EN6200), both in the right arm at 78 years of age for COVID-19 immunization. Medical history included known allergies to lisinopril, ongoing high blood pressure, and 1 heart blockage 20yrs ago (from 2001). No Covid prior to vaccination. Concomitant medications were not reported. No other vaccine in four weeks. With other medications in two weeks (unspecified). The patent experienced a spike in his blood pressure readings from his normal of 130/80/48 to 152/85/58 on 12Oct2021. No treatment the event. No Covid test post vaccination. The patient recovered from the event on an unspecified date.