chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Confusional state, Dizziness, Drug screen, Ear discomfort
Clinical narrative: pressure in his head; swollen eyelids; ringing in his ears; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included Prednisone. Patient had second dose of the Pfizer CIVID 19 vaccine on 7Apr2021. Caller stated he was having some pressure in his head, swollen eyelids, ringing in his ears and diarrhea for the last five days. Caller stated the diarrhea could be because he was taking ibuprofen for the symptoms. Caller stated he had gone to the ER, his PCP and urgent care but has gotten no relief. Caller stated he was taking prednisone. Caller wanted to know if there was a specific doctor he should go to. Caller stated he was trying to find help and there was no clarity on where to go. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Fibrin D dimer, Full blood count, Metabolic function test, Red blood cell nucleated morphology
Clinical narrative: pressure in his head; swollen eyelids; ringing in his ears; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included Prednisone. Patient had second dose of the Pfizer CIVID 19 vaccine on 7Apr2021. Caller stated he was having some pressure in his head, swollen eyelids, ringing in his ears and diarrhea for the last five days. Caller stated the diarrhea could be because he was taking ibuprofen for the symptoms. Caller stated he had gone to the ER, his PCP and urgent care but has gotten no relief. Caller stated he was taking prednisone. Caller wanted to know if there was a specific doctor he should go to. Caller stated he was trying to find help and there was no clarity on where to go. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Tinnitus, Troponin I, Urine analysis
Clinical narrative: pressure in his head; swollen eyelids; ringing in his ears; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included Prednisone. Patient had second dose of the Pfizer CIVID 19 vaccine on 7Apr2021. Caller stated he was having some pressure in his head, swollen eyelids, ringing in his ears and diarrhea for the last five days. Caller stated the diarrhea could be because he was taking ibuprofen for the symptoms. Caller stated he had gone to the ER, his PCP and urgent care but has gotten no relief. Caller stated he was taking prednisone. Caller wanted to know if there was a specific doctor he should go to. Caller stated he was trying to find help and there was no clarity on where to go. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Head discomfort, Swelling of eyelid, Tinnitus
Clinical narrative: pressure in his head; swollen eyelids; ringing in his ears; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date was not reported) via unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included Prednisone. Patient had second dose of the Pfizer CIVID 19 vaccine on 7Apr2021. Caller stated he was having some pressure in his head, swollen eyelids, ringing in his ears and diarrhea for the last five days. Caller stated the diarrhea could be because he was taking ibuprofen for the symptoms. Caller stated he had gone to the ER, his PCP and urgent care but has gotten no relief. Caller stated he was taking prednisone. Caller wanted to know if there was a specific doctor he should go to. Caller stated he was trying to find help and there was no clarity on where to go. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebral thrombosis, Cerebrovascular accident
Clinical narrative: ADVERSE EVENTS: dizziness ,nausea, vomiting, could'nt move neck, seizure, flat lined, aneurysm, Death.  TREATMENT: Hospitilization with hundereds of tests. OUTCOME: DEATH on April 2, 2021
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Aneurysm, Death, Dizziness, Musculoskeletal stiffness, Nausea
Clinical narrative: ADVERSE EVENTS: dizziness ,nausea, vomiting, could'nt move neck, seizure, flat lined, aneurysm, Death.  TREATMENT: Hospitilization with hundereds of tests. OUTCOME: DEATH on April 2, 2021
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulseless electrical activity, Seizure, Vomiting
Clinical narrative: ADVERSE EVENTS: dizziness ,nausea, vomiting, could'nt move neck, seizure, flat lined, aneurysm, Death.  TREATMENT: Hospitilization with hundereds of tests. OUTCOME: DEATH on April 2, 2021
Age: 48.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Passed out; Blood clots in lungs; almost died from the vaccine; Problem in breathing; This is a spontaneous report from a contactable consumer (patient) reported that a 48-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration, administered in arm right on 21Jan2021 (at the age of 48-years-old) as a single dose for covid-19 immunisation. The patient was healthy and had no suffering from any medical condition. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient had his/her shot on 21Jan2021 and about 10 days later he/she was having problem in breathing. When the patient went to work, he/she passed out at work and they sent him/her to the hospital and he/she wound up in the hospital on 12Feb2021 and they found out that he/she have blood clots in his/her lungs. The patient added that the matter of concern was he/she almost died from the vaccine. The patient was discharged on 14Feb2021 and he/she went in on 12Feb2021 and they did the catheter to remove the blood clot. The patient was hospitalized due to blood clots in his/her lungs and prior to going to the hospital, a week, and a half before that he/she was having breathing issues. The patient underwent lab tests and procedures which included blood test with unknown results on Feb2021. The patient was supposed to get the 2nd dose on 11Feb2021, but he/she never went because he/she wound up in hospital. The patient right now was taking blood thinner named Eliquis after he/she wind up with clot. The outcome of the events was unknown.
Age: 48.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dyspnoea, Loss of consciousness, Near death experience, Pulmonary thrombosis
Clinical narrative: Passed out; Blood clots in lungs; almost died from the vaccine; Problem in breathing; This is a spontaneous report from a contactable consumer (patient) reported that a 48-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration, administered in arm right on 21Jan2021 (at the age of 48-years-old) as a single dose for covid-19 immunisation. The patient was healthy and had no suffering from any medical condition. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient had his/her shot on 21Jan2021 and about 10 days later he/she was having problem in breathing. When the patient went to work, he/she passed out at work and they sent him/her to the hospital and he/she wound up in the hospital on 12Feb2021 and they found out that he/she have blood clots in his/her lungs. The patient added that the matter of concern was he/she almost died from the vaccine. The patient was discharged on 14Feb2021 and he/she went in on 12Feb2021 and they did the catheter to remove the blood clot. The patient was hospitalized due to blood clots in his/her lungs and prior to going to the hospital, a week, and a half before that he/she was having breathing issues. The patient underwent lab tests and procedures which included blood test with unknown results on Feb2021. The patient was supposed to get the 2nd dose on 11Feb2021, but he/she never went because he/she wound up in hospital. The patient right now was taking blood thinner named Eliquis after he/she wind up with clot. The outcome of the events was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pruritus, Rash, Skin exfoliation, Urticaria
Clinical narrative: rash all over the body, on chest, shoulder, stomach, on abdomen; relief the itching.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 via unspecified route of administration in left arm on 06Apr2021 (lot number ER8734, and expiration date not provided) at single dose for COVID-19 immunization. The patient's medical history included Crohn's disease. The patient's concomitant medications included azathioprine and balsalazide disodium both for Crohn's disease. The patient experienced rash all over the body, on chest, shoulder, stomach, on abdomen. The patient asked what can do to relief the itching. No Investigation Assessment for the event. The patient was taking diphenhydramine hydrochloride (BENADRYL) 25mg one every 4 hours for the rash. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash all over the body, on chest, shoulder, stomach, on abdomen; relief the itching.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received bnt162b2 via unspecified route of administration in left arm on 06Apr2021 (lot number ER8734, and expiration date not provided) at single dose for COVID-19 immunization. The patient's medical history included Crohn's disease. The patient's concomitant medications included azathioprine and balsalazide disodium both for Crohn's disease. The patient experienced rash all over the body, on chest, shoulder, stomach, on abdomen. The patient asked what can do to relief the itching. No Investigation Assessment for the event. The patient was taking diphenhydramine hydrochloride (BENADRYL) 25mg one every 4 hours for the rash. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral normal, Blood pressure increased, Computerised tomogram head normal, Fluid retention, Headache
Clinical narrative: HIGH PULSE RATE; HIGH BLOOD PRESSURE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced high pulse rate, high blood pressure, headache and was hospitalized for 2 days (date unspecified). Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 198/112 mmHg, and Pulse rate (NR: not provided) 161 {beats}/min. It was reported that the patient had headache, after 10 days and that lasted for 03 days and on 3rd day it raised his pulse to 161 and BP to 198/112. The patient called to 911 and went to hospital. The patient wasn't sick before the vaccine, the patient had really poor insurance and the hospital ran a lot of tests and he could not afford that, its 1000s of dollars in bills because of his reaction to medication. The reported that he was an inch from death with 198/112 BP(blood pressure). The patient was hospitalized for 02 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, high pulse rate and high blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210452065-COVID-19 VACCINE AD26.COV2.S-HIGH PULSE RATE,HIGH BLOOD PRESSURE . These events are considered unassessable. The events have  compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210452065-COVID-19 VACCINE AD26.COV2.S-headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb mass, Magnetic resonance imaging head normal
Clinical narrative: HIGH PULSE RATE; HIGH BLOOD PRESSURE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced high pulse rate, high blood pressure, headache and was hospitalized for 2 days (date unspecified). Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 198/112 mmHg, and Pulse rate (NR: not provided) 161 {beats}/min. It was reported that the patient had headache, after 10 days and that lasted for 03 days and on 3rd day it raised his pulse to 161 and BP to 198/112. The patient called to 911 and went to hospital. The patient wasn't sick before the vaccine, the patient had really poor insurance and the hospital ran a lot of tests and he could not afford that, its 1000s of dollars in bills because of his reaction to medication. The reported that he was an inch from death with 198/112 BP(blood pressure). The patient was hospitalized for 02 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, high pulse rate and high blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210452065-COVID-19 VACCINE AD26.COV2.S-HIGH PULSE RATE,HIGH BLOOD PRESSURE . These events are considered unassessable. The events have  compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210452065-COVID-19 VACCINE AD26.COV2.S-headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Headache, Heart rate, Heart rate increased, Hypertension
Clinical narrative: HIGH PULSE RATE; HIGH BLOOD PRESSURE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced high pulse rate, high blood pressure, headache and was hospitalized for 2 days (date unspecified). Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 198/112 mmHg, and Pulse rate (NR: not provided) 161 {beats}/min. It was reported that the patient had headache, after 10 days and that lasted for 03 days and on 3rd day it raised his pulse to 161 and BP to 198/112. The patient called to 911 and went to hospital. The patient wasn't sick before the vaccine, the patient had really poor insurance and the hospital ran a lot of tests and he could not afford that, its 1000s of dollars in bills because of his reaction to medication. The reported that he was an inch from death with 198/112 BP(blood pressure). The patient was hospitalized for 02 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, high pulse rate and high blood pressure was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210452065-COVID-19 VACCINE AD26.COV2.S-HIGH PULSE RATE,HIGH BLOOD PRESSURE . These events are considered unassessable. The events have  compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210452065-COVID-19 VACCINE AD26.COV2.S-headache. This event(s) is labeled per RSI and is therefore considered potentially related.
Age: 56.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Computerised tomogram abnormal, Unevaluable event
Clinical narrative: Woke up with chest pains diagnosed as blood clots in both lungs.; Mental confusion; This is a spontaneous report from a contactable consumer reporting for herself.    A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left Arm  on 31Mar2021 13:00 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation  .  Medical history included sleep apnoea syndrome , depression , drug hypersensitivity to penicillin.  Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; meloxicam (MELOXICAM) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Biaxin and experienced drug hypersensitivity, first dose of bnt162b2 for covid-19 immunisation on 10Mar2021.  The patient  woke up with chest pains diagnosed as blood clots in both lungs  on 10Apr2021 08:30 with outcome of recovering , mental confusion  on 10Apr2021 08:30 with outcome of recovering.  The patient was hospitalized for  3 days because of the events.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 14Apr2021  .  The patient is receiving apixaban (ELIQUIS) as treatment of the reported events.  Follow up information has been requested. Lot number already received.
Age: 56.0
Sex: F
Vaccine: UNK, UNK, COVID19
Symptoms: Confusional state, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: Woke up with chest pains diagnosed as blood clots in both lungs.; Mental confusion; This is a spontaneous report from a contactable consumer reporting for herself.    A 56-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left Arm  on 31Mar2021 13:00 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation  .  Medical history included sleep apnoea syndrome , depression , drug hypersensitivity to penicillin.  Concomitant medications included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; meloxicam (MELOXICAM) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Biaxin and experienced drug hypersensitivity, first dose of bnt162b2 for covid-19 immunisation on 10Mar2021.  The patient  woke up with chest pains diagnosed as blood clots in both lungs  on 10Apr2021 08:30 with outcome of recovering , mental confusion  on 10Apr2021 08:30 with outcome of recovering.  The patient was hospitalized for  3 days because of the events.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative   on 14Apr2021  .  The patient is receiving apixaban (ELIQUIS) as treatment of the reported events.  Follow up information has been requested. Lot number already received.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF test abnormal, Computerised tomogram head normal, Computerised tomogram neck, Epstein-Barr virus test negative, Headache
Clinical narrative: 9 days after the Moderna covid 19 vaccine: Severe headache, steadily increased over 24 hours Unable to move head ER visit, transferred to hospital Treatments: IV anti bacterial,  IV anti viral, dexamethasone, morphine, toradol DIAGNOSIS Meningitis Hospitalized overnight Patient recovered within 5 days
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes simplex test negative, Meningitis aseptic, SARS-CoV-2 test negative, Viral test, West Nile virus test negative
Clinical narrative: 9 days after the Moderna covid 19 vaccine: Severe headache, steadily increased over 24 hours Unable to move head ER visit, transferred to hospital Treatments: IV anti bacterial,  IV anti viral, dexamethasone, morphine, toradol DIAGNOSIS Meningitis Hospitalized overnight Patient recovered within 5 days
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: CSF protein increased, Computerised tomogram normal, Headache, Lymphocyte count increased, Meningitis
Clinical narrative: 9 days after the Moderna covid 19 vaccine: Severe headache, steadily increased over 24 hours Unable to move head ER visit, transferred to hospital Treatments: IV anti bacterial,  IV anti viral, dexamethasone, morphine, toradol DIAGNOSIS Meningitis Hospitalized overnight Patient recovered within 5 days
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paralysis, SARS-CoV-2 test negative
Clinical narrative: 9 days after the Moderna covid 19 vaccine: Severe headache, steadily increased over 24 hours Unable to move head ER visit, transferred to hospital Treatments: IV anti bacterial,  IV anti viral, dexamethasone, morphine, toradol DIAGNOSIS Meningitis Hospitalized overnight Patient recovered within 5 days
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging, Nerve injury, Trigeminal neuralgia
Clinical narrative: patient got bell's palsy on 4/11 after second dose moderna on 4/8
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Magnetic resonance imaging
Clinical narrative: patient got bell's palsy on 4/11 after second dose moderna on 4/8
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Computerised tomogram, Computerised tomogram head, Dyspnoea
Clinical narrative: Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Full blood count, Headache, Heart rate increased
Clinical narrative: Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Injection site pain, Insomnia, Myalgia, Nervousness
Clinical narrative: Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sinus congestion, Troponin
Clinical narrative: Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Hypertension
Clinical narrative: Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Myalgia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Muscle aches; head aches; injection site soreness; hypertension; tiredness; increased back and shoulder pain; increased back and shoulder pain/ hip pain; sleepless; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in right arm on 07Apr2021 at 13:45 (lot number: ER8737; expiry date: unknown) at a single dose, for COVID-19 immunisation. Medical history included non-Hodgkin's lymphoma, fibromyalgia, and hypertension. Concomitant medications included meloxicam, rosuvastatin and lisinopril. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. The patient had no known allergies. On 08Apr2021 at 12:00 AM, the patient experienced muscle aches, headaches, injection site soreness, hypertension, tiredness, increased back and shoulder pain, sleepless, and hip pain. The events resulted in emergency room visit, physician's office visit, and one day hospitalization on unspecified date. The patient received unspecified treatment for the events. The patient underwent lab tests and procedures which included nasal swab: negative on 15Apr2021. Outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Ultrasound scan
Clinical narrative: Pain on both legs, Tiredness, Fatigue.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Thrombosis
Clinical narrative: Pain on both legs, Tiredness, Fatigue.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on arms, Back, Stomach and legs; This is a spontaneous report from a contactable consumer (patient). This 46-year-old female patient received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL 3247/ EP6955), via an unknown route on at 10Mar2021 at 13:00 and 31Mar2021 (at the age of 46-years-old) at single dose on the left arm for COVID-19 immunization. Relevant medical history and concomitant medication was not reported. The patient had allergies to Tide Laundry Detergent. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not pregnant at the time of vaccination. On 14Mar2021, the patient had rash on arms, back, stomach and legs. She received prednisone as a treatment within two weeks of vaccination. The patient was not tested positive for COVID-19. Outcome of the event Rash on arms, Back, Stomach and legs was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle disorder, Pain, Pain in extremity, Sinus headache, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 63-years-old female patient received bnt162b2 dose 2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE , for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 via an unspecified route of administration on 26Mar2021 11:30 with Lot Number: EP6955 as single dose for COVID-19 immunization. The patient experienced couldn't raise arm above head or put on a coat without pain (limb discomfort), pain radiating from neck down to left arm, felt like muscles were being shredded (myalgia) on an unspecified date, pain radiating from neck down to left arm (pain in extremity) on 26Mar2021 14:00, a few hours after 1st pfizer vaccine dose had a sinus pressure headache which eventually went away within 24 hrs had soreness in left arm injection site plus pain lifting and moving arm (sinus headache) on an unspecified date, had soreness in left arm injection site plus pain lifting and moving arm (injection site pain) on 30Mar2021 14:00. Therapeutic measures were taken as a result of had soreness in left arm injection site plus pain lifting and moving arm (injection site pain). The outcome of the events were unknown and the outcome for the event injection site pain was not recovered. She still has pain intermittent in her arm where she can't put a coat on without pain or sleep on that side with pain. The pharmacist told her to take Aleve twice daily and use ice packs. The pain is the same and is the same consistency. She states the pharmacist states she had the exact same situation but it was after her second shot and that it lasted a month for her. Patient that pharmacist described the exact same pain and experiences that the patient had, noting that the pain went into the neck, she could not put her coat on and that it was not constant. Patient verified that the pharmacist was female. She did not know her name or initials. Patient stated that the pharmacist provided her with the information to call Pfizer. Patient states she thinks the pharmacist might have called in and reported her events also. The Pharmacist had the same as patient did after second dose and it lasted a month. Patient is also concerned that the second dose will be more severe than the first dose. Stated that the PI doesn't state if they vaccine should be given in the same arm for both doses or if you can get one dose in each arm. It simply states it is an intramuscular injection 2 DOSAGE AND ADMINISTRATION LAB-1457-7.0 Revised on 06 April 2021 Request Name: REQ-242581 Product: PFIZER-BIONTECH COVID-19 VACCINE. No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Myalgia, Pain in extremity, Sinus headache, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 63-years-old female patient received bnt162b2 dose 2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE , for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 via an unspecified route of administration on 26Mar2021 11:30 with Lot Number: EP6955 as single dose for COVID-19 immunization. The patient experienced couldn't raise arm above head or put on a coat without pain (limb discomfort), pain radiating from neck down to left arm, felt like muscles were being shredded (myalgia) on an unspecified date, pain radiating from neck down to left arm (pain in extremity) on 26Mar2021 14:00, a few hours after 1st pfizer vaccine dose had a sinus pressure headache which eventually went away within 24 hrs had soreness in left arm injection site plus pain lifting and moving arm (sinus headache) on an unspecified date, had soreness in left arm injection site plus pain lifting and moving arm (injection site pain) on 30Mar2021 14:00. Therapeutic measures were taken as a result of had soreness in left arm injection site plus pain lifting and moving arm (injection site pain). The outcome of the events were unknown and the outcome for the event injection site pain was not recovered. She still has pain intermittent in her arm where she can't put a coat on without pain or sleep on that side with pain. The pharmacist told her to take Aleve twice daily and use ice packs. The pain is the same and is the same consistency. She states the pharmacist states she had the exact same situation but it was after her second shot and that it lasted a month for her. Patient that pharmacist described the exact same pain and experiences that the patient had, noting that the pain went into the neck, she could not put her coat on and that it was not constant. Patient verified that the pharmacist was female. She did not know her name or initials. Patient stated that the pharmacist provided her with the information to call Pfizer. Patient states she thinks the pharmacist might have called in and reported her events also. The Pharmacist had the same as patient did after second dose and it lasted a month. Patient is also concerned that the second dose will be more severe than the first dose. Stated that the PI doesn't state if they vaccine should be given in the same arm for both doses or if you can get one dose in each arm. It simply states it is an intramuscular injection 2 DOSAGE AND ADMINISTRATION LAB-1457-7.0 Revised on 06 April 2021 Request Name: REQ-242581 Product: PFIZER-BIONTECH COVID-19 VACCINE. No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Headache, Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Pfizer colleague (patient) or other non-healthcare professional and other non-HCP via Medical Information Team. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot : EL3248; Expiration Date: Apr2021) via an unspecified route of administration in left arm on 13Jan2021 09:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Solution for injection, Lot : EL3248; Expiration Date: Apr2021) via an unspecified route of administration in left arm on 02Feb2021 06:30 both as single dose for covid-19 immunization. The patient was 48-years-old at the time of vaccination. Medical history included blood pressure. Concomitant medication(s) included Norvasc 10mg daily for blood pressure and was ongoing. On 12Apr2021, patient experienced tested positive for COVID-19. On 12Apr2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the event was unknown.   Follow-up (12Apr2021): New information received from the same Pfizer colleague which included: patient details, start date of event, suspect vaccine information and concomitant medication.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Pfizer colleague (patient) or other non-healthcare professional and other non-HCP via Medical Information Team. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot : EL3248; Expiration Date: Apr2021) via an unspecified route of administration in left arm on 13Jan2021 09:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Solution for injection, Lot : EL3248; Expiration Date: Apr2021) via an unspecified route of administration in left arm on 02Feb2021 06:30 both as single dose for covid-19 immunization. The patient was 48-years-old at the time of vaccination. Medical history included blood pressure. Concomitant medication(s) included Norvasc 10mg daily for blood pressure and was ongoing. On 12Apr2021, patient experienced tested positive for COVID-19. On 12Apr2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the event was unknown.   Follow-up (12Apr2021): New information received from the same Pfizer colleague which included: patient details, start date of event, suspect vaccine information and concomitant medication.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Pfizer colleague (patient) or other non-healthcare professional and other non-HCP via Medical Information Team. A 48-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot : EL3248; Expiration Date: Apr2021) via an unspecified route of administration in left arm on 13Jan2021 09:00 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE mRNA, Solution for injection, Lot : EL3248; Expiration Date: Apr2021) via an unspecified route of administration in left arm on 02Feb2021 06:30 both as single dose for covid-19 immunization. The patient was 48-years-old at the time of vaccination. Medical history included blood pressure. Concomitant medication(s) included Norvasc 10mg daily for blood pressure and was ongoing. On 12Apr2021, patient experienced tested positive for COVID-19. On 12Apr2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the event was unknown.   Follow-up (12Apr2021): New information received from the same Pfizer colleague which included: patient details, start date of event, suspect vaccine information and concomitant medication.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Feeling hot, Headache, Migraine
Clinical narrative: Hasn't eaten much; Really bad headache; Migraine; nausea; vomiting; This is a spontaneous report from a contactable consumer reported for herself. This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 09:35 Arm Left at single dose (Lot: EW0151) for COVID-19 immunisation. Family medical history included Migraines. No other products. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at age of 61-year-old Left Upper Arm at single dose (Lot: ER8727) for COVID-19 immunisation. She had only a sore arm after the first dose of the vaccine. Says it started the day of the vaccine and lasted for a couple of days then it was gone. She got her second dose of the vaccine on Saturday 10Apr2021. States right after that she started having a really bad headache on 10Ap2021, not long after the vaccine, that turned into a migraine, Continues but has gotten better. She was nauseous and vomiting on 10Apr2021. States she stayed in bed most of the weekend. Nausea and Vomiting began on 10Apr2021. States she had eaten that day. Hasn't eaten much since then besides crackers. States the nausea and vomiting started before the headache got really bad. States the nausea and vomiting have improved and then again mentions she hasn't eaten anything besides some crackers. States she has also taken some nausea medication. Lab data included a CT Scan of her sinuses and throat; about a week or so ago; has not received any results. Outcome of the event headache, Migraine, nausea, vomiting was recovering. Outcome of other events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Hasn't eaten much; Really bad headache; Migraine; nausea; vomiting; This is a spontaneous report from a contactable consumer reported for herself. This 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10Apr2021 09:35 Arm Left at single dose (Lot: EW0151) for COVID-19 immunisation. Family medical history included Migraines. No other products. No additional vaccines administered on same date of the Pfizer Suspect. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Mar2021 at age of 61-year-old Left Upper Arm at single dose (Lot: ER8727) for COVID-19 immunisation. She had only a sore arm after the first dose of the vaccine. Says it started the day of the vaccine and lasted for a couple of days then it was gone. She got her second dose of the vaccine on Saturday 10Apr2021. States right after that she started having a really bad headache on 10Ap2021, not long after the vaccine, that turned into a migraine, Continues but has gotten better. She was nauseous and vomiting on 10Apr2021. States she stayed in bed most of the weekend. Nausea and Vomiting began on 10Apr2021. States she had eaten that day. Hasn't eaten much since then besides crackers. States the nausea and vomiting started before the headache got really bad. States the nausea and vomiting have improved and then again mentions she hasn't eaten anything besides some crackers. States she has also taken some nausea medication. Lab data included a CT Scan of her sinuses and throat; about a week or so ago; has not received any results. Outcome of the event headache, Migraine, nausea, vomiting was recovering. Outcome of other events was unknown.   No follow-up attempts are needed. No further information is expected.