chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Cough; Shortness of breath (except at rest); Fever; Chills; Weakness; Tiredness; Pain in vaccinated arm; Red blotches/soreness on front of upper arm and shoulder; Red blotches/soreness on front of upper arm and shoulder; Red blotches/soreness on front of upper arm and shoulder; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 67-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EN6203), via an unspecified route of administration, in Left arm on 07Mar2021 05:00 PM (at the of 67 years old) as dose 2, single for COVID-19 immunization. Medical history included cancer survivor with ongoing maintenance. Concomitant medications included trastuzumab (HERCEPTIN), carvedilol (CARVEDILOL), valsartan (VALSARTAN) taken in two weeks. Patient had no known allergies. Patient was not tested positive for COVID post vaccination and patient not had COVID prior vaccination. patient had not received any other vaccine in four weeks. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EL9266), via an unspecified route of administration, in Left arm on 14Feb2021 05:15 PM as dose 1, single for COVID-19 immunization. On 08Mar2021 07:00 AM the patient experienced Fever, chills, weakness, tiredness, pain in vaccinated arm with red blotches/soreness on front of upper arm and shoulder, cough, shortness of breath (except at rest), dizziness. Patient had not received any treatment for events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cold sweat, Dry eye, Dyspepsia, Dyspnoea
Clinical narrative: headache; fatigued; shortness of breath; very thirsty; clammy; my eyes were very dry; heart palpitations; feeling similar to heart burn; feeling of heat (not quite burning) in upper arm; tingling of throat and tongue; tingling of throat and tongue; mild shivers; feel of coldness on my chest; This is a spontaneous report from a non-contactable consumer or Non-healthcare Professional (patient).  A 33-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in left arm on 11Mar2021 01:45 PM (at the age of 33 years old) as dose 1, single for COVID-19 immunization. Medical history included cardiac murmur (has never effected) , childhood asthma (outgrown) , gastrointestinal pain (sporadic and painful upset colon) psoriasis with beginning stages arthritis (not yet diagnosed as psoriatic arthritis),  variant (methylenetetrahydrofolate reductase gene mutation), pre-hypertensive. I am on no medications. The patient's concomitant medications were not reported. Patient is not allergic. Patient was not tested positive for post vaccination and not had COVID prior to vaccination. Patient did not receive any other vaccine in last 4 weeks and any other medication in last 2 weeks. On 11Mar2021 the patient experienced starting to get a headache at 15:45 (2 hours later), tingling of throat and tongue at 13:50, mild shivers at 13:50, feel of coldness on her chest at 13:50, feeling of heat in upper arm at 13:55, heart palpitations at 14:00 (15 minutes), feeling similar to heart burn at 14:00 (15 minutes), patient eyes were very dry at 14:45 (1 hr), fatigued at 15:45 (2 hours later), shortness of breath at 15:45 (2 hours later), very thirsty at 15:45 (2 hours later), clammy at 15:45 (2 hours later), warm clammy palms, elbows, and armpits (10 minutes). It was reported that patient had effort required to swallow saliva (clear my throat), NO difficulty breathing The patient did not receive any treatment for adverse events and outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Feeling hot, Headache, Palpitations
Clinical narrative: headache; fatigued; shortness of breath; very thirsty; clammy; my eyes were very dry; heart palpitations; feeling similar to heart burn; feeling of heat (not quite burning) in upper arm; tingling of throat and tongue; tingling of throat and tongue; mild shivers; feel of coldness on my chest; This is a spontaneous report from a non-contactable consumer or Non-healthcare Professional (patient).  A 33-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in left arm on 11Mar2021 01:45 PM (at the age of 33 years old) as dose 1, single for COVID-19 immunization. Medical history included cardiac murmur (has never effected) , childhood asthma (outgrown) , gastrointestinal pain (sporadic and painful upset colon) psoriasis with beginning stages arthritis (not yet diagnosed as psoriatic arthritis),  variant (methylenetetrahydrofolate reductase gene mutation), pre-hypertensive. I am on no medications. The patient's concomitant medications were not reported. Patient is not allergic. Patient was not tested positive for post vaccination and not had COVID prior to vaccination. Patient did not receive any other vaccine in last 4 weeks and any other medication in last 2 weeks. On 11Mar2021 the patient experienced starting to get a headache at 15:45 (2 hours later), tingling of throat and tongue at 13:50, mild shivers at 13:50, feel of coldness on her chest at 13:50, feeling of heat in upper arm at 13:55, heart palpitations at 14:00 (15 minutes), feeling similar to heart burn at 14:00 (15 minutes), patient eyes were very dry at 14:45 (1 hr), fatigued at 15:45 (2 hours later), shortness of breath at 15:45 (2 hours later), very thirsty at 15:45 (2 hours later), clammy at 15:45 (2 hours later), warm clammy palms, elbows, and armpits (10 minutes). It was reported that patient had effort required to swallow saliva (clear my throat), NO difficulty breathing The patient did not receive any treatment for adverse events and outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Thirst
Clinical narrative: headache; fatigued; shortness of breath; very thirsty; clammy; my eyes were very dry; heart palpitations; feeling similar to heart burn; feeling of heat (not quite burning) in upper arm; tingling of throat and tongue; tingling of throat and tongue; mild shivers; feel of coldness on my chest; This is a spontaneous report from a non-contactable consumer or Non-healthcare Professional (patient).  A 33-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in left arm on 11Mar2021 01:45 PM (at the age of 33 years old) as dose 1, single for COVID-19 immunization. Medical history included cardiac murmur (has never effected) , childhood asthma (outgrown) , gastrointestinal pain (sporadic and painful upset colon) psoriasis with beginning stages arthritis (not yet diagnosed as psoriatic arthritis),  variant (methylenetetrahydrofolate reductase gene mutation), pre-hypertensive. I am on no medications. The patient's concomitant medications were not reported. Patient is not allergic. Patient was not tested positive for post vaccination and not had COVID prior to vaccination. Patient did not receive any other vaccine in last 4 weeks and any other medication in last 2 weeks. On 11Mar2021 the patient experienced starting to get a headache at 15:45 (2 hours later), tingling of throat and tongue at 13:50, mild shivers at 13:50, feel of coldness on her chest at 13:50, feeling of heat in upper arm at 13:55, heart palpitations at 14:00 (15 minutes), feeling similar to heart burn at 14:00 (15 minutes), patient eyes were very dry at 14:45 (1 hr), fatigued at 15:45 (2 hours later), shortness of breath at 15:45 (2 hours later), very thirsty at 15:45 (2 hours later), clammy at 15:45 (2 hours later), warm clammy palms, elbows, and armpits (10 minutes). It was reported that patient had effort required to swallow saliva (clear my throat), NO difficulty breathing The patient did not receive any treatment for adverse events and outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on arm after 2nd dose; This is a spontaneous report from a contactable consumer (Patient herself). A 43-year-old non pregnant female patient received bnt162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Em9810), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 as dose 2, single (at the age of 43-year-old) for COVID-19 immunisation. The patient received first dose of bnt162b2 on 14Jan2021 at 02.00 PM (lot number El3249, Administration date 14Jan2021 at 02:00 PM, administered in right arm) (at the age of 43-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included Pituitary tumor, diabetes and known allergies from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. Concomitant medications included in two weeks semaglutide (OZEMPIC) and sitagliptin phosphate (JANUVIA). The patient did not receive any other vaccine in four weeks. The patient experienced rash on arm after 2nd dose on 12Feb2021. The events resulted in physician office visit. The patient not tested for covid post vaccination. Therapeutic measures were taken as a result of rash on arm after 2nd dose and treatment included with Benadryl, cortisone cream. The outcome of event reported as recovered on an unknown date of 2021.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Dizziness, Malaise
Clinical narrative: Dizzy; no appetite; feel like garbage; high fever; Chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 35-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6202; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:30 as 1st dose, single for covid-19 immunisation. (Age at vaccination was 35years). Medical history and concomitant medications were not reported.  The patient experienced high fever, chills on 06Mar2021, dizzy on 07Mar2021, no appetite on 06Mar2021, feel like garbage. The patient underwent lab tests and procedures which included body temperature: high   on 06Mar2021, body temperature: 104   on 07Mar2021 High fever peaked Sunday at 104. Therapeutic measures were taken as a result of high fever. Patient feels a little tiny bit better each day, but it is cyclical through the day. Looked online, says side effects are worse for the second dose. So, he doesn't even know where to go for the information. Patient details about this morning had it 250 but usually it's between 250-260, somewhere in there, at least it was last week, but he hasn't eaten very much. Often when patient gets the regular flu shot, he feels a little crappy the next day, under the weather. Emergency room visit was no, physician office visit was no, prior vaccinations (within 4 weeks) was none.AE(S) following prior vaccinations was only the flu vaccine, caller does not have NDC, lot number, and expiration date to provide. Adverse event: under the weather, feel a little crappy the next day. Patient's medical history (including any illness at time of vaccination was none. Family medical history relevant to AE(s) was none. Relevant tests:  none. Yes, there a Product Complaint. Description of complaint patient is a consumer reporting his experience with Pfizer Covid-19 Vaccine. He states he has high fever. He states he has been diligent about Advil and Tylenol and when he doesn't take them the fever comes back but it's getting better little by little. No further information provided. Outcome of the events for high fever was recovering, chills was recovered, dizzy, no appetite not recovered, feel like garbage was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Dizzy; no appetite; feel like garbage; high fever; Chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 35-years-old male patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6202; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:30 as 1st dose, single for covid-19 immunisation. (Age at vaccination was 35years). Medical history and concomitant medications were not reported.  The patient experienced high fever, chills on 06Mar2021, dizzy on 07Mar2021, no appetite on 06Mar2021, feel like garbage. The patient underwent lab tests and procedures which included body temperature: high   on 06Mar2021, body temperature: 104   on 07Mar2021 High fever peaked Sunday at 104. Therapeutic measures were taken as a result of high fever. Patient feels a little tiny bit better each day, but it is cyclical through the day. Looked online, says side effects are worse for the second dose. So, he doesn't even know where to go for the information. Patient details about this morning had it 250 but usually it's between 250-260, somewhere in there, at least it was last week, but he hasn't eaten very much. Often when patient gets the regular flu shot, he feels a little crappy the next day, under the weather. Emergency room visit was no, physician office visit was no, prior vaccinations (within 4 weeks) was none.AE(S) following prior vaccinations was only the flu vaccine, caller does not have NDC, lot number, and expiration date to provide. Adverse event: under the weather, feel a little crappy the next day. Patient's medical history (including any illness at time of vaccination was none. Family medical history relevant to AE(s) was none. Relevant tests:  none. Yes, there a Product Complaint. Description of complaint patient is a consumer reporting his experience with Pfizer Covid-19 Vaccine. He states he has high fever. He states he has been diligent about Advil and Tylenol and when he doesn't take them the fever comes back but it's getting better little by little. No further information provided. Outcome of the events for high fever was recovering, chills was recovered, dizzy, no appetite not recovered, feel like garbage was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: severe fatigue; headache; joint pain; nausea; vomiting; chills; sweats; low grade temp 100; This is a spontaneous report from a contactable other healthcare professional (patient).   A 47-year-old adult female patient (Non pregnant) received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration at left arm, on 20Feb2021 at 06:30 PM (age at vaccination: 47 years), as a dose 1, single for COVID-19 immunization. The patient's medical history includes controlled high blood pressure. Patient was allergy to Cephalosporin and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medication included Amlodipine 5mg daily. 24 hours after getting vaccine, On 21Feb2021 05:30 PM, the patient had experienced severe fatigue, headache, joint pain, nausea and vomiting, chills, sweats and low grade temp 100-symptoms still present. On 02Mar2021, the patient had laboratory investigations on nasal swab rapid test and nasal swab PCR which test results negative. On 04Mar2021, the patient had nasal swab rapid test and nasal swab PCR test result negative. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. At the time of reporting, the outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, SARS-CoV-2 antibody test, Vomiting
Clinical narrative: severe fatigue; headache; joint pain; nausea; vomiting; chills; sweats; low grade temp 100; This is a spontaneous report from a contactable other healthcare professional (patient).   A 47-year-old adult female patient (Non pregnant) received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration at left arm, on 20Feb2021 at 06:30 PM (age at vaccination: 47 years), as a dose 1, single for COVID-19 immunization. The patient's medical history includes controlled high blood pressure. Patient was allergy to Cephalosporin and penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient concomitant medication included Amlodipine 5mg daily. 24 hours after getting vaccine, On 21Feb2021 05:30 PM, the patient had experienced severe fatigue, headache, joint pain, nausea and vomiting, chills, sweats and low grade temp 100-symptoms still present. On 02Mar2021, the patient had laboratory investigations on nasal swab rapid test and nasal swab PCR which test results negative. On 04Mar2021, the patient had nasal swab rapid test and nasal swab PCR test result negative. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was tested for COVID-19. At the time of reporting, the outcome of the events were not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Rash pruritic, SARS-CoV-2 antibody test
Clinical narrative: rash on back and side; Large red itchy bumps; bumps are sore with a little pain; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old non- pregnant female patient received bnt162b2 (BNT162B2) formulation solution for injection, dose 2 (Lot Number: EN5318 expiry date was unknown) via an unspecified route of administration at arm Left on 26Feb2021 13:45 (at the age of 63-years-old) as a single dose for covid-19 immunisation. Medical history included hiv infection from an unknown date and unknown if ongoing HIV undetected viral load, hypertension from an unknown date and unknown if ongoing High blood pressure. The patient previously took codeine and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation. Patient had known allergies with Codeine. Historical vaccine dose 1 (Lot Number: EN518 expiry date was unknown) via unspecified route of administration at arm right on 29-JAN-2021 as a single for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.Other medications in two weeks: Same maintenance medications as before first shot. On 06Mar2021 rash on back and side. Large red itchy bumps that have fluid inside. The risings vary in size. The largest bump was the size of a dime that has burst and has a black scab. The other bumps are in a line along her waist and are approximately 1/4 of a dime. There was also a bump on her ear. The bumps are sore with a little pain. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 04Mar2021. No treatment was given for adverse events. Outcome of the events was on rash was unknown and other events was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Chills, Dizziness, Myalgia
Clinical narrative: Fever 104 F; Muscle aches-whole body; Chills; Nausea; Chest tightness; Dizziness; This is a spontaneous report from a contactable consumer. This 58-year-old male consumer (Patient) reported. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:45 (at the age of 58-years-old) as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, hypertension, haemochromatosis. Concomitant medication(s) medications in two weeks included insulin glargine (TOUJEO); losartan potassium; gabapentin; metformin; fenofibric acid. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 15:00, the patient experienced fever 104 F, muscle aches-whole body, chills, nausea, chest tightness, dizziness. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever 104 F; Muscle aches-whole body; Chills; Nausea; Chest tightness; Dizziness; This is a spontaneous report from a contactable consumer. This 58-year-old male consumer (Patient) reported. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:45 (at the age of 58-years-old) as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, hypertension, haemochromatosis. Concomitant medication(s) medications in two weeks included insulin glargine (TOUJEO); losartan potassium; gabapentin; metformin; fenofibric acid. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 15:00, the patient experienced fever 104 F, muscle aches-whole body, chills, nausea, chest tightness, dizziness. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Back pain, Chills, Painful respiration, Pyrexia
Clinical narrative: chills; felt like someone punched me in the back; low grade fever; pain when I would breath; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on 17Feb2021 (12 days past the 21 days) as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as a single dose for covid-19 immunization and her arm was sore. On an unknown date, patient experienced chills, felt like someone punched her in the back, had low grade fever, and had pain when she would breathe. She had no antibodies when they checked. She got an antibody test they pricked her finger and said she had no antibodies (negative IgC and IgM). They advised her to come back in 1 month to test again. The patient underwent lab test and procedure, which included antibody test they pricked her finger and said she had no antibodies (negative IgC and IgM). The clinical outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: red deltoid muscle just below injection site; Swollen; sore; somewhat itchy; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 62-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration (at the age of 62-years), administered in arm left on 02Mar2021 at 17:30 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medica-tions included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfeta-mine sulfate (ADDERALL) taken as 30mg, sertraline hydrochloride (ZOLOFT), clonazepam (KLONOPIN), zinc (ZINC), colecalciferol (D) taken for an unspecified indication, start and stop date were not report-ed. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. The vaccination facility type was reported as other. The patient previously took opioids and experienced known allergies. On 11Mar2021 at 20:00, the patient experienced red deltoid muscle just below injection site, swollen, sore, somewhat itchy. The treatment was not received for all the adverse events. The clinical outcome for all the events was reported as not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient himself). A 73-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6206), at the age of 73, via an unspecified route of administration, right arm, on Mar 10, 2021, at 16:30, single dose, for COVID-19 immunization. Vaccination facility type: urgent care center. Patient did not receive other vaccine in four weeks or other medications in two weeks. Medical history and concomitant medications not reported.  The patient did not have COVID-19 prior to vaccination. Patient was not COVID-19 tested post vaccination. Patient has no known allergies. Patient experienced moderate back/backache and joint pain on Mar 11, 2021. Reportedly, moderate back and joint pain evident the morning after vaccination (12 hours after vaccination).The pain manifested when moving and exercising, but not when motionless or sleeping/resting. The moderate back and joint pain was still present 36 hours after vaccination. The patient did not receive any treatment for the adverse events. The outcome of the events: not recovered. No follow-up attempts possible. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Fatigue, Migraine
Clinical narrative: After second dose my migraines have been severe.; arthritis pain in my hands has increased exponentially and I'm experiencing joint pain all over my body; Also experience serious fatigue; arthritis pain in my hands has increased exponentially and I'm experiencing joint pain all over my body; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 24-year-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6201) via an unspecified route of administration in left arm on 04Mar2021 as dose 2, single (at the age of 24-years-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient medical history included anxiety, depression, arthritis. Also had mild arthritis, panic disorder. Patient was currently being treated for chronic migraine (migraine), panic disorder and major depressive disorder. Patient received unknown concomitant medications in last 2 weeks. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EM9808) via an unspecified route of administration in left arm on 11Feb2021 13:15 as dose 1, single for COVID-19 immunization and was severely depressed. The patient did not have Covid prior vaccination, did not have any other vaccine in four weeks, did not test covid post vaccination and did not have known allergies. It was reported that after the first administration she became severely depressed, but this could have been a result of outside factors. Had to change medications. After second dose on 04Mar2021 16:00 the patient experienced migraines had been severe for which she had been receiving treatment for them for over a year and now they were as bad as they were prior to starting treatment. On same day, the patient also experienced arthritis pain in her hands on 04Mar2021 16:00 which had increased exponentially, experiencing joint pain all over her body on 04Mar2021 14:00 and also serious fatigue on 04Mar2021 16:00. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip is very sore; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Mar2021 08:30 (at the age of 64-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Hospital. Medical history included arthritis, diabetes, known allergies of penicillin, hip replacement 8 years ago. Concomitant medications included yes, as prescribed (other medications in two weeks). No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. On 12Mar2021 08:00, the patient experienced hip was very sore morning after covid vaccine. There were no other injuries to this hip. No treatment received for event. Outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: chills; fever; tiredness; headache; nausea; This is a spontaneous report from a contactable consumer (patient). This 67-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration in arm left on 03Mar2021 at 10:00 am (age at vaccination 67 years) as dose 1, single dose for COVID-19 immunization. Medical history included asthma and HBP (high blood pressure). Patient was not pregnant at time of vaccination and received no other vaccine in four weeks. No COVID prior vaccination, no COVID tested post vaccination and no known allergies. Concomitant medications included losartan, sertraline, simvastatin and amitriptyline all were taken for an unspecified indication, start and stop date were not reported. It was reported that after receiving the dose of vaccine on 03Mar2021 at 21:00 pm, the patient experienced chills, fever, tiredness, headache and nausea. No treatment received for the events. The outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash /Hives all over the body. Itchy for approximately 3 days.; Rash /Hives all over the body. Itchy for approximately 3 days.; Rash /Hives all over the body. Itchy for approximately 3 days.; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:00 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included type 1 diabetes mellitus from an unknown date and unknown if ongoing Type 1 Diabetes, sleep apnoea syndrome from an unknown date and unknown if ongoing Sleep Apnea, drug hypersensitivity sulfa from an unknown date and unknown if ongoing. Concomitant medications included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at the time of vaccination. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient experienced rash /hives all over the body, itchy for approximately 3 days. On 10Mar2021 pruritus 20:00, rash /hives all over the body, itchy for approximately 3 days, rash, rash /hives all over the body, itchy for approximately 3 days, urticaria. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Insomnia
Clinical narrative: aching chest all the way across and down to my elbows on both arms; unable to sleep.; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Mar2021 08:45 (at the age of 67-year-old) as dose 2, single for COVID-19 immunisation at other facility. The patient medical history was not reported. Concomitant medication included atorvastatin taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. The patient had no known allergies. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The evening of the vaccination date (11Mar2021 at 21:00), he had an aching chest all the way across and down to his elbows on both arms, was unable to sleep and was not head achy. Do not think he had a temperature. It was improving "this" morning. It was currently 23.5 hours after receiving his 2nd dose. The patient did not receive any treatment for the events. The outcome of the events was reported as resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Vomit; chills; fever; body ache; exhaustion; headaches; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208, Expiry date: not reported), via an unspecified route of administration on 11Mar2021 (at the age of 37-years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Melatonin, Polycarbophil calcium (FIBER), Multi vitamin and Hyde pre workout. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6203, Expiry date: not reported), via an unspecified route of administration on 18Feb2021 15:00 (at age of 36-years-old) as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 12Mar2021 at 12:00, the patient experienced vomit, chills, fever, body ache, exhaustion and headaches. Treatment for the adverse events was Theraflu. The outcome of all the events was reported as not recovered.   No follow-up attempts were possible. No further information was expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomit; chills; fever; body ache; exhaustion; headaches; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208, Expiry date: not reported), via an unspecified route of administration on 11Mar2021 (at the age of 37-years) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included Melatonin, Polycarbophil calcium (FIBER), Multi vitamin and Hyde pre workout. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6203, Expiry date: not reported), via an unspecified route of administration on 18Feb2021 15:00 (at age of 36-years-old) as dose 1, single for covid-19 immunisation. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 12Mar2021 at 12:00, the patient experienced vomit, chills, fever, body ache, exhaustion and headaches. Treatment for the adverse events was Theraflu. The outcome of all the events was reported as not recovered.   No follow-up attempts were possible. No further information was expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Body temperature, Chills, Headache, Injection site pain
Clinical narrative: Fever of 102; chills; muscle aches; headache; brief loss of taste; insomnia; tenderness at the site of injection; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 40 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 09Mar2021 07:15 (Batch/Lot Number: EL3248) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and oral birth control. The patient experienced fever of 102 causing pyrexia on 10Mar2021 03:00 with outcome of recovered, chills on 10Mar2021 03:00 with outcome of recovered, muscle aches causing myalgia on 10Mar2021 03:00 with outcome of recovered, headache on 10Mar2021 03:00 with outcome of recovered, brief loss of taste causing ageusia on 10Mar2021 03:00 with outcome of recovered, insomnia on 10Mar2021 03:00 with outcome of recovered and tenderness at the site of injection causing injection site pain on 10Mar2021 03:00 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature at 102.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Myalgia, Pyrexia
Clinical narrative: Fever of 102; chills; muscle aches; headache; brief loss of taste; insomnia; tenderness at the site of injection; This is a spontaneous report from a non-contactable consumer or other non healthcare professional. A 40 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 09Mar2021 07:15 (Batch/Lot Number: EL3248) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EL3248) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune thyroiditis from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and oral birth control. The patient experienced fever of 102 causing pyrexia on 10Mar2021 03:00 with outcome of recovered, chills on 10Mar2021 03:00 with outcome of recovered, muscle aches causing myalgia on 10Mar2021 03:00 with outcome of recovered, headache on 10Mar2021 03:00 with outcome of recovered, brief loss of taste causing ageusia on 10Mar2021 03:00 with outcome of recovered, insomnia on 10Mar2021 03:00 with outcome of recovered and tenderness at the site of injection causing injection site pain on 10Mar2021 03:00 with outcome of recovered. The patient underwent lab tests and procedures which included body temperature at 102.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: First dose: 11Feb2021 and Second dose: 03Apr2021; Sharp pain in thigh and calf; pain in hip jots; This is a spontaneous report from a contactable consumer (reported for himself). A 73-years-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL9267/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 11Feb2021 at 12:00 AM (at the age of 73-years-old) as dose 1, single and second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Apr2021 (at the age of 73-years-old) as dose 2, single; both for covid-19 immunisation at other. Medical history included hypertension from an unknown date and unknown if ongoing and diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN) taken for blood pressure measurement, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The consumer reported that, sharp pain in thigh and calf and pain in hip joints from week after first shot to one week after second shot 03Apr2021. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in Apr2021.  No follow up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Fever/Fever was at about 100-101 degrees; general soreness; This is a spontaneous report from a contactable consumer (patient). A 40-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration, administered in Arm Left on 10Mar2021 15:45 (at the age of 40-years-old) as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: Lot number: EN6201), via an unspecified route of administration, administered in Arm Left on 17Feb2021 03:45 PM as dose 1, single for COVID-19 immunisation. No other vaccine in four weeks. The patient did not tested covid prior vaccination and also not tested covid post vaccination. On 11Mar2021 07:00 AM the patient experienced fever about 100-101 degrees and general soreness. It was reported that events lasted about 30 hours after shot (about 9pm day after, (11Mar2021)). The patient underwent lab tests and procedures which included body temperature: 100-101 degrees. No therapeutic measures was taken. The outcome of events was recovered on 11Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and tenderness at injection site; swelling and tenderness at injection site; swelling of lymph nodes in armpit on the side of injection site; joint pain; headache; This is a spontaneous report from a contactable other health care professional (patient). A 31-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 10Mar2021 16:30 (at the age of 31-year-old) as single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hypertension, anxiety and depression. Concomitant medications included sertraline, buspirone, lotensin and nortriptyline taken for an unspecified indication and start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208) via an unspecified route of administration, administered in left arm on 17Feb2021 at 09:30 at single dose for COVID-19 immunisation. On 11Mar2021 at 10:00 AM, the patient experienced swelling and tenderness at injection site, swelling of lymph nodes in armpit on the side of injection site, joint pain and headache. Facility type vaccine was reported as Doctor office/urgent care. The patient did not receive treatment for the events. The clinical outcome of events was recovering at the time of report.  No follow-up attempts are possible. No further information is expected