chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Hypersensitivity, Rash, Tinnitus
Clinical narrative: allergic reaction; body rash; Blood pressure has gone up; Ears ring a little bit; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EP4534) via an intramuscular route of administration in left arm on 28Mar2021 at 10:15 AM (at the age of 63-year-old) as single dose for COVID-19 immunization. Patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities, diabetes and obesity. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 28Mar2021 at 10:15 AM, the patient experienced body rash, blood pressure has gone up and ears ring a little bit, on an unspecified date patient experienced allergic reaction. The events were considered as a non-serious. Therapeutic measures were taken as a result of body rash and treatment included diphenhydramine hydrochloride (BENADRYL). The outcome of the event body rash was reported as not recovered and other events was reported as unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Investigation
Clinical narrative: allergic reaction; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EP7534), via an unspecified route of administration, administered in left arm on 01Apr2021 at 14:00 (at the age of 64-years-old) as single dose for COVID-19 immunisation.  Medical history included high blood pressure (diagnosed with high blood pressure at age 40). Concomitant medications included losartan taken for hypertension, hydrochlorothiazide and carbinoxamine maleate (OMEGA 100) taken for an unspecified indication from 2018. The patient took also an unspecified multivitamin once a day form 1995. The patient experienced allergic reaction on 03Apr2021 with outcome of unknown. The patient reported that she had an allergic reaction to the first dose of the Pfizer COVID-19 vaccine and her pharmacist told her to take Benadryl to help prevent hives from happening with the second dose which was scheduled on 22Apr2021. Caller states she was calling to report that she broke out in hives after getting the Covid shot. She had a rash, after getting the Covid shot, on her hands. Caller states she started breaking out in hives on 03Apr2021, it was all over her body head to especially her torso which was super red and her arms. States there wasn't hardly a spot that wasn't covered in pimply hives. States her husband told he she looked like she got the measles. The patient stated that when she first broke out it was on her arms and underneath her bra. States she was taking Benadryl and Zyrtec and that she called her dermatologist and she had a skin rash on her hands and her dermatologist had given her a tube of medicine to use. Caller clarified this was before the vaccine and that had cleared up for a good say 3 months but now she has a rash, after getting the Covid shot, on her hands. It started on her hands and arms and under her bra. The patient put on the salve the dermatologist recommended Triamcinolone 1% was what she recommended for after the hives started. Hives was reported as worsened. The patient reported that she itched. The outcome of event allergic reaction was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: Impaired healing, Rash papular, Rash pruritic, Scar
Clinical narrative: broke out in a really bad itchy rash allover my body; red bumps; some healing; some are scaring; This is a spontaneous report received from a non-contactable consumer, the patient via medical information team. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via unspecified route of administration on 21Mar2021 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Had first Pfizer covid vaccine on 21Mar2021, a couple hours after vaccination in Mar2021, broke out in a really bad itchy rash all over my body that itchiness was really bad for first 24 to 36 hours, then continued to be itchy and stayed for a total of about 10 days, but continually got less and less, here we are a couple weeks out, still a few red bumps, some healing, some are scaring, all on an unknown date in Mar2021, concerned about getting the second shot. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; itching; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 16Mar2021 at single dose for COVID-19 immunization. Medical history included allergic to antibiotics. Concomitant medications were not reported. Patient Had 1st Pfizer shot 16Mar2021, went for 2nd dose but got refused because had a rash and itching from 1st dose in Mar2021. Dr advised to get the shot anyway. Pharmacy won't give it without her speaking with Pfizer. Also allergic to antibiotics but it's not the same allergic reaction she got from the vaccine. The outcome of the events was unknown. Serious was No.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Fatigue, Headache
Clinical narrative: sick; have symptoms of covid-19 was tested on 3 Apr 2021 and received positive results for Covid 19; her husband all of a sudden coughed up a bunch of gunk, but he was not congested; Headache/ his head still hurts/headache; Low grade fever; her husband was really tired; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old male patient received bnt162b2 first dose of (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunization. Medical history included ongoing hypertension, blood cholesterol increased, body mass index increased from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced have symptoms of covid-19 was tested on 03Apr2021 and received positive results for COVID-19. Also reported headache/his head still hurts on, low grade fever, tired on 30Mar2021. It was reported her husband got all of sudden coughed up a bunch of gunk, but he was not congested on 02Apr2021 and sick on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on 29Mar2021, sars-cov-2 test as positive on 03Apr2021. She said her husband would really like to have the second COVID-19 Vaccine for protection against the COVID-19 Virus. Treatment as reported her husband took Mucinex, Ibuprofen, and drank a lot of tea with honey in it. She said her husband had the Mucinex and Ibuprofen with him in isolation, so she couldn't provide the NDC, Lot, and Expiration Dates. She clarified her husband took generic brand Ibuprofen, and Mucinex. She said her husband had been on a statin for a while. She said the only other medicine her husband took was Vyvanse, and he had been on Vyvanse forever. She said her husband had a second COVID-19 Virus test on 03Apr2021, and he was told on 04Apr2021 that he was positive for the COVID-19 Virus. She said her husband had his temperature checked on Saturday (03Apr2021) and it was 98.5 degrees. She said when her husband got home last night (05Apr2021), he had a fever of 101 degrees. She said her husband had been sleeping since. The outcome of the event was unknown for cough and illness and not recovered for the other events.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pyrexia, SARS-CoV-2 test
Clinical narrative: sick; have symptoms of covid-19 was tested on 3 Apr 2021 and received positive results for Covid 19; her husband all of a sudden coughed up a bunch of gunk, but he was not congested; Headache/ his head still hurts/headache; Low grade fever; her husband was really tired; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old male patient received bnt162b2 first dose of (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunization. Medical history included ongoing hypertension, blood cholesterol increased, body mass index increased from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced have symptoms of covid-19 was tested on 03Apr2021 and received positive results for COVID-19. Also reported headache/his head still hurts on, low grade fever, tired on 30Mar2021. It was reported her husband got all of sudden coughed up a bunch of gunk, but he was not congested on 02Apr2021 and sick on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on 29Mar2021, sars-cov-2 test as positive on 03Apr2021. She said her husband would really like to have the second COVID-19 Vaccine for protection against the COVID-19 Virus. Treatment as reported her husband took Mucinex, Ibuprofen, and drank a lot of tea with honey in it. She said her husband had the Mucinex and Ibuprofen with him in isolation, so she couldn't provide the NDC, Lot, and Expiration Dates. She clarified her husband took generic brand Ibuprofen, and Mucinex. She said her husband had been on a statin for a while. She said the only other medicine her husband took was Vyvanse, and he had been on Vyvanse forever. She said her husband had a second COVID-19 Virus test on 03Apr2021, and he was told on 04Apr2021 that he was positive for the COVID-19 Virus. She said her husband had his temperature checked on Saturday (03Apr2021) and it was 98.5 degrees. She said when her husband got home last night (05Apr2021), he had a fever of 101 degrees. She said her husband had been sleeping since. The outcome of the event was unknown for cough and illness and not recovered for the other events.  No follow-up attempts are needed. Information about lot/Batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus
Clinical narrative: redness and itchiness at the injection site; redness and itchiness at the injection site; the patient had a red, itchy hard spot where she got the injection; soreness; This is a spontaneous report received from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (lot number unknown, expiration date: Jun2021), via an unspecified route of administration in left arm, on 02Apr2021 at single dose for COVID-19 immunization. The patient's medical history included pre-diabetic(Diagnosed about a year ago), hypothyroidism(Diagnosed in her 20's), high cholesterol(diagnosed with high cholesterol a long time ago, about the same time as when the hypothyroidism was diagnosed). Concomitant medications included metformin at 1000 mg twice a day for pre-diabetic (the patient has been taking Metformin for about a year or so), levothyroxine sodium(L-THYROXINE) at 50 mcg once daily for thyroid(the patient started taking L-thyroxine probably 40 years ago when she was in her 20's), rosuvastatin calcium(CRESTOR) at 20 mg once daily for high cholesterol (the patient began taking Crestor probably within the last 6 months), Allergy shots from the end of Nov2020 or beginning of Dec2020. The patient gets allergy shots every Friday.  The patient reported that her last allergy shot was on 22Mar2021.  The patient reported that she was told that she had to wait 5 days between getting an allergy shot and the Covid-19 vaccine, so she didn't get allergy shot on Friday, 02Apr2021.The patient was previously taking Atorvastatin for high cholesterol. The patient received 1st dose on 02Apr2021 and later that afternoon along with soreness, the patient had a red, itchy hard spot where she got the injection. The patient reported that her arm at the injection site has been red and itchy.  The patient reported that the injection site is still red and itchy today, 06Apr2021, and inquired if that is normal. The patient reported that the redness and itchiness at the injection site is not as bad as it was.  The patient reported that she has been putting ice on the injection site. No Emergency Room visit was required. The outcome of the event "soreness" was unknown and of the other events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: He has developed a red spot on his arm where they gave him the vaccine; The red spot is slightly warm to touch; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received second dose of BNT162B2 via an unspecified route of administration in left arm on 01Apr2021 13:00 (Lot Number: ER8734, expiration date was unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included apixaban (ELIQUIS) taken as blood thinner for a long time about four or five years now. The patient previously received first dose of BNT162B2 via an unspecified route of administration in left arm on 11Mar2021 at 13:00 (Lot Number: EN6206, expiration date: 24Mar2021) for covid-19 immunisation. He had no reaction at all after his first dose. After a couple days of second dose of BNT162B2 in Apr2021, the patient had developed a red spot on his arm where they gave him the vaccine. The red patch was about as big as his hand. The red spot was slightly warm to touch He felt that it might have increased in size over night. It was not sore, and his arm was not impaired at all. The outcome of event "a red spot on his arm where they gave him the vaccine" was not recovered. The outcome of event "The red spot is slightly warm to touch" was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: tested positive for covid virus; This is a spontaneous report from a contactable consumer, the patient via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection) via an unspecified route of administration on 11Mar2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 19March, tested positive for COVID virus and on 22March had antibody infusion. Wondering when she would be able to get 2nd dose of vaccine. Event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Photophobia, Pyrexia
Clinical narrative: Two days later she tested positive for covid; fever; really bad headaches; light sensitivity; sore throat; runny nose; muscle soreness; This is a spontaneous report received from a contactable consumer (patient).   A 33-year-old female patient received first dose of BNT162B2(BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 18Mar2021(at the age of 33-year-old) as a SINGLE DOSE for COVID-19 vaccination. Patient medical history and concomitant medications were not reported. Patient had some muscle soreness at the time but thought she had just worked out too much. Two days later she tested positive for COVID and experienced side effects such as fever, really bad headache, light sensitivity, sore throat and runny nose.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-1 test positive
Clinical narrative: Two days later she tested positive for covid; fever; really bad headaches; light sensitivity; sore throat; runny nose; muscle soreness; This is a spontaneous report received from a contactable consumer (patient).   A 33-year-old female patient received first dose of BNT162B2(BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Lot number: UNKNOWN) via an unspecified route of administration on 18Mar2021(at the age of 33-year-old) as a SINGLE DOSE for COVID-19 vaccination. Patient medical history and concomitant medications were not reported. Patient had some muscle soreness at the time but thought she had just worked out too much. Two days later she tested positive for COVID and experienced side effects such as fever, really bad headache, light sensitivity, sore throat and runny nose.    No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Eye swelling, Swelling face
Clinical narrative: He thinks he has angioedema/suspected angioedema; swelling all over his face; He has big water bags under his eyes; my eyes are still swollen up; This is a spontaneous report from a contactable consumer reporting for himself   A 59 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02Apr2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included suspected Covid- 19 and cough as reported that patient thought he had the virus last year because he had a cough that wouldn't go away for about 3 months and he had to take over the counter OTC medicines. Concomitant medications were not reported. The day after vaccination patient experienced swelling all over his face, He stated he had big "water bags" under his eyes (as such). He thought he had angioedema. He wanted also to confirm that he shouldn't get the second vaccine. At the time of the reporting events outcome was unknown.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Eye swelling
Clinical narrative: He thinks he has angioedema/suspected angioedema; swelling all over his face; He has big water bags under his eyes; my eyes are still swollen up; This is a spontaneous report from a contactable consumer reporting for himself   A 59 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 02Apr2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included suspected Covid- 19 and cough as reported that patient thought he had the virus last year because he had a cough that wouldn't go away for about 3 months and he had to take over the counter OTC medicines. Concomitant medications were not reported. The day after vaccination patient experienced swelling all over his face, He stated he had big "water bags" under his eyes (as such). He thought he had angioedema. He wanted also to confirm that he shouldn't get the second vaccine. At the time of the reporting events outcome was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Feeling hot, Headache, Hyperhidrosis, Illness
Clinical narrative: sick; feeling hot; sweating; cant eat; massive headache; This is a spontaneous report from a non-contactable consumer (Patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient took first dose of Pfizer covid vaccine on 31Mar and still sick. She was told side effects would last only 2 days but she was still sick as though she just had the shot. Reported feeling hot; sweating, can not eat, massive headache since received shot. The outcome of the events was not resolved at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Facial paralysis, Facial paresis, Headache, Insomnia
Clinical narrative: drooping face; complaining of right facial weakness; has difficulty closing right eye; headache; neck pain; hard to get into sleep last night; This is a spontaneous report from a non-contactable Other-Healthcare professional. A 31-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer, Formulation: Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 16Mar2021 (age at vaccination 31 years) at single dose for Covid-19 immunization. Reportedly, there were no known allergies to medications, food or other products other medical history. Patient did not have COVID prior to vaccination. Patient was not tested for COVID post vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was complaining of right facial weakness since 04Apr2021 (the day before yesterday), drooping face, has difficulty closing right eye. It was associated with headache, neck pain. The neck and headache pain scale was 7/10 for 4-5 days. It was reported that pain comes and goes. The headache was less when he works and exercise. But the headache was more severe at night. It was hard to get into sleep last night. There was no n/v/c/d, blurred vision, cp, sob, doe, fever, chills, cough, sore throat, runny nose, etc. There was no rash, numbness. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The reporter assessed the case as non-serious with no seriousness criteria (Seriousness criteria-Results in death/ Seriousness criteria-Life threatening/ Seriousness criteria-Caused/prolonged hospitalization/ Seriousness criteria-Disabling/Incapacitating/ Seriousness criteria-Congenital anomaly/birth defect). No treatment was given for adverse events. Outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of drooping face cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain assessment
Clinical narrative: drooping face; complaining of right facial weakness; has difficulty closing right eye; headache; neck pain; hard to get into sleep last night; This is a spontaneous report from a non-contactable Other-Healthcare professional. A 31-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Pfizer, Formulation: Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration on 16Mar2021 (age at vaccination 31 years) at single dose for Covid-19 immunization. Reportedly, there were no known allergies to medications, food or other products other medical history. Patient did not have COVID prior to vaccination. Patient was not tested for COVID post vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was complaining of right facial weakness since 04Apr2021 (the day before yesterday), drooping face, has difficulty closing right eye. It was associated with headache, neck pain. The neck and headache pain scale was 7/10 for 4-5 days. It was reported that pain comes and goes. The headache was less when he works and exercise. But the headache was more severe at night. It was hard to get into sleep last night. There was no n/v/c/d, blurred vision, cp, sob, doe, fever, chills, cough, sore throat, runny nose, etc. There was no rash, numbness. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The reporter assessed the case as non-serious with no seriousness criteria (Seriousness criteria-Results in death/ Seriousness criteria-Life threatening/ Seriousness criteria-Caused/prolonged hospitalization/ Seriousness criteria-Disabling/Incapacitating/ Seriousness criteria-Congenital anomaly/birth defect). No treatment was given for adverse events. Outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of drooping face cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a non-contactable consumer via medical information team. A patient of unknown demographics received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via unknown route on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The seriousness was non-serious with seriousness criteria results in death/life threating/caused or prolonged hospitalization/ Disabling/Incapacitating/Congenital anomaly/birth defect all reported as no. There was no PQC present. On an unknown date, the patient had shingles. Reporter asked should a person who got shingles 2 1/2 weeks after first dose of Pfizer, delay getting second dose which was scheduled 4 weeks after first dose. The outcome of the events was unknown.   No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, Syncope, Vertigo
Clinical narrative: I move around and I feel like something about to faint; breast feeding; intermittent  dizziness; headaches; I have to laid down, and I feel like teh room is spinning little bit; This is a spontaneous report received from a contactable consumer (patient). A 25-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8729 and expiry date: Jul2021) via an unspecified route of administration in left arm on 06Apr2021 (at the age of 25-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included folic acid, iron (PRENATAL). Reporter states she talked to a safety agent and reported her side effects and safety agent referred her to MI for inquiry. The patient experienced intermittent dizziness (dizziness), lightheadedness (dizziness), breast feeding (inappropriate schedule of product administration). Reports has become worse. concerned as she is at home with a toddler. also reports headaches (headache) also states she is breast feeding. On 06Apr2021 it was reported as consumer stated the concern, "she got her vaccine today that's at 8:45, it said if she got any other symptoms other than what was on that sheet she should report it and she had a another symptom and she was concerned if that's or not related to vaccine or not. But she very dizzy, very light headed she move around and she feel like something about to faint and she has to laid down, and she feel like the room is spinning little bit." The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up (06Apr2021): New information was received from a spontaneous report via a contactable consumer includes: Suspect product information, concomitant medication, Events "Faint and Vertigo" and clinical information was added.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021383728 same reporter/ drug, different AE/ patient.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Drug ineffective, Suspected COVID-19
Clinical narrative: 5-6 Covid symptoms; 5-6 Covid symptoms; This is the spontaneous report from a contactable consumer (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 18Mar2021 for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient received first dose of Pfizer BioNTech Covid 19 vaccine. Then on this past Sunday (04Apr2021), she started having 5-6 Covid symptoms, but was feeling somewhat better today. She was having headaches, stomach cramping, chills, body temperature 100.4F, muscle aches, fatigue and diarrhea. She was due to receive her second dose on Thursday and was awaiting Covid test results. Patient asked if she should hold off on receiving the second dose, and how long side effects could start happening. The outcome of events was resolving.   The information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Myalgia, Vaccination site pain
Clinical narrative: could not sit down; She could not sit down and sleep before; muscle pain in right leg, from right foot and traveled up to knee/It came on and off/the pain was unbearable/The muscle pain at first was on the right leg only and last night it was both legs.; Right arm soreness; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 63 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534) via intramuscular, administered in arm right on 25Mar2021 14:30 as single dose for covid-19 immunisation.  Medical history included high cholesterol. She is pretty healthy. No vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Concomitant medications included pravastatin (40 mg tablet) for high cholesterol taking for 2 years and stopped since Friday (unspecified date); Vitamin D. After having the first injection at a hospital, patient did not feel anything, just a little right arm soreness (25Mar2021 14:30).  But exactly a week after, on Thursday (30Mar2021), she started to feel muscle pain in her right leg, from right foot and traveled up to knee. It came on and off.  She did not take any medication. But Friday (02Apr2021) it got worse, she took only one paracetamol (TYLENOL Arthritis PAIN 650 mg, Count size 24 caplet, Lot: SLA055, Expiration: Jul2023) and felt okay.  On Saturday (03Apr2021) happened again, she also took one in the morning and at night. On Sunday (04Apr2021), she felt again in morning took 1 paracetamol and at night she took another one, the pain was unbearable. Next Monday (05Apr2021), she almost called 911 at 7pm but she didn't do it, her neighbor is a nurse for 46 years and she told her to take two paracetamol. Last night (05Apr2021), she took two.  She could not sit down and sleep before (Apr2021).  She was able to sleep.  This morning she felt it again (06Apr2021), her neighbor told her to take 2 for 3 times or every 6 hours.  She took 2 this morning.  She is scared.  She called her doctor. She was going to call 911 last night because the pain was bad and she was scared.  The muscle pain at first was on the right leg only and last night (05Apr2021), it was both legs. She needs the right medicine.  The doctor said she should call Pfizer and discuss. She wondered if it is okay to take second dose and what the right medication is to take to help with the pain. Patient did not visit emergency room. The patient assessed the report as serious. Outcome of muscle pain in legs was not recovered, outcome of other events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Body temperature, Chills, Headache, Myalgia
Clinical narrative: headache; stuffy nose; sore throat; muscle aches; fever; chills; arthritis and her pain was more excruciating; This is a spontaneous report received from a contactable consumer(patient) via Medical Information Team.   A 50-year old female consumer reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: ER8733; Expiry date: unknown) as a single dose for COVID-19 immunization via an unspecified route of administration in the left arm on 01Apr2021. The patients medical history and concomitant medications were not reported. The patient wanted to know if her reaction is common 4 days after receiving the vaccine. In 2021, The pati8ent had experienced with fever, chills, headache, and stuffy nose. She waned to know if her reaction is common 4 days after receiving the vaccine. On Follow up: the patients, Weight (kg): 90.72 and Height(cm): 157 were updated and the patient also experienced sore throat, fever, and muscle aches. It was unknown: Possible training facility for military. There were no other additional Vaccines administered on Same Date of the Pfizer Suspect. There was no emergency room visit or physician office visit for any of the events. There were no other vaccinations given prior to 4 weeks of the vaccine.The outcome for the events fever, stuffy nose, sore throat was not recovered. On 06Apr2021, chills and muscle aches were recovered. The outcome for headache and arthritis was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: headache; stuffy nose; sore throat; muscle aches; fever; chills; arthritis and her pain was more excruciating; This is a spontaneous report received from a contactable consumer(patient) via Medical Information Team.   A 50-year old female consumer reported for herself that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: ER8733; Expiry date: unknown) as a single dose for COVID-19 immunization via an unspecified route of administration in the left arm on 01Apr2021. The patients medical history and concomitant medications were not reported. The patient wanted to know if her reaction is common 4 days after receiving the vaccine. In 2021, The pati8ent had experienced with fever, chills, headache, and stuffy nose. She waned to know if her reaction is common 4 days after receiving the vaccine. On Follow up: the patients, Weight (kg): 90.72 and Height(cm): 157 were updated and the patient also experienced sore throat, fever, and muscle aches. It was unknown: Possible training facility for military. There were no other additional Vaccines administered on Same Date of the Pfizer Suspect. There was no emergency room visit or physician office visit for any of the events. There were no other vaccinations given prior to 4 weeks of the vaccine.The outcome for the events fever, stuffy nose, sore throat was not recovered. On 06Apr2021, chills and muscle aches were recovered. The outcome for headache and arthritis was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site warmth
Clinical narrative: a raised hot erythematous lesion around the injection site on her left deltoid; a raised hot erythematous lesion around the injection site on her left deltoid; This is spontaneous report received from contactable Physician. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration at left deltoid on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The medical history and concomitant medications were not reported. The Medical Assistant (patient) had a raised hot erythematous lesion around the injection site on her left deltoid in Apr2021. It appeared to be subsiding somewhat today 06Apr2021. The Medical Assistant got the shot Friday 02Apr2021. Outcome of event was recovering.    No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Fatigue, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; cough; fatigue; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 58-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6204), via an unspecified route of administration, administered in left arm on 17Mar2021 at 12:30 (at the age of 58 years old) at a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure, high cholesterol, all were ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ongoing metformin HCL at 1000 mg for diabetes, ongoing fenofibrate at 135 mg, once a day and ongoing amlodipine besilate, atorvastatin calcium once a day (5-40 mg once daily). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the caller tested positive for COVID-19. He was and continues to be symptomatic. He stated that he still had a cough and fatigue on an unspecified date in 2021. He also stated that his 10 day required isolation period would be completed and he would like to know if he should proceed with receiving his second dose of the Pfizer COVID-19 vaccine on 07Apr2021 as scheduled. Patient was scheduled to receive his second dose on 07Apr2021. The patient underwent Covid-19 test performed on 30Mar2021 positive results were yielded on 31Mar2021. The patient was treated for the cough with cough pills. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Caller would like to know if he is still okay to receive his second dose following this exposure to COVID-19.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that he was scheduled to receive his dose of the Pfizer BioNTech COVID-19 vaccine on 06Apr2021 but reports that last Thursday he was around someone who ended up testing positive for COVID-19 on Saturday. He mentioned that that person had their shots already but because his wife had it, he wanted to get tested as well, despite showing no symptoms. Patient also reported that he himself had gotten tested but had not gotten the results yet. Patient would like to know if he was still okay to receive his second dose following this exposure to COVID-19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test not gotten his results on unspecified date has not gotten his results yet. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: developed hives; This is a spontaneous report received from a contactable consumer (patient). An 89-year-old-female patient received 1st dose of Pfizer-BioNTech Covid-19 Vaccine BNT162B2 (Lot number: EL8982) on 21Jan2021 10:15 am on Left arm at single dose for covid-19 immunization; second dose (Lot number: EM9809) on 11Feb2021 10:15 am on Left arm at single dose for covid-19 immunization. Medical history included high blood pressure (diagnosed maybe 30 years before, ongoing), high cholesterol (diagnosed maybe 30 years before, ongoing), low thyroid (it's low thyroid and was diagnosed maybe 25 years before, ongoing). For Concomitant products, Caller states she's on a lot of medications. Caller said that she and her daughter had developed hives after receiving the Pfizer COVID-19 vaccine. She wanted to know if that could be a reaction from the vaccine. She also wanted to know how long it would last. Caller wanted to know if the hives she has can be transmitted to her daughter. Caller states hives started about 2 or 3 months before, she received the vaccine in Feb2021 and hives started in Feb2021 (as reported). States she is on medications (Caller states she's taking Tagamet and there is another name for it but that is the generic that she's been taking. States she's been taking it since 2 months ago) so it's improved. Clarified with caller that she experienced hives after the first dose of the Pfizer Covid-19 vaccine (as reported). No Emergency Room visit. Caller states she went to the doctor's office for hives. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384101 same reporter/event/drug, different patient
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Asthenia, Chest discomfort, Chills, Dizziness
Clinical narrative: nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life.   No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Malaise, Nausea, Quality of life decreased
Clinical narrative: nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Feeding disorder, Hyperhidrosis
Clinical narrative: he got positive with Covid-19; dizziness; woke up sweating; chills; muscle spasms; can not eat; Coughing; This is a spontaneous case is received from a contactable consumer. A 60-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced he got positive with covid-19 (sars-cov-2 test positive), dizziness on 06Apr2021, chills on 04Apr2021, muscle spasms on 04Apr2021, coughing (cough) on 01Apr2021, woke up sweating (hyperhidrosis) on 06Apr2021, cannot eat (feeding disorder)on 03Apr2021. The patient underwent lab tests and procedures which included sars-cov-1 test: positive. Therapeutic measures were taken as a result of, woke up sweating (hyperhidrosis). The outcome of the events sars-cov-2 test positive was unknown, chills, cough, feeding disorder were recovering, dizziness, hyperhidrosis were recovered on 06Apr2021, muscle spasms were recovered on 04Apr2021.  Follow-up activities have been completed and no further information is expected.