chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: Nerve pain is really flaring up and hurting her a lot was reported as worsened.; Nerve pain is really flaring up and hurting her a lot; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), second dose via an unspecified route of administration, administered in arm right on 25Jan2021 (at the age of 69 years) as single for covid-19 immunization. Medical history included ongoing diabetes mellitus and was diagnosed when she was around 40 years old. It is under control. It has never been bad. She goes through her doctor all the time. It was under control, shingles a couple of years ago, burning sensation and after pain from an unknown date and unknown if ongoing and explains had gone away but left after pain and she gets burning sometimes. There were no concomitant medications. Historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm left on unspecified date as single for covid-19 immunization. On 26Jan2021 the patient experienced pain started. patient had it from her naval to her back and patient would get little flares by her naval but nothing she could not deal with. But the pain flared up so bad in her nerves that she could not stand it, making her feel like she had going back to the beginning when she was getting over the shingles. It was so bad. It had been some years since then. Patient tried Tylenol which helped and was more like a mellow pain, which she was used to and what she can deal with. The outcome of the event Nerve pain is really flaring up and hurting her a lot was not recovered and outcome of the event Nerve pain is really flaring up and hurting her a lot was reported as worsened was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Bite, Erythema, Pruritus, Urticaria
Clinical narrative: bites broke out on my inner calves on both legs; itching; redness; Welts around 15 on each leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL1284), via an unspecified route of administration, administered in Arm Left on 08Jan2021 13:30 (at the age of 77-year-old) as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 29Jan2021 13:00 (Batch/Lot Number: EL9262) as dose 2, single for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing Known allergies: Latex, allergy to animal from an unknown date and unknown if ongoing Known allergies: animal dander. Concomitant medications included metoprolol taken for an unspecified indication, 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. On 15Jan2021 13:00, the patient experienced bites broke out on her inner calves on both legs, Welts around 15 on each leg up to her knee with extreme itching and redness. Same after 2nd vaccine 1week later other locations larger but fewer. One on under side of upper arm and 2 on upper thigh. Taking a Claritin helped itching but red blotches remain. Therapeutic measures taken as a result of events included claritin and Cortisone cream. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were recovering.   Follow-up attempts are completed. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Parosmia
Clinical narrative: Experiencing rancid smells with food that make eating difficult.; Experiencing rancid smells with food that make eating difficult.; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 26-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 at 15:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19. The patient had no known allergies. Concomitant medication included ethinylestradiol, norethisterone (PIRMELLA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced experiencing rancid smells with food that make eating difficult on 02Feb2021. No treatment was received for the event. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury
Clinical narrative: turned her ankle, can hardly move it/hurting her ankle; This is a spontaneous report from a contactable consumer or other non hcp.     An 81-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: EL9263) as DOSE 1 SINGLE for covid 19 immunization. Medical history included surgery from Dec2018. She states she has had many eye surgeries but the last eye surgery was in Dec2018. The patient's concomitant medications were not reported. It was reported that, the patient experienced turned her ankle, can hardly move it/hurting her ankle on 08Feb2021 with outcome of unknown.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Flushing; This is a spontaneous report from a contactable pharmacist. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via intramuscular, administered in the right arm on 09Feb2021 (at the age of 66-years-old) (Lot Number: EN8982) as dose 1, single for COVID-19 immunisation. Medical history included hypertension, cancer, reflux, and enlarged prostate. Concomitant medications included amlodipine, calcium, clindamycin, clomiphene, famotidine, finasteride, furosemide, potassium, lanreotide, lidocaine/prilocaine, ondansetron, sildenafil, tamsulosin, triamcinolone, vitamin B12, vitamin D3, zoledronic acid (ZOMETA), and prednisone. The patient has known allergies to epinephrine, CT contrast, medrol, lovastatin, losartan, and adhesive. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient did not have COVID prior to vaccination. On 09Feb2021, the patient experienced flushing. The patient had not been tested for COVID post-vaccination. The outcome of the event was recovering/resolving.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Headache, Nausea
Clinical narrative: Fever; nausea; headache; chills; cough; fatigue; This is a spontaneous report from a contactable consumer (reported for self).  A 23-year-old non pregnant female patient received second dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration, on 05Feb2021 (at the age of 23-year-old) 02:00 PM, in Left arm as dose 2, single for Covid-19 immunization. The patient had Known allergies: Penicillin. Concomitant medications were not provided. The patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of ad-ministration, on 15Jan2021 (at the age of 23-year-old) 12:00 Pm, in Left arm as dose 1, single for Covid-19 immunization. She did not have any other vaccine in four weeks. On 06Feb2021 04:45 PM, the patient experienced Fever, nausea, headache, chills, cough, and fatigue. The patient did not receive any treatment for events. The outcome of the events was reported as recovering. She did not have covid prior vaccination and was not tested for it post vaccination.   No follow-up attempts were Possible. Information on lot/batch could not be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; nausea; headache; chills; cough; fatigue; This is a spontaneous report from a contactable consumer (reported for self).  A 23-year-old non pregnant female patient received second dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of administration, on 05Feb2021 (at the age of 23-year-old) 02:00 PM, in Left arm as dose 2, single for Covid-19 immunization. The patient had Known allergies: Penicillin. Concomitant medications were not provided. The patient received first dose of BNT162B2 (Solution for injection, Lot number: unknown) via an unspecified route of ad-ministration, on 15Jan2021 (at the age of 23-year-old) 12:00 Pm, in Left arm as dose 1, single for Covid-19 immunization. She did not have any other vaccine in four weeks. On 06Feb2021 04:45 PM, the patient experienced Fever, nausea, headache, chills, cough, and fatigue. The patient did not receive any treatment for events. The outcome of the events was reported as recovering. She did not have covid prior vaccination and was not tested for it post vaccination.   No follow-up attempts were Possible. Information on lot/batch could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 42-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left arm on 06Feb2021 at 12:00 as dose 2, single for COVID-19 immunisation. The medical history of the patient included gastritis and arthritis. The concomitant medications of the patient included calcium (CALCIUM), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and amitriptyline (AMITRIPTYLINE) all taken for an unspecified indication, start and stop dates were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration in arm left on 13Jan2021 at 16:00 as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. On 07Feb2021 at 01:00, the patient experienced joint pain. Therapeutic measures were not taken as a result of event. The patient recovered from the event on an unspecified date in 2021.  Information about Batch/Lot number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (Reporter's daughter) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever on 15Feb2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for himself). A 85-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL9264; Expiration Date: 31May2021), via an unspecified route of administration, administered in left shoulder on 06Feb2021 at 16:00 (4:00 PM) (at the age of 85-year-old) as dose 1, single for COVID-19 immunization. The patient medical history included high blood pressure, a little diabetes. The patient concomitant medications included lisinopril 40mg once a day, atenolol 50mg once a day, atorvastatin 20mg once a day, warfarin (5mg except two days a week he takes 2.5mg), amlodipine 10mg once a day, glyburide; metformin tablet (takes three tablets per day; it is 2.5-500 unknown units), all drugs taken for an unspecified indication, start and stop date were not reported. The patient previously took flu vaccine, shingles vaccines for immunization and never had a reaction (Patient does not have NDC, lot, and expiry for Flu vaccine or Shingles vaccine). The patient did not receive any other vaccines within 4 weeks prior vaccinations. On 07Feb2021, the patient experienced diarrhea. Diarrhea started between 12:00 PM and 2:00 PM. Patient got the shot on Saturday, 06Feb2021 in Massachusetts. The next day, 07Feb2021, he had diarrhea. Patient wanted to wait a couple of days to see if it continued. It was only on that one day, 07Feb2021. Patient clarified shot as COVID19 Vaccine. First dose of vaccine was 06Feb2021. Patient clarified that the vaccine was given at 4:00 PM on 06Feb2021. The diarrhea started on Sunday between 12:00PM and 2:00PM. Patient only had a couple incidents. The event did not result in emergency room and physician office visit. Outcome of the event was recovered on 07Feb2021.  Follow-up (PRD/SRD 11May2021): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: arm was in pain; Painful rash; This is a spontaneous report from a contactable consumer. A 75-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 01Feb2021 15:00 PM as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included Hemochromatosis (gets phlebotomy due to excess iron) and high blood pressure from an unknown date and unknown if ongoing. Concomitant medications included diltiazem (DILTIAZEM) taken for blood pressure abnormal from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) and ergocalciferol, retinol palmitate (VITAMINS A & D) taken for an unspecified indication, start and stop date were not reported. The patient previously took prednisone and cortisone and experienced allergy. (She is allergic to steroids. She knows she is allergic to Prednisone and Cortisone.) The patient previously received a flu shot on an unspecified date many years ago and she has had normal fever a day after the vaccine. She stopped taking the flu vaccine. She had the first COVID19 vaccine on 01Feb2021. The next day her arm was in pain and that went away that day. She also developed a rash; it was like bumps. She went to the doctor and he said it was eczema. Caller states it is not eczema. It spread all over the body. She is concerned so she is calling. It is over a week and she still have some rash. Her concern is if she should take the second vaccine if this one made her this ill. The rash is a little less, it wasn't so much itchy as it was painful. The doctor gave her an ointment to put on the rash. It did nothing. The cream is Triamcinolone Acetonide 0.1 percent, (Lot: 1014221, expiry: Jul2022). The outcome of the event pain in arm was recovered and outcome for event painful rash was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea
Clinical narrative: I have extremely swollen and very painful lymph glands under my right arm. The swelling is the size of a baseball and the pain extends to my arm and side.; I have no fever and only had some nausea.; This is a spontaneous report from a non-contactable consumer. A 50-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 08Feb2021 08:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Not known allergies. The patient previously received first dose of bnt162b2 on an unspecified date of covid-19 immunisation and had no issues other than a sore arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Feb2021 patient reported that I have extremely swollen and very painful lymph glands under my right arm. The swelling is the size of a baseball and the pain extends to my arm and side. I have no fever and only had some nausea. The patient was not received treatment medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: mild arm soreness; nausea; chills; fever; headache; fatigue; Aching; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9810, patient was 43-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Left on 09Feb2021 at 08:30 AM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included depression, anxiety. No other vaccine received in four weeks. Concomitant medication(s) included lamotrigine (LAMICTAL); fluoxetine hydrochloride (PROZAC); monascus purpureus (RED YEAST RICE); curcuma longa (TURMERIC [CURCUMA LONGA]); boswellia serrata (BOSWELLIA); chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE; GLUCOSAMINE]); vitamin d3 (VITAMIN D3); chromium picolinate (CHROMIUM PICOLINATE) all were taken for an unspecified indication, within two weeks of vaccination, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL1283, patient was 43-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Left on 19Jan2021 at 09:00 AM as DOSE 1, SINGLE for covid-19 immunisation and experienced only Arm soreness. No covid prior vaccination, no covid tested post vaccination, no known allergies reported. On 09Feb2021 at 04 PM, the patient experienced mild arm soreness, nausea, chills, fever, headache, fatigue, aching. Patient did not receive treatment for events. The outcomes of events were recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: mild arm soreness; nausea; chills; fever; headache; fatigue; Aching; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9810, patient was 43-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Left on 09Feb2021 at 08:30 AM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included depression, anxiety. No other vaccine received in four weeks. Concomitant medication(s) included lamotrigine (LAMICTAL); fluoxetine hydrochloride (PROZAC); monascus purpureus (RED YEAST RICE); curcuma longa (TURMERIC [CURCUMA LONGA]); boswellia serrata (BOSWELLIA); chondroitin sulfate, glucosamine (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE; GLUCOSAMINE]); vitamin d3 (VITAMIN D3); chromium picolinate (CHROMIUM PICOLINATE) all were taken for an unspecified indication, within two weeks of vaccination, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL1283, patient was 43-year-old at the time of vaccination), via intramuscular route of administration, administered in Arm Left on 19Jan2021 at 09:00 AM as DOSE 1, SINGLE for covid-19 immunisation and experienced only Arm soreness. No covid prior vaccination, no covid tested post vaccination, no known allergies reported. On 09Feb2021 at 04 PM, the patient experienced mild arm soreness, nausea, chills, fever, headache, fatigue, aching. Patient did not receive treatment for events. The outcomes of events were recovering.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Movement disorder, Myalgia, Sleep disorder
Clinical narrative: Extremely tired back muscles; body heat; felt unstable; lost a lot of sleep; could not lay prone; This is a spontaneous report from a contactable consumer. The consumer reported similar events for 2 patients (gal and another person). This is second of two reports. This consumer reported for another patient that. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that there was a call from the caller who said that she knows it was experimental she did had a reaction and others did as well. She said that she had extremely tired back muscles and body heat. While reporting on herself, the caller mentioned that another gal had the same thing and another person she knew had the same thing. She also mentioned that felt unstable, lost a lot of sleep, could not lay prone on unspecified date. Outcome of all events was unknown.   Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021178927 same reporter, different patient
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced body aches. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Pain in extremity
Clinical narrative: metallic taste; arm soreness; This is a spontaneous report from a contactable other-HCP (patient herself) via Medical Information Team. A 65 (units unknown) old female received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 01Feb2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization and experienced arm soreness with first dose. Patient stated she received both doses of the vaccine, the second dose was on 01Feb2021. She had no side effects with either dose, except for a slight metallic taste on an unspecified date in Feb2021 after the second dose but nothing major. She had nothing with the first injection and nothing with the second. She had arm soreness with the first dose and slight arm soreness with the second dose on an unspecified date in Feb2021. She stated she had nothing, absolutely nothing and it worried her. She also asked if she needed to have antibodies checked to see if there was something with the dose that was not right. She stated she needed to have lab work done anyway. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lip swelling, Pyrexia, Swollen tongue
Clinical narrative: Swelling of the lips & tongue, fever with chills; Swelling of the lips & tongue, fever with chills; Swelling of the lips & tongue, fever with chills; Swelling of the lips & tongue, fever with chills; This is a spontaneous report from a contactable other health care professional (patient). A 62-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as DOSE1, SINGLE (at the age of 62-years-old) for covid-19 immunisation. The patient has no medical history. There were no concomitant medications. The patient had no known allergies. On 09Feb2021 at 02:00 PM, the patient experienced swelling of the lips and tongue, fever with chills. The patient underwent lab tests and procedures which included body temperature: fever on 09Feb2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The patient did not have COVID prior to vaccination. It was unknown whether the patient got COVID tested post vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient recovered from the events on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Ill-defined disorder
Clinical narrative: He currently has a leg problem; This is a spontaneous report from a contactable consumer (patient's wife) from a Pfizer-sponsored program.    A male patient of an unspecified age received (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Feb2021 as dose 1, single for COVID-19 immunisation.  Medical history included diabetic. Concomitant medications were not reported.  On an unspecified date, the patient experienced currently has a leg problem. It was reported that patient will get his second dose on 23Feb2021, and since patient is diabetic, need to take MOBIC (meloxicam). It was reported that the patient does not want to mess up with the vaccine and wanted to know if he can take the medication. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Pain; Little fever; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported for a male patient (husband). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced pain, little fever. Verbatim and Event Description: Reporter calling in for her husband. Reporter said her husband got the vaccine yesterday and experienced pain and a little fever. Asking if her husband can take Tylenol. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Headache; Site where the injection was that is the little sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache and site where the injection was that is the little sore on 09Feb2021. It was reported patient had Pfizer Vaccine earlier this morning and right about patient having a headache and site where the injection was that was the little sore. Would you suggest that patient could have Tylenol, that's all patient can really take everything else upsets stomach (further clarification unknown). The outcome for events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain, Rhinorrhoea, Sneezing
Clinical narrative: Caller had a lot of sneezing and a runny nose; Caller had a lot of sneezing and a runny nose; sore throat; congestion; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller had a lot of sneezing and a runny nose. She also had sore throat and congestion after the 1st dose. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm. Patient is asking if she can get symptoms on second dose. The outcome of the event was unknown.   Follow-up attempts are completed. Information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Lip swelling
Clinical narrative: Swollen lips; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose unknown via an unspecified route of administration, administered in right arm on 05Feb2021 (at the age of 69-years-old) (Batch/Lot Number: EM9809) as dose number unknown, 0.3ml single for COVID-19 Vaccination. Medical history included Blood pressure high. She has high blood pressure but that is under control. The patient's concomitant medications was not reported. The patient had received the Pfizer Vaccine on 05Feb2021 and that morning got up with swollen lips on 09Feb2021. The breathing was okay, just the lips are like swollen and that's the only thing that happens in the past for like more than a week. She was not sure about the dose but she know they gave 0.3 ml. It was not written, she do not have that and the center have all that information. She was not sure if it was from the vaccine and what caused this but that was the only thing different that happened from the past several weeks. She also confirms there was no new food, no new medication taken. The patient underwent lab tests and procedures which included blood pressure measurement resulted high blood pressure. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle disorder
Clinical narrative: Muscle disorder; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration as dose 1, single on an unspecified date for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "So, I have gotten the first shot already. I am supposed to get the second one in 2 weeks but today I looked at the doctor and I was diagnosed with a muscle disorder that I have, which now require me to take Prednisone every day. I do not know what the LOT number is, I do not have it." Therapeutic measures were taken in response to event with prednisone. At the time of this report, outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Macule, Rhinorrhoea, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Small round disc where I got the, at the injection site, kind of itching and kind of red and itching and in a big round circle; Runny nose; Small round disc where I got the, at the injection site, kind of itching and kind of red and itching and in a big round circle; slightly tender to the touch; Small round disc where I got the, at the injection site, kind of itching and kind of red and itching and in a big round circle; slightly tender to the touch; Slightly tender to the touch; This is a spontaneous report from a contactable Nurse (patient). A 78-years-old female patient received second dose BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL9267), via an unspecified route of administration on unspecified date (Age at the time of vaccination was 78 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included diabetes, hypertension and haemoglobin low. Concomitant medications included Aspirin. The patient previously took first dose of vaccine BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EL3249), via an unspecified route of administration on 16Jan2021 (Age at the time of vaccination was 78 years) as DOSE 1, SINGLE for COVID-19 immunisation. Patient experienced runny nose, small round disc where she got the, at the injection site, kind of itching and kind of red and itching and in a big round circle, slightly tender to the touch in 2021. Patient had not received treatment for events. The outcome of events was unknown.  Follow-up attempts were completed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Medical history included cough from an unknown date and unknown if ongoing. It was reported that the patient always has a cough when winter is over. The patient's concomitant medications were not reported. The patient experienced cough on an unspecified date after the first dose. Treatment with cough medicine was taken for the event. The outcome of the event was unknown. The patient was querying where to get her 2nd dose.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache on an unspecified date. Patient inquired if he was allowed to take paracetamol (TYLENOL) after his second COVID shot because he has a headache. The outcome of event was unknown.   No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further Information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: I still have a large, looks like a bruise but more purple; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 01Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced i still have a large, looks like a bruise but more purple on an unspecified date (I got my Pfizer my second shot. It is been 8 days ago now and I still have a large, looks like a bruise but more purple. The patient was asking Is that normal). Outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This is a spontaneous report from a contactable consumer (patients husband). A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that his wife experienced fever and headache (date unknown) after the 1st. His wife already took 2 Aspirins and would like to ask if taking Amoxicillin will interfere with the 1st dose vaccine. The outcome for both the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: I had the shot, in my arm and my arm has been hurting ever since where I got the shot, site of injection site pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/ batch number unknown) via an unspecified route of administration on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the shot in arm and arm had been hurting ever since where patient got the shot, site of injection site pain. The patient stated that patient had the covid test on 23Jan2021 and result was unknown. The outcome of events was unknown.  Lot/Batch number has been requested. Follow-up attempts were completed. No further information was expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: vomited; Body aches; fever; severe headache; fatigue; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 09:30 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 11:15 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Not known allergies. On 17Feb2021 19:00 PM patient experienced Fever 38.5 starting 10 hours after injection, lasting 16 hours, went down to 37.5 after taking Tylenol. Body aches, severe headache, vomited once. Now is 48 hours after injection temperature is normal, there is some fatigue. The patient was not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited; Body aches; fever; severe headache; fatigue; This is a spontaneous report from a contactable consumer. A 58-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 09:30 (Batch/Lot Number: EL3247) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 11:15 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Not known allergies. On 17Feb2021 19:00 PM patient experienced Fever 38.5 starting 10 hours after injection, lasting 16 hours, went down to 37.5 after taking Tylenol. Body aches, severe headache, vomited once. Now is 48 hours after injection temperature is normal, there is some fatigue. The patient was not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Injection site joint pain, Pain, Rash macular
Clinical narrative: Red blotch on my skin that was hot, a rash and it was achy; It was a little painful where the shot was injected; I have a hot red flash; Red blotch on my skin that was hot, a rash and it was achy; This is a spontaneous report from a contactable consumer or other non hcp.     An 80-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 05Feb2021 as single dose for covid 19 immunization. The patient medical history and concomitant was not reported. The patient experienced red blotch on my skin that was hot, a rash and it was achy, it was a little painful where the shot was injected, i have a hot red flash, red blotch on my skin that was hot, a rash and it was achy on 08Feb2021 with outcome of unknown. No treatment was received for the event.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Groin pain, Pain, Rash, Walking disability
Clinical narrative: rash; he could not walk; sharp pain in his groin; terrible pain everywhere; This is a spontaneous report from a contactable consumer or other non-Health Care Professional reported for an 89-year-old male patient (father). A 89-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiry date: Unknown), dose 2 via an unspecified route of administration on 09Feb2021,at the age of 89-years-old as DOSE 2, SINGLE for covid-19 immunization. Medical history included chronic inflammatory demyelinating polyradiculoneuropathy from an unknown date and unknown if ongoing Concomitant medication: Reporter stated, "Yeah, but nothing new, newest thing is he was diagnosed with CIDP Chronic inflammatory demyelinating polyneuropathy about 8 weeks ago and he had his second infusion of IVIG so Intravenous, so you are a pharmacist so you know what I am talking about, so he has his immunoglobulin infusion, so we had the big thing about delaying or when to do his vaccine because this IVIG infusion that he had on Feb 1st, he had his second infusion of IVIG." , bone marrow transplant from an unknown date and unknown if ongoing Results and name of the test: Reporter stated, "They did everything BMT, it was a Dr.'s office, the neurologist that ordered the IVIG for him.". Concomitant medication(s) included immunoglobulins nos taken for chronic inflammatory demyelinating polyradiculoneuropathy, start and stop date were not reported. On 10Feb2021 the patient experienced terrible pain everywhere, sharp pain in his groin and he is getting a little bit better, but he started having the new symptoms this morning with this rash. On 11Feb2021 the patient experienced he could not walk, so basically, he lost his left leg and he has a sharp pain in his groin and basically he stayed in bed another. On 13Feb2021 the patient experienced rash. The patient underwent lab tests and procedures which included blood test: unknown results on Lab work: The last blood work would have been 4th when he had the IVIG infusion. February 1st, I think around then he had blood work. Treatment included doctor said to hold off, not take the Benadryl not to take anything like right now. The outcome of events terrible pain everywhere, sharp pain in his groin, he could not walk was recovering while the outcome of event rash was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Diarrhoea, Dysstasia, Oropharyngeal pain
Clinical narrative: diarrhea; can't barely stand / Can stand only for 40 minutes; loss of appetite; sore throat; loss of taste; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support from a contactable female consumer (patient). A female patient of unspecified age received first dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for injection, Lot number: Unknown), via an unspecified route on 06Feb2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced diarrhea, loss of appetite/not using the toilet due to loss of appetite, can't barely stand/ can stand only for 40 minutes, sore throat and loss of taste. She can only stand today. Asking what must be done? The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.