chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: 6 hrs post vax and 48 hours post vax: injection site pain; 6 hrs post vax:  headache/ 48 hours post vax: remaining symptoms headache; 24 hours post vax: as above plus extreme fatigue/ 48 hours post vax: extreme fatigue; 24 hours post vax: chills/inability to feel warm; 24 hours post vax: inability to feel warm; 28 hours post vax: hot and cold flashes/ 48 hours post vax: remaining symptoms hot and cold flashes; 28 hours post vax: as the above plus nausea; 32 hours post vax: as above plus vomiting/ 38 hours post vax: vomiting ended; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 38 hours post vax: otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body; 48 hours post vax: general physical weakness and malaise; 48 hours post vax: general physical weakness and malaise; This is a spontaneous report from a contactable other Health professional (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261), via an unspecified route of administration on 28Jan2021 at single dose in left arm for COVID-19 immunisation. The patient was vaccinated at Workplace clinic. Age at vaccination was 50-years. No other vaccine was given within 4 weeks prior to the COVID vaccine. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL0142) administered on 07Jan2021 (at the age of 50 years), at single dose in left arm. Medical history included anxiety, depression, obesity. The patient has allergies to certain unspecified antibiotics. Concomitant medications included citalopram, linum usitatissimum seed oil (FLAX SEED OIL), daily multivitamin 50+. It was reported that 6 hrs post vax on 29Jan2021 the patient experienced injection site pain, headache, 24 hours post vax: as above plus extreme fatigue, chills/inability to feel warm, 28 hours post vax: as the above plus nausea, hot and cold flashes, 32 hours post vax: as above plus vomiting, 38 hours post vax: vomiting ended, otherwise as above with simultaneous hot sweats at upper body and cold sweats at lower body, 48 hours post vax: remaining symptoms headache, injection site pain, hot and cold flashes, ex-treme fatigue, general physical weakness and malaise. The events were reported as non serious. No treatment was received for the events. The events resolved on an unspecified date. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Sensitive skin, Vaccination site pain
Clinical narrative: fever of 100.4 [unit unspecified]; Sensitive Skin (all over); pain/tenderness at injection site; generalized aches and pains; This is a spontaneous report from a non-contactable consumer (patient). An adult male patient received his second dose of bnt162b2 (BNT162B2 reported as COVID-19 VACCINE; lot number: EL9264; expiration date: unknown), via an unspecified route of administration right arm on 02Feb2021 at a single dose for covid-19 immunization. The patient medical history was none. The patient has no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient received his first dose of bnt162b2 (BNT162B2 reported as COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. On 02Feb2021 05:00 PM, the patient experienced fever of 100.4 [unit unspecified], sensitive skin (all over), pain/tenderness at injection site, and generalized aches and pains. He reported that the symptoms cleared up by the following morning (today). It was unknown if the patient received treatment for the adverse event. The events were considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 03Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable consumer (patient) reported that an adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: Not available) first dose via an unspecified route of administration on an unspecified date at single dose and second dose via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization in hospital. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has contracted COVID after second dose administered in Jan2021. Also reported that 10 + of his colleagues at the hospital had symptomatic COVID after receiving second dose of the vaccine. Event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events. The patient considered the events as non-serious. Patient had COVID test positive in Jan2021 post vaccination. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: head ache; Chills; body ache; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced chills, body ache, headache. No treatment was received for the events. Outcome of the events was recovered on an unspecified date. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Illness, Pain
Clinical narrative: got super sick; high fever/body was on fire; chills; bad body aches; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient is pregnant. It was unknown if patient had other vaccine in four weeks, if she had covid prior vaccination and if covid tested post vaccination. The patient got super sick at about 1 am with a high fever/body was on fire, chills, bad body aches and headache. It was unknown if the patient received treatment. 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: Pyrexia
Clinical narrative: got super sick; high fever/body was on fire; chills; bad body aches; headache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if the patient is pregnant. It was unknown if patient had other vaccine in four weeks, if she had covid prior vaccination and if covid tested post vaccination. The patient got super sick at about 1 am with a high fever/body was on fire, chills, bad body aches and headache. It was unknown if the patient received treatment. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: moderate headache; a bit tired; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 31Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, it has been unknown if the patient has been tested for COVID-19. It was unknown if the patient had allergies to medications, food, or other products. On 01Feb2021, the patient experienced moderate headache and was a bit tired. It was unknown if treatment was given as a result of the events. Clinical outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Rhinorrhoea, SARS-CoV-1 test
Clinical narrative: Monday I felt like I had sinus issues.; I have now tested positive; I have now tested positive; on Sunday I started having some chills and sniffles; on Sunday I started having some chills and sniffles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on Sunday, 31Jan2021, the patient started having some chills and sniffles. On Monday, 01Feb2021, the patient felt like she had sinus issues. On Tuesday, 02Feb2021, a friend said they were tested positive and recommended she get tested. The patient reported that she now tested positive in Feb2021. Patient was asking what to do about her second dose. Outcome of events was unknown.   Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: Monday I felt like I had sinus issues.; I have now tested positive; I have now tested positive; on Sunday I started having some chills and sniffles; on Sunday I started having some chills and sniffles; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on Sunday, 31Jan2021, the patient started having some chills and sniffles. On Monday, 01Feb2021, the patient felt like she had sinus issues. On Tuesday, 02Feb2021, a friend said they were tested positive and recommended she get tested. The patient reported that she now tested positive in Feb2021. Patient was asking what to do about her second dose. Outcome of events was unknown.   Information on Lot/Batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Body aches; Fever (Body temperature 1 week after 99.3 Fahrenheit consistentaly); Large swollen lymph node on right clavical area (same side as injection site); headache; This is a spontaneous report from a contactable nurse (patient).  A 27-year-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 28Jan2021 at 08:15, for COVID-19 immunisation. COVID-19 vaccine was administered at Hospital. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included type 1 diabetes mellitus, hypothyroidism, irritable bowel syndrome (IBS) and anxiety and latex allergy, all from an unspecified date. Past drug event included drug hypersensitivity due to liraglutide (VICTOZA). Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included insulin for type 1 diabetes mellitus, buspirone hydrochloride (BUSPAR), levothyroxine sodium (SYNTHROID), vitamin D and folic acid. On 28Jan2021 at 08:00 PM, the patient experienced large swollen lymph node on right clavical area (same side as injection site) and headache. Body aches and fever 24 hours after. No treatment was received. Body temperature 1 week after 99.3 Fahrenheit consistentaly. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse events was unknown at time of this report.   The information on the lot number has been requested.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SARS-Cov2-RT PCR tested positive; SARS-Cov2-RT PCR tested positive; This is a spontaneous report from a contactable nurse. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 13Jan2021 at single dose for covid-19 immunisation. Medical history included dementia. The patient's 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 was not diagnosed with COVID-19; Since the vaccination, the patient had been tested for COVID-19, patient underwent covid test type post vaccination nasal swab, SARS-Cov2-RT PCR on 01Feb2021, result was positive. The reporter considered all events was non-seriousness. There was no treatment received for the adverse events. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and SARS-CoV2-RT PCR test positive cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness; SOB; This is a spontaneous report from a contactable pharmacist. A 33-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL0142) intramuscular, in left arm, on 02Feb2021 at 15:00, for COVID-19 immunisation. The patient received the first dose of BNT162B2 on 14Jan2021 at 19:30, from lot EL3302, intramuscular, in left arm. 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 vaccination, the patient had not been tested for COVID-19. Medical history included lymphoid leukemia, allergies to asparaginase and pegaspargase (anaphylaxis), vancomycin, fluticasone propionate (FLONASE). Concomitant medications were not reported. The patient waited 30 minutes in clinic. As she was exiting, she felt chest tightness and SOB starting from 02Feb2021 at 15:15. Rapid response called. She was evaluated by RR and dc'd back to clinic. Chest tightness improved. Refused ED. No treatment was administered. The events were reported as non-serious and resolved on an unspecified date in Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever up to 102; chills; Body aches; soreness at site of injection; This is a spontaneous report from a non-contactable consumer. An adult male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Jan2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced Fever up to 102 and chills for 2 days following vaccination. Body aches and soreness at site of injection was as well reported. No treatment was received for the events. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. This 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EL9265), via an unspecified route of administration at single dose in the left arm on 31Jan2021 11:30 for covid-19 immunisation. Medical history included liver disorder, kidney disease, asthma, allergies to PCN, Sulpr, Iodine dye, pineapple, spinach. Concomitant medications were not reported. On 01Feb2021, the patient experienced achy, fever, chills and neck muscle sorenesswith. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. The vaccine was administered at Health Clinc and  facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 since the vaccination. The patient had not been diagnosed with COVID-19 prior the vaccination.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Pharyngeal swelling, Rash
Clinical narrative: Rash is on my chest and on my upper back; Can barely breath; I can't really eat or swallow because my throat is swollen; I can't really eat or swallow because my throat is swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 02Feb2021 at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization. Medical history included asthma, diabetes, autism and attention deficit hyperactivity disorder (ADHD). The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 03Feb2021, the patient had rash on the chest and upper back; can barely breathe; and could not really eat or swallow because the throat was swollen. The patient did not receive any treatment for the reported events. The outcome of the events, 'rash on the chest and upper back', 'can barely breathe', 'could not really eat or swallow because the throat was swollen', was unknown. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Heart rate, Heart rate increased, Nasopharyngitis
Clinical narrative: Initial soreness in shoulder; unusually high pulse rate; feeling of tired; achy; cold; This is a spontaneous report from a contactable consumer.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration second dose on 02Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at time of vaccination. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose for Covid-19 Immunization on an unspecified date and patient age was 42-year-old.  On an unspecified date, the patient experienced initial soreness in shoulders. Next day unusually high pulse rate (99-104); pulse was normally 70. Also, the patient experienced feeling of tired, achy, and cold. No fever. The patient did not received treatment for the events. The outcome of the events was not recovered. The reporter assess the events as non-serious.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Initial soreness in shoulder; unusually high pulse rate; feeling of tired; achy; cold; This is a spontaneous report from a contactable consumer.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration second dose on 02Feb2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient was not pregnant at time of vaccination. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose for Covid-19 Immunization on an unspecified date and patient age was 42-year-old.  On an unspecified date, the patient experienced initial soreness in shoulders. Next day unusually high pulse rate (99-104); pulse was normally 70. Also, the patient experienced feeling of tired, achy, and cold. No fever. The patient did not received treatment for the events. The outcome of the events was not recovered. The reporter assess the events as non-serious.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glossodynia, Inflammation, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself).  A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 29Jan2021 (at 14:30) at single dose on the left arm for COVID-19 immunisation, administered at clinic. Relevant medical history included persistent genital arousal disorder. Past drug history included allergy to codeine. The subject was receiving concomitant medications (unspecified). No other vaccine was received in four weeks. On 01Feb2021, the patient developed severe fatigue, inflammation, swelling, and soreness under tongue....5 days and counting (as reported). The events were assessed as non-serious. The patient had not recovered from the events.  Information on the Batch/Lot number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting for herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) on 28Jan2021 18:30 (at the age of 35 years) at single dose for Covid-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam, and "omniprozol" (as reported); all taken from an unspecified date (reported as received within 2 weeks of vaccination) for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 18:30 (also reported as "24 hours after vaccine"), the patient experienced pain and swelling at injection site. The patient also experienced rash on leg and elbows starting day 3 (as reported) to present. There was no treatment received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Menstrual disorder, Rash, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting for herself). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration (left arm) on 28Jan2021 18:30 (at the age of 35 years) at single dose for Covid-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant at the time of vaccination. Concomitant medications included sertraline hydrochloride (ZOLOFT), clonazepam, and "omniprozol" (as reported); all taken from an unspecified date (reported as received within 2 weeks of vaccination) for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021 18:30 (also reported as "24 hours after vaccine"), the patient experienced pain and swelling at injection site. The patient also experienced rash on leg and elbows starting day 3 (as reported) to present. There was no treatment received for the adverse events. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.  Information on the lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Folliculitis, Inappropriate schedule of product administration, Laboratory test
Clinical narrative: First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; This is a spontaneous report from a contactable healthcare professional (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283, expiration date not reported), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication included cefalexin monohydrate (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY), and triamcinolone. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5760, on right arm, on 19Dec2020, and experienced urticaria and folliculitis with severe exacerbation after both vaccination. It was reported that on Jan2021, the patient was under successful treatment for urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; experience of rash and dyspnea on Jan2021 required steroids and epipen. Treatment included Prednisone course, epipen, and H2 blockers. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. It was also reported that the patient had first dose administration on 19Dec2020 and second dose administration on 12Jan2021. The patient was recovering from all events, except for "First dose administration on 19Dec2020 and second dose administration on 12Jan2021" with outcome of unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: First dose administration on 19Dec2020 and second dose administration on 12Jan2021; Dyspnea; Rash; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; Urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; This is a spontaneous report from a contactable healthcare professional (the patient). A 45-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El1283, expiration date not reported), via an unspecified route of administration (left arm) on 12Jan2021 at a single dose, for COVID-19 immunization. Medical history was not reported. Concomitant medication included cefalexin monohydrate (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY), and triamcinolone. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ek5760, on right arm, on 19Dec2020, and experienced urticaria and folliculitis with severe exacerbation after both vaccination. It was reported that on Jan2021, the patient was under successful treatment for urticaria and folliculitis with near resolution. Severe exacerbation after both vaccinations 2 and 1; experience of rash and dyspnea on Jan2021 required steroids and epipen. Treatment included Prednisone course, epipen, and H2 blockers. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. It was also reported that the patient had first dose administration on 19Dec2020 and second dose administration on 12Jan2021. The patient was recovering from all events, except for "First dose administration on 19Dec2020 and second dose administration on 12Jan2021" with outcome of unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Crying, Movement disorder, Nausea, Pain in extremity
Clinical narrative: trouble lifting my arm; Pain in arm; Nauseous; Chills; Urge to cry; This is a spontaneous report from a contactable consumer who reported for herself . This 41-years-old no pregnant female patient received first dose of  bnt162b2 (BNT162B2)  from LOT# E19262, on  03Feb2021 17:30 on right arm at SINGLE DOSE for covid-19 immunisation .Age at vaccination:41 years. The patient didn't  receive any other vaccines within 4 weeks prior to the COVID vaccine . The patient received other medications within 2 weeks of vaccination .Medical history included :Allergy to adhesive, ADHD, high blood pressure (HBP), depression, anxiety, gerd. On 04Feb2021 20:00 the patient experienced chills, urge to cry, trouble lifting in arm , pain in arm and she was Nauseous. Events reported as non serious .No treatment received. Outcome was not recovered. Prior to vaccination  the patient was not  diagnosed with COVID-19Since the vaccination, the patient has not  been tested for COVID-19
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Movement disorder, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other hcp reported for herself. A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL9265), intramuscular on the right arm at the age of 49 years old, on 02Feb2021 at a SINGLE DOSE for covid-19 immunisation. Medical history reported as none. The patient had the first dose of the vaccine on 13Jan2021. The patient experienced fever 102, body aches, could barley move on 03Feb2021 12:00. The patient underwent lab tests and procedures which included body temperature: 102 on an unspecified date. The outcome of the event was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable unspecified healthcare professional (patient).  A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: 1284, via an unspecified route of administration in the right arm on 16Jan2021 15:00 at SINGLE DOSE for covid-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included sulfur allergy. Patient was taking unspecified blood pressure medication/s concomitantly. Patient previously took codeine and experienced allergy. 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 hasn't been tested for COVID-19. On 17Jan2021 08:00, the patient experienced just redness and swelling at injection site, no other side effects. Patient did not receive treatment for the events. The outcome of events was recovered. the events were considered as non-serious. Follow-up attempts are completed. No further information is expected. Information on the batch/lot number has been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Inappropriate schedule of product administration, Myalgia
Clinical narrative: This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation .  Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before).  Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation.  Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00  temperature of 100.6, arthralgias and myalgias, dizziness.  Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness,  Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias  was recovering.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse reported for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3247) intramuscular in right arm on 01Feb2021 at 11:30 am (at 60 years) at single dose for covid-19 immunisation .  Medical history included hypertension (HTN) , hypergammaglobulinaemia benign monoclonal (MGUS) , mononucleosis (recent mononucleosis one year before).  Patient was not pregnant. Concomitant medication included venlafaxine hydrochloride (EFFEXOR), hydrochlorothiazide/ losartan potassium (HYZAAR), amfepramone hydrochloride (TENUATE). The patient previously took IV dramamine, tetanus and ceclor and experienced allergy. Previously, on 18Jan2021 at 10:30 am (at 60 years) she took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL3248) intramuscular in right arm for covid-19 immunisation.  Patient took the 1st dose of the vaccine on 18Jan2021 and 2nd dose on 01Feb2021 (inappropriate schedule of vaccine administered). Events were described as follows: next day, on 02Feb2021 at 06:00  temperature of 100.6, arthralgias and myalgias, dizziness.  Second day (Feb2021), temp lower but still around 99.8 (normal for her 97.2), vasovagal, dizziness, arthralgias and myalgias. Events were non serious. Patient (a nurse) treated herself with dramamine for the dizziness,  Nyquil and Advil. The final outcome of pyrexia, vasovagal, dizziness, arthralgias and myalgias  was recovering.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Soreness; headache; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old male patient received the second dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown), via an unspecified route of administration on 02Feb2021 at 06:15 AM at a single dose on the left arm in the workplace clinic for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. The patient received the first dose of BNT162B2 (lot number: EL3248) on 13Jan2021 at 07:15 AM on the left arm for COVID-19 immunization. The patient experienced soreness, headache and fatigue on 03Feb2021 at 10:00 AM. The patient did not receive treatment for the events. The outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Speech disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program.  A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 25Jan2021 at 13:00 (at 78 years) at single dose for COVID-19 immunization. The patient medical history included anxiety, headache, dry eye and low potassium, each from an unknown date and unknown if ongoing. The patient's concomitant medication included potassium oral at 10 meq daily for low potassium, cholecalciferol (D3) oral at 2000 iU once a day to help with bones, fish oil oral at 1200 mg once a day, alprazolam at 0.5 mg as needed (take one three times a day) for anxiety, clonazepam oral at 0.5 mg once a day for anxiety, nortriptyline HCl oral at 10 mg once a day, paracetamol (TYLENOL) at 500 mg as needed for headache, estradiol (SYSTEN) ophthalmic one drop as needed, all from an unknown date and ongoing.  The patient experienced one or two hours after the vaccine (on 25Jan2021), she went to talk, she couldn't get her sentence straight. She knew what she wanted to say but she couldn't say it. Her first thought was that she was having a stroke and it really scared her. She became very tired and went to sleep, when she woke up, she was talking straight but she was still really tired. The next morning (on 26Jan2021) she had diarrhea three time and after that she felt better. The patient outcome of speech disorder and diarrhea was recovered on 26Jan2021 and the outcome of tiredness was recovering.  The information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Vaccination site pain
Clinical narrative: Extremely sore injection site; woke me from sleep; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 03Feb2021 18:00 at a SINGLE DOSE for covid-19 immunisation. Medical history was reported as none. The patient experienced extremely sore injection site and woke me from sleep on an unspecified date. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 31Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included diabetes (reported as diabetis), high blood pressure, allergy to penicillin and sulfer; and COVID-19 (prior to vaccination). Concomitant medications included metformin, apixaban (ELIQUIS), valsartan, propafenone and amlodipine besilate (AMLODI). On 31Jan2021 10:30 AM, the patient experienced redness, warm and itchy around injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report from a non-contactable consumer. A 35-year-old male patient (age at vaccination 35-years-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on an unspecified date, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. At the time of the report, the patient recovered from the event on an unspecified date. No treatment was received for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. It was unknown if the patient had been COVID tested post vaccination.   No follow-up attempts are possible; information about the lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hyperhidrosis, Hypersensitivity, Nasal congestion
Clinical narrative: it feels like when she has an allergic reaction; nasal congestion; chest tightness; diaphoresis; This is a spontaneous report from a contactable pharmacist. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), intramuscular on the left arm on 26Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included allergy to seafood. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on the left arm on 04Jan2021 08:00 for COVID-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient complained of nasal congestion, chest tightness, and diaphoresis approximately 20 mins after the second COVID vaccine on 26Jan2021 10:30. She had an allergy to seafood and stated this was what it felt like when she had an allergic reaction. The patient received one dose of Benadryl 50 mg IV, famotidine 20 mg IV, Solumedrol 125 mg IV, Zofran 4 mg IV and normal saline 500ml bolus. Patient became nauseated after receiving Benadryl and improved after receiving medications. The events were reported non-serious and required emergency room/department or urgent care. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported allergic reaction with symptoms of nasal congestion, chest tightness, and diaphoresis occurred approximately 20 mins after the second COVID vaccine is considered related to the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect.   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 RA, IEC, as appropriate.
Sex: U
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; This is a spontaneous report from a non-contactable other healthcare professional (HCP; "Pharmacy tech").  A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name unspecified, lot number: not provided), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced arm soreness on an unspecified date, after use of product. Outcome of the event was unknown. The reporter mentioned that arm soreness is a common occurrence when administering pneumococcal pneumonia vaccines. She did not mention which vaccine or any other details.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate decreased, Hypertension
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 72-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: BN5318, expiry date unknown) in the School or Student Health Clinic, via an unspecified route of administration on 01Feb2021 at 00:15 on the right arm at a single dose for COVID-19 immunization.  Medical history included cardiac effusion and mild emphysema both from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ciclosporin (NEORAL), mycophenolate mofetil (CELLCEPT [MYCOPHENOLATE MOFETIL]) and losartan (manufacturer unknown).  The patient previously took Cipro and tacrolimus and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced low pulse and high blood pressure on 04Feb2021 at 09:00. The patient did not receive any treatment for the event. The outcome of the events was unknown. The events were reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19.