chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Caller states that 5 deaths, from that vaccine was reported; This is a spontaneous report from a contactable consumer. This is the 1st of 5 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, Consumer stated that 5 deaths, from that vaccine was reported and over 50% of people reported a debilitating disease, or cannot function, and have thousands of dollars in medical bills. The outcome of event was fatal. Autopsy was unknown.  Information on the lot/ batch number has been requested. ; Reported Cause(s) of Death: Caller states that 5 deaths, from that vaccine was reported
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: 1st Injection-Lot# EL3247 given 19Jan2021  2nd Injection: Lot# EL9269 given 09Feb2021/tested positive for COVID on  01Jul2021; 1st Injection-Lot# EL3247 given 19Jan2021  2nd Injection: Lot# EL9269 given 09Feb2021/tested positive for COVID on  01Jul2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 (Batch/Lot Number: EL9269) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: EL3247) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. There was no clinical trial. On on 01Jul2021, the patient experienced '1st injection-lot# el3247 given 19Jan2021 2nd injection: lot# el9269 given 09Feb2021/tested positive for covid on 01Jul2021'. Patient stated that she got COVID after having the vaccine. She would like to know if there are any trials going for people who got COVID after being vaccinated. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Jul2021.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid after the second vaccine; tested positive for covid after the second vaccine; This is a spontaneous report from a Pfizer sponsored Program. This consumer (patient) reported similar events for 2 patients. This is 1st of two reports. A 24-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, age at vaccination: 24-year-old), via an unspecified route of administration, in Arm Left (left deltoid) on 12Jan2021 (Batch/Lot Number: EL1284) as single dose, and dose 1 via an unspecified route of administration on 22Dec2020 (Batch/Lot Number: EJ1685, age at the time of vaccination: 24-year-old) as single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. On 19Jul2021, the patient underwent COVID-19 PCR test and tested positive for COVID after second vaccine dose. The patient feels dumb because the patient thought this vaccine was supposed to work, as the patient works in a hospital and believes science. The outcome of events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100919321 same reporter/product/event, different patient
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pain in extremity
Clinical narrative: New Joint pain thumbs and elbows/painful thumb bases and elbows; New Joint pain thumbs and elbows/painful thumb bases and elbows; Early morning pain awakened with pain; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received bnt162b2, dose 1 via intramuscular, administered in right deltoid on 15Apr2021 12:15 (at the age of 66 years old) (Batch/Lot number was not reported) as single dose, dose 2 via intramuscular, administered in right deltoid on 08May2021 at noon (at the age of 66 years old), both for covid-19 immunization. Medical history included high blood pressure. No illness among any family members. Concomitant medication included metoprolol taken for high blood pressure from 2011 and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of the suspect vaccine. The patient experienced new joint pain thumbs and elbows/painful thumb bases and elbows which resulted in disability and medically significant on 18Apr2021 12:15. Not yet initiated anti-inflammatory medication. The patient experienced early morning pain awakened with pain which considered as non-serious on 18Apr2021. The patient might use NSAID if still painful in next week. Relevant tests were none. No treatment for events. The outcome of event new joint pain thumbs and elbows/painful thumb bases and elbows was not recovered, while another event was unknown.   The reporter considered the Pfizer product had a causal effect to the adverse event, more likely than not.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of arthralgia and pain in extremity cannot be excluded. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: positive COVID 19 test; Fully vaccinated and confirmed positive COVID 19 test and symptomatic; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE, and also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA 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 14Jul2021 fully vaccinated and confirmed positive COVID 19 test and symptomatic (medically significant). On 17Jul2021 Confirmed positive test result on Saturday. On 14Jul2021 started showing symptoms as sinus infection, headache, cough, fatigue. Further reported as event did not take place after use of the product. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thrombosis
Clinical narrative: Blood clots; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: EN1283), via an unspecified route of administration on 08May2021 (at the age of 58-Years-old) as Dose number Unknown, Single for COVID-19 immunization. Given facility where the most recent COVD-19 vaccine was administered.  The patient was not pregnant at the time of vaccination. The patient medical history was reported as many and concomitant medications were not reported. Allergies were reported as Yes. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). The patient received other unknown medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced blood clots on 08Jul2021. AE resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care as the event was life threatening illness having immediate risk of death from the event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test with result negative on 10May2021. The patient was treated with blood thinners for the reported event. The patient have known allergies and many other medical history. Device date reported as 20Jul2021. The outcome of the event was reported as not recovered.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Blood clots; strokes; This is a spontaneous report from a contactable consumer. A 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FT8886), via an unspecified route of administration, administered in left arm on an unknown date in Feb2021 (at the age of 81-year-old) as dose 2, single dose for COVID-19 immunisation. Medical history included type II diabetes, arthritis and fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID. The patient taken other medications in two weeks: insulin shots, prescription pain medications, urine medications and anxiety medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), administered in left arm on an unknown date in Feb2021 (at the age of 81-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On an unknown date in Apr2021, the patient had blood clots and strokes. The events resulted in emergency room/department or urgent care, hospitalized for 7 days. The patient did not receive any treatment in response to the events. The patient died on 31May2021. An autopsy was not performed. Cause of death was reported as blood clots and strokes. Outcome of the events was fatal.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: Blood clots; strokes
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report from a contactable consumer (parent) via the Pfizer sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date as single dose, and dose 1 of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose forCOVID-19 immunisation. The patient medical history and concomitant medications were not reported. As parent  reported for the daughter that his/her daughter was fully vaccinated with Pfizer Covid vaccine and she was currently Covid positive and fighting the virus. A study needed to be taken on who was vaccinated and who ended up getting the virus, so the general public was aware. The patient underwent lab tests and procedures which included COVID-19 with result of positive on an unspecified date. The outcome of the events was unknown.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: got the COVID virus after being fully vaccinated; got the COVID virus after being fully vaccinated; This is a spontaneous report from a contactable consumer or other non-health professional. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of ad-ministration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient got the covid virus after being fully vaccinated. Reporter was concerned about the fact that he was hearing quite a few people wind up getting the virus even though they have been fully vaccinated with the COVID vaccine. Reporter cousin went into a assisted living facility 2 months ago, and she has been previously vaccinated. He has been fully vaccinated as well and three of the people got covid at her assisted living that have been fully vaccinated. He was wondering if Pfizer was started to get any more information about the virus and the vaccine. He knows the vaccine was not 100% effective and question was Pfizer getting an uptick in people that are getting the virus after vaccination. Reporter do not have information on the three people at the assisted living. Reporter was just concerned about himself and worried about some of the information out there not being accurate. Just like some places say no mask, and some say mask. He got vaccinated back in Mar2021. He do not know how much longer he has to live and would just like more information. The patient under-went lab tests and procedures which included covid-19: positive on unspecified date. The clinical out-come of events was unknown.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the Pfizer Covid vaccine first dose on 29 Jun 2021, and then 2 days tested positive for covid 2 day slater; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EW0169) via an unspecified route of administration in left arm on 29Jun2021 at 17:00 (at the age of 25-year-old) as dose 1, single for COVID-19 immunisation. Medical history of the patient was not reported. Patient had no other vaccinations on the same day of COVID-19 vaccine or recently and started no new medications. Patient took Tylenol on 29Jun2021 [the day he got the vaccine]. On an unspecified date in Jul2021, patient went to the hospital 2-3 days after he got the vaccine because he could not breathe. Patient reported that since it was after getting the vaccine patient thought it was because of the shot, since usually after 48 days you can feel bad and feeling have a fever. The third day after the vaccination patient woke up and could not breathe, so he was taken to the hospital by ambulance, and he did test positive for COVID virus, so he was surprised. Patient underwent lab test on unspecified date in Jul2021 had COVID-19 PCR test with result: positive and on unspecified date in Jul2021 had COVID-19 PCR test with negative result. Patient was ok right now. When patient went to the hospital, they gave him Ibuprofen and Tylenol and that was all, he was at the hospital for 8 or 9 hours, then they released him home after they told him to go home. No further details provided about Tylenol and Ibuprofen he received at hospital as treatment. Patient wants to know if he can take the second dose now. Sample of the product was not available to be returned and was not provided as vaccine was administered at a pharmacy. Outcome of the event was resolved on an unspecified date in Jul2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: Severe pain from Rheumatoid Arthritis; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Ep7534 and Expiration Date: unknown), via an unspecified route of administration, administered in left arm on 23Mar2021 at 00:30 (at the age of 68-years-old) as dose 2, single for covid-19 immunisation. Medical history included rheumatoid arthritis, heart and diabetes. There were no concomitant medications. The patient previously took lopressor and experienced allergy and first dose of bnt162b2 (Lot Number: En6198), administered in left arm on 02Mar2021 at 13:30 (at the age of 68-years-old) as dose 1, single for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. On 03Apr2021 at 00:30, the patient experienced severe pain from rheumatoid arthritis. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received Meloxicam for the treatment of event. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient underwent lab test and procedure which included nasal swab, covid test: negative on an unknown date. The outcome of event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizure; This is a spontaneous report from a non-contactable consumer via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. As reported, caller was calling regarding his daughter who got the 1st dose and then after the 1st dose she had a seizure. She had about 3500.00 in expenses and wanted to talk to someone about it. The daughter had a seizure 14 minutes after taking 1st dose of the Covid vaccine. 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Thrombosis
Clinical narrative: The clots are thick and heavy; My periods have become increasingly heavy, longer, and painful since the second dose; cramps are extremely painful, erratic/My periods have become increasingly heavy, longer, and painful since the second dose; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0161) via an unspecified route of administration in right arm on 30Apr2021 at 18:00 as dose 2 single (at the age of49-year-old) for COVID-19 immunization. Medical history included ADHD (Attention deficit hyperactivity disorder), Anxiety, allergic to sulfa drugs. Concomitant medications included citalopram 20 mg, methylphenidate ER 50 mg. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0150) via an unspecified route of administration in right arm on 09Apr2021 at 06:30 PM as dose 1 single (at the age of 49-year-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient had no covid prior vaccination. Facility type vaccine at Pharmacy or Drug Store. On 10May2021 at 19:00, patient experienced her periods had become increasingly heavy, longer, and painful since the second dose. Each month the symptoms increase. This month the cramps were extremely painful, erratic, and she was bleeding through super tampons every 2-3 hours. The clots were thick and heavy. This was not normal and she have not had this severe bleeding since I gave birth to my kids. No treatment was received for the adverse events. Patient had not covid tested post vaccination. The outcome of the events was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Inflammation, Platelet count, Pruritus
Clinical narrative: Itching has gotten worse/tips of her ears felt inflamed and were itchy/The itching was so unbearable at times it waked her up at night from sleep; Hives; Bumpiness; Redness; Tips of ears inflamed and are itchy; I have bruised myself from itching my arms; This is a spontaneous report from a contactable other health care professional (patient) reported for herself. A 27-year-old non-pregnant female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27Mar2021 17:00 (at the age of 27 years old) (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Medical history included known allergies as Penicillin-related antibiotics. Concomitant medications within 2 weeks of vaccination included colecalciferol (VIT D3) and cyanocobalamin (VIT B12). The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 12:00 PM (at the age of 27 years old) (Batch/Lot Number: EN6202) as single dose for covid-19 immunization and experienced Itchy arms, red dots, Itching on arms progressively got worse, petechiae. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. 1-2 weeks after first dose, started having itchy arms - didn't think much of it because it would go away. Around the same time, red dots started forming around her ankles up to her lower thighs - not raised or itchy. Itching on arms progressively got worse. Went to the doctor and she attributed it to the vaccine. Rx'd Triamcinolone Cream and checked platelets for possible petechiae on her legs - platelets were normal. Said it was ok for her to get second dose. Itching had gotten worse. Itching leads to hives, bumpiness, and redness. Had spread from arms to legs to torso over last few weeks. At time of report, the tips of her ears felt inflamed and were itchy. The only thing that had somewhat helped was diphenhydramine hydrochloride (BENADRYL). Creams/lotions did not help. The red dots were still present, but more local to her ankles. The itching was so unbearable at times it waked her up at night from sleep. The patient bruised herself from itching her arms. Date of start of reaction/events was Mar2021. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included platelet count: normal in Mar2021, covid test (Spit test): negative on 30Mar2021 (Nasal Swab). The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021367775 same  patient/reporter, different AE/dose
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Skin disorder, Urticaria
Clinical narrative: Itching has gotten worse/tips of her ears felt inflamed and were itchy/The itching was so unbearable at times it waked her up at night from sleep; Hives; Bumpiness; Redness; Tips of ears inflamed and are itchy; I have bruised myself from itching my arms; This is a spontaneous report from a contactable other health care professional (patient) reported for herself. A 27-year-old non-pregnant female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27Mar2021 17:00 (at the age of 27 years old) (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Medical history included known allergies as Penicillin-related antibiotics. Concomitant medications within 2 weeks of vaccination included colecalciferol (VIT D3) and cyanocobalamin (VIT B12). The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 12:00 PM (at the age of 27 years old) (Batch/Lot Number: EN6202) as single dose for covid-19 immunization and experienced Itchy arms, red dots, Itching on arms progressively got worse, petechiae. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. 1-2 weeks after first dose, started having itchy arms - didn't think much of it because it would go away. Around the same time, red dots started forming around her ankles up to her lower thighs - not raised or itchy. Itching on arms progressively got worse. Went to the doctor and she attributed it to the vaccine. Rx'd Triamcinolone Cream and checked platelets for possible petechiae on her legs - platelets were normal. Said it was ok for her to get second dose. Itching had gotten worse. Itching leads to hives, bumpiness, and redness. Had spread from arms to legs to torso over last few weeks. At time of report, the tips of her ears felt inflamed and were itchy. The only thing that had somewhat helped was diphenhydramine hydrochloride (BENADRYL). Creams/lotions did not help. The red dots were still present, but more local to her ankles. The itching was so unbearable at times it waked her up at night from sleep. The patient bruised herself from itching her arms. Date of start of reaction/events was Mar2021. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included platelet count: normal in Mar2021, covid test (Spit test): negative on 30Mar2021 (Nasal Swab). The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021367775 same  patient/reporter, different AE/dose
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report from a non-contactable consumer. This is one of 5 reports      A patient of unspecified age and gender received bnt162b2 (BNT162B2) dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient died on an unknown date from an unknown cause.    It was not reported if an autopsy was performed. The reporter stated that the vaccine was kept in ice box for like 5 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944710 same reporter/drug/event, different patient;US-PFIZER INC-202100944708 same reporter/drug/event, different patient;US-PFIZER INC-202100944711 same reporter/drug/event, different patient;US-PFIZER INC-202100944709 same reporter/drug/event, different patient; Reported Cause(s) of Death: Death
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This is a spontaneous report from a non-contactable consumer. This is one of 5 reports      A patient of unspecified age and gender received bnt162b2 (BNT162B2) dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient died on an unknown date from an unknown cause.    It was not reported if an autopsy was performed. The reporter stated that the vaccine was kept in ice box for like 5 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944572 same reporter/drug/event, different patient; Reported Cause(s) of Death: Death
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chills, Herpes simplex reactivation, Lymphadenopathy, Rhinorrhoea
Clinical narrative: bad runny nose; blisters in both nostrils; mild swollen lymph nodes; bad chills; she believes the vaccine triggered my Herpes Simplex Virus 1; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, in arm right on 27Jan2021 13:30 (Lot Number: EL9264) as dose 1, single (age at vaccination 70-year-old) for COVID-19 immunisation. Medical history included none. Concomitant medication included (vitamin c [ascorbic acid]) and calcium. The patient doesn't have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was not pregnant at vaccination. The patient's other medications in two weeks includes Silver centum multivitamin, Vitamin C and Calcium. On 27Jan2021 18:30, the patient experienced bad chills and on 28Jan2021 mild swollen lymph nodes, on 29Jan2021 experienced bad runny nose, blisters in both nostrils and she believes the vaccine triggered my herpes simplex virus 1 on an unspecified date in 2021. It was reported that patient had bad chills 5 hrs after vaccine lasting about 3 hours, next day had mild swollen lymph nodes, next day started a bad runny nose on 29Jan2021, 2 days later (29Jan2021), blisters in both nostrils. went to see her Dr. a week after the vaccine. Had Covid test which was negative. Dr. said she believes the vaccine triggered her Herpes Simplex Virus 1.m. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021. Therapeutic measures were taken as a result of events includes Valrex. The outcome for all events was recovering.   Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: bad runny nose; blisters in both nostrils; mild swollen lymph nodes; bad chills; she believes the vaccine triggered my Herpes Simplex Virus 1; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, in arm right on 27Jan2021 13:30 (Lot Number: EL9264) as dose 1, single (age at vaccination 70-year-old) for COVID-19 immunisation. Medical history included none. Concomitant medication included (vitamin c [ascorbic acid]) and calcium. The patient doesn't have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient was not pregnant at vaccination. The patient's other medications in two weeks includes Silver centum multivitamin, Vitamin C and Calcium. On 27Jan2021 18:30, the patient experienced bad chills and on 28Jan2021 mild swollen lymph nodes, on 29Jan2021 experienced bad runny nose, blisters in both nostrils and she believes the vaccine triggered my herpes simplex virus 1 on an unspecified date in 2021. It was reported that patient had bad chills 5 hrs after vaccine lasting about 3 hours, next day had mild swollen lymph nodes, next day started a bad runny nose on 29Jan2021, 2 days later (29Jan2021), blisters in both nostrils. went to see her Dr. a week after the vaccine. Had Covid test which was negative. Dr. said she believes the vaccine triggered her Herpes Simplex Virus 1.m. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 04Feb2021. Therapeutic measures were taken as a result of events includes Valrex. The outcome for all events was recovering.   Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Pain, Peripheral swelling, Pyrexia
Clinical narrative: chills; fever; my left arm is so swollen; severe pain; huge lump on the injection site and still swollen; huge lump on the injection site and still swollen; This is a spontaneous report from a contactable Other Health Care Professional (HCP) (Patient). A 45-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, Expiration date was not reported), via an unspecified route of administration, in arm left, on 06Feb2021 at 13:00 (at the age of 45-year-old), as a single dose for covid-19 immunization. The patient medical history included high blood pressure. Concomitant medications included zinc and boswellia serrata resin, colecalciferol, collagen (OSTEO BI-FLEX EASE). Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, Expiration date was not reported), via an unspecified route of administration, in left arm, on 16Jan2021 at 12:00 (at the age of 45-year-old), as a single dose for covid-19 immunization. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested post vaccination. Facility type vaccine was reported as Nursing Home/Senior Living Facility. There was no other vaccine received in four weeks. On 07Feb2021 at 15:00, on the second dose the patient had chills, fever and my left arm is so swollen with severe pain. She stated that now its Wednesday and I received the shot on Saturday. There is a huge lump on the injection site and still swollen with a huge bump. There was no treatment received for adverse events. Outcome of the events huge lump on the injection site and still swollen was reported as not recovered and chills, fever, swollen arm, pain was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: chills; fever; my left arm is so swollen; severe pain; huge lump on the injection site and still swollen; huge lump on the injection site and still swollen; This is a spontaneous report from a contactable Other Health Care Professional (HCP) (Patient). A 45-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, Expiration date was not reported), via an unspecified route of administration, in arm left, on 06Feb2021 at 13:00 (at the age of 45-year-old), as a single dose for covid-19 immunization. The patient medical history included high blood pressure. Concomitant medications included zinc and boswellia serrata resin, colecalciferol, collagen (OSTEO BI-FLEX EASE). Historical vaccine included the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982, Expiration date was not reported), via an unspecified route of administration, in left arm, on 16Jan2021 at 12:00 (at the age of 45-year-old), as a single dose for covid-19 immunization. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested post vaccination. Facility type vaccine was reported as Nursing Home/Senior Living Facility. There was no other vaccine received in four weeks. On 07Feb2021 at 15:00, on the second dose the patient had chills, fever and my left arm is so swollen with severe pain. She stated that now its Wednesday and I received the shot on Saturday. There is a huge lump on the injection site and still swollen with a huge bump. There was no treatment received for adverse events. Outcome of the events huge lump on the injection site and still swollen was reported as not recovered and chills, fever, swollen arm, pain was reported as recovering.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear discomfort, Headache, Lymphadenopathy, Swelling
Clinical narrative: ear to hurt; swelling in neck and face; swelling in neck and face; more difficulty breathing; little bit of headache; Swollen lymph nodes in her throat on the right side; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (BNT162B2)via intramuscular route, administered in right upper arm on 02Feb2021 10:00 (at the age of 64-year) (Lot Number: EM9810) as dose 1, single for covid-19 immunisation in hospital. Medical history included ongoing chronic obstructive pulmonary disease (diagnosed two years ago), she smoked for 43 years and she quit. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was none. The patient did not receive any vaccinations prior vaccinations (within 4 weeks). The patient did not have concomitant medications. Caller was reporting on herself and her husband. This was the report for the caller herself she had the Pfizer covid vaccine. It was reported that, patient experienced little bit of headache and Swollen lymph nodes in her throat on the right side on 02Feb2021. Also experienced swelling in neck and face and have more difficulty breathing on 03Feb2021 and started ear to hurt on an unknown date. It was reported that, She did not have internet and wanted to report side effects. Stated her husband did not have any side effects aside from a sore arm. Reported she had a little bit of a headache not anything she could not deal with. She has swollen lymph nodes in her throat on the right side, making her ear hurt and has had the swollen lymph nodes since she got the vaccine. She noticed a little bit of swelling in neck and face. First dose administered 02Feb2021. She was going back for her second dose on 23Feb2021. Reported she has not had a headache since, she thought by the third day her headache was gone. Her face was a little swollen, stated that, it was nothing major. Her husband noticed her face was swollen. She already has COPD and noticed a little more difficulty in breathing since after receiving the vaccine, stated it might wear off but she noticed her breathing was a little worse after the shot. She noticed she was short winded and noticed she could not go as far as she could, she could go to mailbox and back before. She thought the difficulty breathing was from her COPD, not the vaccine. The swelling in her lymph nodes was a little worse since it was causing her ear to hurt, it was nothing she could not deal with. Treatment: declines any she was happy with the shot and could not wait to get the second dose. The patient did not visited to emergency room and physician office. The outcome of the event little bit of headache was recovered on an unspecified date in Feb2021; swelling in neck and face was recovering and not recovered for other events.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: ear to hurt; swelling in neck and face; swelling in neck and face; more difficulty breathing; little bit of headache; Swollen lymph nodes in her throat on the right side; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (BNT162B2)via intramuscular route, administered in right upper arm on 02Feb2021 10:00 (at the age of 64-year) (Lot Number: EM9810) as dose 1, single for covid-19 immunisation in hospital. Medical history included ongoing chronic obstructive pulmonary disease (diagnosed two years ago), she smoked for 43 years and she quit. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was none. The patient did not receive any vaccinations prior vaccinations (within 4 weeks). The patient did not have concomitant medications. Caller was reporting on herself and her husband. This was the report for the caller herself she had the Pfizer covid vaccine. It was reported that, patient experienced little bit of headache and Swollen lymph nodes in her throat on the right side on 02Feb2021. Also experienced swelling in neck and face and have more difficulty breathing on 03Feb2021 and started ear to hurt on an unknown date. It was reported that, She did not have internet and wanted to report side effects. Stated her husband did not have any side effects aside from a sore arm. Reported she had a little bit of a headache not anything she could not deal with. She has swollen lymph nodes in her throat on the right side, making her ear hurt and has had the swollen lymph nodes since she got the vaccine. She noticed a little bit of swelling in neck and face. First dose administered 02Feb2021. She was going back for her second dose on 23Feb2021. Reported she has not had a headache since, she thought by the third day her headache was gone. Her face was a little swollen, stated that, it was nothing major. Her husband noticed her face was swollen. She already has COPD and noticed a little more difficulty in breathing since after receiving the vaccine, stated it might wear off but she noticed her breathing was a little worse after the shot. She noticed she was short winded and noticed she could not go as far as she could, she could go to mailbox and back before. She thought the difficulty breathing was from her COPD, not the vaccine. The swelling in her lymph nodes was a little worse since it was causing her ear to hurt, it was nothing she could not deal with. Treatment: declines any she was happy with the shot and could not wait to get the second dose. The patient did not visited to emergency room and physician office. The outcome of the event little bit of headache was recovered on an unspecified date in Feb2021; swelling in neck and face was recovering and not recovered for other events.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Headache, Malaise
Clinical narrative: Blinding headaches; Shortness of breath; Dry cough; Feeling very bad; This is a spontaneous report from a contactable consumer or other non hcp. A female patient unspecified age (82 unspecified units) received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Feb2021 the patient experienced  on Monday she woke up with horrible, horrible blinding headaches, shortness of breath, dry cough, feeling very bad patient wanted to know whether he can receive Tylenol for his headache. The outcome of the event headaches was not recovered and other events were as an 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: Blood pressure increased, Blood pressure measurement, Fatigue, Nausea, Pyrexia
Clinical narrative: had a spike in blood pressure; lead to the caller's thinking that she was having a TIA; fatigue; injection site pain; nausea; fever; This is a spontaneous report from a contactable consumer, the mother's daughter. A female patient on an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in Jan2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history included hemorrhagic (disorder) and ischemic stroke. Concomitant medications were not reported. The patient had adverse events after the first dose which are namely fatigue, injection site pain, onset of violent nausea, fever that lasted for 4 hours in Jan2021. The consumer mentioned that her mother also had a spike in blood pressure (180/90) which lead to the caller's (consumer) thinking that she was having a TIA (transient ischemic attack) in Jan 2021. The outcome of the events fatigue, injection site pain, nausea, fever was recovered in Jan2021. The outcome of the events spike in blood pressure and TIA was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (31Mar2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Vaccination site pain
Clinical narrative: had a spike in blood pressure; lead to the caller's thinking that she was having a TIA; fatigue; injection site pain; nausea; fever; This is a spontaneous report from a contactable consumer, the mother's daughter. A female patient on an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in Jan2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history included hemorrhagic (disorder) and ischemic stroke. Concomitant medications were not reported. The patient had adverse events after the first dose which are namely fatigue, injection site pain, onset of violent nausea, fever that lasted for 4 hours in Jan2021. The consumer mentioned that her mother also had a spike in blood pressure (180/90) which lead to the caller's (consumer) thinking that she was having a TIA (transient ischemic attack) in Jan 2021. The outcome of the events fatigue, injection site pain, nausea, fever was recovered in Jan2021. The outcome of the events spike in blood pressure and TIA was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  Follow-up (31Mar2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in jaw, Swelling, Vaccination site mass
Clinical narrative: Hard knot behind left ear, and down neck; pain; swelling left neck in front of and behind ear and lower neck; pain in left jaw; This is a spontaneous report from a contactable consumer (patient). A 72-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, in right arm on 12Feb2021 12:30 (at the age of 72 years old) (Lot Number: EN6201) as dose 2, single for COVID-19 immunisation. Medical history included hyperthyroid. Patient did not receive any other vaccine in four weeks. Patient was not tested covid prior vaccination. Known allergies was NSAIDS. Concomitant medications included levothyroxine sodium (SYNTHROID). Patient historical vaccine included received first dose of bnt162b2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration in arm right (at the age of 72-years-old) on 22Jan2021 12:45PM (Lot number: El1283) as dose 1, single for COVID-19 immunisation. On 12Feb2021 at 12:50 the patient reported that "About 20 minutes after the injection had pain and swelling left neck in front of and behind ear and lower neck, pain in left jaw. Hard knot behind left ear, and down neck. Painful when touched. Patient was not tested covid post vaccination. No therapeutic measures were taken as a result of events. The outcome of the events was resolved on an unspecified date in 2021.   Follow-up attempts completed. No further information expected.