chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test, Vaccination failure
Clinical narrative: felt 'ill'; tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable Nurse. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in the left arm on 01Jan2021 at 08:30 (Batch/Lot Number: EL3248) as a single dose (at the age of 58-years-old) and dose 2 intramuscular, administered in left arm on 02Feb2021 at 12:15 (Batch/Lot Number: EL3248) as a single dose, (at the age of 58-years-old),  for COVID-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient did not have COVID-19 prior to receiving the BNT162B2 vaccination.  The patient experienced vaccination failure on an unknown date in Mar2021. On 16Mar2021 the patient reported he felt ill and tested positive for COVID on 22Mar2021(as reported).  The events resulted in a doctor or other healthcare professional office/clinic visit. Treatment was reported as unknown. The patient underwent lab test which included on 21Mar2021 COVID-19 test (PCR nasal swab test) was positive. The outcome of events vaccination failure, COVID-19 (tested positive for COVID-19), and felt ill was recovered on an unknown date.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Vaccination failure and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19/ tested positive; COVID 19/ tested positive; This is a spontaneous report from a contactable consumer and a nurse. A 56-year-old male patient received first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified routes of administration on unspecified dates (lot numbers and expiry dates: unknown) at single doses for COVID-19 immunisation. Medical history were not reported. It was unknown if the patient was diagnosed with COVID prior vaccination, unknown if the patient received other vaccines within four weeks prior to COVID vaccination, and unknown if the patient received medications within two weeks prior to COVID vaccination. Facility where vaccine was administered was also unknown. The patient's concomitant medications were not reported. On 31Mar2021, the patient was 'ill'. On the same day, the patient tested positive and was diagnosed with COVID-19. The nurse noted that the patient was "fully vaccinated" however, they were unable to find evidence of vaccination in the Pfizer medical record. The events were considered serious due to other medically important condition and due to hospitalization on unspecified dates. It was unknown if the patient received treatment for the events. The patient was recovering from the events.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed on 03Apr with covid; diagnosed on 03Apr with covid; This is a spontaneous report from a non-contactable consumer (wife). A 62-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history included memory issue. Concomitant medications were not reported. The patient was diagnosed with COVID on 03Apr2021. Patient wants to take the second shot. He was not underage, but he has some memory issues. He needs someone to be with him. Outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Injection site bruising
Clinical narrative: felt woozy and dizzy; bruising at the injection site; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 47-years-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number and expiration was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that he received his first vaccine dose and that night he felt woozy and dizzy. Patient also reported that he was on a blood thinner and experienced bruising at the injection site. He reported, it not red, it just looks bruised. The patient asked should he get the second dose after having side effects from the first. It was reported that he should not get the Pfizer-BioNTech COVID-19 Vaccine if he had a severe allergic reaction after a previous dose of the vaccine or if he had a severe allergic reaction to any ingredient of the vaccine. The decision to received the second dose for any other reason could not be made by Pfizer. To refer him to speak to his healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. His healthcare provider knows his health situation and had access to information that can better help inform this decision. The outcome of the events reported as unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Urticaria
Clinical narrative: Angioedema; Generalized urticaria (hives) all over trunk, arms, buttocks; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8737; Expiration date was not reported) on the left arm on 06Apr2021 (13:15) as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included type 2 diabetes, hypertension (HTN) and obesity. Concomitant medications included atenolol, amlodipine, metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET) and simvastatin. The patient previously took buproprion (WELLBUTIN), and had drug allergy. On 07Apr2021 (14:00), the patient had angioedema and generalized urticaria (hives) all over the trunk, arms and buttocks. The events had resulted into doctor or other healthcare professional office/clinic visit. The patient had received methylprednisolone (MEDROL) as treatment for the reported event. The outcome of the event was not recovered. The patient did not have COVID-19 prior to vaccination, and had not been tested post-vaccination.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: then took the test on 07APR, and the result came out on 09APR which is positive.; exposed to someone who is COVID-19 positive on 28MAR, started to have symptoms on; This is a spontaneous report received from a Pfizer Sponsored Program received from contactable consumer (patient) reporting for himself. A male patient of an unspecified age received the bnt162b2 (PFIZER COVID-19 VACCINE, Lot number and expiry date for both doses were not reported), first dose on 09Jan2021 and second dose on 01Feb2021; both via an unspecified route of administration as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient had his 1st shot on 09Jan2021 and 2nd shot on 01Feb2021. He was exposed to someone who is COVID-19 positive on 28Mar2021 started to have symptoms on 01Apr2021, then took the test on 07Apr2021, and the result came out on 09Apr2021, which was positive. He called to report his case since he was positive with the COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid on 04Apr2021; This is a spontaneous report from the Pfizer sponsored program from a contactable consumer, the patient.  A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 26Mar2021 at 10:00 (Batch/Lot Number: ER8733) as a single dose (at the age of 36-years-old) for COVID-19 immunisation. The patient had no relevant medical history and no relevant family medical history.  There were no concomitant medications. The patient had no other vaccinations within 4 weeks of the vaccination and no other vaccines administered on the same date as bnt162b2. The patient developed symptoms (unspecified) on 03Apr2021, and tested positive for COVID-19 on 04Apr2021. The patient was calling to see when he can receive the second dose. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 04Apr2021. The clinical outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had a covid 19 infection and she is due to her second dose of the Pfizer covid vaccine; had a covid 19 infection and she is due to her second dose of the Pfizer covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient underwent lab tests and procedures which included covid 19 test which gives positive covid 19 infection, and she is due to her second dose of the covid vaccine and  she wonders if she can have it.The event was considered serious as medically significant.The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on an unknown date, as single dose for COVID-19 immunisation. The patient's medical history included hypertension, diabetes, visual problems and kidney transplant. Concomitant medications were not reported. On an unknown date in Apr2021, the patient tested positive for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Apr2021. The patient's doctor told him that because the patient tested positive for COVID he have to wait 90 days before taking the next dose. The event resulted in emergency room visit. The patient was supposed to get his 2nd dose on 14Apr2021 but has to cancel because he tested positive last week for COVID. He wanted to know how long does he have to wait before he can get his 2nd dose of the COVID vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in her arm; This is a spontaneous report received from a contactable consumer. A contactable female consumer (patient) of an unspecified age patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. Patient medical history and concomitant medication were not reported. Patient received the first dose of the COVID-19 vaccine and developed some soreness in arm on unspecified date. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative, SARS-CoV-2 test
Clinical narrative: had blood drawn at the Doctor's office to test for IgG COVID-19 antibodies and tested negative; This is a spontaneous report from a contactable pharmacist reporting on behalf of the patient via a Pfizer-sponsored program. A female (mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on an unspecified date (unknown lot number and expiration) and second dose on 17Feb2021 (unknown lot number and expiration), both as a single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The pharmacist requested information on behalf of her parents who received both doses of COVID vaccine, both got second dose on 17Feb2021, her dad had a finger prick (at local pharmacy) and it came back positive, mom had same finger stick test but mom's was negative. They also both had blood drawn at the doctor's office to test for IgG COVID-19 antibodies and tested negative. The pharmacist further stated, "with my mother when she received second vaccine, she had no symptoms", the pharmacist wanted to know if this would mean a lack of protection/immune response for her mom. The pharmacist requested information on the vaccine coverage or vaccine efficacy in obesity population, and she stated her mom is on prednisone 5mg every day, and held it before vaccination. The pharmacist was concerned her parent negative antibodies test results could be due to a lack of efficacy. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: patient got the Pfizer vaccine and after second dose came down with the covid virus; patient got the Pfizer vaccine and after second dose came down with the covid virus; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), both the first and second dose via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got the "Pfizer vaccine" and after second dose came down with the COVID virus. The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on an unspecified date. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on a temporal association and safety profile, a causal relationship between the reported event and suspect drug  bnt162b2 is assessed as possible.
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Diarrhoea, Hypoaesthesia, Paraesthesia, Tooth disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer HCP (patient). A 63-year old female patient (non-pregnant) received the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, expiration date: unknown) via unspecified route of administration on 18-JAN-2021 at a single dose for COVID-19 immunisation. historic vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, expiration date: unknown) via unspecified route of administration in on DEC-2020at a single dose for COVID-19 immunisation. concomitant medication was not reported. patient experienced diarrhea, she is unable to control her bowels at all and her stools have never gone back to normal, "anterior mandibular sensations in trigeminal nerve". numbness, tingling and now issues with her teeth. She wants to know how long this will keep lasting and wanted to also report it again. She stated she has called before and reported it.
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal nerve disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer HCP (patient). A 63-year old female patient (non-pregnant) received the second dose of BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, expiration date: unknown) via unspecified route of administration on 18-JAN-2021 at a single dose for COVID-19 immunisation. historic vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number unknown, expiration date: unknown) via unspecified route of administration in on DEC-2020at a single dose for COVID-19 immunisation. concomitant medication was not reported. patient experienced diarrhea, she is unable to control her bowels at all and her stools have never gone back to normal, "anterior mandibular sensations in trigeminal nerve". numbness, tingling and now issues with her teeth. She wants to know how long this will keep lasting and wanted to also report it again. She stated she has called before and reported it.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Adverse event, Feeling abnormal
Clinical narrative: got a bad reaction; feeling like she was knocked up by a truck; This is spontaneous report from contactable reporter (reported on behalf of her daughter) via the Pfizer sponsored program.   The female patient of an unspecified age received first dose of BNT162B2 (Pfizer covid-19 vaccine, Lot number: unknown) via an unspecified route of administration as a single dose on 04Apr2021 for Covid-19 immunization. Medical history was not reported. Concomitant medication included Amoxicillin. The day prior to this report, she received metronidazole(FLAGYL) antibiotic. On an unknown date in Apr2021, the patient got a bad reaction from Flagyl antibiotic from her dental visit, she woke up the following morning feeling like she was knocked up by a truck . It was stated that the patient took Amoxicillin together with that Flagyl. The outcome of the event of feeling abnormal and bad reaction was unknown.  No follow up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hangover, Headache, Illness
Clinical narrative: Headache; Bad dreams; Nausea; Lethargy; Feel crappy; Like an endless hangover; Brain still foggy; fever.; Chills; sick; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on 05Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included non-smoker. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date for covid-19 immunisation. The patient received 2nd vaccine last Monday on 05Apr2021. His fever and chills on Wednesday on 07Apr2021 were off the charts. Have not felt that sick in 10-plus years. It is Sunday on 11Apr2021, the patient still feels crappy. Like an endless hangover. Foggy headed. Never clears. Day 7 since 2nd vaccine on 12Apr2021, still foggy. Nausea. Lethargy. Ugh. Subsequently on 13Apr2021, the patient reported, day 8, brain still foggy. Headaches. Bad dreams. Lethargy, nausea, in a fog continues 8 days after vaccination. The patient is a fit male, exercise every day. 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: Lethargy, Malaise, Nausea, Nightmare, Pyrexia
Clinical narrative: Headache; Bad dreams; Nausea; Lethargy; Feel crappy; Like an endless hangover; Brain still foggy; fever.; Chills; sick; This is a spontaneous report from a contactable consumer (patient). A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on 05Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included non-smoker. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unknown date for covid-19 immunisation. The patient received 2nd vaccine last Monday on 05Apr2021. His fever and chills on Wednesday on 07Apr2021 were off the charts. Have not felt that sick in 10-plus years. It is Sunday on 11Apr2021, the patient still feels crappy. Like an endless hangover. Foggy headed. Never clears. Day 7 since 2nd vaccine on 12Apr2021, still foggy. Nausea. Lethargy. Ugh. Subsequently on 13Apr2021, the patient reported, day 8, brain still foggy. Headaches. Bad dreams. Lethargy, nausea, in a fog continues 8 days after vaccination. The patient is a fit male, exercise every day. 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: COVID-19, Drug ineffective, Hypersensitivity, SARS-CoV-2 test
Clinical narrative: she tested positive for the virus.; she tested positive for the virus.; developed some allergies; This is a spontaneous report from a Non contactable consumer (patient's mother). A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 25Mar2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. It was reported that the patient had some allergies without fever on 03Apr2021. Patient's mother mentioned her daughter took some allergy medication and it was resolved thereafter. However, her husband got tested positive for COVID19 infection on last Saturday, 10Apr2021 and out of curiosity, her daughter also took the same test on Sunday, 11Apr2021 and came back positive on Monday, 12Apr2021. Patient was scheduled to take her second shot on Thursday, 15Apr2021 and wanted to know if her daughter should proceed in taking the shot given that she tested positive for the virus. They referred to HCP for further clinical recommendation as to whether or not her daughter should proceed in taking the second dose of the vaccine given her current diagnosis. Outcome of the event hypersensitivity was recovered on an unknown date and for all other events, it was unknown.  No follow-up attempts are possible. Information about batch and lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain
Clinical narrative: body aches; chills; feeling weak; This is a spontaneous report from a contactable consumer(patient).  The 62-year-old female patient received bnt162b2 (COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization.  Medical history was none. The patient's concomitant medications were not reported.  After having first COVID-19 vaccine, she experienced body aches, chills and feeling weak. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza, Pain, Rhinorrhoea
Clinical narrative: like a runny nose, it was liquid non stop; her body hurts worse than usual; feel like she have the flu; tired afterwards; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date), via an unspecified route of administration, administered in arm on an unspecified date as single dose for COVID-19 immunisation. Medical history included medical disability because she has had 3 shoulder surgeries, within the last month she had a fall and she fractured her back, she also mentioned that she was a diabetic and she has all of the comorbidities on the list and she has had pneumonia 4 times out of 5 years and her doctor said that if she gets covid then they can just go on and call her dead. The patient's concomitant medications were not reported. The patient reported that she had her vaccine this past Friday (as reported) and she had some reactions like a runny nose, it was liquid non-stop and her body hurts worse than usual. She reported that she was going to be just fine. She refuses to have anything else, she has enough. She knew that it was normal to feel like you have the flu and tired afterwards and that was exactly how she feels. The patient mentioned that she was told to get the covid vaccine in her dominant arm. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest pain, Dyspnoea, Illness
Clinical narrative: fever of 100.8; pain across her chest; her breathing was horrible; immune system is so bad; pain across her chest and back; she was real sick; This is a spontaneous report received from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection Lot number and expiration was not provided) via unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported that patient was very scared to get the vaccine. Caller stated patient had symptoms after the first dose of the pfizer covid 19 vaccine. Caller stated that everyone she knows said they did not have any side effects to the first dose and that the side effects are worse with the second dose. Caller was concerned her symptoms will be worse after the second dose. Caller reported fever of 100.8, all this other stuff, pain across her chest and back and her breathing was horrible Caller stated she was real sick. Caller stated her immune system was so bad. The patient asked once you get the first dose, how important was it to get the second one. Patient underwent lab test and procedure which included body temperature 100.8 centigrade.The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Immune system disorder, Pyrexia
Clinical narrative: fever of 100.8; pain across her chest; her breathing was horrible; immune system is so bad; pain across her chest and back; she was real sick; This is a spontaneous report received from a contactable consumer. A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection Lot number and expiration was not provided) via unspecified route of administration as a single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. It was reported that patient was very scared to get the vaccine. Caller stated patient had symptoms after the first dose of the pfizer covid 19 vaccine. Caller stated that everyone she knows said they did not have any side effects to the first dose and that the side effects are worse with the second dose. Caller was concerned her symptoms will be worse after the second dose. Caller reported fever of 100.8, all this other stuff, pain across her chest and back and her breathing was horrible Caller stated she was real sick. Caller stated her immune system was so bad. The patient asked once you get the first dose, how important was it to get the second one. Patient underwent lab test and procedure which included body temperature 100.8 centigrade.The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Epistaxis, Haemoptysis, Rash macular
Clinical narrative: My nose started bleeding heavily/Seriously bleeding from my nose; I coughed up blood; I got red blotches on my neck yesterday; brusing on my arm and leg for no reason; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, in right arm on 07Apr2021 at 14:30 (at the age of 58-years-old) as single dose for COVID-19 immunisation. The patient's medical history included asthma and allergies. The patient had known allergies to milk, mold and red dye. Patient was not pregnant at the time of vaccination.  Concomitant medications were not reported. The patient received first dose of BNT162B2 (Lot number: EN6206), administered in right arm, on 17Mar2021 at 02:30PM The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient did not receive any other medications within two weeks of vaccination. On 13Apr2021 at 14:00 she coughed up blood, got red blotches on her neck and bruising on her arm and leg for no reason. On 15Apr2021 at 14:00, the patient's nose started bleeding heavily. There was no treatment received for the adverse events. Outcome of the event bleeding nose was recovering and outcome of all other events was recovered.  Follow-up (21Apr2021): This follow-up is being submitted to amend previously reported information. Lot number for second dose was changed to EN6207, updated relevant medial history, adverse event start date and outcome for the event 'bleeding nose'.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: experienced sore and itch in the injection site; experienced sore and itch in the injection site; This is a spontaneous report received from Pfizer-sponsored program from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 07Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunization.The patient experienced sore and itch in the injection site in Apr2021. She had not removed the bandage in the injection site when she got it until this day. She can't remember when she received the 1st dose but she has no reaction during the first dose. Outcome of events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: headaches; a little bit of fever; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  She received first dose yesterday 12Apr2021, and today (13Apr2021), she was experiencing headache and a little bit of fever, not so much fever, but headache. Outcome of the event was unknown.  No follow-up attempts are Possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: positive for COVID this Sunday after being fully vaccinated 3 months; sick and having breathing problems and is now sick with covid; This is a spontaneous report from a contactable consumer (Reporter's friend of a friend) Follow-up information received on 13Apr2021 was processed together with initial information. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient tested positive for COVID this Sunday after being fully vaccinated 3 months ago with the Pfizer COVID Vaccine. He is afraid of this unfortunate event and is wondering if the vaccine even still offers protection against COVID 19. Patient mentioned they had a cough and were not necessarily hospitalized a friend of his had a friend who got tested positive for COVID even after completing the 2-dose series of the PFIZER-BIONTECH COVID-19 VACCINE. Patient mentioned that this friend actually tested positive last Sunday and it has been 3 months ago since he completed the vaccination series. The patient experienced positive for covid this Sunday after being fully vaccinated 3 months on an unspecified date with outcome of unknown, positive for covid this Sunday after being fully vaccinated 3 months, cough, was sick, having breathing problems. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event is Unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Respiratory disorder
Clinical narrative: breathing changed; headaches all day and night; tiredness; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 42-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8727) via an unspecified route of administration in left arm on 06Apr2021 as single dose for covid-19 immunization. The patient was 42-years-old at the time of vaccination. Patient relevant medical history included high blood pressure from unspecified date and is ongoing (she was on Atenolol for it, but her doctor took her off because her blood pressure was normal), sinus issues from an unspecified date and is ongoing. The concomitant medication included pseudoephedrine hydrochloride (SUDAFED 12 HOUR) taken for sinus issues and it is ongoing. She asked if the headaches and tiredness experienced were also reported as side effect to the vaccine. Response: used headache and fatigue info following the 1st dose of the vaccine under Table 2: Study 2 Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose Participants 18 to 55 Years of Age Safety Population of the Full EUA PI, LAB-1457-7.0, revised: 06Apr2021. Caller asked if the change in her breathing was reported as a side effect of the Pfizer-BioNTech COVID-19 vaccine. Response: For the change in breathing pattern used section Drug or Food Interaction / Concomitant Administration of the VR-Consumer Inquiry Management (Off-Label or No Info). Added currently, symptom pertaining to breathing is under signs of a severe allergic reaction can include: Difficulty breathing from section What are The Risks of The PFIZER-BIONTECH COVID-19 mRNA vaccine?" of Fact Sheet for Recipients and Caregivers, LAB-1451-4.0, revised: 06Apr2021. Patient experienced on 07Apr2021 headaches all day and night, on 06Apr2021 was tired, on 10Apr2021 breathing changed and are persisting. Headaches are not as bad, but they are still there she has taken Tylenol for the headaches. The outcome of the event headache was unknown for tired was recovering and for breathing changed was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pollakiuria, Urinary tract infection
Clinical narrative: Frequent urination; UTI; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 11Mar2021 12:30 PM and 2nd dose on 08Apr2021 12:30PM, both at single dose via an unknown route in left arm for Covid-19 immunization. Medical history included Attention deficit hyperactivity disorder (ADHD), Nonalcoholic fatty liver disease (NAFLD), Obsessive-compulsive disorder (OCD), allergies to ammonium chloride and watermelons. Concomitant drug was "none". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. About a week after the first vaccine a developed a need to urinate frequently, every 5-20 minutes. Patient presumed it was a UTI and took steps to treat it. Event onset date was 16Mar2021 01:00. The symptoms abated about four days before the second vaccine. The symptoms returned on 21Apr021, four days after the second vaccination. Treatment received for the adverse event included antibiotics, pain reliever, antihistamines. Outcome of the events was resolved with sequel. Since the vaccination, the patient was not been tested for COVID-19.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradykinesia, Dizziness, Feeling abnormal, Gait disturbance
Clinical narrative: I felt like I was drugged; I was slow and I was swaying.; I was slow and I was swaying.; I had trouble getting my feet to step up into the garage.; This is a spontaneous report from a contactable consumer (reporting herself).  This 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Apr2021 at a single dose for COVID-19 immunization. The patients medical history and concomitant medication were not reported. The patient received the 2nd shot of the Pfizer vaccine last Friday. Everything was good until 2 and 3 hours into. The patient was outside felt like the patient was drugged. The patient was slow and the patient was swaying. The patient had trouble getting my feet to step up into the garage. Through the rest of the night, stayed in bed, did not like that feeling and did not want to fall. Everything was fine except that feeling. That lasted most of that day, that evening. when the patient woke up the next day felt ok. The patient no issues after that. The patient did not have control of her body. The patient had trouble getting into the garage. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradykinesia, Dizziness, Gait disturbance, Nausea
Clinical narrative: I felt like I was drugged; I was slow and I was swaying.; I was slow and I was swaying.; I had trouble getting my feet to step up into the garage.; This is a spontaneous report from a contactable consumer (reporting herself).  This 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Apr2021 at a single dose for COVID-19 immunization. The patients medical history and concomitant medication were not reported. The patient received the 2nd shot of the Pfizer vaccine last Friday. Everything was good until 2 and 3 hours into. The patient was outside felt like the patient was drugged. The patient was slow and the patient was swaying. The patient had trouble getting my feet to step up into the garage. Through the rest of the night, stayed in bed, did not like that feeling and did not want to fall. Everything was fine except that feeling. That lasted most of that day, that evening. when the patient woke up the next day felt ok. The patient no issues after that. The patient did not have control of her body. The patient had trouble getting into the garage. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Dizziness, Gastrointestinal sounds abnormal
Clinical narrative: soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; nausea; vomiting; accelerated heart rate; dizziness; fever; chills; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK8730; Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 14:45 at SINGLE DOSE for covid-19 immunisation. Medical history included arthropod sting, hypersensitivity, sinus disorder, hypertension, blood cholesterol, covid-19.C oncomitant medications included fluticasone taken for hypersensitivity, sinusitis; hydrochlorothiazide, lisinopril taken for hypertension, simvastatin taken for blood cholesterol. The patient previously took z-pak. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No visit to emergency room and physician office. No patient's medical history (including any illness at time of vaccination), relevant tests and family medical history. On 25Mar2021, the patient experienced had minimal soreness, no discomfort, 26Mar2021, she awoke with accelerated heart rate, upset stomach, rumbling bowels, and ran to the bathroom and vomited. Then she had diarrhea. Eventually her heart rate slowed, it was elevated for a while and slowed to normal that morning. she had 6-7 episodes of each- the vomiting and the diarrhea. In between those episodes, she had chills, dizziness, then fever. It rolled along, then her heart rate gradually slowed down. Her symptoms stopped after 2-3 rounds of diarrhea episodes. Her chills came on after she experienced accelerated heart rate. The chills stopped after the first or second throwing up/diarrhea episodes. She had brief dizziness following that. She had a couple or one more episode of throwing up and diarrhea. She got warm, calling it a fever and it did not last long. She has a tendency to get dizziness and takes Flonase to keep her allergies at bay. She thinks the dizziness this time went along with her chills and fever. On 27Mar2021, her stomach had a little discomfort, but nothing major. On 28MAr2021, 02:45 she awakened feeling ill and though she might vomit. It ended up being diarrhea and had 3 episodes of that, spaced out. It was over at 09:00. On 29Mar2021, her stomach was queasy and it went away by evening. On 1Apr2021, she had been experiencing tummy aches, taking Tums and her bowels were a little iffy. Therapeutic measures were taken for dizziness with Flonase. The outcome of the events nausea, vomiting, diarrhea, upset stomach, soreness and abdominal discomfort were unknown and events accelerated heart rate, dizziness, fever, chills and illness were recovered.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Illness, Nausea, Pain, Pyrexia
Clinical narrative: soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; nausea; vomiting; accelerated heart rate; dizziness; fever; chills; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK8730; Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 14:45 at SINGLE DOSE for covid-19 immunisation. Medical history included arthropod sting, hypersensitivity, sinus disorder, hypertension, blood cholesterol, covid-19.C oncomitant medications included fluticasone taken for hypersensitivity, sinusitis; hydrochlorothiazide, lisinopril taken for hypertension, simvastatin taken for blood cholesterol. The patient previously took z-pak. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No visit to emergency room and physician office. No patient's medical history (including any illness at time of vaccination), relevant tests and family medical history. On 25Mar2021, the patient experienced had minimal soreness, no discomfort, 26Mar2021, she awoke with accelerated heart rate, upset stomach, rumbling bowels, and ran to the bathroom and vomited. Then she had diarrhea. Eventually her heart rate slowed, it was elevated for a while and slowed to normal that morning. she had 6-7 episodes of each- the vomiting and the diarrhea. In between those episodes, she had chills, dizziness, then fever. It rolled along, then her heart rate gradually slowed down. Her symptoms stopped after 2-3 rounds of diarrhea episodes. Her chills came on after she experienced accelerated heart rate. The chills stopped after the first or second throwing up/diarrhea episodes. She had brief dizziness following that. She had a couple or one more episode of throwing up and diarrhea. She got warm, calling it a fever and it did not last long. She has a tendency to get dizziness and takes Flonase to keep her allergies at bay. She thinks the dizziness this time went along with her chills and fever. On 27Mar2021, her stomach had a little discomfort, but nothing major. On 28MAr2021, 02:45 she awakened feeling ill and though she might vomit. It ended up being diarrhea and had 3 episodes of that, spaced out. It was over at 09:00. On 29Mar2021, her stomach was queasy and it went away by evening. On 1Apr2021, she had been experiencing tummy aches, taking Tums and her bowels were a little iffy. Therapeutic measures were taken for dizziness with Flonase. The outcome of the events nausea, vomiting, diarrhea, upset stomach, soreness and abdominal discomfort were unknown and events accelerated heart rate, dizziness, fever, chills and illness were recovered.  No follow-up attempts are needed. No further information is expected.