chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Root canal infection
Clinical narrative: she had a little infection in her root canal; This is a spontaneous report from a contactable consumer reported for herself. A 60-years-old female patient received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 01Apr2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 01Apr2021 and is scheduled for her second dose on 22Apr2021. She stated she had a routine dental visit and approximately on unknown date in 2021, found out she had a little infection in her root canal, and they are going to need to do a root canal. This was scheduled after the first shot. She wanted to know if it is safe or if she had this procedure before her second dose. She stated he is trying to schedule it after the second dose of the vaccine, but she wants it done as soon as possible. She asked if she should have this done before or after the vaccine. No PQC present. The outcome of event was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction immediately after vaccination; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162B2 (BNT162B2; Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 18Mar2021 16:00 at single dose for COVID-19 immunization. The patient's medical history included asthma, known allergies to legumes, soy, egg, and tree nuts. The patient's concomitant medications were not reported. The facility type vaccine was hospital. The patient had no other vaccine in four weeks. The patient experienced anaphylactic reaction immediately after vaccination on 18Mar2021 16:00. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the event and included treatment with Epi pen injection. The patient had no COVID prior vaccination and has not been tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: feel sick; she began to feel sick and got tested and she also tested positive on April 1st; This is a spontaneous report from a contactable consumer (grandfather) via medical information team. A 19-year-old female patient was administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown,), via an unspecified route of administration on 28Mar2021 as a single dose for COVID-19 immunization. A few days later someone she works with tested positive for Covid, she began to feel sick and got tested and she also tested positive on 01Apr2021 and It was reported that, now patient was feeling much better and her second vaccine dose was scheduled on 18Apr2021. He asked, can she go as planned to get her second dose or does she have to wait since she had covid. Outcome of the events was unknown.  Information about lot and batch number was requested.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea real bad; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included constipation (had planned to take a stool softener) and maybe deaf or hard of hearing. The patient's concomitant medications were not reported. Right after the shot on 08Apr2021, patient almost did not make it to the bathroom. She had diarrhea real bad, off and on, that whole day for about 3 hours and was fine after that. Outcome of the event was recovered on 08Apr2021. The reporter considered the event non-serious.  No follow-up attempts are completed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Body temperature, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I have taken both shots./ I am in an isolated room for 14 days.; asymptomatic, but came up with a positive reading; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. An 84-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first (Batch/Lot number was not reported)  and second dose (Batch/Lot number was not reported); both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that he have taken both shots, his temp range has been between 97.2 to 98.4 and was asymptomatic, but came up with a positive reading. He was in an isolated room for 14 days. The patient underwent lab tests and procedures which included body temperature: between 97.2 to 98.4 and SARS-CoV-2 test: positive both on unspecified dates. The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: diagnosed with Covid 19/tested positive for Covid-19; diagnosed with Covid 19/tested positive for Covid-19; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age (Age: 62 Unit: Unspecified) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1st via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for covid-19 (drug ineffective) on an unspecified date. It was reported that the patient called in to ask if he can still get his second dose of the vaccine. He got his first dose last 26Mar2021. Second dose is scheduled on 17Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Memory impairment, SARS-CoV-2 test
Clinical narrative: memory issue; Got covid; Got covid; This is a spontaneous report from a non-contactable consumer. A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. On unspecified date, the patient was diagnosed with COVID and she just got out of hospital before day. The reason why the patient called was she was supposed to take the second dose next day. The patient was still under quarantine and her brother was supposed to get the shot. The patient cannot take him. The patient brother stayed with her cousin and he wanted to take the second shot. The patient was not underage but had some memory issues. The patients brother needed someone to be with him. 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: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer.   A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH 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 immunisation.  The patient medical history was and concomitant medications were not reported.  The patient experienced sore arm on an unspecified date.  Outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021406291 same patient, different  event in seperate vaccine
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she developed symptoms and tested positive; This is a spontaneous report received from a contactable consumer (patient's friend). A 54-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date (reported as a couple of weeks ago) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient developed symptoms and tested positive for COVID. He enquired if my friend would have the 2nd dose on later than 21 days, will it have the same effectiveness. she already completed her isolation and showed no symptoms at all. He wants to confirm if the patient can now have the 2nd dose on the scheduled appointment which is 21 days after since her primary care physician advised her to wait until she completely recovered and have the 2nd dose in between 21 and 42 days. The pharmacist told her that she can have the 2nd dose on the scheduled appointment which is 21 days. He says she scheduled the vaccine, and a major medical center are saying to wait the 90 days before the vaccine, she was not sure if she should get the second dose to start over. The outcome of the event was recovered.  Information on lot/ batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: he tested positive for covid; he tested positive for covid; This is a spontaneous report from a contactable consumer (parent) via Pfizer sponsored program . A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot and expiry date not provided) via an unspecified route of administration on an unspecified date in 2021 (reported as 3.5 weeks ago) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date in 2021, patient tested positive for covid. Reporter believes that her son had an exposure with Covid before the 1st dose. Patient just finished the 10day quarantine today and scheduled to have the 2nd dose tomorrow (i.e., 14Apr2021). Reporter would like to know if her son should still proceed with the 2nd dose as scheduled because she believes that her son should not get too many antibodies, since the 1st dose was given almost 3weeks ago. Outcome for the events were unknown.  Information on lot number/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Dyskinesia, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: My bones feel like they are exploding; stabbing pains; brain fog; Involuntary muscle movements; joint/muscle pain; joint/muscle pain; fever chills; hypersensitivity to skin; muscle weakness; migraine; skin burning; rashes; hives; muscles spasms; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in the  left arm on 08Apr2021 12:30 at single dose for covid-19 immunisation. Medical history included tachycardia, depression, migraines. Concomitant medications included escitalopram oxalate (LEXAPRO); metoprolol tartrate; clarithromycin (CLARITIN [CLARITHROMYCIN]); topiramate. The patient previously took vicodin and experienced hypersensitivity (known allergies), first dose of bnt162b2 on 22Mar2021 04:00 pm (lot number: EN6207, expiration date was not reported) for covid-19 immunisation. On 08Apr2021 at 14:00, the patient experienced involuntary muscle movements, stabbing pains, joint/muscle pain, brain fog, fever chills, hypersensitivity to skin, muscle weakness, migraine, skin burning, rashes, hives, muscles spasms. This has been the most painful experience of my life and it still isn't over. It gets a little better each day but is still just so painful. I can't believe a vaccine can make someone feel this way. My bones feel like they are exploding. No treatment was given in response to the events. No prior covid vaccination. Not tested for covid post vaccination. Outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle spasms, Muscular weakness, Myalgia, Off label use
Clinical narrative: My bones feel like they are exploding; stabbing pains; brain fog; Involuntary muscle movements; joint/muscle pain; joint/muscle pain; fever chills; hypersensitivity to skin; muscle weakness; migraine; skin burning; rashes; hives; muscles spasms; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in the  left arm on 08Apr2021 12:30 at single dose for covid-19 immunisation. Medical history included tachycardia, depression, migraines. Concomitant medications included escitalopram oxalate (LEXAPRO); metoprolol tartrate; clarithromycin (CLARITIN [CLARITHROMYCIN]); topiramate. The patient previously took vicodin and experienced hypersensitivity (known allergies), first dose of bnt162b2 on 22Mar2021 04:00 pm (lot number: EN6207, expiration date was not reported) for covid-19 immunisation. On 08Apr2021 at 14:00, the patient experienced involuntary muscle movements, stabbing pains, joint/muscle pain, brain fog, fever chills, hypersensitivity to skin, muscle weakness, migraine, skin burning, rashes, hives, muscles spasms. This has been the most painful experience of my life and it still isn't over. It gets a little better each day but is still just so painful. I can't believe a vaccine can make someone feel this way. My bones feel like they are exploding. No treatment was given in response to the events. No prior covid vaccination. Not tested for covid post vaccination. Outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Sensitive skin, Skin burning sensation
Clinical narrative: My bones feel like they are exploding; stabbing pains; brain fog; Involuntary muscle movements; joint/muscle pain; joint/muscle pain; fever chills; hypersensitivity to skin; muscle weakness; migraine; skin burning; rashes; hives; muscles spasms; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in the  left arm on 08Apr2021 12:30 at single dose for covid-19 immunisation. Medical history included tachycardia, depression, migraines. Concomitant medications included escitalopram oxalate (LEXAPRO); metoprolol tartrate; clarithromycin (CLARITIN [CLARITHROMYCIN]); topiramate. The patient previously took vicodin and experienced hypersensitivity (known allergies), first dose of bnt162b2 on 22Mar2021 04:00 pm (lot number: EN6207, expiration date was not reported) for covid-19 immunisation. On 08Apr2021 at 14:00, the patient experienced involuntary muscle movements, stabbing pains, joint/muscle pain, brain fog, fever chills, hypersensitivity to skin, muscle weakness, migraine, skin burning, rashes, hives, muscles spasms. This has been the most painful experience of my life and it still isn't over. It gets a little better each day but is still just so painful. I can't believe a vaccine can make someone feel this way. My bones feel like they are exploding. No treatment was given in response to the events. No prior covid vaccination. Not tested for covid post vaccination. Outcome of the events was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: My bones feel like they are exploding; stabbing pains; brain fog; Involuntary muscle movements; joint/muscle pain; joint/muscle pain; fever chills; hypersensitivity to skin; muscle weakness; migraine; skin burning; rashes; hives; muscles spasms; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; Dose: 1 Start date: 22Mar2021; Dose: 2 Start date: 08Apr2021; This is a spontaneous report from a contactable consumer (patient).   A 34-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiration date was not reported), via an unspecified route of administration, administered in the  left arm on 08Apr2021 12:30 at single dose for covid-19 immunisation. Medical history included tachycardia, depression, migraines. Concomitant medications included escitalopram oxalate (LEXAPRO); metoprolol tartrate; clarithromycin (CLARITIN [CLARITHROMYCIN]); topiramate. The patient previously took vicodin and experienced hypersensitivity (known allergies), first dose of bnt162b2 on 22Mar2021 04:00 pm (lot number: EN6207, expiration date was not reported) for covid-19 immunisation. On 08Apr2021 at 14:00, the patient experienced involuntary muscle movements, stabbing pains, joint/muscle pain, brain fog, fever chills, hypersensitivity to skin, muscle weakness, migraine, skin burning, rashes, hives, muscles spasms. This has been the most painful experience of my life and it still isn't over. It gets a little better each day but is still just so painful. I can't believe a vaccine can make someone feel this way. My bones feel like they are exploding. No treatment was given in response to the events. No prior covid vaccination. Not tested for covid post vaccination. Outcome of the events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: Received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021 and his second dose was scheduled for 30Mar2021, but on 23Mar2021 he tested positive for COVID-19; Received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021 and his second dose was scheduled for 30Mar2021, but on 23Mar2021 he tested positive for COVID-19; Started to feel ill; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old male patient received first dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot Number and expiration date were unknown) via an unspecified route of administration in left arm on 09Mar2021 14:45 (age at vaccination 67 years old) at single dose for COVID-19 immunisation at pharmacy. There was no medical history, no relevant family history and concomitant medication. There were no other vaccines in four weeks and no AEs following prior vaccinations. There was no history of previous immunizations with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no additional vaccines administered on same date of the Pfizer Suspect. The patient stated that he received his first shot of the Pfizer Covid-19 vaccine on 09Mar2021, and his second dose was scheduled for 30Mar2021, but on Tuesday 23Mar2021 he felt ill and had a Covid 19 test on 23Mar2021 17:00 which was positive and was quarantined for 12 to 15 days. He would like to know if he should schedule his second dose. Has been over 3 weeks since first vaccination; hasn't gotten second yet. He took 10-12 days off an away from everyone. He was supposed to have his second vaccine on 30Mar2021, but he was still on quarantine for 2 more days at that time. The patient stated that he was trying to reschedule his second vaccine and wanted to know if that was the right thing to be doing. The patient also stated that since it was beyond the 3 weeks period from his first one, he wants to make sure whether he was doing the right thing by scheduling his second one for tomorrow. The patient stated that he had no issues after the vaccine and states that the illness was not that bad for him. Reporter states that he just needs to confirm his appointment online and he can get his vaccination tomorrow at 14:45. The patient also said since it was beyond the 3 weeks from his first vaccine, he just wants to make sure he was doing the right thing. The patient did not visit emergency room or physician office, states he only spoke on the phone with his doctor after his positive test. The report is not related to a study program. Patient did not have lot number as he was at work and does not have his card. Also states he thought he took a picture of it on his phone but he didn't. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: pain/arm pain; shakiness of left arm; This is a spontaneous report from a contactable pharmacist. A 31-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 27Mar2021 on the left arm as single dose for COVID-19 immunization. Medical history included irregular menses, low thyroid, high prolactin. No allergies to medications, food, or other products. There were no concomitant medications, no other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not test for COVID-19. On 27Mar2021, patient experienced pain and shakiness of left arm within a few minutes after the shot. The shakiness lasted for about 15 minutes then went away. The arm pain lasted for about 1 day then stopped. There was no treatment received for the adverse event. The outcome of events was recovered on unspecified date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She got the first dose on 01APR2021.She tested positive to COVID-19 on 06APR2021.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided) via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first dose on 01Apr2021. She tested positive to COVID-19 on 06Apr2021. The next dose is scheduled on 25Apr2021. She wanted to know if she should still get the dose on the scheduled date or she should wait for a specific time. The outcome of the event was unknown. The event was assessed as non-serious.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: He got COVID19 after his first shot; He got COVID19 after his first shot; This is a spontaneous report from a contactable pharmacist via a Medical information team. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), 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. The patient got COVID19 after his first shot, followed by an antibody therapy. He has to wait 90 days before getting his second shot. Seriousness of the events was considered as medically significant. The outcome of events was unknown.  Information about lot/batch has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event Drug ineffective and covid-19 cannot be ruled out.But also consider relevant medical history and concomitant drug history.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Nasal congestion, SARS-CoV-2 test
Clinical narrative: wife just tested positive for COVID-19; wife just tested positive for COVID-19; cough; congested head; sinus infection; yellow mucus; This is a spontaneous report from a contactable consumer(patient's husband). An 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot number was not reported), first dose via an unspecified route of administration on 26Mar2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date the reporter stated that his wife just tested positive for COVID-19. Second dose will be on 16Apr2021. He would like to know if she is still able to get it. He reports that the only symptoms she has are cough, "congested head", feels like a sinus infection, and "spitting out" yellow mucus. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive on an unspecified date. Outcome of the events was unknown.  Follow-up (12Apr2021): This is a follow-up spontaneous report. No new information received.   Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge, Sinusitis
Clinical narrative: wife just tested positive for COVID-19; wife just tested positive for COVID-19; cough; congested head; sinus infection; yellow mucus; This is a spontaneous report from a contactable consumer(patient's husband). An 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, (Batch/Lot number was not reported), first dose via an unspecified route of administration on 26Mar2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date the reporter stated that his wife just tested positive for COVID-19. Second dose will be on 16Apr2021. He would like to know if she is still able to get it. He reports that the only symptoms she has are cough, "congested head", feels like a sinus infection, and "spitting out" yellow mucus. The patient underwent lab tests and procedures which included sars-cov-2 test: tested positive on an unspecified date. Outcome of the events was unknown.  Follow-up (12Apr2021): This is a follow-up spontaneous report. No new information received.   Information about lot/batch has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she received her first dose of the Pfizer COVID-19 vaccine on 23Mar2021 and last Wednesday she tested positive for COVID-19; she received her first dose of the Pfizer COVID-19 vaccine on 23Mar2021 and last Wednesday she tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A 49-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration in upper left arm on 23Mar2021 at 13:15at single dose for COVID-19 immunization. Patient took covid vaccine because she was immunocompromised and wanted to get vaccinated. The patient had medical history of immunocompromisation. The patient did not received other vaccine in four weeks. Concomitant medications were not reported. the patient had unspecified chronic medical condition. On 05Apr2021, patient tested positive for COVID-19 and got result on Wednesday 07Apr2021.The patient stated she has a chronic medical condition but that is does not effect weather or not she tested positive. Her second dose is scheduled for tomorrow, 13Apr2021, however her healthcare professional told her to wait for 10 days after the symptoms subside. She wants clarification on whether or not she will need to restart the vaccination series if she reschedules her second dose for a later date. It was further reported that her doctor that since her quarantine period is not up tomorrow she was told to wait until her 14 day quarantine is over to get her second dose which is 2 or 3 days more. Patient asked will this effect her getting it a few days late or will she have to start the process over. The patient also stated that her mother tested positive for COVID-19 after being vaccinated with the Pfizer COVID-19 vaccine and this happened about a month after her second dose. The patient states that she filed a report for herself, however, she did not file an official report for her mother. She did confirm that she told DSU about her mother's AE. The patient asks when should I test for COVID-19 again to make sure I'm negative? I have upcoming tests that I have to complete and they require me to have a negative COVID-19 test before I can complete them. The patient further states, I guess your vaccine is not providing as much protection as you thought since my mom got COVID after being fully vaccinated with the Pfizer Covid vaccine for a month. Patient declined to provide email address as she is not good at checking it. The outcome of the events was unknown.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasal congestion, Nasopharyngitis, Pain in extremity
Clinical narrative: Fatigue/tiredness; cough; head cold; congestion; arm pain; This is a spontaneous report from a contactable consumer reported for himself. A 50-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 01Apr2021 11:45 as single dose for COVID-19 immunisation. Medical history included diabetes mellitus. No known allergies. Concomitant medications included metformin 500 mg, amlodipine besilate (NORVASC) 2.5 mg. The patient experienced fatigue, cough, head cold, congestion, tiredness, arm pain on 08Apr2021 (also reported that on the 4Apr2021 was when the symptoms started), that lasted 24 hours, no treatment received for the adverse events. The events were reported as non-serious. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. The patient became aware that it may have to do with the vaccine and not with his seasonal allergies on the 11Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she felt fatigue which she still feels today; This is a spontaneous report from a contactable consumer (Patient). A 73-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 1 via an unspecified route of administration on 08Apr2021 as SINGLE DOSE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient experienced she felt fatigue which she still feels today on 08Apr2021. On 08Apr2021 was her first dose of the covid vaccine. Within 3-4 hours she started experiencing fatigue and still has it as of 12Apr2021. She is wondering if she should still get the second dose. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: started experiencing all the symptoms last week Wednesday and tested positive; started experiencing all the symptoms last week Wednesday and tested positive; This is a spontaneous report from a contactable consumer (patient). This (Age: 55; Unit: unknown) female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIOTECH-COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry was not reported), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient started experiencing all the symptoms last week Wednesday and tested positive yesterday (11Apr2021) or today (12Apr2021) with lab test sars-cov-2 test. Second dose was scheduled for this Friday and she would like to know whether she could get the 2nd dose of the covid vaccine as she has tested positive for covid or whether she would need to start the vaccination series again if she was unable to get the 2nd dose of the covid vaccine as scheduled. And she was suggesting that they need to put something happier on hold music because she already felt like she was dying. The outcome of started experiencing all the symptoms last week Wednesday and tested positive was unknown.  Information about the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Injection site pain
Clinical narrative: pain on the injection site; he states that the vaccination provider squeezed the area where he received the second dose; This is a spontaneous report from a contactable consumer .     A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm on 09Apr2021 (Lot number was not reported) as single dose for covid-19 immunisation.The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported) via an unspecified route of administration, on an unspecified date as single dose for covid-19 immunisation. He said when he got the 2nd dose, the one who injected the vaccine squeezed his arm. He reported that the arm should not be squeezed if the vaccine will be administered, he wants to know if that's true and if there would be a problem with the vaccine administered since his arm was squeezed and reported that the 2nd dose seems to have no effect. He said he felt the needle when it was administered, but he only felt a little pain on the injection site, but no other side effects. He wants to confirm if he really got the 2nd dose of the vaccine. On an unspecified date, the patient experienced pain on the injection site and he states that the vaccination provider squeezed the area where he received the second dose. Outcome of the events was unknown.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). This 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Apr2021 (Lot Number: EP6955) as single dose for COVID-19 immunization.  Medical history included Pencillin allergy. The patient's concomitant medication was none.  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) on left arm on 19Mar2021 (at age of 34-year-old) for covid-19 immunization, took codeine and experienced allergies.  The patient experienced headache and fatigue on 10Apr2021.  The patient had no covid prior vaccination, and no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event headache was recovered on 12Apr2021, of event fatigue was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypertension, Hypoaesthesia, Palpitations
Clinical narrative: Feeling faint; tingling of tongue; numbness left side face; heart racing; red blotchy rash on chest; unusual high blood pressure; headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 11Mar2021 08:30 as single dose for COVID-19 immunization in an unspecified facility. Medical history included Shingles from Aug2020, mild lymphedemia legs, mild arthritis, and history of stroke from an unknown date. The patient had no known allergies, no COVID prior to vaccination, and has not been tested for COVID post vaccination. The patient has not received other vaccine in four weeks. The patient's concomitant medication includes an unspecified medication taken in two weeks. On 11Mar2021 8:45 am, immediately following injection, the patient experienced feeling faint, tingling of tongue, numbness left side face, heart racing, red blotchy rash on chest, unusual high blood pressure, and a 5-day headache. No treatment was given. The outcome of the events was reported as recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Rash erythematous
Clinical narrative: Feeling faint; tingling of tongue; numbness left side face; heart racing; red blotchy rash on chest; unusual high blood pressure; headache; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6204), via an unspecified route of administration, administered in left arm on 11Mar2021 08:30 as single dose for COVID-19 immunization in an unspecified facility. Medical history included Shingles from Aug2020, mild lymphedemia legs, mild arthritis, and history of stroke from an unknown date. The patient had no known allergies, no COVID prior to vaccination, and has not been tested for COVID post vaccination. The patient has not received other vaccine in four weeks. The patient's concomitant medication includes an unspecified medication taken in two weeks. On 11Mar2021 8:45 am, immediately following injection, the patient experienced feeling faint, tingling of tongue, numbness left side face, heart racing, red blotchy rash on chest, unusual high blood pressure, and a 5-day headache. No treatment was given. The outcome of the events was reported as recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Disorientation, Dizziness, Hypoaesthesia
Clinical narrative: disoriented; confusion; weak/lack energy; facial and tongue numbness; facial and tongue numbness; dizzy and light headed; This is a spontaneous report from a contactable other HCP. A 63-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 02Apr2021 11:00 (Lot Number: EW0151) as single dose for COVID-19 immunization.  Medical history included hypothyroid (long standing with no new meds), allergies to nkda. Concomitant medication included levothyroxine sodium (SYNTHYROID).  On 02Apr2021 11:15 am, the patient felt disoriented, confusion, weak, facial and tongue numbness, dizzy and light headed, lack energy lasted 10 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The outcome of the events was recovered on 12Apr2021.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: disoriented; confusion; weak/lack energy; facial and tongue numbness; facial and tongue numbness; dizzy and light headed; This is a spontaneous report from a contactable other HCP. A 63-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 02Apr2021 11:00 (Lot Number: EW0151) as single dose for COVID-19 immunization.  Medical history included hypothyroid (long standing with no new meds), allergies to nkda. Concomitant medication included levothyroxine sodium (SYNTHYROID).  On 02Apr2021 11:15 am, the patient felt disoriented, confusion, weak, facial and tongue numbness, dizzy and light headed, lack energy lasted 10 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the adverse event. The outcome of the events was recovered on 12Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: stated that his friends father got covid three weeks after the first dose of vaccine; stated that his friends father got covid three weeks after the first dose of vaccine; This is a spontaneous report from a contactable physician reported for a patient. An male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 12Apr2021, 19:09:26 , as a single dose for COVID-19 immunization. Patient medical history and concomitant medications were not provided. Physician was reported that his friends father got covid three weeks after the first dose of vaccine. Patient underwent lab tests and procedure SARS-CoV-2 test (positive). Outcome of the events were unknown.   Information about Lot/Batch number is requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event and the suspect drug.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller found out she tested positive for COVID-19; Caller found out she tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 20-years-old female patient 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 22Mar2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 12Apr2021 the patient experienced she tested positive for covid-19. she asked if she can still get the second dose of the vaccine. She took first dose on 22Mar2021 and scheduled to take the 2nd dose 12Apr2021 but she was tested covid 19 positive. She was asking if she can take the 2nd dose today. The patient underwent lab tests and procedures which included COVID-19 test positive on 12Apr2021. The clinical outcome of the event was unknown.  Follow up (12Apr2021): This follow up report contains no new medically significant safety information.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Diarrhoea, Fatigue, Feeding disorder
Clinical narrative: Diagnosed with COVID-19; Diagnosed with COVID-19; Nausea; Tired; Unable to eat; Diarrhea; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 (15:15) (Lot number: EM9809; Expiration date was not reported) and the second dose on 01Mar2021 (Lot number: EN6203; Expiration date was not reported), both on the right arm as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included myasthenia gravis and diabetes. The patient had unspecified concomitant medications. On 05Apr2021, the patient had nausea; was tired; unable to eat; and had diarrhea. On 10Apr2021, the patient was diagnosed with COVID-19 (tested positive for SARS COV-2 RT-PCR nasal swab). The events had resulted into doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The patient's computerized tomogram (CT) value was 16.1-33.0 on an unspecified date. The outcome of the events was not recovered.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Diagnosed with COVID-19; Diagnosed with COVID-19; Nausea; Tired; Unable to eat; Diarrhea; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 (15:15) (Lot number: EM9809; Expiration date was not reported) and the second dose on 01Mar2021 (Lot number: EN6203; Expiration date was not reported), both on the right arm as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included myasthenia gravis and diabetes. The patient had unspecified concomitant medications. On 05Apr2021, the patient had nausea; was tired; unable to eat; and had diarrhea. On 10Apr2021, the patient was diagnosed with COVID-19 (tested positive for SARS COV-2 RT-PCR nasal swab). The events had resulted into doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The patient's computerized tomogram (CT) value was 16.1-33.0 on an unspecified date. The outcome of the events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Excessive Menstrual bleeding with period after 1st vaccination; This is a spontaneous report from a contactable consumer. A 42-year-old female patient (pregnant no) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at age of 42-year-old, dose 1 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  Medical history included covid. The patient's concomitant medications were not reported. There was no other vaccine in four weeks. The patient had covid prior vaccination. No covid tested post vaccination. No known allergies and no other medical history. The patient experienced excessive menstrual bleeding with period after 1st vaccination on 03Apr2021. There was no treatment for the event. The outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.