chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Nausea
Clinical narrative: Brain fog; Dizzy; Body aches; Headaches; Nausea; Chills; This is a spontaneous report received from a contactable consumer (patient herself). A 31-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: unknown) via an unspecified route of administration on 25Mar2021 at 01:00 PM as a single dose in the left arm for COVID-19 immunization in Public Health Clinic/Veterans Administration facility. Medical history included Diabetes, high blood pressure, severe asthma/type e asthma and Known allergies included Sulfa and shellfish. Patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications in two weeks included mepolizumab (NUCALA), lisinopril, metformin, salbutamol (ALBUTEROL), breo and insu. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 01:00 PM, the patient experienced headaches, nausea, dizzy, brain fog, chills and body aches. The patient did not receive any treatment for the events. The outcome of the events headaches, nausea, dizzy, brain fog, chills and body aches were not recovered.  Information about the Lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Brain fog; Dizzy; Body aches; Headaches; Nausea; Chills; This is a spontaneous report received from a contactable consumer (patient herself). A 31-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: unknown) via an unspecified route of administration on 25Mar2021 at 01:00 PM as a single dose in the left arm for COVID-19 immunization in Public Health Clinic/Veterans Administration facility. Medical history included Diabetes, high blood pressure, severe asthma/type e asthma and Known allergies included Sulfa and shellfish. Patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications in two weeks included mepolizumab (NUCALA), lisinopril, metformin, salbutamol (ALBUTEROL), breo and insu. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 01:00 PM, the patient experienced headaches, nausea, dizzy, brain fog, chills and body aches. The patient did not receive any treatment for the events. The outcome of the events headaches, nausea, dizzy, brain fog, chills and body aches were not recovered.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Sinusitis
Clinical narrative: Sinus infection; Tested positive for COVID 19; Tested positive for COVID 19; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 24-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on 10Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Mar2021, she started with a sinus infection that she gets every year. She tested positive for COVID 19 on an unknown date in Mar2021. The patient was due to get her second dose in March 31, asked if that was okay. 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, Malaise
Clinical narrative: developed Covid 19 after receiving 1st dose of the Pfizer vaccine; developed Covid 19 after receiving 1st dose of the Pfizer vaccine; wasn't feeling well enough; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 05Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date of Mar2021, the patient developed COVID19 after receiving first dose of the vaccine. The patient was informed to receive the second dose of vaccine if she felt better but she was not feeling well enough. The outcome of the events was unknown.  Information regarding lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure abnormal, Dizziness, Paraesthesia
Clinical narrative: lightheadedness; some tingling in her left arm; BP improved; This is a spontaneous report from a non-contactable other hcp. A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6205) via an unspecified route of administration, at the age of 38-year-old, 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 22Mar2021, during her 15 minute waiting period after the injection, the patient began to experience lightheadedness. She also had some tingling in her left arm.  She denied rash, hives, difficulty breathing and difficulty swallowing. She admits to eating lunch around noon and drinking lots of water today. Treatment included water. Follow up response to treatment was good. Lightheadedness resolved prior to discharge. BP improved. She was escorted out of the building and denied symptoms while ambulating out. Patient discharge: Stable to go home and follow up with PCP. Outcome of lightheadedness was recovered in Mar2021, some tingling in her left arm was unknown, while BP improved was recovering at the time of the report.  No follow-up attempts needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got covid about 3 days after first dose; This is a spontaneous report from a contactable consumer (Patient) via Pfizer Sponsored Program . A male patient of an unspecified age received first dose of BNT162B2 (PFIZER COVID-19 VACCINE; Solution for injection), via an unspecified route of administration on 26Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Mar2021 (3 days after vaccine first dose), the patient was tested positive for COVID-19. The patient underwent lab tests which included SARS-COV-2 test: Positive on 01Mar2021. The patient second dose was scheduled on 26Mar2021 and he wanted to know if he should still get second dose. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: splitting headache; This is a spontaneous report received from a contactable consumer (reporting on herself) via Pfizer Sponsored Program. A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date was not reported), via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On 24Mar2021, she had a splitting headache since 6AM this morning. Asked if she can take Advil for a headache.  The outcome of the event was unknown.    Information on the lot/batch number has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Depersonalisation/derealisation disorder, Disorientation, Dizziness, Feeling abnormal, Hallucination, visual
Clinical narrative: visual hallucinations; psychosis; derealization/ depersonalization; fuzzy brain, brain fog, brain feels as though it is stuffed with cotton; severe dizziness; disorientation; This is a spontaneous report from a contactable other health professional (patient). A 55-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 25Mar2021 at 10:45 (at the age of 55 years) at a single dose in the right arm for COVID-19 immunization. Medical history included depression and post-traumatic stress disorder (PTSD). Concomitant medications included paliperidone palmitate (INVEGA SUSTENNA); vortioxetine hydrobromide (TRINTELLIX); cariprazine hydrochloride (VRAYLAR); levothyroxine sodium (SYNTHROID); clonazepam (KLONOPIN); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); methylphenidate hydrochloride (RITALIN). The patient previously took NSAID, MAOI'S and synthetic progesterone and experienced allergy; and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 04Mar2021 at 01:45 pm in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 25Mar2021 at 18:30, the patient experienced visual hallucinations, psychosis, derealization/ depersonalization, fuzzy brain, brain fog, brain feels as though it is stuffed with cotton, severe dizziness, and disorientation. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: based on the information available, the contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  to reported events is possible.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Psychotic disorder
Clinical narrative: visual hallucinations; psychosis; derealization/ depersonalization; fuzzy brain, brain fog, brain feels as though it is stuffed with cotton; severe dizziness; disorientation; This is a spontaneous report from a contactable other health professional (patient). A 55-year-old female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 25Mar2021 at 10:45 (at the age of 55 years) at a single dose in the right arm for COVID-19 immunization. Medical history included depression and post-traumatic stress disorder (PTSD). Concomitant medications included paliperidone palmitate (INVEGA SUSTENNA); vortioxetine hydrobromide (TRINTELLIX); cariprazine hydrochloride (VRAYLAR); levothyroxine sodium (SYNTHROID); clonazepam (KLONOPIN); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); methylphenidate hydrochloride (RITALIN). The patient previously took NSAID, MAOI'S and synthetic progesterone and experienced allergy; and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly, on 04Mar2021 at 01:45 pm in the right arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 25Mar2021 at 18:30, the patient experienced visual hallucinations, psychosis, derealization/ depersonalization, fuzzy brain, brain fog, brain feels as though it is stuffed with cotton, severe dizziness, and disorientation. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: based on the information available, the contributory role of the suspect BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  to reported events is possible.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. This consumer reported similar events for two patients (himself and his wife). This is the first of two reports. A male patient of an unspecified age received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number was not reported), via an unspecified route of administration on 17Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that he and his wife received their first dose of the vaccine on 17Mar2021. 1 week later, in Mar2021, he started experiencing flu like symptoms but no fever. He and his wife got tested for COVID-19 about 10 days after the first dose, on 27Mar2021, and the result was positive. Outcome of the event was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021347028 same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: went to the hospital 19 Mar 2021 and had COVID; went to the hospital 19 Mar 2021 and had COVID; This is a spontaneous report received from a contactable consumer (patient) via medical information centre. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. On 19Mar2021, patient went to hospital and had COVID. Patient already had his first round of shots for the Pfizer COVID vaccine and his second dose was scheduled on 31Mar2021. He has tested negative for COVID today and was wondering if he can continue to take his second dose. Outcome for the events were unknown.  Information about batch no/lot no for BNT162B2 is requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Colitis ulcerative, Plantar fasciitis
Clinical narrative: flare up of Ulcerative Colitis; spontaneous plantar fasciitis in her left foot; thumb joint pain; This is a spontaneous report from a contactable consumer (patient).   A 48-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 18:30 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included ulcerative colitis from 2016 and ongoing. Concomitant medications included mesalamine, bupropion hydrochloride (WELLBUTRIN XL), probiotics and xylometazoline hydrochloride (NASAL SPRAY II); all from unspecified dates and for unspecified indications. On 22Mar2021, the patient experienced a flare up of Ulcerative Colitis. The flare included spontaneous plantar fasciitis in her left foot, thumb joint pain in her right had and the standard GI symptoms that come with a UC flare. The outcome of events was reported as recovering. Events required visit to physician's office.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Malaise, Muscle spasms, Presyncope
Clinical narrative: Had 3 muscle spasms on her back; She was not feeling very good; Feeling that she was going to pass out; A frozen sensation; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received the 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 immunization. Medical history and concomitant medications were not reported. It was reported that when she was lying on her chair, she had 3 muscle spasms on her back, she wanted to know what the cause of this could be. She mentioned that she was sitting outside in the sun and all the sudden she was not feeling very good and had the feeling that she was going to pass out and decided to go inside and sit in her reclining chair when she felt the spasms. She described the feeling as a frozen sensation, she was falling asleep when the spasms occurred. The outcome of the events was unknown.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, SARS-CoV-2 antibody test
Clinical narrative: 12 days ago the patient tested positive for the COVID-19 infection; The patient did not present any sever symptoms when he was diagnosed with COVID-19, only a "small cold".; This is a spontaneous report from a contactable consumer reported for a friend. A male patient of an unspecified age 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 an unspecified indication COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The reporter reported that patient received the COVID-19 vaccine 3 weeks ago and is scheduled for the second dose in two days. Twelve days ago, the patient tested positive for the covid-19 infection on an unspecified date with outcome of unknown. The patient did not present any severe symptoms when he was diagnosed with covid-19, only a "small cold" (onset date unspecified). The outcome of the events was unknown.  The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on unknown date.  The reporter inquired if a patient who receive the vaccine could be infected with COVID-19, could it make one test positive for the a COVID-19 test, what the recommended maximum time period that a patient could wait in between the first and second dose of the vaccine and if it vaccine should be taken annually.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is the second of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Bell's palsy on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345756 same reporter, product, and event; different patient.;US-PFIZER INC-2021345758 same reporter, product, and event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer. This consumer reported same event for three patients. This is the third of three reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced bell's palsy on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021345756 same reporter, product, and event; different patient.;US-PFIZER INC-2021345757 same reporter, product, and event; different patient.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Electrocardiogram, Pain in extremity, SARS-CoV-2 test, Weight decreased
Clinical narrative: her left arm was a little bit sore after she got the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported),via an unspecified route of administration, administered in the left arm on 12Mar2021 08:40 (at the age of 61 years-old) as single dose for covid-19 immunization. Medical history included tinnitus from Nov2020 and would get headaches, she had anxiety, panic attacks and insomnia. She had high blood pressure; last visit to her doctor was in Jan2021 and her EKG was fine, and her blood pressure was down. She said her doctor wanted to wean her off of her old blood pressure medicine before starting any new medication). She also had AFib (atrial fibrillation), left ventricular muscle thickening and enlarged right atrium. She reported that she was getting herself a new heart doctor and neurologist. She was also sick in Mar2020, and the doctor was not sure if she had the COVID-19 Virus. She said she quarantined for 16 days, and then found out she was negative for the COVID-19. She said after that, she couldn't leave her house without having extreme anxiety and panic attacks. She said her blood pressure would reach 200 during those times. The patient's concomitant medications were not reported.  The patient received her first dose on 12Mar2021 and had no symptoms, except that her left arm was a little bit sore after she got the COVID-19 Vaccine. She said the soreness started late in the afternoon, or early evening. She said her left arm soreness maybe lasted through to the next day, and the left arm soreness was only for a day. The outcome of event was recovered. The event did not require visit to an emergency room or a physician's office.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt a little sick; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously had first dose of BNT162B2 on unspecified date for COVID-19 immunization and experienced sore arm. The patient previously took Tylenol for back pain and not feeling well; and cortisone injection for her back pain. The patient had a sore arm after the first dose and felt a little sick after the second dose in Mar2021. She explained 2 weeks before the vaccination series, she had a cortisone injection for her back pain; and the day of the first injection, she took a Tylenol "for back pains". She specified she never takes Tylenol and since she was not feeling well, she took it to feel ok because she wanted to drive to her first vaccination appointment. She explained she read about the intake of Tylenol and cortisone prior to vaccination and how it may render the vaccine less effective. She asked how can she find out the effectiveness/how much protection she got from the vaccine? She explained CDC recommended antibody tests, but she was also referred to Pfizer from her department of health. The patient had both of her shots she thinks the second one was completed 03Mar2021. Before she took the first shot she had a Cortisone shot 2 weeks before the day of shot and she took Tylenol before for some  back pain she was having and since then she has found out that both of those things can make the drug ineffective. She talked to the CDC and they recommended an antibody test and they also recommended she call Pfizer. The outcome of the event was unknown. An unspecified treatment was given to the patient for the event.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got tested for COVID-19 about 10 days after the first dose and the result was positive; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (husband) reported that a female patient (wife) of 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 17Mar2021 at single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The reported stated that he and his wife received their first dose of the vaccine on 17Mar2021. He and his wife got tested for COVID-19 about 10 days after the first dose and the result was positive on 27Mar2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 antibody test, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a female patient (consumer) of an unspecified age received first dose BNT162B2 (Solution for injection, lot/batch number has been requested) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported that, she got the first dose of the COVID-19 vaccine then tested positive on an unspecified date and would like to know how long to wait to get the second dose of the vaccine since she just got her first dose. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inflammation, SARS-CoV-2 test
Clinical narrative: had first vaccination 12MAR2021 and then tested positive for covid 22MAR2021/shortness of breath, headache, fever, and body aches/cough; Inflammation in the chest; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6204, Expiry date: unknown) via an unspecified route of administration, unknown location, on 12Mar2021 13:00 pm at a single dose for covid-19 immunisation (age at vaccination was 59 years). The patient took the Pfizer Covid-19 vaccine because she did not want to get Covid. There was no medical history. No family history. Concomitant medication patient received included levothyroxine sodium (SYNTHROID) taken at 0.75 mg dose for hypothyroidism (had been taking for approximately ten years). No other vaccine was received within 4 weeks prior to the COVID vaccine. Historical vaccine included pneumonia vaccine she had a weird reaction to it around 6 years ago. She has no additional information, LOT, NDC, Expirations, or manufacturer for the pneumonia vaccine that she received. The patient's husband was sick for a few days before the patient started getting sick. It was just shortness of breath, headache, fever, and body aches. The patient took Tylenol and did not had dose or information. On Saturday afternoon the patient noticed this and she stayed in bed all day Saturday and Sunday. On Monday she went to Urgent Care because she was not able to take this. On 22Mar2021, the patient had a rapid test for Covid-19 and tested positive for covid. The patient's husband also tested positive and she thinks she got it from him. They both tested positive on the same day. There were no previous immunizations with Pfizer vaccine considered as suspect and no vaccines administered on the same day. The patient did not visit an emergency room or physician office. The patient went to the urgent care the same day when tested positive. They gave her prednisone for the cough and inflammation in the chest. She is taking Tylenol also, over the counter, and does not know the dose. The patient was feeling better. The patient is supposed to have another vaccine this Friday and does not know if she can get it or not. The patient added that she cannot imagine she is the first to call about this and is directed to her physician for medical advice. She offered medical information and stated that she will call her physician. The patient will be calling her physician regarding whether she will be receiving the second vaccine. The outcome of the events was recovering.  Additional information has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, Headache, Investigation
Clinical narrative: Tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; Tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; Tired; A little bit of a headache; Sore throat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 55-years-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on left arm on 8Mar2021 at 11:00 as single dose for COVID-19immunization. Patient medical history and concomitant medication were not reported. Patient had tested positive for covid-19 after receiving the first dose of Pfizer Covid-19 vaccine, Patient had several COVID test done since 26Mar2021 and they have all been positive. Caller stated that she was tired and had a little bit of a headache and sore throat. It was stated that pulse oximeter is fine, showing 97-98%. Caller clarified and stated that she thinks these symptoms started Tuesday 23Mar2021 and on 25Mar2021 the patient was feeling perfect and those symptoms ended. on 26Mar2021 she thinks the PCR test was positive and COVID 19-antigen test was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Outcome of the events tired, headache and sore throat was recovered while outcome of events drug ineffective and COVID-19 were unknown.  Information on the lot/batch number has been requested
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; Tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; Tired; A little bit of a headache; Sore throat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 55-years-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on left arm on 8Mar2021 at 11:00 as single dose for COVID-19immunization. Patient medical history and concomitant medication were not reported. Patient had tested positive for covid-19 after receiving the first dose of Pfizer Covid-19 vaccine, Patient had several COVID test done since 26Mar2021 and they have all been positive. Caller stated that she was tired and had a little bit of a headache and sore throat. It was stated that pulse oximeter is fine, showing 97-98%. Caller clarified and stated that she thinks these symptoms started Tuesday 23Mar2021 and on 25Mar2021 the patient was feeling perfect and those symptoms ended. on 26Mar2021 she thinks the PCR test was positive and COVID 19-antigen test was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Outcome of the events tired, headache and sore throat was recovered while outcome of events drug ineffective and COVID-19 were unknown.  Information on the lot/batch number has been requested
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myelitis transverse, SARS-CoV-2 test
Clinical narrative: Acute transverse myelitis; This is a spontaneous report from a contactable physician (patient). A 42-year-old female patient not pregnant received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Deltoid Left on 18Mar2021 10:30 (Lot Number: Unknown) as single dose (at the age of 42-years-old) for covid-19 immunisation. Medical history included covid-19 (prior to vaccination, the patient was diagnosed with COVID-19). Patient had no allergies to medications, food, or other products. The patient did not receive any other medications within two weeks prior to the vaccination. Patient previously received influenza vaccine (INFLUENZA VACCINE) on unknown date for immunisation and experienced vertigo (Vertigo from flu vaccine). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. The patient experienced acute transverse myelitis on 26Mar2021 19:45. Event resulted in Emergency room/department or urgent care, Prolongation of existing hospitalization (vaccine received during existing hospitalization) and Disability or permanent damage. Patient was treated with Prednisone. The patient underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) positive on 07Jan2021 and negative on 21Jan2021. It was reported that since the vaccination, the patient has been tested for COVID-19, date and results unknown. Therapeutic measures were taken as a result of acute transverse myelitis. Patient had not recovered from the event, at the time of the report.  Information about batch/lot number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; headache.; This is a spontaneous report received from contactable Pfizer Vaccine representative. A 30-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) for covid-19 immunization. After receiving second dose he was experiencing fatigue and headache. The event assessed as non-serious with outcome of unknown.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Feeling cold, Hypoaesthesia, Laboratory test, Migraine
Clinical narrative: Numbness in head and extremities with a cold feeling, migraines.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe ache/pain in injection arm. Body aches Low fever, 99.9
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient), then received from a Pfizer Sponsored Program. This 38-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021, in left arm, for COVID-19 immunisation. Medical history and concomitant medications were not reported. Around 22Mar2021 the patient started to show some symptoms. On 24Mar2021 he tested positive for Covid. He started quarantining on 23Mar2021 and at the time of report he was feeling fine. He hasn't had symptoms for 2-3 days during quarantine. His second vaccine dose was scheduled on 06Apr2021 but was advised to either take the vaccine or put it on hold first. Events outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Light fever (~100F) Stiffness of muscles @ injection site (painful to lift arm) All over body aches symptoms disappeared after 48 hrs.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Influenza like illness, Nausea
Clinical narrative: Nauseous, weak, drowsy, then in the evening shakes, throbbing headache, chills, fever/flu like symptoms, then the next day still having those symptoms and a rash all over my body.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Somnolence, Tremor
Clinical narrative: Nauseous, weak, drowsy, then in the evening shakes, throbbing headache, chills, fever/flu like symptoms, then the next day still having those symptoms and a rash all over my body.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, Injection site pain, Injection site swelling
Clinical narrative: Day 1 - injection site pain and swelling. Duration 15 mins. Day 2 - body ache mainly located in neck and shoulders. Treated with ibuprofen and rest Day 3 - body ache. Treated with ibuprofen Day 4- body ache Day 5- severe vertigo and dizziness. Treated with meclizine, Phenergan Day 6- vertigo,  dizziness, and headache . Treated with meclizine and aspirin  Day 7- vertigo, dizziness.  Treated with meclizine  Day 8- vertigo, dizziness. Treated with meclizine  Day 9- vertigo,  dizziness. Treated with meclizine and Valium Day 10- vertigo,  dizziness,  headache. Treated with meclizine
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain, Vertigo
Clinical narrative: Day 1 - injection site pain and swelling. Duration 15 mins. Day 2 - body ache mainly located in neck and shoulders. Treated with ibuprofen and rest Day 3 - body ache. Treated with ibuprofen Day 4- body ache Day 5- severe vertigo and dizziness. Treated with meclizine, Phenergan Day 6- vertigo,  dizziness, and headache . Treated with meclizine and aspirin  Day 7- vertigo, dizziness.  Treated with meclizine  Day 8- vertigo, dizziness. Treated with meclizine  Day 9- vertigo,  dizziness. Treated with meclizine and Valium Day 10- vertigo,  dizziness,  headache. Treated with meclizine
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Lightheaded ness 36 hours after.  Off balance when standing, or moving head
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Headache & tinnitus  9 days after shot
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Bursitis, Gait disturbance, Gait inability
Clinical narrative: 4/8/21- unable to walk with normal stride 4/9/21 severe pain in right hip making it difficult to walk or go up stairs 4/10/21 morning - unable to walk at all. Called my doctor, who after discussion, prescribed 5 days of prednisone for severe inflammatory response 4/11/21 able to walk again and complete course of steroid.   4/16/21 some inflammation in joints and hip persists.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular disorder, Death, Life support, Mobility decreased, Thrombosis
Clinical narrative: Blood clot blocking blood flow to brain -  1st episode: ( 3/12/21) stabilized, minor limited movement left side -  2nd episode: (3/24/21) no blood flow to brain, death (maintained on life support for organ donation)
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Delayed injection site response. 3 inches diameter hard raised red circular lump at injection site that will occasionally be very itchy.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Somnolence
Clinical narrative: headache, severe drowziness. i couldnt get out of bed for 2 days.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Body aches, fatigue, headache, covid arm rash at injection site (hard, red and itchy).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Pain
Clinical narrative: Body aches, fatigue, headache, covid arm rash at injection site (hard, red and itchy).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, COVID-19, Respiratory symptom, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for covid-19; tested positive for covid-19; suspected bronchitis; Become sick with respiratory symptoms; This is a spontaneous report received from contactable reporter (patients daughter). This patient daughter reported that non-pregnant female of 75-year-old received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) assumed it was given on the right arm on 12Feb2021 as SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. The patients medical history was reported as COPD, congestion heart disease, cardiomyopathy and diabetic. Patient was allergic to Levaquin. There were no concomitant medications. The patient historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, Expiration date: 31May2021) received on the right arm as patient is lefty on 22Jan2021 at SINGLE DOSE for covid-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. On 24Mar2021, the patient had fever and became sick with respiratory symptoms. On 30Mar2021, was suspected to have bronchitis and was tested positive to Covid-19. As of 30Mar2021, at 02:30 the patient was transported to the hospital with a fever of 102.7 and difficulty breathing. The patient was prescribed azithromycin for suspected bronchitis. The events resulted in a visit to emergency room/department or urgent care. The clinical outcome of events was not recovered. The patient underwent lab tests and procedures which included Covid test which was positive on 30Mar2021.  More information has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Night sweats, Tremor
Clinical narrative: Shaking, chills, and night sweats.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Rash pruritic, Skin reaction
Clinical narrative: Delayed itchy rash at injection site that felt like bug bites.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Itching, redness, bumps around injection site starting 5 days after 2nd dose
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Headache, chills, body aches.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Extreme pain at injection site which continues over 24 hours  after injection
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She mentioned that she had COVID-19 as well; She mentioned that she had COVID-19 as well; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, lot number unknown, expiration date unknown), via an unspecified route of administration on 26Mar2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had the first dose of the vaccine on the 26Mar2021. She had "adverse reactions" that she'd like to report. She was asking that should she get the second dose? She mentioned that she had COVID-19 as well on an unspecified date in Mar2021. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: 4/15 2 pm started having fast heart rate up to 102 BPM and triggered PVC's. Saw cardiologist Mon prior to shot  SVT and symptomatic PVC's were well controlled. Fast heart rate and PVC's lasted eight hours then stopped.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: Second dose: A big red spot in shot area, hurts, and headache.   First dose: nausea, headache, tired, body hurts.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Ear infection, Paranasal sinus discomfort
Clinical narrative: Have had constant sinus pressure and congestion since getting the vaccine. It hasn?t resolved. I thought it was an ear infection at first, so I took a 14 day run of augmentin. But it hasn?t resolved. Nothing in my diet or medication regimen has changed. 3-4 days after I got the vaccine these symptoms started. Breathing also feels more labored. I can?t drink coffee anymore because it makes me want to pass out. The only thing that helps is pseudoephedrine. I?m seeing a specialist and they are having trouble figuring out what?s wrong.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: After the vaccination the level of my tinnitus increased quite a bit. In other words, it?s much worse than it was.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Covid-19 Arm.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Heart rate abnormal
Clinical narrative: After second COVID vaccine on 4/12/21, I was sick from 4/13-15. I knew of the flu-like symptoms and had those--high, fever, chills, headache and body aches, but it was worse than the flu. Including: --heart rate consistently between 100-112 BPM for more than 24 hours after vaccine, even right after waking, not returning to normal rate for two days --exhaustion and weakness that I have never experienced before
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia
Clinical narrative: After second COVID vaccine on 4/12/21, I was sick from 4/13-15. I knew of the flu-like symptoms and had those--high, fever, chills, headache and body aches, but it was worse than the flu. Including: --heart rate consistently between 100-112 BPM for more than 24 hours after vaccine, even right after waking, not returning to normal rate for two days --exhaustion and weakness that I have never experienced before
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Autoscopy, Blood creatinine normal, Blood glucose normal, Blood potassium, Blood sodium normal
Clinical narrative: Sudden dizziness without any trigger or prior condition, immediate occurrence of numbness in left hand, spreading up to left elbow , and heart palpitations / chest tightness all within 30-60 seconds onset. In the 5 minutes waiting for paramedics, the numbness spread to the right hand and up to the right elbow. Dizziness became intense. Once in the ambulance (5-10 minutes after onset), legs experienced light numbness, and chest tightness increased, with what felt like spasms / clenching of the heart muscle. Chills and out of body feeling occurred as well.   Paramedics examined heart, pulse, oxygen, with all being normal. IV was inserted and Ativan was given. After 10-15 minutes symptoms subsided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea normal, Chest discomfort, Dizziness, Electrocardiogram normal, Feeling cold
Clinical narrative: Sudden dizziness without any trigger or prior condition, immediate occurrence of numbness in left hand, spreading up to left elbow , and heart palpitations / chest tightness all within 30-60 seconds onset. In the 5 minutes waiting for paramedics, the numbness spread to the right hand and up to the right elbow. Dizziness became intense. Once in the ambulance (5-10 minutes after onset), legs experienced light numbness, and chest tightness increased, with what felt like spasms / clenching of the heart muscle. Chills and out of body feeling occurred as well.   Paramedics examined heart, pulse, oxygen, with all being normal. IV was inserted and Ativan was given. After 10-15 minutes symptoms subsided.