chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was barely sore; This is a spontaneous report received from a contactable consumer (patient). A 63- year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EW0169 and expiration date was not reported) via an unspecified route of administration (Anatomical location: Arm) on 16Apr2021 as a single dose for COVID-19 immunisation. Medical history included Crohns disease. Concomitant medications were not reported. Historical vaccine included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8733 and expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunisation. On an unspecified date in Apr2021, (after second dose), patient experienced arm was barely sore.  The Outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021490065 same reporter/drug, different patients/AE;US-PFIZER INC-2021490064 same reporter/drug, different patients/AE
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Pyrexia
Clinical narrative: Fever; Cough; sick; This is a spontaneous report received from a non-contactable consumer (reporting on herself) Via Pfizer Sponsored Program COVAX Support.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL1041 and Expiration Date was not reported), via an unspecified route of administration on 31Dec2020 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient experienced fever and cough. Patient did not provide any of her information since she wants to talk to someone since she was sick she received her first dose on 29Mar2021 (Further clarification unknown), and scheduled for second dose tomorrow 26Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: after taking the first dose, his husband was positive with the COVID; after taking the first dose, his husband was positive with the COVID; This is a spontaneous report from contactable consumer (wife reported for her husband). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 07Apr2021 (Batch/Lot Number: ER8734) as single dose for COVID-19 immunisation. Medical history included blood cholesterol abnormal, kidney stone and blood pressure high. Concomitant medications included atorvastatin oral at 40 mg of unknown frequency taken for blood cholesterol, start and stop date were not reported; allopurinol at 300 mg of unknown frequency, potassium citrate at 1080 mg three time daily,  sodium bicarbonate at 650 mg three times daily, all taken for kidney stone, start and stop date were not reported; lisinopril taken for blood pressure high, start and stop date were not reported. After taking the first dose, patient was positive with the COVID on 21Apr2021 with outcome of unknown. Patient had not got any treatment. Second dose was scheduled on 28Apr2021.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Pneumothorax
Clinical narrative: Developed chest pain and trouble breathing 2 days after the vaccine. Chest xray showed pneumothorax.; This is a spontaneous report from a contactable consumer (patient). This 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 20Apr2021 18:00 in left arm for COVID-19 immunization. There was no medical history. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient developed chest pain and trouble breathing 2 days after the vaccine on 22Apr2021 16:00. Chest X-ray on 22Apr2021 showed pneumothorax. The adverse events result in Doctor or other healthcare professional office/clinic visit. The outcome of event was resolving.   Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Laboratory test
Clinical narrative: My vision disappeared in my right eye; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Mar2021 at approximately 10 o' clock (Lot Number: ER8727) as 2nd dose, single for COVID-19 immunisation. Medical history included High Blood Pressure and Blood cholesterol abnormal, both from an unknown date. Concomitant medications included unspecified medication for High Blood Pressure, cholesterol, and a blood thinner. The patient previously received the first dose of bnt162b2 for COVID-19 immunization at the age of 74-year-old on 08Mar2021. Lot Number of the first shot was reported as "EN it looks like 6205". The patient stated he had an adverse reaction to the vaccine. The patient got the second shot at approximately 10 o' clock in the morning of 29Mar2021 and at 10 o' clock at night his vision disappeared in his right eye. The patient was in hospital for 3 days. The patient was told that his right eye was not going to work anymore, it was absolutely the same. The patient received treatment and stated they told him to go to an ophthalmologist and get the services and he told him that his right eye was gone. The patient underwent lab tests and procedures which included lab work was done with unknown results on unknown date.  The outcome of events was not recovered.  Follow-up attempts are needed. Further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: doesn't feel good; Caller found out he was COVID positive like 5 or 6 days after the first Pfizer COVID 19 vaccine shot.; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 16Apr2021 (Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation. Medical history was none. There were no concomitant medications. Patient had first Pfizer COVID 19 vaccine on 16 Apr 2021 and 2-5 days after that patient thought he was experiencing side effects that were from the shot, but found out he has COVID now. Patient states that he just doesn't feel good. Patient found out he was COVID positive like 5 or 6 days after the first Pfizer COVID 19 vaccine shot. Began to have symptoms 2-5 days after the first Pfizer COVID vaccine. Patient states that he had every symptom except fever - thought it was side effect of the shot but he got tricked. Patient states that the symptoms are starting to get better as of 29 Apr 2021, he can eat and hold it down now. Patient states that he has his second Pfizer COVID 19 vaccine scheduled for 7May2021. Patient wants to know if he should get that next Pfizer COVID 19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Apr2021. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Dysgeusia, Skin odour abnormal, Urine analysis, Urine odour abnormal
Clinical narrative: Smell an odor on his skin, on his clothing in his urine, and in his mouth; Smell an odor on his skin, on his clothing in his urine, and in his mouth; an acid like taste in his mouth after second vaccine; This is a spontaneous report received from a contactable consumer (reporting on himself). A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8733 and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 10Apr2021 13:45 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not re-ported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine includes first dose of BNT162B2 on 20Mar2021 for COVID-19 immunization. It was reported that he was trying to find out if this was a reaction, from the vaccine. He got his first vac-cine on 20Mar2021 and his second vaccine on 10Apr2021. Patient states 3 days after his second vaccine, he noticed a smell, like a smell of medication. He can smell an odor on his skin, on his clothing in his urine, and in his mouth, described as an acid like taste in his mouth after second vaccine. Patient went to the emergency room and he had blood work done and a urinalysis and the results were normal. Patient states he has had intravenous medications before and he has never tasted or smelled those medications. He asks if anyone was reporting this specific event and how long will it last. He has taken medications for years and never had a problem and stated his medication are not relevant to report. Patient still secreting this smell, since 13Apr2021 and asking asks why is he secreting this smell. Patient asks if the vaccine was coming out of his pores. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: I had this shot and then on Saturday and Sunday, I had pretty much all of the symptoms; I tested positive; I get the shot and then I am sick and then I test positive; This is a spontaneous report from a contactable consumer (patient) reported that 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 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that he/she received the shot on Friday of Pfizer (Covid-19 Vaccine). Wednesday, he/she was feeling really good and then Friday he/she had this shot and then on Saturday and Sunday, patient had pretty much all of the symptoms and then on Sunday patient had to go and get a COVID test because he/she am having surgery on Wednesday. It revealed that he/she tested positive. The patient's question is if he/she had a shot on Friday, he/she was having symptoms on Saturday and Sunday, would he/she test positive for COVID on Sunday. Patient said that he/she needs to have that answer because he/she is really feeling like hard that he/she does not have COVID because he/she is fine today. Patient was fine Wednesday and then he/she got the shot and then he/she is sick and then he/she tested positive. Patient felt that none of this really makes too much sense. Outcome of the events was unknown.   Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Hypoaesthesia, Laboratory test, Muscle rigidity, Nervousness
Clinical narrative: A female patient (weight: probably 160 pound) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0150) at single dose via an unknown route in left upper arm on 11Apr2021 for Covid-19 immunization. Medical history was not provided. Concomitant drugs included on occasion melatonin, ascorbic acid (VITAMIN C), and vitamin D. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) on 21Mar2021 for Covid-19 immunization and experienced left arm was numb all the way down to hand was not working and nervous.  Patient went to doctor every year having basic lab work done but none other than that. Since gotten vaccinated she had left arm numbness, to the point that she got up on 25Apr2021 morning and left arm was numb all the way down to hand was not working and it made her nervous enough given her age that she was having another issue. So, she went to the hospital.  It started with her first vaccine dose. She was always been very healthy and this all started pretty much when got vaccination.  She went into the emergency room on 25Apr2021 morning because when woke up entire arm and hand was totally numb. Like she could not move hand. It was like a claw. The reason of hospitalization patient stated that she thought she was having the stroke. She walked into the emergency room and they treated with they had me in the room and headed to the CAT scan within 10 min. Patient was discharge on 25Apr2021. Patient's brain and heart were ok but she still had a numb arm. She also sated that she didn't have a concern. Treatment taken in response to adverse events included paracetamol (TYLENOL). Outcome of the events was unknown.  Follow up needed, further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test, Muscle rigidity, Nervousness
Clinical narrative: left arm was numb all the way down to hand was not working; left arm was numb all the way down to hand was not working; Nervous; This is a spontaneous report received from a contactable consumer(patient). A 63-year-old female patient (weight: probably 160 pound) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6207) at single dose via an unknown route in left arm on 21Mar2021 for Covid-19 immunization. Medical history was not provided. Concomitant drugs included on occasion melatonin, ascorbic acid (VITAMIN C), and vitamin D. Patient went to doctor every year having basic lab work done but none other than that. Her left arm was numb all the way down to hand was not working and it made her nervous.  It started with her first vaccine dose. She was always been very healthy and this all started pretty much when got vaccination.  Treatment taken in response to adverse events included paracetamol (TYLENOL). Outcome of the events was unknown.  Follow up needed, further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swollen arms like two times the size. My other arm it is just huge its still looking sore; Swollen arms like two times the size. My other arm it is just huge its still looking sore; This is a spontaneous report from a non-contactable consumer (patient).   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 'Saturday' on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunization.  The patient medical history and  concomitant medications were not reported.  The patient experienced swollen arms like two times the size. my other arm it is just huge (medically significant, its still looking sore on an unspecified date. Consumer states ' I have been waiting on line for really long time. I ended up calling the local hospital because I was not sure what to do and they are on the other line. The clinical outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Headache, Influenza like illness, Pain
Clinical narrative: fever is around 102/ pretty seamless fever for past 18 hours or 19 hours; I am also achy, body aches; Headache; I feel like I have the flu; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer (patient) reported for himself  that he received the second dose of BNT162B2 (Lot number: ER8731) at single dose on 24Apr2021 for Covid-19 Immunization.   Relevant history included the patient may have some immune condition but was not established yet but he had done blood work and he may have some autoimmune issues. The patient had blood work done in past 6 month. There was evidence on his blood work but it's not diagnosed yet. Relevant concomitant drug was unknown.  The patient previously received the first dose of BNT162B2 (Lot number: EP7533) on 02Apr2021 for Covid-19 Immunization. After the first vaccination he did feel light headed but those were the worst thing, the light headed and the next day felt like he was coming down with something but it never got bad. The patient got the second shot (Covid 19 vaccine) about 32 hours ago and he had pretty seamless fever from 18 hours (on 25Apr2021). He was wondering what would be as his fever is around 102 (Fahrenheit) and he hint that may be contributing to and he was wondering what was a time frame to maybe be concerned, since the fever was too lasting and too high. He got the second shot of vaccine 32 hours ago and he had a fever for past 18 hours or 19 hours (as reported), he was also achy, body aches, headache. Those were the primary issues, but the fever was kind of most concerned about. He was taking Tylenol because he had been 18 hours into having a fever. He felt like he had the flu and he was surprised how was the fever been. The patient received Tylenol on 25Apr2021 morning, 500 mg probably every 5 or 6 hours because of his fever. He was drinking lot of water and trying to just rest.  The patient stated it was about 20 hours into it. It was the same unfortunately actually okay, so body ache had improved somewhat, headache worsened in the past 20 hour and fever stayed about the same (not recovered). The outcome of other events was unknown.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever is around 102/ pretty seamless fever for past 18 hours or 19 hours; I am also achy, body aches; Headache; I feel like I have the flu; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer (patient) reported for himself  that he received the second dose of BNT162B2 (Lot number: ER8731) at single dose on 24Apr2021 for Covid-19 Immunization.   Relevant history included the patient may have some immune condition but was not established yet but he had done blood work and he may have some autoimmune issues. The patient had blood work done in past 6 month. There was evidence on his blood work but it's not diagnosed yet. Relevant concomitant drug was unknown.  The patient previously received the first dose of BNT162B2 (Lot number: EP7533) on 02Apr2021 for Covid-19 Immunization. After the first vaccination he did feel light headed but those were the worst thing, the light headed and the next day felt like he was coming down with something but it never got bad. The patient got the second shot (Covid 19 vaccine) about 32 hours ago and he had pretty seamless fever from 18 hours (on 25Apr2021). He was wondering what would be as his fever is around 102 (Fahrenheit) and he hint that may be contributing to and he was wondering what was a time frame to maybe be concerned, since the fever was too lasting and too high. He got the second shot of vaccine 32 hours ago and he had a fever for past 18 hours or 19 hours (as reported), he was also achy, body aches, headache. Those were the primary issues, but the fever was kind of most concerned about. He was taking Tylenol because he had been 18 hours into having a fever. He felt like he had the flu and he was surprised how was the fever been. The patient received Tylenol on 25Apr2021 morning, 500 mg probably every 5 or 6 hours because of his fever. He was drinking lot of water and trying to just rest.  The patient stated it was about 20 hours into it. It was the same unfortunately actually okay, so body ache had improved somewhat, headache worsened in the past 20 hour and fever stayed about the same (not recovered). The outcome of other events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Cystitis, Peripheral swelling, Pyrexia, Rash
Clinical narrative: Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation.   The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection  (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Urinary tract infection
Clinical narrative: Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation.   The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection  (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: i caught the full blown covid 19; This is a spontaneous report from a non-contactable consumer or other non hcp. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced i caught the full blown covid 19. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Rash
Clinical narrative: the rash is hot, sweaty, stinging and covers her entire body; upset; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 26Mar2021, as single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis. The patient previously took first dose of BNT162B2 on 05Mar2021 and 10 days later she reported rash. The patient's past medication included prednisone for 5 days, taken for rash and when that was completed she was encouraged to get her second dose. On 31Mar2021, 5 days after second dose, the rash came back again. She had been to Urgent care, 4 different doctors at 3 different facilities and had been prescribed prednisone 3 times, which helped for a bit, made the rash fade, but the when the prescription ran out the rash returned in the exact same spots. Patient informed that the rash was hot, sweaty, stinging and covers her entire body, "I look like I've been burned". Patient had been to multiple doctors, and referred to Dermatologist. Patient stated that this was not a skin problem, it was an immune system problem. Patient reported to have a history of rheumatoid arthritis and stated that she believed event was an autoimmune response to the vaccine. Patient was audibly upset. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Movement disorder, Nausea, Polymerase chain reaction
Clinical narrative: PCR test on April 24th, the 26th tested positive; nausea; marked decay/has stayed in bed; This is a spontaneous report from a contactable consumer (caregiver). A 72-years-old female patient received (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported pcr test on april 24th, the 26th tested positive, nausea and marked decay/has stayed in bed on an unspecified date. Reporter and patient received the first dose of the Pfizer Covid 19 vaccine on April 14th. Ten days later, 72-year-old patient started with symptoms, had a PCR test on April 24th, the 26th tested positive. The symptoms she has are nausea and a marked decay, she has stayed in bed. Reporter took her to the ER to rule out pneumonia, they told us there are no major radiological signs, they sent her with antibiotics and prednisone. I am 44 years old and started with symptoms 6 days ago, I have flu-like symptoms, dry cough, tiredness, milder symptoms than my mom. The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 24Apr2021. The action taken in response to the events was not applicable. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: 5 days ago her daughter had a runny nose and cough; 5 days ago her daughter had a runny nose and cough; This is a spontaneous report from a contactable consumer (mother) received from Pfizer-sponsored program. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. on Apr2021, the patient experienced 5 days ago her daughter had a runny nose and cough. Her daughter got the 1st dose 06Apr2021 and the 2nd dose schedule supposed to be on 27Apr2021, but they rescheduled the 2nd dose on 01May2021 because 5 days ago her daughter had a runny nose and cough. The action taken in response to the events for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Memory impairment
Clinical narrative: disoriented; trouble remembering things; This is a spontaneous report from a contactable consumer (patient's daughter) reported that a 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 20Dec2020 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient has taken one shot 5 weeks ago. After the shot the mother became disoriented and having trouble remembering things. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Fall, Malaise
Clinical narrative: she was very weak & still had chest pain.; On wednesday morning 3:30am she tried again to go to bathroom & this time was on floor for two hours with paralyzed legs, chills & pains in her chest; Pains in her Chest; Her legs became paralyzed; She become violently ill; She attempted to get out of bed to go to the bathroom & fell on the floor.; This is a spontaneous report from contactable consumers. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 23Mar2021 11:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Tuesday 23Mar2021 my wife and I took our second Pfizer vaccine at 11:00am. At 7:00pm 23Mar2021 she become violently ill. She attempted to get out of bed to go to the bathroom & fell on the floor. Her both legs became paralyzed. She stayed on the floor until I was able to maneuver her back on the bed. On Wednesday (24Mar2021) morning 3:30am she tried again to go the bathroom & this time was on the floor for two hours with paralyzed legs, chills, & pains in her chest. I wanted to call an ambulance both times she refused. By Friday morning 26Mar2021, her legs were no longer paralyzed but she was very weak & still had chest pain. She started to feel much better one month later. Just wondering if this particular vaccine was tainted in any way. Event outcome of legs became paralyzed was recovered on 26Mar2021, of the remaining events were recovering.  Follow up attempts are needed. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Monoplegia
Clinical narrative: she was very weak & still had chest pain.; On wednesday morning 3:30am she tried again to go to bathroom & this time was on floor for two hours with paralyzed legs, chills & pains in her chest; Pains in her Chest; Her legs became paralyzed; She become violently ill; She attempted to get out of bed to go to the bathroom & fell on the floor.; This is a spontaneous report from contactable consumers. A female patient of an unspecified age received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on 23Mar2021 11:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On Tuesday 23Mar2021 my wife and I took our second Pfizer vaccine at 11:00am. At 7:00pm 23Mar2021 she become violently ill. She attempted to get out of bed to go to the bathroom & fell on the floor. Her both legs became paralyzed. She stayed on the floor until I was able to maneuver her back on the bed. On Wednesday (24Mar2021) morning 3:30am she tried again to go the bathroom & this time was on the floor for two hours with paralyzed legs, chills, & pains in her chest. I wanted to call an ambulance both times she refused. By Friday morning 26Mar2021, her legs were no longer paralyzed but she was very weak & still had chest pain. She started to feel much better one month later. Just wondering if this particular vaccine was tainted in any way. Event outcome of legs became paralyzed was recovered on 26Mar2021, of the remaining events were recovering.  Follow up attempts are needed. Further information has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: Had an antibody test come back negative; This is a spontaneous report from a contactable consumer (wife). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included immunodeficiency, leukaemia (Due to taking chemotherapy) and chemotherapy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced had an antibody test come back negative on an unspecified date. Reporter also mentioned that her 78-year-old husband who is immunocompromised due to taking chemotherapy for leukemia received both doses of the Pfizer BioNTech COVID-19 vaccine and had an antibody test come back negative afterwards. The patient underwent lab tests and procedures which included antibody test: negative (Negative). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: They have had every symptom from COVID.; they both had a "pretty severe" reaction; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that. A 55-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 24Apr2021 (Batch/Lot Number: ER8735) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller wanted to know what should he and his wife would do if they developed "every symptom on the list" of COVID-19 after receiving the first dose of the COVID-19 vaccine, as On 25Apr2021, they both had a "pretty severe" reaction, his reaction was "coming down quite a bit" but his wife´s reaction was not coming down as quick. Within 24 hours of after receiving the first dose of the Pfizer COVID-19 vaccine their symptoms started growing like if they got the shot and got the virus at the same time. During the call he mentioned that maybe the virus was on their systems for weeks or months but did not activate until they received the shot. Caller is trying to figure out the shot he got. On the 24Apr2021, Saturday, he and his wife went to an open vaccination clinic where they didn't have to have appointments. They both got the shot Saturday, and by Sunday afternoon, the next day, they were both getting sick. Now for the last week they have been sick as a dog. They have had every symptom from COVID. They were told that someone can't catch COVID from the vaccine. That is not true. What is he supposed to do Is it safe for them to go out after this sickness or cold? Pfizer needs to change the information that says people cannot get COVID. Him and his wife both have symptoms of COVID. Can they get the virus from the vaccine. It is unlikely both had it before the shot. He did not have diabetes, and he doesn't take medications. He has no health problems. He did not have a prescribing doctor. He went through the city's vaccination site. His COVID symptoms are improving. His wife's COVID symptoms are slowly improving. Caller has not received treatment. Him nor his wife have gone to the doctor or ER, not yet. He got the vaccine in his left arm. He had no diabetes, no heart problems, and no high blood pressure. They were feeling perfectly fine. They figured they may have to travel to Germany out of the blue to see family, so they better get vaccinated. The outcome for the event the patient experienced they have had every symptom from covid was recovering. The outcome for the event they both had a "pretty severe" was unknown. Follow up #1 (03May2021): This is a follow up-spontaneous report received from a contactable reporter that the date of vaccination, event and clinical information. No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021495632 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Incorrect dose administered, Malaise, Pyrexia
Clinical narrative: just had a half dose for her first shot.; mild malaise; slight fever; chills; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (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 as single dose on 10Mar2021 for COVID-19 immunization. The patient's concomitant medications and medical history were not reported. She had the first dose on 03Mar2021 and had mild malaise, slight fever and chills and just had a half dose for her first shot. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: a female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Fomulation: Solution for inejction) via an unspecified route of administration on 02May2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took 1st dose of bnt162b2 on 10Apr2021 for covid-19 immunisation. The patient experienced a headache after receiving the 2nd dose (More than 21 days) and she took Ibuprofen. Treatment was received for the event. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: paralyzed; This is a spontaneous report from a contactable consumer reporting for a patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter interviewed a woman who said she was paralyzed on an unspecified date after receiving the second dose of the Pfizer vaccine. The reporter mentioned they understood this is incredibly rare, and this has not been confirmed to have a connection to the vaccine, but would like to include a statement from Pfizer on these claims. The event outcome was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Swelling face
Clinical narrative: chest is being really hard; short of breath; Right side of my face is getting kind of swollen; This is a spontaneous report from a contactable consumer, the patient. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 28Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date for covid-19 immunisation and had no adverse event. The patient stated, 'I' took the second vaccine today (on 29Apr2021) and I am a little like (voice feeble nor clarified further), I am not sure if its fine, but 'I' feel like my chest is being really hard and I am kind of short of breath, also the right side of my face is getting kind of swollen. So, I am not sure what should 'I' do, if it starts like a normal effect. The patient stated, 'I' just want to make sure that I am fine. The outcome for events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: On the first one he was sleepy tired the next day; On the first one he was sleepy tired the next day; This is a spontaneous report from a contactable consumer, patient. A 57-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration, in the right arm on 24Mar2021 at 11:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from Jan2021 to an unknown date (Verbatim: Blood pressure high). Concomitant medications included losartan for blood pressure measurement from an unspecified start date and ongoing; lorazepam for somnolence from an unspecified start date and ongoing.  The patient received the first shot 24Mar2021 at 1115AM in the upper right arm muscle and was sleepy tired the next day. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Blister, Frustration tolerance decreased, Lip swelling
Clinical narrative: No taste; I am kind of frustrated I can't taste anything; No taste; I am kind of frustrated I can't taste anything; Lips swelled up; Blisters; This is a spontaneous report from a contactable consumer (patient). An 86-years-old patient of unspecified gender received second dose of (solution for injection; Lot number and expiration date were not reported) via an unspecified route of administration, on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced (since had second shot) frustrated, completely no taste and lips swelled up and follow blisters. The symptoms were mild which appeared 10 minutes after vaccination. As such, it was acute. The outcome of blisters was recovered whereas of other events it was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Pyrexia
Clinical narrative: a fever of 100-101 degrees Fahrenheit from 28Apr2021 and ongoing; Cold; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (lot/batch number and expiration date not provided) via an unspecified route of administration in right arm last Tuesday on 27Apr2021 at 12:10 at the age of 52-year-old at 2nd dose, single for COVID-19 immunization(to be able to travel safely, as reported). Medical history was reported as none. The patient previously received bnt162b2 via an unspecified route of administration on 30Mar2021 at first dose, single for COVID-19 immunization. History of all previous immunization with the Pfizer vaccine considered as suspect, additional Vaccines Administered on Same Date of the Pfizer Suspect, Prior Vaccinations within 4 weeks, Family Medical History Relevant to AE(s), and Relevant Tests were all reported as none. Concomitant medications included multivitamin from 2019 and ongoing for maintaining health and estrogens (PREMPRO) at 0.3-1.5 mg, per tablet by mouth once daily from 2020 and ongoing for hormone replacement. The patient experienced a cold from 27Apr2021 and ongoing. It got worse but has since improved. The patient also had a fever from 28Apr2021 and ongoing. She still had a fever of 100-101 degrees Fahrenheit and she was asking if it is normal to have a fever for this long? If she takes excedrin or Ibuprofen the fever goes under 99 degrees. Otherwise it has gone up to a high of 101.3 degrees Fahrenheit. The outcome of fever was not recovered. The outcome of cold was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pyrexia
Clinical narrative: Fever; Aches; felt poorly; This is a spontaneous report from a contactable consumer (patient) reporting for himself. A 52-year-old female patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: ER8130 and expiry date was unknown) via an unspecified route of administration on 25Mar2021 as single dose for covid-19 immunisation. The patient medical history included covid-19 (suspected) a year prior, but she did not get tested at that time. The patient historical vaccine included first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) on 03Mar2021; Lot Number: EN6199. Family history was none. Concomitant medications were not reported. The patient did not use other products. She did not receive any other prior vaccinations within 4 weeks or had AE following prior vaccination. No additional vaccines aministered on same date of the bnt162b2 vaccine. She stated that about 16 hours after her own Covid vaccine, on 26Mar2021, she had fever, aches and felt poorly for a few hours until she took some Advil. The patient declines to provide mailing address and stated that she can just be reached on the phone number provided at the beginning of the call. The declined to provide HCP information. The patient stated that she heard that if you had Covid 19 before your symptoms after the second vaccine might be worse. She stated that she did not know if that was true. She did not require emergency room visit or visit to physician's office. There were no relevant tests performed. The patient declined to speak to  and started that her doctor told her that having symptoms after the vaccine was a good thing as it shows a robust immune response. The patient received treatment with Advil for the events. The clinical outcome of the events was recovered on 26Mar2021.  No follow-up attempts are needed. No further information is expected.