chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Feeling cold, Hot flush, Pyrexia
Clinical narrative: Aching bones; low grade fever; tired; hot and cold flashes; hot and cold flashes; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 at 13:00, the patient experienced aching bones, low grade fever, tired, hot and cold flashes. It was further reported that a Pfizer colleague relayed some side effects associated with her second dose of the Pfizer/BioNTech COVID vaccine. She indicated that she already reported these effects through registry, but I am doing so as well to be compliant. I was informed of these side effects today at 13:00: Aching bones, low grade fever, tired, hot and cold flashes. All side effects have resolved. Also, she relayed that her husband felt tired after receiving his second dose. She did not note any other side effects, and she indicated that she reported his side effects as well. The clinical outcome for all the events was reported as recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444573 same reporter/ drug different patient/event.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eye oedema, Eyelids pruritus, Ocular discomfort, Scar
Clinical narrative: Bottom of the eyelid itching; progressed to swelling; feels like sand paper in my eye; real puffy; it looks like if someone getting scar; they are getting worse; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in Arm Right on 15Apr2021 (at the age of 58 years) as single dose for COVID-19 immunization. Medical history included High blood pressure, Thyroid problems, Acid reflux, Anxiety. Concomitant medications included Amlodipine besilate, Metoprolol, Clonazepam taken for Anxiety attack, Omeprazole (Prilosec [OMEPRAZOLE]) taken for Acid reflux. On 16Apr2021 the patient experienced bottom of the eyelid itching, progressed to swelling, feels like sandpaper in my eye, real puffy, it looks like if someone getting scar, they are getting worse. It was reported that Consumer stated, I took the Pfizer first shot on 15Apr2021 and started on Friday having my bottom of the eyelid itching and was progressed to swelling and it feels like sand paper in my eye. I have been putting some eye drop in my eye to kind of cure it but I noticed an hour ago, it started to run just a little bit. So, it started off in my right eye and I was noticing now this morning in my left eye the bottom lid was started the same thing. If you look at the bottom lid it looks like if someone getting scar or something like that and real puffy and then underneath my eyebrow was real puffy and the corner was puffy. When clarified the name of shot as Covid 19 vaccine, consumer stated, yes, was Moderna too Pfizer shot, or its two different shot (further clarification unknown) second COVID-19 Shot: 2May2021. Treatment: Consumer Stated, Biotrue Eye Drops Bausch & Lomb company name. Still experiencing: Consumer stated, yes, they are getting worse (not clarified for all the events).The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid
Clinical narrative: Bottom of the eyelid itching; progressed to swelling; feels like sand paper in my eye; real puffy; it looks like if someone getting scar; they are getting worse; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0158), via an unspecified route of administration, administered in Arm Right on 15Apr2021 (at the age of 58 years) as single dose for COVID-19 immunization. Medical history included High blood pressure, Thyroid problems, Acid reflux, Anxiety. Concomitant medications included Amlodipine besilate, Metoprolol, Clonazepam taken for Anxiety attack, Omeprazole (Prilosec [OMEPRAZOLE]) taken for Acid reflux. On 16Apr2021 the patient experienced bottom of the eyelid itching, progressed to swelling, feels like sandpaper in my eye, real puffy, it looks like if someone getting scar, they are getting worse. It was reported that Consumer stated, I took the Pfizer first shot on 15Apr2021 and started on Friday having my bottom of the eyelid itching and was progressed to swelling and it feels like sand paper in my eye. I have been putting some eye drop in my eye to kind of cure it but I noticed an hour ago, it started to run just a little bit. So, it started off in my right eye and I was noticing now this morning in my left eye the bottom lid was started the same thing. If you look at the bottom lid it looks like if someone getting scar or something like that and real puffy and then underneath my eyebrow was real puffy and the corner was puffy. When clarified the name of shot as Covid 19 vaccine, consumer stated, yes, was Moderna too Pfizer shot, or its two different shot (further clarification unknown) second COVID-19 Shot: 2May2021. Treatment: Consumer Stated, Biotrue Eye Drops Bausch & Lomb company name. Still experiencing: Consumer stated, yes, they are getting worse (not clarified for all the events).The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Feeling abnormal, Pyrexia
Clinical narrative: Fever; Chills; Diarrhea; Feel crappy; no energy; wonder felling of all that; Feel crappy; no energy; wonder felling of all that; This is a spontaneous report from a contactable consumer reporting same event under the same product for two patients. This is one of two reports:  A 76-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: EW0169, Expiry Date: Not Reported), via an unspecified route of administration on 15Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. This is the 1st case out of 2 cases. When probed for concern consumer stated patient was seventy  (not clarified)  patient and her husband had a shot on Thursday and it is  just really not consoled (not clarified) so I mean we had the fever  chills now diarrhea a day now today is the first day We just feels like crap. No energy so I just do not know how long that last. On 15Apr2021, the patient experienced fever, chills, diarrhea, feel crappy; no energy; wonder felling of all that. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444690 same reporter/drug/event, different patient
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Extensive swelling of vaccinated limb, Pain, Pyrexia, Swelling
Clinical narrative: Yesterday on my right hand arm, this started on right in my arm and then under the armpit it's like a swelling over there, big swelling, very big, it's like, it's paining a lot; Yesterday on my right hand arm, this started on right in my arm and then under the armpit it's like a swelling over there, big swelling, very big, it's like, it's paining a lot; it's paining a lot; I had a high fever yesterday; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was Unknown) via an unspecified route of administration in right arm on 16Apr2021 as dose 1, single (at the age of 36-years-old) for COVID-19 immunization. Patient does not have any other medical condition and there were no concomitant medications. On 17Apr2021 (reported as yesterday, at the time of report), the patient experienced on his right-hand arm (vaccinated arm), this started on his right arm and then under the armpit it's like a swelling over there, big swelling, very big, it's like, it's paining a lot and he also had a high fever. The patient underwent lab tests and procedures which included body temperature resulted high (fever) on 17Apr2021. The seriousness for the events unspecified. No investigation assessment reported. Therapeutic measures were taken for a high fever included Tylenol 2 tablet at a dose of 620 mg (unclear, it is written on the bottle take 2 tablets for adult) in the morning time like around 11:30 and then after 8 hours and then he had taken after having his dinner after 21:00 yesterday evening time (on 17Apr2021). Patient believes it is a very big side effect that he was facing under the armpit was swelling. The clinical outcome of all events was not recovered (still persisting), at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Feeling abnormal, Pyrexia
Clinical narrative: Fever; Chills; Diarrhea; Feel crappy; no energy; wonder felling of all that; Feel crappy; no energy; wonder felling of all that; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (patient's wife). This is the 2nd case out of 2 cases. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection Batch/Lot Number: EWO169) via an unspecified route of administration on 15Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. After receiving the first dose of vaccine on Thursday her husband had a fever, chills, now diarrhoea a day, now today is the first day, he just feels like crap. No energy wonder felling of all that, so she just don't know how long that last. The patient's wife would like to know that does it last sometimes wonder felling of all that. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444648 same reporter/drug/event, different patient
Age: 37.0
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Heart rate increased, Palpitations
Clinical narrative: Have a lot of stomach issues; stomach kind of bothering me; Heart palpitations; elevated heart rate; I wasn't very hungry and then I had severe like lot of diarrhea; Joints sore; heart rate increased; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8732, Expiry date: Unknown) via an unspecified route of administration in Arm Right on 05Apr2021 16:30, as dose 1, single (at the age of 37-years-old) for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Apr2021, the patient had a lot of stomach issues; stomach kind of bothering me, heart palpitations, elevated heart rate, patient wasn't very hungry and then patient had severe like lot of diarrhea, joints sore. Patient didn't receive any treatment for the events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Headache
Clinical narrative: Fever; Headache; Tired; I started feeling bad; My joints hurt very bad, I have got pain in my joints; something and it itch; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; I felt like I kind of had a bad cold, like a flu; I felt like I kind of had a bad cold, like a flu; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 39-year-old unspecified gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8731, Expiry date: unknown) via an unspecified route of administration in upper left arm on 12Apr2021 (at the age of 39- year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Methadone and Citalopram Hydrobromide (CELEXA)] both are from an unknown date for an unspecified indication unknown if ongoing. On 16Apr2021, the patient experienced breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red, I felt like I kind of had a bad cold, like a flu, but I didn't expect to have breakout on my legs, and on an unspecified date, patient got fever, headache, patient also stated I am really tired, Yesterday or maybe Thursday, it was when I started feeling bad, my joints hurt very bad, I have got pain in my joints, it has just got unbearable. Therapeutic measures were taken as a result of the events which included Benadryl, Ibuprofen like Advil and also patient stated he used some Hydrocortisone, it was a cream. Patient bought some Benadryl last night, which was an antihistamine because, thought it might be some allergy, patient don't know, and then got some Ibuprofen like Advil. So, patient just took over the counter medications and also used some Hydrocortisone, it was a cream. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Nasopharyngitis, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Fever; Headache; Tired; I started feeling bad; My joints hurt very bad, I have got pain in my joints; something and it itch; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; I felt like I kind of had a bad cold, like a flu; I felt like I kind of had a bad cold, like a flu; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 39-year-old unspecified gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8731, Expiry date: unknown) via an unspecified route of administration in upper left arm on 12Apr2021 (at the age of 39- year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Methadone and Citalopram Hydrobromide (CELEXA)] both are from an unknown date for an unspecified indication unknown if ongoing. On 16Apr2021, the patient experienced breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red, I felt like I kind of had a bad cold, like a flu, but I didn't expect to have breakout on my legs, and on an unspecified date, patient got fever, headache, patient also stated I am really tired, Yesterday or maybe Thursday, it was when I started feeling bad, my joints hurt very bad, I have got pain in my joints, it has just got unbearable. Therapeutic measures were taken as a result of the events which included Benadryl, Ibuprofen like Advil and also patient stated he used some Hydrocortisone, it was a cream. Patient bought some Benadryl last night, which was an antihistamine because, thought it might be some allergy, patient don't know, and then got some Ibuprofen like Advil. So, patient just took over the counter medications and also used some Hydrocortisone, it was a cream. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Fever; Headache; Tired; I started feeling bad; My joints hurt very bad, I have got pain in my joints; something and it itch; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; Started breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red; I felt like I kind of had a bad cold, like a flu; I felt like I kind of had a bad cold, like a flu; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 39-year-old unspecified gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: ER8731, Expiry date: unknown) via an unspecified route of administration in upper left arm on 12Apr2021 (at the age of 39- year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Methadone and Citalopram Hydrobromide (CELEXA)] both are from an unknown date for an unspecified indication unknown if ongoing. On 16Apr2021, the patient experienced breaking out my leg, my legs right now are really swollen and red, it looks like a rash or something and it itch, I can hardly walk; One of my leg is just completely red, really red, I felt like I kind of had a bad cold, like a flu, but I didn't expect to have breakout on my legs, and on an unspecified date, patient got fever, headache, patient also stated I am really tired, Yesterday or maybe Thursday, it was when I started feeling bad, my joints hurt very bad, I have got pain in my joints, it has just got unbearable. Therapeutic measures were taken as a result of the events which included Benadryl, Ibuprofen like Advil and also patient stated he used some Hydrocortisone, it was a cream. Patient bought some Benadryl last night, which was an antihistamine because, thought it might be some allergy, patient don't know, and then got some Ibuprofen like Advil. So, patient just took over the counter medications and also used some Hydrocortisone, it was a cream. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Malaise, Pyrexia
Clinical narrative: Chills; Fever; Caller wants to reschedule her Pfizer covid-19 vaccine second dose that is due today (April 19, 2021) because she is feeling sick; Feeling sick; This is a spontaneous report received from a contactable consumer (patient) via Pfizer sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 19Apr2021, the patient experienced feeling sick and on an unspecified date, the patient experienced chills, fever and caller wants to reschedule her pfizer covid-19 vaccine second dose that is due today (19Apr2021) because she was feeling sick. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Muscle spasms, Nausea, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (at the age of 58 years old) as dose1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She got the shot on Wednesday the Pfizer when she was very nauseous the next day too typically her arm was so spasmed last night she wakes up with really bad pain in and around her shoulder and under her armpit, it has been there so bad and she gets really nauseous whenever she move her arm and all day she had been like she want to throw up. The pain under her arm, is it that part of shot. The patient reported that very nauseous, she want to throw up and pain was reported as worsened. No treatment provided for the events. The outcome of the events was not resolved and for pain worsened, nausea and vomiting aggravated outcome was unknown .  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in Arm Left on 14Apr2021 (at the age of 58 years old) as dose1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She got the shot on Wednesday the Pfizer when she was very nauseous the next day too typically her arm was so spasmed last night she wakes up with really bad pain in and around her shoulder and under her armpit, it has been there so bad and she gets really nauseous whenever she move her arm and all day she had been like she want to throw up. The pain under her arm, is it that part of shot. The patient reported that very nauseous, she want to throw up and pain was reported as worsened. No treatment provided for the events. The outcome of the events was not resolved and for pain worsened, nausea and vomiting aggravated outcome was unknown .  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Eructation, Fatigue, Gastrointestinal disorder
Clinical narrative: felt tired; gastrointestinal issues; Fever; gurgling and belching; Diarrhea; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 10Apr2021 (at the age of 67-years old) as dose 2, single for COVID-19 immunisation. Medical history included 2 hernias and both of his knees are bad. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]) taken for stomach issues start and stop date were not reported, cimetidine (CIMETIDINE) and fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, 1st dose, Lot: ER8727 (at the age of 67 years old) for covid-19 immunization on 21Mar2021. The patient received the second vaccine last Saturday (10Apr2021), around noon and most of Sunday and most of Monday he did not feel anything from the shot. Then Monday (12Apr2021) night he had a 99.4 fever and started some problems with his stomach. During the day the fever would subside but then at night it would come back up. Tuesday (13Apr2021) night the patient fever was 99.8, it never got over 100. The patient was wondering if the vaccine could cause intestinal problems. 12Apr2021, The patient had gurgling, belching, some diarrhea and loose stools, he had felt tired all week. The gastrointestinal issues was what he was concerned about. The outcome of fever, gurgling, belching and diarrhea was recovering and outcome of gastrointestinal issues and felt tired was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: felt tired; gastrointestinal issues; Fever; gurgling and belching; Diarrhea; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 67-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 10Apr2021 (at the age of 67-years old) as dose 2, single for COVID-19 immunisation. Medical history included 2 hernias and both of his knees are bad. Concomitant medications included omeprazole (PROTONIX [OMEPRAZOLE]) taken for stomach issues start and stop date were not reported, cimetidine (CIMETIDINE) and fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, 1st dose, Lot: ER8727 (at the age of 67 years old) for covid-19 immunization on 21Mar2021. The patient received the second vaccine last Saturday (10Apr2021), around noon and most of Sunday and most of Monday he did not feel anything from the shot. Then Monday (12Apr2021) night he had a 99.4 fever and started some problems with his stomach. During the day the fever would subside but then at night it would come back up. Tuesday (13Apr2021) night the patient fever was 99.8, it never got over 100. The patient was wondering if the vaccine could cause intestinal problems. 12Apr2021, The patient had gurgling, belching, some diarrhea and loose stools, he had felt tired all week. The gastrointestinal issues was what he was concerned about. The outcome of fever, gurgling, belching and diarrhea was recovering and outcome of gastrointestinal issues and felt tired was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Nasopharyngitis
Clinical narrative: Chills; Minor joint pain; Cold; This is a spontaneous report from a contactable consumer. A 58-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: Unknown), dose 1 in the right arm on 08Apr2021 (13.30) as Dose 1 SINGLE for covid-19 immunization (58-year-old). Medical history and concomitant medications were not reported. The patient had not visited emergency room or physician office due to the event and patient had not received any other vaccinations within 4 weeks. On 13Apr2021 the patient had chills and minor joint pain. On an unspecified date of Apr2021 the patient had cold. The reporter stated that only experience he has had is the cold and joints and he has not had a fever, no upset stomach, and no headache, only minor muscle pain and like chills at night.  Reporter clarified he was not experiencing muscle pain it is just chills and minor joint pain. Patient was asked to take Tylenol. The outcome of the event chills was not recovered, event minor joint pain was recovering. The outcome of the event cold was unknown. No follow up attempts are possible. No further information is expected..
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Nausea, Pyrexia
Clinical narrative: got little symptoms like high fever; muscle pain; Joint pain; Little nausea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration date, NDC number and UPC number was unknown), via an unspecified route of administration on 16Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Apr2021 (today), patient got little symptoms like high fever, muscle pain, joint pain and little nausea. Patient asked if it was that normal and wanted to know why it happened like this. Patient also asked that do he/she need to go for COVID test or do he/she need to do that. The outcome of all the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) reported for herself. A 60-years-old female patient received BNT162B2 (solution for injection, Batch/Lot Number: EP7534), via an unknown route of administration in left arm on 19Mar2021 (at the age of 60-years-old) as dose 1, single and (Batch/Lot Number: ER8731), via an unknown route of administration in left arm on 16Apr2021 as dose 2, single for COVID-19 immunization. Expiry date, UPC and NDC, consumer stated that all it was Pfizer and they have same number that was it, she gave you, she did not see any other number that was all she have. The patient's medical history included blood pressure high and acid reflux; both were from an unknown date and unknown if ongoing. Concomitant medication was not reported. Patient stated, "Yes, I do, well for the hypertension, I take prescription and for acid reflux I take a prescription". On an unknown date, the patient noticed the rash on my breast; but I had it couple of weeks, took the shot on Friday (16Apr2021) the rash got yesterday morning really bad, have like a rectangular shape. Patient stated, "I had my second shot of the Pfizer on the 16 this past Friday (16Apr2021) and my first vaccine was on 19Mar2021 and between I noticed the rash on my breast, I did not think anything of it and do not really know when I got this rash, but I had it couple of weeks then I took the shot on Friday (16Apr2021) the rash got, yesterday morning really bad, I may have like a rectangular shape, so I do not know what is it, anything or if it is nothing but I just wanted to report it." Consumer stated, "I had this (rash) for couple of week, it had to be before few weeks, I am gonna say may be before, 4-5 days after the first shot I am not exactly sure". The outcome of event was unknown. No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Fatigue, Headache
Clinical narrative: Muscle pain; Joint pain; Feeling unwell; Hard heartbeat; not fast; but like hard beating out of chest; Injection site pain; Tiredness; Headache; Chills; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:00 (Batch/Lot Number: ER8737; Expiration Date: 01Jul2021) as dose 1, single (at the age of 65-years-old) for covid-19 immunization. Medical history included heart attack from Feb2021 to an unknown date States this was in the first week of Feb2021 had a heart attack a few months ago, chronic obstructive pulmonary disease from 2020 and ongoing and he was diagnosed last summer, stent placement from Feb2021, Blood Thinner (anticoagulant therapy) from an unknown date and unknown if ongoing. Historical Vaccine was Flu Vaccine from an unknown date and unknown if ongoing (Had no dates, NDC, Lot Numbers, or Expiration dates for these vaccines). Concomitant medications included ticagrelor (BRILINTA) taken for anticoagulant therapy from Feb2021 and ongoing (Started medication after heart attack and stent placement); acetylsalicylic acid (ASPIRIN) taken for anticoagulant therapy from Feb2021 and ongoing (Started medication after heart attack and stent placement). History of all previous immunizations with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to Adverse event was None. The patient experienced injection site pain, tiredness, headache, chills, feeling unwell, hard heartbeat; not fast; but like hard beating out of chest on 15Apr2021, joint pain and Muscle pain on 16Apr2021. It was reported that, hard Heartbeat; not fast; hard like it was beating out of his chest: Started yesterday; feels it had worsened; states can place hand on chest and feel it. Stated his pulse was normal at 77 and his blood pressure was fine. Other than the symptoms mentioned were worse, the rest was persisting at about the same level. Patient stated that, wasn't given the fact sheet for the vaccine until after received it, did not know to tell anyone that was on blood thinners until read that sheet. There was no Emergency Room visit or Physician Office visit. Investigation Assessment was No. Patient asked considering side effects, should get the second dose of the vaccine. Then asked if that was something should ask doctor. The patient underwent lab test and procedure which include blood pressure: fine; Heart rate: normal at 77 on unspecified date; Heart rate: not fast on 15Apr2021 (hard like it was beating out of his chest was reported as worsened). The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Muscle pain; Joint pain; Feeling unwell; Hard heartbeat; not fast; but like hard beating out of chest; Injection site pain; Tiredness; Headache; Chills; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:00 (Batch/Lot Number: ER8737; Expiration Date: 01Jul2021) as dose 1, single (at the age of 65-years-old) for covid-19 immunization. Medical history included heart attack from Feb2021 to an unknown date States this was in the first week of Feb2021 had a heart attack a few months ago, chronic obstructive pulmonary disease from 2020 and ongoing and he was diagnosed last summer, stent placement from Feb2021, Blood Thinner (anticoagulant therapy) from an unknown date and unknown if ongoing. Historical Vaccine was Flu Vaccine from an unknown date and unknown if ongoing (Had no dates, NDC, Lot Numbers, or Expiration dates for these vaccines). Concomitant medications included ticagrelor (BRILINTA) taken for anticoagulant therapy from Feb2021 and ongoing (Started medication after heart attack and stent placement); acetylsalicylic acid (ASPIRIN) taken for anticoagulant therapy from Feb2021 and ongoing (Started medication after heart attack and stent placement). History of all previous immunizations with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to Adverse event was None. The patient experienced injection site pain, tiredness, headache, chills, feeling unwell, hard heartbeat; not fast; but like hard beating out of chest on 15Apr2021, joint pain and Muscle pain on 16Apr2021. It was reported that, hard Heartbeat; not fast; hard like it was beating out of his chest: Started yesterday; feels it had worsened; states can place hand on chest and feel it. Stated his pulse was normal at 77 and his blood pressure was fine. Other than the symptoms mentioned were worse, the rest was persisting at about the same level. Patient stated that, wasn't given the fact sheet for the vaccine until after received it, did not know to tell anyone that was on blood thinners until read that sheet. There was no Emergency Room visit or Physician Office visit. Investigation Assessment was No. Patient asked considering side effects, should get the second dose of the vaccine. Then asked if that was something should ask doctor. The patient underwent lab test and procedure which include blood pressure: fine; Heart rate: normal at 77 on unspecified date; Heart rate: not fast on 15Apr2021 (hard like it was beating out of his chest was reported as worsened). The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Face injury, Feeling abnormal
Clinical narrative: heaviness in my face; chills; light headedness; don't feel like myself; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not reported, expiry date: not reported, Age at vaccination: 55-year-old) via an unspecified route of administration on 07Apr2021 as DOSE 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198, expiry date: not reported, Age at vaccination: 55-year-old) via an unspecified route of administration in arm left on 17Mar2021 04:00 PM as DOSE 1, single for COVID-19 immunisation. On an unspecified date, patient experienced heaviness in my face, occasional chills, light headedness and don't feel like myself. Facility type Vaccine was Workplace clinic. No other vaccine received in four weeks. No other vaccine received in two weeks. Patient had not covid prior vaccination. Patient was not covid tested post vaccination. No known allergies present. Lab test included PCR test: negative (nasal swab) on 25Mar2021. The outcome of events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On an unspecified date the patient experienced rash with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Illness, Malaise
Clinical narrative: Feeling like drugged; feel sick; Feeling unwell; Feel very tired and very weak; I could not drive; I feel terrible; Joint pain; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 63-year old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 15Apr2021 (Batch/Lot Number: ER8735; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for covid-19 immunisation  .  Medical history included schizoaffective disorder bipolar type from an unknown date and unknown if ongoing Schizo-affective Bipolar  disorder 1  Diagnosis date: have it for "30" (not clarified) years, think from 1993 or 1994 , diabetes mellitus from Apr1998 to an unknown date Verbatim: Diabetes type 2 , hypothyroidism from an unknown date and unknown if ongoing. Low Thyroid    Diagnosis date may be in September 1999. The patient's concomitant medications were not reported. The patient experienced feeling like drugged; feel sick on an unspecified date with outcome of unknown, feeling unwell causing malaise on an unspecified date with outcome of unknown, feel very tired and very weak, could not drive; feels terrible causing asthenia on an unspecified date with outcome of unknown and joint pain causing arthralgia on an unspecified date with outcome of unknown.  No follow-up attempts are possible; No further information expected .
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: Injection site, my arm is sore; Red mark like a bug bite its little lumpy and it hurts when I touch it; injection site, my arm is sore and there is red mark like a bug bite its little lumpy and it hurts when I touch it; injection site, my arm is sore and there is red mark like a bug bite its little lumpy and it hurts when I touch it; This is a spontaneous report from a contactable consumer, the patient.   A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had her Pfizer 2nd dose exactly 2 weeks and 1 day from today and injection site, her arm was sore and there was red mark like a bug bite it was little lumpy and it hurted when she touched it. The patient wanted to know if it was normal and she had to put ice on it. The patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation on an unknown date. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Lymphadenopathy, Malaise, Swelling face
Clinical narrative: Since I received my shot I was really in a bad and feeling side effects; Swollen face; Lymph node swollen; Right in front of my ear and underneath my ear are swollen; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 33-years-old female patient received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: EW0158, expiry date: not reported), via an unspecified route of administration, administered in Arm Left on 09Apr2021 (at the age of 33 years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 17Apr2021, the patient experienced lymph node swollen, right in front of my ear and underneath my ear are swollen and on an unspecified date since i received my shot i was really in a bad and feeling side effects, swollen face. Patient did not received any treatment. When probed still having the problem (event), consumer stated, this was not the only symptoms that she had since she received my shot she was really in a bad, what the date after my shot but everything kind of cleared up she was concerned and she was calling because this whatever the week after she received her shot her face was swollen thats why she was calling. She was feeling side effects and just wanted to make sure that this is something that happen or she should go to the emergency room. Clinical outcome of the events was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: On the left arm where they put the Pfizer vaccine, just under my armpit closer to the chest, it is swollen, right under the armpit, it is like between the chest and below the armpit; This is a spontaneous report from a contactable consumer (patient). A 59-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EWV161), via an unspecified route on 14Apr2021 (at the age of 59-years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 15Apr2021, the patient experienced on the left arm where they put the Pfizer vaccine, just under his armpit closer to the chest, it was swollen, right under the armpit, it was like between the chest and below the armpit. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.