chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swollen tongue
Clinical narrative: 2 weeks after the vaccine developed tongue and lip swelling; 2 weeks after the vaccine developed tongue and lip swelling; This is a spontaneous report from a contactable pharmacist. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included dental work. The patient's concomitant medications were not reported.  The patient received first dose of vaccine and 2 weeks after the vaccine developed tongue and lip swelling. Patient was not sure if it was from the vaccine or from dental work that she had done. The reporter was calling to see if there was any information on this. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: She felt some swelling and tenderness on the side of her neck to the side of the shoulder; She felt some swelling and tenderness on the side of her neck to the side of the shoulder; This is a spontaneous report from a contactable consumer (patient) via information team. A 56-year-old female patient received BNT162b2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that when she woke up, she felt some swelling and tenderness on the side of her neck to the side of the shoulder. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Site on my left arm after the Covid Vaccine became warm to touch, red, and very itchy; Site on my left arm after the Covid Vaccine became warm to touch, red, and very itchy; Site on my left arm after the Covid Vaccine became warm to touch, red, and very itchy; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 14Mar2021 15:45 (at the age of 64-year-old) (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ascorbic acid (ESTER C) taken for an unspecified indication, start and stop date were not reported; zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient reported that site on her left arm after the COVID vaccine became warm to touch, red, and very itchy on 15Mar2021 10:00. Therapeutic measures were taken with Benadryl 4 times per day, ice on area, hydrocortisone. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN6703), at the age of 68, via an unspecified route of administration, left arm, on Mar 13, 2021, at 12:30, single dose, for COVID-19 immunization. The patient's medical history: none. Concomitant medications not reported. No additional vaccines administered on same date of vaccination with BNT162B2. Prior to vaccination, patient did not receive any vaccines within four weeks. The patient experienced pain in left arm on Mar 13, 2021, at 15:30; injection site pain in her left arm on Mar 13, 2021; headache, joint pain, muscle pain and tiredness on Mar 25, 2021, nausea, dizziness and weakness on Mar 18, 2021. The outcome of pain in left arm and injection site pain in her left arm resolved on Mar 14, 2021. Headache, joint pain, muscle pain and tiredness resolved on Mar 17, 2021. Nausea, dizziness and weakness not resolved. No follow-up attempts possible. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN6703), at the age of 68, via an unspecified route of administration, left arm, on Mar 13, 2021, at 12:30, single dose, for COVID-19 immunization. The patient's medical history: none. Concomitant medications not reported. No additional vaccines administered on same date of vaccination with BNT162B2. Prior to vaccination, patient did not receive any vaccines within four weeks. The patient experienced pain in left arm on Mar 13, 2021, at 15:30; injection site pain in her left arm on Mar 13, 2021; headache, joint pain, muscle pain and tiredness on Mar 25, 2021, nausea, dizziness and weakness on Mar 18, 2021. The outcome of pain in left arm and injection site pain in her left arm resolved on Mar 14, 2021. Headache, joint pain, muscle pain and tiredness resolved on Mar 17, 2021. Nausea, dizziness and weakness not resolved. No follow-up attempts possible. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Pain, Vaccination site pain
Clinical narrative: first vaccine: injection site pain; first vaccine: weakness; first vaccine: body aches; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN5318, Expiry date was not reported) administered in hand right via an unknown route of administration on 09Feb2021 (at the age of 67 years old) as dose 1, single for covid-19 immunisation. Medical history included ongoing shellfish allergy. The patient's concomitant medications were not reported. The patient had not received any other medications within two weeks. The patient had not received any other vaccine within 4 weeks. The patient also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6201, Expiry date was not reported) via an unspecified route of administration, administered in Hand Right on 02Mar2021 at 14:15 as dose 2, single for covid-19 immunisation. On 09Feb2021 at 18:00 (6 hours later), the patient experienced first vaccine: injection site pain, first vaccine: weakness, and first vaccine: body aches. It was reported that the events were stopped completely 24 hours. The outcome for the events first vaccine: injection site pain, first vaccine: weakness, and first vaccine: body aches was recovered on 10Feb2021. No follow-up attempts are possible; information about lot/batch no cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site redness/right arm injection site is a little red; swelling/right arm injection site swelled up; itchiness/right arm injection site itched; This is a spontaneous report from a contactable consumer (patient) from medical information team. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported) via an unspecified route of administration, in right arm, on 11Mar2021 (at the age of 53-years-old), at dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. After a week of vaccination on 18Mar2021, the patient experienced injection site redness/right arm injection site is a little red, swelling/right arm injection site swelled up, itchiness/right arm injection site itched; it swelled up, was a little red and it itched and clarified that it is the injection site on her right arm in the muscle area. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: left shoulder pain; pain in left armpit; general fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Mar2021(at the age of 53-years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced left shoulder pain, pain in left armpit, and general fatigue on 16Mar2021. The events were assessed as non-serious. These side effects lasted until approximately 6 pm on 16Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Cough, Dizziness, Peripheral swelling, Rash
Clinical narrative: asthma like symptoms (coughing, mild respiratory distress); My legs were also a bit swollen; The next morning(around 5:45 am) felt light headed and clammy after workout; The next morning(around 5:45 am) felt light headed and clammy after workout; I had a rash on my legs, trunk and arms; asthma like symptoms (coughing, mild respiratory distress).; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ENG208, expiration date was not reported) via an unspecified route of administration, in left arm, on 14Mar2021 15:30 (at the age of 55-years-old), at dose 1, single for covid-19 immunization from pharmacy or drug Store. Medical history included asthma. Concomitant medications included estradiol; progesterone; sertraline hydrochloride (ZOLOFT). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. It was reported that the next morning (15Mar2021 06:00), the patient felt lightheaded and clammy after workout, her legs were bit swollen, rash on legs, trunk and arms and experienced asthma like symptoms (described as coughing, mild respiratory distress). The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory distress
Clinical narrative: asthma like symptoms (coughing, mild respiratory distress); My legs were also a bit swollen; The next morning(around 5:45 am) felt light headed and clammy after workout; The next morning(around 5:45 am) felt light headed and clammy after workout; I had a rash on my legs, trunk and arms; asthma like symptoms (coughing, mild respiratory distress).; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ENG208, expiration date was not reported) via an unspecified route of administration, in left arm, on 14Mar2021 15:30 (at the age of 55-years-old), at dose 1, single for covid-19 immunization from pharmacy or drug Store. Medical history included asthma. Concomitant medications included estradiol; progesterone; sertraline hydrochloride (ZOLOFT). Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 after the vaccination. It was reported that the next morning (15Mar2021 06:00), the patient felt lightheaded and clammy after workout, her legs were bit swollen, rash on legs, trunk and arms and experienced asthma like symptoms (described as coughing, mild respiratory distress). The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Severe fever; severe body aches; headache; nausea; This is a spontaneous report from a non-contactable consumer (patient).  A 26-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on 26Feb2021 (at the age of 26-years-old), at dose number unknown, single for covid-19 immunization. Medical history included postural orthostatic tachycardia syndrome (POTS), covid-19 and allergies to Ibuprofen and amoxicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced severe fever, severe body aches, headache, and nausea on 26Feb2021. The events resulted in doctor's office/urgent care. No treatment was administered for the events. The outcome of the event was recovered on an unspecified date in 2021.    No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: 102(F) fever/Having real bad reactions has temperature over 102.6; face swelling/Facial swelling; chills; headache; muscle pain; This is a spontaneous report from a contactable consumer. A 58-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER2613, expiration date was not reported) via an unspecified route of administration, in right arm, on 19Mar2021 08:00 (at the age of 58-years-old), at dose 1, single for covid-19 immunization. Medical history included covid-19 from Nov2020. The patient had no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced real bad reactions of temperature over 102.6 /102(f) fever, face swelling/facial swelling, chills, headache, muscle pain on 19Mar2021 18:00. No treatment was received for the events. The patient underwent lab tests and procedures which included body temperature: over 102.6 Fahrenheit and 102 Fahrenheit on 19Mar2021 18:00. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: 102(F) fever/Having real bad reactions has temperature over 102.6; face swelling/Facial swelling; chills; headache; muscle pain; This is a spontaneous report from a contactable consumer. A 58-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER2613, expiration date was not reported) via an unspecified route of administration, in right arm, on 19Mar2021 08:00 (at the age of 58-years-old), at dose 1, single for covid-19 immunization. Medical history included covid-19 from Nov2020. The patient had no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient has not been tested with covid-19 since the vaccination. The patient experienced real bad reactions of temperature over 102.6 /102(f) fever, face swelling/facial swelling, chills, headache, muscle pain on 19Mar2021 18:00. No treatment was received for the events. The patient underwent lab tests and procedures which included body temperature: over 102.6 Fahrenheit and 102 Fahrenheit on 19Mar2021 18:00. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nightmare, Paraesthesia, Pruritus
Clinical narrative: ankles were just stinging and itching terrible/her wrists were doing the same things as her ankles; her right ankle and foot feels a little, she doesn't know how to say, tingly; spot on the inside of her right knee and one below her shoulder that would itch and sting; awful dreams; sick to her stomach; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 15Mar2021 at 14:00 (at the age of 69-years-old) as single dose for covid-19 immunisation. Medical history included she had a very light case of COVID in Sep2020, couldnot smell. Concomitant medications were not reported. Patient stated that she got the shot on 15Mar2021, that day she was sick to her stomach and by 4:30 PM the next afternoon she was better, then she got a spot on the inside of her right knee and one below her shoulder that would itch and sting, like a bee stinging her, and that was in the afternoon on 16Mar2021. She had terrible dreams the night of the 16Mar2021 and the 17Mar2021. Patient stated that her ankles stinging and itching terrible went away, her wrists were doing the same things as her ankles, this was last night, her right ankle and foot feels a little, she doesn't know how to say, tingly, but other than that, it's not as bad. States the itching of the ankles started last night and went away. She stated that has to go, she will call the doctor office, and see what he thinks, she thought she will get some advice. On an unspecified date in Mar2021, ankles were just stinging and itching terrible/her wrists were doing the same things as her ankles was recovered. The outcome of the event spot on the inside of her right knee and one below her shoulder that would itch, and sting was recovered on 16Mar2021. The outcome of the event sick to her stomach and awful dreams was not recovered while the outcome of the event her right ankle and foot feels a little, she doesn't know how to say, tingly was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Illness, Myalgia
Clinical narrative: she felt very ill; vomiting; severe headache; severe joint muscle ache; fatigue; severe joint muscle ache; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 16:00 as dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The day after vaccination patient  felt very ill, vomiting, severe headache, severe joint muscle ache, fatigue and went to the emergency room. Patient reported it took her 2 weeks to get rid of these symptoms. She said that she cancelled her schedule of second dose and wanted to know if she is still protected with only getting the first dose. Patient wanted to know whether it was safe for her to get the second dose of the vaccine as she recovered with the side effects 2 weeks after getting the first dose. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she felt very ill; vomiting; severe headache; severe joint muscle ache; fatigue; severe joint muscle ache; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 16:00 as dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. The day after vaccination patient  felt very ill, vomiting, severe headache, severe joint muscle ache, fatigue and went to the emergency room. Patient reported it took her 2 weeks to get rid of these symptoms. She said that she cancelled her schedule of second dose and wanted to know if she is still protected with only getting the first dose. Patient wanted to know whether it was safe for her to get the second dose of the vaccine as she recovered with the side effects 2 weeks after getting the first dose. The outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain, Tenosynovitis stenosans
Clinical narrative: pain; lack of mobility in my right wrist and thumb; The symptoms matched exactly what I saw online for De Quervains syndrome; having joint pain throughout my body; 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 and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included joint issue from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, about 24 hours after receiving the Covid vaccine, patient experienced pain and lack of mobility in right wrist and thumb. Patient did not tie it to the vaccine, but to a joint issue. The symptoms matched exactly what saw online for De Quervains syndrome. Patient followed the medical advice given, and pain subsided after about a week. As that pain started to go away, though, patient started to have joint pain throughout body, that lasted a few days, too. Now, almost 2 weeks to the day of receiving the vaccine, all the symptoms were completely gone, and patient was back to normal. Patient had no idea if it was a coincidence or not. The outcome of all the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pruritus, Rash, Weight
Clinical narrative: He did have itching and rash after the first one; He did have itching and rash after the first one; This is a spontaneous report from a contactable consumer (patient's friend).  A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Feb2021 (at the age of 70 year old) as dose 1, single for COVID-19 immunisation. The patient's medical history included, he had complication from egg and orange from an unspecified date and has unspecified health conditions. The patient takes unspecified concomitant medications. A couple of weeks ago, he was weighed down to 135. It was reported that patient has serious health issues already, where he has severe rheumatoid arthritis from an unspecified date. He has been given every rheumatoid arthritis medication (unspecified) on the market but none of them really helped him. Patient is now on an infusion of some kind of drugs (unspecified). He is on so many different unspecified medications and then he was having problems with his feet on an unspecified date, so the reporter bought the patient Gold Bond Diabetic Lotion (product name as reported), to put on his feet. The reporter does not know if this was all related because he is on so many medications. On an unspecified date, after the first shot, patient had itching and rash. It has been about a month since he had extensive lab test because he has to go for extensive lab test every time before he has that infusion of those drugs. On 26Feb2021 and on 03Mar2021, patient had extensive lab test and results were unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-HCP, from a Pfizer-sponsored program. A female patient, of an unspecified age, received the 1st dose of  BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Mar 11, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Reportedly, patient had the vaccine on Thursday, Mar 11, 2021. 2 days later, Saturday, Mar 13, 2021 she had a rash. She also asked if it was a normal reaction. The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: lowgrade fevers/he had fever; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional (Patient's husband). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low-grade fevers/he had fever. It was reported as consumer said he received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and wanted to know if he can take Montelukast. He said that after receiving the 1st dose of the vaccine, he had fever, felt unsettled, and thought his lungs were inflamed so he took Montelukast. He said he only took it one time and wants to know if this has affected the vaccine. Consumer also mentioned that he had COVID-19 in July last year, and prior to that he has already been taking Montelukast to treat his allergies. He also said that this medication helped with his pneumonia. Consumer also mentioned that he was allergic to NSAIDs. Consumer also mentioned that he and his wife received the 1st dose of the vaccine at the same time and experienced low-grade fevers ranging from 99.7 to 99.8. He said his fever ranged from a low temperature of 96.2, and the highest it reached was 99.8. He said the fever comes and goes for a week now. He also said he had headache and felt unwell. Consumer also mentioned he and his wife took Tylenol to treat the symptoms and it seemed to have helped. Consumer said he was taking allergy shots and wants to know if it would be okay to take the shots before or after receiving his 2nd dose of the Pfizer-BioNTech COVID-19 Vaccine. He said he was scheduled for the 2nd dose on 24Mar. The patient underwent lab tests and procedures which included pyrexia: 99.7 to 99.8 on his wife received the 1st dose of the vaccine at the same time and experienced low-grade fevers ranging from 99.7 to 99.8. Therapeutic measures were taken as a result of low-grade fevers/he had fever (pyrexia) with Tylenol. No product quality complaint was reported. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program. A 71-year-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6202) via an unspecified route of administration, administered in arm left on 05Mar2021 14:30 (at the age of 71-year-old) at dose 1, single for covid-19 immunisation. Medical history included gout (Mentions predating treatment with vaccine, he has gout). Concomitant medications were not reported. Patient did not have prior vaccinations within 4 weeks. On 20Mar2021 the patient experienced fever and on an unspecified date in Mar2021 patient experienced headaches. Reporter reported that he had the first dose of the Pfizer COVID 19 vaccine 05Mar2021 at 14:30 PM in the left arm. He will be getting the second dose this Friday 26Mar2021. Reports he was fine for two weeks after the first dose; he was cutting the grass and playing pickup ball but then on Saturday he spiked a fever and the has continues Sunday, and today 22Mar2021. Reporter had some head-aches too, for the past couple of weeks. He is asking can he get the second dose if he still has the fever or should he reschedule it. Is it unusual for a fever to show up 2 weeks after the 1st dose. Verbatim and event description: Reporter took the first dose of the Pfizer Covid-19 Vaccine on (05Mar2021) and scheduled to get his second dose on (26Mar2021). He mentioned that he experienced fever after the first dose. Outcome of the event fever was not resolved, and headaches was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain
Clinical narrative: fever; Injection site pain/ pain at the injection site; overall muscle pain/ generalized muscle pain; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired, the consumer called requesting information about the symptoms experienced after the administration of the first dose of the Pfizer COVID-19 vaccine. It was reported that, the patient was administered with the first dose of the Pfizer COVID-19 vaccine on Saturday and on Sunday, 24 hours later, he started with fever, injection site pain/ pain at the injection site and overall muscle pain/ generalized muscle pain. Stated that, the pain has gradually diminishing. Stated that, he was suggested to take Tylenol for symptom management. Enquired, the consumer called requesting information as to whether he could be administered with the second dose of the vaccine considering that he has experienced symptoms after the administration of the first dose of Pfizer's COVID-19 vaccine. The patient was advised to refer to his physician for further information and management. Treatment was received for the events. 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: Body temperature, Pyrexia
Clinical narrative: fever; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced fever. It was reported that she had fever (probably around 99 F) a week after the first shot of the COVID-19 vaccine, she wanted to know if she should consult her physician about this, she was unsure if she should get tested for COVID-19 "again" or if that was a normal reaction. The patient underwent lab tests and procedures on an unspecified date, which included body temperature: 99 fahrenheit (probably around 99 F). The seriousness of the event was reported as non-serious. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Her second dose is scheduled for 07Apr2021. Medical history included knee operation from an unknown date and unknown if ongoing she has gotten amniotic fluid injected in her knee and now scheduled to get hyaluronic acid, a cushioning gel, shot in her knee. The patient's concomitant medications were not reported. The patient experienced fever and chills on an unspecified date with outcome of unknown.    No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained.
Age: 87.0
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Got 2nd shot on 17Feb2021 only had 4 hives; This is a spontaneous report from a contactable consumer or other non HCP (patient). A 87-year-old patient of an unspecified gender received bnt162b2 (Pfizer/BioNTech COVID-19 vaccine ,Formulation: Solution for injection), via intramuscularly on 17Feb2021 (Batch/Lot Number: EL9269) as Dose 2, Single (at the age of 87-year-old) for covid-19 immunisation. Medical history included ongoing CHF (cardiac failure congestive), ongoing COPD (chronic obstructive pulmonary disease), ongoing heart (Heart disorder) and Cancer (Chemo and Radiation Onset Date: Apr2013, Stop date: Jul2013) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 25Jan2021 (Anatomical site location: Upper left arm, Route of administration: Intramuscular, Lot number: Pfizer EN5318) for covid-19 immunisation and experienced itch and Hives. The patient experienced got 2nd shot on 17feb2021 only had 4 hives. The outcome of event reported as recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Hepatic pain, Pain, Pyrexia, Vomiting
Clinical narrative: sore liver area; Fever of 101; body aches; vomiting; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old non-pregnant female patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: En6204) via an unspecified route of administration in Arm Left on 18Mar2021 (age at vaccination: 40-Year-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient didn't had Covid-19 prior to vaccination, patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had received other medications was Adderall, Vitamin d, Escitalopram within 2weeks of vaccination. The patient medical history was not reported. Concomitant medications included amphetamine aspartate, amphetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported; escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported; cholecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: En6202) via unspecified route of administration in Arm Left on 25Feb2021 06:30(age at vaccination: 40 Years) as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced fever of 101 on 19Mar2021 10:00, body aches on 19Mar2021 10:00, vomiting on 19Mar2021 10:00, sore liver area on 20Mar2021. The patient underwent lab tests and procedures which included body temperature: 101 on unspecified date Fever of 101. Patient was not tested for Covid-19 to post vaccination. No therapeutic measures were taken for the events. The outcome of the events pyrexia, pain, vomiting, hepatic pain was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Decreased appetite, Pain in extremity, Pyrexia
Clinical narrative: sore arm; fevers Tmax 103; weakness; loss of appetite; This is a spontaneous report from a contactable other health care professional.   A patient of unspecified age and gender received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 as dose 2, single for covid-19 immunization.  The patient medical history was not reported. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]).  Patient historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 19Feb2021 as dose 1, single for covid-19 immunization and experienced arm soreness and lower back pain. The patient experienced sore arm after vaccination. Patient had fevers Tmax 103, weakness, and loss of appetite starting on 17Mar2021 and had no vomiting or diarrhea. Patient was  feeling much better 21Mar2021. No further fevers but now taking Advil. The patient underwent lab tests and procedures which included body temperature: 103 (units unspecified). The outcome of the event sore arm, weakness and loss of appetite was recovering, outcome of fever was resolved on an unspecified date in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: an itchy rash; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 12Mar2021 16:00 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was Reported that, Patient stated, got her first dose of the vaccine last Friday, 12Mar, at 4 p.m. (Pfizer). had developed an itchy rash on my upper body that surfaced overnight on Monday and not concerned about it at all but haven't seen anything out there about this being a reaction. Treating it by applying moisturizer. My doctor recommended that I report the rash to Pfizer for your information collection. The patient experienced an itchy rash on 15Mar2021 with outcome of unknown.  Therapeutic measures were taken moisturizer as a result of an itchy rash (rash pruritic).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Nausea, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6198), at the vaccination age of 79, via an unspecified route of administration, on Mar 8, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient has an allergy to penicillin. On an unspecified date, patient experienced severe itching all over; burning in the palms of her hands/it felt like burning and she felt slightly nauseous. The outcome of severe itching all over recovered on an unspecified date; and of others: unknown. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: arm is red; center of injection is red, hard, and warm; center of injection is red, hard, and warm; center of injection is red, hard, and warm; injection site sore; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 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 previously took first dose of BNT162B2 for covid-19 immunisation. The patient experienced arm is red, center of injection is red, hard, and warm (vaccination site erythema, vaccination site induration, and vaccination site warmth), and injection site sore on an unspecified date. Caller is calling about the Pfizer Covid19 vaccine because she had her second shot on Monday, and she did not have any side effects except that her arm is red and has an area about the size of two coins. Adds that the center where she got her injection is hard and red, and hot. She is wondering if this is a common side effect. The area was red and warm where she touched it and wanted to know if that is also a common side effect. Caller is worried the vaccine did not go in properly. The injection area is sore when she moves it and today it was sore when she touched it. She tried to put ice on it a few days and it really did not help. Caller would like to talk to somebody to make sure the vaccine is going to be effective, because she is concerned that it did not go in properly, and she would like to see if this is a common result of the vaccine. Caller asks who would be answering if she was transferred. Caller does not want to complete safety report. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal tenderness, Chills, Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6200; expiration date: Jun 30, 2021), at the age of 63, via an unspecified route of administration, right arm, on Feb 16, 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history: none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Feb 16, 2021, at 19:20, patient experienced low-grade fever, stuffy nose, chills and stomach near where the ribs separate right under the breastbone was kind of tender. She received her injection in the right arm. It is still hurting and was reported as worsened. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative on an unspecified date, SARS-CoV-2 test: negative on an unspecified date in 2020. The events did not result in emergency room or physician office visit. Therapeutic measures taken as a result of stuffy nose included Zyrtec. The outcome of she received her injection in the right arm and is still hurting: not recovered; and outcome of all other events: unknown. No follow-up attempts possible. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 63-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6200; expiration date: Jun 30, 2021), at the age of 63, via an unspecified route of administration, right arm, on Feb 16, 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history: none. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Feb 16, 2021, at 19:20, patient experienced low-grade fever, stuffy nose, chills and stomach near where the ribs separate right under the breastbone was kind of tender. She received her injection in the right arm. It is still hurting and was reported as worsened. The patient underwent lab tests and procedures, which included SARS-CoV-2 test: negative on an unspecified date, SARS-CoV-2 test: negative on an unspecified date in 2020. The events did not result in emergency room or physician office visit. Therapeutic measures taken as a result of stuffy nose included Zyrtec. The outcome of she received her injection in the right arm and is still hurting: not recovered; and outcome of all other events: unknown. No follow-up attempts possible. No further information expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN9809), via an unspecified route of administration in left arm on 18Feb2021 11:00 (at the age of 73-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing blood pressure high, ongoing diabetes mellitus, ongoing fibromyalgia, ongoing depression, ongoing anxiety, ongoing cholesterol, and ongoing glaucoma. The patient's concomitant medications were not reported. The patient said she has a lot of medical conditions; they might have been diagnosed since 2008. Prior to vaccination, the patient did not have any other recent vaccinations or started any new medications. The patient experienced rash on an unspecified date in Feb2021. No treatment was received for the event. Outcome of event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: fever up to 106; headaches; muscle pains; chills; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 15:45 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included meloxicam (MELOXICAM) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive other vaccine in four weeks of vaccination. Patient received Meloxicam as medications in two weeks of vaccination. Patient had no allergies to medications, food, or other products. Ethnicity information was available. On 21Mar2021 15:45 the patient experienced fever up to 106, headaches, muscle pains, chills, nausea. The patient underwent lab tests and procedures which included body temperature: 106 Fahrenheit on 21Mar2021 fever up to 106. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.