chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; A spontaneous report was received from a consumer on a social media, concerning a 58-years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and died.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event, the patient received dose of mRNA-1273 (Lot number: unknown), for the prophylaxis of COVID-19 infection.  On 17-Feb-2021, social media interaction was posted concerning a death of a patient on an unknown date after receiving Moderna vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient died on an unknown date. The cause of death was not provided. Plans for autopsy were not provided.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. The cause of death was not provided. Plans for autopsy were not provided.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-018302:Same Reporter; Reported Cause(s) of Death: Unknown cause of death
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Pain in vaccine shot site; Headaches; This is a spontaneous report from a contactable consumer (patient).  A 19-year-old male patient, who is 19-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number: EL9261, via an unspecified route of administration at Left arm on 28Jan2021 13:30 as SINGLE DOSE for COVID-19 immunization.  Medical history included Brain trauma injury. On 28Jan2021 16:00, the patient experienced Pain in vaccine shot site and headaches. The outcome of the events was recovered. Therapeutic measures were taken as a result of the events which includes Tylenol and Motrin.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Mild nausea; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 28Jan2021 18:30 at single dose (right arm) for covid-19 immunization. Medical history included allergies, asthma and Clostridium difficile (c.dif). Patient had allergies to medications, food or other products. The patient was not pregnant. Concomitant medication included rosuvastatin within 2 weeks of vaccination. The patient received other vaccine within 4 weeks prior to Covid vaccine included 1 dose of pneumonia vaccine on 07Jan2021 at a clinic. On 28Jan2021 18:30, the patient experienced mild nausea. Treatment was not received for the event. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient has not patient been tested for covid-19. Outcome of event was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: antibodies which was negative; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot/batch number and expiry date unknown), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on Dec2020. On an unspecified date in 2021, the patient had his/her antibodies checked which was negative. Patient was concerned that the vaccine was not effective as advertised. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Myalgia, Pain
Clinical narrative: experiencing a bit of body aches; a little achy; This is a spontaneous report from a contactable consumer (patient's husband) from the medical information team. A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 28Jan2021 at a single dose (at the age of 67-years-old) for COVID-19 immunization. Medical history included pacemaker/defibrillator and 25% of heart function. Concomitant medications were not reported. The patient received the first dose on 28Jan2021 and was experiencing a bit of body aches (since Jan2021) and was taking paracetamol (TYLENOL), no other symptoms. The consumer had a little concern because the patient has a pacemaker/defibrillator. Before he had the defibrillator, his heart rate was over 300 but now it was normal and the patient was monitored. The patient's doctor recommended everybody to get the vaccine. The consumer had a concern about the second shot because he heard that the dose was stronger than the first dose. The consumer wanted to know if that was true. The consumer wanted to know if the patient would be fine for the second dose. The consumer added that the patient only has 25% of heart function. They have talked to his doctors, his cardiologist about getting the vaccine. All the heart doctors were telling their heart patient to get the vaccine to prevent them from getting COVID. The consumer added that after receiving the first COVID-19 vaccine, the patient was a little achy (Jan2021) like when he has the flu shot (for immunization on an unspecified date.) He was going to get over that. It was not raising his heart rate or anything. The consumer clarified further that the patient was just achy but has done really well. The patient slept good last night. He has a heart monitor in the bedroom and had no problems. The consumer wanted to understand if the second shot was thicker than the first shot and what was the difference between the first and second vaccine. The patient has not recovered from the events.  Information on the lot/ batch number has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Incorrect route of product administration
Clinical narrative: A blister was noted 2 days after injection that was bigger than a pea but smaller than a dime.; The injection appeared to be low than deltoid and concern it was subcutaneous rather than IM; This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiration date: unknown), via subcutaneous route on her right deltoid from 25Jan2021 10:15 to 25Jan2021 10:15 at SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 04Jan2021 at 10:15 via intramuscular route on her right arm. On 27Jan2021 at 22:00, a blister was noted 2 days after injection that was bigger than a pea but smaller than a dime. The injection appeared to be low than deltoid and concern it was subcutaneous rather than intramuscular (IM). The outcome of the event was recovered on an unspecified date. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Joint swelling, Muscular weakness, Myalgia
Clinical narrative: swelling in the wrist, hand, fingers; swelling in the wrist, hand, fingers; muscle soreness in the left arm and difficulty in the lifting; muscle soreness in the left arm and difficulty in the lifting; soreness in shoulder, upper left quadrant, back, neck; soreness in shoulder, upper left quadrant, back, neck; achy injection site/throbbing in left arm where she got the vaccine; soreness in the upper arm, in the forearm; throbbing and tingling in left arm where she got the vaccine; achy elbow 3 hours after the injection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 40; Unit: Unknown) received BNT162B2 (Pfizer-Biontech covid-19 vaccine, Solution for injection, Lot number: EL3247, exp date not reported), via an unspecified route of administration on 28Jan2021 08:25 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient wanted to report a reaction that she had after receiving the Pfizer covid vaccine. She said she received the vaccine on site (not specified). On 28Jan2021, after receiving the vaccine she had achy injection site, soreness in the upper arm, in the forearm; throbbing and tingling in left arm where she got the vaccine; and achy elbow 3 hours after the injection. She said around 3 PM, she had swelling in the wrist, hand, and fingers; she had to remove the ring she was wearing. She also experienced muscle soreness in the left arm and difficulty in the lifting; soreness in shoulder, upper left quadrant, back, neck. Patient took ibuprofen for the events. The events improved over night and she just have some soreness the day of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Peripheral swelling, Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: swelling in the wrist, hand, fingers; swelling in the wrist, hand, fingers; muscle soreness in the left arm and difficulty in the lifting; muscle soreness in the left arm and difficulty in the lifting; soreness in shoulder, upper left quadrant, back, neck; soreness in shoulder, upper left quadrant, back, neck; achy injection site/throbbing in left arm where she got the vaccine; soreness in the upper arm, in the forearm; throbbing and tingling in left arm where she got the vaccine; achy elbow 3 hours after the injection.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (Age: 40; Unit: Unknown) received BNT162B2 (Pfizer-Biontech covid-19 vaccine, Solution for injection, Lot number: EL3247, exp date not reported), via an unspecified route of administration on 28Jan2021 08:25 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient wanted to report a reaction that she had after receiving the Pfizer covid vaccine. She said she received the vaccine on site (not specified). On 28Jan2021, after receiving the vaccine she had achy injection site, soreness in the upper arm, in the forearm; throbbing and tingling in left arm where she got the vaccine; and achy elbow 3 hours after the injection. She said around 3 PM, she had swelling in the wrist, hand, and fingers; she had to remove the ring she was wearing. She also experienced muscle soreness in the left arm and difficulty in the lifting; soreness in shoulder, upper left quadrant, back, neck. Patient took ibuprofen for the events. The events improved over night and she just have some soreness the day of reporting.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Skin reaction, Vaccination site pain
Clinical narrative: sore at inj. site; breaking out on legs and top of feet; This is a spontaneous report from a contactable consumer (patient himself). An 84-year-old male patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not available), via an unspecified route of administration on the left arm, on 28Jan2021 at 14:15 at single dose for COVID-19 immunisation. Medical history included diabetes and allergies, both from an unknown date. Concomitant medications included unspecified "regular meds." On 29Jan2021 at 19:00, it was reported that the patient experienced sore at inj. site and breaking out on legs and top of feet. No treatment was received. The events were considered as non-serious by the reporter. The events did not lead to death, life-threatening condition, hospitalization, disabling/incapacitating, or congenital anomaly. The patent has not been diagnosed with COVID 19 prior to vaccination and has not been tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior. The outcome of the events was unknown. The patient was vaccinated at a hospital.   Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Fatigue, Haemoptysis, Pain, Tooth disorder
Clinical narrative: thought  it was my tooth bleeding because that's what it looked like if you cut yourself; the phlegm she spitted up this morning had blood in it; she started to bleed/nose bleed coming out of my mouth; achy; tired; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) via an unspecified route of administration on 28Jan2021 08:05 (at the age of 75-years-old) as a single dose for COVID-19 immunization. Medical history included an unspecified sinus disorder, unspecified allergies and reflux usually after eating, all from unknown dates and unknown if ongoing. The patient's historical vaccinations included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown) on 06Jan2021 with no specified side effects. The patient's concomitant medications were reported as unspecified medications for sinus problems and allergies. The patient stated that she got the second dose on "Thursday."  She experienced side effects "that everybody has like achy and tired for two days." She continued to say that she normally spits up phlegm in the morning from sleeping overnight because she has sinus issues and she snores. This morning ("Saturday") it was pinched with blood and she was bleeding, just bleeding. She's not bleeding anymore because she has a mouthwash medication to make gargles and also with salty water. She thought it was her tooth bleeding because that's what it looked like if you cut yourself. It has stopped. She also noted that it was more like a nose bleed coming out of her mouth. She gargled with warm salted water. Treatment of the events blood in sputum, nose bleed and tooth disorder included using a mouthwash medication to make gargles and also warm salt water. The clinical outcomes of achey and tired for two days were reported as unknown. The clinical outcomes of blood in sputum, nose bleed and tooth disorder were reported as recovered on an unspecified date in Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nausea, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat; Pounding headache; Congested nose; Vomiting; Nausea; This is a spontaneous report from a contactable nurse (the patient). A female patient (Age: 26, Units: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 08Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she received the second dose of the Pfizer COVID vaccine on 08Jan2021, and her fiance tested positive after 2 weeks of it. She stated she had more symptoms than him, but she tested negative 3 times when she had the COVID tests done. Her fiance tested positive on 26Jan2021. The patient's symptoms were sore throat, pounding headache, congested nose, vomiting, and nausea, on an unspecified date. The patient wanted to know if the vaccine was preventing it to show positive and if this could be a false negative. The clinical outcome of sore throat, pounding headache, congested nose, vomiting, and nausea was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Sore throat; Pounding headache; Congested nose; Vomiting; Nausea; This is a spontaneous report from a contactable nurse (the patient). A female patient (Age: 26, Units: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 08Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she received the second dose of the Pfizer COVID vaccine on 08Jan2021, and her fiance tested positive after 2 weeks of it. She stated she had more symptoms than him, but she tested negative 3 times when she had the COVID tests done. Her fiance tested positive on 26Jan2021. The patient's symptoms were sore throat, pounding headache, congested nose, vomiting, and nausea, on an unspecified date. The patient wanted to know if the vaccine was preventing it to show positive and if this could be a false negative. The clinical outcome of sore throat, pounding headache, congested nose, vomiting, and nausea was unknown.  Information about batch/lot number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node left arm; This is a spontaneous report from a contactable Other Health Care Professional, the patient.  A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El3264), intramuscularly on 28Jan2021 at 15:45 (at the age of 47-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included asthma from an unknown date and unknown if ongoing. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number El1284), on  07Jan2021at 16:40 in the left arm for COVID-19 immunization. The paktient has unspecified allergies to Penicillin. The patient previously too clindamycin (UNKNOWN MANUFACTURER) and experienced an unspecified allergy.The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Concomitant medications were not provided.  On  28Jan2021 at 19:15, the patient experienced a swollen lymph node in the left arm. The patient did not receive any treatment for the event. The clinical outcome of swollen lymph node was reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Hypoaesthesia, Influenza
Clinical narrative: dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Limb discomfort, Malaise, Migraine, Nausea
Clinical narrative: dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: dizziness.; migraine; arm swollen; My finger on my left side is numb and it has a little bit of purple on the center of it; My legs were hurting like really heavy; I have not gone back to sleep and I feel like a bus hit me.; chills; the body ache; legs hurt really bad; fever; symptoms associated with the flu for a few days; feeling like really bad headache; nauseated; not feel so good; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265, expiration date: unknown), via an unspecified route of administration from 28Jan2021 to 28Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. Concomitant medication included verapamil for blood pressure. The patient received her first dose of BNT162B2 on 08Jan2021 and experienced arms a little sore. On 28Jan2021 at 18:00, the patient started feeling like really bad headache and then really nauseated. The patient took medicine and took Tylenol before went in to take her shot and started getting a headache again and not feel so good. On 29Jan2021 at 02:00, the patient stated that her legs were hurting like really heavy and had not been back to sleep since 2 o clock in the morning and she felt like a bus hit her. On 29Jan2021 at 11:00, the patient stated that her finger on the left side was numb and it has a little bit of purple on the center of it. On 29Jan2021, the patient experienced chills, body ache, her legs hurt really bad, fever, symptoms associated with the flu for a few days. On 30Jan2021, the patient experienced arm swollen. On 01Feb2021, the patient experienced dizziness and migraine. The patient already took Tylenol and ibuprofen. The outcome of the event chills, fever, flu symptoms, arm swollen was recovered on an unspecified date and the outcome of the other events was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3286), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included clonidine, losartan and propranolol. It was reported that the patient called after the first shot also which was on the 8th. She called on 9th because she got a fever and I asked if she can take a medication because she is trying to figure out if it is same thing interacting with anything. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer who reported for her husband via a Pfizer Sponsored Program, Pfizer First Connect. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that "her husband received the first shot and tested positive for COVID-19. Her husband had fever, colds and sore throat." The reporter wanted to know if her husband could still receive the 2nd dose of the vaccine. The clinical outcome of the event "positive COVID-19 test with symptoms" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Headache, Hypertension, Pyrexia
Clinical narrative: shot started to hurt; blood pressure was gone up; Fever; my head feels like it is going to explode; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) solution for injection, via an unspecified route of administration on 29Jan2021 at 08:30 at single dose for COVID-19 immunization. The patient has a lot of medical conditions (unspecified). Concomitant medications included unspecified medications. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 (lot number: EL3286) at single dose for COVID-19 immunization and experienced fever. The patient reported that she had her shot this morning (29Jan2021) at about 08:30 and towards evening, the shot started to hurt and so she wanted to make sure that it didn't go against anything, and put a little ice on it or maybe it was worthless on ice on certain situations after the fact that she thought this was too late. She wanted to make sure she could do that. The patient's blood pressure also went up on 29Jan2021. She was taking several different medicines for blood pressure. She took them already tonight. She was hoping that she will be feeling a little bit better. Sometimes, she gets a little fever on Jan2021, also like maybe 99 (unspecified). She just wanted to know if any of the medications were good or not for the shot. The patient was asking whether the drugs interacted. The patient also reported that when she took her first shot, she had a little fever and asked what she could take for it. An agent stated that she could take paracetamol (TYLENOL). The patient mentioned that she took her pills, otherwise, her head felt like it was going to explode on Jan2021. She took her high blood pressure medicines. She has three medications namely clonidine, losartan and propranolol. She has a lot of medical conditions that was why she was calling because she takes other medications. The outcome of the events was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: shot started to hurt; blood pressure was gone up; Fever; my head feels like it is going to explode; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) solution for injection, via an unspecified route of administration on 29Jan2021 at 08:30 at single dose for COVID-19 immunization. The patient has a lot of medical conditions (unspecified). Concomitant medications included unspecified medications. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 (lot number: EL3286) at single dose for COVID-19 immunization and experienced fever. The patient reported that she had her shot this morning (29Jan2021) at about 08:30 and towards evening, the shot started to hurt and so she wanted to make sure that it didn't go against anything, and put a little ice on it or maybe it was worthless on ice on certain situations after the fact that she thought this was too late. She wanted to make sure she could do that. The patient's blood pressure also went up on 29Jan2021. She was taking several different medicines for blood pressure. She took them already tonight. She was hoping that she will be feeling a little bit better. Sometimes, she gets a little fever on Jan2021, also like maybe 99 (unspecified). She just wanted to know if any of the medications were good or not for the shot. The patient was asking whether the drugs interacted. The patient also reported that when she took her first shot, she had a little fever and asked what she could take for it. An agent stated that she could take paracetamol (TYLENOL). The patient mentioned that she took her pills, otherwise, her head felt like it was going to explode on Jan2021. She took her high blood pressure medicines. She has three medications namely clonidine, losartan and propranolol. She has a lot of medical conditions that was why she was calling because she takes other medications. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site hypersensitivity
Clinical narrative: Skin allergic reaction at the site of pfizer covid 19 vaccine injection; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced skin allergic reaction at the site of Pfizer COVID 19 vaccine injection on an unspecified date. The 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: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (the patient). A female patient (Age: 65, Units: Unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 08Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history included reactions to 'every vaccine' (unspecified). Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. Prior to receiving the first dose of Pfizer COVID-19 vaccine, the patient took ibuprofen (ADVIL) 600 mg. After the first dose, she took Advil again. In the second dose of the vaccine, initially she didn't take Advil, but 2 days after the second dose, she took Advil again. The patient wanted to know if that would affect the effect of the vaccine, since she confirmed that she was having this headache in any vaccine. The patient asked if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. She received her first Pfizer COVID vaccine; however, due to a history of reactions to 'every vaccine', she took 600 mg of Advil prior to her appointment. After her second dose, she took Advil for 2 days after due to her headache. The patient wanted to know how long after taking the COVID vaccine does Pfizer recommend taking the antibodies test, and if it was possible for her doctor to recommend a third dose of the COVID vaccine. The clinical outcome of headache was unknown.  Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experiencing upper leg pain (flu); This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A female patient of unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unknown route of administration on 29Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unknown date. The patient experienced upper leg pain (flu) on an unknown date. The clinical outcome of the event upper leg pain was unknown.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: she took a Tylenol 1 hour before her covid vaccine; This is a spontaneous report from a contactable consumer via the Pfizer Sponsored Program.  A 67-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. Medical history included ear infection.  The patient's concomitant medications were not reported. The patient reported that she got the COVID-19 vaccine on Wednesday 27Jan2021. The Prior Sunday she developed inner ear infection, so she took Tylenol about an hour before the vaccine. She heard taking a pain reliever could lessen effectiveness if taken before shot. She took Tylenol about an hour before the vaccine, she inquired if that is okay. The clinical outcome was unknown.   Information about Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: she will take medication for her Sinus/she is having some sinus problems; This is a spontaneous report from a Pfizer-sponsored program. A 72-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (at the age of 72-years-old), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization.  Medical history included sinus problems "this time of year and takes Mucinex DM for it." Concomitant medications were not reported. On an unspecified date, she experienced some sinus problems. The clinical outcome of the event sinus problems was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: suspected COVID-19 with symptoms; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-Sponsored Program, Pfizer First Connect. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that "on 01Jan2021 she had COVID like symptoms. Her husband got COVID-19. She had not received her second dose because she was sick. Her second dose was supposed to be on 20Jan2021. She was scheduled to go back to work on 01Feb2021 and would be able to get a dose on 02Feb2021." The patient wondered if she was supposed to start over or if she could just get the second dose. The clinical outcome of the event "suspected COVID-19 with symptoms" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: her mom tested positive with Covid-19 vaccine; COVID-19 confirmed by postiive COVID-19 test; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on an unknown date. The clinical outcome of the event COVID-19 was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Lethargic; Flu like symptoms; Lower part of my leg, I have little bit rash, a redness; Lower part of my leg, I have little bit rash, a redness; I have few spots on my right forearm; This is a spontaneous report from a contactable consumer.  A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration at the age of 75 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation from an unknown date and unknown if ongoing and anticoagulant therapy from an unknown date and unknown if ongoing. Concomitant medication included dronedarone hydrochloride (MULTAQ) at 400mg, twice daily and apixaban (ELIQUIS) at 5mg, two times daily. The patient stated, "Both my husband and I took the Covid the first shot on 22Jan2021 which was week ago today. I noticed about 4 days later (Jan2021) like I started feeling you know flu like symptoms but they were mild, if I took two an Extra strength Tylenol it went away. You know what I mean. So that one for about may be one, two may three days and that was it. I was very lethargic. The only thing I did notice that on both my legs from the ankles of about midways I have you know my leg, the lower part of my leg, I have little bit rash, a redness. It does not itch, it was not hard to the touch. My body temperature was normal. It was little red or pinkish to a little bit of red. Now, I noticed tonight that I have few spots on my right forearm. Like I said we have shot on 22nd, everything was fine, no immediate reaction or anything else and everything is okay. I just you know I feel fine but is this normal?" The patient stated, "No, they are healthy and safe about 20-25 minutes. Everything was fine and then let us go and I said couple of days later it hasn't progressed, it is very, it is on both of my lower legs from ankles midway up my legs and I noticed couple of spots on my left forearm but it hasn't gotten any worst and it hasn't gotten spread on any place other than right forearm." The patient also stated, "You mean the rash or any other the symptoms. We have the shot Friday, Saturday, Sunday, Monday. I was say this past Tuesday, around 26th (further not clarified)." The patient stated, "It was there on my legs. It hasn't moved. It hasn't gotten any worse and it is only on front it is not back on my legs. The only thing I noticed tonight that it is couple of spots on my right forearm." The consumer stated, "No, I went to see my doctor the other day for her to take look at it. I went to see PA at my doctor's office, I saw her and she said if it doesn't get worse it would probably go away." The patient also stated, "The only thing that I had done right before the Covid Vaccine. I had injection in my knee of amniotic fluid for a torn meniscus but that should not affect it." The patient underwent lab tests and procedures which included body temperature: normal on an unspecified date. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysstasia, Gait inability, Headache, Lymphadenopathy
Clinical narrative: significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; headache; sore throat; This is a spontaneous report from a non-contactable nurse.  A 28-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 21Jan2021 at single dose for COVID-19 immunisation.  Medical history included asthma, fibromyalgia, anxiety, depression and known allergies: penicillin.  Concomitant medication included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN [LORATADINE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA).  The patient previously took first dose of BNT162B2 on 02Jan2021 on the left arm. The patient experienced significant lymph node swelling, body aches, unable to walk/stand, chills, headache, sore throat on 21Jan2021.The patient received no treatment.  The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: significant lymph node swelling; body aches; unable to walk/stand; unable to walk/stand; chills; headache; sore throat; This is a spontaneous report from a non-contactable nurse.  A 28-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the left arm on 21Jan2021 at single dose for COVID-19 immunisation.  Medical history included asthma, fibromyalgia, anxiety, depression and known allergies: penicillin.  Concomitant medication included escitalopram oxalate (LEXAPRO), loratadine (CLARITIN [LORATADINE]), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA).  The patient previously took first dose of BNT162B2 on 02Jan2021 on the left arm. The patient experienced significant lymph node swelling, body aches, unable to walk/stand, chills, headache, sore throat on 21Jan2021.The patient received no treatment.  The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: My face is swelled; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration (at the age of 84years) on 29Jan2021 at 09:00 at single dose for covid-19 immunisation and diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date at unspecified dose and frequency for an unspecified indication. Medical history included have a pacemaker. Concomitant medications were unspecified as stated, "I am taking lot of medication." The patient reported, "My face is swelled" on 29Jan2021. Consumer stated, "I got the Pfizer vaccine today and I looked in a mirror a couples of hours ago and my face is swelled. So, my question is should I take diphenhydramine hydrochloride or not? It got a little better but it is still swollen. I wonder if I took diphenhydramine hydrochloride would that be helpful. I am getting better." There was no treatment for the event. The action taken in response to the event for diphenhydramine hydrochloride was unknown. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number FF09262), via an unspecified route of administration on 28Jan2021 12:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had pain at the injection site with the Covid-19 vaccine. It has been over 21 hours. Is due for the second one on 18Feb2021. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Lacrimation increased, Pain, Pyrexia, Sneezing
Clinical narrative: Coughing and nasal symptoms are listed as possible signs of Covid19 infection; reporting body aches; fever; watery eyes; sneezing; dry cough; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history included Exposure to SARS-CoV-2 (around an elderly co-worker that tested positive for Covid19 infection). Concomitant medications were not reported.  The patient experienced body aches (not 'itch' as reported), fever, watery eyes, sneezing, and a dry cough. Caller wanted to know if these symptoms are normal? Coughing and nasal symptoms were listed as possible signs of covid19 infection. The patient had been around an elderly co-worker that tested positive for Covid19 infection, caller did not find out until after receiving his first dose. He spent 4 - 5 hours with him, before getting his shot. If he tests positive for Covid19 infection, how does that affect his next dose which was scheduled for 01Mar2021? The outcome of the events was unknown.  Information on Lot/Batch number has been requested.