chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: low grade fever; chills; felt like crap; possible food poisoning; I did not want to eat; sick; nausea; vomiting; diarrhea; normal soreness in arm; I feel more tired and 'not rested' now; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 17Mar2021 (at the age of 59-years-old) as dose 1, single for covid 19 immunization. The patients medical history include Food poisoning (that was only cured by going to the hospital). The patients concomitant medications were not reported. On 17Mar2021, patient received the first dose of the Pfizer Biontech COVID 19 vaccine. After the first dose, she had normal soreness in arm and the pain went away after 24 hours. Currently, on unspecified date in Mar2021 she feel more tired and not rested now as compared to the first 3 days after the injection. she went out on Saturday, 20Mar2021, for her birthday and had no side effects from the vaccine besides a hang over the next morning since her grandkids were buying her so many alcoholic shots. On Sunday, 21Mar2021, she went to a casino, ate around 5:30-6 PM and was feeling fine. There was something she had not eaten so took that home and ate that at 8 PM and a couple of hours after that, 10:30 PM she started getting sick: had nausea, vomiting, diarrhea. The vomiting and diarrhea lasted until 2 AM; then she fell asleep after that. The nausea continued the next day (22Mar2021) because she did not want to eat. On Monday night, 22Mar2021, she had low grade fever (99.4 F at 10:30 PM), chills and felt like crap. This morning she was feeling better but still feel chills; she was only eating soup and crackers. So the possible food poisoning only lasted 24 hours. As of this morning on 23Mar2021, she had no temperature. Outcome of events normal soreness in arm recovered on unspecified date in Mar2021, vomiting, diarrhea recovered on 22Mar2021 02:00 AM, low grade fever and possible food poisoning recovered on 23Mar2021, I feel more tired and not rested now, sick, nausea, I did not want to eat, chills, felt like crap, was unknown   No follow up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: currently it's my shoulder. The pain comes periodically/at the wrist pain and upper muscle where the shot was given/pain was in her shoulder, upper muscles, wrist, elbow, mostly on her arm- her wrist, middle finger, and thumb; at the wrist pain and upper muscle where the shot was given; throbbing; pain was in her shoulder, upper muscles, wrist, elbow, mostly on her arm- her wrist, middle finger, and thumb; pain was in her shoulder, upper muscles, wrist, elbow, mostly on her arm- her wrist, middle finger, and thumb; This is a spontaneous report from a contactable consumer or other non hcp (patient herself) via medical information team. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202, Expiry date: Unknown) via an unspecified route of administration on 09Mar2021 as dose 1, single (at the age of 50-years-old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 12Mar2021, the patient experienced currently it's my shoulder, the pain comes periodically/at the wrist pain and upper muscle where the shot was given/pain was in her shoulder, upper muscles, wrist, elbow, mostly on her arm- her wrist, middle finger, and thumb, at the wrist pain and upper muscle where the shot was given, throbbing, pain was in her shoulder, upper muscles, wrist, elbow, mostly on her arm- her wrist, middle finger, and thumb, pain was in her shoulder, upper muscles, wrist, elbow, mostly on her arm, her wrist, middle finger, and thumb. Therapeutic measures were taken which included ibuprofen, she took ibuprofen in the night but, she don't want to continue to take it to get relief from it. Patient received treatment for the events. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: The first one was 2 weeks before the second; body feels on fire at night/Body feels like it is on fire; joints hurting/Joints are hurting; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) intramuscular, administered in Arm Left on 12Mar2021 14:00 (at the age of 73-years-old) as dose 2, single for COVID-19 immunization. Medical history included diabetic heart disease and low kidney function from an unknown date and unknown if ongoing. There were no concomitant medications. No investigation assessment was performed. On an unspecified date, the first one was 2 weeks before the second. On 13Mar2021 22:00, the body feels on fire at night/body feels like it is on fire and joints hurting/joints are hurting. No relevant test reported. No emergency room or physician's office required. The outcome of the event the first one was 2 weeks before the second was unknown. The outcome of the events body feels on fire at night/body feels like it is on fire and joints hurting/joints are hurting was not recovered.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: runny nose; sore throat; eye itchiness; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A female patient of an unspecified age received first 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 25Feb2021 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 23Mar2021, patient experienced runny nose, sore throat and eye itchiness. Patient said her schedule appointment is at 2:00 pm today but it's 45 minutes away from here. I don't want to drive all the way there. Can you tell me if I can receive the second dose today. caller was frustrated because she is been on the call since 9:00 a.m. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number and UPC number: not reported), via an unspecified route of administration on 20Mar2021 at 11:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever on 21Mar2021. Reporter stated that the patient had the vaccine on 20Mar2021, Saturday at approximately 11:00 am. It was fine and then in the afternoon of 21Mar2021, fever started spiking and at that night of 22Mar2021 it was 103.5. It really worried him. His concern was that, at 08:15 it was coming out as 101.7. It was coming up so they gave him three Advil, Ibuprofen. And it climbed when they just checked it a few minutes ago. So, they wanted to know why was it not responding to the fever reduce and What else could the reporter gave him to get the fever come down because the fever was going up. Reporter stated that the patient took it at 8. By then, it should have kicked in and then at 10:13, his fever was a 103.5 and it might have not worked from 101.7 at 08:15 up to the groove. The reporter meant a lot in 2 hours. The reporter gave him Advil, you could not give him more. But it did not respond to the fever. What could the reporter give him to reduce his fever. Reporter was informed about the role of Pfizer drug safety. Reporter gave him Advil more but it did not response to the fever reduce. Reporter asked what could the reporter give him to reduce fever. Reporter asked whether you could not give the reporter an answer at that time. Reporter asked whether it was the emergency contact number. The patient underwent lab tests and procedures which included body temperature: 101.7 on 22Mar2021 at 08:15 (fever), body temperature: 103.5 on 22Mar2021 at 10:13 (fever at night). Therapeutic measures were taken as a result of fever. The outcome of event was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema
Clinical narrative: Blister; Redness; This is a spontaneous report from a contactable consumer or other non hcp. A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration, administered in Arm on 17Mar2021 (at the age of: 49-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Caller says that his wife got the Pfizer COVID-19 vaccine on 17Mar2021, then yesterday on 18Mar2021 she got a blister on her arm with a little redness on the spot, which he wonders if this is normal or if they should worry about it. Caller says that the blister had stayed the same after 24 hours, the same size, with no treatment. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: her arm was in pain from shoulder to the tips of her fingers; her arm muscle is still sore; her arm was in pain from shoulder to the tips of her fingers; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiration date was unknown) via an unspecified route of administration on 10Mar2021, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient would like to know what was considered a long time for side effects because for 4-5 days her arms was in pain from shoulder to the tips of her fingers, after it got better however 14 days after the injection her arm muscle was still sore. When she raises it over her head or her shoulder to get dressed. The patient wondered how long will this side effect last and if it will go away before the second dose of the vaccine. The outcome of the event arm muscle is still sore was not resolved and outcome of other events was resolving.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Rhinorrhoea
Clinical narrative: feeling shortness of breath; headache; runny nose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on 18Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient was feeling shortness of breath, headache and runny nose. The outcome of the events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation
Clinical narrative: soreness; pain in his shoulder; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 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 dose 1, single for COVID-19 immunization. Medical history included, diabetes mellitus from an unknown date and unknown if ongoing, parkinson's disease from an unknown date and unknown if ongoing. Concomitant medication(s) included dabigatran etexilate mesilate (PRADAXA) taken for an unspecified indication from an unspecified start date and ongoing; dabrafenib mesilate (TAFINLAR) taken for an unspecified indication from an unspecified start date and ongoing; ramipril (RAMIPRIL) taken for an unspecified indication from an unspecified start date and ongoing; levodopa (LEVODOPA) taken for parkinsons disease from an unspecified start date and ongoing; carbidopa (CARBIDOPA) taken for parkinsons disease from an unspecified start date and ongoing; primidone (PRIMIDONE) taken for parkinsons disease from an unspecified start date and ongoing. Patient previously received Flu shot for Flu prevention on an unspecified date. It was reported that patient asking if he can take Pradaxa and Tafinlar with the second dose of Pfizer's COVID vaccine. Male consumer stated after his first dose of Pfizer COVID vaccine, he only had soreness on the 2nd day. On the 3rd day, there was nothing. He only had minor pain in his shoulder for a day. No swelling, no redness, nothing. Caller is on Pradaxa, Tafinlar (2 capsules twice daily), Ramipril 10mg, and Carbidopa/Levodopa for Parkinson's and he has diabetes. Patient states he was discontinued from Xarelto because it interacted with his Parkinson medication Primidone. He had always had flu shots and passed with flying colors. The outcome of the soreness was recovered on an unspecified date and event pain in his shoulder outcome was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Big hives that itches about half an inch away where I got the vaccine; Big hives that itches about half an inch away where I got the vaccine; This is a spontaneous report from a contactable consumer or other non-health professional (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: ER8727, expiry date: not reported), via an unspecified route of administration on 18Mar2021 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 big hives that itches about half an inch away where patient got the vaccine. Patient did not saw anything on the paper that says you could get hives so much (intent not clarified, hence MI not documented). The patient stated, "No, all I know is that I got an injection yesterday and just about a "quarter of an inch" (not clarified) away I have a big hives that is itching, about a quarter of an inch. Clinical outcome of the events was reported as unknown.  No follow-up attempt are possible. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, SARS-CoV-2 test, Wheezing
Clinical narrative: chest pain; wheezing; complaining of breathlessness; This is a spontaneous report from a contactable consumer (patient son). A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 (at the age of 65-year-old) as single dose for COVID-19 immunization. Medical history included a SARS-CoV-2 infection back in Nov2020 and tested negative afterward on 12Dec2020. The patient's concomitant medications were not reported. It was reported that recently, the patient received her first dose of Pfizer-Biontech Covid19 vaccine on 19Mar2021. That evening, the patient experienced some chest pain and she's been wheezing and complaining of some breathlessness since then. They had noticed that from that day she had been experiencing breathlessness. Of note, she had a SARS-CoV-2 infection back in Nov2020 and tested negative afterward on 12Dec2020. The caller stated he had seen the CDC guidelines that recommended waiting 90 days after infection before getting vaccinated and the interval between infection and vaccination for his mom was 96 or 97 days. He wanted to know if this is commonly reported, and what he should do next. He asked if they should take her to the urgent care or the ER. It was reported that the patient even had a negative covid19 test last week (Mar2021). Outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Muscle spasms, Pain
Clinical narrative: Chills; Achy; Headache; had spasms in her stomach and diarrhea; had spasms in her stomach and diarrhea; 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), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date for covid-19 immunisation. The patient experienced chills, achy, headache, had spasms in her stomach and diarrhea on an unspecified date. Therapeutic measures were taken as a result of events. It was reported states that she had the vaccine on Wednesday morning at 9am, and for the next 2 days she went through the whole list of side effects; she had chills, was achy, had a headache; she had everything but no fever. States that when she woke up this morning, she felt great. Then about 2 hours after waking up, she had spasms in her stomach and diarrhea; this has happened 4 times so far today and it's wearing her out. States that the last 2 times were very watery. Is there anything she can do for this? Is this usual? She knows it's on the list of possibilities, the diarrhea, but it doesn't say anything about spasms in the stomach. States the she has pressed down all over her stomach and nothing hurts. She took 1 Imodium a little while ago, is there anything else she should do or take.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Insomnia, Malaise
Clinical narrative: Terrible headache; Joint pains all over her body; Was up all night; Sick; This is a spontaneous report from a contactable consumer (wife).  A female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number and Expiration date were not provided), via an unspecified route of administration on unspecified date as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Reporter (calling on behalf of her wife) stated that his wife had her second vaccination yesterday and on unspecified date she was up all night and was sick today with a terrible headache and joint pains all over her body. Reported further stated that was wondering how long this last. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Dizziness, Headache, Insomnia, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This 61-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. Patient's medical history and concomitant medications not reported. Patient was not in poor health and exercised daily. Reportedly, after the first dose of the Pfizer-BioNTech COVID-19 vaccine, for 3 days patient had very bad side effects. She didn't have to go to the hospital. On an unspecified date, patient was "sick as a dog" and the vaccine really knocked her down for 2 to 3 days. She felt like her legs were being cut off. Her legs ached really very bad and they ached for 2 nights so much she could not sleep. She felt like she had a fever. She hyperventilated and remembered getting up to turn the fan on. She had no appetite and was nauseated but did not regurgitate. She was also dizzy and had a headache. She spoke with her doctor about the events she experienced. It was advised to still get the second dose because she was not fully protected. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Respiration abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This 61-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. Patient's medical history and concomitant medications not reported. Patient was not in poor health and exercised daily. Reportedly, after the first dose of the Pfizer-BioNTech COVID-19 vaccine, for 3 days patient had very bad side effects. She didn't have to go to the hospital. On an unspecified date, patient was "sick as a dog" and the vaccine really knocked her down for 2 to 3 days. She felt like her legs were being cut off. Her legs ached really very bad and they ached for 2 nights so much she could not sleep. She felt like she had a fever. She hyperventilated and remembered getting up to turn the fan on. She had no appetite and was nauseated but did not regurgitate. She was also dizzy and had a headache. She spoke with her doctor about the events she experienced. It was advised to still get the second dose because she was not fully protected. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This 61-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. Patient's medical history and concomitant medications not reported. Patient was not in poor health and exercised daily. Reportedly, after the first dose of the Pfizer-BioNTech COVID-19 vaccine, for 3 days patient had very bad side effects. She didn't have to go to the hospital. On an unspecified date, patient was "sick as a dog" and the vaccine really knocked her down for 2 to 3 days. She felt like her legs were being cut off. Her legs ached really very bad and they ached for 2 nights so much she could not sleep. She felt like she had a fever. She hyperventilated and remembered getting up to turn the fan on. She had no appetite and was nauseated but did not regurgitate. She was also dizzy and had a headache. She spoke with her doctor about the events she experienced. It was advised to still get the second dose because she was not fully protected. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Nausea, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This 61-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. Patient's medical history and concomitant medications not reported. Patient was not in poor health and exercised daily. Reportedly, after the first dose of the Pfizer-BioNTech COVID-19 vaccine, for 3 days patient had very bad side effects. She didn't have to go to the hospital. On an unspecified date, patient was "sick as a dog" and the vaccine really knocked her down for 2 to 3 days. She felt like her legs were being cut off. Her legs ached really very bad and they ached for 2 nights so much she could not sleep. She felt like she had a fever. She hyperventilated and remembered getting up to turn the fan on. She had no appetite and was nauseated but did not regurgitate. She was also dizzy and had a headache. She spoke with her doctor about the events she experienced. It was advised to still get the second dose because she was not fully protected. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thirst
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This 61-year-old female patient received the 1st dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via unspecified route of administration, on an unknown date, single dose, for COVID-19 immunization. Patient's medical history and concomitant medications not reported. Patient was not in poor health and exercised daily. Reportedly, after the first dose of the Pfizer-BioNTech COVID-19 vaccine, for 3 days patient had very bad side effects. She didn't have to go to the hospital. On an unspecified date, patient was "sick as a dog" and the vaccine really knocked her down for 2 to 3 days. She felt like her legs were being cut off. Her legs ached really very bad and they ached for 2 nights so much she could not sleep. She felt like she had a fever. She hyperventilated and remembered getting up to turn the fan on. She had no appetite and was nauseated but did not regurgitate. She was also dizzy and had a headache. She spoke with her doctor about the events she experienced. It was advised to still get the second dose because she was not fully protected. The outcome of all the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: At night her face had swelling which was only in her face; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 61-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 18Mar2021 as dose 2, single (at the age of 61-years-old) for COVID-19 immunization. The patient previously received first dose of BNT162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on an unspecified date as dose 1, single (at the age of 61 years old) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced at night her face had swelling which was only in her face on 18Mar2021 (reported as ongoing). Patient wanted to know what she should take or what is the cure for the swelling or is this normal. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pruritus, Throat irritation
Clinical narrative: Feeling congestion and itching to arms and throat; Feeling congestion and itching to arms and throat; Feeling congestion and itching to arms and throat; This is a spontaneous report from a contactable Other HCP. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported, Expiry date: unknown) via intramuscular route of administration on 06Mar2021 15:00 (at the age of 23-years-old) as dose 1, single for COVID-19 immunization administered at Public Health Clinic/Veterans Administration facility. It was unknown if patient was pregnant at the time of vaccination. The patient other medical history was unknown. It was unknown if the patient had allergies to medications, food or other products. The patient concomitant medications were not reported. It was unknown If the patient was diagnosed with COVID-19 prior to vaccination. It was unknown since the vaccination, has the patient been tested for COVID-19. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine and list of any other medications the patient received within 2 weeks of vaccination. On 06Mar2021 15:00, the patient reported she was feeling congestion and itching to arms and throat. The reporter assessed the events as non-serious. The patient received Benadryl 50mg PO total. Patient was able to drink water without difficulty. Patient discharged home after 60 minutes of observation for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: he is exposed with people who got tested positive with the virus and he stated that he got the same symptoms; This is a spontaneous report from a Pfizer sponsored program a contactable consumer(patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route of administration, administered on 06Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. On an unspecified date the caller reported that his 2nd appointment would be tomorrow 20Mar2021 he got the 1st dose last on 06Mar2021 (early than 21 days). He stated as well that he was exposed with people who got tested positive with the virus and he stated that he got the same symptoms. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Erythema, Fatigue, Neck pain, Pain
Clinical narrative: red; Injection site redness; swelling; Pain; Itching; Tiredness; Neck pain; Lower back pain; This is a spontaneous report from a contactable consumer. A 75-year-oldnon pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Right on 20Mar2021 13:15 (at the age of 75 years) as single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history included arthritis, low thyroid. Concomitant medications included Selenium, Kelp [ASCOPHYLLUM NODOSUM) and Vitamin D Nos, Multiple Daily Vitamin. Patient had no Known allergies. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm 27Feb2021 01:15 PM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. On 21Mar2021 13:45 the patient experienced injection site redness, swelling, pain, itching, tiredness, neck pain, lower back pain, on unspecified date patient had red (erythema). It was reported that the caller, called to say that she got both of the doses of covid 19 vaccine, and she was reporting adverse events like red, swollen and itchiness in the Injection site. She got the first dose of the covid 19 vaccine last 27Feb2021 and the second dose last 20Mar2021. Patient had no treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site erythema
Clinical narrative: red; Injection site redness; swelling; Pain; Itching; Tiredness; Neck pain; Lower back pain; This is a spontaneous report from a contactable consumer. A 75-year-oldnon pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Right on 20Mar2021 13:15 (at the age of 75 years) as single dose for COVID-19 immunization at Pharmacy or Drug Store. Medical history included arthritis, low thyroid. Concomitant medications included Selenium, Kelp [ASCOPHYLLUM NODOSUM) and Vitamin D Nos, Multiple Daily Vitamin. Patient had no Known allergies. Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm 27Feb2021 01:15 PM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not have covid prior vaccination and no covid tested post vaccination. On 21Mar2021 13:45 the patient experienced injection site redness, swelling, pain, itching, tiredness, neck pain, lower back pain, on unspecified date patient had red (erythema). It was reported that the caller, called to say that she got both of the doses of covid 19 vaccine, and she was reporting adverse events like red, swollen and itchiness in the Injection site. She got the first dose of the covid 19 vaccine last 27Feb2021 and the second dose last 20Mar2021. Patient had no treatment received. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Hypoaesthesia, Nausea, Palpitations, Paraesthesia
Clinical narrative: allergic reaction; face became tingly and numb; face became tingly and numb; real bad heart palpitations/heart racing; nauseousness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Mar2021 (age at vaccination was 41 years) as dose 1, single for COVID-19 immunization. The patient's medical history included food allergies. The patient was allergic to esters and anything that ends in "caine" like Novacaine (any esters in product, ie: something that ends in "caine" like novacaine). The patient's concomitant medications were not reported. On 10Mar2021, the patient experienced what she considered was a mild allergic reaction after first dose. Because she had some sensitivity to medications, she waited and was observed for 30 minutes after the first dose. Approximately 3 minutes into the drive home, on 10Mar2021, her face became tingly and numb, which lasted about 9-10 hours. That was a similar reaction she had before with food allergies or other sensitivities. She had real bad heart palpitations or heart racing, felt like a lot of adrenaline, to the point she did not fall asleep until 3:00 am. It was an uncomfortable feeling with the heart. She had mild nauseousness for 8 hours. Everything resolved by about 1:00-2:00 am and was able to sleep by 3:00 am. The patient's second dose was scheduled on 31Mar2021. The patient wanted to know if it was advisable for next dose. The patient's neighbor who was ER nurse suggested taking Benadryl before next dose. The outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I have a fever of 101.2; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number: EP7534; expiry date: unknown) at the age of 69-years-old, as dose 2, single, for Covid-19 immunisation. Medical history included ongoing high blood pressure (takes medication so it's under control). Concomitant medications included losartan and hydrochlorothiazide taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunisation. The patient experienced fever of 101.2 on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Heart rate increased, Malaise, Pain
Clinical narrative: Body ache/she is in pain; Chills; Her heart beat is a little bit faster than normal; Feeling so bad in heart; Little bit of chest pain coming from the front to the back; Don't feel good; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported, dose unknown via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient medical history included anxiety. The concomitant medications were not reported. The consumer reported that, he was calling on behalf of his wife who recently, on Saturday, took Corona virus Covid-19 vaccine by Pfizer. On an unspecified date, the patient experienced some body ache and had chills. Her heartbeat was a little bit faster than normal, feeling so bad in heart and little bit of chest pain coming from the front to the back. She used to take medication for anxiety occasionally and she wanted to know if she would take her medication for anxiety to help possibly with the pain of heart because did not feel good and experienced pain. Outcome of the events was unknown.  No follow-up attempt are needed. Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Feeling of body temperature change, Pain, Pyrexia
Clinical narrative: She is feeling weak because she has pain all over her body; She is feeling weak because she has pain all over her body; getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth; getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth; This is a spontaneous report from contactable consumer (patient daughter) reported for her mother. A female patient of unknown age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207, Expiry Date: unknown, Solution for injection), via an unspecified route of administration on 19Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunisation. Consumer stated, yesterday on 19Mar2021 her mother got her second shot for the vaccine and today 20Mar2021 she was feeling weak because she has pain all over her body, she was getting hot and cold, fever like she was feeling hot and then cold, hot and cold both back and forth." Reporter confirmed the vaccine as Pfizer Covid 19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lip swelling
Clinical narrative: started feeling something weird on my upper lip, the left one; feeling something like it was, the lips is something wrong; I am been swollen from the lip, the upper left lip; This is a spontaneous report from a contactable consumer. This 67-years-old female consumer (patient) reported for herself.  A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 10:40 (at the age of 66-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Mar2021 20:30, the patient experienced started feeling something weird on my upper lip, the left one, feeling something like it was, the lips is something wrong and i am been swollen from the lip, the upper left lip. The patient reported regarding COVID vaccine reaction. After the vaccine it is been 15 minutes everything was okay but the on 20Mar2021 about 8:30 she started feeling something weird on my upper lip, the left one and I was feeling something like it was, the lips is something wrong. It looks like swollen but I am been swollen from the lip, the upper left lip." The patient not received any treatment (No, because I do not know what to take). The outcome of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: I just got progressively tired; Headache a still a bit. It is still affecting my eyesight; Headache a still a bit. It is still affecting my eyesight; Injection site is very sore; I am freezing, I have the chills on badly.; Fever over 100; Severe muscle aches; Pains in my joint; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 20Mar2021 (age at vaccination: 68 years), as a dose 1, single for COVID-19 immunization. The patient's medical history includes asthma (Start: Unspecified Stop: Unspecified). The patient concomitant medications include levothyroxine sodium (Synthroid) (Start: Unspecified Stop: Unspecified), montelukast sodium (singulair) for asthma (Start: Unspecified Stop: Unspecified), pitavastatin calcium (livalo) (Start: Unspecified Stop: Unspecified). On an unspecified date in Mar2021, later in the night, the patient got severe headache, chills and the patent have fever over 100. Reportedly the patient muscles and joints ache like crazy and her headache was so bad, it was affecting patient eyesight. Reportedly the patient felt tired when they gave her injection. The patient was fine yesterday. It was reported that 3 hours afterwards the patient walked out of there at 10:45. The patient stayed there for 15 minutes and then just got progressively tired, and at about 7 O'clock late night, I started getting the chills. the patient was freezing and cannot get warm. Reportedly the patient was freezing and have the chills on badly. Patient heated blanket around her. The injection site was very sore. It was reported that the patient had a Covid-19 first dose yesterday. The patient did not receive the treatment because the patient was told to not take any kind of Aspirin or Ibuprofen because it has an adverse effect on the needle and the patient dont not know what to do. That why the patient was calling. Outcome of the event was unknown.  No follow-up attempts are possible. information about batch/ lot number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site pain, Visual impairment
Clinical narrative: I just got progressively tired; Headache a still a bit. It is still affecting my eyesight; Headache a still a bit. It is still affecting my eyesight; Injection site is very sore; I am freezing, I have the chills on badly.; Fever over 100; Severe muscle aches; Pains in my joint; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number and expiry date were not reported), via an unspecified route of administration, on 20Mar2021 (age at vaccination: 68 years), as a dose 1, single for COVID-19 immunization. The patient's medical history includes asthma (Start: Unspecified Stop: Unspecified). The patient concomitant medications include levothyroxine sodium (Synthroid) (Start: Unspecified Stop: Unspecified), montelukast sodium (singulair) for asthma (Start: Unspecified Stop: Unspecified), pitavastatin calcium (livalo) (Start: Unspecified Stop: Unspecified). On an unspecified date in Mar2021, later in the night, the patient got severe headache, chills and the patent have fever over 100. Reportedly the patient muscles and joints ache like crazy and her headache was so bad, it was affecting patient eyesight. Reportedly the patient felt tired when they gave her injection. The patient was fine yesterday. It was reported that 3 hours afterwards the patient walked out of there at 10:45. The patient stayed there for 15 minutes and then just got progressively tired, and at about 7 O'clock late night, I started getting the chills. the patient was freezing and cannot get warm. Reportedly the patient was freezing and have the chills on badly. Patient heated blanket around her. The injection site was very sore. It was reported that the patient had a Covid-19 first dose yesterday. The patient did not receive the treatment because the patient was told to not take any kind of Aspirin or Ibuprofen because it has an adverse effect on the needle and the patient dont not know what to do. That why the patient was calling. Outcome of the event was unknown.  No follow-up attempts are possible. information about batch/ lot number cannot be obtained.