chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Malaise
Clinical narrative: some pain in his stomach; He was not feeling well; dizziness; This is a spontaneous report from a contactable consumer (patient). A male patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: unknown) via unknown route of administration on an unknown date, dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that he was not feeling well and had some pain in his stomach and dizziness after the 1st dose. Patient wants to schedule for his 2nd dose. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain in extremity
Clinical narrative: she was in so much pain; unable to use her hand; This is a spontaneous report from a contactable consumer (patient), via Pfizer-sponsored program Pfizer First Connect. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN9581), via an unspecified route of administration, on an unspecified date at 13:30 (at the age of 68-year-old), as dose 2, single, in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's past drug included cortisone, taken for dog bite in left hand. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), via an unspecified route of administration, on 23Jan2021 (at the age of 68-year-old), as single dose for COVID-19 immunization and experienced no symptoms. On 14Feb2021, after the second dose of vaccine, the patient was unable to use her hand "at all." Patient reported that it was improving but "just still hard to open that hand." Patient thought that the vaccine shot "may have hit a tendon and brought the pain back from the dog bite." On an unspecified date, after the second dose of vaccine, the patient was in so much pain. It was really bad. Patient reported that it was getting better. The clinical outcome of both the events was resolving.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Low fever of 100.2 F; This is a spontaneous report from a contactable consumer and other Health Professional. A 34-year-old male patient (consumer) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 07:15 (Age 34-year-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation. The medical history included Factor XI bleeding disorder from an unknown date and unknown if ongoing, Left and Right hip replacements (Summer of 2003 and Summer of 2007). The patient had Non-hodgkin's lymphoma from 01Aug2001 and finished the treatment in the fall of 2003. Since then, the patient did not had cancer. Historical Vaccine included BNT162B2 dose1 given on 22Jan2021 at administration time 7:15 AM on Left arm (age 34-year-old at the time of vaccination, lot number unknown) for COVID-19 immunisation and developed Mild headache after first dose. The concomitant medication included dextroamphetamine [dexamfetamine] taken for an unspecified indication, start and stop date were not reported. Facility type vaccine was given at hospital. No other vaccine received in four weeks. The patient did not have covid prior vaccination and was not tested covid post vaccination. There were no Known allergies. The patient developed Low fever of 100.2 F the next morning on 13Feb2021 at 4:15 AM, after the second dose. Also, the patient mentioned, two days after the first dose, the patient developed a mild headache, but that could have been due to any number of other things. The patient underwent lab tests and procedures which included body temperature, which was found to be 100.2 Fahrenheit on 13Feb2021. The outcome of the event was reported as recovering.  Follow-up attempts completed. No further information expected. Information on the lot/ batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms; chills; Fever; body pain; This is a spontaneous report from a contactable consumer or other non hcp. A 55-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL 9267) via an unspecified route of administration, administered in Arm Left on 13Feb2021 13:00(age at vaccination: 55 years) as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't had covid prior to vaccination. Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medication Lisinopril 10mg 1 tab daily within 2 weeks of vaccinations. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported. Patient had no allergies. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number EL9261) via unspecified route of administration in Arm left on 23Jan2021(age at vaccination: 55 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not tested for covid to post vaccination. On 14Feb2021 10:00 the patient experienced flu like symptoms, chills, fever, body pain. No therapeutic measures were taken for the events. The outcome of the events influenza like illness, chills, pyrexia, pain was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Limb discomfort
Clinical narrative: Diarrhea; fatigue; sore arm; This is a spontaneous report from a contactable physician. A 3-decade-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was not provided) as DOSE NUMBER UNKNOWN, SINGLE for an unspecified indication. The medical history included infected with COVID-19 prior to being vaccinated from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient in her 20's received the Pfizer Covid-19 vaccine on an unspecified date and had severe reaction on an unspecified date. The patient had been infected with COVID-19 prior to being vaccinated on an unspecified date. When she received the vaccine, the patient developed diarrhoea and fatigue that lasted about 3 days on an unspecified date. She also had a sore arm that lasted about a day on an unspecified date. The outcome of the events was reported as recovered on an unspecified date.  Follow-up attempts completed. No further information expected. Information about lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Headache, Neck pain
Clinical narrative: Slept almost the entire day; Headache; Joint pain in legs and neck; Joint pain in legs and neck; Joint pain in legs and neck; Loss of appetite; Chills and Shivers; Chills and Shivers; Sore left arm; Sore arm started at 5pm that day. It has improved, but it is a little itchy now.; This is a spontaneous report from a contactable consumer or other non hcp (patient). The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 15Feb2021, this case now contains all required information to be considered valid. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6021; Expiration Date: Jun2021) via intramuscular route of administration, administered in arm left on 12Feb2021 09:45 (at the age of 73-year-old) at dose 1, single for covid-19 immunisation. Medical history included Retroperitoneal Liposarcoma/Diagnosed 10 years ago with 4 surgeries last one being Aug 2020 and cancer (I am a cancer patient). Concomitant medications were not reported. The patient experienced Sore arm started at 5pm that day. It has improved, but it is a little itchy now on an unspecified date in 2021, sore left arm on 12Feb2021 17:00, chills and shivers on 12Feb2021 22:00, slept almost the entire day, headache, joint pain in legs and neck, loss of appetite on 13Feb2021. Reporter has experienced quite some side effects from the 1st dose of the vaccine and is asking if the side effects of the 2nd dose will be more severe as she's heard it to be like that. She is also asking for any contraindications of the vaccine as she is a cancer patient. Received covid vaccine on Friday. Calling in to report her side effects. Received call from consumer regarding the Pfizer COVID vaccine. She had her first dose last Friday. She would like to report symptoms from that. She did not wish to provide an address or email. There was no prescriber. She is with a Health Service and filled out a questionnaire, and the next day found out she was eligible. Sore arm started at 5pm that day. It has improved, but it is a little itchy now. She was not aware of the joint pain on 13Feb2021 because she was wiped out and was not totally aware. She was not eating and was sleeping all day that day. She is still feeling wiped out since yesterday, but it has improved. She has questions about second dose. She wanted to know if it will be worse with second dose. NO ER or physician's office required. Prior Vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Outcome of the event Sore arm started at 5pm that day. It has improved, but it is a little itchy now was unknown and remaining other events was resolving.  Follow-up (01Apr2021): Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Somnolence
Clinical narrative: Slept almost the entire day; Headache; Joint pain in legs and neck; Joint pain in legs and neck; Joint pain in legs and neck; Loss of appetite; Chills and Shivers; Chills and Shivers; Sore left arm; Sore arm started at 5pm that day. It has improved, but it is a little itchy now.; This is a spontaneous report from a contactable consumer or other non hcp (patient). The initial case was missing the following minimum criteria: unspecified AE. Upon receipt of follow-up information on 15Feb2021, this case now contains all required information to be considered valid. A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6021; Expiration Date: Jun2021) via intramuscular route of administration, administered in arm left on 12Feb2021 09:45 (at the age of 73-year-old) at dose 1, single for covid-19 immunisation. Medical history included Retroperitoneal Liposarcoma/Diagnosed 10 years ago with 4 surgeries last one being Aug 2020 and cancer (I am a cancer patient). Concomitant medications were not reported. The patient experienced Sore arm started at 5pm that day. It has improved, but it is a little itchy now on an unspecified date in 2021, sore left arm on 12Feb2021 17:00, chills and shivers on 12Feb2021 22:00, slept almost the entire day, headache, joint pain in legs and neck, loss of appetite on 13Feb2021. Reporter has experienced quite some side effects from the 1st dose of the vaccine and is asking if the side effects of the 2nd dose will be more severe as she's heard it to be like that. She is also asking for any contraindications of the vaccine as she is a cancer patient. Received covid vaccine on Friday. Calling in to report her side effects. Received call from consumer regarding the Pfizer COVID vaccine. She had her first dose last Friday. She would like to report symptoms from that. She did not wish to provide an address or email. There was no prescriber. She is with a Health Service and filled out a questionnaire, and the next day found out she was eligible. Sore arm started at 5pm that day. It has improved, but it is a little itchy now. She was not aware of the joint pain on 13Feb2021 because she was wiped out and was not totally aware. She was not eating and was sleeping all day that day. She is still feeling wiped out since yesterday, but it has improved. She has questions about second dose. She wanted to know if it will be worse with second dose. NO ER or physician's office required. Prior Vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Outcome of the event Sore arm started at 5pm that day. It has improved, but it is a little itchy now was unknown and remaining other events was resolving.  Follow-up (01Apr2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer via Pfizer sales Representative. (patient, reported for self). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date) as dose 2, single for COVID-19 Immunisation. The patient medical history and patient's concomitant medications were not reported. The patient experienced chills, Headache on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Lymphadenopathy, Pyrexia, Vaccination site erythema
Clinical narrative: Well my arm at the injection site is about 5 times in size/ her arm is swollen 2-3 times the size since she received the vaccine on Sunday; My arm at the injection site is about 5 times in size; it's huge and hot to touch, it's red also; My arm at the injection site is about 5 times in size; it's huge and hot to touch, it's red also; the lymph nodes under arm are swollen; has been running fever with 100.5 being the highest that it has gotten.; redness; This is a spontaneous report received via Pfizer-sponsored Program Pfizer First Connect from a contactable nurse (the patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received 1st dose of Covid vaccine and was experiencing some side effects such as her arm was swollen 2-3 times the size since she received the vaccine on Sunday, the Lymph nodes under arm are swollen and she had been running fever with 100.5 being the highest that it has gotten. Nurse stated, I was trying to speak with someone regarding the vaccine, I received on Friday, I mean on Sunday. I know that it specified that you could have redness, swelling, fever and all of that stuff which I've had all of that and the swelling in the lymph node and stuff, well my arm at the injection site is about 5 times in size, when confirmed if nurse wanted to know if it was normal or not, nurse stated, yeah it was huge and it was hot to touch, and it's red also. The patient underwent lab tests and procedures which included fever (body temperature): 100.5 on an unspecified date. The outcome of all the events was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Well my arm at the injection site is about 5 times in size/ her arm is swollen 2-3 times the size since she received the vaccine on Sunday; My arm at the injection site is about 5 times in size; it's huge and hot to touch, it's red also; My arm at the injection site is about 5 times in size; it's huge and hot to touch, it's red also; the lymph nodes under arm are swollen; has been running fever with 100.5 being the highest that it has gotten.; redness; This is a spontaneous report received via Pfizer-sponsored Program Pfizer First Connect from a contactable nurse (the patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received 1st dose of Covid vaccine and was experiencing some side effects such as her arm was swollen 2-3 times the size since she received the vaccine on Sunday, the Lymph nodes under arm are swollen and she had been running fever with 100.5 being the highest that it has gotten. Nurse stated, I was trying to speak with someone regarding the vaccine, I received on Friday, I mean on Sunday. I know that it specified that you could have redness, swelling, fever and all of that stuff which I've had all of that and the swelling in the lymph node and stuff, well my arm at the injection site is about 5 times in size, when confirmed if nurse wanted to know if it was normal or not, nurse stated, yeah it was huge and it was hot to touch, and it's red also. The patient underwent lab tests and procedures which included fever (body temperature): 100.5 on an unspecified date. The outcome of all the events was unknown.  Information on the Lot/Batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: patch on my stomach/rectangular area on her stomach double the size of a stamp/woke up with a patch double the size of a stamp; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration, administered in Arm Left on 13Feb2021 between 8:45 and 9:00 as dose 1, single for COVID-19 immunisation. Patient medical history included Shellfish allergy, Nut allergy, Chocolate allergy (had the allergy for quite some time), High cholesterol and high blood pressure. Concomitant medications included Amlodipine 10mg and Hydrochlorothiazide 12.5 mg taken for high blood pressure, Rosuvastatin 10mg taken for High cholesterol, Colecalciferol (D3), Pyridoxine hydrochloride (B6) and multivitamin. The patient previously took Allegra as she suffers with hay fever. She didn't take Allegra the day she got the vaccine. She did not take any vaccinations within 4 weeks prior to COVID-19 vaccine. It was reported that, on 14Feb2021 between 7:30 and 8:00, the patient experienced patch on her stomach. She woke up with a patch double the size of a stamp. It is rectangular in shape. It is like a frame on her stomach on the right side. On the left side it is very faint and didn't completely come through. She reports that the area is not itchy and is not swollen. The patch has not worsened. It might of had a little improvement but she would say it has stayed the same. She has not visited the Emergency room or physician's office. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Joint swelling
Clinical narrative: muscle pain; headaches; joint pain; chills; hands are swelling; knuckles are swelled up; breathing issues; This is a spontaneous report from a contactable consumer. This male consumer reported.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had nothing but side effects since the patient got his first shot. The patient experienced muscle pain, headaches, joint pain, chills at times, hands are swelling, and knuckles are swelled up all on an unspecified date. The patient had breathing issues for a while one evening on an unspecified date. The patient called to ask what the patient should take for the side effects he had been experiencing since his first dose. The patient also asked whether he should take the second dose. Outcome of the events muscle pain, headaches, joint pain, chills at times, hands are swelling, and knuckles are swelled up were reported as Unknown at this time of the report. Outcome of the event breathing issues was reported as recovered on an unspecified date at this time of the report.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: muscle pain; headaches; joint pain; chills; hands are swelling; knuckles are swelled up; breathing issues; This is a spontaneous report from a contactable consumer. This male consumer reported.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had nothing but side effects since the patient got his first shot. The patient experienced muscle pain, headaches, joint pain, chills at times, hands are swelling, and knuckles are swelled up all on an unspecified date. The patient had breathing issues for a while one evening on an unspecified date. The patient called to ask what the patient should take for the side effects he had been experiencing since his first dose. The patient also asked whether he should take the second dose. Outcome of the events muscle pain, headaches, joint pain, chills at times, hands are swelling, and knuckles are swelled up were reported as Unknown at this time of the report. Outcome of the event breathing issues was reported as recovered on an unspecified date at this time of the report.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. Patient stated he is allergic to Amoxicillin where he didn't have a rash reaction until 8 to 10 days later. On 12Feb2021, patient experienced swelling in his left armpit, the same side where he received the shot, little swelling in the right armpit. On an unspecified date in Feb2021, patient experienced little swelling of the arm. The outcome of the event little swelling of the arm was unknown, swelling in his left armpit, the same side where he received the shot was recovering, little swelling in the right armpit was recovered on an unspecified date in Feb2021.   No follow up attempts are possible. Information about Lot and batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: She developed an allergic reaction with a rash; She developed an allergic reaction with a rash; This is a spontaneous report received from a non-contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter called for information about if the treatment she was receiving for the management of an allergy could interact with the administration of the second dose of the Pfizer's COVID-19 vaccine on 03Mar2021. The consumer reports that she developed an allergic reaction with a rash on unknown date and she was received treatment for this condition. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, Paraesthesia oral, Pyrexia
Clinical narrative: lost his sense of taste; cannot feel anything in his mouth; lost his sense of taste and smell; runny nose; fever; headache; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 37-year-old male patient reported that they received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9269), via unspecified route of administration in right arm on 05Feb2021 14:25 (at the age of 37 years) as a DOSE 1, SINGLE for COVID-19 immunization. Patient had no medical history and had not received concomitant medications (Other Products). Patient was not administered with any other additional Vaccines on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that he had a very slight headache on 10Feb2021 that was no big deal. Patient stated that he received the Pfizer vaccine 10 days ago, on Friday before, then six days later on 11Feb2021 he had a fever which he knew was a side effect of the vaccine. The day before the fever was very brief, maybe two hours in the night. Then a couple of days later on 13Feb2021 he had a runny nose. It was a crazy runny nose, he had to breathe out of his mouth and was using lots of paper. On 14Feb2021 patient woke up and lost his sense of smell and on 15Feb2021 lost his sense of taste and he cannot feel anything in his mouth. He wanted to know if these are reported adverse events (AEs) associated with the vaccine. Then he noticed he could not smell anything. He put perfume up to his nose and could smell nothing. He thought maybe he lost his sense of smell due to the runny nose but the next day on 15Feb2021 he lost his sense of taste and he was concerned about that and was querying were these all are part of the side effects of the vaccine or something else and queried for was that the vaccine working on him. Patient reported that his wife cooks and puts in lots of flavors but he can smell or taste nothing, perfume nothing. He can't smell or taste cheese or ham. He doesn't taste or smell coffee. He can only tell hot or cold. He was scheduled to receive the second dose of the vaccine on 26Feb2021. Patient had not attended any physician or emergency room (ER) visit for the experienced events. Outcome of event headache was recovered on 10Feb2021, fever was recovered on 11Feb2021, runny nose recovered on 14Feb2021, lost his sense of taste and smell was not recovered, cannot feel anything in his mouth was unknown.   Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: lost his sense of taste; cannot feel anything in his mouth; lost his sense of taste and smell; runny nose; fever; headache; This is a spontaneous report from a contactable consumer (patient) via medical information team.  A 37-year-old male patient reported that they received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9269), via unspecified route of administration in right arm on 05Feb2021 14:25 (at the age of 37 years) as a DOSE 1, SINGLE for COVID-19 immunization. Patient had no medical history and had not received concomitant medications (Other Products). Patient was not administered with any other additional Vaccines on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that he had a very slight headache on 10Feb2021 that was no big deal. Patient stated that he received the Pfizer vaccine 10 days ago, on Friday before, then six days later on 11Feb2021 he had a fever which he knew was a side effect of the vaccine. The day before the fever was very brief, maybe two hours in the night. Then a couple of days later on 13Feb2021 he had a runny nose. It was a crazy runny nose, he had to breathe out of his mouth and was using lots of paper. On 14Feb2021 patient woke up and lost his sense of smell and on 15Feb2021 lost his sense of taste and he cannot feel anything in his mouth. He wanted to know if these are reported adverse events (AEs) associated with the vaccine. Then he noticed he could not smell anything. He put perfume up to his nose and could smell nothing. He thought maybe he lost his sense of smell due to the runny nose but the next day on 15Feb2021 he lost his sense of taste and he was concerned about that and was querying were these all are part of the side effects of the vaccine or something else and queried for was that the vaccine working on him. Patient reported that his wife cooks and puts in lots of flavors but he can smell or taste nothing, perfume nothing. He can't smell or taste cheese or ham. He doesn't taste or smell coffee. He can only tell hot or cold. He was scheduled to receive the second dose of the vaccine on 26Feb2021. Patient had not attended any physician or emergency room (ER) visit for the experienced events. Outcome of event headache was recovered on 10Feb2021, fever was recovered on 11Feb2021, runny nose recovered on 14Feb2021, lost his sense of taste and smell was not recovered, cannot feel anything in his mouth was unknown.   Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 6-decade-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had a sore arm for 1 day post vaccination. The clinical outcome of the event was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, Pain, Pharyngeal erythema, Pyrexia
Clinical narrative: small fever; aching; high chest congestion; sore throat; getting sick; sore throat feels like there is ground up glass in there, and is red; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 76-year-old female patient received bnt162b2 (BNT162B2, formulation; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 10:30 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE (at the age of 76-year-old) for COVID-19 immunisation. Medical history included mitral valve prolapse from 1980 to an unknown date, hypertension from an unknown date and unknown if ongoing (Caller says this was diagnosed 13 years ago). There were no concomitant medications. The patient did not receive any other product. The patient experienced small fever, aching, draining, high chest congestion and sore throat on 10Feb2021. It was reported that the patient started getting sick on 10Feb2021. Patient stated doesn't know if it was correlated to the vaccine, she has some symptoms and has been to the doctor twice, the worst thing was a terrible sore throat. Patient says that she has been taking a Z-Pak and was on day 5 of 6 days of that, but it doesn't seem to be helping. She says that they swabbed her throat for strep test, which was negative and had underwent a COVID test, waiting for results. Patient stated that her next dose was due 23Feb2021 for the vaccine and she has been terribly sick for 6 days. Patient wonders if 11-12 days afterwards would be too long for getting side effects of vaccine or if it was still within that time. The patient received Z-Pak sixth dose today (NDC 59762-2198-1, LOT ER7479, EXP 31Oct2024 manufactured by Greenstone) which was prescribed by the urgent care. The patient felt sore throat feels like there is ground up glass in there, and is red. The patient received gargle with salt, honey, lemon and used Chloraseptic spray. No details provided about Chloraseptic spray. It reported that patient wanted to know was sore throat a side effect of the Covid-19 vaccine. The patient took Z-pack but it was not helping. Therapeutic measures were taken as a result of sore throat and sore throat feels like there is ground up glass in there, and is red. The outcome of events small fever, aching and high chest congestion reported as unknown. The outcome of events sore throat feels like there is ground up glass in there, and is red, sore throat was not recovered and outcome of the other events was unknown.  the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, SARS-CoV-2 test, Streptococcus test
Clinical narrative: small fever; aching; high chest congestion; sore throat; getting sick; sore throat feels like there is ground up glass in there, and is red; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 76-year-old female patient received bnt162b2 (BNT162B2, formulation; solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 10:30 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE (at the age of 76-year-old) for COVID-19 immunisation. Medical history included mitral valve prolapse from 1980 to an unknown date, hypertension from an unknown date and unknown if ongoing (Caller says this was diagnosed 13 years ago). There were no concomitant medications. The patient did not receive any other product. The patient experienced small fever, aching, draining, high chest congestion and sore throat on 10Feb2021. It was reported that the patient started getting sick on 10Feb2021. Patient stated doesn't know if it was correlated to the vaccine, she has some symptoms and has been to the doctor twice, the worst thing was a terrible sore throat. Patient says that she has been taking a Z-Pak and was on day 5 of 6 days of that, but it doesn't seem to be helping. She says that they swabbed her throat for strep test, which was negative and had underwent a COVID test, waiting for results. Patient stated that her next dose was due 23Feb2021 for the vaccine and she has been terribly sick for 6 days. Patient wonders if 11-12 days afterwards would be too long for getting side effects of vaccine or if it was still within that time. The patient received Z-Pak sixth dose today (NDC 59762-2198-1, LOT ER7479, EXP 31Oct2024 manufactured by Greenstone) which was prescribed by the urgent care. The patient felt sore throat feels like there is ground up glass in there, and is red. The patient received gargle with salt, honey, lemon and used Chloraseptic spray. No details provided about Chloraseptic spray. It reported that patient wanted to know was sore throat a side effect of the Covid-19 vaccine. The patient took Z-pack but it was not helping. Therapeutic measures were taken as a result of sore throat and sore throat feels like there is ground up glass in there, and is red. The outcome of events small fever, aching and high chest congestion reported as unknown. The outcome of events sore throat feels like there is ground up glass in there, and is red, sore throat was not recovered and outcome of the other events was unknown.  the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pruritus
Clinical narrative: experience itching at vaccine site; Patient complains of itching of skin; This is a spontaneous report from a non-contactable other health care professional. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266), via intramuscular route of administration in left arm on 12Feb2021 (at the age of 33 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. During her 15-minute waiting period after the injection, the patient began to experienced itching at vaccine site on an unspecified date in Feb2021. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient complains of itching of skin. The patient denies facial swelling, sore throat, frequent throat clearing, chest tightness, shortness of breath and wheezing. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: Little bit of soreness at the site of injection; Constant runny nose; Sneezing; This is a spontaneous report from a contactable Nurse (patient).A 65-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization.The patient medical history and concomitant medications were not reported.  On 14Feb2021, the patient experienced constant runny nose and sneezing and on an unknown date patient experienced little bit of soreness at the site of injection, but that has gone now. She had no other symptoms, but her allergy medicine and Sudafed was not working when it normally would work for her with these symptoms. The outcome of the events runny nose and sneezing was unknown and little bit of soreness at the site of injection was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Maternal exposure during pregnancy, Pregnancy
Clinical narrative: I tested (+) on my pregnancy test on 07Jan2021; Mild chills; This is a spontaneous report from a contactable nurse (Patient).  A 30-years-old pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVI-19 VACCINE, Solution for injection, Batch/Lot Number: EJ1686), via intramuscular route of administration, administered in Deltoid Right on 06Jan2021 15:20 (Age at vaccination: 30-years-old) as single dose for covid-19 immunization. Medical history included colitis ulcerative from 01Jan2015 to an unknown date Currently taking Remicade IV infusions every 8 weeks. Concomitant medication included infliximab (REMICADE) taken for Ulcerative colitis from 04Feb2020 and ongoing. It was reported that patient received covid-19 vaccine both doses on 26Dec2020 and 06Jan2021 respectively. she tested positive on her pregnancy test on 07Jan2021. Currently, under a care of her high risk (obstetrician) OB. She is 9 weeks pregnant. she would like to make us aware of it, Since she know, these not a lot of data about pregnancies and vaccine. she is willing to be in a study or research for observation. It was also reported that patient experienced Very mild chills 11 hours after second dose. Patient did not receive any treatment for the event. Adverse event not resulted in Emergency room or Physician office visit. Patient did not receive any treatment for the event. The mother reported she became pregnant while taking bnt162b2. The mother was 9 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included pregnancy: positive on 07Jan2021. The outcome for the event Very mild chills was reported as resolved on 2021.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Tendonitis
Clinical narrative: having joint pain or inflammation of joints and tendons/  joint pain or pain around the joint, so it might be tendons or ligaments.; having joint pain or inflammation of joints and tendons/  joint pain or pain around the joint, so it might be tendons or ligaments.; having joint pain or inflammation of joints and tendons/  joint pain or pain around the joint, so it might be tendons or ligaments.; This is a spontaneous report from a contactable pharmacist (patient).  A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EM9810), via an unspecified route of administration, administered in Left arm on 05Feb2021 at 10:30 as dose 2, single (at the age of 66 years), for covid-19 immunization. There were no medical history and concomitant medications (Other Products: No, Patient History: No). The patient previously received fist dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL0140), via an unspecified route of administration, on an unspecified date as dose 1, single for (at the age of 66 years), covid-19 immunization. The patient stated that, on 07Feb2021, she was having joint pain or inflammation of joints and tendons. She said her side effects were joint pain, though she was not sure if it was joint pain or pain around the joint, so it might be tendons or ligaments. She told that the side effects began, though she did not notice it right away, on Sunday night, on like the 7th. She reported that, it was not a lot of pain, more discomfort, but it was in her wrists, elbows, shoulders, and knees. She was not sure if it was her joints also because sometimes pain radiates into her arm. She told that the joint pain had gotten more noticeable yesterday and today, and she had done no treatment for it. She personally felt it was not serious, unless this was something that did not go away, and then that would be serious, depending on what was happening. She said that was the question, since she had never been diagnosed with arthritis and never had these before. No corrective treatment was received for the events. The outcome for the events was not recovered at the time of report.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on her trunk and hair line; This is a spontaneous report from a contactable consumer or other non-hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 10Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history included allergic to penicillin from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced rash on her trunk and hair line on an unspecified date. Therapeutic measures were taken with Prednisone and benadryl as a result of event. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Loss of personal independence in daily activities, Rash
Clinical narrative: fatigue/exhaustion; headaches; she couldn't lift her arms, she couldn't do anything; short of breath; a little tired and has a rash on her arm; a little tired and has a rash on her arm; This is a spontaneous report from a contactable nurse. A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 11Feb2021 as dose 2, single for COVID-19 immunization. Historical vaccine included dose 1 of BNT162B2 via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue/exhaustion, headaches on 16Feb2021, she couldn't lift her arms, she couldn't do anything, short of breath, a little tired and has a rash on her arm on an unspecified date in Feb2021. It was reported that, patient received the second dose on Thursday, 11Feb2021. She stated her mother "felt fine" that Thursday and she had: "fatigue , exhaustion and headaches", on the following Friday. She added patient "felt better" on the next day, Saturday and on the Sunday, she got up and had an "episode", which she described as: "she couldn't lift her arms, she couldn't do anything, she rested in bed all day, and she thought she felt short of breath". This morning, Monday, caller explained patient still felt "short of breath, a little tired and has a rash on her arm". Reporter enquired if the shortness of breath was reported as a side effect of the COVID-19 vaccine and what was suggested to do for the shortness of breath. The outcome of the events she couldn't lift her arms, she couldn't do anything, short of breath, a little tired and has a rash on her arm was unknown and fatigue/exhaustion, headaches was recovered on an unspecified date in Feb2021.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Little soreness in the arm after the 1st dose of the vaccine yesterday; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) received from a Pfizer-sponsored program Pfizer First Connect. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced little soreness in the arm after the 1st dose of the vaccine yesterday. It was further reported that Caller is calling for her friend who had breast enhancement surgery and she had a reaction to the anesthesia. Is it safe for her friend to get the Pfizer COVID-19 vaccine? Caller mentioned that she had the first dose of the Pfizer BioNTech COVID-19 vaccine yesterday (09Feb2021) and had a little arm soreness from it. Caller declined to report the adverse events to DSU. The clinical outcome of the event little soreness in the arm after the 1st dose of the vaccine yesterday was reported as unknown.  Follow-up attempts are completed. No further information is expected.