chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Headache, Malaise, Pain, Pyrexia
Clinical narrative: Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel a bit achy; Mild headache; vision is hard to focus; Not feeling right on and off; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0150, expiry date: unknown), via an unspecified route of administration, administered in right arm on 02Apr2021 as 1st dose, single for covid-19 immunization. The patient's medical history included Type 2 Diabetes mellitus, patient reported that it was diagnosed at least 10 years ago, and his sugar levels had been in very good control, Covid-19 from unknown date in Nov2020 to unknown date in Dec2020. The patient's concomitant medications were not reported. On 03 Apr 2021maybe started Saturday after the vaccination the patient experienced with mild Headache and not feeling right on and off for 6 days. Patient reported that his head feels worse since he got the slight fever, he took Tylenol to deal with the fever in morning, like 11:00 AM then he did not feel quite right, probably feels worse to next day, sometimes his vision was Hard to focus he was to struggle a bit to focus or just worse because of the fever. since he got the vaccine, in the first couple days, he might have just felt like things were a little blurry and again it was very mild, but it seems worse than it had. on 08Apr2021 the patient feels little achy, and he took the Tylenol and only felt worse because of the fever and later felt better and had general body aches the patient did have COVID back in the end of November, then he recovered in the beginning of December, he got an asthma episode still that he believes was triggered by the COVID. The patient reported that he had a blood work on 03 MAR 2021, he saw his doctor on 10 MAR 2021 and his blood work was pretty normal. His blood sugar was very good, and he also has been very active, he walks every day. The patient enquired second dose was scheduled for 23 APR 2021, was it fine to have a second dose. The patient did not visit Emergency Room or No Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient took TYLENOL 500 mg for the treatment to the events (LOT: SJA014, scan code:30044439; NDC: 50580-449-36EXP: 06/2024). The outcome of the events headache, vision is hard to focus was not recovered, fever was recovering, feeling unwell, general body aches, feel a bit achy asthma episode and was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss, Visual impairment
Clinical narrative: Feeling unwell, General body aches; he does every once in a while get an asthma episode; Fever; Feel a bit achy; Mild headache; vision is hard to focus; Not feeling right on and off; This is a spontaneous report from a contactable consumer or other non hcp (Patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0150, expiry date: unknown), via an unspecified route of administration, administered in right arm on 02Apr2021 as 1st dose, single for covid-19 immunization. The patient's medical history included Type 2 Diabetes mellitus, patient reported that it was diagnosed at least 10 years ago, and his sugar levels had been in very good control, Covid-19 from unknown date in Nov2020 to unknown date in Dec2020. The patient's concomitant medications were not reported. On 03 Apr 2021maybe started Saturday after the vaccination the patient experienced with mild Headache and not feeling right on and off for 6 days. Patient reported that his head feels worse since he got the slight fever, he took Tylenol to deal with the fever in morning, like 11:00 AM then he did not feel quite right, probably feels worse to next day, sometimes his vision was Hard to focus he was to struggle a bit to focus or just worse because of the fever. since he got the vaccine, in the first couple days, he might have just felt like things were a little blurry and again it was very mild, but it seems worse than it had. on 08Apr2021 the patient feels little achy, and he took the Tylenol and only felt worse because of the fever and later felt better and had general body aches the patient did have COVID back in the end of November, then he recovered in the beginning of December, he got an asthma episode still that he believes was triggered by the COVID. The patient reported that he had a blood work on 03 MAR 2021, he saw his doctor on 10 MAR 2021 and his blood work was pretty normal. His blood sugar was very good, and he also has been very active, he walks every day. The patient enquired second dose was scheduled for 23 APR 2021, was it fine to have a second dose. The patient did not visit Emergency Room or No Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient took TYLENOL 500 mg for the treatment to the events (LOT: SJA014, scan code:30044439; NDC: 50580-449-36EXP: 06/2024). The outcome of the events headache, vision is hard to focus was not recovered, fever was recovering, feeling unwell, general body aches, feel a bit achy asthma episode and was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: headache; nausea; fatigue; chills; This is a Spontaneous report from contactable consumer (patient) via MEDICAL INFORMATION TEAM. A female patient of age 61 (unspecified units) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 02Apr2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 08Apr2021, she had headache, fatigue, nausea, chills. All that symptoms or the side effects, is it possible that would have occurred 6 days after the shot. Patient was informed about Pfizer Medical information department and was provided with the number. Call could not be transferred in Medical information department as the department was busy and the patient was requested to call the number. Limited information was available over the call. It was reported that reason of delay: daily spike of incoming calls due to COVID19 vaccine. The outcome of the events was unknown.   No follow-up information needed. Information on the lot/batch number has been requested. .
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: Just a headache with the second vaccine; felt like I had flu; This is a spontaneous report from a contactable consumer(Patient) from a Pfizer sponsored program. A 65-year-old female patient received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date as 2nd DOSE SINGLE for covid-19 immunization. The patient medical history and concomitants medications were not provided. The patient received historical vaccine of first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection; Lot number: unknown) for covid-19 immunization. On an unspecified date during an inbound call with the patient, the patient stated that her hands don't hurt all the time. she haven't felt this good in years and could walk down the stairs. She reacted to first Pfizer vaccine but not the second. Felt like she had the flu. Had Just a headache with the second vaccine. The patient is prescribed XELJANZ XR 11mg tablets. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Terrible headache; This is a spontaneous report received from a contactable consumer (Patient's wife). A male patient of an un-specified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced terrible headache. Patient's wife would like to confirm what painkillers can her husband take as her husband is having a terrible headache. The outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Somnolence
Clinical narrative: headache; dizziness; nausea; Chills; sleepiness; This is a spontaneous report received from a contactable consumer. A 54-year-old non-pregnant female patient received BNT162B2 (BNT162b2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8737), via an unspecified route of administration on 07Apr2021 at 07:30 (at the age of 54-year-old) as 1st dose, single dose, in left arm for COVID-19 immunization. The patient's medical history included Ehlers Danlos Syndrome, Lyme Disease, Epstein Barr Virus. Patient had allergies to penicillin. Concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 07Apr2021 at 08:00, about 30 minutes after vaccination, the patient experienced dizziness, nausea, chills, sleepiness and headache. Even after 5 days, the headache and sleepiness was not resolved. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events headache and sleepiness was not resolved and outcome of all other events was unknown.  No follow-up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache; This is a spontaneous report received from Other Company. A contactable 70-year-old female reported for herself. A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/batch number and Expiration were not reported) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 for COVID-19 immunisation. On an unspecified date, the patient had experienced a bad headache after the 2nd COVID-19 vaccine and about 24 hours. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Headache, Pain, Sneezing
Clinical narrative: Headache; pain; site pain; Dry cough; Sneezing; This is a spontaneous report (letter response) received from a contactable consumer. This 60-years-old female consumer reported.  A 60-years-old female patient received second dose of BNT162B2 (BNT162B2, Pfizer-BioNTech COVID-19 Vaccine, Solution of injection, Lot Number: EN6208), via intramuscular, administered in left arm on 31Mar2021 at 11:30 (at the age of 60-year-old) as 2nddose, single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EN9899) on 23Dec2020 at 10:00 via intramuscular, administered in arm left for COVID-19 immunisation and tested positive for Covid (drug ineffective), symptoms similar to flu, Loss of taste, Loss of smell, Body ache, On 28Dec2020 she went to hospital to get neurocloral infusion. Medical history included, seasonal allergy and concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); metoprolol (METOPROLOL); atorvastatin (ATORVASTATIN). On an unspecified date, the patient experienced headache, pain, site pain, dry cough, sneezing. The patient still had dry cough. The patient did not require medical intervention. The patient was visited the emergency department. The patient was not hospitalized. The patient was not admitted to an Intensive Care. There is no information about organ involvement. On 27Dec2020, the patient underwent lab tests and procedures which included covid-19: positive. Patient was treated with Advil also took Vit D, Vit C, Zinc Nuletomy for sneezing and dry cough. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The outcome of the event dry cough was not resolved and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; pain; site pain; Dry cough; Sneezing; This is a spontaneous report (letter response) received from a contactable consumer. This 60-years-old female consumer reported.  A 60-years-old female patient received second dose of BNT162B2 (BNT162B2, Pfizer-BioNTech COVID-19 Vaccine, Solution of injection, Lot Number: EN6208), via intramuscular, administered in left arm on 31Mar2021 at 11:30 (at the age of 60-year-old) as 2nddose, single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (Lot number: EN9899) on 23Dec2020 at 10:00 via intramuscular, administered in arm left for COVID-19 immunisation and tested positive for Covid (drug ineffective), symptoms similar to flu, Loss of taste, Loss of smell, Body ache, On 28Dec2020 she went to hospital to get neurocloral infusion. Medical history included, seasonal allergy and concomitant medications included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); metoprolol (METOPROLOL); atorvastatin (ATORVASTATIN). On an unspecified date, the patient experienced headache, pain, site pain, dry cough, sneezing. The patient still had dry cough. The patient did not require medical intervention. The patient was visited the emergency department. The patient was not hospitalized. The patient was not admitted to an Intensive Care. There is no information about organ involvement. On 27Dec2020, the patient underwent lab tests and procedures which included covid-19: positive. Patient was treated with Advil also took Vit D, Vit C, Zinc Nuletomy for sneezing and dry cough. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The outcome of the event dry cough was not resolved and other events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Maternal exposure timing unspecified
Clinical narrative: patient has been pregnant or breastfeeding the whole time, so she only has an OB; Headache; This is a spontaneous report from a contactable consumer (patient husband). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in right arm on 20Mar2021 at 10:30-11:30 at single dose for covid-19 immunisation. Reportedly, patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration in right arm on 10Apr2021at 10:30-11:30 at single dose for covid-19 immunisation. The patient medical history included chronic stress, reporter stated other than going through a pretty lengthy season of chronic stress. Reportedly, they have had a bunch of crap happen. It was reported place where they live, they had massive outages and they also were going through a transition period professionally with some things. Patient had no other relevant medical or family history. On an unspecified date in Apr2021 after first dose of vaccination patient experienced headache. The patient experienced pretty bad headache after the first dose, and it was for a few days, it got pretty bad then it began to improve then it came back somewhat, and it was not as bad. Reporter stated either unknown or persistent. Reporter stated patient also experienced headaches semi-regularly before the vaccine. Reporter stated her headache is ongoing. Reporter stated he remembers it was being pretty persistent, bad, and it peaked probably around 3-5 days after getting the first dose. Reporter verified it started sometime in Apr2021. It was also reported that patient did not have a primary care doctor and patient has not established one yet. Reporter stated patient has been pregnant or breastfeeding the whole time, so she only has an OB. Reporter stated the patient was taking acetaminophen or ibuprofen for headaches. No investigation assessment. No relevant tests were done. The outcome of event was not recovered for headache and unknown for maternal exposure timing unspecified.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Facial spasm, Headache, Hypoaesthesia
Clinical narrative: and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head, after the second vaccine; Face spasms on the left side of face; after the second vaccine and it was worsened; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips after first and second dose; Left side of the body had tingling, numbness; This is a spontaneous report from female contactable consumer (Patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, lot number was not reported) via unspecified route of administration, administered in left arm on 31Mar2021 at 14:00 (at the age of 76-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6204) via unspecified route of administration in left arm on 03Mar2021 at 14:00 as single dose for COVID-19 immunization and on same day patient experienced outbreak, looked like hives, on her torso and stomach area, chills, injection site sore (which subsided after 18-days), arm was numb, tingley and painful from the shoulder to the fingertips. Medical History and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations within 4 weeks prior vaccinations. On 31Mar2021 (same day of 2nd dose of vaccination), patient experienced face spasms on the left side of face, after the second vaccine which was intermittent in the evening, headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head and left side of the body had tingling, numbness and pain down to the foot, ankle and calf areas, along with the events of first dose, which were worsened after second dose that included chills and injection site sore (which subsided 18-days after first dose), arm was numb, tingley and painful from the shoulder to the fingertips. Patient required to visit physician office, primary care doctor for her numbness, tingling and pain. Reporter stated she was very interested in percentages in age groups who have experienced any numbness and tingling and asked if there are any correlation with developing blood clots and would like the information to see if she needs further medical attention and to prevent a serious outcome and discuss it with her doctor and agrees to be transferred to Medical Information. The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Vaccination site pain
Clinical narrative: and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head, after the second vaccine; Face spasms on the left side of face; after the second vaccine and it was worsened; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips after first and second dose; Left side of the body had tingling, numbness; This is a spontaneous report from female contactable consumer (Patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, lot number was not reported) via unspecified route of administration, administered in left arm on 31Mar2021 at 14:00 (at the age of 76-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6204) via unspecified route of administration in left arm on 03Mar2021 at 14:00 as single dose for COVID-19 immunization and on same day patient experienced outbreak, looked like hives, on her torso and stomach area, chills, injection site sore (which subsided after 18-days), arm was numb, tingley and painful from the shoulder to the fingertips. Medical History and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations within 4 weeks prior vaccinations. On 31Mar2021 (same day of 2nd dose of vaccination), patient experienced face spasms on the left side of face, after the second vaccine which was intermittent in the evening, headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head and left side of the body had tingling, numbness and pain down to the foot, ankle and calf areas, along with the events of first dose, which were worsened after second dose that included chills and injection site sore (which subsided 18-days after first dose), arm was numb, tingley and painful from the shoulder to the fingertips. Patient required to visit physician office, primary care doctor for her numbness, tingling and pain. Reporter stated she was very interested in percentages in age groups who have experienced any numbness and tingling and asked if there are any correlation with developing blood clots and would like the information to see if she needs further medical attention and to prevent a serious outcome and discuss it with her doctor and agrees to be transferred to Medical Information. The outcome of all the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Diarrhoea, Headache
Clinical narrative: developed a fever of up to 99F; sore throat; headache; diarrhea off and on for 2 days; chills; weakness; pains on the side of her neck; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On the second day (28Apr2021) the patient experienced a fever of up to 99 degrees Fahrenheit. She had chills and weakness. She had a sore throat with pains on the side of her neck, headache, and diarrhea off and on for 2 days. Today (03May2021) her headache was gone. Towards the latter part of the day her temperature goes up. The outcome of headache was recovered on 03May2021. The outcomes of fever, chills, weakness, sore throat, pains on the side of her neck, and diarrhea were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Oropharyngeal pain, Pyrexia
Clinical narrative: developed a fever of up to 99F; sore throat; headache; diarrhea off and on for 2 days; chills; weakness; pains on the side of her neck; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 27Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date for COVID-19 immunization. On the second day (28Apr2021) the patient experienced a fever of up to 99 degrees Fahrenheit. She had chills and weakness. She had a sore throat with pains on the side of her neck, headache, and diarrhea off and on for 2 days. Today (03May2021) her headache was gone. Towards the latter part of the day her temperature goes up. The outcome of headache was recovered on 03May2021. The outcomes of fever, chills, weakness, sore throat, pains on the side of her neck, and diarrhea were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated he was to receive the second dose, and he has had a sore throat for about 24 hours. He asked if he was still eligible to receive product (the second dose). The outcome of sore throat was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Feeling a little tired; Fever; This is a spontaneous report from a contactable consumer (reported for his wife) from a Pfizer-sponsored program.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose yesterday (unspecified date), and she was feeling a little tired and had a fever. The reporter wanted to know if she can take ibuprofen. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; sneezing; sore arm; low grade fever; joint pain; tiredness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:00 (at the age of 59-years-old), as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tiredness on 23Apr2021, and she had runny nose, sneezing and sore arm on an unspecified date and also experienced low grade fever, joint pain on 24Apr2021. The caller reports that she received her first vaccine dose on 23Apr2021. That night she started having mild symptoms which lasted through the weekend. Symptoms reported were sore arm, tiredness, achy joints, runny nose and sneezing. Caller reports that she took Tylenol and her symptoms improved but she reports that her problem is the achy joints have not gone away. Her second dose is due next week and she is concerned about getting the second dose concerned that her achy joints will not improve. The caller wanted to know this something that is going to continue and should she consider holding off on getting the second dose. The seriousness criteria of the events were reported as non-serious. Therapeutic measures were taken as a result of tiredness, runny nose, sneezing, low grade fever, joint pain and sore arm. The outcome of the events low grade fever resolved on 24Apr2021, tiredness resolved on 25Apr2021, runny nose, sneezing and sore arm resolving and for joint pain not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: runny nose; sneezing; sore arm; low grade fever; joint pain; tiredness; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in Arm Right on 23Apr2021 10:00 (at the age of 59-years-old), as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced tiredness on 23Apr2021, and she had runny nose, sneezing and sore arm on an unspecified date and also experienced low grade fever, joint pain on 24Apr2021. The caller reports that she received her first vaccine dose on 23Apr2021. That night she started having mild symptoms which lasted through the weekend. Symptoms reported were sore arm, tiredness, achy joints, runny nose and sneezing. Caller reports that she took Tylenol and her symptoms improved but she reports that her problem is the achy joints have not gone away. Her second dose is due next week and she is concerned about getting the second dose concerned that her achy joints will not improve. The caller wanted to know this something that is going to continue and should she consider holding off on getting the second dose. The seriousness criteria of the events were reported as non-serious. Therapeutic measures were taken as a result of tiredness, runny nose, sneezing, low grade fever, joint pain and sore arm. The outcome of the events low grade fever resolved on 24Apr2021, tiredness resolved on 25Apr2021, runny nose, sneezing and sore arm resolving and for joint pain not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: had cold sores; This is a spontaneous report from a contactable nurse reporting different events under the same suspect product for 5 patients. This is one of the 5 reports (for the 1st of 2 additional people).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had cold sores after getting the COVID-19 vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541866 Same reporter/ drug/ event for different patients
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cognitive disorder, Electroencephalogram, Fatigue, Gait disturbance
Clinical narrative: Started experiencing Neurological symptoms; Essential Tremors are very prominent/Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair; body is becoming weaker by the week; The EEG is showing a slowing in her memory; She is not able to shower, dress, eat herself.; Walking-very small footsteps (shuffling); Speech-difficulty with word finding, difficulty ordering food mixes conversations; Fatigue - really tired all the time; Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out; Sleeps 9 hours at night/Feels like she can't wake up at all; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 70 years old as single dose for covid-19 immunisation.  There was no medical history.   No known allergies. No covid prior vaccination. There were no concomitant medications.  There was no other vaccine in four weeks, no other medications in two weeks. On 19Feb2021, the patient started experiencing neurological symptoms, and essential tremors were very prominent. She had rapidly declined and was now seeing a neurologist, her body was becoming weaker by the week., She's been to the Emergency Room 2 times to receive help. There wasn't much they can do to help her. She had an MRI and EEG. The EEG was showing a slowing in her memory. She was not able to shower, dress, eat herself. She was a capable women before the shot. Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair, Walking-very small footsteps (shuffling), Speech-difficulty with word finding, difficulty ordering food mixes conversations, Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out, Fatigue - really tired all the time. Sleeps 9 hours at night. Feels like she can't wake up at all. Adverse event start date was 19Feb2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received: Meds for tremors and memory issues. The outcome of events was not recovered. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Feb2021 10:00.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Memory impairment, Mobility decreased, Nervous system disorder, Somnolence
Clinical narrative: Started experiencing Neurological symptoms; Essential Tremors are very prominent/Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair; body is becoming weaker by the week; The EEG is showing a slowing in her memory; She is not able to shower, dress, eat herself.; Walking-very small footsteps (shuffling); Speech-difficulty with word finding, difficulty ordering food mixes conversations; Fatigue - really tired all the time; Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out; Sleeps 9 hours at night/Feels like she can't wake up at all; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 70 years old as single dose for covid-19 immunisation.  There was no medical history.   No known allergies. No covid prior vaccination. There were no concomitant medications.  There was no other vaccine in four weeks, no other medications in two weeks. On 19Feb2021, the patient started experiencing neurological symptoms, and essential tremors were very prominent. She had rapidly declined and was now seeing a neurologist, her body was becoming weaker by the week., She's been to the Emergency Room 2 times to receive help. There wasn't much they can do to help her. She had an MRI and EEG. The EEG was showing a slowing in her memory. She was not able to shower, dress, eat herself. She was a capable women before the shot. Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair, Walking-very small footsteps (shuffling), Speech-difficulty with word finding, difficulty ordering food mixes conversations, Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out, Fatigue - really tired all the time. Sleeps 9 hours at night. Feels like she can't wake up at all. Adverse event start date was 19Feb2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received: Meds for tremors and memory issues. The outcome of events was not recovered. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Feb2021 10:00.  Information about lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder, Tremor
Clinical narrative: Started experiencing Neurological symptoms; Essential Tremors are very prominent/Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair; body is becoming weaker by the week; The EEG is showing a slowing in her memory; She is not able to shower, dress, eat herself.; Walking-very small footsteps (shuffling); Speech-difficulty with word finding, difficulty ordering food mixes conversations; Fatigue - really tired all the time; Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out; Sleeps 9 hours at night/Feels like she can't wake up at all; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) at age of 70 years old as single dose for covid-19 immunisation.  There was no medical history.   No known allergies. No covid prior vaccination. There were no concomitant medications.  There was no other vaccine in four weeks, no other medications in two weeks. On 19Feb2021, the patient started experiencing neurological symptoms, and essential tremors were very prominent. She had rapidly declined and was now seeing a neurologist, her body was becoming weaker by the week., She's been to the Emergency Room 2 times to receive help. There wasn't much they can do to help her. She had an MRI and EEG. The EEG was showing a slowing in her memory. She was not able to shower, dress, eat herself. She was a capable women before the shot. Motor-hand, head, speech intention tremors (difficulty writing, using utensils), when concentrating, tremors get worse, can't comb hair, Walking-very small footsteps (shuffling), Speech-difficulty with word finding, difficulty ordering food mixes conversations, Cognitive-memory (remembering names of long time friends, slow to respond, takes a long time to get a story out, she feels like ideas are clear in her mind, but unable to get it out, Fatigue - really tired all the time. Sleeps 9 hours at night. Feels like she can't wake up at all. Adverse event start date was 19Feb2021 and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Disability or permanent damage. Treatment received: Meds for tremors and memory issues. The outcome of events was not recovered. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 27Feb2021 10:00.  Information about lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic, Urticaria, X-ray
Clinical narrative: Severe rash/like little bumps or pimples on both of her daughter's arms. Then, the same little rash got on her daughter's back; It is really itching; Daughter work up and it looks awful like welts; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 20-year-old female (reporter's daughter) patient who received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0172) via an unspecified route of administration in left arm on 10May2021 (at the age of 20-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (Lot number EW0150) on 14Apr2021 (at the age of 20-year-old) and had tiredness. The patient did not undergo any prior vaccination within 4 weeks. The patient had a flu shot and never had a reaction other than soreness at the immunization site. Concomitant medications included vitamins and probiotics. The patient developed a severe rash in what she claims to be a severe allergic reaction 7 days after receiving the Pfizer COVID-19 vaccination. She had just broken out with it. It started 2 to 3 days before like little bumps or pimples on both of her arms at around day 7. Then, the same little rash got on her back. Then, today, her daughter worked up and it looks awful like welts. It looks like welts like maybe she got into poison oak. It was on her face, back, and really bad on her arms. It was just huge welts. It did look worse. Her daughter was really itching. They are going to treat it like chicken pox. It was just a little bit, it did not really bother her daughter, but it looked awful. She was going to give her Benadryl and do an oatmeal bath and calamine lotion. The reporting consumer added she would also ask the pharmacist what else they recommend. The events were serious as medically significant. Outcome of the events was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acne, Pruritus, Rash, Skin disorder, Urticaria
Clinical narrative: Severe rash/like little bumps or pimples on both of her daughter's arms. Then, the same little rash got on her daughter's back; It is really itching; Daughter work up and it looks awful like welts; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 20-year-old female (reporter's daughter) patient who received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0172) via an unspecified route of administration in left arm on 10May2021 (at the age of 20-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (Lot number EW0150) on 14Apr2021 (at the age of 20-year-old) and had tiredness. The patient did not undergo any prior vaccination within 4 weeks. The patient had a flu shot and never had a reaction other than soreness at the immunization site. Concomitant medications included vitamins and probiotics. The patient developed a severe rash in what she claims to be a severe allergic reaction 7 days after receiving the Pfizer COVID-19 vaccination. She had just broken out with it. It started 2 to 3 days before like little bumps or pimples on both of her arms at around day 7. Then, the same little rash got on her back. Then, today, her daughter worked up and it looks awful like welts. It looks like welts like maybe she got into poison oak. It was on her face, back, and really bad on her arms. It was just huge welts. It did look worse. Her daughter was really itching. They are going to treat it like chicken pox. It was just a little bit, it did not really bother her daughter, but it looked awful. She was going to give her Benadryl and do an oatmeal bath and calamine lotion. The reporting consumer added she would also ask the pharmacist what else they recommend. The events were serious as medically significant. Outcome of the events was unknown.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: Severe rash/like little bumps or pimples on both of her daughter's arms. Then, the same little rash got on her daughter's back; It is really itching; Daughter work up and it looks awful like welts; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 20-year-old female (reporter's daughter) patient who received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EW0172) via an unspecified route of administration in left arm on 10May2021 (at the age of 20-year-old) at single dose for COVID-19 immunisation. The patient received the first dose of BNT162b2 (Lot number EW0150) on 14Apr2021 (at the age of 20-year-old) and had tiredness. The patient did not undergo any prior vaccination within 4 weeks. The patient had a flu shot and never had a reaction other than soreness at the immunization site. Concomitant medications included vitamins and probiotics. The patient developed a severe rash in what she claims to be a severe allergic reaction 7 days after receiving the Pfizer COVID-19 vaccination. She had just broken out with it. It started 2 to 3 days before like little bumps or pimples on both of her arms at around day 7. Then, the same little rash got on her back. Then, today, her daughter worked up and it looks awful like welts. It looks like welts like maybe she got into poison oak. It was on her face, back, and really bad on her arms. It was just huge welts. It did look worse. Her daughter was really itching. They are going to treat it like chicken pox. It was just a little bit, it did not really bother her daughter, but it looked awful. She was going to give her Benadryl and do an oatmeal bath and calamine lotion. The reporting consumer added she would also ask the pharmacist what else they recommend. The events were serious as medically significant. Outcome of the events was unknown.