chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: overwhelmingly sick; nauseous/nauseousness; Light-headed; Headache; Flush sensation; Fever; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 18Feb2021 at 15:00 (Batch/Lot Number: EL8982) as dose 1, single (at the age of 68-years-old) for Covid-19 immunisation. Medical history included Thyroid (as reported). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced felt overwhelmingly sick, got very nauseous - nauseousness is so bad, light-headed, headache, flush sensation and fever. It was reported that the patient has had Thursday on 18Feb2021 (not clarified), and had the shot at 3 o' clock PM. It was reported that the patient usually has reaction to shots (unspecified shots) but was excited that it did not. So, she came with an ice pack and put it on her arm shortly when she got the shot just for ten seconds and then she moved her arm for like thirty minutes and she had no reaction with her arm. But, forty-eight hours later, on Saturday at 20Feb2021, at dinner as she got up from her chair as she was going for the second serving, she felt overwhelmingly sick and just wanted to lay down. She got very nauseous, very light-headed. Since that day, she has been consistently overwhelmed with nauseous, no vomiting but very nauseous. She has been having headache and it was like flush sensation like she has a slight fever and the flushing sensation stopped after a week. But that day, she still has nausea. She has gone to a doctor and he gave her some medication (treatment) for nauseousness and she finally used it last Saturday because the nauseousness was so bad and it helped her but she didn't take on Sunday, Monday or that day. She still has nauseousness but not severe like she can function and a rate to describe it was like she doesn't do vomit, like it is very similar to when a woman is pregnant and is nauseous. It was also reported that the patient had some blood work that day (09Mar2021). The patient was reportedly still experiencing the events, not as severe but she was and guessed that they were still persisting. Treatment for nausea included Zofran 4 mg on Saturday. Due date for the next shot was reportedly on 11Mar2021. Therapeutic measures were taken as a result of the event nauseous/nauseousness. The outcome of the events was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in left shoulder and arm; Pain in left shoulder and arm; Can't raise his arm very good; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6201; expiration date: Jun2021), via an unspecified route of administration, administered in the left arm on 23Feb2021 09:30 (at the age of 73-years-old) as dose 1, single for COVID-19 immunization. Medical history included fever of 104.10, sick, severe pain in the shoulder, pain in arm on an unspecified date in 2020 (patient Went to the ER four months ago); calcium deposits in his shoulder, arm, and shoulder blades unspecified date in 2020, and overweight. The patient has no concomitant medications.  The patient previously took acetylsalicylic acid (BAYER ASPIRIN) for pain. The patient reported that he got the Pfizer COVID-19 vaccine on 23Feb2021, a Tuesday morning, for his vaccine first round. On 27Feb2021, the patient experienced pain in left shoulder and it was very painful ever since. The patient mentioned that he went to the ER 4 months prior to the report for severe pain to his shoulder and arm, a fever of 104.10. He went by ambulance because he was very sick. The patient said that it was the same left arm that was giving him problems that did back then. The patient said that he has had no problems since then after he was given antibiotics for the "virus thing", he had a 10-day antibiotic and he took one pill a day. The patient said that he has never had an allergy to medicine, and he doesn't think it was really that, he thinks it was the other problem, the same as he had before about 4 months ago. The patient said that he can't raise his arm very good, so he was planning on going to the emergency room at the time of the report since the ER takes good X-rays and can see if it was calcium deposits around where his shoulder blades are, he also needed them to give him a shot of cortisone to straighten this back up, and he needed to go to the emergency room because he needs stuff for the pain. The patient mentioned that he did not have any other recent vaccinations or started any new medications. The patient said that he doesn't think that it was the vaccine, he thinks it was the calcium deposits that must have been built up again. He said that he has a plan to got to the ER at the time of the report. The patient said that he doesn't think the cause was the vaccine solution since if it was that he would be aching in all of his other joints too, this was only just the shoulder where he had the problem four months ago. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of suspect vaccine BNT162B2 cannot be excluded for the reported events pain in left shoulder and arm, cant raise his arm very good.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Mild rash on the small of his back at the bottom down to each of his butt cheeks and down both his legs slightly/Rash in the hip area; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number was not reported), via an unspecified route of administration, administered in the left arm on 08Mar2021 15:00 (at the age of 61-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he received the first Pfizer COVID vaccine on 08Mar2021 at 15:00. On 09Mar2021, when he came home from work the patient noticed that he had a mild rash on the small of his back at the bottom down to each of his butt cheeks and down both his legs slightly. He had a little of the rash in the hip area and no other reactions or issues. The patient stated that he just had a minor rash in those areas. The patient first noticed rash in the afternoon around 15:00. The patient wanted to know if this was a normal or a common thing and if it is okay to take a Benadryl or something like it in association with the slight rash. The patient denied receiving any other vaccines the same day or 4 weeks prior. He has no history of problems with vaccines in past. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: bottom of legs and both forearms itching; Rash; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in the left arm (upper) on 03Mar2021 at 15:45 (Batch/Lot Number: EN6199) as dose 1, single (at the age of 67-years-old) for Covid-19 immunisation. The patient's medical history and concomitant medications were reported as 'no'. No history of previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available and no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) and no adverse events (AEs) following prior vaccinations. No relevant test done. She got the Covid 19 vaccine last Wednesday. She did not think she had any reaction. On Friday night, 05Mar2021, about 48 hours later, the bottom of her legs and both forearms started itching. Then on Sunday, she noticed a rash, it's not bad, she knows it is there, if she looks at it up closely. Stated she has elderly skin that is sun damaged, wrinkled, and dry. Stated the rash may have worsened. She knew she was itching and could not tell there was a rash there, states she may have had the rash as of Friday, but she could not see it or feel it. The rash is located on her lower legs below the knee down to the ankles on both legs. She took Benadryl the day prior and an anti-itch over the counter cream like Benadryl, when she puts on the cream it stops it a good bit. She was asking if she should get the second injection. The events had not resolved at the time of the report.   No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Hypokinesia, Pain
Clinical narrative: Fever; couldn't get out of the bed; aches and chills; chills; didn't eat anything for two days; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 03Mar2021 at 12:00 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as dose 2, single (at the age of 74-years-old) for Covid-19 immunisation. Medical history included triple bypass at least 10 years, Penicillin allergy and has had the allergy since 2000 (he does not have NDC, lot, and expiry to provide for Penicillin), rotator cuff problems on both shoulders, and Parkinson's with no investigation assessment. Concomitant medications included a bunch of stuff (takes 14 different medication) and a list is in his wallet in his car in the garage. He doesn't have his list with him to provide medication names. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 02Feb2021 (Batch/Lot Number: EL9266; Expiration Date: May2021) as dose 1, single (at the age of 74-years-old) for Covid-19 immunisation. The patient wanted to complain about the shot he got. It was the second COVID-19 vaccine. He got the shot on a Wednesday at noonish. He couldn't get out of the bed on Thursday (04Mar2021). He had fever of 100 to 101 around 6AM. He had aches and chills and he didn't eat anything for two days. He didn't eat anything much for two days. It was on Saturday before he felt like he could get up and then Monday before he was feeling better. By 08Mar2021, everything had resolved. He is not sure if he lost weight or not, weighs between 176 and 177 pounds. The patient underwent lab tests and procedures which included body temperature: fever of 100 to 101 on 04Mar2021. The patient recovered from the events on 08Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Weight
Clinical narrative: Fever; couldn't get out of the bed; aches and chills; chills; didn't eat anything for two days; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm on 03Mar2021 at 12:00 (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as dose 2, single (at the age of 74-years-old) for Covid-19 immunisation. Medical history included triple bypass at least 10 years, Penicillin allergy and has had the allergy since 2000 (he does not have NDC, lot, and expiry to provide for Penicillin), rotator cuff problems on both shoulders, and Parkinson's with no investigation assessment. Concomitant medications included a bunch of stuff (takes 14 different medication) and a list is in his wallet in his car in the garage. He doesn't have his list with him to provide medication names. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the right arm on 02Feb2021 (Batch/Lot Number: EL9266; Expiration Date: May2021) as dose 1, single (at the age of 74-years-old) for Covid-19 immunisation. The patient wanted to complain about the shot he got. It was the second COVID-19 vaccine. He got the shot on a Wednesday at noonish. He couldn't get out of the bed on Thursday (04Mar2021). He had fever of 100 to 101 around 6AM. He had aches and chills and he didn't eat anything for two days. He didn't eat anything much for two days. It was on Saturday before he felt like he could get up and then Monday before he was feeling better. By 08Mar2021, everything had resolved. He is not sure if he lost weight or not, weighs between 176 and 177 pounds. The patient underwent lab tests and procedures which included body temperature: fever of 100 to 101 on 04Mar2021. The patient recovered from the events on 08Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal pain, Pain in extremity
Clinical narrative: soreness. shoulders, buttocks, hips/thighs/legs.; soreness. shoulders, buttocks, hips/thighs/legs.; soreness. shoulders, buttocks, hips/thighs/legs.; soreness. shoulders, buttocks, hips/thighs/legs.; This is a spontaneous report from a contactable consumer.   A 72-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  On Mar2021, the patient experienced soreness in shoulders, buttocks, hips, thighs, and legs. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Flushing, Pruritus, Rash, Vaccination site erythema
Clinical narrative: Asthma; Red warm spot and pain at injection site; Red warm spot and pain at injection site; Red warm spot and pain at injection site; Two inch wide rash stripe down middle of face; Rash stripe down middle of face, flushing/Facial flushing- a red stripe down middle of face; Mild itching/Itching spreading to chest, arms, and palms/Body pruritus; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: en6206), via an unspecified route on 09Mar2021 at 15:30 (at the age of 39-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included Ehlers-Danlos Hypermobile Type, Mast Cell Activation Syndrome, Asthma, COVID-19 from an unknown date and unknown if ongoing and Known allergies to Aspirin, Albuterol, Yellow dye, Sulfites, sulfa drugs. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. On 09Mar2021 at 15:35, the patient experienced two inch wide rash stripe down middle of face, flushing and mild itching that started 5 minutes after injection, at 15:45 red warm spot and pain at injection site. Patient took OTC Benadryl and Ibuprofen 400 mg and it resolved in 2 hours. But then repeated worse the next day around 5pm, rash in same place down middle of face with itching spreading to chest, arms, and palms/ Body pruritus and on 10Mar2021 at 17:00 started having asthma symptoms. Took Epipen and Benadryl. Those symptoms fully resolved again within two hours. Still had red warm spot and pain at injection site 3 days later. Treated self with Ibuprofen and Benadryl immediately after injection to calm effects. After taking the above, reaction subsided within 30 minutes. The outcome of the events was Two inch wide rash stripe down middle of face was unknown, rash stripe down middle of face, flushing/facial flushing- a red stripe down middle of face, Mild itching/Itching spreading to chest, arms, and palms/body pruritus was resolved on unspecified date of 2021, asthma was resolved on 10Mar2021, Red warm spot and pain at injection site was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site warmth
Clinical narrative: Asthma; Red warm spot and pain at injection site; Red warm spot and pain at injection site; Red warm spot and pain at injection site; Two inch wide rash stripe down middle of face; Rash stripe down middle of face, flushing/Facial flushing- a red stripe down middle of face; Mild itching/Itching spreading to chest, arms, and palms/Body pruritus; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: en6206), via an unspecified route on 09Mar2021 at 15:30 (at the age of 39-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included Ehlers-Danlos Hypermobile Type, Mast Cell Activation Syndrome, Asthma, COVID-19 from an unknown date and unknown if ongoing and Known allergies to Aspirin, Albuterol, Yellow dye, Sulfites, sulfa drugs. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications in two weeks prior to the vaccination. On 09Mar2021 at 15:35, the patient experienced two inch wide rash stripe down middle of face, flushing and mild itching that started 5 minutes after injection, at 15:45 red warm spot and pain at injection site. Patient took OTC Benadryl and Ibuprofen 400 mg and it resolved in 2 hours. But then repeated worse the next day around 5pm, rash in same place down middle of face with itching spreading to chest, arms, and palms/ Body pruritus and on 10Mar2021 at 17:00 started having asthma symptoms. Took Epipen and Benadryl. Those symptoms fully resolved again within two hours. Still had red warm spot and pain at injection site 3 days later. Treated self with Ibuprofen and Benadryl immediately after injection to calm effects. After taking the above, reaction subsided within 30 minutes. The outcome of the events was Two inch wide rash stripe down middle of face was unknown, rash stripe down middle of face, flushing/facial flushing- a red stripe down middle of face, Mild itching/Itching spreading to chest, arms, and palms/body pruritus was resolved on unspecified date of 2021, asthma was resolved on 10Mar2021, Red warm spot and pain at injection site was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on left thigh; This is a spontaneous report from a contactable consumer (patient).   A 69-year-old male patient received bnt162b2, via an unspecified route of administration on 05Mar2021, at the age of 69-years-old, (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient medical history was not reported.     The patient's concomitant medications were not reported.  On 09Mar2021, the patient developed rash on left thigh on an unspecified date with outcome of unknown.    No follow-up attempt is needed. Information about lot/ batch number has be requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: Chills / shivering; Caller started not feeling well; Sore arm; Fever; Tiredness; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:30 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation and received co-suspect as ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included thyroid operation (synthroid: started taking this medication 10 years ago. They just changed her dose. Thyroid removed from nodules and a goiter) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid operation, start and stop date were not reported. Patient took swine flu shot in 1970 and experienced flu and shingles vaccine on unknown date and experienced mild flu. The patient took covid 19 vaccine to prevent from covid. Patient received vaccination facility in senior citizen building. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller was stated she spoke with an agent to report milder symptoms she experienced after the first dose of the vaccine. The caller wanted to report that on 11Mar2021, she had the normal reaction, sore arm, fever, tiredness, headache and chills on unknown date. The caller got her first shot yesterday morning and it was about 12 hours after it that her symptoms came on. Today is the next day and she wanted to know if it is okay to take Ibuprofen or Tylenol. The caller asked if she will have these symptoms again after the second dose or will they be worse. The caller thinks that she had the fever all night but was unsure, right now her temperature was 99.8, she took it right before she called. The caller wanted to know if she is able to take aspirin or ibuprofen. Or have there been interactions. The caller does not know what her temperature was in the night, she was shivering under her blankets. On unknown date, At 9:30 pm the caller started not feeling well. The caller has a mild headache which has never been bad. The caller chills happened in the night she does not know when they started. The patient underwent lab tests and procedures which included body temperature: 99.8 on 12Mar2021. The outcome of the events pyrexia, chills, malaise was reported as unknown and while other events was recovering.  No follow-up attempts are possible. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Chills / shivering; Caller started not feeling well; Sore arm; Fever; Tiredness; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:30 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation and received co-suspect as ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included thyroid operation (synthroid: started taking this medication 10 years ago. They just changed her dose. Thyroid removed from nodules and a goiter) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid operation, start and stop date were not reported. Patient took swine flu shot in 1970 and experienced flu and shingles vaccine on unknown date and experienced mild flu. The patient took covid 19 vaccine to prevent from covid. Patient received vaccination facility in senior citizen building. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller was stated she spoke with an agent to report milder symptoms she experienced after the first dose of the vaccine. The caller wanted to report that on 11Mar2021, she had the normal reaction, sore arm, fever, tiredness, headache and chills on unknown date. The caller got her first shot yesterday morning and it was about 12 hours after it that her symptoms came on. Today is the next day and she wanted to know if it is okay to take Ibuprofen or Tylenol. The caller asked if she will have these symptoms again after the second dose or will they be worse. The caller thinks that she had the fever all night but was unsure, right now her temperature was 99.8, she took it right before she called. The caller wanted to know if she is able to take aspirin or ibuprofen. Or have there been interactions. The caller does not know what her temperature was in the night, she was shivering under her blankets. On unknown date, At 9:30 pm the caller started not feeling well. The caller has a mild headache which has never been bad. The caller chills happened in the night she does not know when they started. The patient underwent lab tests and procedures which included body temperature: 99.8 on 12Mar2021. The outcome of the events pyrexia, chills, malaise was reported as unknown and while other events was recovering.  No follow-up attempts are possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site swelling
Clinical narrative: temperature of 100.4; he had chills; little swelling around the injection site; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), dose 2 via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included budesonide at 6 mg, once a day. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient on 05Mar2021, experienced a little swelling around the injection site. 7 days later on 10Mar2021, the patient had chills, and a temperature of 100.4. The patient wanted to know whether it was normal to have these side effects even days after receiving the vaccine. The patient was taking 6 mg a day of Budesonide, a medication that weakens his immune system and queried whether this medication affected the vaccine's efficacy. The patient underwent lab tests and procedures which included body temperature: 100.4 on 10Mar2021. The clinical outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the top of both hands; This is a spontaneous report from a contactable consumer (Pfizer colleague), reported for a female patient. An adult (47-49 years old range) female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 14Feb2021 at 07:00 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that two days after receiving the first vaccination (Feb2021), the patient indicated they had a rash on the top of both hands. The patient did not receive any treatment. The clinical outcome for the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Muscle tightness, Vaccination site erythema, Vaccination site pain
Clinical narrative: soreness at the injection site and is red; 3 red dots on her arm/soreness at the injection site and is red; Chills; tightness behind her neck; some redness after the vaccine/3 little red dots on her left arm; This is a spontaneous report from a contactable consumer. This 52-Year-old female consumer (patient) reported for self that: A 52-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204, NDC number and Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 10Mar2021 at 16:18 (at the age of 52-year-old) as single dose for COVID-19 immunisation at clinic. Medical history included ongoing breast cancer, sickle cell trait from 1987 and ongoing, ongoing double mastectomy in 2014-2015, lymph nodes removed, ongoing memory loss, ongoing immune system was low, fatty tissues removed from her stomach to form breasts, allergic to Sulfa, Vitamin D and chemo and radiation. The patient concomitant medication was not reported. No other vaccines were given within 4 weeks. History of all previous immunization with the Pfizer vaccine considered as suspect reported as None. On 11Mar2021 the patient experienced soreness at the injection site and is red, 3 red dots on her arm/soreness at the injection site and is red, chills, tightness behind her neck, some redness after the vaccine. AE had not resulted to emergency room/ physician office as caller reported she will go to the doctor if it gets bigger. She said that she may just go by her doctor's clinic to get seen today so they can add this information to her chart. Caller reported that she wanted to know if all of that was normal before she gets her second dose. Caller said that she was a cancer survivor, and she was also allergic to Sulfa. She wanted to make sure that there was no Sulfa in the vaccine. Caller didn't not have the physician email to provide. Soreness and redness at the injection site: She said that sometimes it will go up and go down and she said that she will rub alcohol on it. She rubbed alcohol on its last night and this morning. Caller said that her second dose of the Covid-19 vaccine was scheduled for 31Mar2021. Caller said that she cannot get shots, or her blood pressure taken in her right arm since she has had cancer. Caller said that her immune system was low when she had cancer and she was on a strong Vitamin D with the cancer and after her surgeries. She was off the Vitamin D now. She said that sometimes she has memory loss concerning her cancer experience because of the chemo and radiation. She was told it was a side effect. She said that she had fatty tissues removed from her stomach to form breasts. The clinical outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body height, Oropharyngeal pain, Pruritus, Rash
Clinical narrative: sore throat; severe rash/rash on stomach and back/rash on rear end; rash on legs and arms; rash on neck; rash itching like crazy; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6199, Expiry date was not reported) via an unspecified route of administration, administered in the left arm on 09Mar2021 12:30 (at the age of 67-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included from Lung cancer, fibromyalgia, legs are full of cellulitis, cancer, her voice has gone astray, chemotherapy, unknown date and unknown if ongoing and blood transfusion from 05Mar2021 to an unknown date. The patient had not received any other vaccine within 4 weeks. Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported. On 10Mar2021, the patient experienced severe rash/rash on stomach and back/rash on rear end, rash on legs and arms, rash on neck, rash itching like crazy and sore throat. The events do not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. As a treatment patient were told to take Benadryl and that doesn't work. The patient underwent lab tests and procedures which included blood test: unknown result on unspecified date, body height 4' 8" on unspecified date. The outcome for the event's severe rash/rash on stomach and back/rash on rear end, rash on legs and arms, rash on neck was not recovered and for the event sore throat was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia
Clinical narrative: lower back pain; pain in her hips; muscle aches in her thighs; This is a spontaneous report from a contactable consumer (Patient). A 82 (units: unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 28Feb2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Mar2021, the patient experienced lower back pain, pain in her hips and muscle aches in her thighs, she would like to know if this could be related to the vaccine. She would like to know if it would be safe for her to receive the second dose of the vaccine next week. She had her shot 16 days ago and this week she has started hurting in her lower back and hips and she has muscle aches in her thighs. She asks, should this be expected even after 16 days?. Confirmed with caller that she is calling in regard to the COVID vaccine. she would rather just have her question answered and declined to complete a safety report at this time. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Myalgia
Clinical narrative: Muscle pain; Joint pain; Almost like a burning sensation; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 05Mar2021, at the age of 70-years-old, (Lot Number: EN6201) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On 05Mar2021, the patient experienced muscle pain, joint pain, almost like a burning sensation. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: bruise on arm after COVID Vaccine; This is a spontaneous report from a contactable consumer.   A 33-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced bruise on arm after COVID vaccine but didn't have anything else. Felt absolutely fine. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; solution for injection; batch/lot# EN6208), at the age of 66, via an unspecified route of administration, left arm, on Tuesday, Mar 9, 2021, at approximately 12:20, single dose, for COVID-19 immunization. Medical history included diabetic (diagnosed about 25 years ago). Patient has no known allergies. Patient did not receive any other concomitant products. On Mar 10, 2021, around 19:00 on Wednesday, patient experienced an itchy red face, a little swelling and facial rash (still there today). She wanted to know if there was anything she needed to worry about. Patient had no treatment for it. She thinks it has gotten better. Patient was thinking about taking Benadryl. The outcome of the events: unknown. No follow-up attempts needed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Eating disorder, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: her throat swollen; difficulty eating; sore throat; This is a spontaneous case received from a contactable reporter for a 74-year-old female consumer (patient) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on 09Mar2021 as DOSE 2, SINGLE for COVID-19 immunization and patient also received diphenhydramine hydrochloride, paracetamol (TYLENOL PM EXTRA STRENGTH), via an unspecified route of administration from 11Mar2021 to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient experienced her throat swollen and difficulty eating on 12Mar2021. Patient also experienced sore throat on an unspecified date in Mar2021. Caller reported that, her mother took some Tylenol PM last night and woke up this morning with her throat swollen and difficulty eating. Caller denied compilations with breathing. Caller asking if symptom was possible reaction or not. It was unknown if patient had received any treatment for AEs. The action taken in response to the event(s) for diphenhydramine hydrochloride, paracetamol was unknown.The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Vaccination site pain
Clinical narrative: slight cough; Sore arm at injection site; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), dose 1 via an unspecified route of administration, administered in arm right on 10Mar2021 11:00 (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was none (No known allergies and no other medical history). The patient's concomitant medications were none as no medications in two weeks. No other vaccine in four weeks. No Covid prior vaccination and no Covid tested post vaccination. On 11Mar2021 20:00 (the evening after the injection around 8PM), the patient started having symptoms of sore arm at injection site, fatigue, headache, and slight cough. No treatment received for the events. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced fever and chills.  The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a Regulatory Authority. A contactable health care professional reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient developed a rash on an unknown date. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Aches; Fever; Headache; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6198), via an unspecified route of administration, administered in the right arm on 25Feb2021 13:00 (at the age of 52-years-old) as dose 2, single for COVID-19 immunization. Medical history included high blood pressure (BP) and sulfa allergy. Concomitant medications included sambucus nigra fruit (ELDERBERRY), lisinopril, ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318) via an unspecified route of administration, administered in the left arm in Feb2021 13:00 (at the age of 52-years-old) for COVID-19 immunization, and experienced soreness in arm. The patient did not receive any other vaccine within four weeks of the COVID vaccination. Prior to vaccination, the patient had no history of COVID-19. on 25Feb2021 16:00, the patient experienced headache. On 26Feb2021, the patient woke up with fever (100.2), with aches and headache. The patient was able to work and then went to bed early. On 27Feb2021, the patient woke up to fever of 99.9, but felt well enough to go about her day. The fever was gone by afternoon. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were not taken as result of the events. The outcome of event fever was recovered on 27Feb2021 while the outcome of the remaining events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Influenza like illness, Myalgia
Clinical narrative: every joint in her body started hurting; she started hurting first in her back; aching like a terrible case of the flu; muscles started aching; This is a spontaneous report from a contactable consumer (patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm on 06Feb2021 08:00 (Batch/Lot Number: EL9269) as dose 1, single (at the age of 73-years-old) for Covid-19 immunisation. Medical history included ongoing Raynaud's phenomenon diagnosed probably in 2010. There were no concomitant medications. The patient previously took Synthroid for her thyroid because she has underactive thyroid and that was diagnosed in her 30's when she began taking Synthroid. States the first dose she had a sore arm and it took almost a week for the soreness to resolve. Within less than 2 hours after she had the first dose, every joint in her body started hurting and she started hurting first in her back which she does not typically have pain in her back. States her elbows, wrists, shoulders, knees and feet and everything started acting like a terrible case of the flu and it came on like a slap, her muscles then started aching in her large muscles, in her biceps and the big muscles started aching too and the muscles were being sore and that only lasted a couple of days. After the first dose, two weeks later the aching and soreness started easing and so she was just still having trouble with her hands and especially in her knees but it has eased a lot after the 2nd week after her 1st dose of the vaccine. The events resolved in Feb2021.   No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 14:00 (at the age of 59-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 12Mar2021 at 22:00, about 8 hours after administration of vaccine, the patient had shoulder pain and stiffness. The patient did not receive treatment for the events. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever; aches; headache; This is a spontaneous report from a contactable consumer (patient. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 11Mar2021 12:30 (lot number and expiry date: unknown) at the age of 76-years-old, as dose 1, single, for Covid-19 immunisation. Medical history included Covid-19 (prior vaccination) high blood pressure and allergies: penicillin, some foods. Concomitant medications included losartan, cimetidine (TAGAMET); cetirizine hydrochloride (ZYRTEC) taken for unspecified indications, start and stop dates were not reported. The vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks. The patient was not diagnosed with Covid-19 prior vaccination. On 12Mar2021, the patient experienced fever, aches, and headache for 24 hours. The patient did not receive treatment for the events. The patient recovered from the events on unspecified date. The patient has not been tested for COVID-19 since vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.