chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Headache, Heart rate increased, Hypoaesthesia, Lymphadenopathy
Clinical narrative: Drooping of left side of face; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head/throbbing pain in left side of head; Facial swelling; neck and arm swelling; neck and arm swelling; Fast heart rate; Numbness in face, neck, and left arm; swollen lymph nodes in chest, under arm, left arm, neck, back, and head; This is a spontaneous report from a contactable other health care professional (consumer, patient). A 33-year-old non-pregnant female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27May2021 09:15 (at the age of 33 years old) (Batch/Lot Number: EW0182) as single dose for covid-19 immunization. Medical history included known allergies: ondansetron hydrochloride (ZOFRAN) and dairy. There were no concomitant medications in two weeks. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 06May2021 11:30 AM (at the age of 33 years old) (Batch/Lot Number: EW0176) as single dose for covid-19 immunization. No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. On 28May2021 07:00 AM, the patient experienced severe muscle pain in left arm, neck, and head. Facial swelling, neck and arm swelling. Fast heart rate. Numbness in face, neck, and left arm, swollen lymph nodes in chest, under arm, left arm, neck, back, and head. Drooping of left side of face and throbbing pain in left side of head. All for 11 days. No treatment for events. The outcome of events was not recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neck pain, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Drooping of left side of face; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head/throbbing pain in left side of head; Facial swelling; neck and arm swelling; neck and arm swelling; Fast heart rate; Numbness in face, neck, and left arm; swollen lymph nodes in chest, under arm, left arm, neck, back, and head; This is a spontaneous report from a contactable other health care professional (consumer, patient). A 33-year-old non-pregnant female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27May2021 09:15 (at the age of 33 years old) (Batch/Lot Number: EW0182) as single dose for covid-19 immunization. Medical history included known allergies: ondansetron hydrochloride (ZOFRAN) and dairy. There were no concomitant medications in two weeks. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 06May2021 11:30 AM (at the age of 33 years old) (Batch/Lot Number: EW0176) as single dose for covid-19 immunization. No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. On 28May2021 07:00 AM, the patient experienced severe muscle pain in left arm, neck, and head. Facial swelling, neck and arm swelling. Fast heart rate. Numbness in face, neck, and left arm, swollen lymph nodes in chest, under arm, left arm, neck, back, and head. Drooping of left side of face and throbbing pain in left side of head. All for 11 days. No treatment for events. The outcome of events was not recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Drooping of left side of face; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head; Severe muscle pain in left arm, neck, and head/throbbing pain in left side of head; Facial swelling; neck and arm swelling; neck and arm swelling; Fast heart rate; Numbness in face, neck, and left arm; swollen lymph nodes in chest, under arm, left arm, neck, back, and head; This is a spontaneous report from a contactable other health care professional (consumer, patient). A 33-year-old non-pregnant female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27May2021 09:15 (at the age of 33 years old) (Batch/Lot Number: EW0182) as single dose for covid-19 immunization. Medical history included known allergies: ondansetron hydrochloride (ZOFRAN) and dairy. There were no concomitant medications in two weeks. The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in right arm on 06May2021 11:30 AM (at the age of 33 years old) (Batch/Lot Number: EW0176) as single dose for covid-19 immunization. No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. On 28May2021 07:00 AM, the patient experienced severe muscle pain in left arm, neck, and head. Facial swelling, neck and arm swelling. Fast heart rate. Numbness in face, neck, and left arm, swollen lymph nodes in chest, under arm, left arm, neck, back, and head. Drooping of left side of face and throbbing pain in left side of head. All for 11 days. No treatment for events. The outcome of events was not recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak for the first time.; This is a spontaneous report from a contactable consumer. This 42-year-old male consumer (Patient) received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 18May2021 09:00 (Batch/Lot Number: EW0185) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported.  The patient experienced shingles outbreak for the first time on 27May2021. The patient received treatment of valtrex medication. Patient had no covid prior vaccination and did no covid tested post vaccination. The patient had no other vaccine in four weeks, had no allergies. The outcome of event was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Possibly be giving me the diarrhea; Medicine is giving me diarrhea which is possible because lots of time antibiotics does do they; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0173, Expiry date not reported) via unspecified route of administration on 10Jun2021 as dose 1, single for COVID-19 Immunisation. Patient medical history and concomitant medications were not reported. Patient enquired that possibly be giving me the diarrhea; Medicine is giving me diarrhea which is possible because lots of time antibiotics does  they do, on unspecified date in Jun2021. Consumer stated, "Yes, I was reading over the paper that they gave me when I took the shots today the first one at (withheld) and I was looking at the paper it doesn't say anything about diarrhea. Now I am on an Antibiotic and 'Microbial' (further not clarified hence captured as Unspecified medication) is the Generic for 'Microbial' and I have to got after tonight, I have to take the other one tonight, I have two more day. So, would that possibly be giving me the diarrhea. In response to patient, they informed role of Medical Information and Drug Safety for further information. Patient received treatment for the event. The outcome of event was unknown.   Information on Lot/Batch number was available. Additional information has been requested.   .
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: 1st shot had a thin line of numbness on the tip of my tongue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8733) via an unspecified route of administration in left arm on 16Apr2021 at 04:00 (age at vaccination 65-year-old) as dose 1, single for covid-19 immunization. The patients medical history was none. Patient did not have any known allergies. The patients concomitant medications included calcium, vit d [vitamin d nos] and bupropion hydrochloride (WELLBUTRIN). Patient did not have covid prior to vaccination. Patient did not test post vaccination. On an unspecified date in 2021, after dose 1, patient had a thin line of numbness on the tip of tongue. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: genital herpes outbreak; genital herpes outbreak; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8736), via an unspecified route of administration in left arm on 21Apr2021 (age at the time of vaccination was 28-year-old) single dose for COVID-19 immunisation. The patient's medical history included genital herpes from 2014, the patient had rare outbreaks usually only when she was not taking her medications or she was stressed. The patient had allergic to Indomethacin. The patient's concomitant medication in two weeks included acyclovir. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. The two weeks after received vaccine on 24May2021, the patient had a herpes outbreak. The patient did not receive treatment in response to the events. The outcome of the event was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.  Follow-Up (12Jul2021): No Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nose bleeding; This is a spontaneous report from a contactable consumer (parent). A 17-year-old male patient (son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 27May2021 as dose 1, single and second dose (Batch/Lot number was not reported) via an unspecified route of administration on 17Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated that his son who was 17 years old, he was a minor received the 1st dose of Pfizer Covid19 vaccine on 27May2021 and had nose bleeding few days after the injection for 15 minutes. On his 2nd dose on 17Jun2021 he experience another nose bleeding after few days it lasted for about 15 minutes. He had his shot on Thursday and now he had a nose bleed again today, that was his second shot. She wants to know if this was one of the side effects of the vaccine and what they should do about it. He was wondering if have had this on many occasions or if we should seek medical attention. He want to know if that was a standard reaction that you contain or if we need to seek medical attention. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Somnolence, Vaccination site swelling, Vaccination site warmth
Clinical narrative: I pretty much slept all day; Felt like I had a fever; Injection site is swollen and very hot; Injection area is very swollen; Injection site is swollen and very hot; Injection area is very swollen; Itches all over my arms; Severe itching; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 17Jun2021 at 09:45 as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date, after the vaccination, the patient experienced sleepy and slept all day, had a fever and injection site was swollen and very hot, patient doesn't feel like running a fever. patient also got itches all over arms. On the next day also injection area was very swollen and very hot. Patient was asking what to do with the reactions. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Drooling, Hypoaesthesia, Swelling face
Clinical narrative: My left side of the face is been swelled; being numbed recently and also I have been drooling; My left side of the face is been swelled; being numbed recently and also I have been drooling; My left side of the face is been swelled; being numbed recently and also I have been drooling; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 15Jun2021 (Batch/Lot Number: EW0178; Expiration Date: 31Aug2021) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that received Covid-19 vaccine couple of days ago and started yesterday on 19Jun2021 left side of the face was numb and started to drool out of outside and wanted to report some minor side-effect which the patient never had until took 1st shot of the Pfizer Vaccine and was curious if other people having the same side-effects. The outcome of the events was unknown.  Further probing could not be done as consumer don't want to share further information. Hence, limited information available over the call.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Bad colds; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced bad colds and scheduled for the second dose of the Pfizer COVID-19 vaccine on 23Jun2021, his doctor said to wait a week before getting the vaccine. The outcome the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after; This is a spontaneous report from a contactable consumer (patient's mother) who reported for her son via Pfizer sponsored program. A male patient of an unspecified age 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 17Jun2021 as a single dose for covid-19 immunization. Medical history included that the patient was autistic with catatonia and had combination of Lyme disease and Epstein Barr virus. He also had some hives from sand that they bought from store to make a sandbox, wherein he had head-to-toe dots and blotches everywhere, and the only cause his mother could see was silica. He was also gluten intolerant. The patient visited to doctor on 04Jun2021, and he said okay for vaccination. Concomitant medication included lorazepam (LORAZEPAM) taken for an unspecified indication, start and stop date were not reported. The medication was not working lately, and they had to increase the dose. The insurance company didn't allow the same manufacturer, so they also changed manufacturer on the pharmacy. He was perfectly fine before but had severe allergic reaction with different manufacturer. The patient experienced sore arm on an unspecified date in Jun2021. His mother wanted to know if the vaccine contained gluten, silica or if the ingredients of the vaccine might be used in some other medications that may be hidden and trigger an allergic reaction. She said that she always carries Benadryl that had to go with his Prednisone. The outcome of the event was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue
Clinical narrative: Diarrhea; Dizziness; Tired; This is a spontaneous report from a contactable consumer or other non hcp. A consumer reported for a male patient (reporters' brother) that. A male patient of an unspecified age received dose number unknown of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EWO191) via an unspecified route of administration on 15Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhoea, dizziness, tired in Jun2021. The clinical course was reported as he said he got the shot on last Tuesday and he is still experiencing side effect like diarrhea and dizziness. The clinical outcome of events not recovered.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Headache; Migraine; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Jun2021, the patient experienced headache. On Jun2021, experienced migraine Therapeutic measures were taken as a result of headache and migraine. She had excedrin and aspirin and ibuprofen. The patient received the first dose of Pfizer's COVID-19 vaccine yesterday, she had a bit of a headache today and wanted to know if she could take Ibuprofen to relieve her symptoms. She received the vaccine at a pharmacy. The patient suffered from migraine. The response was received, Pfizer does not have an specific recommendation as it is still unknow how medications like Ibuprofen could affect the COVID-19 vaccination. According to the CDC, medications like Ibuprofen could be taken to treat side effects of the vaccination if medically appropriate. For additional recommendations refer to her physician. The clinical outcome of the events was reported as unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Hypokinesia, Pain in extremity
Clinical narrative: hard to move around; she feels weak; she felt the exhaustion was progressively worse and that she had some chills; she felt her arm being sore; a little bit of tiredness/she felt the exhaustion was progressively worse and that she had some chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on 22Jun2021 09:00 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 49-year-old, Female patient reported that post vaccination of her first dose of the PFIZER-BIONTECH COVID-19 VACCINE on Tuesday (22Jun2021) at 9 AM, she felt her arm being sore and a little bit of tiredness. However, 4 days after, she felt the exhaustion was progressively worse and that she had some chills. In line with this, patient would like to know if it was common for side effects to start a few days after the vaccines. As she had read that side effects are commonly occurring within 1-2 days and was resolved thereafter. The clinical outcome of the event was fatigue was not recovered, remaining all other events was unknown at the time of report. Follow-up actions are needed. Further information has been requested.  The lot number for the vaccine, [PFIZER-BIONTECH COVID-19 VACCINE], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her left arm where she had the shot was also sore for a day; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself) via medical information team. A 65-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced her left arm where she had the shot was also sore for a day on an unspecified date. Patient got the second dose of the Pfizer BioNTech COVID-19 vaccine yesterday and her left arm where she got the shot was a little sore. Patient also mentioned that when she got the first dose, her left arm where she had the shot was also sore for a day. Patient mentioned she has a headache and wanted to know if it is safe to take Tylenol Extra Strength. Patient mentioned that a friend told her not to take Advil after 24 hours because you will lose the effect of the shot. Outcome of the event was unknown.  Information on lot/batch number has been requested.  Follow-up (PRD/SRD 26Jul2021): No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Conjunctivitis, Ocular hyperaemia
Clinical narrative: I was calling I got my second Covid shot yesterday, last time my left eye is all kind of red and so this morning I woke up kind of crested,  I never had pinkeye before I don't know if its is pinkeye; I was calling I got my second Covid shot yesterday, last time my left eye is all kind of red and so this morning I woke up kind of crested,  I never had pinkeye before I don't know if its is pinkeye; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE and as dose 2 via an unspecified route of administration on 25Jun2021 (Batch/Lot Number: FA6780) as DOSE 2, SINGLE, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got second Covid shot yesterday, last time patient's left eye was all kind of red and so this morning patient woke up kind of crested, patient never had pinkeye before don't know if it was pinkeye (Jun2021), patient concern was it something might be having a shot would get. Patient stated, yes would like to talk to someone, patient just want to if it was a side effect, it was Saturday, his/her doctors office was not open. The outcome of both events was not recovered.  Call could not be transferred to Medical information department and Patient hung up the call abruptly.  Limited information available over the call.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Colonoscopy, Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm on 07Apr2021 (at the age of 80-year-old) at dose 2, single for covid-19 immunisation. Medical history included hysterectomy (Additional Information: Done when the caller was 31 years old). Concomitant medication included omeprazole (OMEPRAZOLE) at 20 mg; lisinopril (LISINOPRIL) at 20 mg once a day taken for blood pressure measurement; acetylsalicylic acid (ASPIRIN 81) at 81 mg once a day; calcium (CALCIUM) at once a day; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The reporter was taking 20 mg of the Omeprazole and then her doctor increased it when the diarrhea started. Lot, NDC, and expiration date unknown. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, on 17Mar2021 (at the age of 80-year-old) at dose 1, single for covid-19 immunisation. No reaction on previous exposure to vaccine. On 09Apr2021 the patient experienced diarrhea. Adverse event led to physician office visit. The reporter is calling about the Pfizer covid vaccine. On 17Mar2021 the reporter had her first shot and everything was fine afterwards. On 07Apr2021 the reporter had her second dose, she was in at the time. 2 days after the second shot the reporter got diarrhea when they were leaving to come back and it wasn't very pleasant. The reporter had the diarrhea for 4.5 weeks. The reporter went to her doctor after having the diarrhea for 2 weeks and the doctor started her on rice and all sorts of things, some diet. The reporter was sticking to the diet and it didn't do any good. The reporter doctor referred the reporter to the colonoscopy doctor. The reporter had the colonoscopy last Friday and they found nothing. The reporter felt like the diarrhea came from the shot. The diarrhea left after 4.5 weeks and then 2 weeks after that, the caller had the colonoscopy. Event: The caller clarifies and confirms that before the colonoscopy the diarrhea has stopped probably a week and a half prior. First Dose: Received 17Mar2021, lot EP7534, unknown expiration date and NDC. Second Dose: Received 07Apr2021, lot EW0151, unknown expiration date and NDC. Investigation: The reporter had routine blood work done a couple of days ago and said it was fine. The reporter would not get a booster shot if we offered it because she doesn't want to go through this again. The patient underwent lab tests and procedures which included Blood work: normal on an unspecified date, colonoscopy: normal on 18Jun2021. Description of Product Complaint: The reporter was taking 20 mg of the Omeprazole and then her doctor increased it to 40mg when the diarrhea started. Lot, NDC, and expiration date unknown. Outcome of the event was resolved on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Left arm where she got the shot was a little sore; Headache; This is a spontaneous report from a contactable consumer. This 65-year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Jun2021 in left arm as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization and her arm was sore for a day. On an unknown date in Jun-2021 after the second dose her left arm where she got the shot was a little sore. Caller mentioned she had a headache and wanted to know if it is safe to take Tylenol Extra Strength. Caller mentioned that a friend told her not to take Advil after 24 hours because you will lose the effect of the shot. The outcome of events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: Pfizer Covid Vaccine made her sick; She is not feeling well; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), dose 1 via an unspecified route of administration on 23Jun2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced pfizer covid vaccine made her sick and she is not feeling well in Jun2021, she is not going to get her second dose of pfizer covid vaccine on an unspecified date. She reported the Pfizer Covid Vaccine caused her to have some reactions behind it. She just wanted to let Pfizer know that the Pfizer Covid Vaccine made her sick and she is not going to get her second dose of Pfizer Covid Vaccine. She is not feeling well, she has got to go lay down. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: Feel a little weird, so very fatigue; Feel a little weird, so very fatigue; This is a spontaneous report from a contactable consumer (patient). patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had the first dose almost a week ago and when patient had the vaccine her arm wasn't even sore, she really doesnt feel like she had any reaction to it at all, but today which is almost a week since she had the first dose, she felt a little weird, so very fatigue and just wondering one could had a reaction to vaccine this far. Reporter seriousness for Feel a little weird, so very fatigue was unspecified. Outcome of the events was unknown.  Information about lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bowel movement irregularity
Clinical narrative: All this time, since last Wednesday, 23JUN2021, has had all these stomach cramps; Have had to have three bowel movements every day.; This is a spontaneous report from a contactable consumer (patient herself). An unspecified aged female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 23Jun2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021 patient reported that she has three bowel movements every day and Saturday, the caller had four bowel movements. Since last wednesday 23Jun2021 patient has had all these stomach cramps. The stomach cramps you get when you have to go to the bathroom. Saturday the patient had to go to the bathroom four times. All day the patient has had stomach cramps and had to go. Then on 28Jun2021, the patient has had constant stomach cramps, finally around 11:30 the patient went to the bathroom. The patient has never had these stomach cramps before. Outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient that a 50-year-old male patient received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date (at the age of 50 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was calling on behalf of her 50-year-old boyfriend. He received the Pfizer COVID19 Vaccine and a week later reports a rash. He called reporter this AM saying he has a rash and he thought it may be from the vaccine. The reporter does not think this was so because it "has been over one week." She stated, "he was going to be honest, reporter don't think it has anything to do with the vaccine. For most people if they get a bee sting or eat something body reacts right away because it recognized something abnormal. Usually people get rashes and different things right away, not a week later. It doesn't correlate or make sense. She stated she just wanted to see if we had any data or anything that would suggest that. Reporter also questions possible reaction to the detergent that linens were washed in at the hotel that he stayed at last night as being a possible cause of his reaction/rash today. Response: What are the risks of the Pfizer-biotech covid-19 vaccine? A bad rash all over your body. Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine included: non-severe allergic reactions such as rash. Advised caller per attached document regarding "how long side effects last" In general, local side effects; the ones they get on the arm where they got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that they may experienced throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter. Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days. The outcome of event was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin disorder
Clinical narrative: I feel like tickle's in my face under left side; On next day I have a something like a small rash in my face in my left side; I have little bump in my chin area in my left side/I feel something in my back of my ear like a bump or something like that; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (CONMINTARY, Solution for injection, Lot No: was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history concomitant medications were not reported.  The patient experienced i feel like tickles in my face under left side on an unspecified date, on next day i have a something like a small rash in my face in my left side on an unspecified date, i have little bump in my chin area in my left side/i feel something in my back of my ear like a bump or something like that on an unspecified date. Patient stated, do you want me to call again  my English is not that good so that's why I prefer in Spanish but I just have a question, I just have a Pfizer vaccination on Thursday in my left arm that day in the night I feel like tickles in my face under left side and then on next day I have a something like a small rash in my face in my left side and then I have little bump in my chin area in my left side also and then I feel something in my back of my ear like a bump or something like that so I just want to make sure as it is not like an allergy or the reaction of the vaccination or the side effect,  because I was healthy I don't have any problems I am not allergic to any medication and I used Benadryl but it not helped so I am concerned about that. Patient stated, no not a Benadryl, I want to know is it like something about vaccination because I took the Benadryl because I had an allergy or about something that, but it doesn't help me, so I want to know what next I want to look for the doctor or have to wait Benadryl, the one is for allergy. I just got the vaccination on Thursday and on that night, I feel some tickle in my left side on my face. But it was before Benadryl (Treatment). I am not on any medication I took vaccination then I feel the tickle in my face then next day I feel the same thing I had a rash on left side. I didn't take any medications just the symptoms that I feel looks like before the I take the vaccination. Treatment confirmed was Benadryl. The outcome of the events was unknown  Information on the lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Bedridden, Blood test, Feeding disorder, Headache
Clinical narrative: I was so sick on 03Jun2021; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; sweating; migraine; Headache; nausea; hair still falling; shaking; I was aching worse on 2nd shot; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0172), via intramuscular route of administration on 03Jun2021 at 09:10 AM (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from 18Feb2021 to an unknown date (my hairs still falling out after had covid by hands full as of 18Feb2021. I had Covid & so sick. I could not get out of bed). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP753), via intramuscular route of administration on 12May2021 at 09:00 AM (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and experienced shaking, I was aching all over. The patient experienced shaking, I was aching worse on 2nd shot, hair still falling on an unspecified date in 2021, sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed on an unspecified date in Jun2021, I was so sick on 03Jun2021. Pertinent Details: shaking, I was aching worse on 2nd shot & had to go to bed when got up at 10 AM and sweating, migraine, headache & nausea. Could not eat, had to stay in bed & whole Day & Night. My hairs still falling out after had covid by hands full as of 18Feb2021. Family medical History: Patient husband (withheld) took Moderna & no symptoms at all. But patient was so sick on 03Jun2021. Patient never want to take that shot again because patient felt like I did when I had Covid & so sick. Patient could not get out of bed. The patient underwent lab tests and procedures which included COVID test: had covid (my hairs still falling out after had covid by hands full as of 18Feb2021) on 18Feb2021, blood test was kidney, liver, heart all good and thyroid good (everything good & doctor still don't know why my hair is falling out in hands full) on 01Jun2020. The patient received Tylenol, Chicken soup as a treatment for the event shaking. Outcome of the events I was aching worse on 2nd shot, hair still falling was not recovered; sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed was unknown; shaking was recovered on an unspecified date in 2021, I was so sick was recovered on 03Jun2021.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Migraine, Nausea, Pain
Clinical narrative: I was so sick on 03Jun2021; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; sweating; migraine; Headache; nausea; hair still falling; shaking; I was aching worse on 2nd shot; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0172), via intramuscular route of administration on 03Jun2021 at 09:10 AM (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from 18Feb2021 to an unknown date (my hairs still falling out after had covid by hands full as of 18Feb2021. I had Covid & so sick. I could not get out of bed). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP753), via intramuscular route of administration on 12May2021 at 09:00 AM (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and experienced shaking, I was aching all over. The patient experienced shaking, I was aching worse on 2nd shot, hair still falling on an unspecified date in 2021, sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed on an unspecified date in Jun2021, I was so sick on 03Jun2021. Pertinent Details: shaking, I was aching worse on 2nd shot & had to go to bed when got up at 10 AM and sweating, migraine, headache & nausea. Could not eat, had to stay in bed & whole Day & Night. My hairs still falling out after had covid by hands full as of 18Feb2021. Family medical History: Patient husband (withheld) took Moderna & no symptoms at all. But patient was so sick on 03Jun2021. Patient never want to take that shot again because patient felt like I did when I had Covid & so sick. Patient could not get out of bed. The patient underwent lab tests and procedures which included COVID test: had covid (my hairs still falling out after had covid by hands full as of 18Feb2021) on 18Feb2021, blood test was kidney, liver, heart all good and thyroid good (everything good & doctor still don't know why my hair is falling out in hands full) on 01Jun2020. The patient received Tylenol, Chicken soup as a treatment for the event shaking. Outcome of the events I was aching worse on 2nd shot, hair still falling was not recovered; sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed was unknown; shaking was recovered on an unspecified date in 2021, I was so sick was recovered on 03Jun2021.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: I was so sick on 03Jun2021; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; Could not eat, had to stay in bed & whole Day & Night/I could not get out of bed.; sweating; migraine; Headache; nausea; hair still falling; shaking; I was aching worse on 2nd shot; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0172), via intramuscular route of administration on 03Jun2021 at 09:10 AM (at the age of 60-year-old) as dose 2, single for COVID-19 immunization. Medical history included COVID-19 from 18Feb2021 to an unknown date (my hairs still falling out after had covid by hands full as of 18Feb2021. I had Covid & so sick. I could not get out of bed). The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP753), via intramuscular route of administration on 12May2021 at 09:00 AM (at the age of 60-year-old) as dose 1, single for COVID-19 immunization and experienced shaking, I was aching all over. The patient experienced shaking, I was aching worse on 2nd shot, hair still falling on an unspecified date in 2021, sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed on an unspecified date in Jun2021, I was so sick on 03Jun2021. Pertinent Details: shaking, I was aching worse on 2nd shot & had to go to bed when got up at 10 AM and sweating, migraine, headache & nausea. Could not eat, had to stay in bed & whole Day & Night. My hairs still falling out after had covid by hands full as of 18Feb2021. Family medical History: Patient husband (withheld) took Moderna & no symptoms at all. But patient was so sick on 03Jun2021. Patient never want to take that shot again because patient felt like I did when I had Covid & so sick. Patient could not get out of bed. The patient underwent lab tests and procedures which included COVID test: had covid (my hairs still falling out after had covid by hands full as of 18Feb2021) on 18Feb2021, blood test was kidney, liver, heart all good and thyroid good (everything good & doctor still don't know why my hair is falling out in hands full) on 01Jun2020. The patient received Tylenol, Chicken soup as a treatment for the event shaking. Outcome of the events I was aching worse on 2nd shot, hair still falling was not recovered; sweating, migraine, headache, nausea, could not eat, had to stay in bed & whole day & night/I could not get out of bed was unknown; shaking was recovered on an unspecified date in 2021, I was so sick was recovered on 03Jun2021.  Follow-Up: Follow-up attempts are completed. No further information is expected.