chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: My period is now 11 days late; This is a spontaneous report from a contactable consumer (Patient). A 29-years-old Non-Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0181 and Expiry date was not reported), via an unspecified route of administration on 08Jul2021 15:00 (at the age of 29-years-old) in Arm Right as dose 2, single for COVID-19 immunization. The patient other medical history was none, The concomitant medications was not reported. The patient previously took tramadol and experienced allergies. (Known Allergies: Tramadol). Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0191 and Expiry date was not reported), via an unspecified route of administration on 15Jun2021 12:00, (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0191 and Expiry date was not reported), via an unspecified route of administration on 15Jun2021 12:00, (at the age of 29-years-old) as dose 1, single for COVID-19 immunization. The patient did not received other medications in two weeks. The patient was not pregnant. The patient had not received other vaccine in 4 weeks. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had not tested for COVID-19 since the vaccination. On 08Jul2021, the patient experienced her period was now 11 days late, she have had a regular period before this (within the same 1-2 day cycle) and there was no way this was stress-related from life because she was not feeling stressed from life. This was definitely from the vaccine. The patient had not received treatment for the adverse event. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: a sore/swollen arm; a sore/swollen arm; upset stomach; This is a spontaneous from a contactable consumer (patient). This report is based on the information received by Pfizer (Manufacturer Control No: 2021-00909871).  A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 1, single for COVID-19 immunization. Patient reports that she recently received her 2nd COVID vaccine and had experienced a sore/swollen arm and an upset stomach. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have had all the side effects and I am having Headache; This is a spontaneous report from a contactable consumer. A 15-year-old female consumer(patient) reported for herself. A 15-year-old female adolescent patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 14Jul2021 (at the age of 15-year-old) 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 headache. Patient took Benadryl as treatment option. The events assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (01Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient's sister). A male patient (reporter's brother) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm. The reporter stated that all that the patient got from the first shot was a sore arm, basically just that and then with the second shot, nothing. The reporter does not know whether the patient got a headache, she would have to ask, but the patient said he got nothing other than sore arm, was perfectly fine, and advised the reporter to take the second shot as there was nothing wrong. The patient received second shot, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation and was fine. It did not affect his appetite, he did not complain of headache, did not complain of taking Aspirins or anything like that. The clinical outcome for the event was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Diarrhoea, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Had a large reaction; Arms are real sore; Fever; Chills; Going to throw up; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number, UPC number and Expiry Date are unknown, Lot number: not specified (reported as EW0181 but not sure if the lot number belongs to her or the daughter or the husband)), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included Parkinson (not appropriately clarified) from unspecified date. she had COVID on an unspecified date in Jan2021 and she was hospitalized. She was in the hospital for five days. She had strong steroids as treatment. The patient's concomitant medications were not reported. The reporter stated that her husband, herself and her daughter, three of them had out COVID Shot, the Pfizer at (Facility name) and they all three had a large reaction on an unspecified date. She had (incomplete sentence), all 'three' arms are real sore on an unspecified date. When again probed for the concern as call handler was unable to hear the reporter, She stated, she has 'Parkinson' (Not appropriately clarified). She does not understand. She cannot hear good. She further stated that she had COVID back in January and she was hospitalized. She was in the hospital for five days. She had strong steroids as treatment. She was safe for two days (Clarification unknown), after she got the shot, on an unspecified date, she had fever, chills, she was going to throw up and she had a diarrhea and she was due to get it again on 23rd. She asked, does she get it again or does she not?" She added, she talked to the pharmacist. She just wanted to know with the reaction that she had and her daughter, does they take the second shot or does they not? She was scared, she was afraid to 'fell' into the COVID again. She stated, "It's Pfizer. It says, COVID-19 Vaccine, LOT number, it looks like EWC101 or EWC0101 maybe. Pfizer that is the LOT number and it says come back on the 23rd. Are there different LOT number? She was getting a magnifying glass so she can see it. (Later clarified as EW0181)." (Not sure if the LOT number belongs to the consumer or the daughter or the husband). She stated expiration date as 30Aug202 (Further not clarified). She stated she was having a hard time. When again probed for the age and date of birth, she stated, "When I (incomplete sentence), six or couple of days (Clarification unknown). I am scared to get another one, I had (incomplete sentence)." The outcome of events was unknown.  Information about Lot/Batch number is requested
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination complication
Clinical narrative: Had a large reaction; Arms are real sore; Fever; Chills; Going to throw up; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number, UPC number and Expiry Date are unknown, Lot number: not specified (reported as EW0181 but not sure if the lot number belongs to her or the daughter or the husband)), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included Parkinson (not appropriately clarified) from unspecified date. she had COVID on an unspecified date in Jan2021 and she was hospitalized. She was in the hospital for five days. She had strong steroids as treatment. The patient's concomitant medications were not reported. The reporter stated that her husband, herself and her daughter, three of them had out COVID Shot, the Pfizer at (Facility name) and they all three had a large reaction on an unspecified date. She had (incomplete sentence), all 'three' arms are real sore on an unspecified date. When again probed for the concern as call handler was unable to hear the reporter, She stated, she has 'Parkinson' (Not appropriately clarified). She does not understand. She cannot hear good. She further stated that she had COVID back in January and she was hospitalized. She was in the hospital for five days. She had strong steroids as treatment. She was safe for two days (Clarification unknown), after she got the shot, on an unspecified date, she had fever, chills, she was going to throw up and she had a diarrhea and she was due to get it again on 23rd. She asked, does she get it again or does she not?" She added, she talked to the pharmacist. She just wanted to know with the reaction that she had and her daughter, does they take the second shot or does they not? She was scared, she was afraid to 'fell' into the COVID again. She stated, "It's Pfizer. It says, COVID-19 Vaccine, LOT number, it looks like EWC101 or EWC0101 maybe. Pfizer that is the LOT number and it says come back on the 23rd. Are there different LOT number? She was getting a magnifying glass so she can see it. (Later clarified as EW0181)." (Not sure if the LOT number belongs to the consumer or the daughter or the husband). She stated expiration date as 30Aug202 (Further not clarified). She stated she was having a hard time. When again probed for the age and date of birth, she stated, "When I (incomplete sentence), six or couple of days (Clarification unknown). I am scared to get another one, I had (incomplete sentence)." The outcome of events was unknown.  Information about Lot/Batch number is requested
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain in extremity, Vaccination complication
Clinical narrative: Had a large reaction; Arms are real sore; Fever; Chills; Going to throw up; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC number, UPC number and Expiry Date are unknown, Lot number: not specified (reported as EW0181 but not sure if the lot number belongs to her or the daughter or the husband)), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included Parkinson (not appropriately clarified) from unspecified date. she had COVID on an unspecified date in Jan2021 and she was hospitalized. She was in the hospital for five days. She had strong steroids as treatment. The patient's concomitant medications were not reported. The reporter stated that her husband, herself and her daughter, three of them had out COVID Shot, the Pfizer at (Facility name) and they all three had a large reaction on an unspecified date. She had (incomplete sentence), all 'three' arms are real sore on an unspecified date. When again probed for the concern as call handler was unable to hear the reporter, She stated, she has 'Parkinson' (Not appropriately clarified). She does not understand. She cannot hear good. She further stated that she had COVID back in January and she was hospitalized. She was in the hospital for five days. She had strong steroids as treatment. She was safe for two days (Clarification unknown), after she got the shot, on an unspecified date, she had fever, chills, she was going to throw up and she had a diarrhea and she was due to get it again on 23rd. She asked, does she get it again or does she not?" She added, she talked to the pharmacist. She just wanted to know with the reaction that she had and her daughter, does they take the second shot or does they not? She was scared, she was afraid to 'fell' into the COVID again. She stated, "It's Pfizer. It says, COVID-19 Vaccine, LOT number, it looks like EWC101 or EWC0101 maybe. Pfizer that is the LOT number and it says come back on the 23rd. Are there different LOT number? She was getting a magnifying glass so she can see it. (Later clarified as EW0181)." (Not sure if the LOT number belongs to the consumer or the daughter or the husband). She stated expiration date as 30Aug202 (Further not clarified). She stated she was having a hard time. When again probed for the age and date of birth, she stated, "When I (incomplete sentence), six or couple of days (Clarification unknown). I am scared to get another one, I had (incomplete sentence)." The outcome of events was unknown.  Information about Lot/Batch number is requested
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arms are real sore; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (reporter's husband). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number unknown) via unspecified route of administration as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. The reporter stated that her husband had COVID shot and he had a large reaction and arm was real sore. The outcome of event was unknown.  Information about lot/batch number has been requested
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Musculoskeletal chest pain, Pain in extremity, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Administered after sitting at room temperature for 16-18 hours; Administered after sitting at room temperature for 16-18 hours; Sore arm; pain round rib cage and chest area; pain round rib cage and chest area; This is a spontaneous report from a contactable pharmacist (patient's husband).  A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 18Jul2021 (age at vaccination was 43 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included dose 1 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 1, SINGLE. The reporter pharmacist said he took home the Pfizer-BioNTech Covid-19 Vaccine and administered the 2nd dose to his 43-year-old wife. However, he said prior to that, it was sitting at room temperature at around 1:00 for 16-18 hours. He wants to know if this is considered a temperature excursion. When asked what specific temperature the vaccine was exposed to, HCP said he does not know. He said it was a diluted vaccine stored inside a vial. HCP also said that after receiving the 2nd dose, his wife experienced sore arm, and pain around her ribcage and chest area. He wants to know what are the side effects she should be expecting. At the time of this report, the outcome of all the events was unknown.  Information about lot/batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: snotty nose; can't breathe well out of her nose; body aches; fever; This is a spontaneous report from a contactable consumer (Mother). This consumer reported for 2 patients. This report is for 1st of 2 patients. A 12-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration, administered in Arm Right on 15Jul2021 (at age of 12-year-old) as single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient experienced fever of 102.1 on the first night on 15Jul2021, 101.1 the next day (16Jul2021), and since then has had a fever ranging from 99.3 up to 100. On 16Jul2021, the patient experienced snotty nose, can't breathe well out of her nose and body aches. The patient got vaccinated on 15Jul2021 and about an hour later the patient had a huge fever which the caller knew would happen. The patient was snotty, could not breathe well, and had body aches. Caller wondering if these side effects were due to the vaccine. Outcome of the event fever was recovering; snotty nose, can't breathe well out of her nose, body aches was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Pain, Pyrexia
Clinical narrative: Fever; Severe body aches; Felt weak the rest of the day; Having horrible diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 16Jul2021 10:00 (vaccination at the age of 28 years) as dose 1, single for covid-19 immunisation at Doctor's office/urgent care. Medical history included irritable bowel syndrome, seasonal allergies and known allergy: crawfish from an unknown date and unknown if ongoing. Concomitant medication was reported as none as Other medications in two weeks were reported as no. It was reported that patient received no other vaccine in four weeks. The patient did not have Covid prior vaccination. On an unspecified date in Jul2021, the patient experienced fever, severe body aches, felt weak the rest of the day and was having horrible diarrhea. It was reported that, adverse event nearly 48 hours after injection he began having a fever and severe body aches. he got rid of the fever, felt weak the rest of the day, and his fever came back. He then began having horrible diarrhea that afternoon that had lasted over 24 hours, where he have had to go every hour since then. His fever has come back multiple times as well. The patient was not tested for Covid post vaccination. It was reported that no treatment was received for AE. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Vaginal haemorrhage
Clinical narrative: I have started to have occasional, and unusual spotting/bleeding; I have started to have occasional, and unusual spotting/bleeding; This is a spontaneous report from a contactable consumer (patient). This 50-year-old female consumer reported for herself that. A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 12:00 PM as (At the age of 50-years) dose 2, single for covid-19 immunisation. Medical history included contraception from an unknown date and unknown if ongoing. Concomitant medication included medroxyprogesterone acetate (DEPO PROVERA) taken for contraception, start and stop date were not reported. No known allergies ware reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 09:00 AM as dose 1, single for covid-19 immunisation. The patient experienced i have started to have occasional, and unusual spotting/bleeding (intermenstrual bleeding and vaginal haemorrhage) on 29Mar2021. Patient did not receive any tenement for events. The outcome of events was not recovered.  Information about lot/batch number has been requested.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Bursitis, Vaccination site pain
Clinical narrative: bursitis of the rotator cuff; terrible pain at the site of the injection; This is a spontaneous report from a contactable consumer(patient). An 82-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: not reported), dose 2 via unspecified route of administration on 04Feb2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown) on unspecified date as DOSE 1, SINGLE for COVID-19 Immunization and experienced pain. On 04feb2021 the patient had experienced terrible pain at the site of the injection that started when the band aid was put on it and it was exactly there. It was reported that she had underlying problems that were dormant, and the vaccine exacerbated the problem. Since 04Feb2021, she has been in agony and done Physical Therapy. Caller stated they said it is bursitis of the rotator cuff, bit she is in agony every day and it is her right hand and she is useless without it. The outcome of the event terrible pain at the site of the injection was not recovered and the event bursitis of the rotator cuff is unknown.   Information on the lot/batch number has been requested.  Follow up (01Sep2021): No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: After the second dose, I stopped having a menstrual cycle; After the second dose, I stopped having a menstrual cycle; This is a spontaneous report from a contactable consumer.   A 46-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications not reported. on 15May2021 the patient experienced after the second dose, i stopped having a menstrual cycle she taken several tests and she know it isn't due to pregnancy the patient underwent lab tests and procedures which included sars-cov-2 test: negative on 17Jul2021. Outcome of events was recovered with sequelae.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Feeling abnormal, Myalgia, Pain in extremity
Clinical narrative: pain in her arm; swelling on her upper chest on the left side where she got her shot and then on the left side of her throat coming down to her shoulder/swollen on top; feeling some type of way/not normal; whole left side of her back and under her shoulder blade are also concerning her with muscle and joint pain.; whole left side of her back and under her shoulder blade are also concerning her with muscle and joint pain.; rising under her armpit; This is a spontaneous report from a contactable consumer (patient herself). A 40-years-old female patient received 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 19Jul2021 08:00 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient received the Pfizer COVID-19 Vaccination on Monday 08:00 AM and was concerned with the duration of her side effects that she seemed to be occurring, still, today (unspecified date). Caller would like to know if there were other side effects noted other than what she has on the paperwork she received when she got the vaccination. On an unspecified date she stated that she had swelling on her upper chest on the left side where she got her shot and then on the left side of her throat coming down to her shoulder. She felt pain in her arm as well that was slightly swollen. She stated the whole left side of her back and under her shoulder blade were also concerning her with muscle and joint pain. She thought there might be a boil or rising under her arm pit. She stated she knew this was not normal. She felt off. She knew she was not supposed to feel this way. Patient wanted to call and see what were the other side effects. She got the shot on Monday and today was Wednesday and she was still feeling some type of way. It was swollen on top and rising under her armpit. It was not normal. This report was not serious. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: pain in her arm; swelling on her upper chest on the left side where she got her shot and then on the left side of her throat coming down to her shoulder/swollen on top; feeling some type of way/not normal; whole left side of her back and under her shoulder blade are also concerning her with muscle and joint pain.; whole left side of her back and under her shoulder blade are also concerning her with muscle and joint pain.; rising under her armpit; This is a spontaneous report from a contactable consumer (patient herself). A 40-years-old female patient received 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 19Jul2021 08:00 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient received the Pfizer COVID-19 Vaccination on Monday 08:00 AM and was concerned with the duration of her side effects that she seemed to be occurring, still, today (unspecified date). Caller would like to know if there were other side effects noted other than what she has on the paperwork she received when she got the vaccination. On an unspecified date she stated that she had swelling on her upper chest on the left side where she got her shot and then on the left side of her throat coming down to her shoulder. She felt pain in her arm as well that was slightly swollen. She stated the whole left side of her back and under her shoulder blade were also concerning her with muscle and joint pain. She thought there might be a boil or rising under her arm pit. She stated she knew this was not normal. She felt off. She knew she was not supposed to feel this way. Patient wanted to call and see what were the other side effects. She got the shot on Monday and today was Wednesday and she was still feeling some type of way. It was swollen on top and rising under her armpit. It was not normal. This report was not serious. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: lump at injection site; This is a spontaneous report from a contactable consumer (Patients father reported for daughter). A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration in 2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lump at injection site on 22Jul2021. Reporter stated, His daughter received the shot about 5 weeks ago. They read the fact sheet which states that if there may be a lump when having the shot. He wanted to know Is it normal for it to appear 5 weeks later. The outcome of 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: Vaccination site mass
Clinical narrative: patient read the fact sheet which states that if there may be a lump when having the shot. Stated when he got his, he got it immediately and it went away; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VCCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported as on Jul2021 patient read the fact sheet which states that if there may be a lump when having the shot. Stated when he got his, he got it immediately and it went away. The outcome for the event was reported as resolved on an unspecified date in Jul2021.   Information about Lot/batch number has been requested.  Follow-up (01Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Vaginal Bleeding; This is a spontaneous report from a contactable other HCP (patient) reported herself that a 45-years-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, lot number: FA6780), via an unknown route of administration in left arm on 18Jul2021 at 16:45 (at the age of 45-years-old) as single for COVID-19 immunisation. Facility type vaccine was other. No other vaccine in four weeks prior to the COVID vaccine. The patient's medical history included IBS (Irritable bowel syndrome), cervical polyp and Gastriris; all were from an unknown date and unknown if ongoing. Concomitant medication was not reported. No other medications in two weeks of vaccination. The patient previously took Reglan and experienced allergy. On 20Jul2021 at 18:45, the patient experienced vaginal bleeding. No COVID prior vaccination. No COVID tested post vaccination. No treatment received for event. The outcome of the event was not recovered.  Follow up (26Jul2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query.   Follow up (27Jul2021): This follow-up report contains no new safety information.  Follow-Up (16Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea
Clinical narrative: pityriasis rosea developed on her abdomen and spread across torso, back, and legs; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 12Apr2021 (Lot Number: EW0158) as dose 2, single at the age of 33-year-old for COVID-19 immunisation. Medical history included migraines from an unknown date. No known allergies. The patient was not pregnant. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in left arm on 22Mar2021 (Lot Number: EN6204) as dose 1, single at the age of 33-year-old for COVID-19 immunization. Concomitant medications included spironolactone;  supplements included colecalciferol (VITAMIN D) and iron, all taken for an unspecified indication, in two weeks. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced pityriasis rosea developed on her abdomen and spread across torso, back, and legs on 15May2021. The event resulted in: doctor or other healthcare professional office/clinic visit. Treatment received which included antihistamines and topical medicine. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body height
Clinical narrative: pain in his back; This is a spontaneous report from a contactable consumer (patient himself). A 67-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EW0198, expiry date: unknown) via unspecified route of administration on 07Jul2021 as dose 1, single for Covid-19 immunisation. Vaccination facility type was Clinic and was not administered at Military facility. Medical history and concomitant medications were not reported. Patient stated he was getting his second dose today, and 30 minutes ago he took a 500mg acetaminophen, one tablet for pain in his back, to help ease the pain and asked if that is ok to do before the second dose? He was questioning second dose today after taking acetaminophen today also on 28Jul2021. He was scheduled to take his second dose today and he forgot. Patient had pain in his back for 3 days on 24Jul2021, Sunday. He also asked how long he should wait after one pill of 500mg of acetaminophen to take the vaccination? Patient stated that he would like to make sure, so that he doesn't make any mistakes, that it was okay to take his second dose if he took a 500mg Acetaminophen today. He denied any medical conditions, medications, labs, testing, or treatments relevant to report. He stated that he took daily medications but his doctor told him that they were safe. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines was administered on same date of the Pfizer suspect. There was no emergency room or physician office visit for the adverse events. There was no prior vaccinations (within 4 weeks) or other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient stated that he doesn't know about vaccines he had as a child or a baby. He stated that he had the Tetanus Vaccine about 8 years ago with no reactions. Patient underwent lab test for height, with results as 5 foot 3 inches or 5 foot 4 inches on an unspecified date. The outcome of event was back pain was not recovered.  Follow-up attempts completed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event Circumstance or information capable of leading to medication error was deleted
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: second vaccine dose which she got at the beginning of March she had arm soreness; skin abnormality on her left shin disappeared/skin abnormality on her right wrist cleared up and disappeared; This is a spontaneous report received from a contactable physician via Pfizer sales representative. A elderly female patient received 2nd dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine,Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported. The patient experienced after receiving second vaccine dose which she got at the beginning of march she had arm soreness on an unspecified date and skin abnormality on her left shin disappeared/skin abnormality on her right wrist cleared up and disappeared on an unspecified date.The outcome of the event was unknown.The case was accessed as non serious by the reporter.Reporter described about therapeutic benefits after receiving 2nd dose of Pfizer covid19 vaccine. Pfizer sales Rep reports that reporter said she got her first Pfizer COVID-19 vaccine dose in February and had zero adverse events.Sales representative reported that after the patient second vaccine dose which she got at the beginning of March she had arm soreness. Rep reports she said she had a couple of abnormalities on her skin that her dermatologist wanted to cut out and biopsy prior to having the vaccine shots, and after getting both shots the skin abnormality on her left shin disappeared and the other one on her right wrist cleared up and disappeared within a couple months. No further details captured, reported, or documented at this time. Product strength and count size dispensed: not provided, two doses.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021900915 similar report from same reporter
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal, Swelling face
Clinical narrative: Brain foggy; joint pain; swelling on the face; This is a spontaneous report from a contactable other health care professional (patient). A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0151), via an unspecified route of administration in left arm on 19Jan2021 at 10:00 (at the age of 41-year-old) as dose 2, single for COVID-19 immunisation at nursing home/senior living facility. Medical history included neuropathy peripheral from an unknown date and unknown if ongoing, thyroid disorder from an unknown date and unknown if ongoing, food allergy (peanut butter) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took metoclopramide and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on an unknown date (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Jan2021 at 08:00, the patient experienced brain foggy, joint pain, swelling on the face. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. X-rays, blood work was done, and pain medication was received as treatment for all the events. The outcome of events was reported as not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: fatigue; sore arm; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 74-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206), dose 1 intramuscular, administered in Arm Right on 11Mar2021 12:45 at dose 1, single for COVID-19 immunisation. Medical history included ongoing migraine (onset date: Decades ago) and patient- 3 weeks of guillian barre symptoms with flu shot 1960's. Family history included Nephew's child- Respiratory arrest with 1st childhood vaccine. The patient concomitant medications were not reported. The patient experienced sore arm on 11Mar2021 18:00 and fatigue on 12Mar2021 07:00. The clinical outcome of the event sore arm was recovered on an unspecified date in 2021 (lasted 3 weeks) and fatigue was recovered on an unspecified date in May2021 (lasted 7 days).  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling on the area; painful; limited my mobility; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: 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 and concomitant medications were not reported. On an unspecified date, the patient experienced swelling on the area, painful and limited my mobility. The patient reported that several months ago and the day after the patient received Covid-19 vaccine, there was swelling on the area where the patient received the injection. This swelling lasted for several days and it was painful when applying pressure to that area. The muscle was also firm to the touch. Although the symptom subsided this week and the day after the patient did exercise, the problem came back. The pain was more unbearable and limited the mobility, like tucking in the shirt was painful. Outcome of the events swelling on the area and painful were not recovered and outcome of the other event was unknown.   The lot number for the vaccine was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pruritus, Rash, Skin discolouration
Clinical narrative: Having like the hive rash all over her entire body and in the trunk; Having like the hive rash all over her entire body and in the trunk; it makes her hands itch; Little blackness on her knee cap; Cold; Stuffy nose; This is a spontaneous report from a contactable consumer or other non-health care professional (parent) reporting for her daughter. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route administered in left arm on an unspecified date in Jul2021 as DOSE 1, SINGLE for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient received other vaccines prior to the COVID vaccine. Historical vaccine included that on an unspecified date in 2021 patient previously took Hepatitis B Booster and another unspecified meningitis booster for immunization. Reporter stated that actually 2 weeks prior to that day, I read and waited for 2 weeks and she had her full physical and they gave her Hepatitis B Booster and there is new Meningitis, I think it is B and also her Meningitis booster (Unspecified Medications). So, she ended up having three that day and then it was told that she was fine to get a shot. Reporter stated that her daughters got their first vaccine on Friday and then yesterday and today and she kind of done her own research to the 'local three hours department of zero health'. She reported has been having like the hive rash all over her entire body and in the trunk. It is coming and going, she can feel it coming and then it be there for couple of hours and then it goes away and it is weird, they are all over her body, they are all over and then it makes her hands itch. Reporter stated that she got her shot on Friday at about 11 o' clock am and on saturday afternoon or evening, she had maybe a little blackness on her knee cap and then yesterday about mid-day, that would have been on sunday, that is kind of when like it is all over her back, all over her stomach, over her butt, her torso like all over her body, her face and everything, just totally broke out and then it kind of went away and then it came back again, she could feel it, it was like, so that when it was. Reporter further stated that on saturday, it was just like on her kneecap and then sunday, yesterday, it was kind of all over her body. For second shot due date reporter stated that she believes its in three weeks on 13Aug. Other medical conditions: Reporter stated that she has got like a cold and stuffy nose and is almost kind of stuffed up. Reporter stated that I don't know if this is fine or is there any stuff in her throat or I don't know but her breathing is fine'. Patient did not receive any treatment for her events. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Having like the hive rash all over her entire body and in the trunk; Having like the hive rash all over her entire body and in the trunk; it makes her hands itch; Little blackness on her knee cap; Cold; Stuffy nose; This is a spontaneous report from a contactable consumer or other non-health care professional (parent) reporting for her daughter. A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route administered in left arm on an unspecified date in Jul2021 as DOSE 1, SINGLE for covid-19 immunization. Patient medical history and concomitant medications were not reported. The patient received other vaccines prior to the COVID vaccine. Historical vaccine included that on an unspecified date in 2021 patient previously took Hepatitis B Booster and another unspecified meningitis booster for immunization. Reporter stated that actually 2 weeks prior to that day, I read and waited for 2 weeks and she had her full physical and they gave her Hepatitis B Booster and there is new Meningitis, I think it is B and also her Meningitis booster (Unspecified Medications). So, she ended up having three that day and then it was told that she was fine to get a shot. Reporter stated that her daughters got their first vaccine on Friday and then yesterday and today and she kind of done her own research to the 'local three hours department of zero health'. She reported has been having like the hive rash all over her entire body and in the trunk. It is coming and going, she can feel it coming and then it be there for couple of hours and then it goes away and it is weird, they are all over her body, they are all over and then it makes her hands itch. Reporter stated that she got her shot on Friday at about 11 o' clock am and on saturday afternoon or evening, she had maybe a little blackness on her knee cap and then yesterday about mid-day, that would have been on sunday, that is kind of when like it is all over her back, all over her stomach, over her butt, her torso like all over her body, her face and everything, just totally broke out and then it kind of went away and then it came back again, she could feel it, it was like, so that when it was. Reporter further stated that on saturday, it was just like on her kneecap and then sunday, yesterday, it was kind of all over her body. For second shot due date reporter stated that she believes its in three weeks on 13Aug. Other medical conditions: Reporter stated that she has got like a cold and stuffy nose and is almost kind of stuffed up. Reporter stated that I don't know if this is fine or is there any stuff in her throat or I don't know but her breathing is fine'. Patient did not receive any treatment for her events. The outcome of all the events was unknown.  Follow-up attempts are completed. No further information is expected.