chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Swelling
Clinical narrative: fever; headache; could not walk due to the pain and swelling; swollen and non-responsive left leg; could not walk due to the pain and swelling; could not walk due to the pain and swelling; left leg was unresponsive and numb; severe allergic reaction; This is a spontaneous report from a contactable consumer reported for a 33-year-old male (patient). A 33-year-old male patient received second dose of bnt162b2 (Pfizer-biotech COVID-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown), via an unspecified route in left arm on 16Jul2021 (age at vaccination: 33-year-old) as a single dose for covid-19 immunization. The patient was a perfectly healthy person and has no medical conditions. No pre-existing condition was reported before getting the bnt162b2 Vaccine. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-biotech COVID-19 vaccine, Solution for injection) on 25Jun2021, as a single dose for covid-19 immunization. On 25Jul2021, patient was taken to the ER (from last Sunday afternoon, 25Jul2021, to almost midnight) due to swollen and numb, non-responsive left leg. He could not walk due to the pain and swelling and wanted to know if this is something that has been previously reported before. Patient also experienced a fever, headache and other issues after receiving the second dose Pfizer Covid 19 Vaccine and was taken to the emergency room on 25Jul2021. The patient was discharged from the emergency room close to midnight and was taken to the emergency room mid-afternoon. On 16Jul2021, patient had severe allergic reaction. Reporter wanted to know how long AEs usually last after receiving a dose of the Pfizer BioNTech covid-19 Vaccine. The patient was perfectly healthy person and normal person and now the patient can't walk. The patient can't touch the ground with his foot. How is the patient going to work? What is causing this? What is going to happen now? How long will it take the patient to recover from this? Reporter is mostly concerned about his leg that is unresponsive and numb and the patient can't walk. No information was reported on treatment recommendation for AE. The clinical outcome of numb, non-responsive left leg was ongoing, the leg was also extremely painful, it has not improved and was persisting; could not walk on foot because it was swollen and in a lot of pain was not improved; fever, severe allergic reaction, headache was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dysphagia, Pyrexia
Clinical narrative: hasn't been able to hold anything down, just sips of water; Has been running a fever consistently since 22Jul2021 until now, 27Jul2021 of 101; This is a spontaneous report from a contactable nurse. This nurse reported similar event for two patient. This is the 2nd of 2 reports. This nurse reported for a male patient (husband). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number and expiry date was not provided) via an unspecified route of administration, on 21Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The caller reported that both the patient and the patient's husband received the first dose Pfizer Covid Vaccine on the same day. Since 22Jul2021, the patient had been running a fever consistently until now, 27Jul2021 of 101. The fever has been consistent for many days for the husband. The patient underwent lab tests and procedures which included body temperature resulted as 101 on 27Jul2021. On an unspecified date, the patient experienced had not been able to hold anything down, just sips of water. The outcome of the event pyrexia was not recovered, and dysphagia was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hurting her foot so bad; This is a spontaneous report from a contactable consumer or other non hcp reported. A 74-years-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 on 20Mar2021 (age at vaccination: 74 years old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received her 1st dose of the Pfizer Covid vaccine on 20Mar2021 and was scheduled for her 2nd dose on 14Apr2021 but she missed the 2nd dose due to her hurting her foot so bad. there was stated that patient couldn't walk or drive at that time. Agent relays she advised to contact the facility to reschedule. there was reported when patient got the 1st dose she couldn't tell she got it, she went home and her arm didn't get sore and she had no side effects, it went smooth. it was reported that patient weight was probably 170 and she is not sure, she lost some since she hurt her foot. It was stated patient had a problem sometimes breathing and she knew with her breathing problem that she didn't think she could take Covid 19 so she decided to take a chance on the shot. patient had been in contact with her drug store, they are usually really good and had an answer for everything, she asked the young lady to reschedule and was told to call a certain number and she gave it to her real fast and she didn't get it written down correctly. Stated she got on the computer to reschedule and it lets her put in everything but the date she took the 1st dose. The outcome of the event was reported as unknown.  Information about Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: Nausea; Fever; This is a spontaneous report from a contactable nurse. A 60 year old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unspecified) via an unspecified route of administration, administered in the arm. On 21Jul2021 as DOSE 1, SINGLE for COVID-19 immunization (at the age of 56 Years). Medical history includes Colon cancer on 08Jan2021 stage 2. The caller stated the patient is now in remission and is not on any medication for the colon cancer right now. And allergies on unknown date (The caller stated the patient does see an allergist and is on other medications, inhaler, albuterol and another allergy medicine.). Concomitant medication(s) included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE(Advair Diskus) 250mcg-50mcg twice a day). Albuterol Inhaler 90mcg, 2 inhalations as directed for allergies. On 22Jul2021 the patient experienced fever, until 27Jul2021 of 101. On an unspecified date patient experienced Nausea. The caller stated the fever has been persistent since 22Jul2021. Ratio of 101-103, today, 27Jul2021 at 1500 the fever was 103.6. This morning,27Jul2021 at 1000 the fever was 101.1 with Tylenol in the patient's system. The caller told the patient to take another dose of Tylenol and recheck temperature in 30 minutes. Product strength and count size dispensed: 650mg. The patient saw her primary care physician and was given Zofran 4mg for nausea. Outcome for fever was not resolved and the outcome for nausea was unknown. Information on lot/batch number has been requested.  Follow Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Cough, Diarrhoea, Nausea, Productive cough
Clinical narrative: Nausea; Fever; This is a spontaneous report from a contactable nurse. A 60 year old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unspecified) via an unspecified route of administration, administered in the arm. On 21Jul2021 as DOSE 1, SINGLE for COVID-19 immunization (at the age of 56 Years). Medical history includes Colon cancer on 08Jan2021 stage 2. The caller stated the patient is now in remission and is not on any medication for the colon cancer right now. And allergies on unknown date (The caller stated the patient does see an allergist and is on other medications, inhaler, albuterol and another allergy medicine.). Concomitant medication(s) included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE(Advair Diskus) 250mcg-50mcg twice a day). Albuterol Inhaler 90mcg, 2 inhalations as directed for allergies. On 22Jul2021 the patient experienced fever, until 27Jul2021 of 101. On an unspecified date patient experienced Nausea. The caller stated the fever has been persistent since 22Jul2021. Ratio of 101-103, today, 27Jul2021 at 1500 the fever was 103.6. This morning,27Jul2021 at 1000 the fever was 101.1 with Tylenol in the patient's system. The caller told the patient to take another dose of Tylenol and recheck temperature in 30 minutes. Product strength and count size dispensed: 650mg. The patient saw her primary care physician and was given Zofran 4mg for nausea. Outcome for fever was not resolved and the outcome for nausea was unknown. Information on lot/batch number has been requested.  Follow Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Nausea; Fever; This is a spontaneous report from a contactable nurse. A 60 year old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unspecified) via an unspecified route of administration, administered in the arm. On 21Jul2021 as DOSE 1, SINGLE for COVID-19 immunization (at the age of 56 Years). Medical history includes Colon cancer on 08Jan2021 stage 2. The caller stated the patient is now in remission and is not on any medication for the colon cancer right now. And allergies on unknown date (The caller stated the patient does see an allergist and is on other medications, inhaler, albuterol and another allergy medicine.). Concomitant medication(s) included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE(Advair Diskus) 250mcg-50mcg twice a day). Albuterol Inhaler 90mcg, 2 inhalations as directed for allergies. On 22Jul2021 the patient experienced fever, until 27Jul2021 of 101. On an unspecified date patient experienced Nausea. The caller stated the fever has been persistent since 22Jul2021. Ratio of 101-103, today, 27Jul2021 at 1500 the fever was 103.6. This morning,27Jul2021 at 1000 the fever was 101.1 with Tylenol in the patient's system. The caller told the patient to take another dose of Tylenol and recheck temperature in 30 minutes. Product strength and count size dispensed: 650mg. The patient saw her primary care physician and was given Zofran 4mg for nausea. Outcome for fever was not resolved and the outcome for nausea was unknown. Information on lot/batch number has been requested.  Follow Up (10Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Thyroid disorder
Clinical narrative: One of my cousin explain that her thyroid is rushed out now from vaccine; This is a spontaneous report from a contactable consumer reported for a patient (cousin). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Reporter stated that his/her friend wants to take the Pfizer vaccine (Unspecified Vaccine) and reporters friend has 8 goiter's (History) and she has been researching and reporter told her that Pfizer has less reactions than Moderna and she wants to take the Pfizer but she was very concerned about the 8 goiter's, so she was been working with doctor, she just said that, she was not comfortable taking it unfortunately they live in  and delta virus was rapid, so she was afraid not to take it. Reporter asked, regarding any adverse reaction to thyroid because one of his/her cousin explain that her thyroid was rushed out now from vaccine. Further reporter informed friend regarding same, she said oh my gosh, reporter did not know if he/she should take it and should definitely research it. Reporter stated, he/she really need to, he/she got children, need to go. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, SARS-CoV-2 test
Clinical narrative: felt tired; weak; This is a spontaneous report from a contactable consumer or other non hcp. A contactable consumer (Patient's husband) reported for 77-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, (Batch/Lot Number: unknown, expiry date: unknown) dose 1 via an unspecified route of administration, administered in Arm Left on 23Jul2021 17:00 as DOSE 1 SINGLE for covid-19 immunization (age at vaccination:77Yearold). Medical history included coronavirus infection from Jan2021 to an unknown date. She stayed in quarantine for 14 days. There were no concomitant medications reported. On 24Jul2021 SATURDAY, the patient experienced felt tired (fatigue) and weak (asthenia). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021.The outcome of all the events was recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling abnormal, Pyrexia
Clinical narrative: Chills; Fever; doesn't feel comfortable reporting his details; felt like crap; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient had fever and chills too and felt like crap after getting the vaccination. Reporter stated she was not with patient or anything and has no further information to provide; did not feel comfortable for reporting patient's details. The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: doesn't really feel good; This is a spontaneous report from a contactable consumer (daughter) reported for a female patient (mother) that: A female 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 unspecified route of administration on an unspecified date, as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced doesn't really feel good. It was reported that Consumer calling to report an AE for the Pfizer COVID 19 vaccine mentions her mother had the same vaccine; she was supposed to get the second dose in 21 days, but she missed it. When ask to provide details for her mother, she states she prefers not to report on her mother; states she doesn't have much to say. Adds she just got back from the doctor and doesn't really feel good. Full report details for mother were unable to be obtained. This was a clone report was created for the mother's experience. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100957762 same reporter/drug, different event/ patient
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for 2-3 days; This is a spontaneous report from a contactable consumer (Patient's mother). A 12-years-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 on 01Jul2021 (at the age of 12-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not report any medical history and concomitant medications were not reported. The patient had no prior vaccination within 4 weeks and no AE(s) following prior vaccination. The patient did not had relevant family medical history. On 01Jul2021, the reporter stated that with the first vaccine her daughter had a sore arm for 2-3 days. Patient did not have any AE(s) require a visit to emergency room and physician office. The outcome of sore arm was recovered on 03Jul2021.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer reported for her mother. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection and batch no/lot number: not reported) via an unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced very sore arm on an unspecified date. It was reported that It was reported that My mother (80 years) had a very sore arm; other than that, she was ok. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she was very sick; This is a spontaneous report from a contactable consumer. A 47-years-old female patient (reporter's sister) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was very sick for the first shot. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Illness, Lymphadenopathy
Clinical narrative: She got sick again; Lymph nodes under her arms swelled up; This is a spontaneous report from a contactable consumer patient (sister). A 47-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization and experienced very sick. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she got sick again, and all her lymph nodes under her arms swelled up. The reporter considered the events as non-serious. The outcome of events was unknown.  The lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis contact, Headache, Pain, Rash
Clinical narrative: Had some body aches; Slight headache; Rash kind of came on my right thigh, it is almost like, I don't know like maybe poison ivy, something like that; Rash kind of came on my right thigh, it is almost like, I don't know like maybe poison ivy, 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 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) dose number unknown via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced had some body aches, slight headache, rash kind of came on my right thigh, it is almost like, i don't know like maybe poison ivy, something like that on an unspecified date. Clinical course was reported as I am about three weeks and to this vaccine, I have to take this other injection, I am scheduled to take this next Tuesday and for the last couple of days, I have had some body aches, kind of slight headache and a rash kind of came on my right thigh, it is almost like, I don't know like maybe poison ivy, something like that. I am just wondering if this is attached to the shot because when I got the shot, from that day and up until now, I was doing fantastic. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Disturbance in attention, Fatigue, Nausea
Clinical narrative: Fever; body aches; Back pain; nausea; fatigue; lack of focus; weakness; This is a spontaneous report from a contactable consumer. A 52-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 26Jul2021 14:30 as DOSE 1, SINGLE (at the age of 52-year-old) for covid-19 immunisation. Medical history included hypertension, covid-19 from Dec2020 to an unknown date. Concomitant medication(s) included valsartan; hydrochlorothiazide; vitamin d nos. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jul2021, the patient experienced severe symptoms, such as the same as Covid-19 Virus that patient had in December which was fever, body aches, severe back ache, nausea, fatigue, lack of focus, weakness. The patient did not received any treatment for events. The outcome of the events was resolving.   Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; body aches; Back pain; nausea; fatigue; lack of focus; weakness; This is a spontaneous report from a contactable consumer. A 52-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 26Jul2021 14:30 as DOSE 1, SINGLE (at the age of 52-year-old) for covid-19 immunisation. Medical history included hypertension, covid-19 from Dec2020 to an unknown date. Concomitant medication(s) included valsartan; hydrochlorothiazide; vitamin d nos. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jul2021, the patient experienced severe symptoms, such as the same as Covid-19 Virus that patient had in December which was fever, body aches, severe back ache, nausea, fatigue, lack of focus, weakness. The patient did not received any treatment for events. The outcome of the events was resolving.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Skin disorder, Vaccination site bruising
Clinical narrative: pretty big dark bruise around the site of injection; has water bubbles on top of the area of the bruise and maybe 3 or 4 of them about medium size; Bruising on the injection site and a water bubble; This is a spontaneous report from a contactable consumer (daughter) reported for a 79-year-old male patient (father). A 79-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: unknown), via an unspecified route on 27Jul2021, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection), on 06Jul2021, as a single dose for covid-19 immunization. Patient took second dose of Pfizer Covid 19 vaccine yesterday (27Jul2021) and he got pretty big dark bruise around the site of injection/ huge dark bruise around where he got his shot and he also have water bubbles on top of the area of the bruise and maybe 3 or 4 of them about medium size. Reporter wanted to know what patient can take. Was this normal, was these symptoms wide known about? The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Cough, Influenza like illness, Lethargy
Clinical narrative: started running a fever of 100-1; was lethargic; had flu-like symptoms; began coughing at 48 hours post vaccine; pain in chest once cough appeared; This is a spontaneous report from a contactable consumer (patient) reported for himself that. A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 06Jul2021 17:30 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccination. The patient has not received other medications in two weeks. The patient is a pediatric dentist, so he trained in the field of health care. Approximately, 24 hours of 2nd vaccine, patient started running a fever of 100-101, continued to run fever for 5 days and began lethargic had flu-like symptoms and coughing at 48 hours post vaccine. Patient reported pain in chest once cough appeared on 07Jul2021 Cough lasted 11 days. Patient continued to have lethargy for 9 days post vaccine. At day 4, spoke to pediatrician re: symptoms. The patient is a pediatric dentist, so he trained in the field of health care. Approximately, 24 hours of 2nd vaccine. On 07Jul2021 approximately, 24 hours of 2nd vaccine, patient started running a fever of 100-101. Patient was lethargic and had flu-like symptoms. Patient was given Motrin to help with symptoms. Patient continued to run fever for 5 days. Patient began coughing at 48 hours post vaccine. Patient reported pain in chest once cough appeared. Cough lasted 11 days. Patient continued to have lethargy for 9 days post vaccine. At day 4, spoke to pediatrician re: symptoms. The patient underwent lab tests and procedures which included body temperature: 100-101 on 07Jul2021, chest x-ray: normal on 12Jul2021 At day 6, a chest X-ray was taken and it was normal, echocardiogram: normal on 16Jul2021 At day 10 an echo was done on patient and it was found to be normal , mononucleosis heterophile test: Negative on 13Jul2021 At day 7 patient was evaluated by physician and tested negative for COVID and mono , sars-cov-2 antibody test: negative on 13Jul2021. The events result in doctor or other healthcare professional office/clinic visit. The event outcome was recovered on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: started running a fever of 100-1; was lethargic; had flu-like symptoms; began coughing at 48 hours post vaccine; pain in chest once cough appeared; This is a spontaneous report from a contactable consumer (patient) reported for himself that. A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 06Jul2021 17:30 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccination. The patient has not received other medications in two weeks. The patient is a pediatric dentist, so he trained in the field of health care. Approximately, 24 hours of 2nd vaccine, patient started running a fever of 100-101, continued to run fever for 5 days and began lethargic had flu-like symptoms and coughing at 48 hours post vaccine. Patient reported pain in chest once cough appeared on 07Jul2021 Cough lasted 11 days. Patient continued to have lethargy for 9 days post vaccine. At day 4, spoke to pediatrician re: symptoms. The patient is a pediatric dentist, so he trained in the field of health care. Approximately, 24 hours of 2nd vaccine. On 07Jul2021 approximately, 24 hours of 2nd vaccine, patient started running a fever of 100-101. Patient was lethargic and had flu-like symptoms. Patient was given Motrin to help with symptoms. Patient continued to run fever for 5 days. Patient began coughing at 48 hours post vaccine. Patient reported pain in chest once cough appeared. Cough lasted 11 days. Patient continued to have lethargy for 9 days post vaccine. At day 4, spoke to pediatrician re: symptoms. The patient underwent lab tests and procedures which included body temperature: 100-101 on 07Jul2021, chest x-ray: normal on 12Jul2021 At day 6, a chest X-ray was taken and it was normal, echocardiogram: normal on 16Jul2021 At day 10 an echo was done on patient and it was found to be normal , mononucleosis heterophile test: Negative on 13Jul2021 At day 7 patient was evaluated by physician and tested negative for COVID and mono , sars-cov-2 antibody test: negative on 13Jul2021. The events result in doctor or other healthcare professional office/clinic visit. The event outcome was recovered on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (Patient). A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 26Jul2021 15:00 (at the age of 62-year-old) as single dose for covid-19 immunisation. The patient medical and concomitant medications was reported as none. Family history was reported as none. No additional vaccines administered on same date of the Pfizer suspect. On 26 Jul2021, the patient experienced sore arm. She stated she got her first dose and the only thing she had was a sore arm but they said that was to be expected. Sore arm began the same day of vaccination. She stated that they go back on the 16Aug 2021 to get her second dose. Sore arm was gone away, only lasted a half of day. Any event did not require a visit to emergency Room or physician office. No relevant test was performed. The event was recovered on an unspecified date in Jul2021.   Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint stiffness, Vaccination site mass, Vaccination site pain
Clinical narrative: A knot in my arm at the injection site; Knot is bigger and redder and a bit sore (size of a coin); Knot is bigger and redder and a bit sore (size of a coin); Soreness and stiffness in my joints; Soreness and stiffness in my joints; This is a spontaneous report from a contactable consumer (Patient). A 40-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number not provided), via an unspecified route of administration on 19Jul2021 at 14:00 administered in Arm Left as a single dose for COVID-19 immunisation At Pharmacy or Drug Store. Medical history included allergies to sulfa from an unknown date and unknown if ongoing. Concomitant medication(s) included esomeprazole sodium (NEXIUM); famotidine (PEPCID); levothyroxine sodium (LEVOTHYROXINE) (all taken for an unspecified indication, start and stop date were not reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.On 27Jul2021 at 22:00 pm, after one week and one day I redeveloped A knot in my arm at the injection site last night (size of coin). This morning the Knot is bigger and redder and a bit sore (size of a coin). It's a bit annoying but not affecting my quality of life at the moment. I do still have Soreness and stiffness in my joints but it's very manageable. No treatment was given for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up activities closed. Batch/lot number not available for [Vaccine, BNT162B2], F/UP closure to be managed as significant.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Malaise, Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: my arm is very bad paining; feel flushed; my all body and face go flush; Nauseous; just don't feel good; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified consumer stated that I had a shot yesterday and I took of Pfizer and did a COVID test and further clarification unknown. I just don't feel good and "I don't have the rash and I have the short yesterday, my arm is very bad paining in the arm, no worries it's okay I can handle it and I am Nauseous and I feel flushed too because I do exercise and my all body and face go flush. Patient stated I don't want to go the hospital, I don't want to go such places because I take Psychiatric medication (Further clarification Unknown)". Outcome of events was unknown.  Information about the Lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Diarrhoea, Fatigue, Oropharyngeal pain, Pruritus
Clinical narrative: In my arm there are 2 lines identical, it maybe an inch to an inch and a half and it has tiny little scabs on it; Sore throat; My back is very itchy; Diarrhea; Constipation; I am just getting tired; This is a spontaneous report from a contactable consumer (patient) reported that. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient past Medical history included Kidney failure from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, cardiac failure congestive from an unknown date and unknown if ongoing, Bladder problems from an unknown date and unknown and diverticulum from an unknown date and unknown if ongoing. On an unspecified date the patient experienced where she received her injection, in my arm there are 2 lines identical, now I don't understand how I got the 2nd line, it's almost identical to the 1st line, it may be an inch to an inch and a half and it has tiny little scabs on it, on both of them but I don't understand it because I only got 1 injection and I have 2 lines that have the similar, the same markings, that's the first problem, second is I have a little bit of sore throat and my back is very itchy. I have 2 cases of diarrhea and I have been very constipated for last few months (Further clarification was unknown, hence constipation was captured as event) so, that's very uncommon for me to get diarrhea. The event outcome was unknown.  Consumer was informed about the Medical Information department.   Consumer was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as and 8 am to 8 pm Monday to Friday as per EST.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Scab
Clinical narrative: In my arm there are 2 lines identical, it maybe an inch to an inch and a half and it has tiny little scabs on it; Sore throat; My back is very itchy; Diarrhea; Constipation; I am just getting tired; This is a spontaneous report from a contactable consumer (patient) reported that. A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient past Medical history included Kidney failure from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, cardiac failure congestive from an unknown date and unknown if ongoing, Bladder problems from an unknown date and unknown and diverticulum from an unknown date and unknown if ongoing. On an unspecified date the patient experienced where she received her injection, in my arm there are 2 lines identical, now I don't understand how I got the 2nd line, it's almost identical to the 1st line, it may be an inch to an inch and a half and it has tiny little scabs on it, on both of them but I don't understand it because I only got 1 injection and I have 2 lines that have the similar, the same markings, that's the first problem, second is I have a little bit of sore throat and my back is very itchy. I have 2 cases of diarrhea and I have been very constipated for last few months (Further clarification was unknown, hence constipation was captured as event) so, that's very uncommon for me to get diarrhea. The event outcome was unknown.  Consumer was informed about the Medical Information department.   Consumer was provided with the number of Pfizer Medical Information as # and was requested to select option 3, timings as and 8 am to 8 pm Monday to Friday as per EST.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Rhinorrhoea
Clinical narrative: headache; fever; fatigue; mucus; This is a spontaneous report from a contactable other HCP. This nurse(patient) reported for a 18-year-old female consumer (reporter daughter) that:   A 18-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Expiry date: Unknown), via an unspecified route of administration on 22Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Investigation assessment was not provided. On 28Jul2021 patient complaints of headache, fever, fatigue/ feeling tired and having mucus. The clinical outcome of the event was unknown.  Communication: The caller was provided with phone number of #, option 3, and hours of operation, prior to warm transfer to Agent INT-#  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Off label use, Product use issue, Suppressed lactation
Clinical narrative: significantly decreased breast milk production within 3 days of injection; significantly decreased breast milk production within 3 days of injection; Left axillary lymph node extremely swollen; significantly decreased breast milk production within 3 days of injection; This is a spontaneous report from a contactable other health care professional (Patient). A 38-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 29Jun2021 13:00 (at the age of 38-year-old) as single dose for covid-19 immunisation. Patient was not pregnancy at time of Vaccination. Medical history included unknown-currently undergoing allergy testing for delayed reaction to PEG. Concomitant medications included docusate sodium, (COLACE) PRN and a daily prenatal vitamin both within 2 weeks of vaccination. Patent historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration, administered in Arm Left on 09-JUN-2021 13:30 (at the age of 38-year-old) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. On 02Jul2021, the patient experienced significantly decreased breast milk production within 3 days of injection (Off label use in unapproved population), left axillary lymph node extremely swollen and significantly decreased breast milk production within 3 days of injection. The event left axillary lymph node extremely swollen and significantly decreased breast milk production within 3 days of injection were recovered on an unspecified date in Jul2021 and outcome of all other event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100973972 maternal case and child case
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer. This consumer (husband) reported for a female patient that is (wife's mother).  A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot number: Not available, Expiry: Not specified) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient experienced hives. Investigation Assessment: Not Provided. The report is cross referenced to report ID: WK0SFOYZ. The clinical outcome of the event was unknown.   PSCC Communication: Caller declined to complete a safety report regarding his wife's mother experience. Unable to capture additional details  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100971011 same reporter/drug, different patients/AE;US-PFIZER INC-202100970047 same reporter/drug, different patients/AE
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Condition aggravated, Decreased appetite, Gastrointestinal bacterial overgrowth, Insomnia
Clinical narrative: UTI with extreme pain; UTI with extreme pain; have issues with emptying bladder; worst insomnia; IBS and SIBO both these conditions were worse starting about five days after the second vaccine; IBS and SIBO both these conditions were worse starting about five days after the second vaccine; I have IBS and SIBO both these conditions were worse starting about five days after the second vaccine; nauseous; had no appetite; lost about twelve pounds; This is a spontaneous report received from a contactable consumer. This consumer reported for her sister and stated that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient experienced uti with extreme pain, have issues with emptying bladder, worst insomnia, ibs and sibo both these conditions were worse starting about five days after the second vaccine, nauseous, had no appetite and lost about twelve pounds on an unspecified date. The consumer also went through the same thing after her second covid shot. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202100969975 same reporter/product/event, different patient; PFIZER INC-202100973724 same reporter, different patient/ product/ event.
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Nausea, Pain, Urinary tract infection, Weight decreased
Clinical narrative: UTI with extreme pain; UTI with extreme pain; have issues with emptying bladder; worst insomnia; IBS and SIBO both these conditions were worse starting about five days after the second vaccine; IBS and SIBO both these conditions were worse starting about five days after the second vaccine; I have IBS and SIBO both these conditions were worse starting about five days after the second vaccine; nauseous; had no appetite; lost about twelve pounds; This is a spontaneous report received from a contactable consumer. This consumer reported for her sister and stated that, a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization. The patient experienced uti with extreme pain, have issues with emptying bladder, worst insomnia, ibs and sibo both these conditions were worse starting about five days after the second vaccine, nauseous, had no appetite and lost about twelve pounds on an unspecified date. The consumer also went through the same thing after her second covid shot. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-202100969975 same reporter/product/event, different patient; PFIZER INC-202100973724 same reporter, different patient/ product/ event.