chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Polycystic ovaries
Clinical narrative: polycystic condition; This is a spontaneous report from a Pfizer sponsored. A contactable consumer (patient's husband) reported for a female patient (reporter's wife) of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE both for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported by the reporter that before he was originally part of the original trial of Pfizer covid-19 vaccine and now his wife is part of the booster trial. He stated that he is confused in regards with Pfizer's general plan. He pointed to the 3rd dose/booster if they can get it because they were informed that after 12 months getting the 2nd dose, they will be receiving the 3rd dose but up to now they didn't receive it. Name withheld is aggravated already in regard to what happened and he stated that he wants to go to the media to inform people about Pfizer's general plan because he had diabetes and his wife had a polycystic condition. On an unspecified date, the patient experienced polycystic condition. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Palpitations, Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: I had bumps all over on my neck and next day it went to my face; 15 minutes after the vaccination my necks started itching, the right side of my neck; rash on the neck and her face; rash on the neck and her face; Heart palpitation; my heart just started pounding; Allergic reaction; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer reported for herself that. A 43-years-old female (Non-Pregnant) patient received first dose of bnt162b2 (Pfizer vaccine, COVID 19 Vaccine, mRNA, solution for injection, Batch/Lot number: EL3302, expiry date: unknown), dose 1 via an unspecified route of administration, administered in arm right on 13Jan2021 (Age at vaccination 43 year) as dose 1, single for covid-19 immunisation. Patient medical history included don't have ovaries, don't have gallbladder. Patient concomitant medication included golden pill, echinacea for unspecified indication start from unspecified date if ongoing unknown. Patient experienced her side effects back in Jan's patient had her 1st dose on 13Jan2021, she had rash on the neck and her face, heart palpitation; my heart just started pounding, allergic reaction in Jan2021 and 15 minutes after the vaccination my necks started itching, the right side of my neck on 13Jan2021. Patient had bumps all over on my neck and next day it went to my face on 14Jan2021. Patient taken treatment of Benadryl, 50 mg, two times a day. Patient underwent lab test which included SARS-CoV-2 test which result was unknown on unspecified date. The outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: I had bumps all over on my neck and next day it went to my face; 15 minutes after the vaccination my necks started itching, the right side of my neck; rash on the neck and her face; rash on the neck and her face; Heart palpitation; my heart just started pounding; Allergic reaction; This is a spontaneous report from a contactable consumer. This 43-year-old female consumer reported for herself that. A 43-years-old female (Non-Pregnant) patient received first dose of bnt162b2 (Pfizer vaccine, COVID 19 Vaccine, mRNA, solution for injection, Batch/Lot number: EL3302, expiry date: unknown), dose 1 via an unspecified route of administration, administered in arm right on 13Jan2021 (Age at vaccination 43 year) as dose 1, single for covid-19 immunisation. Patient medical history included don't have ovaries, don't have gallbladder. Patient concomitant medication included golden pill, echinacea for unspecified indication start from unspecified date if ongoing unknown. Patient experienced her side effects back in Jan's patient had her 1st dose on 13Jan2021, she had rash on the neck and her face, heart palpitation; my heart just started pounding, allergic reaction in Jan2021 and 15 minutes after the vaccination my necks started itching, the right side of my neck on 13Jan2021. Patient had bumps all over on my neck and next day it went to my face on 14Jan2021. Patient taken treatment of Benadryl, 50 mg, two times a day. Patient underwent lab test which included SARS-CoV-2 test which result was unknown on unspecified date. The outcome of the event was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, SARS-CoV-2 test
Clinical narrative: He has been quarantined since his wife tested positive.; This case is considered as invalid as there is no indication that the patient experienced an event under BNT162b2.  This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 02Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that he and his wife both got their first Pfizer Covid 19 vaccine on 02Aug2021. The caller confirms the information provided. He was calling because it's time for him to receive his second Covid 19 vaccine tomorrow, 24Aug2021. He states he had the Covid 19 vaccine and did fine. He wants to know how long, if any time, does he have to wait to receive his second Covid 19 vaccine. He is scheduled to receive his second dose tomorrow, 24Aug2021 and he had a home Covid 19 virus test, and it was negative, and he hasn't had any other issues or symptoms in the last 12 days. He wants to get the second dose, but the pharmacist said he had to have a negative Covid 19 virus test before getting the second Covid 19 vaccine and someone else told him he had to wait until after his quarantine time and he should be ok to get the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test negative on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested. This follow up is being submitted to amend previously reported information, Case reassessed as invalid. This case is being deleted from the database for the following reason Existence of an adverse event not confirmed at follow-up.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter via follow-up letter. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 2nd dose.  A 62-years-old patient of an unspecified gender received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: FA7845), via intramuscular, administered in Arm Left on 25Jul2021, 12:08 as 2nddose, single for covid-19 immunisation (Age at vaccination was 62 years). Historical vaccine was a 62-years-old patient of an unspecified gender received BNT162b2 (PFIZER/BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EW0198), via intramuscular, administered in Arm Left on 04Jul2021, 11:40 AM as 1stdose, single for covid-19 immunisation with events of muscle pain in the raise arm, vaccine received within 4 weeks PRIOR: AstraZeneca. Medical history included hyperlipidaemia from 2005 and ongoing, hypertension from 2005 and ongoing. Concomitant medication(s) included amlodipine besilate, hydrochlorothiazide, valsartan (EXFORGE HCT) taken for hypertension from an unspecified start date and ongoing; pitavastatin (PITAVASTATIN) taken for hyperlipidaemia from an unspecified start date and ongoing. The patient experienced chills on 28Jul2021 10:00. Relevant tests where no. Treatment was received. Upon follow-Up on 01Sep2021Follow-up attempts are completed. No further information is expected. Outcome of the event was recovered on same day.  Follow-Up (01Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Heart rate irregular, Lymphadenopathy, Nodule
Clinical narrative: did not take second dose; swollen lymph node under her right arm; fever; She had huge nodules; chills; rapid heartbeat; chest pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored. A 61-years-old female patient received bnt162b2 (Pfizer COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL3248, Age at Vaccination: 61-years) as DOSE 1, SINGLE for Covid prevention. The patient had Covid on 31Mar2020. She has a lot of food allergies such as soy, eggs avocado, you name it. She is also allergic to nuts. No additional vaccines were administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations. Concomitant medications included olmesartan medoxomil (BENICAR) at a dose of 25/12.50mg daily taken for hypertension (has been taking for over 10 years), from an unknown start date and ongoing; rosuvastatin calcium (CRESTOR) taken for Cholesterol (Low dose of either 5mg or 10mg. Has been taking it for the last year), from an unknown start date and ongoing. Patient took the first dose of the Covid 19 vaccine on 14Jan2021. She did not take the second dose. The patient experienced chills on 14Jan2021, rapid heartbeat on 14Jan2021, chest pain on 14Jan2021, swollen lymph node under her right arm on 15Jan2021, fever on 14Jan2021, she had huge nodules on 14Jan2021. She took an Aspirin. The rapid heart beat lasted for 4 hours. She had huge nodules. It lasted longer than the chest pain. The nodules started small the following day and they got bigger for a few days. The patient underwent lab tests and procedures which included Covid-19 test: positive on 31Mar2020. Therapeutic measures were taken as a result of chills, rapid heartbeat, chest pain, swollen lymph node under her right arm, fever, she had huge nodules. AE(s) did not require a visit to: Emergency Room, Physician Office. She was supposed to have the 2nd dose on 03Feb2021 and did not take it due to the reactions - She will go to (Name withheld) 2 weeks from now and wants to know if she can still have the 2nd dose. The outcome of the event rapid heartbeat was recovered on 14Jan2021, chest pain was recovered on 16Jan2021, swollen lymph node under her right arm was recovered on 15Jan2021, fever, chills, she had huge nodules was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: did not take second dose; swollen lymph node under her right arm; fever; She had huge nodules; chills; rapid heartbeat; chest pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored. A 61-years-old female patient received bnt162b2 (Pfizer COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 14Jan2021 (Batch/Lot Number: EL3248, Age at Vaccination: 61-years) as DOSE 1, SINGLE for Covid prevention. The patient had Covid on 31Mar2020. She has a lot of food allergies such as soy, eggs avocado, you name it. She is also allergic to nuts. No additional vaccines were administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). No AE(s) following prior vaccinations. Concomitant medications included olmesartan medoxomil (BENICAR) at a dose of 25/12.50mg daily taken for hypertension (has been taking for over 10 years), from an unknown start date and ongoing; rosuvastatin calcium (CRESTOR) taken for Cholesterol (Low dose of either 5mg or 10mg. Has been taking it for the last year), from an unknown start date and ongoing. Patient took the first dose of the Covid 19 vaccine on 14Jan2021. She did not take the second dose. The patient experienced chills on 14Jan2021, rapid heartbeat on 14Jan2021, chest pain on 14Jan2021, swollen lymph node under her right arm on 15Jan2021, fever on 14Jan2021, she had huge nodules on 14Jan2021. She took an Aspirin. The rapid heart beat lasted for 4 hours. She had huge nodules. It lasted longer than the chest pain. The nodules started small the following day and they got bigger for a few days. The patient underwent lab tests and procedures which included Covid-19 test: positive on 31Mar2020. Therapeutic measures were taken as a result of chills, rapid heartbeat, chest pain, swollen lymph node under her right arm, fever, she had huge nodules. AE(s) did not require a visit to: Emergency Room, Physician Office. She was supposed to have the 2nd dose on 03Feb2021 and did not take it due to the reactions - She will go to (Name withheld) 2 weeks from now and wants to know if she can still have the 2nd dose. The outcome of the event rapid heartbeat was recovered on 14Jan2021, chest pain was recovered on 16Jan2021, swollen lymph node under her right arm was recovered on 15Jan2021, fever, chills, she had huge nodules was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pharyngeal swelling, SARS-CoV-2 test, Throat tightness
Clinical narrative: After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; After 5 minutes of injection, nasal passages congested and throat tightening and swelling.; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jun2021 12:30 (Lot number and Expiration Date was not reported) as dose 1, single for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing, known allergies included Wheat, gluten, wasp, yellow jacket and bee venom. Concomitant medication included gabapentin taken for an unspecified indication, start and stop date were not reported; adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported; cefixime (FLEXERIL [CEFIXIME]) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously took high doses of prednisone and experienced drug allergy. The patient did not receive other vaccine in four weeks. The patient did not receive covid prior vaccination. The patient experienced after 5 minutes of injection, nasal passages congested and throat tightening and swelling. on 27Jun2021 12:35. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Aug2021. Therapeutic measures were taken as a result of after 5 minutes of injection, nasal passages congested and throat tightening and swelling and treatment included benadryl, claritin, albuterol inhaler, water. The events resulted in Doctor's office/urgent care. The outcome of the events was reported as resolved on an unspecified date in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chest discomfort, Chills, Diarrhoea
Clinical narrative: Insomnia; Chills; Fever; Joint pain; Intense headache; Nausea; Diarrhea; Fatigue; Sore arm; Intense body aches; Chest tightness; Abdominal cramping; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 27-year-old non pregnant female patient received bnt162b2 (BNT162B2 Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Aug2021 at 16:30 (Batch/Lot Number: EW0180) as DOSE 2, SINGLE (at the age of 27-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included asthma and generalised anxiety disorder from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 28Jul2021 at 16.00 (Batch/lot number: EW0191, left arm) for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient experienced Insomnia, chills, fever, joint pain, intense headache, nausea, diarrhea, fatigue, sore arm, intense body aches, chest tightness and abdominal cramping on 19Aug2021 at 16:30. The patient was not tested for COVID post vaccination. No treatment received for the event. The outcome of the events reported as recovered on an unknown date of Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Nausea, Pain
Clinical narrative: Insomnia; Chills; Fever; Joint pain; Intense headache; Nausea; Diarrhea; Fatigue; Sore arm; Intense body aches; Chest tightness; Abdominal cramping; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 27-year-old non pregnant female patient received bnt162b2 (BNT162B2 Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Aug2021 at 16:30 (Batch/Lot Number: EW0180) as DOSE 2, SINGLE (at the age of 27-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included asthma and generalised anxiety disorder from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 28Jul2021 at 16.00 (Batch/lot number: EW0191, left arm) for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient experienced Insomnia, chills, fever, joint pain, intense headache, nausea, diarrhea, fatigue, sore arm, intense body aches, chest tightness and abdominal cramping on 19Aug2021 at 16:30. The patient was not tested for COVID post vaccination. No treatment received for the event. The outcome of the events reported as recovered on an unknown date of Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Insomnia; Chills; Fever; Joint pain; Intense headache; Nausea; Diarrhea; Fatigue; Sore arm; Intense body aches; Chest tightness; Abdominal cramping; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 27-year-old non pregnant female patient received bnt162b2 (BNT162B2 Formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Aug2021 at 16:30 (Batch/Lot Number: EW0180) as DOSE 2, SINGLE (at the age of 27-year-old) for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included asthma and generalised anxiety disorder from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on 28Jul2021 at 16.00 (Batch/lot number: EW0191, left arm) for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient experienced Insomnia, chills, fever, joint pain, intense headache, nausea, diarrhea, fatigue, sore arm, intense body aches, chest tightness and abdominal cramping on 19Aug2021 at 16:30. The patient was not tested for COVID post vaccination. No treatment received for the event. The outcome of the events reported as recovered on an unknown date of Aug2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Allergic reaction to excipient
Clinical narrative: allergy to PEG in Covid vaccine/ experienced 3 weeks of severe allergic reaction after each dose of the covid vaccine; This is a spontaneous report from a contactable consumer (patient) via medical information team . This consumer reported similar events for two patients (including self). This is first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified dates  as dose 1, single and dose 2, single (Lot number and Expiry date was not reported) for covid-19 immunization. This vaccine contains Polyethylene Glycol (PEG). The patient medical history and concomitant medications were not reported.  The patient experienced allergy to PEG in covid vaccine/ experienced 3 weeks of severe allergic reaction after each dose of the covid vaccine on an unspecified dates. It was reported, patient was since been diagnosed with PEG allergy. Treatment for the event was not reported. The outcome for the event was unknown.  The lot number for the BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101137872 same reporter, drug, event/ different patient
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: there are a lot of days I have to push myself through the day; I just very weak; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient asked about the data on the long-term side effects to the vaccine. He is asking because he stated that was a very active person and after the vaccine there are some days, he felt good and there are "a lot" of days I have to push myself through the day. He had advised to take iron pills, which he confirms he took. He says today he woke up feeling "fine" and "a few hours ago I just very weak." His symptoms began back in Mar after he received the vaccines a few weeks later. The patient stated he wanted to know if there is any data on an effect it will have on a person who has had postpartum depression. He also stated that he has 2 other daughters that have not received the vaccine and he is trying to convince them to get vaccinated. He stated that they have seen on TV/news or told by a friend that after the vaccine they are losing their hair, and this is a big thing for his daughter, and she will not get the vaccine because of this. He stated that the daughters have also been told, despite the short 7-8 months the vaccine has been out he states, that teenagers are saying from the 12+ age group that they are not able to have children after the vaccine. He also stated that he is fully vaccinated since Mar. He questions why they want "us to get the booster vaccine. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Had some joint pain; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), dose 3 (Lot number was not reported expiry dae was unknown) via an unspecified route of administration on an unspecified date (at the age of 80-years-old) as a single for covid-19 immunisation. Reporter stated that he was called about the Covid 19 Booster. He said thinks this will be of interest because people are not reporting their good results. Reporter stated he was a lawyer with over 30 years' experience with medical cases, so he was not some crazy person. Stated that he got the booster shot because the county he resides in had some that were about to expire, and he was told he could get one. States he is not immune deficient. Reporter stated that about 5 days before the shot he twisted his knee. Said he has had this happen to him before and it's like a meniscus tear and takes about a month to get better. Said that he went and got the booster shot on this past Friday. He woke up that night around 0100, his knee was killing him. He also had joint pains that he knew were just side effects. Stated that he finally got to sleep, the next day it was a little less uncomfortable and the next day it did not hurt at all. Reporter stated he has had no pain in his knee since. Reporter stated that he was convinced. Said he doesn't know what in the vaccine could affect inflammation, but he has never heard of anyone reporting a positive side effect. Reporter states that this is a positive side effect. Said he has hurt his knee a couple of times and knows how long it normally takes to get well. Reporter stated that if enough people take the time to report their positive side effects it would be good. Reporter stated that he called health safety orginization about this as well, but they acted like they didn't understand him. Reporter stated that's when he decided he would call Pfizer. Reporter stated if Pfizer was interested in contacting him that would be fine. He would be willing to be of any further help. Full details not obtained as caller declines to complete report. Declines to provide mailing address, alternative phone number, or email address. Reporter stated that he called the health safety organization about this as well, but they acted like they didn't understand him. Reporter stated that's when he decided he would call Pfizer. Reporter stated if Pfizer is interested in contacting him that would be fine. He would be willing to be of any further help. Full details not obtained as caller declines to complete report. Declines to provide mailing address, alternative phone number, or email address. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Pharyngeal swelling
Clinical narrative: She had some allergic reaction with shrimp; had hard time breathing; throat was swollen; missed the second dose scheduled; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient) reported for herself.  A female patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date 2021, after the vaccination, the patient experienced allergic reaction with shrimp, and she had hard time breathing, and the throat was swollen and she missed the second dose scheduled, which was supposed to be on 20Apr2021. And now she wanted to take the second dose and her doctor advised her to take the second dose but just safety medication of Benadryl, if in case she will take the second dose. she just needs a record, something that shows that she had the first shot, the patient misplaced the card, she cannot find it. she wants to get the second shot in the morning. but she can't, she does not have the record for the first shot. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (08Sep2021): 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: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: did that some type of vaccination of Pfizer; gotten so sick; smelling like some chemicals all kinds of crazy stuff; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient mentioned that did some type of vaccination of pfizer; gotten so sick; smelling like some chemicals all kinds of crazy stuff on an unspecified date. Everybody else in the house had been started to experience like some type of sickness. And very funny that after she got this vaccine then people in house have gotten sick you know one of other daughter says that everyone has gotten sick very bad. Consumer stated will be having COVID test tomorrow. Consumer stated never got really, really sick and got so sick. That was ridiculous but better now but still feeling like I was smelling like some chemicals all kinds of crazy stuff and I liked this thing we part of a regular flu unless we could part of COVID this feel like some kind of mainly or whatever what was going on. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pustular
Clinical narrative: Pustular rash, painful. Only on right side of leg and abdomen; Pustular rash, painful. Only on right side of leg and abdomen; This is a spontaneous report from a contactable consumer or other non hcp.     A 34-years-old female Non-Pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 10Aug2021 12:00 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient previously took cipro [ciprofloxacin] and experienced hypersensitivity. No other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the patient experienced pustular rash, painful, only on right side of leg and abdomen on 19Aug2021 with outcome of not recovered Therapeutic measures were taken as a result of pustular rash, painful. only on right side of leg and abdomen (rash pustular), pustular rash, painful. only on right side of leg and abdomen (rash).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: throat feeling clogged or stuffed; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age 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 date in Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Aug2021 as dose 1, single for covid-19 immunisation. On an unspecified date in Aug2021, the patient experienced throat feeling clogged or stuffed. Reporter stated that "I was wondering if that one of the side effects that you all have been hearing about children because I don't have any side effects with myself and not the family members have any side effects". The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Nausea, Panic attack
Clinical narrative: Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm (reported as left shoulder) on 19Aug2021 12:00 as dose number unknown, single (at the age of 68-years-old) for COVID-19 immunization. Vaccination facility type was reported as Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19 post vaccination. Patient did not receive any other vaccine in four weeks. Patient medical history included known allergies with Lopressor, effient and statins. The concomitant medications were not reported. Patient never had panic attacks or anxiety until received first dose, with nausea on 21Aug2021. Now would not go away. Life was hell. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The therapeutic measures taken as a result of the events included Anxiety medication. The outcome of the event was not resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain, Pain in extremity
Clinical narrative: Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more.; sore arm; Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more.; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: GN6199) via an unspecified route of administration, administered in left arm on 04Mar2021 (at the age of 67-year-old) as dose 1, single for covid-19 immunization. Medical history included COPD (chronic obstructive pulmonary disease) from 2009 and ongoing, h1n1 from 2009 to an unknown date and was on a ventilator because it attacked her lungs, ongoing diabetes and had Covid on an unspecified date in Nov2020 and she had lost of taste and smell with Covid. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Family history not provided. On an unspecified date in Mar2021 the patient stated that the man who gave her the first shot gave it too high she thinks and that's why it hurt more, had a sore arm. It was reported that Sore arm after the first dose of the vaccine. Caller states that she had her first dose of the vaccine on 04Mar2021. Her arm was sore for maybe 4 days. Sore arm after the second dose of the vaccine. Her arm was not as bad with the second one.  Says it was sore for maybe half of a day. Caller states that the man who gave her the first shot gave it too high she thinks; and that's why it hurt more. The AEs does not required a visit to emergency room and physician office. The patient wanted to know if the vaccine that she got was a placebo as she has COPD, so she needs the real vaccine, not a placebo. caller stated that sometimes a sore arm was to be expected if you have a shot that goes in a muscle.   Outcome of the event sore arm was resolved on an unspecified date in Mar2021 and outcome of rest of events were unknown.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dry mouth, Fatigue, Inflammation
Clinical narrative: Tachycardia; frequent palpitations (severe at times); sternal  inflammation and very frequent cracking and popping (never experienced before); sternal  inflammation and very frequent cracking and popping (never experienced before); other chest pains; upper neck and left back/left shoulder also very painful; upper neck and left back/left shoulder also very painful; Increased fatige; Increased need to urinate; insatiable thirst/ "dry mouth" sensation; insatiable thirst/ "dry mouth" sensation; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (at the age of 23 years) (Batch/Lot Number: EP7533) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant medications included Omeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported, he experienced, following vaccination (11Apr). Symptoms persisting for 4 plus months to current date (date not specified) Tachycardia, frequent palpitations (severe at times), sternal inflammation, and very frequent cracking and popping (never experienced before), other chest pains, upper neck and left back/left shoulder also very painful. Increased fatigue, pain when breathing in fully. Increased need to urinate and insatiable thirst, dry mouth sensation. The events resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the treatment as Colchicine 0.6mg Once daily for 30 days. The clinical outcome of the event Increased need to urinate, insatiable thirst, dry mouth sensation, was recovered on an unspecified date in 2021 and remaining all other events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Palpitations, Pollakiuria, Tachycardia, Thirst
Clinical narrative: Tachycardia; frequent palpitations (severe at times); sternal  inflammation and very frequent cracking and popping (never experienced before); sternal  inflammation and very frequent cracking and popping (never experienced before); other chest pains; upper neck and left back/left shoulder also very painful; upper neck and left back/left shoulder also very painful; Increased fatige; Increased need to urinate; insatiable thirst/ "dry mouth" sensation; insatiable thirst/ "dry mouth" sensation; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 23-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (at the age of 23 years) (Batch/Lot Number: EP7533) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing. Concomitant medications included Omeprazole taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported, he experienced, following vaccination (11Apr). Symptoms persisting for 4 plus months to current date (date not specified) Tachycardia, frequent palpitations (severe at times), sternal inflammation, and very frequent cracking and popping (never experienced before), other chest pains, upper neck and left back/left shoulder also very painful. Increased fatigue, pain when breathing in fully. Increased need to urinate and insatiable thirst, dry mouth sensation. The events resulted in visit to Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the treatment as Colchicine 0.6mg Once daily for 30 days. The clinical outcome of the event Increased need to urinate, insatiable thirst, dry mouth sensation, was recovered on an unspecified date in 2021 and remaining all other events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable consumer (mother) reported for a daughter. A 17-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not provided), dose 1 via an unspecified route of administration on an unspecified date in Aug2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller states her daughter had her yearly immunizations on Monday and has been running a fever/temperature on Aug2021 and her paediatrician said to wait a week to get her COVID vaccine. Caller states her daughter already had her first dose, and the family doctor told them to wait a week to initiate the second dose. Caller asks what vaccination provider to call to speak to Referred to call local health department for the information. Outcome of event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: temp of 104.0 after the vaccine/has a fever of 104; This is a spontaneous report received from a contactable consumer (Patient's friend). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on an unspecified date as unknown single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced temp of 104.0 after the vaccine/has a fever of 104. The patient underwent lab tests and procedures which included body temperature: 104.0. 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: Malaise, Pruritus, Rash papular
Clinical narrative: red bumps on his skin and it is itching; red bumps on his skin and it is itching; he does not feel comfort; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Aug2021 as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reported that he got his first shot yesterday (24Aug2021) and explained he did not feel comfort. He experienced red bumps on his skin, and it was itching. Caller wanted to know if this was an allergy to the product. The outcome of events was unknown.    Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: irregular heartbeat; This is a spontaneous report from a contactable consumer or other non-hcp (patient himself). A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in Mar2021 (Lot number and Expiry date was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient previously received bnt162b2 dose 1 via an unspecified route of administration on unspecified date in Feb2021. The patient's concomitant medications were not reported. The patient experienced irregular heartbeat on an unspecified date. The patient underwent lab tests and procedures which included heart rate: irregular. The outcome of the event was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: With in a week of my first shot I developed shingles on my left side. On my back ribcage.; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 43-year-old adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: FA7485), dose 1 via an unspecified route of administration, administered in Arm Right on 12Aug2021 at 18:30 (at the age of 43-year-old), as DOSE 1, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included chicken pox as a child and lactose intolerance from an unknown date and unknown if ongoing. The patient had no covid prior vaccination. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), kachava meal replacement, ion gut health, taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had not been covid tested post vaccination. On 20Aug2021 at 13:00, the patient experienced shingles on her left side and on her back ribcage. The clinical details of the event as follows: within a week of her first shot, she developed shingles on her left side, on her back ribcage. She had chicken pox as a child and am usually very healthy and well. Thought this was strange. The patient received treatment with Antiviral valacyclovir and Gabapentin 100MG to treat the events. The patient outcome of the event was Resolving at the time of this report.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Nervousness
Clinical narrative: he is scared; numbness in his fingers; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age reported for himself that he received BNT162B2 (Comirnaty, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on an unspecified date in Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021, five days later, the patient experienced numbness in his fingers. The patient was scared and asked what he should do and if he should receive the second vaccine. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.