chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: I was extremally tired for over 2 months; when my cycle started I had heavy bleeding for 6 days when I typically only bleed for 4 days; I had spotting for 14 days before my period (with no pain) and very light; This is a spontaneous report from a non-contactable consumer (patient). A 40-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0167, Expiration date: not reported), via an unspecified route of administration in arm right on 04May2021 at 16:00 (at the age of 40-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient's concomitant medications in two weeks were reported as no. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EIR8729, Expiration date: not reported), via an unspecified route of administration in right arm on 13Apr2021 at 16:00 (at the age of 40-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 01Jun2021 at 12:00 AM, the patient experienced extremally tired for over 2 months, taking multiple naps a day. Stated that, the effect she wanted to report was a change to her period. Stated that, she had spotting for 14 days before her period (with no pain) and very light, then when her cycle started, she had heavy bleeding for 6 days when she typically only bleed for 4 days. Stated that, she was not pregnant or sexually active and this was the first time this has happened to her and it was the month after she had her second shot and stated that, by the way the tiredness has gone away too. Treatment was not received for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness
Clinical narrative: it was pain like on her stomach, like cramps all on her stomach.; feeling lightheaded; This is a spontaneous report from a contactable consumer (patient). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported), via an unspecified route of administration, administered in arm right on 22Jul2021 10:38 (at the age of 17 years old) as dose 1, single for COVID-19 immunization. History of all previous immunization with the Pfizer vaccine considered as suspect was none. There were no additional vaccines administered on same date of the Pfizer suspect. There were no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She had not adverse event prior vaccinations. There were no any relevant tests. She did not receive other products. The patient medical history and concomitant medications were none. The patient stated that she started feeling last night, when she was sleeping, she started feeling stomach pain and the whole day yesterday she was feeling lightheaded and it was pain like on her stomach, like cramps all on her stomach on 22Jul2021. Her stomach pain was like she could not move, it hurt her body to move. She stated that since she slept, lightheaded was improved on the time of reporting. She started feeling lightheaded around 17:00 she would say then when she was going to sleep around 22:00, that was when the stomach pain started happening. She was not visited emergency room and physician office. The outcome of event feeling lightheaded was recovering and pain like on her stomach, like cramps was not recovered.  No follow-up attempts were needed, No further information was expected. Information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Achy all over; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced achy all over on an unspecified date. The outcome of the event was unknown.   Information about Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Drug ineffective, Suspected COVID-19
Clinical narrative: autoimmune issues; Uncertain if patient has Covid 19 or if it is her autoimmune issues/whatever is going on with her daughter is affecting every system of her body.; Uncertain if patient has Covid 19 or if it is her autoimmune issues/whatever is going on with her daughter is affecting every system of her body.; This is a spontaneous report from a contactable consumer. This Consumer (patient's mother) reported for a female patient (reporter's daughter).  A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/lot number and Expiry Date: Not Provided), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included celiac disease from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, it was reported that it was uncertain if patient has Covid 19 currently or if it was her autoimmune issues. It was stated that her daughter had Covid 19 when the caller did and has had the Pfizer Vaccines, had never been tested for lupus and whatever was going on with her daughter was affecting every system of her body and she was uncertain if her daughter had Covid 19 or if it was her autoimmune symptoms causing issues. The clinical outcome of the events was unknown.  Information on Batch/lot number not available for [BNT162B2]; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pruritus, Rash, Swelling
Clinical narrative: really bad rash on her body; all over her body;  it comes and goes/it appears on the other parts of her body,  it's in her legs, all over her body; rash that can had her body it got worse like swollen and itching; rash that can had her body it got worse like swollen and itching; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0173), via an unspecified route of administration on 11May2021 as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number/Expiration date: Unknown) on an unspecified date for covid-19 immunization and experienced No reaction on previous exposure to drug. The patient's medical history and concomitant medications were not reported. On an unspecified date of May2021 the patient experienced really bad rash on her body; all over her body; it comes, and goes/it appears on the other parts of her body, it's in her legs, all over her body and rash that can had her body it got worse like swollen and itching. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. The outcome of event was not recovered.  Follow-up (07Sep2021): 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.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Pharyngeal hypoaesthesia
Clinical narrative: Numbness in mouth and throat; Numbness in mouth and throat; This is a spontaneous report from a contactable consumer (patient) reported for self. A 57-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: not available), via an unspecified route on an unspecified date in the left arm in Jul2021 at 15:00, as a single dose for covid-19 immunization. Medical history included hypothryroidism. Concomitant medications included levothyroxine sodium, clonazepam and st johns warts. No known allergies were reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unknown date in Jul2021 at 15:00, patient experienced numbness in mouth and throat. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  Information on the lot/ batch number has been requested.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer, the parent. A 12-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 22Jul2021 as dose 2, single (at the age of 12-years-old) for covid-19 immunization. Medical history reported as none. The patient concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration in the arm left on 01Jul2021 as dose 1, single (at the age of 12-years-old) for covid-19 immunization and experienced sore arm. On 26Jul2021, the patient experienced rash. The patient took allergy medicine for the treatment of event. The patient had not gone in emergency room and also not visited to physician office. There were not any adverse event present prior to the vaccination. The outcome of the event was recovering.  Follow-up attempts were completed. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 ( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection and Batch/Lot number was not reported) via an unspecified route of administration on 25Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced soreness in the arm, rapid heartbeat and dizziness and wanted to know that whether this were emergency symptoms. The patient underwent lab tests and procedures which included heart rate increased: rapid on unspecified date. The outcome of events was unknown. Information on Lot/Batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: CHEST PAIN; SHORTNESS OF BREATH; SWEATING; TACHYCARDIA; DIZZINESS; WEAKNESS; TIREDNESS; Headache; CHILLS; This is a spontaneous report from a contactable pharmacist. A 37-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0196) via an unspecified route of administration in Arm Left on 23Jun2021 17:45 (age at vaccination 37years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history reported as none. The patient had known allergies reported as unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0187) via an unspecified route of administration in Arm Left on 02Jun2021 17:45 (age at vaccina-tion 37years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. On 10Jul2021 13:30 the patient experienced chest pain, shortness of breath, sweating, tachycardia, dizziness, weakness, tiredness, headache, chills. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Tachycardia
Clinical narrative: CHEST PAIN; SHORTNESS OF BREATH; SWEATING; TACHYCARDIA; DIZZINESS; WEAKNESS; TIREDNESS; Headache; CHILLS; This is a spontaneous report from a contactable pharmacist. A 37-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0196) via an unspecified route of administration in Arm Left on 23Jun2021 17:45 (age at vaccination 37years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history reported as none. The patient had known allergies reported as unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included levothyroxine, liothyronine (NP THYROID) taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0187) via an unspecified route of administration in Arm Left on 02Jun2021 17:45 (age at vaccina-tion 37years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. On 10Jul2021 13:30 the patient experienced chest pain, shortness of breath, sweating, tachycardia, dizziness, weakness, tiredness, headache, chills. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Extra dose administered, Headache, Interchange of vaccine products, Off label use
Clinical narrative: a red arm and a bit of a headache; a red arm and a bit of a headache; previously 2 doses of MODERNA COVID-19 VACCINE; previously 2 doses of MODERNA COVID-19 VACCINE; previously 2 doses of MODERNA COVID-19 VACCINE; This is spontaneous report from a contactable consumer (patient).   An 84-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single (Pfizer Covid19 booster dose) for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received previously 2 doses of MODERNA COVID-19 VACCINE (MODERNA COVID-19 VACCINE, Lot Number: not reported) via an unspecified route of administration on an unspecified date (early) in Jan2021 where she experienced a bit of headache, a rash like mosquito bite but not itchy and her arm was sore. The patient went and got her booster shot from Pfizer a few days ago, and she had a red arm and a bit of a headache. The patient received previously 2 doses of MODERNA COVID-19 VACCINE. The patient said that there was no side effects at all compared to withheld, the 2nd shot of withheld hurted a lot for one night but everything was fine. She wanted to know when she could get another booster shot of Pfizer. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: my head is looking terrible; This is a spontaneous report from a non-contactable consumer, the patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that AstraZeneca patient doctor gave AstraZeneca Vaccine a month ago. Then it was successful. Numbness and pressure on the left side of my head. Second Vaccine Biontech, there was no problem in it. But patient head was looking terrible. The patient afraid of thrombosis. Outcome of event was unknown.  Follow-up attempts were completed. No further information was expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: The caller's headache was so bad she was crying.; was sleepy; shortness of breath/It would take the caller a long time to get to the kitchen without getting short of breath; headache; dehydration/The caller was so dehydrated because she was out of it; weakness; extreme tiredness; This is a spontaneous report from a contactable Nurse or other HCP. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Right Arm on 22Jul2021 (at the age of: 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , Solution injection, Lot number/Expiration date: Unknown) on  for covid-19 immunization and experienced no problem. Medical history included covid-19  the caller had covid 3 times. The last time the caller had covid she had double pneumonia & hospitalized for 8 days , breast cancer female from 2010, pneumonia as the last time the caller had covid she had double pneumonia & hospitalized for 8 days. Concomitant medication(s) included magnesium (MAGNESIUM); zinc (ZINC); niacin (NIACIN); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin D [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). Vaccination Facility Type mentioned as Pharmacy. Vaccine was not Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect as None. Additional Vaccines Administered on Same Date of the Pfizer Suspect as None. Family Medical History Relevant to AE(s) as None. On 22Jul2021 the patient experienced headache, dehydration/the caller was so dehydrated because she was out of it, weakness, extreme tiredness. On 24Jul2021 the patient experienced  shortness of breath/it would take the caller a long time to get to the kitchen without getting short of breath. On an unspecified date the patient experienced  the caller's headache was so bad she was crying and was sleepy. She got both doses of the PFIZER-BIONTECH COVID-19 VACCINE. Being that her 2nd dose was given 22July2021.  Post-vaccination she experienced headache, dehydration, weakness, extreme tiredness (she felt like going to the bathroom is already a chore) and shortness of breath. Caller would like to know if the above mentioned side effects were still reported to have been experienced, a week later after getting the vaccine. The outcome of event headache was recovered on 28Jul2021. The outcome of event dehydration/the caller was so dehydrated because she was out of it, the caller's headache was so bad she was crying and was sleepy was unknown. The outcome of rest all event was not recovered. 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.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This is a spontaneous report from a contactable consumer (Patient). A 57-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number: not reported), via an unspecified route of administration on Jul2021 as, DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On Jul2021, the patient experienced cough. Patient stated that She had recently started to have a cough, otherwise feels fine. Reported stated that her daughter told her today that someone she works with was exposed. They were going to take rapid tests because they have people coming to town in a couple of days and are trying to be proactive. She understands that there was no live virus in vaccine. She was asking, if she were to test, could it show a false positive after getting that first dose. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Experiencing rashes from her knees down to her feet; This is a spontaneous report from a contactable pharmacist. A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on 28Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced experiencing rashes from her knees down to her feet on Jul2021. Outcome of the event was unknown.  Follow-up(30Jul2021):This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of a query.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, SARS-CoV-2 antibody test
Clinical narrative: Headache; Nauseous; Tired; Sore; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 18-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on Jul2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID-19 from 17Mar2021 to an unknown date, cough, choking, headache, fatigue, decreased appetite, sensory loss, von willebrand's disease; patient was a carrier from an unknown date and unknown if ongoing. There were no concomitant medications. Patient's medical history: (including any illness at time of vaccination) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s): mother has Von Willebrand disease, patient was a carrier. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior Vaccinations (within 4 weeks): HPV in Jun2021 more than 4 weeks before. It was reported that on an unspecified date in Jul2021 the patient had experienced a headache; was nauseous; very tired, felt completely out of it; and had a sore arm for 24 hours. Adverse event did not require a visit to emergency room or physician Office. This was a clone report is created to document the son's experience. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive on 18Mar2021. The outcome of all events was unknown.The outcome of all events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: 2 shots in each shoulder at different times when pain got very bad/ on 27Mar had slight dull pain in left shoulder where I got the shot; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 71-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date single followed by patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported) second 2 via an unspecified route of administration on 22Mar2021 single for Covid-19 immunization. Medical history included shoulder pain from an unknown date and unknown if ongoing (I have had pain in both shoulders for many years). The patient concomitant medications were not reported. On 27March Patient had slight dull pain in left shoulder where patient got the shot, pain gone next day. On 15Jul had severe pain in same spot, next day pain was gone but not just in that area, all the pain was gone in both shoulders. The outcome of the event was recovered on 28Jul2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer or other non-Health Care Professional via Pfizer sponsored program. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 29Jul2021 as DOSE 1, SINGLE for Covid-19 immunization. The patient medical history was not reported.  The patient's concomitant medications were not reported.On 29Jul2021 the patient experienced headache. The outcome of event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable patient (consumer), of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Jul 29, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient got the first dose on Jul 29, 2021 in the afternoon. Afterwards, she experienced blurry eyesight on Jul 29, 2021. The patient asked if she would need to go to hospital. While doing a warm transfer and talking to the agent, both lines disconnected.  Customer and/or medical inquiry was forwarded or referred. Reason for no lot number: Complainant hung up abruptly/transfer incomplete. Call back done however it was unsuccessful. Hence further probing could not be done. Thus, limited information available. The outcome of the events reported: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Ultrasound scan, X-ray
Clinical narrative: My right ankle becomes swollen after i receive the vaccine; This is a spontaneous report from a contactable consumer or other non hcp.   A 49-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 05May2021 as 2nddose, single for covid-19 immunisation.             (Age at Vaccination was 49 years). Historical vaccine was A 49-years-old female patient received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced my right ankle becomes swollen after i receive the vaccine on 05May2021.  The patient underwent lab tests and procedures which included ultrasound scan: unknown results   on   i got two ultrasounds of my leg, x-ray: unknown results   on   an x-ray of my knee. Upon follow-up 31Jul2021 is a follow-up spontaneous report from a contactable consumer. This 49-year-old consumer (patient) reported for herself about transcription analysis my right ankle became swollen after I received the vaccine my doctor doesn't know why my ankle is swelling i got two ultrasounds of my leg and an x-ray of my knee and there's they still don't know why my ankle was swollen. Outcome of the event was unknown. Follow-up 31Jul2021 is a follow-up spontaneous report from a contactable consumer. This 49-year-old consumer (patient) reported for herself about transcription analysis my right ankle became swollen after I received the vaccine my doctor doesn't know why my ankle is swelling i got two ultrasounds of my leg and an x-ray of my knee and there's they still don't know why my ankle was swollen. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: after getting the first dose it returned to the state it was when she had labored breathing due to covid,; her mom had gotten covid and she was exposed to her; This is a spontaneous report from a contactable consumer (patient herself). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection lot number: unknown, expiry date: unknown) via unspecified route of administration on 21Jul2021 as dose 1, single for covid-19 immunisation. Concomitant medications were not reported. Patients medical history included covid-19 on an unspecified date in Jan2021 (she got sick from having covid and she had labored breathing, but it was not enough to want to be hospitalized). Since then her breathing had been labored but seemed to be getting better. However after getting the first dose it returned to the state it was when she had labored breathing due to covid, not to the point where she couldnt breathe at all but she was worried after the second dose how it would affect her. Was it something she needed to be concerned with, was this common, was it safe to take the second dose, and what was the proper avenue to make sure it is safe to take the second dose. She would like medical guidance on dealing with the covid vaccine. She doesn't have a primary care provider. She generally go to # since they are far and few between for a cough or something but it costs a fortune. She was supposed to get the second dose on 23Jul2021 however, her mom had gotten covid and she was exposed to her. She declined to complete a safety report on behalf of her mother. No further details provided. She was exposed to her and she tested negative. Then she tested negative when she got a second test. She was supposed to get the second dose by Friday and is trying to get medically situated. She was supposed to get it on the 23Jul2021 but for the second dose is says she could not be exposed to covid. The reason she was trying to figure out if she could proceed with it over the next 14 days and who was supposed to guide her. Yes it was safe or no to not get it.   Follow-up attempts have been completed. Batch/lot number not available for BNT162B2. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Swelling
Clinical narrative: Arm hot Day 2 until Day 10; Swollen and hard but not cellulitis; This is a spontaneous report from a contactable consumer (patient herself). A 55-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 11Jul2021 12:00 (at age of 55-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included inflammatory bowel disease, systemic lupus erythematosus, sulfanilamide from an unknown date and unknown if ongoing. Patient had known allergies to Sulfa medications and Azithromycin. Concomitant medications included mesalazine (ASACOL), atorvastatin calcium (LIPITOR), montelukast sodium (SINGULAIR) taken for an unspecified indication. The patient previously took azithromycin and experienced hypersensitivity. 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. On 14Jul2021 19:00 the patient experienced arm hot day 2 until day 10 and swollen and hard but not cellulitis. Patient did not receive any treatment for adverse event. Since the vaccination, patient has not been tested for COVID-19. The outcome of event was recovered on an unspecified date.  The lot number for the vaccine [Pfizer/BioNTech COVID 19 Vaccine] was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pain in extremity
Clinical narrative: headache; fever; chills; body ache; joint pain; arm pain; The initial case was missing the following minimum criteria: Unspecified product and Unspecified AE. Upon receipt of follow-up information on 30Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on the Arm Left on 30Jul2021 15:26 (Batch/Lot Number: EW0196) as dose 2, single for COVID-19 immunization at a pharmacy. There were no concomitant medications. The patient has no medical history. The patient previously received the first dose of bnt162b2 (Lot number: EW0196) on 09Jul2021 12:00, Intramuscular on the Left arm for COVID-19 immunization and experienced headache and arm ache. No other prior vaccinations and relevant tests. On 30Jul2021, the patient experienced headache, fever, chills, body ache, joint pain, and arm pain all considered as important medical event by the reporter. The outcome of the events was recovered on 02Aug2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; fever; chills; body ache; joint pain; arm pain; The initial case was missing the following minimum criteria: Unspecified product and Unspecified AE. Upon receipt of follow-up information on 30Aug2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on the Arm Left on 30Jul2021 15:26 (Batch/Lot Number: EW0196) as dose 2, single for COVID-19 immunization at a pharmacy. There were no concomitant medications. The patient has no medical history. The patient previously received the first dose of bnt162b2 (Lot number: EW0196) on 09Jul2021 12:00, Intramuscular on the Left arm for COVID-19 immunization and experienced headache and arm ache. No other prior vaccinations and relevant tests. On 30Jul2021, the patient experienced headache, fever, chills, body ache, joint pain, and arm pain all considered as important medical event by the reporter. The outcome of the events was recovered on 02Aug2021.   No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Swelling face
Clinical narrative: May 17th I had my first facial reaction.   Face swelled, weeped fluid, itched, skin peeled.     It has been happening off and on ever since.    I went to Dr on 6/22 and was put on prednisone for 5 day; May 17th I had my first facial reaction.   Face swelled, weeped fluid, itched, skin peeled.     It has been happening off and on ever since.    I went to Dr on 6/22 and was put on prednisone for 5 day; May 17th I had my first facial reaction.   Face swelled, weeped fluid, itched, skin peeled.     It has been happening off and on ever since.    I went to Dr on 6/22 and was put on prednisone for 5 day; May 17th I had my first facial reaction.   Face swelled, weeped fluid, itched, skin peeled.     It has been happening off and on ever since.    I went to Dr on 6/22 and was put on prednisone for 5 day; my eyes were puffing up; My cycles have stopped; My cycles have stopped; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EW0169) via an unspecified route of administration (age at vaccination 52-year) in right arm on 02May2021 at 12:30 PM as dose 2, single for COVID-19 immunization. Medical history reported none. There were no concomitant medications. Historical vaccine includes first dose of BNT162B2 (Lot number: EP7533) administered in right arm on 11Apr2021 at 12:30 PM for COVID-19 immunization. No known allergies were reported. The patient received no COVID prior vaccination. The patient not tested COVID post vaccination. Patient received no other vaccine in four weeks. Other medications in two weeks were reported none. On 17May2021 at 05:00 PM the patient experienced she had her first facial reaction, Face swelled, weeped fluid, itched, skin peeled, it had been happened off and on ever since, she went to Dr on 6/22 and was put on prednisone for 5 day, her eyes were puffing up, her cycles have stopped. AE resulted in Doctor or other healthcare professional office/clinic visit. The patient reported that "17May she had her first facial reaction. Face swelled, weeped fluid, itched, skin peeled. It has been happening off and on ever since. She went to Dr on 22Jun and was put on prednisone for 5 days and symptoms improved. Took last medication on a Sunday morning and by Monday evening her eyes were puffing up. They put her on a 10-day lower dosage of prednisone. Did not have the same effect as the first round but kept things in check. she experienced another reaction. They tried to rule out any type of allergy to food or contact. She had no history of any type of allergic reaction to food, plants, or seasonal allergies. She also had regular menstrual cycles with no signs of menopause. Her cycles had stopped." Therapeutic measures were taken as a result of adverse events; the patient was treated with prednisone, started on 22Jun. The clinical outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Muscle discomfort, Musculoskeletal discomfort, Peripheral swelling
Clinical narrative: Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints. Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 40-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Aug2021 16:00 (Batch/Lot Number: FA7484) (at the age of 40-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no known allergies reported. Concomitant medications included hydroxyzine embonate (VISTARIL) as needed taken for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride daily (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jul2021 16:00 (Batch/Lot Number: EWA82) for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. On 04Aug2021 17:00, the patient experienced fingers swollen with redness and pain at the joints.severe discomfort of muscles and joints.raised hives covering most of body including eyelids.doctor gave steroids. The events resulted in emergency room visit. The patient received treatment with antihistamines and steroids. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints. Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; Fingers swollen with redness and pain at the joints.  Severe discomfort of muscles and joints.Raised hives covering most of body including eyelids.  Doctor gave steroids.; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 40-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01Aug2021 16:00 (Batch/Lot Number: FA7484) (at the age of 40-years-old) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. There were no known allergies reported. Concomitant medications included hydroxyzine embonate (VISTARIL) as needed taken for an unspecified indication, start and stop date were not reported; fluoxetine hydrochloride daily (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jul2021 16:00 (Batch/Lot Number: EWA82) for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks of covid-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and Since the vaccination, the patient had not been tested for COVID-19. On 04Aug2021 17:00, the patient experienced fingers swollen with redness and pain at the joints.severe discomfort of muscles and joints.raised hives covering most of body including eyelids.doctor gave steroids. The events resulted in emergency room visit. The patient received treatment with antihistamines and steroids. The clinical outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Illness, Vomiting
Clinical narrative: Normal feel sick, weak after 2nd dose; for 2 days threw-up; 3rd day very weak; Felt pain in my bones; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter send in cross-reference case.   A 55-years-old patient of an unknown gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in right arm via an unknown route of administration on 28May2021 at 11:15 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: ER8735) administered in upper right arm via an unknown route of administration on 01May2021 at 11:15 am and experienced no adverse event. On an unknown date, the patient experienced normal feel sick, weak after 2nd dose, for 2 days threw-up, 3rd day very weak and felt pain in my bones. It was reported that the patient was normal feel sick week after 2nd shot for 2days threw-up and on 3rd day very weak. The patient felt pain in the bones after 5 days was normal fine. The outcome of the events normal feel sick, weak after 2nd dose, for 2 days threw-up, 3rd day very weak was reported as unknown while the outcome of the event felt pain in my bones was reported as recovered on an unknown date in 2021. Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Palpitations, Pyrexia, Rash
Clinical narrative: very big rash on our back; fever; Numbness on the left side the numbness comes and goes its not consistent/left arm where I feeling the numbness; hives; palpitation; rapid heartbeat; This is a spontaneous report from a contactable consumer. This 50-year-old female consumer (patient) reported for herself.  A 50-year-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, after the vaccination patient experienced all this fever and all that from the beginning of the first dose but now what he just breaks into hives, the patient experienced very big rash on back and then on his left side of face. Patient was asking a question can it be normal a little bit like his cheek area underneath his eye can it be become normal its normal a little numb just a little bit. rash has started about a week ago. some weeks a day. The patient wants to be treated because the numbness on the left side comes and goes it's not consistent, but he is feeling a little bit of it especially later underneath of his eye and cheeks. consumer has rash and numbness on the face, consumer stated, "Right on my left side of my face and that she gave me shot on the left side and I can feel it today, underneath my eyes and cheeks and I have the rash, but she does" Patient also have palpitations, rapid heartbeat. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.