chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Pfizer vaccine had something in it that cured my mad itch.; This is a spontaneous report from a Regulatory Authority. A 83-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on Mar2021 as dose number unknown, single for covid-19 immunisation. The patient medical history included severe pruritus of unknown origin for over two years. The patient concomitant medications were not reported. On unspecified date of 2021, the patient experienced and stated that she went to numerous neurologists, dermatologists, allergists, etc. Nothing worked to help her Pruritus. I kept very detailed records of everything, and I am sure that the Pfizer vaccine had something in it that cured my mad itch. The outcome of the event was unknown. The lot number for the vaccine, [Pfizer Covid-19 Vaccine], was not provided and will be requested during follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperkeratosis, Pruritus
Clinical narrative: The site of the injection has a small bump and is still itching 5 months later; The site of the injection has a small bump and is still itching 5 months later; This is a spontaneous report received from a contactable consumer. This 69-year-old female consumer reported.  A 69-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in left arm on 20Mar2021 12:00 AM (at the age of 69-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history includes Blood cholesterol increased and Allergy to arthropod sting from an unspecified date and unknown ongoing and concomitant medications were not reported. On 30Mar2021, after the vaccination, the patient experienced the site of the injection has a small bump and is still itching 5 months later. No other vaccines were taking in four weeks, patient was not diagnosed with Covid before vaccination and patient was not tested for Covid post vaccination. The outcome of the events was not recovered.  No follow-up attempts possible. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy, Pain
Clinical narrative: Swollen lymph nodes (the size of a pea) between armpit and upper chest area with pain in the surrounding area.; Swollen lymph nodes (the size of a pea) between armpit and upper chest area with pain in the surrounding area.; Swollen lymph nodes (the size of a pea) between armpit and upper chest area with pain in the surrounding area.; Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected. This is a spontaneous report from a contactable consumer or other non hcp. A 30-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Fc3184), dose 1 via an unspecified route of administration, administered in Arm Left on 23Aug2021 15:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing Known allergies: Shellfish. The patient's concomitant medications were not reported. Patient did not receive other medications in two weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination.  The patient experienced swollen lymph nodes between armpit and upper chest area with pain in the surrounding area. On 28Aug2021 19:00, swollen lymph nodes between armpit and upper chest area with pain in the surrounding area, axillary pain on 28Aug2021 19:00, swollen lymph nodes between armpit and upper chest area with pain in the surrounding area on 28Aug2021. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Blood urine
Clinical narrative: had a bad reaction to urinating blood; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer sponsored program.    A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced had a bad reaction to urinating blood on an unspecified date in 2021. She had not received the second dose yet. She wanted to know if it was safe for her to start all over again to take the first dose or should she proceed to get the second 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: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Diarrhoea, Dyspepsia, Oropharyngeal pain
Clinical narrative: mild diarrhea; increased blood pressure; sore throat; some difficulty keeping food down; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-098174), for bnt162b2 (COMIRNATY).  A male patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as BOOSTER DOSE (INITIAL PFIZER DOSE), SINGLE for covid-19 immunisation; lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 17Aug2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for thyroid cancer. Medical history included thyroid cancer from an unknown date and unknown if ongoing Medical History. Started Lenvima 24mg on 8/17/2021. The patient's concomitant medications were not reported. On an unspecified date the patient experienced mild diarrhea increased blood pressure, sore throat, some difficulty keeping food down. The patient underwent lab tests and procedures which included blood pressure measurement: increased on.  The action taken in response to the event for lenvatinib mesilate was unknown.  Therapeutic measures were taken as a result of increased blood pressure blood pressure increased. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: The first one i was itchy that night, that was it.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Aug2021 16:30 (Batch/Lot Number: fa7484) as dose 1, single (age at vaccination 55-year-old) for covid-19 immunisation. Medical history included Known allergies: cefadrixal /duricef sometimes if I eat garlic and meat from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took cefadroxil and experienced drug hypersensitivity, duricef and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced the first one i was itchy that night, that was it on Aug2021. It was reported that the first one patient was itchy that night that was it. The second one a couple days later getting these little twinges of pain in the centre of my chest that come and go. The outcome for event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue disorder
Clinical narrative: I have a swollen tongue; My tongue is swollen and around its edges there are some bumps and they started about an hour after I got this vaccine yesterday; I have a swollen tongue; My tongue is swollen and around its edges there are some bumps and they started about an hour after I got this vaccine yesterday; This is a spontaneous report from a contactable consumer (patient) reported herself. A 50-years-old female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: unknown, expiry date: unknown), via an unknown route of administration on 29Aug2021 (at the age of 50-years-old) as dose 2, single for Covid-19 immunization. Reason for no lot number that the consumer think that was 184 (Further not clarified hence not captured in tab). The patient's medical history included anxiety from an unknown date. Consumer stated that she took several medications she was on anxiety medications (not clarified hence not captured in tab) she was also on supplements multivitamins (not clarified hence not captured) she was on few different medications (not clarified hence not captured)." The patient received BNT162B2 on 08Aug2021 as historical vaccine as dose 1, single for Covid-19 immunization. On 29Aug2021, the patient had a swollen tongue; her tongue was swollen and around its edges there were some bumps and they started about an hour after she got this vaccine yesterday. Consumer stated, "Just rinsed with some salt water. I have a swollen tongue. My tongue is swollen and around its edges there are some bumps and they started about an hour after I got this vaccine, yesterday." The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Cough, Head discomfort, Headache
Clinical narrative: Body Aches; loss of energy; slept all day; head pressure; sinus; nose congestion; sneezing; coughing; fever; burning in the chest by the 20 that was worse by the 21 /22nd; Headache; cold; I used my Nebulizer to help with breathing; Wheezing; pain in right back area of the lung.; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for the patient in response to consumer letter sent via follow up letter. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jan2021 as single for COVID-19 immunisation. The patient experienced headache on 17Aug2021, head pressure, sinus, nose congestion, sneezing, coughing, fever, burning in the chest by the 20 that was worse by the 21/22nd on 20Aug2021, loss of energy, slept all day on 21Aug2021, body aches on 23Aug2021, cold, i used my nebulizer to help with breathing, wheezing, pain in right back area of the lung on Aug2021. Reported as, patient was exposed to COVID19 On 31Aug. He had lunch with 4 others that were also fully vaccinated. Patient and his wife were vaccinated with Pfizer in Jan/Feb2021. Symptoms began for him on Monday the 16. Patient began symptoms on Friday the 20. His symptoms included head pressure, sinus, nose congestion, sneezing, coughing, day 7 ended with a fever, day 8 loss of all energy & slept all day with a fever that night. Day 9 & 10 the cough & cold symptoms continue with some energy loss. His symptoms began with a headache on the 17 that persisted for 4 days, then burning in the chest by the 20 that was worse by the 21/22nd. The 23 began with body aches, head pressure, cough, wheezing, chest burning worse with pain in right back area of the lung. patient used nebulizer to help with breathing. Major energy loss. He began taking Prednisone on the evening of the 23 and symptoms have abated greatly by the 25. He still have a cough and cold Symptoms but energy has returned well and the wheezing has abated quite a bit. He continued the Prednisone treatment until the 28. Received Azithromycin 250mg and Benzonatate 100mg on 18Aug to help with symptoms. Patient received the same on Aug2021 along with Prednisone 20mg to take if symptoms worsened. Outcome of the event headache was resolved on 21Aug2021, loss of energy was resolved with sequelae in Aug2021, resolving for wheezing, not resolved for coughing, cold, burning in the chest by the 20 that was worse by the 21/22nd, pain in right back area of the lung, and unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pain, Pulmonary pain, Pyrexia
Clinical narrative: Body Aches; loss of energy; slept all day; head pressure; sinus; nose congestion; sneezing; coughing; fever; burning in the chest by the 20 that was worse by the 21 /22nd; Headache; cold; I used my Nebulizer to help with breathing; Wheezing; pain in right back area of the lung.; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for the patient in response to consumer letter sent via follow up letter. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jan2021 as single for COVID-19 immunisation. The patient experienced headache on 17Aug2021, head pressure, sinus, nose congestion, sneezing, coughing, fever, burning in the chest by the 20 that was worse by the 21/22nd on 20Aug2021, loss of energy, slept all day on 21Aug2021, body aches on 23Aug2021, cold, i used my nebulizer to help with breathing, wheezing, pain in right back area of the lung on Aug2021. Reported as, patient was exposed to COVID19 On 31Aug. He had lunch with 4 others that were also fully vaccinated. Patient and his wife were vaccinated with Pfizer in Jan/Feb2021. Symptoms began for him on Monday the 16. Patient began symptoms on Friday the 20. His symptoms included head pressure, sinus, nose congestion, sneezing, coughing, day 7 ended with a fever, day 8 loss of all energy & slept all day with a fever that night. Day 9 & 10 the cough & cold symptoms continue with some energy loss. His symptoms began with a headache on the 17 that persisted for 4 days, then burning in the chest by the 20 that was worse by the 21/22nd. The 23 began with body aches, head pressure, cough, wheezing, chest burning worse with pain in right back area of the lung. patient used nebulizer to help with breathing. Major energy loss. He began taking Prednisone on the evening of the 23 and symptoms have abated greatly by the 25. He still have a cough and cold Symptoms but energy has returned well and the wheezing has abated quite a bit. He continued the Prednisone treatment until the 28. Received Azithromycin 250mg and Benzonatate 100mg on 18Aug to help with symptoms. Patient received the same on Aug2021 along with Prednisone 20mg to take if symptoms worsened. Outcome of the event headache was resolved on 21Aug2021, loss of energy was resolved with sequelae in Aug2021, resolving for wheezing, not resolved for coughing, cold, burning in the chest by the 20 that was worse by the 21/22nd, pain in right back area of the lung, and unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Respiration abnormal, Sinus disorder, Sneezing, Somnolence, Wheezing
Clinical narrative: Body Aches; loss of energy; slept all day; head pressure; sinus; nose congestion; sneezing; coughing; fever; burning in the chest by the 20 that was worse by the 21 /22nd; Headache; cold; I used my Nebulizer to help with breathing; Wheezing; pain in right back area of the lung.; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for the patient in response to consumer letter sent via follow up letter. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jan2021 as single for COVID-19 immunisation. The patient experienced headache on 17Aug2021, head pressure, sinus, nose congestion, sneezing, coughing, fever, burning in the chest by the 20 that was worse by the 21/22nd on 20Aug2021, loss of energy, slept all day on 21Aug2021, body aches on 23Aug2021, cold, i used my nebulizer to help with breathing, wheezing, pain in right back area of the lung on Aug2021. Reported as, patient was exposed to COVID19 On 31Aug. He had lunch with 4 others that were also fully vaccinated. Patient and his wife were vaccinated with Pfizer in Jan/Feb2021. Symptoms began for him on Monday the 16. Patient began symptoms on Friday the 20. His symptoms included head pressure, sinus, nose congestion, sneezing, coughing, day 7 ended with a fever, day 8 loss of all energy & slept all day with a fever that night. Day 9 & 10 the cough & cold symptoms continue with some energy loss. His symptoms began with a headache on the 17 that persisted for 4 days, then burning in the chest by the 20 that was worse by the 21/22nd. The 23 began with body aches, head pressure, cough, wheezing, chest burning worse with pain in right back area of the lung. patient used nebulizer to help with breathing. Major energy loss. He began taking Prednisone on the evening of the 23 and symptoms have abated greatly by the 25. He still have a cough and cold Symptoms but energy has returned well and the wheezing has abated quite a bit. He continued the Prednisone treatment until the 28. Received Azithromycin 250mg and Benzonatate 100mg on 18Aug to help with symptoms. Patient received the same on Aug2021 along with Prednisone 20mg to take if symptoms worsened. Outcome of the event headache was resolved on 21Aug2021, loss of energy was resolved with sequelae in Aug2021, resolving for wheezing, not resolved for coughing, cold, burning in the chest by the 20 that was worse by the 21/22nd, pain in right back area of the lung, and unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: product was stored under refrigeration and reached its allowable 31-days in the fridge on 31Aug2021 and remained in the vial under refrigeration until being diluted and given on 07Sep2021; product was stored under refrigeration and reached its allowable 31-days in the fridge on 31Aug2021 and remained in the vial under refrigeration until being diluted and given on 07Sep2021; This is a spontaneous report from a contactable Nurse reported for a patient. A 13-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Dose: 0.3 mL, Lot number: EW0178, Expiration date: 30Nov2021) intramuscular, administered in left deltoid on 07Sep2021 (age at vaccination was 13 years) as dose 1, 0.3 ml single for COVID-19 immunization. The patient's medical history was unknown. The patient's concomitant medications were not reported. The product was given in one of the satellite offices. The patient did not receive any prior vaccinations within 4 weeks and last vaccines were in 2012. The additional vaccines administered on same date of the Pfizer Suspect included first dose of HPV Vaccine (Lot number: T027789, Expiration date: 27Feb2023, administered in right deltoid), first dose Meningococcal Vaccine (Lot number: AMVA568A, Expiration date: 31May2022, administered in right deltoid) and first dose of Tdap (Lot number: E55XZ, Expiration date: 24Jun2022, administered in left deltoid). The caller reported a possible invalid dose of Comirnaty (Pfizer-BioNTech COVID-19 vaccine) for a patient. The caller reported that the product was stored under refrigeration and reached its allowable 31-days in the fridge on 31Aug2021. The product reached it's 31 days in the refrigerator on 31Aug2021 and the dose was given that day, 07Sep2021. The product was stored in the vial in the fridge before being diluted and remained in the vial under refrigeration until being diluted and given on 07Sep2021. A dose of Comirnaty given after the beyond use date to a patient. This was the first dose for the patient, he was the only patient involved. The caller asked if the dose should be readministered. The patient did not require a visit to Emergency room or Physician office. It was unknown if any relevant test were done. The case was assessed as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Muscular weakness
Clinical narrative: fell to the ground. I had no control over my legs/legs gave out and I fell to the ground; fell to the ground. I had no control over my legs/legs gave out and I fell to the ground; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 36-year) in left arm on 04Sep2021 at 11:00 AM as dose 1, single for COVID-19 immunization. Medical history included Sulfa allergies, COVID-19 (COVID prior vaccination: Yes), both from an unknown date and unknown if ongoing. There were no concomitant medications. Reported facility type vaccine was Pharmacy or Drug Store. Patient not tested COVID post vaccination. Patient received no other vaccine in four weeks. Patient received no other medications in two weeks. On 05Sep2021 at 07:00 AM the patient experienced fell to the ground. She had no control over my legs/legs gave out and she fell to the ground. It was reported that "the patient received her initial COVID vaccine dose on 04Sep21 at 1100. On the morning of 05Sep21 around 0700, she walked outside her back door, stepped down two steps onto the patio then took a few more steps walking onto the patio and then fell to the ground. She had no control over her legs. The very same thing happened, the very same day later that evening around 1700. Her legs gave out and she fell to the ground." The patient received no treatment for the adverse events. The clinical outcome of the events was 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: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Musculoskeletal disorder
Clinical narrative: fell to the ground. I had no control over my legs/legs gave out and I fell to the ground; fell to the ground. I had no control over my legs/legs gave out and I fell to the ground; This is a spontaneous report from a contactable other hcp (Patient). A 36-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 36-year) in left arm on 04Sep2021 at 11:00 AM as dose 1, single for COVID-19 immunization. Medical history included Sulfa allergies, COVID-19 (COVID prior vaccination: Yes), both from an unknown date and unknown if ongoing. There were no concomitant medications. Reported facility type vaccine was Pharmacy or Drug Store. Patient not tested COVID post vaccination. Patient received no other vaccine in four weeks. Patient received no other medications in two weeks. On 05Sep2021 at 07:00 AM the patient experienced fell to the ground. She had no control over my legs/legs gave out and she fell to the ground. It was reported that "the patient received her initial COVID vaccine dose on 04Sep21 at 1100. On the morning of 05Sep21 around 0700, she walked outside her back door, stepped down two steps onto the patio then took a few more steps walking onto the patio and then fell to the ground. She had no control over her legs. The very same thing happened, the very same day later that evening around 1700. Her legs gave out and she fell to the ground." The patient received no treatment for the adverse events. The clinical outcome of the events was 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: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Peripheral swelling, Swelling of eyelid, Swollen tongue
Clinical narrative: Intermittent and alternating swelling of tongue, eyelids, lips, sole of feet and palm of hands that has not going away since the day after vaccine administration.; Intermittent and alternating swelling of tongue, eyelids, lips, sole of feet and palm of hands that has not going away since the day after vaccine administration.; Intermittent and alternating swelling of tongue, eyelids, lips, sole of feet and palm of hands that has not going away since the day after vaccine administration.; Intermittent and alternating swelling of tongue, eyelids, lips, sole of feet and palm of hands that has not going away since the day after vaccine administration.; Intermittent and alternating swelling of tongue, eyelids, lips, sole of feet and palm of hands that has not going away since the day after vaccine administration.; This is a spontaneous report received from a contactable other hcp. A 62-years-old female patient received 1st dose of bnt162b2 (COMIRNATY,Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 04Mar2021 08:00,at the age of 62 years old,as Dose 1,single for covid-19 immunization.Medical history included covid-19 from an unknown date and unknown if ongoing.There were no concomitant medications.The patient previously took indomethacin and experienced drug hypersensitivity.The patient experienced intermittent and alternating swelling of tongue,eyelids,lips,sole of feet and palm of hands that has not going away since the day after vaccine administration on 05Mar2021 06:00.The patient had not received any other vaccine in 4 weeks.The patient had not received other medications in 2 weeks.The patient was not pregnant at the time of vaccination.The patient was diagnosed with covid prior vaccination and not tested post vaccination.The patient had not received any treatment for the event.The outcome of the events was not recovered.  Follow-Up (13Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: killed this young man/he died of an enlarged heart (500+ grams); The initial case was missing the following minimum criteria: unidentified reporter. Upon receipt of follow-up information on 20Sep2021, this case now contains all required information to be valid.  This is a spontaneous report from Pfizer sponsored Program, via contactable consumers. A 16-year-old male patient received BNT162B2 via an unspecified route of administration on 19Apr2021 (Lot Number: ER8731; Expiration Date: Jul2021) (at 16-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died in 24Apr2021. His father claimed he took the Pfizer vaccine five days before (24Apr2021) he died and that he died of an enlarged heart (500+grams) from Apr2021. It's not reported if autopsy performed.  Follow-up attempts are completed. No further information is expected. ; Reported Cause(s) of Death: died of an enlarged heart
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Chest X-ray, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Sharp pain on the heart; Shortness of breath; Sharp pain on the chest; heart and chest tighten up; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 38-year-old male patient (also the age at vaccination) received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in left arm in the afternoon of 22Jul2021 (Lot Number: ER8731) as single for COVID-19 immunisation. Medical history included ongoing lower back pain (on medication for his back pain for three years), scabs on his head from an unknown date and unknown if ongoing. Family medical history includes father has esophageal cancer and stomach cancer. The patient's concomitant medications include unspecified medication for his back pain. The patient previously received dose 1 of BNT162B2 (COMIRNATY) (lot ER8731) on 01Jul2021 in the right arm as single for Covid-19 immunisation (at the age of 37-year-old) and experienced sharp heart pains/sharp pain on the heart, chest pains/ sharp pain on the chest and shortness of breath. Upon receiving the second dose the caller kept getting a sharp pain on the heart, shortness of breath and a sharp pain on the chest on an unspecified date in 2021. At first it was short sharp pain in the heart but now the pains are lasting longer. Feels like his heart and chest tighten up and it lasts longer than it used to. Yesterday the chest pain lasted from 4:10 pm to 4:15 pm. The caller has charted it on his phone. Outcome of tightness in chest was unknown, for the other events was not recovered. Events required Emergency Room Visit and Physician Office Visit. On 14Aug2021, the patient underwent lab tests and procedures in the emergency room which included Chest X-ray and EKG: everything was fine. The caller was told to follow up with a heart doctor. The caller was not admitted as a patient from the emergency room.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram
Clinical narrative: Sharp pain on the heart; Shortness of breath; Sharp pain on the chest; heart and chest tighten up; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 38-year-old male patient (also the age at vaccination) received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in left arm in the afternoon of 22Jul2021 (Lot Number: ER8731) as single for COVID-19 immunisation. Medical history included ongoing lower back pain (on medication for his back pain for three years), scabs on his head from an unknown date and unknown if ongoing. Family medical history includes father has esophageal cancer and stomach cancer. The patient's concomitant medications include unspecified medication for his back pain. The patient previously received dose 1 of BNT162B2 (COMIRNATY) (lot ER8731) on 01Jul2021 in the right arm as single for Covid-19 immunisation (at the age of 37-year-old) and experienced sharp heart pains/sharp pain on the heart, chest pains/ sharp pain on the chest and shortness of breath. Upon receiving the second dose the caller kept getting a sharp pain on the heart, shortness of breath and a sharp pain on the chest on an unspecified date in 2021. At first it was short sharp pain in the heart but now the pains are lasting longer. Feels like his heart and chest tighten up and it lasts longer than it used to. Yesterday the chest pain lasted from 4:10 pm to 4:15 pm. The caller has charted it on his phone. Outcome of tightness in chest was unknown, for the other events was not recovered. Events required Emergency Room Visit and Physician Office Visit. On 14Aug2021, the patient underwent lab tests and procedures in the emergency room which included Chest X-ray and EKG: everything was fine. The caller was told to follow up with a heart doctor. The caller was not admitted as a patient from the emergency room.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Neuropathy peripheral, Pain in extremity, Paraesthesia, Polyneuropathy
Clinical narrative: neuropathy; polyneuropathy; feeling tingling in my arms/having tingling in my face and all 4 extremities; toes have a burning pain,also feeli it in my fingers; This is a spontaneous report from a contactable consumer (patient). A non pregnant 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FA7485 and expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 10Aug2021 11:30 (at the age of 53-years-old) at unknown dose number single for covid-19 immunization. Medical history included arthritis, dupuytrens nodules, GERD, anxiety. Concomitant medication included calcium carbonate (TUMS  [CALCIUM CARBONATE]) and gummy vitamins received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. Patient had no known allergies. On 10Aug2021 14:30, patient started feeling tingling in her arms - by the next day she was having tingling in my face and all 4 extremities. This was still continuing, and now her toes have a burning pain/neuropathy and intermittently and also feeling it in fingers and doctor said it was polyneuropathy. It was unknown if due to vaccine / all blood work were checked out. The adverse events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient underwent lab tests and procedures included blood work and having EMG on 20Sep2021. Patient was given treatment for the events. The outcome of the events was not recovered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Heart rate increased, Myocarditis
Clinical narrative: symptoms such as myocarditis; occasional and random rapid heart beats along with shortness of breath; occasional and random rapid heart beats along with shortness of breath; This is a spontaneous report from a contactable consumer, the patient. This consumer reported similar events for herself and another one patient. This is 1st of 2 reports. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, second dose) solution for injection intramuscular in left arm on 20Feb2021 at 12:00 (at the age of 72-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included hypertension, blood pressure was usually 120/80 or within 5 numbers of those numbers. The patient had no known allergies. Concomitant medications included lisinopril for hypertension, estradiol (ESTRACE), levothyroxine, fluoxetine hydrochloride (PROZAC), and vitamin B complex (B COMPLETE). Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on 30Jan2021 with no adverse effect reported (no side effects in the following days). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 29May2021 at 12:00, the patient began experiencing occasional and random rapid heartbeats along with shortness of breath. It seemed to be symptoms such as myocarditis (29May2021 at 12:00). The events resulted in doctor or other healthcare professional office/clinic visit. The patient took ibuprofen when experienced the rapid heartbeat. No treatment was provided for the events myocarditis and shortness of breath. The outcome of the events rapid heartbeats and shortness of breath was recovered on 22Jul2021. The outcome of the event myocarditis was recovering. The patient was not tested for Covid post vaccination.  The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Body temperature, Headache
Clinical narrative: BP 154/97; PO2 lowest 87%; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); Fever up to 102.5 F; pulse up to 136; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); headache; pain and mild swelling at injection site; pain and mild swelling at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) Dose 1 via an unspecified route of administration, administered in the right arm on 09Sep2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included seizure disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (penicillin). Concomitant medications included levetiracetam (KEPPRA) for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; prn 1371 (PRN 1371) taken for an unspecified indication, start and stop date were not reported; torsemide for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Sep2021 at 03:00, the patient experienced fever up to 102.5 F, pulse up to 136, BP 154/97, PO2 lowest 87, body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch), headache, and pain and mild swelling at injection site. The patient was recovering from the events.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events blood pressure increased, oxygen saturation decreased and weight bearing difficulty cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Oxygen saturation decreased, PO2, Pain
Clinical narrative: BP 154/97; PO2 lowest 87%; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); Fever up to 102.5 F; pulse up to 136; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); headache; pain and mild swelling at injection site; pain and mild swelling at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) Dose 1 via an unspecified route of administration, administered in the right arm on 09Sep2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included seizure disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (penicillin). Concomitant medications included levetiracetam (KEPPRA) for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; prn 1371 (PRN 1371) taken for an unspecified indication, start and stop date were not reported; torsemide for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Sep2021 at 03:00, the patient experienced fever up to 102.5 F, pulse up to 136, BP 154/97, PO2 lowest 87, body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch), headache, and pain and mild swelling at injection site. The patient was recovering from the events.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events blood pressure increased, oxygen saturation decreased and weight bearing difficulty cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling, Weight bearing difficulty
Clinical narrative: BP 154/97; PO2 lowest 87%; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); Fever up to 102.5 F; pulse up to 136; body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch); headache; pain and mild swelling at injection site; pain and mild swelling at injection site; This is a spontaneous report from a contactable nurse (patient). A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3183) Dose 1 via an unspecified route of administration, administered in the right arm on 09Sep2021 at 13:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included seizure disorder from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (penicillin). Concomitant medications included levetiracetam (KEPPRA) for an unspecified indication, start and stop date were not reported; alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported; prn 1371 (PRN 1371) taken for an unspecified indication, start and stop date were not reported; torsemide for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Sep2021 at 03:00, the patient experienced fever up to 102.5 F, pulse up to 136, BP 154/97, PO2 lowest 87, body aches & joint pain up to 7/10 (couldn't bear weight on left side due to hip pain, had to use crutch), headache, and pain and mild swelling at injection site. The patient was recovering from the events.; Sender's Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events blood pressure increased, oxygen saturation decreased and weight bearing difficulty cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: increased stiffness and pain worse; increased stiffness and pain worse; tired; pain in feet and knees.; pain in feet and knees.; This is a spontaneous report from a contactable other health care professional. A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 (at the age of 52-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis (rheumatoid arthritis symptom including increased stiffness & pain worse following missed Xeljanz XR 11 mg dose; Frequency: Daily; Route: Oral Date of use: May2021 to current) from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 2021, patient reports stiffness that was worse after immobility or when awakening in the morning, pain in feet and knees. Xeljanz XR held for a couple weeks since Aug2021 due to having COIVD vaccine. Rheumatoid arthritis symptoms including increased stiffness and pain worse following missed xeljanz XR doses. Patient continues to be very tired at night. Patient did some cleaning 08Sep2021 that had caused increased pain. Advised to update md with new/worse symptoms. The outcome of the events were unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein, Chest pain, Echocardiogram, Electrocardiogram, Myocarditis
Clinical narrative: myocarditis; chest pain; This is a literature report.  A new trend of myocarditis among young adults who received mRNA vaccines for COVID-19 is emerging. The authors presented the case of a young adult who presented with chest pain 3 days after the second dose of Pfizer-BioNTech COVID-19 vaccine. He had elevated troponin I and C-reactive protein levels at the time of admission. Electrocardiogram (ECG) and echocardiogram findings were unremarkable. The patient improved with conservative management and was discharged home the next day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events myocarditis and chest pain cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.