chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Myocarditis, Unresponsive to stimuli
Clinical narrative: She was taken off of life support 2 weeks ago; found her unresponsive in her home; heart inflammation; This is a spontaneous report from a Pfizer-sponsored program a regulatory authority via a contactable consumer. The consumer reported similar events for three patients. This is the first report. A 42-year-old female patient received bnt162b2 (COMIRNATY Lot number was not reported) via an unspecified route of administration on an unspecified date (at 42-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first single dose of bnt162b2 (COMIRNATY Lot number was not reported) on an unspecified date for covid-19 immunisation. The consumer stated that no past medical history that he is aware of. Her daughter found the patient unresponsive in her home after her second dose of the Pfizer BioNTech Covid-19 vaccine and was diagnosed with heart inflammation. She was taken off of life support 2 weeks ago. The outcome of the events was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101377482 same reporter and drug, different patient and similar event;US-PFIZER INC-202101377481 same reporter and drug, different patient and similar event; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on 14Jan2021, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. In Feb2021, the patient experienced onset of tinnitus and can't recall the exact date in there, all he can recall, it was the beginning of Feb2021 and can't recall if it was after the 1st dose or after the 2nd. After the booster dose in Oct2021, the tinnitus became worse described as it was worsening and has continued. The outcome of the event was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: Extremely low white blood cell count: Aprox. 1.5l; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0170) via an unspecified route of administration on 06May2021 (at 63-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Prostate Cancer Treatment 2019 Now Cancer Free and Possibly Gluten Allergy. Concomitant medications included sertraline; morniflumate (FLOMAX); dextroamphetamine; and pantoprazole (PANTOPRAZOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EC6817) on 10Apr2021. The patient reported for Extremely low white blood cell count: Aprox. 1.5l. He had never had this condition before. They found it via Routine Physical. The adverse event result in Emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, HIV test
Clinical narrative: COVID; COVID; This is a spontaneous report from a non-contactable Other HCP. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included HIV positive and concomitant medications were not reported. The Other HCP reported that patient died recently after receiving COVID vaccine, since he got COVID, but he was HIV positive, it just seemed like he died after he got the shot and it's just, is like, uh, and he got COVID as well. Causality: Not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective (Fatal) and covid-19 (Fatal) and BNT162B2. 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.; Reported Cause(s) of Death: COVID; COVID
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died recently; This is a spontaneous report from a non-contactable other HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced died recently on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died recently
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Herpes zoster, Hypertension, Pain
Clinical narrative: Shingles; Blood pressure was 219/98; Excruciating pain; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 61 year old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 04Oct2021 15:00 (Batch/Lot Number: FE3592) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included , surgery from an unknown date and unknown if ongoing She had recently had surgery about 100 days before the covid shot. The patient's concomitant medications were not reported.  The patient experienced shingles by herpes zoster on 08Oct2021 with outcome of not recovered , blood pressure was 219/98 leading to hypertension on 08Oct2021 with outcome of unknown and excruciating pain on 08Oct2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement at 219/98 on 08Oct2021  Follow-up (20Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: heart inflammation/myocarditis; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. The consumer reported similar events for three patients. This is the second report. A 32-year-old female patient received bnt162b2 (COMIRNATY Lot number was not reported) 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. The patient received her first dose of the Pfizer BioNTech Covid-19 vaccine and was in observation at the hospital for 8 hours, then admitted for 3 days, again with heart inflammation, he specifically said myocarditis. The outcome of the events was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101375428 same reporter and drug, different patient and similar event;US-PFIZER INC-202101377482 same reporter and drug, different patient and similar event
Sex: M
Vaccine: COVID19
Symptoms: Heart rate abnormal
Clinical narrative: had to shock his heart back into rhythm 3 times 3 hours after getting the dose; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer. The consumer reported similar events for three patients. This is the third report. A 23-year-old male patient received bnt162b2 (COMIRNATY Lot number was not reported) 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. The patient got his first dose of the Pfizer BioNTech Covid-19 vaccine, and they had to shock his heart back into rhythm 3 times 3 hours after getting the dose. He is a football player, and is now on heart medication. The outcome of the events was unknown.   The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101377481 same reporter and drug, different patient and similar event;US-PFIZER INC-202101375428 same reporter and drug, different patient and similar event
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Completed suicide, Feeling abnormal, Movement disorder, Nausea, Parkinson's disease
Clinical narrative: committed suicide/gun shot went to the head; Parkinson; He couldn't turn his head; nausea; never the same; This is a spontaneous report from a contactable consumer. A 38-year-old male patient (reporter's husband) received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration (Batch/Lot number was not reported) Arm Right on 22Sep2021 at age of 38-year-old as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Asthma. Concomitant drugs included Montelukast, fluticasone propionate (FLOVENT) for Asthma, salbutamol (ALBUTEROL HFA) allergies (Not Clarified) his Montelukast. No Prior vaccination within 4 weeks. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. After the first shot he could not see for three days. He received the COVID vaccine his second dose on 22Sep2021 and he was never the same. He started having what look like Parkinson. He couldn't turn his head, took him to the hospital they gave him three shot (Treatment)one to sedate him, a Benadryl shot (Treatment) and one to stop nausea (further not clarified) He was never the same and he just committed suicide. He had a gun shot went to the head and it appears to be some inflicting but they are going to check. Events were in 2021 and Hospitalized and death. No Autopsy performed. Death date: Reporter stated, "We don't know if it was 8Oct or 9Oct2021,we are still waiting on the coroner." Outcome of the events was fatal.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Parkinson; He couldn't turn his head; nausea; never the same; He was never the same and he just committed suicide
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip discolouration, Pneumonia, Pulmonary oedema
Clinical narrative: My grandmother died three hours back her lungs started filling with fluid and turned blue; Pneumonia; couldn''t breath; lips were blue; This is a spontaneous report from a contactable consumer. A 99-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration (Batch/Lot number was not reported) on 22Sep2021 at age of 99-year-old as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. The patient died three hours after getting the Pfizer vaccine. The patient died three hours back her lungs started filling with fluid and turned blue. She got home she couldn't breath, her lips were blue and she went to the hospital and never came up. Medical Condition include she was perfectly fine great heart. Cause of death: They said pneumonia, funny she didnt go in with pneumonia when she got the shot but she died of Pneumonia after taking the shot her lungs were filled with fluid because of Pneumonia. She went to the hospital and than died after treatment. The patient died on 03Apr2021. Autopsy Performed was unknown. Outcome of the event Pulmonary oedema and Pneumonia was fatal. Outcome of other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: Pneumonia; Pulmonary oedema
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: she knows someone who is vaccine injuired who had severe neurological injuries; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of unknown age received bnt162b2 on unknown date (lot number: unknown) via unknown route of administration at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Caller seeking information regarding legal differences between Pfizer BioNTech covid 19 vaccine and Comirnaty. Caller stated that the media said the vaccine was only 39% effective. Caller also stated that there were studies in other countries who were far more advanced in their vaccination rates that support this. Caller stated that the media said the vaccine was 100% safe but she knew someone who was vaccine injured who had severe neurological injuries who was not receiving any help from Pfizer. 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: Death
Clinical narrative: 2nd pfizer vaccine killed the patient; This is a spontaneous report from a Contactable Consumer reported for mother. A 78-Year-Old Female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for covid-19 immunisation. Know that the 2nd Pfizer vaccine killed the patient. she took it and in three days she was dead. It is unknown if autopsy was done. Outcome of the event was fatal.  The Lot number for [BNT162B2] was not provided and will be requested during Follow-up.; Reported Cause(s) of Death: 2nd pfizer vaccine killed the patient
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Immunisation, Lip swelling, Off label use, Swelling
Clinical narrative: Anaphylaxis; hives on limbs and back; lip swelling; throat tightness; swelling; dose received 3; dose received 3; This is a spontaneous report from a contactable nurse. A 65-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Right at the age of 65 years old on 09Oct2021 02:45 (Batch/Lot Number: 30135BA) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), hypothyroidism, migraine, mid high blood pressure, and anaphylaxis (known allergies: CT dye). Concomitant medications included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported; thyroid (THYROID) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (Batch/Lot No: EN6203) on 26Feb2021, second dose of BNT162B2 (Batch/Lot No: EP6955) on 20Mar2021 for COVID-19 immunization. The patient previously took rocephin, Levaquin, Omnicef, Reglan and Bactrim and experienced drug allergies. On 09Oct2021 at 04:30, the patient experienced anaphylaxis, hives on limbs and back, lip swelling, throat tightness and swelling. The patient went to emergency room and was treated with Epipen, IV steroids, Benadryl, Claritin. The outcome of the events was recovered with sequel.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Anaphylactic reaction, Urticaria, Lip swelling, Throat tightness, and Swelling and BNT162B2.  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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: Anaphylaxis; hives on limbs and back; lip swelling; throat tightness; swelling; dose received 3; dose received 3; This is a spontaneous report from a contactable nurse. A 65-year-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration, administered in Arm Right at the age of 65 years old on 09Oct2021 02:45 (Batch/Lot Number: 30135BA) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD), hypothyroidism, migraine, mid high blood pressure, and anaphylaxis (known allergies: CT dye). Concomitant medications included esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) taken for an unspecified indication, start and stop date were not reported; celecoxib (CELEBREX) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported; thyroid (THYROID) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (Batch/Lot No: EN6203) on 26Feb2021, second dose of BNT162B2 (Batch/Lot No: EP6955) on 20Mar2021 for COVID-19 immunization. The patient previously took rocephin, Levaquin, Omnicef, Reglan and Bactrim and experienced drug allergies. On 09Oct2021 at 04:30, the patient experienced anaphylaxis, hives on limbs and back, lip swelling, throat tightness and swelling. The patient went to emergency room and was treated with Epipen, IV steroids, Benadryl, Claritin. The outcome of the events was recovered with sequel.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Anaphylactic reaction, Urticaria, Lip swelling, Throat tightness, and Swelling and BNT162B2.  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.
Sex: U
Vaccine: COVID19
Symptoms: Angina pectoris, Blood pressure increased, Blood pressure measurement, Cardiac disorder, Dyspnoea
Clinical narrative: pain in my heart; almost died/almost killed him/her; face turned pale red; loss a lot of weight; heart almost died; right arm still swelled up; lost my breath; it raised my blood pressure; it made me sick; arm feel sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included high blood pressure, high diabetes, and high cholesterol. The patient's concomitant medications were not reported. The patient reported that he/she received the Pfizer shot in (place) on unspecified date. When the patient went back home, his/her face turned pale red and almost died. The patient also experienced loss a lot of weight, heart almost died, and right arm still swelled up on unspecified date. The patient confirmed that he/she didn't receive the booster shot yet as this one almost killed him/her. The patient further stated, "No I almost died, I just can't, I lost my breath, my face was pale red, it raised my blood pressure, and it made me sick. I had pain in my heart, and my arm feel sore". Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Malaise, Near death experience, Pain in extremity, Peripheral swelling
Clinical narrative: pain in my heart; almost died/almost killed him/her; face turned pale red; loss a lot of weight; heart almost died; right arm still swelled up; lost my breath; it raised my blood pressure; it made me sick; arm feel sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included high blood pressure, high diabetes, and high cholesterol. The patient's concomitant medications were not reported. The patient reported that he/she received the Pfizer shot in (place) on unspecified date. When the patient went back home, his/her face turned pale red and almost died. The patient also experienced loss a lot of weight, heart almost died, and right arm still swelled up on unspecified date. The patient confirmed that he/she didn't receive the booster shot yet as this one almost killed him/her. The patient further stated, "No I almost died, I just can't, I lost my breath, my face was pale red, it raised my blood pressure, and it made me sick. I had pain in my heart, and my arm feel sore". Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: pain in my heart; almost died/almost killed him/her; face turned pale red; loss a lot of weight; heart almost died; right arm still swelled up; lost my breath; it raised my blood pressure; it made me sick; arm feel sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history included high blood pressure, high diabetes, and high cholesterol. The patient's concomitant medications were not reported. The patient reported that he/she received the Pfizer shot in (place) on unspecified date. When the patient went back home, his/her face turned pale red and almost died. The patient also experienced loss a lot of weight, heart almost died, and right arm still swelled up on unspecified date. The patient confirmed that he/she didn't receive the booster shot yet as this one almost killed him/her. The patient further stated, "No I almost died, I just can't, I lost my breath, my face was pale red, it raised my blood pressure, and it made me sick. I had pain in my heart, and my arm feel sore". Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Chills, Muscle twitching, Myalgia, Pyrexia
Clinical narrative: she may have had some fluttering of the heart as well.; her arm still hurts/Caller states the soreness is whole area where the vaccine was injected; felt some muscular twitching in a few places including her arm as well; high fever; chills; muscle aches for two days; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: 30135BA; Expiration Date: 30Nov2021) via an unspecified route of administration on 04Oct2021 as dose 3 (booster), single for COVID-19 immunisation (age at vaccination: 69-years-old), (She clarified her age at the time of event was 69. she just turned 70). The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2, on an unknown date as dose 1 and dose 2 for COVID-19 immunisation. The patient experienced she may have had some fluttering of the heart as well., her arm still hurts/caller states the soreness is whole area where the vaccine was injected, felt some muscular twitching in a few places including her arm as well, high fever, chills and muscle aches for two days on Oct2021. She states that her arm still hurts and she wants to know if this was unusual. Caller states she felt some muscular twitching in a few places including her arm as well. Caller states the soreness is whole area where the vaccine was injected. Caller states she did not have a reaction with the first two doses of the vaccine. Caller states but with the booster dose she had a reaction that also included a high fever, chills, muscle aches for two days but her arm is still sore and that is what is calling to get information about. Caller also mentions that it be part of her imagination, but she may have had some fluttering of the heart as well. Caller states she heard on the internet that its unusual for older people to have more side effects than younger people because they have a weaker immune response. The outcome of the events high fever, chills and muscle aches for two days was recovered on an unknown date in Oct2021, she may have had some fluttering of the heart as well and felt some muscular twitching in a few places including her arm as well was Unknown, her arm still hurts/caller states the soreness is whole area where the vaccine was injected was not recovered.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she may have had some fluttering of the heart as well.; her arm still hurts/Caller states the soreness is whole area where the vaccine was injected; felt some muscular twitching in a few places including her arm as well; high fever; chills; muscle aches for two days; This is a spontaneous report from a contactable consumer (patient herself). A 69-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: 30135BA; Expiration Date: 30Nov2021) via an unspecified route of administration on 04Oct2021 as dose 3 (booster), single for COVID-19 immunisation (age at vaccination: 69-years-old), (She clarified her age at the time of event was 69. she just turned 70). The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2, on an unknown date as dose 1 and dose 2 for COVID-19 immunisation. The patient experienced she may have had some fluttering of the heart as well., her arm still hurts/caller states the soreness is whole area where the vaccine was injected, felt some muscular twitching in a few places including her arm as well, high fever, chills and muscle aches for two days on Oct2021. She states that her arm still hurts and she wants to know if this was unusual. Caller states she felt some muscular twitching in a few places including her arm as well. Caller states the soreness is whole area where the vaccine was injected. Caller states she did not have a reaction with the first two doses of the vaccine. Caller states but with the booster dose she had a reaction that also included a high fever, chills, muscle aches for two days but her arm is still sore and that is what is calling to get information about. Caller also mentions that it be part of her imagination, but she may have had some fluttering of the heart as well. Caller states she heard on the internet that its unusual for older people to have more side effects than younger people because they have a weaker immune response. The outcome of the events high fever, chills and muscle aches for two days was recovered on an unknown date in Oct2021, she may have had some fluttering of the heart as well and felt some muscular twitching in a few places including her arm as well was Unknown, her arm still hurts/caller states the soreness is whole area where the vaccine was injected was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood pressure measurement, Body temperature, Delirium, Dyspnoea
Clinical narrative: delirious with the fever; had something in her stomach; nausea with no diarrhea; shortness of breath; a little bit of palpitation; just a little bit of high blood pressure.; a little bit delirious with the fever; armpit swollen near her breast and hurts really bad/ lymph nodes; armpit swollen near her breast and hurts really bad/ lymph nodes; third dose of bnt162b2; third dose of bnt162b2; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route on 12Oct2021 single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient said her armpit was swollen near her breast and it hurt really bad and the lymph nodes was bothering her from 14Oct2021. The patient also added that she had a fever and was a little bit delirious with the fever. She didn't have fever but maybe a very very low grade. In addition to that, she also had something in her stomach and was nausea with no diarrhea. The patient had a shortness of breath and a little bit of palpitation. The patient said that there was nothing wrong in her heart, just a little bit of high blood pressure. Her symptoms now was not as severe as yesterday but still have it now and was not feeling better. The patient took an oxygen yesterday, which she was reserving for cases of emergency. Outcome of the event third dose of bnt162b2 was unknown, outcome of the other events was resolving.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Immunisation, Lymph node pain, Lymphadenopathy, Nausea
Clinical narrative: delirious with the fever; had something in her stomach; nausea with no diarrhea; shortness of breath; a little bit of palpitation; just a little bit of high blood pressure.; a little bit delirious with the fever; armpit swollen near her breast and hurts really bad/ lymph nodes; armpit swollen near her breast and hurts really bad/ lymph nodes; third dose of bnt162b2; third dose of bnt162b2; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route on 12Oct2021 single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient said her armpit was swollen near her breast and it hurt really bad and the lymph nodes was bothering her from 14Oct2021. The patient also added that she had a fever and was a little bit delirious with the fever. She didn't have fever but maybe a very very low grade. In addition to that, she also had something in her stomach and was nausea with no diarrhea. The patient had a shortness of breath and a little bit of palpitation. The patient said that there was nothing wrong in her heart, just a little bit of high blood pressure. Her symptoms now was not as severe as yesterday but still have it now and was not feeling better. The patient took an oxygen yesterday, which she was reserving for cases of emergency. Outcome of the event third dose of bnt162b2 was unknown, outcome of the other events was resolving.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Palpitations, Pyrexia
Clinical narrative: delirious with the fever; had something in her stomach; nausea with no diarrhea; shortness of breath; a little bit of palpitation; just a little bit of high blood pressure.; a little bit delirious with the fever; armpit swollen near her breast and hurts really bad/ lymph nodes; armpit swollen near her breast and hurts really bad/ lymph nodes; third dose of bnt162b2; third dose of bnt162b2; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route on 12Oct2021 single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient said her armpit was swollen near her breast and it hurt really bad and the lymph nodes was bothering her from 14Oct2021. The patient also added that she had a fever and was a little bit delirious with the fever. She didn't have fever but maybe a very very low grade. In addition to that, she also had something in her stomach and was nausea with no diarrhea. The patient had a shortness of breath and a little bit of palpitation. The patient said that there was nothing wrong in her heart, just a little bit of high blood pressure. Her symptoms now was not as severe as yesterday but still have it now and was not feeling better. The patient took an oxygen yesterday, which she was reserving for cases of emergency. Outcome of the event third dose of bnt162b2 was unknown, outcome of the other events was resolving.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Haematochezia, Vomiting
Clinical narrative: blood in stool; vomited; Tiredness; This is a solicited report from the marketing program marketing program FACILITATED COLLECT based on information received by Pfizer from facilitating company, manufacturer control number: 21K-163-4115580-00.    A contactable consumer (patient) reported that a 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 01Oct2021 (vaccination age was 16 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported)  at unknown dose and frequency for an unspecified indication.  The patient's medical history and concomitant medications was not reported. On 09Oct2021, the patient experienced used bathroom more. On 11Oct2021, the patient experienced vomited, tired, stool had blood. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the event(s) for adalimumab was unknown. The outcome of events was unknown.  The causality assessment per reporter for used bathroom more, vomited, tired, stool had blood to bnt162b2 was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Blood in stool, Vomiting and Fatigue. The case will be reassessed further upon receipt of additional information. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a Pfizer-sponsored program, Optum Xeljanz Program, received from a contactable healthcare professional and a non-contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from 01Sep2021 (Batch/Lot number was not reported) to an unspecified date at 11 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced very severe flu like symptoms on an unspecified date, following the second dose of bnt162b2 while on Xeljanz, with outcome of unknown. The action taken in response to the event for tofacitinib citrate was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Electric shock sensation, Gait disturbance, Muscle disorder, Pain
Clinical narrative: lost all of her hearing; lost all muscle control; could not even walk; sensation on her skin like there was electricity going through all of her skin and it was really painful, sensation was from the top of her head to her toes; extreme pain in the whole outside of her body; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left (between 1400 to 1500) on 23Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 76-year-old. There were no medical history and concomitant medications. She was one of the healthiest people and before the vaccination she used to walk two miles per day. The patient previously took the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left (between 1400 to 1500) on 02Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation at the age of 76-year-old. She had one question based on her second Pfizer covid vaccination. When she had the second vaccination, she had several things that affected her severely. She just got the third shot, the booster shot, she was worried that she will have the severe reaction again. After the second dose, she felt ok for 2 days and then 48 hours later (25Mar2021) she lost all muscle control and could not even walk to the bathroom, she called her neighbor to help her. She had a sensation on her skin like there was electricity going through all of her skin and it was really painful, sensation was from the top of her head to her toes. It was an extreme pain in the whole outside of her body. On the third day (26Mar2021) she completely lost all of her hearing, totally. This freaked her out since she has really good hearing.  After she had the symptoms about two days later everything went away, the bad things went away. These events did not result in emergency room or physician office. Patient declined any treatment, and she was told to just wait it out and was recommended to get the booster. Outcome of events was recovered on 28Mar2021.  The lot number for BNT162B2 was not provided and will be requested during follow-up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: after the 2nd dose, they have been diagnosed with COVID19.; after the 2nd dose, they have been diagnosed with COVID19.; This is a spontaneous report from a contactable nurse reported for a patient. A 85-years-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection Batch/Lot number: Unknown) via an unspecified route of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received BNT162B2 (COMIRNATY Formulation: Solution for injection Batch/Lot number: Unknown) via an unspecified route of administration on an unknown date as historical vaccine as dose 1, single for COVID-19 immunization. Reporter stated two patients (one male 85-years-old and second female 85-years-old) who already received first 2 doses of the Pfizer Biontech COVID19 vaccine. Reporter said that after the second dose, they have been diagnosed with COVID-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test diagnosed with COVID-19.   The lot number for [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE(Drug ineffective,Covid-19) The case will be reassessed once new information is available.,Linked Report(s) : US-PFIZER INC-202101383070 same reporter/drug/event, different pt
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Tachycardia
Clinical narrative: Tachycardia; This is a spontaneous report from a contactable nurse (patient herself) via Medical Information Team.   A 44-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at vaccination: 44 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, about 7-8 hours after that administration, the patient experienced tachycardia. She described the tachycardia was pretty significant and ongoing. She saw her HCP and was referred to a Cardiologist. She has gone to the doctor since onset of this event and her heart rate has been in the 130s, was 136 when she saw the doctor. Her second dose was scheduled for 21Oct2021 at this time. She was asking if tachycardia has been reported or was listed as a side effect from the Pfizer Covid-19 Vaccine. The patient underwent lab test and procedure which include 136 beats per minute on 13oct2021. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information expected.   Follow up (15Oct2021): This is a follow-up spontaneous report from a contactable nurse. This female nurse (patient) reported for herself that: The event of tachycardia was assessed to be medically significant.   The lot number for the vaccine, bnt162b2 (COMIRNATY) was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of tachycardia . 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
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Cough, Illness, Nasal congestion
Clinical narrative: feeling weak; fever; cough; congestion; sick; he is now Covid positive; he is now Covid positive; This is a spontaneous report from a contactable pharmacist (parent). A 17-years-old male patient (son) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0181, Expire Date: Unknown), via an unspecified route of administration, administered in left arm on 28Jun2021 (mid-morning) (age at vaccination: 17 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included asthma, seasonal allergy, environmental allergies. SARS-CoV2 antibodies at diagnosis was reported as unknown. Prior Vaccinations (within 4 weeks) included had allergy shots. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EW0182) via an unspecified route of administration, administered in left arm on 22May2021 (at the age of 17 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient was administered vaccine in a mass vaccination site, mall. On 11Oct2021, the patient experienced was now covid positive. Patient was sick a week and a half prior to testing positive. They did a home test and it was negative. He went to the doctor's office 01Oct2021 to confirm if self home test was negative. He had a molecular test done and it was negative. All of his symptoms at that time had gone away except the cough. Then symptoms came back. He had a fever on 10Oct2021 and another covid test done on 11Oct2021 and it came back as positive. On an unknown date, the patient was feeling weak, fever, cough and congestion. She stated his is mild to moderate. He has asthma and that is why his symptoms were lingering.The patient underwent lab tests and procedures which included on an unknown date, sars-cov-2 test was negative and on 11Oct2021, sars-cov-2 test was positive. The patient did not require an emergency room visit. No additional vaccines administered on same date of the Pfizer suspect. The patient was treated for symptoms. The patient displayed clinical signs at rest indicative of severe systemic illness included fever. When patient gets sick it goes to his chest. His asthma exacerbates when he was sick. He used a steroid inhaler (Dulera) 2 puffs 2 times a day, rescue inhaler (Ventolin) 4 times in a day, allergy medicine (Zyrtec, Flonase Nasal Spray, Asteline Nasal Spray) and Tylenol for temperature and vitamins to keep immune system healthy. He only takes the inhalers when sick, it's not constant. Only when sick to keep out of his chest. On a regular basis he takes the allergy medicines. There was no product quality complaint (PQC) present.The event did not require the initiation of new medication or other treatment or procedure. patient hospitalized was reported as no. The outcome of the events was unknown.; Sender's Comments: Based on the available information in the case, the causal association between the event vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.