chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a contactable consumer or other non-HCP.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date were unknown), via an unspecified route of administration on 02Oct2021 as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 02Oct2021, same day of vaccination, the patient experienced chest pain. The reporter had a question about the Comirnaty Vaccine, if it was an authorized. The reporter had a friend that took it and had a chest pain. It was Comirnaty the same as the BioNTech vaccine, patient was having Chest pain. So, reporter don't know if should take it. The reporter just wanted to know if the Comirnaty the same BioNTech (further clarification unknown), the two different name that reporter was guessing. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Off label use, Pain in extremity, Pruritus
Clinical narrative: since then I am just been having increasing redness; Swelling; Itching and it''s not stopping; I have pain just like the sore arm as expected; I got my booster done; I got my booster done; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 29Sep2021 (Lot Number: FE3592, Expiry date not reported), as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported.  Historical vaccine included  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as dose 1, single and  on an unspecified date as dose 2, single, both at the age of 32 years for COVID-19 immunization and experienced pain. Nurse stated, "I just want to report a side effect from the booster. I got the Pfizer Covid booster shot and I want to report that I have been having reaction. I got it on Wednesday which was 29Sep2021, I am a healthcare worker so, I got my booster done, then 29 when I got it, since then I am just been having increasing redness, swelling, itching and it's not stopping." The nurse added, "I got it on the 29. I have pain just like the sore arm as expected which I had with the first two and then my booster. I am 32." The patient experienced the events on 29Sep2021. Therapeutic measures were taken for the events redness, swelling, itching and pain in arm that included Benadryl cream, ibuprofen that was for the pain, and pills. Clinical outcome of events redness, swelling, itching and pain in arm was not recovered, while unknown for the other events. The events redness, swelling, itching and pain in arm were reported as serious, medically significant while the other events were non-serious.   Lot number was not provided and will be requested during follow-up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: since then I am just been having increasing redness; Swelling; Itching and it''s not stopping; I have pain just like the sore arm as expected; I got my booster done; I got my booster done; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Deltoid Left on 29Sep2021 (Lot Number: FE3592, Expiry date not reported), as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported.  Historical vaccine included  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as dose 1, single and  on an unspecified date as dose 2, single, both at the age of 32 years for COVID-19 immunization and experienced pain. Nurse stated, "I just want to report a side effect from the booster. I got the Pfizer Covid booster shot and I want to report that I have been having reaction. I got it on Wednesday which was 29Sep2021, I am a healthcare worker so, I got my booster done, then 29 when I got it, since then I am just been having increasing redness, swelling, itching and it's not stopping." The nurse added, "I got it on the 29. I have pain just like the sore arm as expected which I had with the first two and then my booster. I am 32." The patient experienced the events on 29Sep2021. Therapeutic measures were taken for the events redness, swelling, itching and pain in arm that included Benadryl cream, ibuprofen that was for the pain, and pills. Clinical outcome of events redness, swelling, itching and pain in arm was not recovered, while unknown for the other events. The events redness, swelling, itching and pain in arm were reported as serious, medically significant while the other events were non-serious.   Lot number was not provided and will be requested during follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Immunisation, Pain in extremity
Clinical narrative: I have had the headache on and off; But when I get up this morning I can barely walk; My two legs are giving me like 'aches'; Yes, I had a booster shot; Yes, I had a booster shot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: Unknown and Expiry date: Unknown) via an unspecified route of administration on an unspecified date in 2021 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection, Lot Number: Not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced headache on and off, but when patient got up that morning can barely walk, two legs were giving like aches and patient received booster shot. The outcome of the events I have had the headache on and off, But when I get up this morning I can barely walk, My two legs are giving me like aches was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Illness, Nausea, Pain, Vaccination site pain
Clinical narrative: She had a very sore arm; Nausea; She has extreme diarrhea; Feels 'pain'; I got a very sick wife; This is a spontaneous report from a contactable consumer or other non hcp (Patient's husband). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date of 2021 as dose 3 (booster), single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as dose 1, single for COVID-19 immunization. Also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as dose 2, single for COVID-19. The patient's medical history and concomitant medications were not reported. Reporter stated, his wife and he both got the booster shot, the Pfizer on thursday evening (unspecified date) and she had a very sore arm and nausea and things the following day, yesterday she felt pretty good, the arm was not that painful (Further clarification was unknown) but about 30 minutes ago she woke him up, she had extreme diarrhea, felt pain, nauseated, he was just wondering if this was the side effect of the vaccine. Also reported as he got a very sick wife, he needed to know whether he need to call the ambulance and take her to the hospital. Reporter was suggested to reach out to nearest emergency room in case of medical emergency: Reporter stated, they are not a help. The outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Vertigo
Clinical narrative: she has serious vertigo after taking the first shot and can't get out of the bed; she has serious vertigo after taking the first shot and can't get out of the bed; This is a spontaneous report from a contactable consumer (patient's friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient had serious vertigo after taking the first shot and could not get out of the bed. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: Flu like symptoms; don't feel good; This is a spontaneous report from a contactable Consumer (patient) or other non-HCP.  A patient of unspecified gender and age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry Date: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date patient experienced flu like symptoms, and don't feel good. adverse event resulted in patient visited physician office visit. Outcome of the events was unknown.  The lot number for the vaccine, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph nodes; Painful swollen lymph nodes under her arm; This is a spontaneous report from a contactable consumer or other non hcp. A 30-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, administered in Arm on 28Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Painful swollen lymph nodes under her arm, in the arm that was injected on an unspecified date. Painful reaction lasted about 2 days. Booster injection believed/estimated to be Wednesday 28Sep2021. The event outcome for swollen lymph nodes under her arm was reported as unknown and event outcome for painful swollen lymph nodes under her arm reaction was reported as resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: Nausea; Her left arm is very sore and swollen; Her left arm is very sore and swollen; A red mark in her injection site; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left on 30Sep2021 (at the age of 88-years old) as dose 3 (booster), single for covid-19 immunisation. Medical history included cardiac pacemaker insertion from 02Aug2013 and ongoing she has had pacemaker quite a few years. Concomitant medication included warfarin taken for anticoagulant therapy from 2013 and ongoing; metoprolol taken for heart rate from an unspecified start date and ongoing; amiodarone taken for heart rate from an unspecified start date and ongoing. The patient previously received dose 1 and dose2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported) via an unspecified route of administration, for COVID-19 immunisation and did not have any reactions from the first two shots. Patient states she had her Pfizer Booster shot on Thursday, 30Sep2021, she did not have any reactions from the first two shots, caller states this one she has experienced dizziness, on 01Oct2021 her left arm is very sore and swollen. her arm is swelling, has a red mark on arm and today when she got up she was so dizzy the room was spinning. On 04Oct2021, States she is also nauseous today. Patient states she treated the swelling and sore arm with ice and it has improved. The outcome of the events dizziness and nausea was not recovered and for vaccination site erythema was recovering and for all other events recovered on unspecified date.  Follow up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site scab
Clinical narrative: Caller said had a slight reaction on his right arm with the first shot which is a red circle with open area that has scabbed over and never healed which was 7 or 8 months ago; Caller said had a slight reaction on his right arm with the first shot which is a red circle with open area that has scabbed over and never healed which was 7 or 8 months ago; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via unspecified route of administration, in right arm on 01Mar2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On an unspecified date in 2021, the patient experienced a slight reaction on his right arm with the first shot which was a red circle with open area that has scabbed over and never healed which was 7 or 8 months ago. Patient queried if he should get the booster dose and if his reaction would count as a severe allergic reaction. In addition to that, patient also queried if his reaction that never healed was a reported side effect. The outcome for all the reported events was not resolved.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus
Clinical narrative: T1D; This is a spontaneous report from a contactable consumer. A 15-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Jul2021 10:00 (Batch/Lot Number: EW0178) at the age of 15 years old as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. There were no concomitant medications (other medications in two weeks none). Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) received by the patient on 21Jun2021 10:00 (Batch/Lot Number: EW0167) administered in left arm as dose 1, single (at the age of 15 years old) for COVID-19 immunization. No other vaccine received in four weeks. The patient experienced T1D (Type 1 Diabetes Mellitus) on 16Aug2021 12:00. The patient was hospitalized for T1D for 3 days. Therapeutic measures were taken as a result of T1D which included insulin. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient has no history of COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. Outcome of the event was recovered/resolved with sequelae (recovered with lasting effects).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Confusional state, Dizziness, Dyspnoea
Clinical narrative: cannot think straight; fatigue; short of breathe; weakness; confusion,; brain fog; tiredness,; memory issues; dizziness,; twitching extremities; wake up and eyes unable to stay still for a short time; tight chest; headache; low sense of smell; low taste; pain in spine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20Sep2021 09:30 (Batch/Lot Number: 301308A) as dose 2, single for COVID-19 immunisation. Medical history included shingles and mono, both from an unknown date and unknown if ongoing. Concomitant medication included sertraline hcl taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 30Aug2021 3:00 PM (Batch/Lot Number:  FC3182) as dose 1 for COVID-19 immunization. On 22Sep2021 06:00, the patient experienced fatigue, short of breathe, weakness, confusion, brain fog, tiredness, cannot think straight and memory issues, dizziness, twitching extremities a few times, wake up and eyes unable to stay still for a short time, tight chest, headache, low sense of smell, low taste, and pain in spine but did not feel like muscular. The outcome of the events was unknown. The patient underwent Sars-cov-2 test: negative on 04Oct2021.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Hyposmia, Memory impairment
Clinical narrative: cannot think straight; fatigue; short of breathe; weakness; confusion,; brain fog; tiredness,; memory issues; dizziness,; twitching extremities; wake up and eyes unable to stay still for a short time; tight chest; headache; low sense of smell; low taste; pain in spine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20Sep2021 09:30 (Batch/Lot Number: 301308A) as dose 2, single for COVID-19 immunisation. Medical history included shingles and mono, both from an unknown date and unknown if ongoing. Concomitant medication included sertraline hcl taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 30Aug2021 3:00 PM (Batch/Lot Number:  FC3182) as dose 1 for COVID-19 immunization. On 22Sep2021 06:00, the patient experienced fatigue, short of breathe, weakness, confusion, brain fog, tiredness, cannot think straight and memory issues, dizziness, twitching extremities a few times, wake up and eyes unable to stay still for a short time, tight chest, headache, low sense of smell, low taste, and pain in spine but did not feel like muscular. The outcome of the events was unknown. The patient underwent Sars-cov-2 test: negative on 04Oct2021.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Mental impairment, Muscle twitching, Ocular discomfort, SARS-CoV-2 test, Spinal pain
Clinical narrative: cannot think straight; fatigue; short of breathe; weakness; confusion,; brain fog; tiredness,; memory issues; dizziness,; twitching extremities; wake up and eyes unable to stay still for a short time; tight chest; headache; low sense of smell; low taste; pain in spine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20Sep2021 09:30 (Batch/Lot Number: 301308A) as dose 2, single for COVID-19 immunisation. Medical history included shingles and mono, both from an unknown date and unknown if ongoing. Concomitant medication included sertraline hcl taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 30Aug2021 3:00 PM (Batch/Lot Number:  FC3182) as dose 1 for COVID-19 immunization. On 22Sep2021 06:00, the patient experienced fatigue, short of breathe, weakness, confusion, brain fog, tiredness, cannot think straight and memory issues, dizziness, twitching extremities a few times, wake up and eyes unable to stay still for a short time, tight chest, headache, low sense of smell, low taste, and pain in spine but did not feel like muscular. The outcome of the events was unknown. The patient underwent Sars-cov-2 test: negative on 04Oct2021.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: cannot think straight; fatigue; short of breathe; weakness; confusion,; brain fog; tiredness,; memory issues; dizziness,; twitching extremities; wake up and eyes unable to stay still for a short time; tight chest; headache; low sense of smell; low taste; pain in spine; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 20Sep2021 09:30 (Batch/Lot Number: 301308A) as dose 2, single for COVID-19 immunisation. Medical history included shingles and mono, both from an unknown date and unknown if ongoing. Concomitant medication included sertraline hcl taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 30Aug2021 3:00 PM (Batch/Lot Number:  FC3182) as dose 1 for COVID-19 immunization. On 22Sep2021 06:00, the patient experienced fatigue, short of breathe, weakness, confusion, brain fog, tiredness, cannot think straight and memory issues, dizziness, twitching extremities a few times, wake up and eyes unable to stay still for a short time, tight chest, headache, low sense of smell, low taste, and pain in spine but did not feel like muscular. The outcome of the events was unknown. The patient underwent Sars-cov-2 test: negative on 04Oct2021.
Sex: F
Vaccine: COVID19
Symptoms: Fluid retention, Inflammation
Clinical narrative: fluid retention; inflammation; This is a spontaneous report from contactable consumer via Pfizer. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported) via an unspecified route of administration on an unspecified date as dose 1, single and received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration dates were not reported), via an unspecified route of administration on 01Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history included immune system disorder, inflammation and infection those from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. It was reported received her second dose of Pfizer Covid-19 Vaccine on 01Sep2021. She has heard a lot of different recommendations of when to get the booster or third dose. she is asking to clarify when to receive her additional dose of the Pfizer COvid-19 Vaccine. She has a compromised immune system, not technically classified, but her body does not function properly. She has a hell of a time healing from infections. She takes a lot of supplements, some for inflammation, and ever since her Pfizer Covid-19 Vaccine, she has had more issues with fluid retention and inflammation in her. She reported all this after her first dose. Possible duplicate AE details E-transmitted. Response: Disclaimer provided, spoke from the attached documents and referred caller to her HCP. LAB-1457-14.0 on 22Sep2021. The patient experienced fluid retention and inflammation on 2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No follow-up attempts are possible.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Swelling face
Clinical narrative: Jaw infection with facial swelling; Jaw infection with facial swelling; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 51 year old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13May2021 12:00 (Batch/Lot Number: EW0182) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included dose 1 via an unspecified route of administration, administered in Arm Left on 22Apr2021 12:00 (Batch/Lot Number: EW0164) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing..Concomitant medication(s) included clonazepam (CLONAZEPAM) taken for an unspecified indication, start and stop date were not reported; venlafaxine (VENLAFAXINE) taken for an unspecified indication, start and stop date were not reported; trazodone (TRAZODONE) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced jaw infection with facial swelling on 03Jun2021 with outcome of not recovered, Therapeutic measures were taken as a result of jaw infection and facial swelling with 4 courses of various antibiotics required to kill infection.   Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Insomnia, Pruritus
Clinical narrative: stop the itching/severe itching; redness like she was burned; chills; fever; take the heat out of her arm; She did not sleep much Friday or Saturday night since it was miserable and could not do much with it; a spot about 3 or 4 inches around that was bright red; This is spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left upper arm on 01Oct2021 11:15 (Batch/Lot Number: FY8841) (at the of 82 years old) as dose 3 (booster), single for COVID-19 immunisation. There were no patient medical history. Prior vaccinations, probably within 4 weeks, she got the regular flu shot (in 2021), she does not know the name of it or have lot number, stated that its the one for older people. The patient received the first dose of bnt162b2 (Covid-19 vaccine)  on 03Feb2021 (Lot: EL9265) and the second dose of bnt162b2 (COVID-19 vaccine) on 22Feb2021 (Lot: EL9262), both for COVID-19 immunisation. With the second COVID vaccine she had a mild irritation but it was tolerable. She had a severe reaction to the COVID vaccine booster shot. She was asking what can be done to take the heat out of her arm and stop the itching. She was advised to contact health care professional. Severe reaction started in the middle of the night on 02Oct2021. She described the reaction experiencing fever, chills, severe itching (medically significant), and redness like she was burned (medically significant). Redness was still there, itching was mild, she did not think she has any more fever or chills. She did not sleep much on Friday or Saturday night since it was miserable and could not do much with it. She was in the military and with all the shots she never had a reaction like this. She went to the doctor this morning and they indicated that she may want to put Benadryl cream on it to possibly lessen the itching and redness. She has a spot about 3 or 4 inches around that was bright red. No additional vaccines administered on same date of the Pfizer suspect. Events required a visit to Physician Office. The outcome of the events fever, chills was recovered; event redness was not recovered; event itching was recovering; and unknown outcome for the other events.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular
Clinical narrative: stop the itching/severe itching; redness like she was burned; chills; fever; take the heat out of her arm; She did not sleep much Friday or Saturday night since it was miserable and could not do much with it; a spot about 3 or 4 inches around that was bright red; This is spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left upper arm on 01Oct2021 11:15 (Batch/Lot Number: FY8841) (at the of 82 years old) as dose 3 (booster), single for COVID-19 immunisation. There were no patient medical history. Prior vaccinations, probably within 4 weeks, she got the regular flu shot (in 2021), she does not know the name of it or have lot number, stated that its the one for older people. The patient received the first dose of bnt162b2 (Covid-19 vaccine)  on 03Feb2021 (Lot: EL9265) and the second dose of bnt162b2 (COVID-19 vaccine) on 22Feb2021 (Lot: EL9262), both for COVID-19 immunisation. With the second COVID vaccine she had a mild irritation but it was tolerable. She had a severe reaction to the COVID vaccine booster shot. She was asking what can be done to take the heat out of her arm and stop the itching. She was advised to contact health care professional. Severe reaction started in the middle of the night on 02Oct2021. She described the reaction experiencing fever, chills, severe itching (medically significant), and redness like she was burned (medically significant). Redness was still there, itching was mild, she did not think she has any more fever or chills. She did not sleep much on Friday or Saturday night since it was miserable and could not do much with it. She was in the military and with all the shots she never had a reaction like this. She went to the doctor this morning and they indicated that she may want to put Benadryl cream on it to possibly lessen the itching and redness. She has a spot about 3 or 4 inches around that was bright red. No additional vaccines administered on same date of the Pfizer suspect. Events required a visit to Physician Office. The outcome of the events fever, chills was recovered; event redness was not recovered; event itching was recovering; and unknown outcome for the other events.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Nausea, Pain, Pyrexia
Clinical narrative: felt faint / faintness / pervasive feeling of fainting; nauseous; had a fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in the left arm on 04Mar2021 11:00 (at the age of 70-years-old; lot number: EN6199, expiration date not reported) as dose 1, single and via an unspecified route of administration on 25Mar2021 13:54 (at the age of 70-years-old; lot number: EP7534, expiration date not reported) as dose 2, single both for COVID-19 immunization. The patient has no relevant medical history and no concomitant medications. It was reported that the patient was really healthy with normal blood pressure and no other medical complications. The patient has no additional vaccines administered on same date of the Pfizer Suspect product. The patient had no prior vaccinations within 4 weeks. The patient had no family medical history relevant to the adverse events. It was reported that the patient had all of the shots of Pfizer COVID Vaccines. The patient experienced she felt faint, faintness, pervasive feeling of fainting, nauseous, had a fever and body aches on an unspecified date after receiving the first 1st dose and 2nd dose of the vaccine. The patient described the events as follows: stated that she did have a little fever and body aches and so forth which was the normal reaction except she also had the pervasive feeling of fainting and the nausea which was abnormal. It was reported that there was absolutely nothing different in the patient's routine for food or any medications and that she currently does not take any medication and therefore attributed the reported events to the Pfizer COVID Vaccine. The patient underwent lab test and procedures which included blood pressure: normal on an unspecified date. The outcome of the events faint, faintness, pervasive feeling of fainting, nauseous and fever was recovered on an unspecified date; reported as the faintness and nausea did pass, and fever and nausea were not ongoing, and they resolved the day after the vaccine doses were administered that same day. The outcome of body aches was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9263, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 04Feb2021 (age at vaccination was 60 years) as dose 2, single for COVID-19 immunization. The patient's medical history included none (Patient's Medical History (including any illness at time of vaccination) No Family Medical History Relevant to AE(s): None) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE following prior vaccinations was none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3246, Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 14Jan2021 at 14:00 as dose 1, single for COVID-19 immunization. Patient received third dose on 29Sep2021. On Feb2021, after second dose patient experienced sore arm. The outcome of the events was unknown.  Follow-up attempts have been completed and no further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myocarditis, Pyrexia, SARS-CoV-2 test
Clinical narrative: myocarditis; Fever; swelling at injection with redness to elbow for a week; swelling at injection with redness to elbow for a week; extreme joint pain; severe headache; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old non-pregnant female patient received bnt162b2 (BNT162B2), second single dose intramuscularly, administered in arm left on 06Jan2021 (Batch/Lot Number: EK9231) for covid-19 immunisation at age of 50-year-old. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. The patient received the first dose of bnt162b2 on 02Dec2020 at age of 50-year-old for covid-19 immunisation (lot number: EL0140) intramuscularly at arm left and experienced fever, swelling at injection with redness to elbow for a week, extreme joint pain, and severe headache. After the second dose, the events were worse than first. All adverse reactions were felt except myocarditis. Fever, swelling at injection with redness to elbow for a week, extreme joint pain, severe headache, all for 2 days before subsiding. Missed worked for both shots. The patient had Covid test post vaccination (nasal swab) was negative. Outcome of the events was recovered without treatment.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Myocarditis, Pyrexia, Vaccination site swelling, Vaccination site erythema, Arthralgia, Headache  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: myocarditis; Fever; swelling at injection with redness to elbow for a week; swelling at injection with redness to elbow for a week; extreme joint pain; severe headache; This is a spontaneous report from a contactable other health professional (patient). A 51-year-old non-pregnant female patient received bnt162b2 (BNT162B2), second single dose intramuscularly, administered in arm left on 06Jan2021 (Batch/Lot Number: EK9231) for covid-19 immunisation at age of 50-year-old. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. The patient received the first dose of bnt162b2 on 02Dec2020 at age of 50-year-old for covid-19 immunisation (lot number: EL0140) intramuscularly at arm left and experienced fever, swelling at injection with redness to elbow for a week, extreme joint pain, and severe headache. After the second dose, the events were worse than first. All adverse reactions were felt except myocarditis. Fever, swelling at injection with redness to elbow for a week, extreme joint pain, severe headache, all for 2 days before subsiding. Missed worked for both shots. The patient had Covid test post vaccination (nasal swab) was negative. Outcome of the events was recovered without treatment.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Myocarditis, Pyrexia, Vaccination site swelling, Vaccination site erythema, Arthralgia, Headache  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: M
Vaccine: COVID19
Symptoms: Abdominal distension, Fasciitis, Prostate infection, Prostatitis
Clinical narrative: infection of the prostate; fasciitis; stomach got kind of bloated; prostatitis flare up; This is a spontaneous report from a Pfizer-sponsored program regulatory authority. A contactable consumer (patient) reported that a 78-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration in Feb2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his second dose of the Pfizer BioNTech COVID 19 vaccine in Feb2021, and two weeks later developed a prostatitis flare up and his stomach got kind of bloated. At the time he didn't think much of it but "now" thinks it may be correlated. The patient was having fasciitis or infection of the prostate. He is receiving his booster dose later the day of reporting; he will have the booster shot "now". He wants to know about the adverse reaction or side effects, if there have been any reports of prostatitis or stomach bloating after receiving the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Fully vaccinated and contracted COVID disease; Fully vaccinated and contracted COVID disease; This is a spontaneous report from a contactable other health care professional (HCP). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), intramuscular at the age of 50-year-old administered in arm left on 12Mar2021 at single dose for covid-19 immunisation. Medical history included prior cardiac surgery in 2010. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2(COMIRNATY, Batch/Lot number: EL3247) Intramuscular on 19Feb2021 at the age of 50-year-old at left arm for COVID-19 immunisation. The patient experienced fully vaccinated and contracted covid disease on 03Sep2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Facility type vaccine was reported as workplace clinic. The patient underwent lab tests included polymerase chain reaction (PCR): contracted covid on 03Sep2021, polymerase chain reaction (PCR): positive on 04Oct2021. The outcome of events was not recovered.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported vaccination failure / COVID-19 cannot be ruled out.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Immunisation, Off label use
Clinical narrative: Bell's palsy; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose; received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose; This is a spontaneous report from a contactable pharmacist. A 72-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the third dose via intramuscular in left arm on 28Sep2021 as single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. The patient previously received BNT162B2, the first dose on 12Jan2021 (Dose Number: 1, Batch/Lot No: Unknown. Location of injection: Arm Left, Route of Administration: Intramuscular) and the second dose on 02Feb2021 (Dose Number: 2, Batch/Lot No: Unknown. Location of injection: Arm Left, Route of Administration: Intramuscular), both at the age of 72 years old for COVID-19 Immunization. The patient experienced Bell's palsy on 29Sep2021. Unknown if received treatment for this event. The patient had physician office visit due to this event. The outcome of the event Bell's palsy was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The event Bell's palsy was considered related to suspect drug based on strong temporal association and known safety profile of the drug.  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: Allergy to vaccine, Bone pain, Ear pain, Neck pain, Rash
Clinical narrative: ache/pain on the left side of her neck (somehow near her left ear, close to the base of her left skull, not in the middle but close to the left side); ear pain; the pain is more bothersome underneath and moved to the base of her skull; she was nervous and does have several allergies; rash on her face; hives; bump in the arm which is sore; bump in the arm which is sore; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (COMIRNATY), first single dose via an unspecified route of administration, administered in arm left on 04Oct2021 at 13:00 (Batch/Lot number was not reported) for covid-19 immunisation at age of 52-year-old. Medical history included pre-existing thyroid condition, a little bit overweight, but over-all healthy. The patient's concomitant medications were not reported. Patient reported to have gotten her 1st dose of the COMIRNATY vaccine the day before this report on 04Oct2021. Post-vaccination she developed rash on her face, hives and bump in the arm which was sore. She reported that the rash completely cleared up. However, she observed around 8:30- 9:30 AM the day at this report on 05Oct2021 that she woke up with the ache/pain on the left side of her neck (somehow near her left ear, close to the base of her left skull, not in the middle but close to the left side. She also mentioned that she got the vaccine on her left arm. Patient stated she had the 1st dose of the Pfizer Vaccine and after the shot around 1:00pm she did have a reaction as far as she broke out in a rash on her face with hives and was taking Benadryl; stated she talked to the pharmacist who noticed this an hour after the shot was given and she had waited after her shot because she was nervous and did have several allergies; stated by this morning her face was all cleared up except for one bump which was good and her arm being sore; stated what was bothering her now was that she woke up with some aching up the left side of her neck into her left ear and that is doable and was there so she will see how that pans out. Patient stated the pain went away and then came back and she did not know why this is happening. Patient stated she can ignore the ear thing but what made her nervous was that pain in the base of her skull close to the left side and it is bothersome. Patient stated she did print everything out before she got the shot and did not see anyone reporting anything like neck or ear pain and the neck was what was being annoying now and the ear pain was there. Outcome of the events rash on her face and hives was recovered in Oct2021, while outcome of the other events was unknown. Events rash on her face and hives reported as serious as medically significant.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.