chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Papule
Clinical narrative: large fluid filled blisters developed and covered her entire body; small bumps on left leg/small bumps with a dark nucleus on right arm/small bumps on left arm/ clusters on both arms; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for herself that a 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FP8730) at the age of 59-years, via an unspecified route of administration, administered in left arm on 09Apr2021 at 09:30 at single dose for COVID-19 immunisation, in pharmacy or drug store. Medical history included hypertension; allergies to adhesives. The patient was not pregnancy at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient historically received first dose of BNT162B2 (lot number: EN6207) at the age of 59-years, via an unspecified route of administration in left arm on 12Mar2021 at 09:00 PM at single dose for COVID-19 immunisation. It was reported that two clusters of small bumps formed on left leg by 10Apr2021 at 01:00. On 18Apr2021, she started seeing two clusters of small bumps with a dark nucleus on the right arm. Another large cluster of small bumps developed on the left arm in a day. The clusters engulfed her left arm by 28Apr2021. By 30Apr2021, the clusters had spread and covered more area on both arms. By 04May2021, large fluid filled blisters developed and covered her entire body (legs, arms, hands, back, stomach, chest, and buttocks). By 28May2021, the clusters had reached her neck, face, cheeks, eyes, and ears. The events were reported as serious due to hospitalization for 2 days, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient received initially given mixtures of antibiotics as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Fatigue, Obstructive airways disorder
Clinical narrative: I felt swelling in my neck; throat tightness; trachetis; hyperallegic; fatigue; lethargy; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that:  A patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced swelling in neck followed by throat tightness About 4-6 hours, patient was diagnosed with tracheitis several days later. Patient also experienced in a hyperallergic way to things that previously didn't affect and fatigue or lethargy at times. At day 25 since then patient continue to experience symptoms, about seven times a day. Patient would like to make himself available to the team for study and willing to even take some chances in controlled settings to test stimuli.   patient would very much like to get to the bottom of what happened, and/or what the trigger may have been, so patient can know for my own pathway forward, as well as helping other people who may also be in the same position. Patient was not sure if this is because of how patient immune system reacted, or some allergic reaction. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling, Throat tightness, Tracheitis
Clinical narrative: I felt swelling in my neck; throat tightness; trachetis; hyperallegic; fatigue; lethargy; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that:  A patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced swelling in neck followed by throat tightness About 4-6 hours, patient was diagnosed with tracheitis several days later. Patient also experienced in a hyperallergic way to things that previously didn't affect and fatigue or lethargy at times. At day 25 since then patient continue to experience symptoms, about seven times a day. Patient would like to make himself available to the team for study and willing to even take some chances in controlled settings to test stimuli.   patient would very much like to get to the bottom of what happened, and/or what the trigger may have been, so patient can know for my own pathway forward, as well as helping other people who may also be in the same position. Patient was not sure if this is because of how patient immune system reacted, or some allergic reaction. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Fatigue, Hypersensitivity, Swelling
Clinical narrative: I felt swelling in my neck; throat tightness; trachetis; hyperallegic; fatigue; lethargy; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that:  A patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced swelling in neck followed by throat tightness About 4-6 hours, patient was diagnosed with tracheitis several days later. Patient also experienced in a hyperallergic way to things that previously didn't affect and fatigue or lethargy at times. At day 25 since then patient continue to experience symptoms, about seven times a day. Patient would like to make himself available to the team for study and willing to even take some chances in controlled settings to test stimuli.   patient would very much like to get to the bottom of what happened, and/or what the trigger may have been, so patient can know for my own pathway forward, as well as helping other people who may also be in the same position. Patient was not sure if this is because of how patient immune system reacted, or some allergic reaction. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat tightness, Tracheitis
Clinical narrative: I felt swelling in my neck; throat tightness; trachetis; hyperallegic; fatigue; lethargy; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that:  A patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced swelling in neck followed by throat tightness About 4-6 hours, patient was diagnosed with tracheitis several days later. Patient also experienced in a hyperallergic way to things that previously didn't affect and fatigue or lethargy at times. At day 25 since then patient continue to experience symptoms, about seven times a day. Patient would like to make himself available to the team for study and willing to even take some chances in controlled settings to test stimuli.   patient would very much like to get to the bottom of what happened, and/or what the trigger may have been, so patient can know for my own pathway forward, as well as helping other people who may also be in the same position. Patient was not sure if this is because of how patient immune system reacted, or some allergic reaction. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Hypersensitivity, Lethargy, Swelling, Throat tightness
Clinical narrative: I felt swelling in my neck; throat tightness; trachetis; hyperallegic; fatigue; lethargy; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that:  A patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced swelling in neck followed by throat tightness About 4-6 hours, patient was diagnosed with tracheitis several days later. Patient also experienced in a hyperallergic way to things that previously didn't affect and fatigue or lethargy at times. At day 25 since then patient continue to experience symptoms, about seven times a day. Patient would like to make himself available to the team for study and willing to even take some chances in controlled settings to test stimuli.   patient would very much like to get to the bottom of what happened, and/or what the trigger may have been, so patient can know for my own pathway forward, as well as helping other people who may also be in the same position. Patient was not sure if this is because of how patient immune system reacted, or some allergic reaction. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tracheal disorder
Clinical narrative: I felt swelling in my neck; throat tightness; trachetis; hyperallegic; fatigue; lethargy; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that:  A patient with unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced swelling in neck followed by throat tightness About 4-6 hours, patient was diagnosed with tracheitis several days later. Patient also experienced in a hyperallergic way to things that previously didn't affect and fatigue or lethargy at times. At day 25 since then patient continue to experience symptoms, about seven times a day. Patient would like to make himself available to the team for study and willing to even take some chances in controlled settings to test stimuli.   patient would very much like to get to the bottom of what happened, and/or what the trigger may have been, so patient can know for my own pathway forward, as well as helping other people who may also be in the same position. Patient was not sure if this is because of how patient immune system reacted, or some allergic reaction. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Bedridden, Impaired work ability, Influenza like illness, Malaise, Pain in extremity
Clinical narrative: SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; VERY ILL; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 28Apr2021 12:00 am (Age at Vaccination:36 year) (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:00 am (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunisation. The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021, the patient experienced severe flu like symptoms severe pain all over body 24 hrs after getting shot, arm felt like someone hit it with a claw hammer he had real bad headaches he was in bed for over a week very ill still having flu like symptoms one month later. The patient did not received treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Vaccination complication
Clinical narrative: SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; VERY ILL; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 28Apr2021 12:00 am (Age at Vaccination:36 year) (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:00 am (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunisation. The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021, the patient experienced severe flu like symptoms severe pain all over body 24 hrs after getting shot, arm felt like someone hit it with a claw hammer he had real bad headaches he was in bed for over a week very ill still having flu like symptoms one month later. The patient did not received treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; VERY ILL; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 28Apr2021 12:00 am (Age at Vaccination:36 year) (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:00 am (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunisation. The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021, the patient experienced severe flu like symptoms severe pain all over body 24 hrs after getting shot, arm felt like someone hit it with a claw hammer he had real bad headaches he was in bed for over a week very ill still having flu like symptoms one month later. The patient did not received treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Illness, Influenza like illness, Limb deformity, Pain in extremity, Vaccination site pain
Clinical narrative: SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; VERY ILL; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 28Apr2021 12:00 am (Age at Vaccination:36 year) (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:00 am (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunisation. The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021, the patient experienced severe flu like symptoms severe pain all over body 24 hrs after getting shot, arm felt like someone hit it with a claw hammer he had real bad headaches he was in bed for over a week very ill still having flu like symptoms one month later. The patient did not received treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot batch number cannot be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Illness, Influenza like illness, Limb discomfort, Pain
Clinical narrative: SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; SEVERE FLU LIKE SYMPTOMS SEVERE PAIN ALL OVER BODY 24 HRS AFTER GETTING SHOT, ARM FEELS LIKE SOMEONE HIT IT WITH A CLAW HAMMER I HAD REAL BAD HEADACHES I WAS IN BED FOR OVER A WEEK VERY ILLSTILL HAV; VERY ILL; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 28Apr2021 12:00 am (Age at Vaccination:36 year) (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 12:00 am (Batch/Lot Number: Unknown) as 2ND DOSE ,SINGLE for covid-19 immunisation. The patient Did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 30Apr2021, the patient experienced severe flu like symptoms severe pain all over body 24 hrs after getting shot, arm felt like someone hit it with a claw hammer he had real bad headaches he was in bed for over a week very ill still having flu like symptoms one month later. The patient did not received treatment for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: Heartbeat raising like tachycardia; going up 115 and then dropped down to 65; Average heartbeat is around 65-70 but still feels like heart is racing; It felt some pain in my ribs every time; I do have medicine allergy; heightened anxiety; This is a spontaneous report from a contactable consumer(patient) reported that. A 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 via an unspecified route of administration on 11May2021 (age at vaccination was 24-year-old) (Lot Number: EW0173 Expiry date was UNKNOWN) as a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Anaphylaxis to some food allergies from an unknown date and unknown if ongoing. Concomitant medication included albuterol sulfate 90 mcg (Inhaler about 1-2 puffs as needed) (ALBUTEROL SULFATE) taken for asthma, start and stop date were not reported; loratadine (took every 12 hours rather than 24 hours, but do not know the dosage) (CLARITINE) taken for an unspecified indication, start and stop date were not reported. On an unknown date patient stated that few days after vaccination probably on thursday started feeling like her heartbeat was raising a little bit, but she didn't really think it was that much figured it was maybe because she worked out that morning or maybe she had much coffee or something. she didn't do anything in last couple of days and her heartbeat has been going up and down doing actually nothing, it was 115 and then dropped to 65. It feels almost like tachycardia. Average heartbeat was around 65-70 but it still feels like heart was racing even though she was taking oxygen puff and it says normal. On Friday her heart rate going up every time. she was breathing in the right side of her chest and it was about for 30 minutes. It felt like there was some pain almost in her ribs every time she takes a deep breath to relax herself, the patient had medicine allergy. She mentioned that her heart would start racing out of nowhere, which had then caused her heightened anxiety. While sitting down, her pulse would go up to 115 then drop to 50- 60. She already went to a doctor and they were not sure, so she was referred to a cardiologist. She mentioned that it was almost like sinus tachycardia. No treatment received for the events. The patient underwent lab tests and procedures which included heart rate 115, going up 115 and then dropped down to 65, heart rate 65, going up 115 and then dropped down to 65, heart rate 65-70, average heartbeat was around 65-70. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Drug hypersensitivity, Heart rate, Musculoskeletal chest pain, Palpitations
Clinical narrative: Heartbeat raising like tachycardia; going up 115 and then dropped down to 65; Average heartbeat is around 65-70 but still feels like heart is racing; It felt some pain in my ribs every time; I do have medicine allergy; heightened anxiety; This is a spontaneous report from a contactable consumer(patient) reported that. A 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 via an unspecified route of administration on 11May2021 (age at vaccination was 24-year-old) (Lot Number: EW0173 Expiry date was UNKNOWN) as a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Anaphylaxis to some food allergies from an unknown date and unknown if ongoing. Concomitant medication included albuterol sulfate 90 mcg (Inhaler about 1-2 puffs as needed) (ALBUTEROL SULFATE) taken for asthma, start and stop date were not reported; loratadine (took every 12 hours rather than 24 hours, but do not know the dosage) (CLARITINE) taken for an unspecified indication, start and stop date were not reported. On an unknown date patient stated that few days after vaccination probably on thursday started feeling like her heartbeat was raising a little bit, but she didn't really think it was that much figured it was maybe because she worked out that morning or maybe she had much coffee or something. she didn't do anything in last couple of days and her heartbeat has been going up and down doing actually nothing, it was 115 and then dropped to 65. It feels almost like tachycardia. Average heartbeat was around 65-70 but it still feels like heart was racing even though she was taking oxygen puff and it says normal. On Friday her heart rate going up every time. she was breathing in the right side of her chest and it was about for 30 minutes. It felt like there was some pain almost in her ribs every time she takes a deep breath to relax herself, the patient had medicine allergy. She mentioned that her heart would start racing out of nowhere, which had then caused her heightened anxiety. While sitting down, her pulse would go up to 115 then drop to 50- 60. She already went to a doctor and they were not sure, so she was referred to a cardiologist. She mentioned that it was almost like sinus tachycardia. No treatment received for the events. The patient underwent lab tests and procedures which included heart rate 115, going up 115 and then dropped down to 65, heart rate 65, going up 115 and then dropped down to 65, heart rate 65-70, average heartbeat was around 65-70. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Heartbeat raising like tachycardia; going up 115 and then dropped down to 65; Average heartbeat is around 65-70 but still feels like heart is racing; It felt some pain in my ribs every time; I do have medicine allergy; heightened anxiety; This is a spontaneous report from a contactable consumer(patient) reported that. A 24-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, dose 1 via an unspecified route of administration on 11May2021 (age at vaccination was 24-year-old) (Lot Number: EW0173 Expiry date was UNKNOWN) as a SINGLE DOSE for covid-19 immunisation. Medical history included asthma and Anaphylaxis to some food allergies from an unknown date and unknown if ongoing. Concomitant medication included albuterol sulfate 90 mcg (Inhaler about 1-2 puffs as needed) (ALBUTEROL SULFATE) taken for asthma, start and stop date were not reported; loratadine (took every 12 hours rather than 24 hours, but do not know the dosage) (CLARITINE) taken for an unspecified indication, start and stop date were not reported. On an unknown date patient stated that few days after vaccination probably on thursday started feeling like her heartbeat was raising a little bit, but she didn't really think it was that much figured it was maybe because she worked out that morning or maybe she had much coffee or something. she didn't do anything in last couple of days and her heartbeat has been going up and down doing actually nothing, it was 115 and then dropped to 65. It feels almost like tachycardia. Average heartbeat was around 65-70 but it still feels like heart was racing even though she was taking oxygen puff and it says normal. On Friday her heart rate going up every time. she was breathing in the right side of her chest and it was about for 30 minutes. It felt like there was some pain almost in her ribs every time she takes a deep breath to relax herself, the patient had medicine allergy. She mentioned that her heart would start racing out of nowhere, which had then caused her heightened anxiety. While sitting down, her pulse would go up to 115 then drop to 50- 60. She already went to a doctor and they were not sure, so she was referred to a cardiologist. She mentioned that it was almost like sinus tachycardia. No treatment received for the events. The patient underwent lab tests and procedures which included heart rate 115, going up 115 and then dropped down to 65, heart rate 65, going up 115 and then dropped down to 65, heart rate 65-70, average heartbeat was around 65-70. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Pain in extremity, Rash
Clinical narrative: I am experiencing sharp pain in my shoulder and elbow; a large sore appeared at the vaccine site on my shoulder.; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This 53-year-old male consumer received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204), via an intramuscularly administered in right arm on 18Mar2021 (at the age of 53-year-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medication were reported as none. No prior vaccination (within 4 weeks). The patient received the first dose of pfizer covid vaccine on 18Mar2021 and in the past two weeks a large sore appeared at the vaccine site on his shoulder. He was experiencing sharp pain in his shoulder and elbow. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Vaccination site ulcer
Clinical narrative: I am experiencing sharp pain in my shoulder and elbow; a large sore appeared at the vaccine site on my shoulder.; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. This 53-year-old male consumer received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6204), via an intramuscularly administered in right arm on 18Mar2021 (at the age of 53-year-old) as a single dose for covid-19 immunization. The patient medical history and concomitant medication were reported as none. No prior vaccination (within 4 weeks). The patient received the first dose of pfizer covid vaccine on 18Mar2021 and in the past two weeks a large sore appeared at the vaccine site on his shoulder. He was experiencing sharp pain in his shoulder and elbow. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin decreased, Heavy menstrual bleeding, Immune thrombocytopenia
Clinical narrative: 4-5 days of severe menorrhagia about 2-3 days after vaccination. Presented to the ED with dizziness. Labs showed Hb of 4.5, platelet count of 17, and neutrophils in the 1600 range. Bone marrow biopsy was performed, which did not show any underlying bone marrow process, assuming peripheral etiology. A burst of steroids (dexamethasone 40mg x 4 days) given improved her platelet count to the 200s. Diagnosis of vaccine-induced ITP with autoimmune neutropenia.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mean cell haemoglobin concentration decreased, Mean cell haemoglobin decreased, Mean cell volume decreased, Platelet count decreased, Platelet transfusion
Clinical narrative: 4-5 days of severe menorrhagia about 2-3 days after vaccination. Presented to the ED with dizziness. Labs showed Hb of 4.5, platelet count of 17, and neutrophils in the 1600 range. Bone marrow biopsy was performed, which did not show any underlying bone marrow process, assuming peripheral etiology. A burst of steroids (dexamethasone 40mg x 4 days) given improved her platelet count to the 200s. Diagnosis of vaccine-induced ITP with autoimmune neutropenia.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Red blood cell count decreased, Transfusion, White blood cell count decreased
Clinical narrative: 4-5 days of severe menorrhagia about 2-3 days after vaccination. Presented to the ED with dizziness. Labs showed Hb of 4.5, platelet count of 17, and neutrophils in the 1600 range. Bone marrow biopsy was performed, which did not show any underlying bone marrow process, assuming peripheral etiology. A burst of steroids (dexamethasone 40mg x 4 days) given improved her platelet count to the 200s. Diagnosis of vaccine-induced ITP with autoimmune neutropenia.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Autoimmune neutropenia, Biopsy bone marrow normal, Dizziness, Haemoglobin decreased, Heavy menstrual bleeding
Clinical narrative: 4-5 days of severe menorrhagia about 2-3 days after vaccination. Presented to the ED with dizziness. Labs showed Hb of 4.5, platelet count of 17, and neutrophils in the 1600 range. Bone marrow biopsy was performed, which did not show any underlying bone marrow process, assuming peripheral etiology. A burst of steroids (dexamethasone 40mg x 4 days) given improved her platelet count to the 200s. Diagnosis of vaccine-induced ITP with autoimmune neutropenia.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia, Neutrophil count decreased, Platelet count decreased, Vaccination complication
Clinical narrative: 4-5 days of severe menorrhagia about 2-3 days after vaccination. Presented to the ED with dizziness. Labs showed Hb of 4.5, platelet count of 17, and neutrophils in the 1600 range. Bone marrow biopsy was performed, which did not show any underlying bone marrow process, assuming peripheral etiology. A burst of steroids (dexamethasone 40mg x 4 days) given improved her platelet count to the 200s. Diagnosis of vaccine-induced ITP with autoimmune neutropenia.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram
Clinical narrative: a blood clot in the brain; Dural sinus thrombosis; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; formulation: Solution for injection, Batch/Lot Number: Not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 14:00 (at the age of 43-years-old) as a single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. It was reported that the patient took birth control pills within two weeks of vaccination (unspecified name). Prior to the vaccination the patient was not diagnosed with covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021 14:00 the patient experienced a blood clot in the brain, dural sinus thrombosis. The patient was hospitalized for a blood clot in the brain and dural sinus thrombosis for 12 days. On 07Jun2021 and 21Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Device Date: 27Jun2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, SARS-CoV-2 test, Thrombosis
Clinical narrative: a blood clot in the brain; Dural sinus thrombosis; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; formulation: Solution for injection, Batch/Lot Number: Not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 14:00 (at the age of 43-years-old) as a single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. It was reported that the patient took birth control pills within two weeks of vaccination (unspecified name). Prior to the vaccination the patient was not diagnosed with covid-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021 14:00 the patient experienced a blood clot in the brain, dural sinus thrombosis. The patient was hospitalized for a blood clot in the brain and dural sinus thrombosis for 12 days. On 07Jun2021 and 21Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Device Date: 27Jun2021. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood culture, C-reactive protein increased, Condition aggravated, Epstein-Barr virus infection, Epstein-Barr virus test positive
Clinical narrative: LOW-GRADE FEVER; HEADACHE; FATIGUE; ACTIVE EPSTEIN BARR INFECTION; CHRONIC BODY ACHES; EVERYDAY ACTIVITIES DIFFICULT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced active epstein barr infection. On APR-2021, the subject experienced chronic body aches. On APR-2021, the subject experienced everyday activities difficult. Laboratory data included: COVID-19 antibody test (NR: not provided) Positive, and Epstein-Barr virus test (NR: not provided) Elevated. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced low-grade fever. Laboratory data included: Body temperature (NR: not provided) 99 to 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and had not recovered from fatigue, low-grade fever, active epstein barr infection, chronic body aches, and everyday activities difficult. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count, Headache, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: LOW-GRADE FEVER; HEADACHE; FATIGUE; ACTIVE EPSTEIN BARR INFECTION; CHRONIC BODY ACHES; EVERYDAY ACTIVITIES DIFFICULT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced active epstein barr infection. On APR-2021, the subject experienced chronic body aches. On APR-2021, the subject experienced everyday activities difficult. Laboratory data included: COVID-19 antibody test (NR: not provided) Positive, and Epstein-Barr virus test (NR: not provided) Elevated. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced low-grade fever. Laboratory data included: Body temperature (NR: not provided) 99 to 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and had not recovered from fatigue, low-grade fever, active epstein barr infection, chronic body aches, and everyday activities difficult. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Migraine, Pain, Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 antibody test positive
Clinical narrative: LOW-GRADE FEVER; HEADACHE; FATIGUE; ACTIVE EPSTEIN BARR INFECTION; CHRONIC BODY ACHES; EVERYDAY ACTIVITIES DIFFICULT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced active epstein barr infection. On APR-2021, the subject experienced chronic body aches. On APR-2021, the subject experienced everyday activities difficult. Laboratory data included: COVID-19 antibody test (NR: not provided) Positive, and Epstein-Barr virus test (NR: not provided) Elevated. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced low-grade fever. Laboratory data included: Body temperature (NR: not provided) 99 to 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and had not recovered from fatigue, low-grade fever, active epstein barr infection, chronic body aches, and everyday activities difficult. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Epstein-Barr virus infection, Epstein-Barr virus test, Fatigue, Headache
Clinical narrative: LOW-GRADE FEVER; HEADACHE; FATIGUE; ACTIVE EPSTEIN BARR INFECTION; CHRONIC BODY ACHES; EVERYDAY ACTIVITIES DIFFICULT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced active epstein barr infection. On APR-2021, the subject experienced chronic body aches. On APR-2021, the subject experienced everyday activities difficult. Laboratory data included: COVID-19 antibody test (NR: not provided) Positive, and Epstein-Barr virus test (NR: not provided) Elevated. On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced low-grade fever. Laboratory data included: Body temperature (NR: not provided) 99 to 101 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and had not recovered from fatigue, low-grade fever, active epstein barr infection, chronic body aches, and everyday activities difficult. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.