chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Computerised tomogram thorax, Decreased appetite, Dyspnoea, Dyspnoea exertional
Clinical narrative: Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in:  Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded  based on a compatible temporal relation. 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.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Heart rate increased, Hypoaesthesia, Insomnia, Magnetic resonance imaging head
Clinical narrative: Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in:  Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded  based on a compatible temporal relation. 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.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Night sweats, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in:  Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded  based on a compatible temporal relation. 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.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Vaginal haemorrhage
Clinical narrative: Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in:  Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded  based on a compatible temporal relation. 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.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Dyspnoea, Hypoaesthesia, Neuralgia
Clinical narrative: Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in:  Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded  based on a compatible temporal relation. 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.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Uterine haemorrhage
Clinical narrative: Uterine abnormal bleeding for 7 days; My face, head and ears started tingling; Shortness of breath; Numbness; Weakness; Severe burning all over my nerves of my body; Severe burning all over my nerves of my body; This is a spontaneous report received a contactable other healthcare professional, the patient. This other healthcare professional reported similar events for the same patient with each dose of the same product; this case refers to the first dose. A 44-year-old adult [non-pregnant] female received the first dose of BNT162b2 (solution for injection; Lot unknown expiry information not provided) in the left arm via unspecified route on 13Mar2021 at 12:00 (at 44-yeasr-old), for COVID-19 immunisation. Relevant medical history included thyroid. Concomitant medications included levothyroxine sodium (TIROSINT) for thyroid. The patient denied any known allergies as well as being diagnosed with COVID-19 prior to the vaccine. The patient was not pregnant at the time of vaccination and receiving any other vaccine within four weeks of this vaccine. The patient reported that on 13Mar2021 at 16:00 she experienced her face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body. On 14Mar2021, the day after the vaccine, the patient developed abnormal uterine bleeding. The patient reported that events resulted in:  Doctor or other healthcare professional office/clinic visit; Emergency room/department or urgent care, Hospitalization, Disability or permanent damage; with hospitalization for three days. The patient has not been tested for COVID-19 since the vaccine. Treatment for the events included intravenous (IV) anti-inflammatory. The outcome of the abnormal uterine bleeding was recovered on 21Mar2021 after seven days. The outcome of the events face, head and ears started tingling, she had shortness of breath, numbness and weakness and severe burning all over her nerves of her body, was not recovered.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded  based on a compatible temporal relation. 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.,Linked Report(s) : US-PFIZER INC-2021413774 PFIZER (Same reporter/patient/product, similar events with second dose)
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Started shaking uncontrollably; I am very sick; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) (at age of 42-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 16Mar2021 (Lot number: EN6207, Expiration Date: 31Jul2021) and was okay after the first one.  The patient experienced shaking uncontrollably and very sick on Apr2021. The events result in emergency room visit. The patient stated, "I am calling because I got the 2nd COVID Vaccine shot, the Pfizer one and I am very sick, I had to go to the emergency room '2' days after I got the shot. I started shaking uncontrollably and I can't stop the shaking and the hospital that I went, they just gave me a little bit of medicine (Unspecified Medication) to try to calm down my nerve but there is something really wrong with the shot and me (Clarification unknown). I need to feel better." When probed for the date when consumer went to the emergency room, consumer stated, "I was yesterday (11Apr2021) and I came yesterday (11Apr2021), so 1 day and they told me to call a neurologist."  Therapeutic measures were taken as a result of shaking uncontrollably. The outcome of events was unknown.  No follow-up attempts are needed. No further information are expected.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Illness, Tremor
Clinical narrative: Started shaking uncontrollably; I am very sick; This is a spontaneous report from a contactable consumer. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Apr2021 (Batch/Lot Number: ER8729; Expiration Date: 31Jul2021) (at age of 42-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 16Mar2021 (Lot number: EN6207, Expiration Date: 31Jul2021) and was okay after the first one.  The patient experienced shaking uncontrollably and very sick on Apr2021. The events result in emergency room visit. The patient stated, "I am calling because I got the 2nd COVID Vaccine shot, the Pfizer one and I am very sick, I had to go to the emergency room '2' days after I got the shot. I started shaking uncontrollably and I can't stop the shaking and the hospital that I went, they just gave me a little bit of medicine (Unspecified Medication) to try to calm down my nerve but there is something really wrong with the shot and me (Clarification unknown). I need to feel better." When probed for the date when consumer went to the emergency room, consumer stated, "I was yesterday (11Apr2021) and I came yesterday (11Apr2021), so 1 day and they told me to call a neurologist."  Therapeutic measures were taken as a result of shaking uncontrollably. The outcome of events was unknown.  No follow-up attempts are needed. No further information are expected.
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Fatigue, Incomplete course of vaccination, Neuralgia, Paraesthesia
Clinical narrative: Distal paraesthesia, pins and needles, tingling feeling throughout body.; This is a spontaneous report from a contactable consumer reported for self. This 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34 years old on 05Mar2021 04:00 PM Arm Right at single dose (Lot: EN6204) for COVID-19 immunisation. Medical history included Childhood food allergies, but years since allergic reaction. Prior to vaccination, was the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None other medications the patient received within 2 weeks of vaccination. He experienced Distal paraesthesia, pins and needles, tingling feeling throughout body on 09Mar2021 08:00 which result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, has the patient has not been tested for COVID-19. 4mg 6 day course of Prednisone was received for the events. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Distal paraesthesia, pins and needles, tingling feeling throughout body.; This is a spontaneous report from a contactable consumer reported for self. This 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 34 years old on 05Mar2021 04:00 PM Arm Right at single dose (Lot: EN6204) for COVID-19 immunisation. Medical history included Childhood food allergies, but years since allergic reaction. Prior to vaccination, was the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None other medications the patient received within 2 weeks of vaccination. He experienced Distal paraesthesia, pins and needles, tingling feeling throughout body on 09Mar2021 08:00 which result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Since the vaccination, has the patient has not been tested for COVID-19. 4mg 6 day course of Prednisone was received for the events. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Photophobia, Skin burning sensation, Tongue eruption
Clinical narrative: First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; This is a spontaneous report from a 44-year-old female consumer (patient). A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 07Apr2021 11:30 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included asthma and allergies multiples (all antibiotics) from an unknown date and unknown if ongoing. Concomitant medications included vitamins and collagen received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced first 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. after: abdominal pain, malaise, nausea, eye puffiness, water retention on 07Apr2021 12:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered. The events were assessed as non-serious.  No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea, Eye oedema, Fluid retention, Malaise
Clinical narrative: First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; This is a spontaneous report from a 44-year-old female consumer (patient). A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 07Apr2021 11:30 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included asthma and allergies multiples (all antibiotics) from an unknown date and unknown if ongoing. Concomitant medications included vitamins and collagen received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced first 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. after: abdominal pain, malaise, nausea, eye puffiness, water retention on 07Apr2021 12:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered. The events were assessed as non-serious.  No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain in extremity, Petechiae, Skin burning sensation, Tongue discomfort
Clinical narrative: First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; First 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. After: abdominal pain, malaise, nausea, eye puffiness, water retention; This is a spontaneous report from a 44-year-old female consumer (patient). A 44-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in left arm on 07Apr2021 11:30 (Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Medical history included asthma and allergies multiples (all antibiotics) from an unknown date and unknown if ongoing. Concomitant medications included vitamins and collagen received within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced first 12 hours: skin burning shoulder, fizzy tongue, petechia on tongue, arm pain, diarrhea. after: abdominal pain, malaise, nausea, eye puffiness, water retention on 07Apr2021 12:00. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of the events was not recovered. The events were assessed as non-serious.  No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain
Clinical narrative: Got tremendous pain in my right ear; it was outside of the ear; pain was really bad; This is a spontaneous report from a contactable consumer. A 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0151 and expiry date: unknown), via an unspecified route on 10Apr2021 (at the age of 84-year-old) as single dose on left arm for COVID-19 immunization. Relevant medical history included blood pressure. Concomitant medication included lisinopril (5 mg every morning), amlodipine (10 mg), simvastatin (10 mg), Vitamin D, calcium and alendronate sodium (once in a week), and temazepam. On an 11Apr2021 (Sunday), the patient had tremendous pain in her right ear, and it was outside of the ear not the inside and persisted for every '20 seconds'. She also stated the pain was bad. In 1 to 10 pain scale, it was 8 and it persisted for whole day. On the same date, night the patient received treatment with paracetamol (Tylenol) and it calm down a little bit. The patient was wondering that if same thing will happen, when she will take her next shot. The patient stated that she did not have a computer. Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Pain, Pain assessment
Clinical narrative: Got tremendous pain in my right ear; it was outside of the ear; pain was really bad; This is a spontaneous report from a contactable consumer. A 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0151 and expiry date: unknown), via an unspecified route on 10Apr2021 (at the age of 84-year-old) as single dose on left arm for COVID-19 immunization. Relevant medical history included blood pressure. Concomitant medication included lisinopril (5 mg every morning), amlodipine (10 mg), simvastatin (10 mg), Vitamin D, calcium and alendronate sodium (once in a week), and temazepam. On an 11Apr2021 (Sunday), the patient had tremendous pain in her right ear, and it was outside of the ear not the inside and persisted for every '20 seconds'. She also stated the pain was bad. In 1 to 10 pain scale, it was 8 and it persisted for whole day. On the same date, night the patient received treatment with paracetamol (Tylenol) and it calm down a little bit. The patient was wondering that if same thing will happen, when she will take her next shot. The patient stated that she did not have a computer. Outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Loss of personal independence in daily activities, Muscle spasms
Clinical narrative: they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Cardiac flutter, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Heart rate, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: they did an ekg and it was abnormal, I have 2 extra heartbeats; having a hard time walking moving her muscles; having a hard time walking moving my muscles/Every muscle and joint ached severely; having a hard time walking moving my muscles/Every muscle and joint ached severely; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; Redness and swelling in left arm for 2 days with pain; I have had fluttering and my heart feels like it is jumping in my chest.; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 08:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypothyroidism, fibromyalgia, Type 2 diabetes. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included atorvastatin, duloxetine, glimepiride, and levothyroxine. The patient had not received other vaccine in four weeks. The patient previously received pregabalin (LYRICA) and had allergies. On 02Apr2021 12:00, the patient had Redness and swelling in left arm for 2 days with pain. 2 days after shot (04Apr2021) she was having a hard time walking moving her muscles. Every muscle and joint ached severely nothing helped the pain. Now she was 13 days past the shot with muscle pain. She went to doctor yesterday (14Apr2021) and they did an EKG and it was abnormal. She had 2 extra heartbeats in Apr2021. Since shot she had had fluttering and her heart felt like it was jumping in her chest. The patient had Blood work in Apr2021. The outcome of all events was not resolved.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Peripheral vein occlusion, Ultrasound Doppler, Ultrasound scan abnormal
Clinical narrative: RIGHT LEG DEEP VEIN THROMBOSIS; PERIPHERAL VEIN OCCLUSION; This spontaneous report received from a patient via VAERS (Vaccine Adverse Event Reporting System) (VAERS ID: 1201107) concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and chronic obstructive pulmonary disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included ferrous sulfate, ipratropium bromide/salbutamol sulfate, montelukast, salbutamol sulfate, budesonide, ipratropium, olodaterol hydrochloride/tiotropium bromide monohydrate and prednisone for chronic obstructive pulmonary disease.  On 07-APR-2021, the patient experienced right leg deep vein thrombosis. Patient was hospitalized for 4 days. On 07-APR-2021, the patient experienced peripheral vein occlusion. On 07-APR-2021, the patient had ultrasound scan abnormal. Laboratory data included: Ultrasound Doppler (NR: not provided) unknown, and right leg duplex Ultrasound Scan confirms right leg occlusive DVT involving common femoral, superficial femoral, and popliteal vein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right leg deep vein thrombosis, and peripheral vein occlusion. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210447773-Covid-19 vaccine ad26.cov2.s-Right leg deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.