chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Vision blurred
Clinical narrative: client complained of dizziness 3 mins after receiving vaccine. Client signaled EMTs for assistance. EMT began assessment and vitals and EMT informed PHN and PHN. Upon arrival client sitting upright in chair, alert and oriented x4. PHN continued assessment. Per client felt dizzy, blurred vision and sweaty. Vitals at 1854: blood pressure 148/96, pulse 71, oxygen 99%. Client denied chest pain, shortness of breath, headache, no swelling or flushing noted. Medical history of hypertension, per client takes medication at night. Medication Micardis for blood pressure. No known allergies. EMT gave client water. Vitals at 1900: blood pressure 149/98, pulse 72, oxygen 99%. Client stated dizziness improving and blurry vision resolved. Vitals at 1905: blood pressure 139/86, pulse 70, oxygen 98%. Vitals at 1910: blood pressure: 147/92, pulse 68, oxygen 98%. Per client normal blood pressure 130s/80s. Per client dizziness resolved. 1915 vitals: blood pressure 128/91, pulse 68, oxygen 98%. PHN advised client to follow up with provider and gave ER precautions. Last vitals at 1920: blood pressure 140/95, pulse 64, oxygen 99%. Per client all symptoms resolved, able to stand with no dizziness. Wife present with client and would drive client home. Client left facility at 1922 with steady gait.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Contusion, Full blood count, Headache, Injection site erythema
Clinical narrative: After second injection on 6/3/2021, I felt fine. Upon waking on 6/4, I had a fever of 101, severe headache and body pain. On 6/5, I developed a 5? x 5? irritated red patch on my injection arm. On 6/6 I awoke to no fever. I then noticed sores in my mouth and busies on my abdomen, left leg and left foot. I went to urgent care. They ran a CBC. My platelet count was down 30% since ,my last test a few months ago. My average was about 180,000 for the last 6 years. My test number was 127,000.  I have no history of a low platelet count. This appeared within days of the 2nd vaccination along with the sores and spontaneous bruising. A CAT and v,MRI were performed that same day. Those tests were normal.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging normal, Pain, Platelet count decreased, Pyrexia, Stomatitis
Clinical narrative: After second injection on 6/3/2021, I felt fine. Upon waking on 6/4, I had a fever of 101, severe headache and body pain. On 6/5, I developed a 5? x 5? irritated red patch on my injection arm. On 6/6 I awoke to no fever. I then noticed sores in my mouth and busies on my abdomen, left leg and left foot. I went to urgent care. They ran a CBC. My platelet count was down 30% since ,my last test a few months ago. My average was about 180,000 for the last 6 years. My test number was 127,000.  I have no history of a low platelet count. This appeared within days of the 2nd vaccination along with the sores and spontaneous bruising. A CAT and v,MRI were performed that same day. Those tests were normal.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic, Skin warm, Tenderness
Clinical narrative: A rash on my left arm that was visibly red, warm to the touch, hurt when touched, and itched.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: patient received his 2nd dose and as he was waiting the 15 minutes he passed out . patients significate other/ girlfriend  . stayed with him . 911 called patient  was okay , all vitals fine . patient had similar passing out first dose but dr said he was okay to get  2nd . patient denied any further treatment from paramedics
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears started approximately 48 hours after second dose. Happens a couple times a day and lasts 10 seconds. Not always the same ear.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase MB, Blood creatine phosphokinase increased, C-reactive protein normal, Chest discomfort, Chest pain
Clinical narrative: Patient having pain 7am 6/8 upon awakening. Sharp, heavy 10/10 left sided chest pain radiated to L arm. Shortness of breath. pain worse with inspiration, no positional changes. Similar to previous myocarditis episode in 2019 (thought to be 2/2 virus as had fevers, fully resolved). No recent URI, last sick 1 year ago, no covid per knowledge. Had COVID vaccine week prior without side effects. Presented to hospital. Initial troponin 0.819> 4.43. CK-MB 42.8, CK 471. BMP, CBC, CRP within normal limits. ECG non ischemic however mild j-point elevation in anterior leads consistent with myocarditis. POCT echo normal. Patient admitted for IVIG, steroids, viral panel and monitoring.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment elevation, Full blood count normal
Clinical narrative: Patient having pain 7am 6/8 upon awakening. Sharp, heavy 10/10 left sided chest pain radiated to L arm. Shortness of breath. pain worse with inspiration, no positional changes. Similar to previous myocarditis episode in 2019 (thought to be 2/2 virus as had fevers, fully resolved). No recent URI, last sick 1 year ago, no covid per knowledge. Had COVID vaccine week prior without side effects. Presented to hospital. Initial troponin 0.819> 4.43. CK-MB 42.8, CK 471. BMP, CBC, CRP within normal limits. ECG non ischemic however mild j-point elevation in anterior leads consistent with myocarditis. POCT echo normal. Patient admitted for IVIG, steroids, viral panel and monitoring.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Metabolic function test normal, Myocarditis, Pain, Painful respiration
Clinical narrative: Patient having pain 7am 6/8 upon awakening. Sharp, heavy 10/10 left sided chest pain radiated to L arm. Shortness of breath. pain worse with inspiration, no positional changes. Similar to previous myocarditis episode in 2019 (thought to be 2/2 virus as had fevers, fully resolved). No recent URI, last sick 1 year ago, no covid per knowledge. Had COVID vaccine week prior without side effects. Presented to hospital. Initial troponin 0.819> 4.43. CK-MB 42.8, CK 471. BMP, CBC, CRP within normal limits. ECG non ischemic however mild j-point elevation in anterior leads consistent with myocarditis. POCT echo normal. Patient admitted for IVIG, steroids, viral panel and monitoring.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory viral panel, Troponin
Clinical narrative: Patient having pain 7am 6/8 upon awakening. Sharp, heavy 10/10 left sided chest pain radiated to L arm. Shortness of breath. pain worse with inspiration, no positional changes. Similar to previous myocarditis episode in 2019 (thought to be 2/2 virus as had fevers, fully resolved). No recent URI, last sick 1 year ago, no covid per knowledge. Had COVID vaccine week prior without side effects. Presented to hospital. Initial troponin 0.819> 4.43. CK-MB 42.8, CK 471. BMP, CBC, CRP within normal limits. ECG non ischemic however mild j-point elevation in anterior leads consistent with myocarditis. POCT echo normal. Patient admitted for IVIG, steroids, viral panel and monitoring.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Rash, Skin weeping
Clinical narrative: I received the shot the Friday afternoon.  On that Monday (the 3rd day after the 2nd shot) I noticed small bumps on my right forearm.  By Wednesday the 2nd of June the bumps presented as Shingles.  It is now June 8th and I have Five Small clusters of Shingles on my right forearm, and they are now at the oozing fluid stage.  Previously I have had 3 Shingles outbreaks on the chest and abdominal area since age 32.  There are no clusters on the chest or abdominal area this time.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Angina pectoris, Back pain, Pain
Clinical narrative: My heart has been hurting since I received the vaccin.  I get a sharp pain, especially at night. The pain goes all the way to my back.
Age: 72.0
Sex: F
Vaccine: UNK
Symptoms: Vaccine positive rechallenge
Clinical narrative: My mother got her Moderna vaccine 1st dose last May 8,2021 , She had reaction called covid arm. With rash , redness and her arm was very swollen. we were not able to bring her to urgent care.  She had her 2nd dose June 6, and she already got the reaction yesterday , same as her 1st dose .
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Severe swelling, pain and redness of upper left arm at injection site for 5 days and redness, swelling and pain in left elbow for 7 days to date.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint swelling
Clinical narrative: Severe swelling, pain and redness of upper left arm at injection site for 5 days and redness, swelling and pain in left elbow for 7 days to date.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Induration, Mass, Pruritus
Clinical narrative: Mom stated it is a really hard lump, size is about a inch, minimal pinkish color, very itchy but, stated that itchiness had went away just the  hard lump is still there, no increase in size, and minimal warmth.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: received Havrix that had been exposed to a freezing excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received HAV (Havrix) (batch number 5575N, expiry date 19th June 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. A medical assistant reported that the patient received Havrix that had been exposed to a freezing excursion, which led to incorrect storage of drug. The reporter consented to follow up. This is 1 of 11 cases reported by same reporter.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Fatigue, Herpes zoster, Neck pain, Oral candidiasis
Clinical narrative: suspected Vaccination failure; the outbreak was behind her right ear and on the facial nerves/Shingles (herpes zoster); rash was in her mouth; fatigued; This case was reported by a consumer and described the occurrence of vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case medically confirm). The patient had received the vaccine on 11 February 2019 and 25 April 2019, the patient suffered no symptoms after the first vaccine shot on 11 February 2019. On 25 April 2019, the patient had vaccine, the patient experienced symptoms the next day after the second shot like severe back and neck pain, rashes, ears started ringing, ears were buzzing (tinnitus), broke out in hives on neck and chest, thrush in mouth, itching. The patient was diagnosed with the Shingles (herpes zoster) on 2 May 2019, refer case US2020GSK100538. The patient suffered another outbreak on 23 October 2019 and went to the urgent care, the outbreak was behind her right ear and on the facial nerves. She also stated the rash was in her mouth, and she was greatly fatigued.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020GSK100538:same patient
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral mucosal eruption, Pruritus, Rash, Tinnitus, Urticaria
Clinical narrative: suspected Vaccination failure; the outbreak was behind her right ear and on the facial nerves/Shingles (herpes zoster); rash was in her mouth; fatigued; This case was reported by a consumer and described the occurrence of vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case medically confirm). The patient had received the vaccine on 11 February 2019 and 25 April 2019, the patient suffered no symptoms after the first vaccine shot on 11 February 2019. On 25 April 2019, the patient had vaccine, the patient experienced symptoms the next day after the second shot like severe back and neck pain, rashes, ears started ringing, ears were buzzing (tinnitus), broke out in hives on neck and chest, thrush in mouth, itching. The patient was diagnosed with the Shingles (herpes zoster) on 2 May 2019, refer case US2020GSK100538. The patient suffered another outbreak on 23 October 2019 and went to the urgent care, the outbreak was behind her right ear and on the facial nerves. She also stated the rash was in her mouth, and she was greatly fatigued.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020GSK100538:same patient
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected Vaccination failure; the outbreak was behind her right ear and on the facial nerves/Shingles (herpes zoster); rash was in her mouth; fatigued; This case was reported by a consumer and described the occurrence of vaccination failure in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case medically confirm). The patient had received the vaccine on 11 February 2019 and 25 April 2019, the patient suffered no symptoms after the first vaccine shot on 11 February 2019. On 25 April 2019, the patient had vaccine, the patient experienced symptoms the next day after the second shot like severe back and neck pain, rashes, ears started ringing, ears were buzzing (tinnitus), broke out in hives on neck and chest, thrush in mouth, itching. The patient was diagnosed with the Shingles (herpes zoster) on 2 May 2019, refer case US2020GSK100538. The patient suffered another outbreak on 23 October 2019 and went to the urgent care, the outbreak was behind her right ear and on the facial nerves. She also stated the rash was in her mouth, and she was greatly fatigued.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020GSK100538:same patient
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin exfoliation
Clinical narrative: Bleeding; Losing skin on hands and feet; Losing finger and toe nails; Excessive pain; Allergic reaction; Eczema; This is spontaneous report received from a contactable consumer (patient).  A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL3249), via an unspecified route of administration on 21Jan2021 on the right arm at 02:00 pm as a single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EJ1685), via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced bleeding, was losing skin on hands and feet, losing finger and toenails. The patient also had excessive pain, and also had a allergic reaction. Caller stated that he had an allergic reaction to the vaccine in January and was still having these side effects. The patient visited emergency room and physician office due to the events. The case was assessed as serious (medically significant). Patient's lab tests and Investigation results on an unknown date on Biopsy of skin on hands and feet revealed Eczema. Lot of blood work (uknown) done. The patient did not receive any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts needed. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Blood test, Chest X-ray, Dry skin, Skin exfoliation
Clinical narrative: Bleeding; Losing skin on hands and feet; Losing finger and toe nails; Excessive pain; Allergic reaction; Eczema; This is spontaneous report received from a contactable consumer (patient).  A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL3249), via an unspecified route of administration on 21Jan2021 on the right arm at 02:00 pm as a single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EJ1685), via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced bleeding, was losing skin on hands and feet, losing finger and toenails. The patient also had excessive pain, and also had a allergic reaction. Caller stated that he had an allergic reaction to the vaccine in January and was still having these side effects. The patient visited emergency room and physician office due to the events. The case was assessed as serious (medically significant). Patient's lab tests and Investigation results on an unknown date on Biopsy of skin on hands and feet revealed Eczema. Lot of blood work (uknown) done. The patient did not receive any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts needed. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin fissures
Clinical narrative: Bleeding; Losing skin on hands and feet; Losing finger and toe nails; Excessive pain; Allergic reaction; Eczema; This is spontaneous report received from a contactable consumer (patient).  A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL3249), via an unspecified route of administration on 21Jan2021 on the right arm at 02:00 pm as a single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EJ1685), via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced bleeding, was losing skin on hands and feet, losing finger and toenails. The patient also had excessive pain, and also had a allergic reaction. Caller stated that he had an allergic reaction to the vaccine in January and was still having these side effects. The patient visited emergency room and physician office due to the events. The case was assessed as serious (medically significant). Patient's lab tests and Investigation results on an unknown date on Biopsy of skin on hands and feet revealed Eczema. Lot of blood work (uknown) done. The patient did not receive any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts needed. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Eczema, Haemorrhage, Hypersensitivity, Onycholysis
Clinical narrative: Bleeding; Losing skin on hands and feet; Losing finger and toe nails; Excessive pain; Allergic reaction; Eczema; This is spontaneous report received from a contactable consumer (patient).  A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL3249), via an unspecified route of administration on 21Jan2021 on the right arm at 02:00 pm as a single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EJ1685), via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced bleeding, was losing skin on hands and feet, losing finger and toenails. The patient also had excessive pain, and also had a allergic reaction. Caller stated that he had an allergic reaction to the vaccine in January and was still having these side effects. The patient visited emergency room and physician office due to the events. The case was assessed as serious (medically significant). Patient's lab tests and Investigation results on an unknown date on Biopsy of skin on hands and feet revealed Eczema. Lot of blood work (uknown) done. The patient did not receive any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts needed. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Skin exfoliation
Clinical narrative: Bleeding; Losing skin on hands and feet; Losing finger and toe nails; Excessive pain; Allergic reaction; Eczema; This is spontaneous report received from a contactable consumer (patient).  A 49-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EL3249), via an unspecified route of administration on 21Jan2021 on the right arm at 02:00 pm as a single dose for COVID-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection: Lot number: EJ1685), via an unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced bleeding, was losing skin on hands and feet, losing finger and toenails. The patient also had excessive pain, and also had a allergic reaction. Caller stated that he had an allergic reaction to the vaccine in January and was still having these side effects. The patient visited emergency room and physician office due to the events. The case was assessed as serious (medically significant). Patient's lab tests and Investigation results on an unknown date on Biopsy of skin on hands and feet revealed Eczema. Lot of blood work (uknown) done. The patient did not receive any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts needed. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dizziness, Incorrect dose administered, Injection site pain
Clinical narrative: Dizziness; Chills; Headache; body aches; nausea; loss of Appetite; general malaise; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Feb2021 10:15 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included Minor digestive difficulties. Concomitant medication(s) included Lipitor 10 mg, vitamin C, calcium supplement. Known allergies reported as amoxicillin, sulfa drugs. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 07Feb2021 18:15, administration site (left arm) for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received. The patient was not tested positive prior vaccination. The patient experienced dizziness, chills, headache, body aches, nausea, loss of appetite, general malaise on 28Feb2021 22:00. The outcome for all events was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Nausea
Clinical narrative: Dizziness; Chills; Headache; body aches; nausea; loss of Appetite; general malaise; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Feb2021 10:15 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included Minor digestive difficulties. Concomitant medication(s) included Lipitor 10 mg, vitamin C, calcium supplement. Known allergies reported as amoxicillin, sulfa drugs. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 07Feb2021 18:15, administration site (left arm) for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received. The patient was not tested positive prior vaccination. The patient experienced dizziness, chills, headache, body aches, nausea, loss of appetite, general malaise on 28Feb2021 22:00. The outcome for all events was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Malaise
Clinical narrative: Dizziness; Chills; Headache; body aches; nausea; loss of Appetite; general malaise; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Feb2021 10:15 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included Minor digestive difficulties. Concomitant medication(s) included Lipitor 10 mg, vitamin C, calcium supplement. Known allergies reported as amoxicillin, sulfa drugs. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 07Feb2021 18:15, administration site (left arm) for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received. The patient was not tested positive prior vaccination. The patient experienced dizziness, chills, headache, body aches, nausea, loss of appetite, general malaise on 28Feb2021 22:00. The outcome for all events was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain
Clinical narrative: Dizziness; Chills; Headache; body aches; nausea; loss of Appetite; general malaise; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 28Feb2021 10:15 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. Medical history included Minor digestive difficulties. Concomitant medication(s) included Lipitor 10 mg, vitamin C, calcium supplement. Known allergies reported as amoxicillin, sulfa drugs. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 07Feb2021 18:15, administration site (left arm) for covid-19 immunisation. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received. The patient was not tested positive prior vaccination. The patient experienced dizziness, chills, headache, body aches, nausea, loss of appetite, general malaise on 28Feb2021 22:00. The outcome for all events was recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Ageusia, Anosmia, Arthralgia
Clinical narrative: increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Burning sensation, Chest pain, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dehydration, Electrocardiogram, Metabolic function test, Paraesthesia, Ultrasound biliary tract
Clinical narrative: increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood pressure increased, Blood pressure measurement, Burning feet syndrome, Chest discomfort
Clinical narrative: increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Dehydration, Electrocardiogram, Paraesthesia, SARS-CoV-2 test
Clinical narrative: increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound biliary tract
Clinical narrative: increased blood pressure; pressure center sternum; tingly limbs; bottoms of feet felt slapped/burned; pain behind r. knee; dehydration; This is a spontaneous report from a contactable consumer (patient). A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6201) via an unspecified route of administration on 17Feb2021 at 15:00 (age at vaccination 57-year-old) at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient's medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL3302) on 27Jan2021 via an unspecified route of administration in right arm at single dose for covid-19 immunization. On 22Feb2021 at 14:00 patient experienced increased blood pressure, pressure centre sternum, tingly limbs, bottoms of feet felt slapped/burned, pain behind right knee and dehydration. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment included computerised tomogram of abdomen and pelvis, electrocardiogram and ultrasound gallbladder (Right Upper Quadrant) RUQ. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 22Feb2021, computerised tomogram of abdomen and pelvis: unknown results, electrocardiogram: unknown results, sars-cov-2 test: negative on 01Mar2021, ultrasound Gallbladder right upper quadrant (RUQ): unknown result. The outcome of event was not recovered.  No follow-up attempts are possible. No further information expected.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular, Rash papular
Clinical narrative: Diffuse red splotches that appeared like severe sunburn; Rash appeared as red, raised areas causing itching and burning; Rash appeared as red, raised areas causing itching and burning; Raised hive like areas; itching - mostly on face, neck and head which were the areas most recently to erupt; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6200), via an unspecified route of administration, administered in right arm on 23Feb2021 (at the age of 85 years old), at second dose, single dose for COVID-19 immunisation. Medical history included atrial fib, CAD, DM type 2, implanted pacer/defib, gout, and known allergies to Sulfa. Concomitant medications included glipizide, amiodarone, apixaban (ELIQUIS), propranolol hydrochloride (INDERAL), levothyroxine, atorvastatin, furosemide (LASIX), and lisinopril. On 04Mar2021, rash developed in groin area and forearms 9 days after the second injection. Rash appeared as red, raised areas causing itching and burning. Rash continued to evolve migrating to abdomen, chest, legs, buttocks, back, face and head between 05Mar2021 and 09Mar2021. Raised hive like areas would morph into diffuse red splotches that appeared like severe sunburn, usually within 24-48 hrs. The patient consulted his physician on 05Mar2021, and cortisone 120 mg injection was administered with further direction to take diphenhydramine (BENADRYL).On 08Mar2021, cetirizine (ZYRTEC) was added to the regimen. As of report date, the patient was still experiencing itching - mostly on face, neck and head which were the areas most recently to erupt. The patient has no other symptoms other than those related to the rash. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit, and treatment received included cortisone injection, BENADRYL, and ZYRTEC. The patient had no COVID prior vaccination and was not COVID tested post vaccination. The patient experienced only soreness in arm following first injection of BNT162B2 given for COVID-19 immunisation. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.