chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Stridor, Swelling face
Clinical narrative: delayed anaphylaxis; This is a spontaneous report from a contactable other-HCP (patient) reported for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Brand= Pfizer), dose 2 intramuscularly, administered in arm right on 21Jan2021 (lot number: EJ1686) (30-year-old at vaccination) as single dose for COVID-19 immunisation. The patient was not pregnant. Facility type vaccine was hospital. Medical history included allergy induced asthma, known allergies: keflex, pine, amoxicillin, methyl methacrylate, adhesives, monocryl sutures, triclosan, tramadol. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Brand= Pfizer), dose 1 intramuscularly in left arm on 27Dec2021 (lot number: EL1284) (30-year-old at vaccination) for COVID-19 immunization. No COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced delayed anaphylaxis (hospitalization, life threatening) on 21Jan2021 16:15 with outcome of recovered in 2021. The patient was hospitalized for delayed anaphylaxis for 1 days. Delayed anaphylaxis requiring 4 epipens to be given and then started on an epinephrine drip for over 12 hours. AE resulted in: Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). No COVID tested post vaccination.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: delayed anaphylaxis; This is a spontaneous report from a contactable other-HCP (patient) reported for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Brand= Pfizer), dose 2 intramuscularly, administered in arm right on 21Jan2021 (lot number: EJ1686) (30-year-old at vaccination) as single dose for COVID-19 immunisation. The patient was not pregnant. Facility type vaccine was hospital. Medical history included allergy induced asthma, known allergies: keflex, pine, amoxicillin, methyl methacrylate, adhesives, monocryl sutures, triclosan, tramadol. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Brand= Pfizer), dose 1 intramuscularly in left arm on 27Dec2021 (lot number: EL1284) (30-year-old at vaccination) for COVID-19 immunization. No COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced delayed anaphylaxis (hospitalization, life threatening) on 21Jan2021 16:15 with outcome of recovered in 2021. The patient was hospitalized for delayed anaphylaxis for 1 days. Delayed anaphylaxis requiring 4 epipens to be given and then started on an epinephrine drip for over 12 hours. AE resulted in: Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). No COVID tested post vaccination.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: I noticed a very itchy rash on both forearms about 7 days after the second shot.; The rash continued to spread to my entire arms, back, chest, neck, past of face, legs, hips; Kept her up at night; This is a spontaneous report from a contactable Other HCP reported for herself. A 40-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6203), via an unspecified route in the left arm on 28Feb2021 at 09:15 (age at vaccination: 40-year-old), as a single dose for covid-19 immunization. Medical history included asthma, migraines and known allergies to Pink & red dyes (food colouring). Concomitant medications included vitamin b complex (B COMPLEX), vitamin D, cetirizine hydrochloride (ZYRTEC), drospirenone, ethinylestradiol (YASMIN) and Probiotic. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL9264), via an unspecified route in the left arm on 05Feb2021 at 16:45, as a single dose for covid-19 immunization. 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. Since the vaccination, patient has not been tested for COVID-19. On 07Mar2021, patient had minor covid arm the day after the second shot. She noticed a very itchy rash on both forearms about 7 days after the second shot. The rash continued to spread to her entire arms, back, chest, neck, part of face, legs, hips. It was incredibly itchy like poison ivy. Kept her up at night. On 10Mar2021, she went to doctor and started Rx cream and on 11Mar2021 continued to spread hence started steroids. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Insomnia, Rash, Rash pruritic
Clinical narrative: I noticed a very itchy rash on both forearms about 7 days after the second shot.; The rash continued to spread to my entire arms, back, chest, neck, past of face, legs, hips; Kept her up at night; This is a spontaneous report from a contactable Other HCP reported for herself. A 40-year-old non-pregnant female patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EN6203), via an unspecified route in the left arm on 28Feb2021 at 09:15 (age at vaccination: 40-year-old), as a single dose for covid-19 immunization. Medical history included asthma, migraines and known allergies to Pink & red dyes (food colouring). Concomitant medications included vitamin b complex (B COMPLEX), vitamin D, cetirizine hydrochloride (ZYRTEC), drospirenone, ethinylestradiol (YASMIN) and Probiotic. Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL9264), via an unspecified route in the left arm on 05Feb2021 at 16:45, as a single dose for covid-19 immunization. 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. Since the vaccination, patient has not been tested for COVID-19. On 07Mar2021, patient had minor covid arm the day after the second shot. She noticed a very itchy rash on both forearms about 7 days after the second shot. The rash continued to spread to her entire arms, back, chest, neck, part of face, legs, hips. It was incredibly itchy like poison ivy. Kept her up at night. On 10Mar2021, she went to doctor and started Rx cream and on 11Mar2021 continued to spread hence started steroids. The clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test normal, Body temperature fluctuation, Chills, Computerised tomogram normal
Clinical narrative: Muscle pain; weakness in arms and legs; joint pain; restless legs; dizziness; brain fog; cold/numb hands and feet; sensitive to hot and cold; irritability; fatigue; cold/numb hands and feet; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Jan2021 16:30 (at the age of 37 years) as dose 2, single for COVID-19 immunization (Hospital). Medical history included depression and anxiety. Concomitant medications included venlafaxine. The patient has no reported allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 07Jan2021 16:15 (at the age of 37 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 21:30 the patient experienced muscle pain, weakness in arms and legs, joint pain, restless legs, dizziness, brain fog, cold/numb hands and feet, sensitive to hot and cold, irritability and fatigue. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient received treatment for the events. On 05Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative. Patient had no covid prior vaccination. The patient had no other vaccine in four weeks. On an unknown date patient underwent test procedure includes blood tests, ekg and ct scan with an unknown result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Electrocardiogram normal, Feeling abnormal, Head discomfort, Headache
Clinical narrative: Muscle pain; weakness in arms and legs; joint pain; restless legs; dizziness; brain fog; cold/numb hands and feet; sensitive to hot and cold; irritability; fatigue; cold/numb hands and feet; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Jan2021 16:30 (at the age of 37 years) as dose 2, single for COVID-19 immunization (Hospital). Medical history included depression and anxiety. Concomitant medications included venlafaxine. The patient has no reported allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 07Jan2021 16:15 (at the age of 37 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 21:30 the patient experienced muscle pain, weakness in arms and legs, joint pain, restless legs, dizziness, brain fog, cold/numb hands and feet, sensitive to hot and cold, irritability and fatigue. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient received treatment for the events. On 05Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative. Patient had no covid prior vaccination. The patient had no other vaccine in four weeks. On an unknown date patient underwent test procedure includes blood tests, ekg and ct scan with an unknown result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Myalgia, Nausea, Palpitations, Paraesthesia
Clinical narrative: Muscle pain; weakness in arms and legs; joint pain; restless legs; dizziness; brain fog; cold/numb hands and feet; sensitive to hot and cold; irritability; fatigue; cold/numb hands and feet; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Jan2021 16:30 (at the age of 37 years) as dose 2, single for COVID-19 immunization (Hospital). Medical history included depression and anxiety. Concomitant medications included venlafaxine. The patient has no reported allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 07Jan2021 16:15 (at the age of 37 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 21:30 the patient experienced muscle pain, weakness in arms and legs, joint pain, restless legs, dizziness, brain fog, cold/numb hands and feet, sensitive to hot and cold, irritability and fatigue. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient received treatment for the events. On 05Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative. Patient had no covid prior vaccination. The patient had no other vaccine in four weeks. On an unknown date patient underwent test procedure includes blood tests, ekg and ct scan with an unknown result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Restless legs syndrome, Vitamin D decreased
Clinical narrative: Muscle pain; weakness in arms and legs; joint pain; restless legs; dizziness; brain fog; cold/numb hands and feet; sensitive to hot and cold; irritability; fatigue; cold/numb hands and feet; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Jan2021 16:30 (at the age of 37 years) as dose 2, single for COVID-19 immunization (Hospital). Medical history included depression and anxiety. Concomitant medications included venlafaxine. The patient has no reported allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 07Jan2021 16:15 (at the age of 37 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 21:30 the patient experienced muscle pain, weakness in arms and legs, joint pain, restless legs, dizziness, brain fog, cold/numb hands and feet, sensitive to hot and cold, irritability and fatigue. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient received treatment for the events. On 05Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative. Patient had no covid prior vaccination. The patient had no other vaccine in four weeks. On an unknown date patient underwent test procedure includes blood tests, ekg and ct scan with an unknown result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Muscle pain; weakness in arms and legs; joint pain; restless legs; dizziness; brain fog; cold/numb hands and feet; sensitive to hot and cold; irritability; fatigue; cold/numb hands and feet; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Jan2021 16:30 (at the age of 37 years) as dose 2, single for COVID-19 immunization (Hospital). Medical history included depression and anxiety. Concomitant medications included venlafaxine. The patient has no reported allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 07Jan2021 16:15 (at the age of 37 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 21:30 the patient experienced muscle pain, weakness in arms and legs, joint pain, restless legs, dizziness, brain fog, cold/numb hands and feet, sensitive to hot and cold, irritability and fatigue. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient received treatment for the events. On 05Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative. Patient had no covid prior vaccination. The patient had no other vaccine in four weeks. On an unknown date patient underwent test procedure includes blood tests, ekg and ct scan with an unknown result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Hypoaesthesia, Irritability, Muscular weakness
Clinical narrative: Muscle pain; weakness in arms and legs; joint pain; restless legs; dizziness; brain fog; cold/numb hands and feet; sensitive to hot and cold; irritability; fatigue; cold/numb hands and feet; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Jan2021 16:30 (at the age of 37 years) as dose 2, single for COVID-19 immunization (Hospital). Medical history included depression and anxiety. Concomitant medications included venlafaxine. The patient has no reported allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 07Jan2021 16:15 (at the age of 37 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 21:30 the patient experienced muscle pain, weakness in arms and legs, joint pain, restless legs, dizziness, brain fog, cold/numb hands and feet, sensitive to hot and cold, irritability and fatigue. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient received treatment for the events. On 05Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative. Patient had no covid prior vaccination. The patient had no other vaccine in four weeks. On an unknown date patient underwent test procedure includes blood tests, ekg and ct scan with an unknown result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasopharyngitis, Restless legs syndrome, SARS-CoV-2 test, Sensitive skin
Clinical narrative: Muscle pain; weakness in arms and legs; joint pain; restless legs; dizziness; brain fog; cold/numb hands and feet; sensitive to hot and cold; irritability; fatigue; cold/numb hands and feet; This is a spontaneous report from a contactable consumer (patient). A 37-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 28Jan2021 16:30 (at the age of 37 years) as dose 2, single for COVID-19 immunization (Hospital). Medical history included depression and anxiety. Concomitant medications included venlafaxine. The patient has no reported allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899, Expiry date: unknown) via an unspecified route of administration, administered in arm left on 07Jan2021 16:15 (at the age of 37 years) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 21:30 the patient experienced muscle pain, weakness in arms and legs, joint pain, restless legs, dizziness, brain fog, cold/numb hands and feet, sensitive to hot and cold, irritability and fatigue. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient received treatment for the events. On 05Mar2021 the patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative. Patient had no covid prior vaccination. The patient had no other vaccine in four weeks. On an unknown date patient underwent test procedure includes blood tests, ekg and ct scan with an unknown result. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is excepted.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid disorder, Facial paralysis, Feeling hot, Headache, Hypoaesthesia
Clinical narrative: The entire left side of my body was effected with muscle aches; numbness; pain; fever; woke up with night sweats; left leg muscles were very sore; left side of my face was hot and the right side was cool; headache only on the left side; left side of my face (lips, eyelids, cheeks, gums...) was swollen and mildly numb in places; my face still a bit swollen and sensitive; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration in left arm on 04Mar2021 at 14:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included known allergies to sulfa. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. On 04Mar2021 at 20:00, the patient experienced the entire left side of body was effected with muscle aches, numbness, pain, and fever but only the left side. Patient woke up with night sweats but only sweating on the left side, left leg muscles were very sore. The left side of face was hot and the right side was cool. Patient had a headache only on the left side. The left side of face (lips, eyelids, cheeks, gums) was swollen and mildly numb in places. This all lasted for 5 days off and on, getting milder every day. By the 5th day, it was just face still a bit swollen and sensitive. Patient did not receive treatment for the events. Patient needed advice if patient should get the next shot, or if her body was having a weird neurological reaction that she should not get the next dose. Patient mentioned that it had been 1 week and patient felt back to normal. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Limb discomfort, Muscle contracture, Night sweats, Swelling face
Clinical narrative: The entire left side of my body was effected with muscle aches; numbness; pain; fever; woke up with night sweats; left leg muscles were very sore; left side of my face was hot and the right side was cool; headache only on the left side; left side of my face (lips, eyelids, cheeks, gums...) was swollen and mildly numb in places; my face still a bit swollen and sensitive; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration in left arm on 04Mar2021 at 14:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included known allergies to sulfa. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. On 04Mar2021 at 20:00, the patient experienced the entire left side of body was effected with muscle aches, numbness, pain, and fever but only the left side. Patient woke up with night sweats but only sweating on the left side, left leg muscles were very sore. The left side of face was hot and the right side was cool. Patient had a headache only on the left side. The left side of face (lips, eyelids, cheeks, gums) was swollen and mildly numb in places. This all lasted for 5 days off and on, getting milder every day. By the 5th day, it was just face still a bit swollen and sensitive. Patient did not receive treatment for the events. Patient needed advice if patient should get the next shot, or if her body was having a weird neurological reaction that she should not get the next dose. Patient mentioned that it had been 1 week and patient felt back to normal. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling of body temperature change, Headache, Hypoaesthesia, Myalgia, Night sweats
Clinical narrative: The entire left side of my body was effected with muscle aches; numbness; pain; fever; woke up with night sweats; left leg muscles were very sore; left side of my face was hot and the right side was cool; headache only on the left side; left side of my face (lips, eyelids, cheeks, gums...) was swollen and mildly numb in places; my face still a bit swollen and sensitive; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration in left arm on 04Mar2021 at 14:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included known allergies to sulfa. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. On 04Mar2021 at 20:00, the patient experienced the entire left side of body was effected with muscle aches, numbness, pain, and fever but only the left side. Patient woke up with night sweats but only sweating on the left side, left leg muscles were very sore. The left side of face was hot and the right side was cool. Patient had a headache only on the left side. The left side of face (lips, eyelids, cheeks, gums) was swollen and mildly numb in places. This all lasted for 5 days off and on, getting milder every day. By the 5th day, it was just face still a bit swollen and sensitive. Patient did not receive treatment for the events. Patient needed advice if patient should get the next shot, or if her body was having a weird neurological reaction that she should not get the next dose. Patient mentioned that it had been 1 week and patient felt back to normal. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Sensitive skin, Swelling face
Clinical narrative: The entire left side of my body was effected with muscle aches; numbness; pain; fever; woke up with night sweats; left leg muscles were very sore; left side of my face was hot and the right side was cool; headache only on the left side; left side of my face (lips, eyelids, cheeks, gums...) was swollen and mildly numb in places; my face still a bit swollen and sensitive; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration in left arm on 04Mar2021 at 14:00 (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included known allergies to sulfa. Concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. On 04Mar2021 at 20:00, the patient experienced the entire left side of body was effected with muscle aches, numbness, pain, and fever but only the left side. Patient woke up with night sweats but only sweating on the left side, left leg muscles were very sore. The left side of face was hot and the right side was cool. Patient had a headache only on the left side. The left side of face (lips, eyelids, cheeks, gums) was swollen and mildly numb in places. This all lasted for 5 days off and on, getting milder every day. By the 5th day, it was just face still a bit swollen and sensitive. Patient did not receive treatment for the events. Patient needed advice if patient should get the next shot, or if her body was having a weird neurological reaction that she should not get the next dose. Patient mentioned that it had been 1 week and patient felt back to normal. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Rash/hives on back of neck; Rash/hives on back of neck; This is a spontaneous report from a contactable consumer. This 61-Years-old female consumer reported that:  A 61-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in Arm Left on 06Mar2021 18:15 (at the age of 61 years old) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications was not reported. It was reported that no other vaccine was administered in four weeks. Patient had taken Other medications in two weeks. Patient did not have Covid prior to vaccination. Covid tested post vaccination was no. Patient had no known allergies.The patient experienced rash/hives on back of neck 06Mar2021 21:00. Therapeutic measure were taken as no as a result of events. The outcome of events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives on back of neck; Rash/hives on back of neck; This is a spontaneous report from a contactable consumer. This 61-Years-old female consumer reported that:  A 61-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration, administered in Arm Left on 06Mar2021 18:15 (at the age of 61 years old) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications was not reported. It was reported that no other vaccine was administered in four weeks. Patient had taken Other medications in two weeks. Patient did not have Covid prior to vaccination. Covid tested post vaccination was no. Patient had no known allergies.The patient experienced rash/hives on back of neck 06Mar2021 21:00. Therapeutic measure were taken as no as a result of events. The outcome of events was not recovered.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dermatitis acneiform, Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: 150-200 red bumps mostly on my torso over past 1-1.5 days/ new bumps now on my legs and my arms; hives are itchy; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6198) via an unspecified route of administration on 23Feb2021 at 13:00 (at the age of 45-years-old) in right arm as a single dose for covid-19 immunization. Medical history included core HepB antibody positive (liver disease); AnBI (anoxic brain injury); hypertension all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No known allergies were reported. The patient did not receive any other vaccine in four weeks. The patient's concomitant medications in two weeks were reported as none. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number=EL9265) on 30Jan2021 at 16:45 in left arm for covid-19 immunization. On 09Mar2021 at 20:00, the patient experienced 150-200 red bumps mostly on his torso over past 1-1.5 days. He had new bumps on his legs and arms. Red bumps/hives were itchy, and some can be squeezed/popped. Last vaccine dose was more than 10 days ago. The patient was treated with Hydrocortisone cream and Benadryl. The outcome of both the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular, Urticaria
Clinical narrative: 150-200 red bumps mostly on my torso over past 1-1.5 days/ new bumps now on my legs and my arms; hives are itchy; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6198) via an unspecified route of administration on 23Feb2021 at 13:00 (at the age of 45-years-old) in right arm as a single dose for covid-19 immunization. Medical history included core HepB antibody positive (liver disease); AnBI (anoxic brain injury); hypertension all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No known allergies were reported. The patient did not receive any other vaccine in four weeks. The patient's concomitant medications in two weeks were reported as none. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number=EL9265) on 30Jan2021 at 16:45 in left arm for covid-19 immunization. On 09Mar2021 at 20:00, the patient experienced 150-200 red bumps mostly on his torso over past 1-1.5 days. He had new bumps on his legs and arms. Red bumps/hives were itchy, and some can be squeezed/popped. Last vaccine dose was more than 10 days ago. The patient was treated with Hydrocortisone cream and Benadryl. The outcome of both the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Circular induration: 3cm diameter Erythema Localized Pruritus; Circular induration: 3cm diameter Erythema Localized Pruritus; This is a spontaneous report from a contactable nurse (patient). A 68-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm on 02Mar2021 13:00 (at the age of 68-year-old) as dose 1, single for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included Exemestane (AROMASIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 post vaccination. On 10Mar2021 15:00 the patient experienced circular induration: 3cm diameter erythema localized pruritus. No treatment was received for the events. Outcome of all events were resolving.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Circular induration: 3cm diameter Erythema Localized Pruritus; Circular induration: 3cm diameter Erythema Localized Pruritus; This is a spontaneous report from a contactable nurse (patient). A 68-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in left arm on 02Mar2021 13:00 (at the age of 68-year-old) as dose 1, single for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Patient had no known allergies. Concomitant medications included Exemestane (AROMASIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had been not tested for COVID-19 post vaccination. On 10Mar2021 15:00 the patient experienced circular induration: 3cm diameter erythema localized pruritus. No treatment was received for the events. Outcome of all events were resolving.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Skin burning sensation
Clinical narrative: severe rash on neck; burning sensation on skin; Itchy skin; This is a spontaneous report from a contactable consumer or other non-health care professional(patient). A 66-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262, Expiry date: unknown) via an unspecified route of administration, administered in Arm Right on 17Feb2021 09:30 (at the age of 66-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient had no known allergies. The patient had not received any other vaccine within 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. Medical history included Environmental allergies, hypothyroidism, sleep apnea. Concomitant medication in two weeks included sertraline (SERTRALINE), azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE, diphenhydramine hydrochloride (BENADRYL) and Flonase (FLUTICASONE) taken for an unspecified indication, start and stop date were not reported. On 21Feb2021 18:15, Four days after first vaccine, the patient experienced severe rash on neck. Major symptom was burning sensation on skin and itchy skin. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6Z08, expiry date: not reported) via an unspecified route of administration, administered in Arm Right on 10Mar2021 as DOSE 2 SINGLE for COVID-19 immunization. Therapeutic measures steroid cream 2.5% was taken for the events. Adverse resulted in physician office visit. The outcome of the events was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash, Rash erythematous, Rash macular, Vaccine positive rechallenge
Clinical narrative: red blotchy rash and itching on face; red blotchy rash and itching on face; This is a spontaneous report from a contactable consumer or other non hcp. An 69-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 as 2 nd dose DOSE, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medications included fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient previously took amoxicillin and experienced drug hypersensitivity, oxycodone, and experienced drug hypersensitivity. The patient experienced red blotchy rash and itching on face on 10Feb2021, red blotchy rash and itching on face on 10Feb2021. Therapeutic measures were taken as a result of red blotchy rash and itching on face, red blotchy rash and itching on face. Exactly 2 weeks after 1st shot got a red blotchy rash and itching on face. Took benadryl for 2 days then Claritin for 2 days and it cleared up. Then exactly 2 weeks after 2nd shot got same rash and itching. Took Benadryl again for 2 days and claritin for 2 days and again it cleared up. The outcome of the events were recovered. No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: red blotchy rash and itching on face; red blotchy rash and itching on face; This is a spontaneous report from a contactable consumer or other non hcp. An 69-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 10:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Left on 17Feb2021 as 2 nd dose DOSE, SINGLE for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Concomitant medications included fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (D3) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccine in four weeks of vaccination. Patient did not receive other medications in two weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient previously took amoxicillin and experienced drug hypersensitivity, oxycodone, and experienced drug hypersensitivity. The patient experienced red blotchy rash and itching on face on 10Feb2021, red blotchy rash and itching on face on 10Feb2021. Therapeutic measures were taken as a result of red blotchy rash and itching on face, red blotchy rash and itching on face. Exactly 2 weeks after 1st shot got a red blotchy rash and itching on face. Took benadryl for 2 days then Claritin for 2 days and it cleared up. Then exactly 2 weeks after 2nd shot got same rash and itching. Took Benadryl again for 2 days and claritin for 2 days and again it cleared up. The outcome of the events were recovered. No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Cough, Dry skin, Fatigue, Injection site pain
Clinical narrative: Fatigue; Tingling in face, neck and hands; Tingling in face, neck and hands; Dryness in lips and hands; Dryness in lips and hands; Temperature 99.8; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 44-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6199) via an unspecified route of administration in left arm on 12Mar2021 10:30 as dose 1, single (at the age of 44 years-old) for COVID-19 immunization. Patient was not a pregnant at the time of vaccination. The patient was allergic to Cipro, Sulfa, Flagyl, Percocet. There were no concomitant medications. The vaccination facility type is reported as Pharmacy or Drug Store. Patient did not receive any other vaccine in four weeks and any other medications in two weeks. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19, post vaccination. The patient underwent lab tests and procedures which included body temperature: 99.8 on 12Mar2021. The patient experienced fatigue, tingling in face, neck and hands, dryness in lips and hands, temperature: 99.8 on 12Mar2021 17:00. No treatment received for the adverse events. The outcome of the adverse events was unknown.   No follow-up attempts are possible. No further information is expected.