chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash macular, Rash pruritic, Retching
Clinical narrative: generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID.  The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Upper-airway cough syndrome
Clinical narrative: generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID.  The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: She is anaphylactic to some ingredients of the pneumonia shot a few years ago; This is a spontaneous report from a contactable consumer (parent). A female patient (daughter) received Pneumococcal 13-Val Conj Vac (Dipht Crm197 Protein) (Lot/Batch Number and Expiration Date unknown) via unspecified route of administration on an unspecified date at single dose for immunisation.  The patient's medical history and concomitant medications was not reported. Patient was a front liner and was supposed to get the vaccine last week. However, she was anaphylactic to some ingredients of the pneumonia shot a few years before unspecified date, but does not know which specific ingredient. Patient wanted to know the ingredients of the covid vaccine so that they may cross check it with their pharmacist. The outcome of event was unknown.  Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  Information on the batch number has been requested.; Sender's Comments: A possible causal association between administration of Pneumococcal 13-Val Conj Vaccine and the onset of anaphylactic reaction might not be fully excluded, considering the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives first on my lower back and right temple later that evening many hives on my left arm hand and left foot late that night developed more hives on my right foot  the next day more hives on my right hand and left right arm still developing new hives but the older ones are getting  better
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pain in extremity
Clinical narrative: headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 18Dec2020 15:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma and diagnosed with COVID-19 prior to vaccination. Patient has unspecified allergies. Unspecified concomitant medication were taken (List of any other medications the patient received within 2 weeks of vaccination: Yes). The patient experienced fever 102.7, Chills, vomiting, arm pain body aches and headache on 19Dec2020 03:00. No treatment received for the events. The outcome of the events was recovered with sequelae (Recovered with lasting effects). The events were considered as non-serious. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 08Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: headache; fever 102.7; Chills; vomiting; arm pain; body aches; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 18Dec2020 15:00 at a single dose on left arm for COVID-19 immunization. Medical history included asthma and diagnosed with COVID-19 prior to vaccination. Patient has unspecified allergies. Unspecified concomitant medication were taken (List of any other medications the patient received within 2 weeks of vaccination: Yes). The patient experienced fever 102.7, Chills, vomiting, arm pain body aches and headache on 19Dec2020 03:00. No treatment received for the events. The outcome of the events was recovered with sequelae (Recovered with lasting effects). The events were considered as non-serious. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140), intramuscular on 08Jan2021 at a single dose for COVID-19 immunization. The patient was not pregnant at time of vaccination. Since the vaccination, the patient has not been tested for COVID-19. Location of injection information is available for all vaccines received on the same date.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I tested positive for COVID 8 days after my first dose.; I tested positive for COVID 8 days after my first dose.; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got his first dose of Pfizer COVID 19 vaccine 21 days ago in Dec2020. He mentioned that he tested positive for COVID 8 days after his first dose in Dec2020. He stated that he got the second dose yesterday (unspecified date) and queried if should he not have gotten it. The outcome of the events was unknown.  Information about Lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Arthralgia, Computerised tomogram head, Electrocardiogram, Fatigue
Clinical narrative: 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Full blood count, Headache, Magnetic resonance imaging brain, Metabolic function test
Clinical narrative: 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain, Pregnancy test, Pyrexia
Clinical narrative: 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Restlessness, Troponin, Urticaria, Vertigo, Vestibular neuronitis
Clinical narrative: 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling cold, Headache, Influenza like illness, Laboratory test
Clinical narrative: 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain, Pyrexia, Restlessness
Clinical narrative: 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, Somnolence, Urticaria, Vestibular neuronitis, Vomiting
Clinical narrative: 9th: cold (?fever?), restless, body aches (especially headache, neck pain, bilateral knee pain), nausea, vomiting 10th: profound fatigue, hives, intermittent vertigo 11-17th: vertigo, mild headache and neck pain, nausea, vomiting 18th-current: vertigo, nausea, vomiting *Hospitalized from 17-18th, diagnosed with vestibular neuritis secondary to the vaccine
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: I experienced extreme vertigo and dizziness on 1/17/21, the day after my first vaccination.  It lasted most of the day and subsided later that evening.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: I experienced extreme vertigo and dizziness on 1/17/21, the day after my first vaccination.  It lasted most of the day and subsided later that evening.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable 39-year-old male healthcare professional reported to have received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Jan2021, after the first dose of vaccine, the patient felt sick at some point, so he took a rapid test which came back positive. He stated that the test if testing the antigens (as reported). Antibody testing was not currently recommended to assess for immunity to COVID-19 following Pfizer-BioNTech COVID-19 vaccination. Events outcome was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Coronavirus test positive
Clinical narrative: 13 people, who were applied the vaccine previously, were corona positive after a week; 13 people, who were applied the vaccine previously, were corona positive after a week; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 13 patients. This is first of 13 reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiration date: not known), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that 13 people, who were applied the vaccine previously, were corona positive after a week on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018408 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018409 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018410 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018411 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018412 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018413 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018414 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018415 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018416 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018417 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018418 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018419 same reporter, similar suspect drug and event; different patient;US-PFIZER INC-2021018410 same reporter, similar suspect drug and event; different patient.;US-PFIZER INC-2021018412 same reporter, similar suspect drug and event; different patient.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling at injection site, red, hard, itching. Happened 8 days after first dose.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Vaccination site pain
Clinical narrative: headaches; Right deltoid is very tender to touch at injection site; A little weak feeling running to right shoulder blade; This is a spontaneous report from a contactable pharmacist reporting for himself. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL1284), intramuscular (right arm) on 08Jan2021 07:15 at SINGLE DOSE for COVID-19 immunization. The patient's other medical history was not reported. The vaccine was given at hospital. No other vaccines in four weeks. Patient did not have COVID-19 prior vaccination and was not tested for COVID-19 after vaccination. Patient has no known allergies. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot: EJ1685) on 21Dec2020 07:15, left arm at single dose and experienced headaches, general malaise, moderate soreness at left deltoid running down thru left shoulder and mid back on 21Dec2020 18:00, with no treatment given. Concomitant medication included krill oil and an unspecified multivitamin; unspecified dates and indication. On the second vaccine, patient experienced same headaches starting the evening of after getting second vaccine on 08Jan2021. Patient also experienced headaches feel exactly the same as before, seemingly in the middle, top half of head, right deltoid is very tender to touch at injection site, and a little weak feeling running to right shoulder blade all on unspecified date in Jan2021. No treatment was given. Outcome of the events was unknown. The reporter assessed the events as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Bone pain, Chills
Clinical narrative: Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6. Fever post Tylenol 100.8.; Racing heart rate recorded at 120 bpm; Severe chills; body ache; muscle and bone pain; muscle and bone pain; Shooting pains in various joints; Brief stomach pain; Sore axillary lymph node on side of injection arm; Sore arm at injection; dizziness; weakness; This is a spontaneous report from a non-contactable other HCP. A 31-year-old female patient received BNT162b2 (lot: EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. Medical history included covid (Previous covid was diagnosed with serology antibody test in doctors office. Not diagnosed with a covid test). The patient's concomitant medications were not reported. Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6 (Jan2021). Fever post Tylenol 100.8 (Jan2021). Racing heart rate recorded at 120 bpm (08Jan2021). Severe chills and body ache, including muscle and bone pain. Shooting pains in various joints. Brief stomach pain. Sore axillary lymph node on side of injection arm. Sore arm at injection site began 3/4 hours post injection (08Jan2021). All other symptoms began 11 hours post injection (08Jan2021). Continued dizziness and weakness 56 hours post injection (Jan2021). The patient was not pregnant at the time of vaccination. The outcome of the events was Resolved with Sequel in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Lymph node pain, Myalgia
Clinical narrative: Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6. Fever post Tylenol 100.8.; Racing heart rate recorded at 120 bpm; Severe chills; body ache; muscle and bone pain; muscle and bone pain; Shooting pains in various joints; Brief stomach pain; Sore axillary lymph node on side of injection arm; Sore arm at injection; dizziness; weakness; This is a spontaneous report from a non-contactable other HCP. A 31-year-old female patient received BNT162b2 (lot: EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. Medical history included covid (Previous covid was diagnosed with serology antibody test in doctors office. Not diagnosed with a covid test). The patient's concomitant medications were not reported. Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6 (Jan2021). Fever post Tylenol 100.8 (Jan2021). Racing heart rate recorded at 120 bpm (08Jan2021). Severe chills and body ache, including muscle and bone pain. Shooting pains in various joints. Brief stomach pain. Sore axillary lymph node on side of injection arm. Sore arm at injection site began 3/4 hours post injection (08Jan2021). All other symptoms began 11 hours post injection (08Jan2021). Continued dizziness and weakness 56 hours post injection (Jan2021). The patient was not pregnant at the time of vaccination. The outcome of the events was Resolved with Sequel in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6. Fever post Tylenol 100.8.; Racing heart rate recorded at 120 bpm; Severe chills; body ache; muscle and bone pain; muscle and bone pain; Shooting pains in various joints; Brief stomach pain; Sore axillary lymph node on side of injection arm; Sore arm at injection; dizziness; weakness; This is a spontaneous report from a non-contactable other HCP. A 31-year-old female patient received BNT162b2 (lot: EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. Medical history included covid (Previous covid was diagnosed with serology antibody test in doctors office. Not diagnosed with a covid test). The patient's concomitant medications were not reported. Fever for 36 hours even with use of Tylenol. Fever prior to Tylenol was recorded at 102.6 (Jan2021). Fever post Tylenol 100.8 (Jan2021). Racing heart rate recorded at 120 bpm (08Jan2021). Severe chills and body ache, including muscle and bone pain. Shooting pains in various joints. Brief stomach pain. Sore axillary lymph node on side of injection arm. Sore arm at injection site began 3/4 hours post injection (08Jan2021). All other symptoms began 11 hours post injection (08Jan2021). Continued dizziness and weakness 56 hours post injection (Jan2021). The patient was not pregnant at the time of vaccination. The outcome of the events was Resolved with Sequel in Jan2021.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Burning, itching and swelling at injection site 9 days after. Called nurse and was given steroid cream. Resolved swelling and itching in 2 days. Still red 2weeks later. No other symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test
Clinical narrative: After getting the first shot and the patient test positive for Corona virus; After getting the first shot and the patient test positive/perhaps positive; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a patient of unspecified age and gender started to receive BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration, first dose on an unspecified date at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. A pharmacist in a hospital wanted to know if after getting the first shot and the patient test positive for Corona virus, how long do they have to wait to get the second? A colleague is perhaps positive. He doesn't know if they got tested. Outcome of the events was unknown.   Information on the lot/ batch number has been requested.; Sender's Comments: A causal association between reported event and BNT162B2 cannot be excluded.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Feeling cold, Heart rate
Clinical narrative: cold sensation in back of head; trouble breathing; lightheadedness; racing heart; anxiety; This is a spontaneous report from a contactable nurse (patient).  A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231, expiry date: unknown), via an unspecified route of administration on 09Jan2021 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Infertility, IVF, known allergies: Penicillin. Patient is not pregnant. There were no concomitant medications.  Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. While driving home the patient experienced cold sensation in back of head, trouble breathing, lightheadedness, and racing heart. Paramedics called. Patient was better after 30minutes. They thought it was anxiety. They were asking if it was safe to get 2nd vaccine. The patient did not receive any treatment. Patient experienced the events on 09Jan2021 10:30.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included heart rate: racing heart on 09Jan2021. Outcome of the events was recovered on an unspecified date.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: cold sensation in back of head; trouble breathing; lightheadedness; racing heart; anxiety; This is a spontaneous report from a contactable nurse (patient).  A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231, expiry date: unknown), via an unspecified route of administration on 09Jan2021 10:00 at single dose (Left arm) for COVID-19 immunization. Medical history included Infertility, IVF, known allergies: Penicillin. Patient is not pregnant. There were no concomitant medications.  Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. While driving home the patient experienced cold sensation in back of head, trouble breathing, lightheadedness, and racing heart. Paramedics called. Patient was better after 30minutes. They thought it was anxiety. They were asking if it was safe to get 2nd vaccine. The patient did not receive any treatment. Patient experienced the events on 09Jan2021 10:30.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included heart rate: racing heart on 09Jan2021. Outcome of the events was recovered on an unspecified date.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site warmth, SARS-CoV-2 test negative
Clinical narrative: 1/17/2021: Sudden onset of redness around the site of injection 1 week and 1 day prior. Slightly warm to the touch but not terribly. Has not grown, but tends to vary degree of redness with body temperature.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Cough, Headache, Impaired work ability
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.  Information of lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Nausea, Pain, Productive cough
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.  Information of lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test positive, Sneezing
Clinical narrative: Tested positive for COVID; Tested positive for COVID; Phlegm in throat; Cough; Runny nose; cold; Sneezing; Body aches; Nausea; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 14:50 at single dose at right arm for covid-19 immunization. No additional vaccines administered on the same date. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing migraine. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN EXTRA STRENGTH) for migraine, patient had been alternating this with paracetamol (TYLENOL) while she has been recovering. She clarified the symptoms she experienced as the same day she got the vaccine that evening she had a headache on 29Dec2020. It eventually became a migraine and she left work early. On 30Dec2020 she had body aches, little nausea, and chills. On 31Dec2020, she had more chills, a runny nose, she felt like she was coming down with a cold. She was sneezing, had more chills, more body aches. On 01Jan2021 she felt like she noticed she had phlegm in her throat, but she did not have any pain. The phlegm was causing her to cough more. She had a runny nose the next morning as well. She did the rapid test for COVID on 02Jan2021 evening, and it was positive. She had a headache almost every day. The body aches had pretty much worn off. Runny nose and sneezing resolved in Jan2021. Phlegm in throat confirmed with no pain. This also resolved, as well as coughing. Outcome of event tested positive for COVID was unknown, outcome of event headache was not recovered. outcome of event nausea was recovered on 07Jan2021, event chills was recovered on 08Jan2021, outcome of other events was recovered on unspecified date in Jan2021. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care.  Information of lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Headache, Pain, Pyrexia
Clinical narrative: fever; joint pain; bad headache; body aches; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELI283;  expiry date: unknown) via an unspecified route of administration (arm left), on 06Jan2021 at 09:00, at a single dose, for COVID -19 immunisation (front line worker, taking care of sick patients with COVID). Relevant medical history included high blood pressure. The patient has no relevant concomitant medications. Family medical history included high blood pressure. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) at a single dose, for COVID -19 immunisation. Patient's weight was between 130 lbs and 140lbs. Patient reported side effects with second COVID-19 vaccine on 06Jan2021. Yesterday (07Jan2021), patient had high fever, joint pain, and bad headache. Right now, temperature was 100.6. Yesterday temperature was 39.5. Patient felt body aches night before (06Jan2021). Patient stated that probably, it was all in her mind. Then high fever was next day around 10:00-11:00. Patient stated that the reading effects (unspecified) are probably just a few days and will be gone. She was hoping it is just the way her body was reacting. Patient was taking ibuprofen for temperature (lot number: ODE2208A; expiry date: Feb2022). The patient wanted to know if this is a common side effect and if actual people are getting the same. Outcome of the events was unknown. The reporter assessed the events related to the suspect drug.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: fever; joint pain; bad headache; body aches; This is a spontaneous report from a contactable nurse. A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ELI283;  expiry date: unknown) via an unspecified route of administration (arm left), on 06Jan2021 at 09:00, at a single dose, for COVID -19 immunisation (front line worker, taking care of sick patients with COVID). Relevant medical history included high blood pressure. The patient has no relevant concomitant medications. Family medical history included high blood pressure. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) at a single dose, for COVID -19 immunisation. Patient's weight was between 130 lbs and 140lbs. Patient reported side effects with second COVID-19 vaccine on 06Jan2021. Yesterday (07Jan2021), patient had high fever, joint pain, and bad headache. Right now, temperature was 100.6. Yesterday temperature was 39.5. Patient felt body aches night before (06Jan2021). Patient stated that probably, it was all in her mind. Then high fever was next day around 10:00-11:00. Patient stated that the reading effects (unspecified) are probably just a few days and will be gone. She was hoping it is just the way her body was reacting. Patient was taking ibuprofen for temperature (lot number: ODE2208A; expiry date: Feb2022). The patient wanted to know if this is a common side effect and if actual people are getting the same. Outcome of the events was unknown. The reporter assessed the events related to the suspect drug.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia
Clinical narrative: red and swollen and HOT around injection site.  Was itchy but that passed.  Have a slight fever...
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive COVID test; Positive COVID test; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for 2 patients. This is the 2nd of 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was an Odontist and received COVID vaccine on Monday. He was scheduled to have a cath done on Thursday, but that was not happening now. The patient has positive COVID test. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021013678 same reporter/drug, similar event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Palpitations
Clinical narrative: slight headache; Nauseated; Palpitations; This is a spontaneous report from a contactable consumer (co-worker). This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received her first dose of bnt162b2 (BNT162B2 reported as Covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The reporter stated that her co-worker reported having a slight headache the first day and then started feeling nauseated. She stated she felt something about her chest like she felt palpitations in her heart. The patient declines she taken any treatment. The reporter stated that her co-worker was ok. The outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018865 same reporter/drug, similar events, different patient
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness
Clinical narrative: Tightening of the muscle at the injection site; This is a spontaneous report from a  contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced tightening of the muscle at the injection site on an unspecified date. Clinical outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Dyspnoea, Urticaria
Clinical narrative: Approximately 15 minutes after the vaccination the patient reported dizziness and possible rash on her upper chest. It was difficult to assess if the rash was truly a rash or it was simply skin lesions that were already present (patient claimed she did not know). It did not resemble a maculopapular rash. It marginally resembled minor hives/urticaria. Patient did not report any localized symptoms at injection site. Patient was informed to remain seated and that her vitals would be taken and she would be further observed. Then about 10 minutes after this (25 minutes after vaccination), patient reported difficulty breathing. Facial redness was noted at this point and patient's breathing sounded difficult. Emergency medical services were called and EpiPen was administered at this point. Patient began to tremble and pace of breathing increased. Emergency medical technicians arrived, took vitals / EKG, and assessed the patient. EMT assessment did not reveal urticaria. EMT instructed patient to control her breathing. The EMTs believe that it may not have been a true reaction but rather the patient may have been suffering from an anxiety attack. Patient was then taken to local ER for further evaluation.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dyspepsia, Gastric disorder, Illness, Laboratory test normal
Clinical narrative: Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization.  Medical history was none.  The patient's concomitant medications were not reported.  At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long.  She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.