chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreaks of herpes zoster; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and zoster-related conditions.  On an unspecified date, subsequent to the patient vaccination, the patient presented multiple outbreaks of herpes zoster. As a direct and proximate result, the patient had been treated by a medical provided. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered severe and permanent physical injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the event multiple outbreaks of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (first experienced when she was 21 years old and it developed 2 to 3 times a year since then).   On 9th July 2019, the patient received the 1st dose of Shingrix. On 9th July 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On 9th July 2019, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information was provided as follows: The patient reported pain at the injection site during administration of Shingrix in the left deltoid and said it lasted a few seconds and then resolved. For tolerance of 2nd dose, refer case US2020245637. The reporter consented to follow up. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020245637:same patient
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash spread on his face to his cheeks/rash spread to cheeks on face; This case was reported by a consumer via call center representative and described the occurrence of rash aggravated in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (On 10th September 2020, the patient received 1st dose, please refer the case US2020248551.). Concurrent medical conditions included rash.   On 7th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). In December 2020, less than a week after receiving Shingrix, the patient experienced rash aggravated. On an unknown date, the outcome of the rash aggravated was not recovered/not resolved.   It was unknown if the reporter considered the rash aggravated to be related to Shingrix.  Additional details were provided as follows: After the first Shingrix, the patient experienced rash on his forehead. The rash was unresolved when he received his second vaccine. After the second vaccine, he reported, the rash spread on his face to his cheeks. The patient permission to contact HCP; Sender's Comments:  US-GLAXOSMITHKLINE-US2020248551:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
Clinical narrative: performs a lot of activity with the arm the pain worsens at night / unable to move the arm due to the pain; had pain and some swelling at site of injection /  pain did not diminish but worsened; swelling at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 7TB74, expiry date unknown) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injection site pain, injection site swelling and injected limb mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however it could be 74 or 75 years. The patient experienced pain and some swelling at site of injection, first 4 to 5 days after the vaccination. Over the weeks, pain did not diminish but worsened and if the patient performs a lot of activity with the arm the pain worsens at night. Recently during the time of reporting, the patient was unable to move the arm due to the pain. The reporter consented to follow-up. This case had been linked with US2020231855, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231855:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Swelling of eyelid
Clinical narrative: Face swelled / with eyes almost shut; eye almost shut; This case was reported by a nurse via call center representative and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies (unspecified allergies).   On 19th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced facial swelling and swelling of eyelid. On an unknown date, the outcome of the facial swelling and swelling of eyelid were unknown.   The reporter considered the facial swelling and swelling of eyelid to be related to Shingrix. Additional details were provided as follows: The patient was reporter's mother. The patient had a medical history or unspecified allergies The age at vaccination was not reported. The patient was vaccinated with Shingrix and her face swelled. The reporter showed the GSK representative pictures of patient's face which was swollen and her eyes looked, in the picture, to be almost shut. The nurse was asking the sales representative if her mother should get the 2nd Shingrix shot or not. The reporter consent to follow up. No further information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse asked if there is any DVT cases reported following the administration of Pfizer-BioNTech COVID-19 Vaccine. E-transmitting duplicate AE caller already reported a DVT case post vaccination. Caller also asked "Why is there's a statement indicating that individuals with a history of bleeding disorder or taking anti-coagulant should contact their vaccination provider? How did they prove 95 % efficacy? Why aren't antibodies produced after the 1st dose of Covid-19 vaccine?" The outcome of the event DVT was unknown.  Information on Lot/batch number has been requested.; Sender's Comments: Very limited information was provided for this individual patient, such as pre-existing medical history, suspect administration details, clinical course and relevant supportive lab data for the reported Deep vein thrombosis (DVT). Pending further details, the Company would handle this reported DVT related to the administration of BNT162B2, COVID-19 immunization, for reporting purpose.   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 RA, IEC, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Headache, Irritability, Pharyngeal paraesthesia
Clinical narrative: throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: throat swelling; Initially had headache; dizziness; irritability; Throat tingling; difficulty swallowing; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EJ1685) as the first dose via an unspecified route of administration in the left arm on 29Dec2020 06:00 for COVID-19 immunization. Medical history included fibromyalgia, asthma, prediabetes, and carpal tunnel syndrome. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no previous allergies to vaccines. The patient allergies to medications which included: doxycycline, medroxyprogesterone acetate (DEPO-PROVERA), metoclopramide (REGLAN), gluten. The patient initially had headache, dizziness and irritability, throat tingling, throat swelling, and difficulty swallowing started around 12 hours after injection, event onset date reported as 29Dec2020 18:00. The events resulted in emergency room/ department or urgent care. The events were reported as non-serious by HCP. Treatment received for the events included diphenhydramine and hydroxyzine embonate (HYDROXYZINE PAMOATE). The outcome of the events was recovering.; Sender's Comments: The reported pharyngeal swelling together with other symptoms was likely related to the single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.  The case will be reassessed should additional information become available.  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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness neurosensory, Headache
Clinical narrative: Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; Moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection; This is a spontaneous report from a contactable physician (patient). A 37-year-old female non-pregnant patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 17:15 at single dose on her left arm for covid-19 immunization. Medical history included known allergies to penicillin. The patient had no other medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and the patient was not received list of any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced moderate to severe headache 24-48 hours post injection. Complete sensorineural hearing loss in left ear 1 week after injection on 23Dec2020. These events resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. The patient had received prednisone to treat the events. The outcome of the events was not recovered.; Sender's Comments: A possible contribution role of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of sensorineural hearing loss in left ear and headache cannot be excluded due to temporal relationship.  The case will be reassessed should additional information become available. 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: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarriage; patient was pregnant while taking BNT162B2; patient was pregnant while taking BNT162B2; This is a spontaneous report from a contactable Other Health Professional. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140), intramuscularly on 22Dec2020 06:00 AM at single dose at Arm Right at Hospital for COVID.  Medical history included ongoing sleep apnoea. There were no concomitant medications. There were no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced miscarriage on 29Dec2020 13:00.  The patient was pregnant while taking BNT162B2. The patient was 4 Weeks pregnant at the onset of the event.  Patient last menstrual period date was 24Nov2020. The Pregnancy due to deliver was on 07Sep2021. The pregnancy resulted in spontaneous abortion. Since the vaccination, the patient has been tested for COVID-19 on an unknown date with unknown results. Nasal Swab on 28Dec2020 was Negative. There was no treatment received for the adverse event. The outcome of event was recovering.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. 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 agency, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: DVT left calf; This is a spontaneous report from a contactable Physician (patient). A 60-year-old male patient started to receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular on 20Dec2020 08:00 at single dose on right arm for COVID-19 immunization. Medical history included Gastric reflux. The patient had no known allergies. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medications included omeprazole (PRILOSEC) and ergocalciferol (VIT D). The patient had not received other vaccine in four weeks. The patient experienced deep vein thrombosis (DVT) left calf on 27Dec2020 09:00 which resulted emergency room visit. Treatment received for the event included Xarelto. The outcome of the event was not resolved.   Information on the lot/batch number has been requested.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Acute kidney injury, Reaction to excipient, Renal failure
Clinical narrative: reaction to excipient; kidneys tried to shut down; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program.  A female patient of an unspecified age received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), and potassium (MANUFACTURER UNKNOWN); both via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history included ongoing kidney issues from an unknown date, allergic to antibiotics and pain pills from an unknown date and unknown if ongoing. Concomitant medications were not reported. On an unspecified date, the patient experienced: kidneys tried to shut down and reaction to excipient; which were assessed as medically significant. The consumer stated, "I looked at the ingredient list: potassium is listed. I have kidney issues and potassium is really bad, my kidneys tried to shut down on me. I'm allergic to "antibiotics and pain pills." The clinical outcome of the events, renal failure and reaction to excipient, was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: reported increased hand stiffness after vaccination; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. Medical history included psoriasis and psoriatic arthritis. The patient's concomitant medications were not reported. The patient previously took adalimumab (HUMIRA) and non compliant with Humira. The patient had psoriasis and psoriatic arthritis, reported increased hand stiffness after vaccination on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "psoriasis and psoriatic arthritis with increased hand stiffness after vaccination" and the administration of BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of psoriasis and psoriatic arthritis might have provided alternative explanations.   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 RA, IEC, as appropriate.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Pain in extremity, SARS-CoV-2 test positive, Ultrasound scan abnormal
Clinical narrative: Confirmed DVT in the left leg; COVID test (PCR swab): positive on 26Dec2020; COVID test (PCR swab): positive on 26Dec2020; This is a spontaneous report from a contactable other healthcare professional. An 85-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELO140, expiration date: Mar2021), via an unspecified route of administration in arm (deltoid; unknown side) on 23Dec2020 at single dose for Covid-19 immunisation. Medical history included type 2 diabetes mellitus from 2017 and ongoing, high blood pressure from 2017 and ongoing, atrial fibrillation (A-Fib) from 2019 and ongoing. The patient's concomitant medications were not reported. The patient was administered first dose of the COVID vaccine on 23Dec2020 and then was swabbed for COVID on 26Dec2020, and then on 28Dec2020 her PCR swab was positive for COVID. She was asymptomatic until she started complaining of leg pain. She ordered an ultrasound for the patient on 30Dec2020, and it confirmed a deep vein thrombosis (DVT) in left leg. The patient was being treated with anticoagulant apixaban (ELIQUIS) currently. Caller stated that this could be that it (DVT) is from COVID, but her real question was, could it be from the vaccine? In Pfizer's information packet for patients, there is section on what to tell your provider prior to getting vaccinated. One of the things on there is if you have a bleeding disorder or are on an anticoagulant. There is no explanation as to why it was in the packet of information. Caller has looked everywhere and can not figure out why that is on the FAQ/packet information. The patient was due for the second dose on 13Jan2020, but she was worried and hesitant to approve it. The patient underwent lab tests and procedures which included COVID test (PCR swab): positive on 26Dec2020, ultrasound of the left leg: confirmed DVT on 30Dec2020. The outcome of events was not recovered.; Sender's Comments: There is not a reasonable possibility that event "COVID test (PCR swab): positive" is related to BNT162B2 vaccine.  The event occurred 3 days after vaccination, when vaccine was not expected to achieve the effect.  The event DVT of legs is not considered related to BNT162B2 vaccine.  The patient had underlying diabetes and cardiovascular disorders, which are considered as risk factors for DVT. 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.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Diabetes mellitus, Diplopia, Headache, Laboratory test abnormal
Clinical narrative: diabetes was high; seeing double vision; Headache on the right side; This is a spontaneous report from a contactable nurse. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the vaccine in a hospital on a Friday (18Dec2020). No side effect was noted over the weekend. On 21Dec2020, when the patient woke up, s/he was seeing double vision, so s/he went to the doctor; they ran some test (unknown result). Because the patient was having headache on the right side in Dec2020, s/he went back to the doctor on 23Dec2020; the patient was sent to the eye doctor and they ran all kind of test. On 24Dec2020, the only thing they could find was that the patient's diabetes was high, so they kind of felt that what that could have been was kind of coincidental. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The mentioned "diabetes was high" is likely an intercurrent disease, unlikely related to the administration of BNT162B2, the COVID-19 immunization.   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 RA, IEC, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Palpitations, Tachycardia
Clinical narrative: Tachycardia; Palpitations; had a strong, whole body heat, and flushing; had a strong, whole body heat, and flushing; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 4th of 6 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 28Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend is a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardic and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. There is unknown whether the patient received the treatment or not. The outcome of the events was recovered on 28Dec2020.  Information on lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, feeling hot, tachycardia and palpitations. 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.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea, Tachycardia
Clinical narrative: It sounds like to be an allergic reaction; She passed out; Tachycardia; Nausea; Lightheadedness; This is a spontaneous report from a non-contactable physician. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Dec2020 at single dose to be vaccinated for her protection. Medical history was none. The patient's concomitant medications were not reported.  Patient took the Pfizer COVID-19 vaccine and next day she had a very serious reaction. She did not know that if it was due to the vaccine. But she had tachycardia requiring her to go to the emergency room and she passed out and she had nausea and lightheadedness as well. It sounds like to be an allergic reaction. Given the seriousness of tachycardia and passing out as well as the lightheadedness and nausea it sounds too severe just to be a mild immune response. So, it was sort of rare immune response or it was unrelated it was unknown at this time. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the compatible time association, the contribution of suspect BNT162B2 to the events cannot be excluded. 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.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Palpitations, Tachycardia
Clinical narrative: strong, whole body heat, and flushing; strong, whole body heat, and flushing; Tachycardia; Palpitations; This is a spontaneous report from a contactable Nurse. This Nurse reported for similar events for 6 patients. This is 2nd of 6 reports. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter said her friend was a registered nurse, and received the COVID-19 Vaccine on Monday, 28Dec2020. She said her friend stated she, and 5 other registered nurses she works with, had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient said she became tachycardia and had palpitations that lasted a few minutes. She said the tachycardia and palpitations then slowly resolved in less than 5 minutes. She had no other symptoms after receiving the COVID-19 Vaccine. It was unknown whether the patient received the treatment or not. The outcome of the events was recovered on 28Dec2020. Information on lot/batch number has been requested.; Sender's Comments: The reported transient events of whole body heat, flushing, tachycardia and palpitations were likely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship and clinic course. The case will be reassessed should additional information become available. 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.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patients.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Palpitations, Tachycardia
Clinical narrative: Serious, weird reaction/had a strong, whole body heat, and flushing; Serious, weird reaction/had a strong, whole body heat, and flushing; Serious, weird reaction/tachycardic; Serious, weird reaction/had palpitations; This is a spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is 5th of 6 reports.  A patient of unspecified gender and age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter did not know if the patient had received any other vaccines at the same time as the COVID-19 Vaccine, and if the patient had received any other vaccines within the last 4 weeks. It was reporter that the reporter's friend texted her last night, on 30Dec2020, at around midnight. The reporter, and 5 other registered nurses she works with in a hospital, received the COVID-19 vaccine at the same time and had the same exact symptoms she experienced. They had a serious reaction right after receiving the COVID-19 Vaccine. The patient had a weird reaction right after being injected with the COVID-19 Vaccine. The patient had a strong, whole body heat, and flushing. The patient became tachycardic and had palpitations that lasted a few minutes. The tachycardia and palpitations then slowly resolved in less than 5 minutes. The patient had no other symptoms after receiving the COVID-19 Vaccine. The registered nurse who was monitoring the people who received the COVID-19 Vaccine indicated that the same feeling had occurred in many other workers who had received the COVID-19 vaccine.  For treatment information, the reporter didn't believe the patient received any medical attention. Reporter believed that the patient just waited symptoms out, and within 5 minutes the symptoms had gone away. The outcome of the events was recovered on 28Dec2020.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events flushing, feeling hot, tachycardia and palpitations. 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.,Linked Report(s) : US-PFIZER INC-2021001345 same reporter/drug/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Limb mass
Clinical narrative: Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch; Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch; Back of my right leg has a quarter size oblong shape lump it's little bit red but not warm to the touch, it may be a blood clot; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 30Dec2020 18:30 SE for immunization. The patient's medical history and concomitant medications were not reported. Patient received the Pfizer Vaccine the day of reporting: 30Dec2020 at about 06:30 (tonight). Patient felt fine and still felt fine but when was going to rub some lotion on the back of right leg, has a quarter size oblong shaped lump (onset date not reported) which was little bit red but not warm to the touch. Patient didn't do anything to make it happen. Patient doesn't know if it may be a blood clot which was patient's question. "The blood clot something may be concerned about." Patient asked "Is this a blood clot, it could go to my heart and I could die tomorrow? So I am going to call my family doctor but thank you." The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: FLUX
Symptoms: Unevaluable event
Clinical narrative: after a flu shot that had numerous elements in it patient was allergic to; Initial information was received on 05-Jan-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via social media.  This case involves a patient of unknown age and after a flu shot that had numerous elements in it patient was allergic to (hypersensitivity), while patient received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient had numerous elements in it patient was allergic to (hypersensitivity).  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  Information on lot number was requested for this case.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu; Initial information was received on 05-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer.  This case is linked to case 2021SA003714 (same reporter).  This case involves male patient (unknown age) who got the flu (influenza), while he received INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious had the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received the rabies vaccine all three doses within the 30 days but not on schedule/No AE; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via call-center via Medical Information (Reference number- 00393542) and transmitted to Sanofi on 15-Dec-2020).  This case involves a female patient of unknown age who received all three doses of RAGE DIPLOIDE   VACCINE [IMOVAX RABIES] ((frequency, strength, lot number and expiry date unknown) via an unknown route within the 30 days but not on schedule (wrong schedule) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error case due to Inappropriate schedule of vaccine administered.  Reporter wanted to know the efficacy of the rabies vaccine when it had not been administered on time and received all three doses of RAGE DIPLOIDE  VACCINE [IMOVAX RABIES].  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling, itchiness at injection site (left deltoid) that began 7 days after injection
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood albumin decreased, Blood creatinine decreased, Blood glucose increased, Blood urea nitrogen/creatinine ratio increased, Blood urea normal
Clinical narrative: Patient presented to the ED with c/o of injection site reaction of firmness approximately baseball sized to the left deltoid and redness. This is not what triggered the visit. The reason for the visit was that she felt itchy all over, and this started at approximately 4:30 pm. Patient was given IV normal saline, benadryl 50 mg IM and Pepcid 20 mg IV. Patient had significant improvement in itching and was discharged from the ED at 6:10 pm.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Mean cell volume normal, Monocyte count normal, Monocyte percentage
Clinical narrative: Patient presented to the ED with c/o of injection site reaction of firmness approximately baseball sized to the left deltoid and redness. This is not what triggered the visit. The reason for the visit was that she felt itchy all over, and this started at approximately 4:30 pm. Patient was given IV normal saline, benadryl 50 mg IM and Pepcid 20 mg IV. Patient had significant improvement in itching and was discharged from the ED at 6:10 pm.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Red cell distribution width normal
Clinical narrative: Patient presented to the ED with c/o of injection site reaction of firmness approximately baseball sized to the left deltoid and redness. This is not what triggered the visit. The reason for the visit was that she felt itchy all over, and this started at approximately 4:30 pm. Patient was given IV normal saline, benadryl 50 mg IM and Pepcid 20 mg IV. Patient had significant improvement in itching and was discharged from the ED at 6:10 pm.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Parasthesia on injection arm and parasthesia on ipsilateral skull base
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: There is swelling, hardness, redness and pain at the site of injection with some itching. The area also feels warm compared to other arm.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: There is swelling, hardness, redness and pain at the site of injection with some itching. The area also feels warm compared to other arm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Woke up at 3am with the chills took my temp was 99.8.  Took my morning medicines and then some ibuprofen, was having body aches and severe chills.  Went back to bed and took my temp an hour later was 101.0.   Had body aches, chills, thirst, weakness, headache for the rest of the day.  Temperature went from 99.0 to the highest of 102.0.  Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs.  If not then I would need to get covid tested.  Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done.  It has been 24 hour since and now I no longer have a fever and am feeling better just tired.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Thirst
Clinical narrative: Woke up at 3am with the chills took my temp was 99.8.  Took my morning medicines and then some ibuprofen, was having body aches and severe chills.  Went back to bed and took my temp an hour later was 101.0.   Had body aches, chills, thirst, weakness, headache for the rest of the day.  Temperature went from 99.0 to the highest of 102.0.  Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs.  If not then I would need to get covid tested.  Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done.  It has been 24 hour since and now I no longer have a fever and am feeling better just tired.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Decreased appetite, Dysgeusia
Clinical narrative: Right after injection had  vaccine taste  in her mouth  bodycache, chills, headache, nosebleed left nostril,could not move had joint pain,  nausea and loss of  appetite  ,arm tenderness swollen" Popeye arm" temp 99.5
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Headache, Immediate post-injection reaction, Mobility decreased, Nausea
Clinical narrative: Right after injection had  vaccine taste  in her mouth  bodycache, chills, headache, nosebleed left nostril,could not move had joint pain,  nausea and loss of  appetite  ,arm tenderness swollen" Popeye arm" temp 99.5
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Tenderness
Clinical narrative: Right after injection had  vaccine taste  in her mouth  bodycache, chills, headache, nosebleed left nostril,could not move had joint pain,  nausea and loss of  appetite  ,arm tenderness swollen" Popeye arm" temp 99.5
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1 week out injection site red, warm, swollen, itchy, slightly painful visiting PCP January 11th.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Human chorionic gonadotropin negative, Nausea, Retching
Clinical narrative: dry heaving and nausea
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling abnormal, Migraine, Nausea
Clinical narrative: On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches.  Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous.  Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am  some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone  97.4.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: On 1/5/21 pm sore arm . On 1/5/21 noontime 1000 mg Tylenol. On 1/6/21 5 am body aches during early am got up at 5 am. Took Tylenol 1000mg. Went to work. Around 9am of 1/6/21 chills more pronounced body aches.  Temp 99.3. Continued to feel poorly, rechecked temp 1.00 pm. Now 99.9. Sent home. At 2:15 pm temp 104.00. More severe chills and body pain, nauseous.  Toast for dinner, Tylenol again at 6 pm , recheck temp 100.8. Went to bed. 1/7/22 am  some body aches, not as severe, nauseous and migrai. Type headache. Did no take temp, because didn't feel one. Call to nurse at covid vaccine holiness. Check temp while on phone  97.4.