chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th December 2020, the patient received Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received vaccine to prevent shingle and got shingles from the vaccine and the patient was still fighting them at the time of reporting. The patient would never take another shingle shot again. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Had the shot still had shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient had the shot still had shingles. The patient would not wish that on anyone. This case was considered as suspected vaccination failure since the details regarding dose number, time to onset and laboratory confirmation for shingles was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I got the vaccine but still got shingles / Suspected vaccination failure; I got the vaccine but still got shingles; Miserable; Terrible pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, feeling miserable and pain. On an unknown date, the outcome of the vaccination failure, shingles, feeling miserable and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, feeling miserable and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient got the vaccine but still got shingles, he/she was miserable and had terrible pain. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: After the second shot. Shingles really bad / Suspected vaccination failure; After the second shot. Shingles really bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient experienced really bad shingles and he/she still had them. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Feeling very light headed / Light headed 4 hours after 2nd shingles vaccine; This case was reported by a consumer via  interactive digital media and described the occurrence of light headedness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd May 2021, the patient received the 2nd dose of Shingrix. On 3rd May 2021, 4 hrs after receiving Shingrix, the patient experienced light headedness. On an unknown date, the outcome of the light headedness was unknown.   It was unknown if the reporter considered the light headedness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient felt light headed after the Shingrix vaccination. The follow-up would not possible as no contact details were available
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received three shots; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, a year ago of reporting date) and Shingrix (received 2nd dose, a year ago of reporting date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The health care provider reported that, the patient after having 2 doses already, received another dose of Shingrix recently, which lead to extra dose administered. No further information was provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: administer your vaccine subcutaneously instead of IM; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated, one immunizer administered Singrix vaccine subcutaneously instead of intramuscularly to the patient, which led to intramuscular formulation administered by other route. The reporter asked if any guidance was helpful, they were wondering if any harm was done and if patient should be getting her second dose again just to maintain full coverage. The reporter did not have DOB (date of birth) at time of chat and stopped responding when asked for more vaccine details (date of administration, lot and expiry date). No further information was reported The reporter was unable to obtain permission for follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose / on April 39th 2021 / first dose was / on March 12th 2021; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number F5XN2, expiry date 8th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th April 2021, the patient received the 2nd dose of Shingrix. On 29th April 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional information was provided as follows:  The patient received 1st dose of Shingrix on 12 March 2021. The nurse reported that the patient received 2nd dose of Shingrix, less than recommended interval, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Injection site pain, Pain, Product preparation issue
Clinical narrative: sore at the injection site; Pain; administered the diluent component; administered the diluent component; This case was reported by a pharmacist and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number F93YS, expiry date 8th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain, pain, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site pain, pain, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site pain and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist reported that the patient's arm was sore at the injection site, pain, but no other symptoms were reported by the patient.  The pharmacist consulted with medical information. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent of Shingrix; received only the diluent of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows:  The reporter was patient's daughter. The age at vaccination was not reported. The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, on the same day, patient received complete dose of Shingrix. The reporter declined to provide any information or a FU and mentioned that if the patient wants to provide any information they will call us back. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: September of 2020 when he received his first dose; This case was reported by a consumer and described the occurrence of social problem in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in Septmber 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional information was provided follows:  The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, as the patient stated the reason for missing 2nd dose as he had his Covid - 19 vaccine too close to his scheduled appointment for his second dose of Shingrix. The VAERS details for 1st dose were provided. The reporter consented to follow up.
Age: 42.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: on 03May2021 a patient / received an expired Boostrix / expired on 09Marc2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2774D, expiry date 9th March 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd May 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 3rd May 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided follows:  On 3rd May 2021, the  patient received Boostrix  which was expired on 9th March 2021. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received her first dose in April 2018 and the second dose on 5/2/2021.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in April 2018).   On 2nd May 2021, the patient received the 2nd dose of Shingrix. On 2nd May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional information was provided follows:  The patient received Shingrix more than recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the first dose of Shingrix 2 years ago and would like the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th April 2019, 2 years prior to reporting, batch number-X5XY4 and expiration date-2nd July 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The pharmacist called in on guidance of a Shingrix second dose.  The pharmacist stated  that the patient received the first dose of Shingrix 2 years ago and would like the second dose. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The healthcare professional (HCP) did not confirm a second dose being administered. The HCP wanted guidance on how to proceed with second dose. The reporter did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received HAV (Havrix) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided follows:  On 30th April 2021, the patient received Havrix, which was expired on 6th March 2021. The reported batch number 37RYN4 was not found in sales data sheet, hence correct batch number was updated as 37RY4 as per sales data sheet. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: received a dose of Bexsero instead of Menactra; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 30th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, the patient received a dose of Bexsero instead of Menactra, which led wrong vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: experienced shingles; only received the first dose; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In April 2021, the patient received COVID 19 VACCINE. On an unknown date, between 6 and 8 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient himself. The age at vaccination was not reported for 1st dose of Shingrix and Covid 19 vaccine and was not applicable for the 2nd dose of Shingrix. The patient received 1st dose of Shingrix and 4 weeks before reporting date, the patient received the covid vaccine and Less than 4 weeks after receiving dose of Covid 19 Vaccine, the patient experienced shingles. The patient was late for the 2nd dose and till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination. It was unknown if the reporter considered the shingles to be related to Covid 19 Vaccine. The reporter did not consent to follow up. No further information was reported.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: FEVER; HEADACHE; This spontaneous report received from a patient concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included runny nose, and sneezing, and concurrent conditions included seasonal allergies, consume alcohol, and non smoker. The patient experienced upset stomach when treated with ibuprofen, and oxycodone/paracetamol.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 100 to 101 degrees Fahrenheit. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 100 to 101 degrees Fahrenheit. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site swelling, Nausea
Clinical narrative: FLU-LIKE SYMPTOMS; NAUSEA; INJECTION SITE SWELLING; This spontaneous report received from a consumer concerned an adult female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced flu-like symptoms, nausea and injection site swelling. The action taken with covid-19 vaccine  was not applicable. The outcome of the flu-like symptoms, nausea and injection site swelling was not reported. This report was non-serious.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiovascular evaluation, Computerised tomogram thorax, Dizziness, Dyspnoea, Ear, nose and throat examination
Clinical narrative: DIZZINESS; SHORTNESS OF BREATH; PULMONARY EMBOLISM; This spontaneous report received from a physician concerned a 48 year old male. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. The batch number was not reported and has been requested.  No concomitant medications were reported. On APR-2021, the patient experienced pulmonary embolism.  Laboratory data included: Computerized tomogram thorax (NR: not provided) positive, Ear, nose and throat examination (NR: not provided) negative and Platelet count (NR: not provided) 197.  On 04-APR-2021, the patient experienced dizziness and shortness of breath. Full neuro, cardiac, Ear, nose and throat workup and evaluation was negative in Erectile dysfunction and follow up clinics. Patient had a Wells Criteria of zero, and was hemodynamically stable, platelet was 197. Patient started with DDIMER which was 560 and later chest Computerized tomogram thorax was positive for right lower lobe Pulmonary embolus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, shortness of breath and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s-Pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Haemodynamic test, Neurological examination, Platelet count, Pulmonary embolism
Clinical narrative: DIZZINESS; SHORTNESS OF BREATH; PULMONARY EMBOLISM; This spontaneous report received from a physician concerned a 48 year old male. The patients weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination. Vaccination site was not reported. The batch number was not reported and has been requested.  No concomitant medications were reported. On APR-2021, the patient experienced pulmonary embolism.  Laboratory data included: Computerized tomogram thorax (NR: not provided) positive, Ear, nose and throat examination (NR: not provided) negative and Platelet count (NR: not provided) 197.  On 04-APR-2021, the patient experienced dizziness and shortness of breath. Full neuro, cardiac, Ear, nose and throat workup and evaluation was negative in Erectile dysfunction and follow up clinics. Patient had a Wells Criteria of zero, and was hemodynamically stable, platelet was 197. Patient started with DDIMER which was 560 and later chest Computerized tomogram thorax was positive for right lower lobe Pulmonary embolus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, shortness of breath and pulmonary embolism was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: -Covid-19 vaccine ad26.cov2.s-Pulmonary embolism. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via social media through a company representative and concern a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: Unknown) dose, 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Covid-19 vaccine ad26.cov2.s-blood clots.This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebral venous thrombosis, Hypoaesthesia, Visual impairment
Clinical narrative: CEREBRAL VENOUS THROMBOSIS; VISUAL IMPAIRMENT; HYPOAESTHESIA/ NUMBNESS IN ARM; This spontaneous report was received from a health care professional  via a Regulatory Authority Vaccine Adverse event Reporting system (VAERS) (VAER reference number 1207958) and concerned a 64 year old male of unspecified race and ethnicity. The patient's height and weight were not reported. The patient's concurrent conditions included pollen allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported. 1 total, administered on 16-MAR-2021 for prophylactic vaccination on left arm. Concomitant medications included atorvastatin and lisinopril; both for unknown indication.  On 07-APR-2021, the patient experienced cerebral venous thrombosis, hypoaesthesia, and visual impairment. The patient had cerebrovascular thrombus with partial loss of sight and numbness of his left arm.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cerebral venous thrombosis, hypoaesthesia, visual impairment. This report was serious (Disability Or Permanent Damage).  This case version (1) was created on 30-APR-2021 for the purpose of quality improvement the following corrections were made. The MAC was added for the pharmacovigilance narrative.; Sender's Comments: V1: This spontaneous report was received from a health care professional via VAERS (ID: 1207958) and concerned a 64-year-old male of unspecified race and ethnicity who experienced cerebral venous sinus thrombosis (CVST) 22 days after vaccine. Concurrent conditions included pollen allergy and concomitant medications included atorvastatin and lisinopril. Twenty-two days after vaccine, the patient experienced CVST, hypoaesthesia, and visual impairment. The patient had cerebrovascular thrombus with partial loss of sight and numbness of his left arm. Specific imaging and laboratory results, including platelet count, were not reported. Information is limited in this case, and the occurrence of CVST could represent background incidence of such events in the general population. The platelet count is not reported and thus this case does not meet the Brighton Collaboration (BC) definition for Thrombocytopenia Thrombosis Syndrome (TTS) with BC Level 5 (not a case of TTS.)
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: SLIGHT CHILLS FOR FEW HOURS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On APR-2021, the subject experienced slight chills for few hours. The action taken with covid-19 vaccine  was not applicable. The patient recovered from slight chills for few hours on APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Paraesthesia
Clinical narrative: SEVERE DIZZINESS; WEIRD SENSATION IN HANDS; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-APR-2021, the subject experienced severe dizziness. On 25-APR-2021, the subject experienced weird sensation in hands. On 25-APR-2021, the subject experienced fatigue. On 25-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from headache on 27-APR-2021, and the outcome of severe dizziness, fatigue and weird sensation in hands was not reported. This report was non-serious.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability
Clinical narrative: INABILITY TO WALK/COULD NOT PICK HER LEG UP OR WALK; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 185000, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 17:00 for prophylactic vaccination.No concomitant medications were reported. On 26-MAR-2021, the subject experienced inability to walk/could not pick her leg up or walk. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from inability to walk/could not pick her leg up or walk. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test, Pain in extremity
Clinical narrative: NUMBNESS ON RIGHT FOOT; MILD BILATERAL LEG PAIN; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's past medical history included low platelet count, and low iron count, and concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known allergies the patient did not have any history of drug abuse or illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 16:00 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 2017, Laboratory data included: Laboratory test (NR: not provided) Low platelet count. On SEP-2020, Laboratory data included: Laboratory test (NR: not provided) Low IRON count. On 26-APR-2021, the subject experienced mild bilateral leg pain. On an unspecified date, the subject experienced numbness on right foot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild bilateral leg pain, and numbness on right foot. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Computerised tomogram, Depression, Electrocardiogram
Clinical narrative: PRESSURE BEHIND LEFT-SIDE OF HEAD; ANXIETY; DEPRESSION; SENSATION RADIATING FROM HEAD TO NECK; HIVES; FEVER; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies the patient did not have any history of illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced hives. On APR-2021, the subject experienced sensation radiating from head to neck. On APR-2021, the subject experienced depression. On an unspecified date, the subject experienced pressure behind left-side of head, and anxiety. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, CT scan (NR: not provided) NORMAL, EKG (NR: not provided) NORMAL, Heart rate variability test (NR: not provided) NORMAL, Pulmonary function test (NR: not provided) NORMAL, and Scan with contrast (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on 21-MAR-2021, and fever on 14-MAR-2021, and the outcome of sensation radiating from head to neck, pressure behind left-side of head, depression and anxiety was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503208.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Heart rate variability test, Pulmonary function test, Pyrexia, Scan with contrast
Clinical narrative: PRESSURE BEHIND LEFT-SIDE OF HEAD; ANXIETY; DEPRESSION; SENSATION RADIATING FROM HEAD TO NECK; HIVES; FEVER; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies the patient did not have any history of illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced hives. On APR-2021, the subject experienced sensation radiating from head to neck. On APR-2021, the subject experienced depression. On an unspecified date, the subject experienced pressure behind left-side of head, and anxiety. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, CT scan (NR: not provided) NORMAL, EKG (NR: not provided) NORMAL, Heart rate variability test (NR: not provided) NORMAL, Pulmonary function test (NR: not provided) NORMAL, and Scan with contrast (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on 21-MAR-2021, and fever on 14-MAR-2021, and the outcome of sensation radiating from head to neck, pressure behind left-side of head, depression and anxiety was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503208.
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance, Urticaria
Clinical narrative: PRESSURE BEHIND LEFT-SIDE OF HEAD; ANXIETY; DEPRESSION; SENSATION RADIATING FROM HEAD TO NECK; HIVES; FEVER; This spontaneous report received from a patient concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and non alcohol user, and other pre-existing medical conditions included the patient had no known drug allergies the patient did not have any history of illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced fever. On 14-MAR-2021, the subject experienced hives. On APR-2021, the subject experienced sensation radiating from head to neck. On APR-2021, the subject experienced depression. On an unspecified date, the subject experienced pressure behind left-side of head, and anxiety. Laboratory data (dates unspecified) included: Blood test (NR: not provided) normal, CT scan (NR: not provided) NORMAL, EKG (NR: not provided) NORMAL, Heart rate variability test (NR: not provided) NORMAL, Pulmonary function test (NR: not provided) NORMAL, and Scan with contrast (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hives on 21-MAR-2021, and fever on 14-MAR-2021, and the outcome of sensation radiating from head to neck, pressure behind left-side of head, depression and anxiety was not reported. This report was non-serious. This case, from the same reporter is linked to 20210503208.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose, Blood pressure measurement, Body temperature, Gait inability
Clinical narrative: THROBBING PAIN; UNABLE TO WALK (AFTER 4 HOURS OF VACCINATION); WAKE UP IN MIDDLE OF THE NIGHT (AFTER 4 HOURS OF VACCINATION); PAIN IN HIS SHOULDER AND ARM JOINTS; SEVERE HEADACHE/DULL PAIN ON TOP OF HEAD (AFTER 4 HOURS OF VACCINATION); FEVER; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 182 pounds, and height was 165 centimeters. The patient's concurrent conditions included high cholesterol level, diabetic, high blood pressure, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included naltrexone for alcohol dependence.  On 30-APR-2021, the subject experienced throbbing pain. On 30-APR-2021, the subject experienced unable to walk (after 4 hours of vaccination). On 30-APR-2021, the subject experienced wake up in middle of the night (after 4 hours of vaccination). On 30-APR-2021, the subject experienced pain in his shoulder and arm joints. On 30-APR-2021, the subject experienced severe headache/dull pain on top of head (after 4 hours of vaccination). On 30-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) burning, and Pain scale (NR: not provided) 10/10 pain level. On 01-MAY-2021, Laboratory data included: Pain scale (NR: not provided) 05/10 pain level. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 160 mg/dL, and Blood pressure (NR: not provided) 145/110 mmHg. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from severe headache/dull pain on top of head (after 4 hours of vaccination), and fever, had not recovered from pain in his shoulder and arm joints, and the outcome of throbbing pain, unable to walk (after 4 hours of vaccination) and wake up in middle of the night (after 4 hours of vaccination) was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain assessment, Pyrexia, Sleep disorder
Clinical narrative: THROBBING PAIN; UNABLE TO WALK (AFTER 4 HOURS OF VACCINATION); WAKE UP IN MIDDLE OF THE NIGHT (AFTER 4 HOURS OF VACCINATION); PAIN IN HIS SHOULDER AND ARM JOINTS; SEVERE HEADACHE/DULL PAIN ON TOP OF HEAD (AFTER 4 HOURS OF VACCINATION); FEVER; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight was 182 pounds, and height was 165 centimeters. The patient's concurrent conditions included high cholesterol level, diabetic, high blood pressure, alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 1805020, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. Concomitant medications included naltrexone for alcohol dependence.  On 30-APR-2021, the subject experienced throbbing pain. On 30-APR-2021, the subject experienced unable to walk (after 4 hours of vaccination). On 30-APR-2021, the subject experienced wake up in middle of the night (after 4 hours of vaccination). On 30-APR-2021, the subject experienced pain in his shoulder and arm joints. On 30-APR-2021, the subject experienced severe headache/dull pain on top of head (after 4 hours of vaccination). On 30-APR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) burning, and Pain scale (NR: not provided) 10/10 pain level. On 01-MAY-2021, Laboratory data included: Pain scale (NR: not provided) 05/10 pain level. Laboratory data (dates unspecified) included: Blood glucose (NR: not provided) 160 mg/dL, and Blood pressure (NR: not provided) 145/110 mmHg. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from severe headache/dull pain on top of head (after 4 hours of vaccination), and fever, had not recovered from pain in his shoulder and arm joints, and the outcome of throbbing pain, unable to walk (after 4 hours of vaccination) and wake up in middle of the night (after 4 hours of vaccination) was not reported. This report was non-serious.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Afterbirth pain, Fatigue, Memory impairment, Muscle tightness, Pain
Clinical narrative: FEELING TIRED; MEMORY LAPSES; REAL BAD BODY ACHES; MUSCLE TIGHTNING AS SHE WALKS; SEVERE POST PARTUM SHINGLES PAIN  ACTIVATED; This spontaneous pregnancy report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included drug allergy. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced severe post partum shingles pain activated. On 26-APR-2021, the subject experienced muscle tightning as she walks. On 28-APR-2021, the subject experienced memory lapses. On 28-APR-2021, the subject experienced real bad body aches. On an unspecified date, the subject experienced feeling tired. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from real bad body aches, had not recovered from muscle tightning as she walks, severe post partum shingles pain activated, and memory lapses, and the outcome of feeling tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: MUSCLE ACHES; TIREDNESS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced muscle aches, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle aches and tiredness was not reported. This report was non-serious.