chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the 2 shot one and I still got shingles/ suspected vaccination failure; I had the 2 shot one and I still got 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.   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 and shingles were unknown.   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 case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient stated that he/she had the 2 shot one and still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash papular, Vaccination failure
Clinical narrative: I got the vaccination and still got shingles, suspected vaccination failure; I got the vaccination and still got shingles; six bumps; 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 and papular rash. On an unknown date, the outcome of the vaccination failure, shingles and papular rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and papular rash to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient 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 received the shingles shot and still got shingles, but only had six bumps and that was enough.  The vaccination had helped the patient. 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 not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Myalgia, Nipple pain
Clinical narrative: My chest muscle, nipple and rib under right arm are still sore/ chest muscle pain/ rib pain; Nipple sore; This case was reported by a physician and described the occurrence of musculoskeletal chest pain in a adult patient who received Herpes zoster (Shingrix) (batch number Y7JL5, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced musculoskeletal chest pain and nipple pain. On an unknown date, the outcome of the musculoskeletal chest pain and nipple pain were not recovered/not resolved.   It was unknown if the reporter considered the musculoskeletal chest pain and nipple pain to be related to Shingrix.  Additional details were reported as follows: This 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 got vaccine 5 months before the reporting day and stated that his/her chest muscle, nipple and rib under right arm were still sore. The reporter asked whether this happened to others. The follow-up would not possible, as no contact details were available. The batch number for vaccine was reported as YZJL5, however as per sales data sheet it was updated as Y7JL5
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Sick; High fever; Chills; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received Shingrix. In April 2021, less than 2 weeks after receiving Shingrix, the patient experienced sickness, fever and chills. On an unknown date, the outcome of the sickness, fever and chills were unknown.   It was unknown if the reporter considered the sickness, fever and chills to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination not reported. The patient had a shingrix vaccine and was sick. The patient had high fever and chills. The patient's healthcare professional told patient to wait for a week after administration of shingrix vaccine to receive Xeljanz. The patient asked if she has to get booster in a year with pfizer covid vaccine whether she need to stop her xeljanz. No other information was reported. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I took the shot and suffered for about a year with shingles, Suspected vaccination failure; I took the shot and suffered for about a year with 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 was unknown and the outcome of the shingles was recovered/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 case was reported by the patient 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 received the shingles shot and suffered for about a year with shingles.  The patient had planned not to take the shot again. 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 not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Injection site erythema, Pain, Vaccination failure
Clinical narrative: I had shingles vaccine and had shingles 4 years later/Suspected vaccination failure; I had shingles vaccine and had shingles 4 years later; Pain is horrific and hasn't gone away; Not comfortable with shingle vaccines right now; The sight of vaccine was red,covered ,under my upper arm; 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, 4 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site erythema, pain and discomfort. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the injection site erythema was recovered/resolved and the outcome of the pain and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site erythema, pain and discomfort to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and 4 years later had shingles. The patient stated the pain was horrific and had not gone away and was been told it might never go away. The patient stated he/she know vaccines were not 100 percent protective and the shingles he/she had, might had been worse had he/she not had the vaccine and also mentioned that he/she had a reaction to last one where the sight of vaccine was red covered, under his/her upper arm for 3 months. The patient stated he/she could not get any other shots, i.e., allergy shots and was not comfortable with shingle vaccines at the time of reporting and the COVID 19 vaccine was important at the time of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient late for 2nd dose / Dose 1 / in 11/13/2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 13th November 2019 from batch 227FL and expiry date 26th November 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 age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked whether they need to restart the vaccination series. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: I give Kinrix at 4 months of age; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: As per reporter, the age at vaccination for all patients was 4 months. The reporter stated that in order to avoid giving 4 doses of Hepatitis B to patients, reporter gave Kinrix at 4 months of age, which led to inappropriate age at vaccine administration. The reporter stated that this happened about 12 times a year, once a month. The reporter consented to follow up. No further information available regarding product or patients. This case has been linked with case US2021090084, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090084:same reporter
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong technique in product usage process
Clinical narrative: given half of adult dose to substitute for pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of wrong technique in product usage process in a 13-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 12th April 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process 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 Havrix adult dose was halved and given to the pediatric patient, which led wrong technique in product usage process. The reporter asked if this dose was valid dose and how to proceed further. No other information was provided. The reporter consented to follow up. This case is linked with US2021090127, by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090127:Same reporter. Patient 1 of 2.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Neuralgia
Clinical narrative: Soreness at injection site; mild nerve feeling all the way down to my elbow in the injected arm; minor version of what shingles feels like; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a day after receiving Shingrix, the patient experienced shingles and nerve pain. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the shingles and nerve pain were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles, injection site pain and nerve pain to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received Shingrix in the left arm.  The patient had soreness at the injection site. Within hours of vaccination, she experienced a mild nerve feeling all the way down to elbow in the injected arm that she described as a minor version of what shingles feels like.  The reporter did not consent to follow-up and did not provide consent to follow-up with Healthcare professional.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose in May 2019 / not sure if patient will get second dose 4/23/21; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in May 2019).   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 age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The pharmacist inquired about delayed Shingrix 2nd dose and asked should the series be restarted or continued. The reporter did not consent to follow-up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: feeling very tired; aches and pains all over; Headache; Chills; fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2021AMR092233).   On 22nd April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2021, 12 hrs after receiving Shingrix, the patient experienced tiredness, general body pain, headache, chills and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, general body pain, headache, chills and fever were not recovered/not resolved.   The reporter considered the tiredness, general body pain, headache, chills and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife.   The patient received 2nd dose of Shingrix in left deltoid. On 23rd April 2022, about 3 in the morning, the patient began to experience very tired, aches and pains all over, headache, chills and fever.  Till the time of reporting, the symptoms were ongoing and had not resolved. The reporter consented to follow up. No further information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR092233:1st dose
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: feeling very tired; aches and pains all over; Headache; Chills; fever; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on an unknown date. For the tolerance of 1st dose, refer linked case US2021AMR092233).   On 22nd April 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In April 2021, 12 hrs after receiving Shingrix, the patient experienced tiredness, general body pain, headache, chills and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tiredness, general body pain, headache, chills and fever were not recovered/not resolved.   The reporter considered the tiredness, general body pain, headache, chills and fever to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife.   The patient received 2nd dose of Shingrix in left deltoid. On 23rd April 2022, about 3 in the morning, the patient began to experience very tired, aches and pains all over, headache, chills and fever.  Till the time of reporting, the symptoms were ongoing and had not resolved. The reporter consented to follow up. No further information was reported.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR092233:1st dose
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of Engerix B today; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B) (batch number 97LJ2, expiry date 27th February 2021) for prophylaxis.   On 23rd April 2021, the patient received Engerix B. On 23rd April 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: All patient identifiers were reported as well as batch number and expiration date. The pharmacist reported that the patient was vaccinated with dose of Engerix B which was already expired on 27th February 2021. No further clarifications. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient received a dose on 23rd April 2021 that has been expired in 2020; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received HAV (Havrix) (batch number 3KT7B, expiry date 10th December 2020) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 23rd 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 details were provided as follows: The reporter was a licensed practice nurse. The patient had received a dose of Havrix in 2021 that had been expired since 12th October 2020, which led to expired vaccine administration. The reporter consented to follow-up.  Note: Expiry date mentioned in narrative as 12th October 2020 seems discrepant as batch number corresponds to expiry date of 10th December 2020 as per structured field which is retained in the case until further clarification obtained in follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received dose 1 about 2 or more years ago, and has yet to receive dose 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date about 2 or more years ago).   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 age at vaccination was not applicable for this report. Patient received first dose of Shingrix. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHE; This spontaneous report was received from a  female patient of an unspecified age, reporting on herself. The patient's weight was 150 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 04-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the subject experienced a headache. It was reported that the subject called to ask if she can take TYLENOL (paracetamol) for her headache after receiving the Janssen Covid-19 vaccine, about 4.5 hours ago (it was unspecified if paracetamol was taken).  Action taken with Covid-19 vaccine AD26.COV2.S was not applicable. The patient had not recovered from headache. The reported considered the causality between the headache and Covid-19 vaccine AD26.COV2.S as related. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEELING SICK POST VACCINE ADMINISTRATION; This spontaneous report received from a consumer concerned a female 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, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on 05-MAR-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 an unspecified date, the Patient was feeling sick post vaccine administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling sick post vaccine administration was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: COVIDVACCINE HURT; This spontaneous report received from a patient via a company representative 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry date: 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 MAR-2021, the patient experienced Covid vaccine hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid vaccine hurt was not reported. This report was non-serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, General physical health deterioration
Clinical narrative: LOSS OF BODILY FUNCTIONS; VOMITING; CHILLS; FEVER; DIARRHEA; TIREDNESS; LIGHT HEADINESS / DIZZINESS; This spontaneous report received from a consumer concerned a 59 year old female. The patient's weight was 80.73 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included codeine allergy, non alcohol, non smoker, breast cancer, higher blood pressure, and thyroid, and other pre-existing medical conditions included no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 13:00 for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, hydrochlorothiazide non-company for high blood pressure, losartan for high blood pressure, and levothyroxine sodium for thyroid. On 19-MAR-2021, the subject experienced vomiting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced light headiness / dizziness. On an unspecified date, the subject experienced loss of bodily functions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, fever, diarrhea, tiredness, and light headiness / dizziness on 21-MAR-2021, and was recovering from loss of bodily functions. This report was non-serious.  Additional information was received from ( patient) on 09-apr-2021. The following information was updated and incorporated into the case narrative; Event details( light headiness subsummed into dizziness, diarrhea, tiredness) Products ( amlodipine, hydrochlorothiazide, losartan, euthyrox), Disease ( high blood pressure, thyroid ,breast cancer) Labelling(diarrhea, tiredness,) Causality(diarrhea, tiredness),Outcome ( diarrhea, tiredness),Anatomical site( right arm), Time of vaccination (13.00), Chemotherapy was added in disease tab as it was given in 2006.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: LOSS OF BODILY FUNCTIONS; VOMITING; CHILLS; FEVER; DIARRHEA; TIREDNESS; LIGHT HEADINESS / DIZZINESS; This spontaneous report received from a consumer concerned a 59 year old female. The patient's weight was 80.73 kilograms, and height was 162.56 centimeters. The patient's concurrent conditions included codeine allergy, non alcohol, non smoker, breast cancer, higher blood pressure, and thyroid, and other pre-existing medical conditions included no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 13:00 for prophylactic vaccination. Concomitant medications included amlodipine for high blood pressure, hydrochlorothiazide non-company for high blood pressure, losartan for high blood pressure, and levothyroxine sodium for thyroid. On 19-MAR-2021, the subject experienced vomiting. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021, the subject experienced diarrhea. On 19-MAR-2021, the subject experienced tiredness. On 19-MAR-2021, the subject experienced light headiness / dizziness. On an unspecified date, the subject experienced loss of bodily functions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, chills, fever, diarrhea, tiredness, and light headiness / dizziness on 21-MAR-2021, and was recovering from loss of bodily functions. This report was non-serious.  Additional information was received from ( patient) on 09-apr-2021. The following information was updated and incorporated into the case narrative; Event details( light headiness subsummed into dizziness, diarrhea, tiredness) Products ( amlodipine, hydrochlorothiazide, losartan, euthyrox), Disease ( high blood pressure, thyroid ,breast cancer) Labelling(diarrhea, tiredness,) Causality(diarrhea, tiredness),Outcome ( diarrhea, tiredness),Anatomical site( right arm), Time of vaccination (13.00), Chemotherapy was added in disease tab as it was given in 2006.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Eye pain, Feeling abnormal, Injection site pain, Malaise
Clinical narrative: COLD SORES; FEELING BAD; RETRO-ORBITAL PAIN; EYE PAIN; BRUISING; MALAISE; FEVERISH; SORENESS AT INJECTION SITE; 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, batch number: Unk) dose was not reported, administered on 15-MAR-2021 14:00 to Right Arm for prophylactic vaccination. The batch number was not reported. Concomitant medications included aciclovir. On 15-MAR-2021, the patient experienced soreness at injection site. On 16-MAR-2021, the patient experienced feverish. On 16-MAR-2021, the patient experienced feeling bad. On 16-MAR-2021, the patient experienced retro-orbital pain. On 16-MAR-2021, the patient experienced eye pain. On 16-MAR-2021, the patient experienced bruising. On 16-MAR-2021, the patient experienced malaise. On 18-MAR-2021, the patient experienced cold sores. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish, feeling bad, retro-orbital pain, eye pain, and malaise on 17-MAR-2021, and bruising, and soreness at injection site on 21-MAR-2021, and was recovering from cold sores. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Pyrexia
Clinical narrative: COLD SORES; FEELING BAD; RETRO-ORBITAL PAIN; EYE PAIN; BRUISING; MALAISE; FEVERISH; SORENESS AT INJECTION SITE; 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, batch number: Unk) dose was not reported, administered on 15-MAR-2021 14:00 to Right Arm for prophylactic vaccination. The batch number was not reported. Concomitant medications included aciclovir. On 15-MAR-2021, the patient experienced soreness at injection site. On 16-MAR-2021, the patient experienced feverish. On 16-MAR-2021, the patient experienced feeling bad. On 16-MAR-2021, the patient experienced retro-orbital pain. On 16-MAR-2021, the patient experienced eye pain. On 16-MAR-2021, the patient experienced bruising. On 16-MAR-2021, the patient experienced malaise. On 18-MAR-2021, the patient experienced cold sores. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish, feeling bad, retro-orbital pain, eye pain, and malaise on 17-MAR-2021, and bruising, and soreness at injection site on 21-MAR-2021, and was recovering from cold sores. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product colour issue
Clinical narrative: COLOR OF THE VACCINE WAS PINK; 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 ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced color of the vaccine was pink. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of color of the vaccine is pink was not reported. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: INCREASED CHEST PAIN; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included congestive heart disease, penicillin allergy, and sulfas allergy. The patient experienced drug allergy when treated with oxycodone hydrochloride.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced increased chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from increased chest pain. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure decreased, Chest discomfort, Dizziness, Dysphonia
Clinical narrative: BLOOD PRESSURE DROPPED; HEADACHE; FATIGUE; BODY PAIN; BACK PAIN LIKE WHERE MY LUNG IS; IT HURTS WHEN I BREATHE; SWELLING OF MY FEET; VOICE CHANGES; DIZZINESS; HOT FEELING IN FEET; FELT LIKE CHEST WAS ACCELARATING; THROAT PAIN; This spontaneous report received from a patient concerned a female 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) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced blood pressure dropped. On an unspecified date, the subject experienced body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, dizziness, hot feeling in feet, felt like chest was accelarating, throat pain, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like chest was accelarating, and headache, and the outcome of body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, fatigue, dizziness, hot feeling in feet, throat pain and blood pressure dropped was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Feeling hot, Headache, Oropharyngeal pain
Clinical narrative: BLOOD PRESSURE DROPPED; HEADACHE; FATIGUE; BODY PAIN; BACK PAIN LIKE WHERE MY LUNG IS; IT HURTS WHEN I BREATHE; SWELLING OF MY FEET; VOICE CHANGES; DIZZINESS; HOT FEELING IN FEET; FELT LIKE CHEST WAS ACCELARATING; THROAT PAIN; This spontaneous report received from a patient concerned a female 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) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced blood pressure dropped. On an unspecified date, the subject experienced body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, dizziness, hot feeling in feet, felt like chest was accelarating, throat pain, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like chest was accelarating, and headache, and the outcome of body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, fatigue, dizziness, hot feeling in feet, throat pain and blood pressure dropped was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: BLOOD PRESSURE DROPPED; HEADACHE; FATIGUE; BODY PAIN; BACK PAIN LIKE WHERE MY LUNG IS; IT HURTS WHEN I BREATHE; SWELLING OF MY FEET; VOICE CHANGES; DIZZINESS; HOT FEELING IN FEET; FELT LIKE CHEST WAS ACCELARATING; THROAT PAIN; This spontaneous report received from a patient concerned a female 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) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced blood pressure dropped. On an unspecified date, the subject experienced body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, dizziness, hot feeling in feet, felt like chest was accelarating, throat pain, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like chest was accelarating, and headache, and the outcome of body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, fatigue, dizziness, hot feeling in feet, throat pain and blood pressure dropped was not reported. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Computerised tomogram, Hemiparesis, Retinal infarction
Clinical narrative: RIGHT OPHTHALMIC STROKE; LEFT SIDED WEAKNESS; CHILLS; This spontaneous report received from a physician concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and seizures. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the patient experienced chills, tremor. On 10-APR-2021 15:00, the patient presented to hospital he was hunched over, gait was unsteady, and stated that over the past day left side gotten weaker, unable to decide the feeling, reports of numbness, decreased strength to left side, shuffling gait. On the same day, 10-Apr-2021, patient was hospitalized with symptoms of stroke, and was diagnosed with right ophthalmic stroke. The patient was in the hospital for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 : 20210427690-covid-19 vaccine ad26.cov2.s -RIGHT OPHTHALMIC STROKE, LEFT SIDED WEAKNESS . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Oxygen saturation, Oxygen saturation decreased, Polymerase chain reaction
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; O2 LEVEL 85%; This spontaneous report received from a patient concerned a 64-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included vedolizumab for Crohn's disease.  On an unspecified date in 2021, the patient experienced flu-like symptoms (fever 100F for about two days, very torturous and unusual headache, body aches). It was reported that the patient spent five days sick in bed. On an unspecified date in 2021, the patient took Tylenol but it did not relieve the pain and nothing seemed to help patient except getting some rest. After the vaccine administration, the patient stayed at home for 14 days, she double-masked, she had not been going out very much. On 11-APR-201, the patient experienced oxygen level 85%, felt ill and went to instant care and did Polymerase chain reaction test (PCR). On 13-APR-2021, the test result came positive. The patients Covid-19 symptoms included cough, fever (100F low grade fever) and oxygen (O2) level 85%.  On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 85 %. Laboratory data included: PCR (NR: not provided) Positive.  In 2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from O2 level 85%, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210427837-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; O2 LEVEL 85%; This spontaneous report received from a patient concerned a 64-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included Crohn's disease, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 04-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included vedolizumab for Crohn's disease.  On an unspecified date in 2021, the patient experienced flu-like symptoms (fever 100F for about two days, very torturous and unusual headache, body aches). It was reported that the patient spent five days sick in bed. On an unspecified date in 2021, the patient took Tylenol but it did not relieve the pain and nothing seemed to help patient except getting some rest. After the vaccine administration, the patient stayed at home for 14 days, she double-masked, she had not been going out very much. On 11-APR-201, the patient experienced oxygen level 85%, felt ill and went to instant care and did Polymerase chain reaction test (PCR). On 13-APR-2021, the test result came positive. The patients Covid-19 symptoms included cough, fever (100F low grade fever) and oxygen (O2) level 85%.  On 2021, Laboratory data included: Body temperature (NR: not provided) 100 F. On APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) 85 %. Laboratory data included: PCR (NR: not provided) Positive.  In 2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from O2 level 85%, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210427837-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Presyncope, Vision blurred
Clinical narrative: NEAR SYNCOPAL EVENT APPROX 2-3 MINS AFTER INJECTION.  PT REPORTED MUFFLED HEARING AND BLURRED VISION DENIED CP, SOB, ITCHINESS,   INITIAL VITALS UPON ENTERING OBSERVATION UNIT: BP-79/43 HR-46  RR-18  SPO2-100%--AOOX4 REPORTED A HEADACHE APPROXIMATELY 10 MINS INTO OBSERVATION  PT DISCHARGED WITH CAREGIVER ASYMPTOMATIC WITH NEGATIVE ORTHOSTATICS. LAST SET OF VITALS: BP 109/76  HR 70  SPO2 99%  RR18
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient reported full body aches causing such a level of pain as to not be able to walk that started the evening of her vaccination. As of the time of this report patient still couldn't ambulate without the help of others.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Blood count, Blood electrolytes, Blood glucose, Blood thyroid stimulating hormone
Clinical narrative: Loss of balance, dizziness,ringing ears, slight headache, pressure at back of head. Prescribed Meclazine, flonase and Zyrtec. Symptoms still on going but improved.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Full blood count, Head discomfort, Headache, Liver function test normal
Clinical narrative: Loss of balance, dizziness,ringing ears, slight headache, pressure at back of head. Prescribed Meclazine, flonase and Zyrtec. Symptoms still on going but improved.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Renal function test normal, Thyroid function test normal, Tinnitus
Clinical narrative: Loss of balance, dizziness,ringing ears, slight headache, pressure at back of head. Prescribed Meclazine, flonase and Zyrtec. Symptoms still on going but improved.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, SARS-CoV-2 test positive
Clinical narrative: + COVID test 2/9/2021; patient asymptomatic, presented to the ED status-post fall and was tested at that visit .  Does not get chronic care at our facility.  Patient was transferred from our ED to Hospital on 2/9/2021, so I do not know whether her COVID progressed or resolved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Injection site erythema, Injection site swelling
Clinical narrative: EYES SWOLLEN, ARM RED AND SWOLLEN AT SITE OF SHOT.  TOLD PATIENT TO TRY BENADRYL, ICE PACK ON SITE OF SHOT AND COOL COMPRESSES ON EYES AND IF GOT WORSE GO TO EMERGENCY   ROOM