chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Palpating feeling in the left neck part/ Pumping in the neck vein; This spontaneous case was reported by a patient and describes the occurrence of PALPITATIONS (Palpating feeling in the left neck part/ Pumping in the neck vein) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient has no known allergies to food, medications or any products. Patient did not receive any other vaccine 1 month prior to getting the Moderna COVID-19 Vaccine.  Concurrent medical conditions included Diabetes (Start date was about 10 years ago and vaccine has no effect on his medical condition.).   On 17-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, the patient experienced PALPITATIONS (Palpating feeling in the left neck part/ Pumping in the neck vein). At the time of the report, PALPITATIONS (Palpating feeling in the left neck part/ Pumping in the neck vein) had not resolved.            Concomitant drugs were not reported.  The patient had pumping in the neck vein after receiving vaccine on 17-Jun-2022 around 11pm. The patient had this events for the first time and that the events had worsened. Patient did not seek medical care.  Treatment medications were not provided.   This case was linked to MOD-2022-592313 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site is red; injection site is swollen; injection site is painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE SWELLING (injection site is swollen) and VACCINATION SITE PAIN (injection site is painful) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A, 046B21A and 041H21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Wellbutrin allergy), Depression and Atrial fibrillation. Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), BREXPIPRAZOLE (REXULTI), CLONAZEPAM (KLONOPIN), DILTIAZEM HYDROCHLORIDE (DILT-XR), METOPROLOL SUCCINATE, LOSARTAN, ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), SIMVASTATIN and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE SWELLING (injection site is swollen) and VACCINATION SITE PAIN (injection site is painful). At the time of the report, VACCINATION SITE ERYTHEMA (injection site is red), VACCINATION SITE SWELLING (injection site is swollen) and VACCINATION SITE PAIN (injection site is painful) outcome was unknown.            It was reported that patient neither diagnosed nor tested positive for COVID-19. No other vaccines was administered within 1 month prior to Moderna COVID-19 vaccine.  The patient had gone to the Emergency Room three times since January 2022. The Emergency Room could not find anything that was causing the welts and the black and blue mark at the injection.  Treatment medications were not reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain in extremity, Pyrexia
Clinical narrative: arms are sore; fever of 100.3/back down to 101.4/103.2; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arms are sore) and PYREXIA (fever of 100.3/back down to 101.4/103.2) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 14B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2022, the patient experienced PYREXIA (fever of 100.3/back down to 101.4/103.2). On an unknown date, the patient experienced PAIN IN EXTREMITY (arms are sore). At the time of the report, PAIN IN EXTREMITY (arms are sore) and PYREXIA (fever of 100.3/back down to 101.4/103.2) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jun-2022, Body temperature: 100.3 degree (High) Body temperature is  100.3 degree.         Concomitant mediations were not reported Treatment information was not reported   This case was linked to MOD-2022-592100.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: Experiencing serious heart arrhythmia; This spontaneous case was reported by a non-health professional and describes the occurrence of ARRHYTHMIA (Experiencing serious heart arrhythmia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Experiencing serious heart arrhythmia) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Experiencing serious heart arrhythmia) outcome was unknown.            No concomitant medication information was reported. The patient had both COVID-19 vaccines and boosters and was experiencing serious heart arrhythmia. After that the patient went into cardioversion for treatment.  Company comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history and with vaccine history of receiving Covid-19 vaccines and boosters. However, product details and batch number was not provided. Patient experienced the unexpected serious (medically significant) AESI event of arrhythmia (experiencing serious heart arrhythmia). The event occurrence was unknown with respect to the unspecified product and dose number of administered Covid-19 vaccine. It was reported that the patient underwent cardioversion for treatment. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history and with vaccine history of receiving Covid-19 vaccines and boosters. However, product details and batch number was not provided. Patient experienced the unexpected serious (medically significant) AESI event of arrhythmia (experiencing serious heart arrhythmia). The event occurrence was unknown with respect to the unspecified product and dose number of administered Covid-19 vaccine. It was reported that the patient underwent cardioversion for treatment. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of the first episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring) and the second episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring) and the second episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring). At the time of the report, last episode of PRODUCT STORAGE ERROR (6 patients vaccinated from vials stored in freezer - no DDL temp monitoring) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Reporter stated the pharmacy hasn't been using a data digital logger to monitor the freezer temperatures that the Moderna COVID-19 vaccine is stored in. The HCP reported 6 patients have received vaccination since February 2022 from these potentially affected vials that were originally stored in the freezer with no DDL monitoring. No concomitant medication information were given. No treatment information were given.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vials were moved from freezer to refrigerated conditions on 28-Dec-2021; Moderna COVID-19 vaccine expired doses were administered to patients after the manufacturer date of expiry.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine expired doses were administered to patients after the manufacturer date of expiry.) and PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-Dec-2021) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 prophylaxis.     It was unknown if patient had acute illnesses at the time of vaccination and up to one month before.It was unknown  if patient had ever been diagnosed with/ tested positive for COVID-19.It was unknown if patient had chronic or long-standing health conditions.  Concurrent medical conditions included Penicillin allergy. Concomitant products included FOLIC ACID, PANCREATIN (CREON), MULTIVITAMIN [VITAMINS NOS] and PANTOPRAZOLE for an unknown indication.    On 08-Feb-2022 at 3:54 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Feb-2022 at 3:54 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine expired doses were administered to patients after the manufacturer date of expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine expired doses were administered to patients after the manufacturer date of expiry.) and PRODUCT STORAGE ERROR (The vials were moved from freezer to refrigerated conditions on 28-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   HCP reported that five Moderna COVID-19 vaccine expired doses were administered which was a mix of doses for those patients.  No  temperature excursions was reported.  On 08-Feb-2022 2 doses were administered to 2 individual patients. The vial was moved from freezer to refrigerator on 28-DEC-2021.  No treatment medication were provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19 Infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 Infection) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (Before the vaccines were available.). Concomitant products included SIMVASTATIN for Cholesterol, ALPRAZOLAM for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 Infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) in June 2022 for COVID-19 treatment, at a dose of 20 milligram once a day. At the time of the report, COVID-19 (Covid-19 Infection) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No adverse event was reported after taking statin drug and paxlovid together. Company comment This spontaneous case reported by a patient, concerns an 83-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 infection, after receiving the 3rd dose of mRNA-1273 vaccine. Vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case reported by a patient, concerns an 83-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 infection, after receiving the 3rd dose of mRNA-1273 vaccine. Vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. It was reported that the patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a mixed primary series consisting of the Pfizer as the 1st dose on 3OCT2021 and Moderna as the 2nd dose on 21DEC2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a mixed primary series consisting of the Pfizer as the 1st dose on 3OCT2021 and Moderna as the 2nd dose on 21DEC2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient has no medical history.  Previously administered products included for Product used for unknown indication: Pfizer vaccine (Initial dose of Pfizer vaccine) on 03-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concomitant products included BUPRENORPHINE;NALOXONE for an unknown indication.    On 21-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a mixed primary series consisting of the Pfizer as the 1st dose on 3OCT2021 and Moderna as the 2nd dose on 21DEC2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a mixed primary series consisting of the Pfizer as the 1st dose on 3OCT2021 and Moderna as the 2nd dose on 21DEC2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.  Patient has not reported any adverse reactions to the previous COVID-19 vaccine doses.
Sex: U
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Sleep disorder, Temperature intolerance, Tinnitus
Clinical narrative: temperature intolerance; tinnitus; exercise intolerance; disruption in my sleep schedule; This spontaneous case was reported by an other health care professional and describes the occurrence of TEMPERATURE INTOLERANCE (temperature intolerance), TINNITUS (tinnitus), EXERCISE TOLERANCE DECREASED (exercise intolerance) and SLEEP DISORDER (disruption in my sleep schedule) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     It was reported that patient had absolutely no underlying issues.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TEMPERATURE INTOLERANCE (temperature intolerance), TINNITUS (tinnitus), EXERCISE TOLERANCE DECREASED (exercise intolerance) and SLEEP DISORDER (disruption in my sleep schedule). At the time of the report, TEMPERATURE INTOLERANCE (temperature intolerance), TINNITUS (tinnitus), EXERCISE TOLERANCE DECREASED (exercise intolerance) and SLEEP DISORDER (disruption in my sleep schedule) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient had received second Moderna vaccine and within about two weeks, patient immediately had temperature intolerance, tinnitus,exercise intolerance and with the disruption in my sleep schedule.  Patient assumed all of this was due to stress and tried to kind of move on with patient's life last year continuing to work and sitting on board seats as patient had done previously in late Dec 2021.  No treatment medication were reported.   This case was linked to MOD-2022-592801 (Patient Link).
Sex: M
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica; Information has been received from a lawyer referring to a male patient of unknown age regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered polymyalgia rheumatica. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of polymyalgia rheumatica was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event polymyalgia rheumatica to be disability.  Upon internal review, polymyalgia rheumatica was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid 19 with an associated reaction of pain in extremity.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR094579   Additional Information: GSK Receipt Date: 15-JUN-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient had arm hurt both times much worse and longer than the Covid shots. Additional Supportive Information: For the tolerance of 2nd dose, refer linked case US2022AMR094579.  The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094579:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: made me sick; arm was swollen under my arm; it hurt to lift it; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness, swelling arm and pain in arm. On an unknown date, the outcome of the sickness, swelling arm and pain in arm were recovered/resolved.   It was unknown if the reporter considered the sickness, swelling arm and pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2022AMR095584   Additional Information: GSK Receipt Date: 19-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient reported that vaccine came in two series. The patient received the dose of Shingles vaccine and it made him/her sick, arm was swollen under arm and it hurt to lift it. But patient knew that he/she would not get it. The patient had twin sister, she got shingles. She said pain it was the worse pain she ever felt. Additional Supportive Information: This case is linked with case US2022AMR095584 reported by same reporter for same patient. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR095584:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Probably 6-8 weeks, and yes it went away/suspected vaccination failure; had the vaccine for them, or they would have been a lot worse; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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 pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Jun-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had shingles for probably 6 to 8 weeks, and it went away. The patient had the Shingles vaccine and was thankful as shingles would have been a lot worse. The patient's doctor gave the patient something for the pain and it really helped. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as 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 be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: I was sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-Jun-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient got the first shot and was sick when it was time to get the second one and was not sure what to do now. Additional Supportive Information: The incomplete course of vaccination was not considered as patient was sick when it was time to get 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had them last month, mild case/suspected vaccination failure; had them last month, mild case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In May 2022, more than 2 years 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 Information: GSK Receipt Date: 19-Jun-2022 Reporters comment: The patient self-reported the case via interactive digital media. The patient had received Shingles vaccine 4 years ago from reporting and experienced mild case of shingles last month. Additional Supportive Information: 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: U
Vaccine: VARZOS
Symptoms: Blister, Varicella
Clinical narrative: Chicken pox all over my body; Getting new blisters daily; This case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced chickenpox and blister. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the chickenpox and blister were recovering/resolving.   It was unknown if the reporter considered the chickenpox and blister to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-Jun-2022. Reporter's comment: This case was reported by patient via  interactive digital media. The patient got the Shingrix vaccine and 2 days later had full blown Chicken pox all over body. It went on for 10 days and was getting new blisters all over body daily. The patient had to get an antiviral to make it stop. Finally on week 3, the patient was better.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: had shingles, had shot before them, second vaccine after; painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's comments: This case was reported by consumer via interactive digital media. The case was reported by the consumer for himself/herself. The patient stated that he/she had shingles and it was so horrible and painful. The patient had the shot before he/she had them. The reporter hoped and pray to never get them again. The reporter also had the second vaccine after. Additional supportive information:  Follow-up would not possible, as no contact details were available. This case also has been linked with case US2022AMR095627, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: I got the shingles; I felt pretty awful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced shingles and feels awful. On an unknown date, the outcome of the shingles and feels awful were unknown.   It was unknown if the reporter considered the shingles and feels awful to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-JUN-2022 Reporters comment: This case was reported by consumer via interactive digital media. The case was reported by the consumer for himself/herself. The patient stated that he/she got the shingles vaccine a few months ago (at the time of reporting). The reporter felt pretty awful he/she was due for the 2nd shot.  The reporter stated that yes, he/she would get the next one because he/she got the shingles and the patient did not like it.  Additional supportive information: Follow-up would not possible, as no contact details were available.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feverishly; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (feverishly) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (feverishly). At the time of the report, PYREXIA (feverishly) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2022-592455 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: sick with covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (sick with covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced COVID-19 (sick with covid). At the time of the report, COVID-19 (sick with covid) outcome was unknown.            No concomitant medication information provided.  Reporter reported that patient experienced sore throat. Patient was vaccinated and boosted with Moderna hence patients case was mild.  No treatment medication information provided. Company comment: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred in month of Jun- 2022 after a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient experienced sore throat and was vaccinated and boosted with Moderna and condition is with mild severity. No treatment medication information was provided. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   This case was linked to MOD-2022-592449 (Patient Link).; Sender's Comments: This spontaneous case concerns a male patient of unspecified age, with no medical history reported, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred in month of Jun- 2022 after a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient experienced sore throat and was vaccinated and boosted with Moderna and condition is with mild severity. No treatment medication information was provided. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low grade fever), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain in back, legs, arm) and PAIN IN EXTREMITY (Sore arm, couldn't be touched) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain in back, legs, arm) and PAIN IN EXTREMITY (Sore arm, couldn't be touched). At the time of the report, PYREXIA (Low grade fever) outcome was unknown and ARTHRALGIA (Joint pain), MYALGIA (Muscle pain in back, legs, arm) and PAIN IN EXTREMITY (Sore arm, couldn't be touched) had resolved. mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged. No concomitant medication were reported. Patient experienced Joint pain, Muscle pain in back, legs and arm which lasted a day and a half. She also experienced Sore arm and could not touched to arm that lasted 5 days. It was reported that patient experienced difficult side effects and scary events. No treatment information was provided by the reporter. This case was linked to MOD-2022-592473, MOD-2022-592474 (Patient Link). Reporter did not allow further contact.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Lip swelling, Oral discomfort, Oral herpes, Paraesthesia oral
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue) and ORAL HERPES (fever blisters) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054a22a, 011h21a and 017b21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient not had any reaction to previous vaccination. The patient's current conditions were just the same might be a little bit better. The patient's past medical history included Fever blister. Concurrent medical conditions included Heart disease, unspecified, Sulfonamide allergy (Sulfa) and Penicillin allergy. Concomitant products included FLECAINIDE for Heart disease, unspecified. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue), ORAL HERPES (fever blisters) and IMMUNISATION REACTION (a reaction not listed in the fact sheet). At the time of the report, ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue), ORAL HERPES (fever blisters) and IMMUNISATION REACTION (a reaction not listed in the fact sheet) had not resolved. Patient was administered with 1st Booster dose. Following vaccination with the booster patient started to experience the following: lip was strange, lip swelled up, tongue tingling, strange feeling at the end of her tongue, fever blisters, a reaction not listed in the fact sheet. The AE did not cause patient to seek medical care. The AE looked the same and were ongoing. Patient went to the pharmacy and was about to put borage oil for lips.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue discomfort
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue) and ORAL HERPES (fever blisters) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054a22a, 011h21a and 017b21a) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The patient not had any reaction to previous vaccination. The patient's current conditions were just the same might be a little bit better. The patient's past medical history included Fever blister. Concurrent medical conditions included Heart disease, unspecified, Sulfonamide allergy (Sulfa) and Penicillin allergy. Concomitant products included FLECAINIDE for Heart disease, unspecified. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue), ORAL HERPES (fever blisters) and IMMUNISATION REACTION (a reaction not listed in the fact sheet). At the time of the report, ORAL DISCOMFORT (lip was strange), LIP SWELLING (lip swelled up), PARAESTHESIA ORAL (tongue tingling), TONGUE DISCOMFORT (strange feeling at the end of her tongue), ORAL HERPES (fever blisters) and IMMUNISATION REACTION (a reaction not listed in the fact sheet) had not resolved. Patient was administered with 1st Booster dose. Following vaccination with the booster patient started to experience the following: lip was strange, lip swelled up, tongue tingling, strange feeling at the end of her tongue, fever blisters, a reaction not listed in the fact sheet. The AE did not cause patient to seek medical care. The AE looked the same and were ongoing. Patient went to the pharmacy and was about to put borage oil for lips.
Sex: F
Vaccine: COVID19
Symptoms: Fear, Immunisation reaction, Pain in extremity, Pruritus, Pyrexia
Clinical narrative: Scared; Scary side effects; Itching felt internal; Intense arm itching from shoulder to elbow on injection site side; High fever for 5 days; Arm pain lasted 10 days; This spontaneous case was reported by a patient and describes the occurrence of FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal), VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side) and PYREXIA (High fever for 5 days) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal), VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side), PYREXIA (High fever for 5 days) and PAIN IN EXTREMITY (Arm pain lasted 10 days). At the time of the report, FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal) and VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side) outcome was unknown and PYREXIA (High fever for 5 days) and PAIN IN EXTREMITY (Arm pain lasted 10 days) had resolved.            No concomitant medications were provided. The patient had no redness or swelling. No treatment medications were reported.   This case was linked to MOD-2022-592471 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: Scared; Scary side effects; Itching felt internal; Intense arm itching from shoulder to elbow on injection site side; High fever for 5 days; Arm pain lasted 10 days; This spontaneous case was reported by a patient and describes the occurrence of FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal), VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side) and PYREXIA (High fever for 5 days) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal), VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side), PYREXIA (High fever for 5 days) and PAIN IN EXTREMITY (Arm pain lasted 10 days). At the time of the report, FEAR (Scared), IMMUNISATION REACTION (Scary side effects), PRURITUS (Itching felt internal) and VACCINATION SITE PRURITUS (Intense arm itching from shoulder to elbow on injection site side) outcome was unknown and PYREXIA (High fever for 5 days) and PAIN IN EXTREMITY (Arm pain lasted 10 days) had resolved.            No concomitant medications were provided. The patient had no redness or swelling. No treatment medications were reported.   This case was linked to MOD-2022-592471 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fear, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Frightened her; Half side of breast beet red,Armpit became beet red; Horrible rash near injection site for 3 days and 4 nights; Itching near injection site for 1 sold day; This spontaneous case was reported by a patient and describes the occurrence of FEAR (Frightened her), ERYTHEMA (Half side of breast beet red,Armpit became beet red), VACCINATION SITE PRURITUS (Itching near injection site for 1 sold day) and VACCINATION SITE RASH (Horrible rash near injection site for 3 days and 4 nights) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEAR (Frightened her), VACCINATION SITE PRURITUS (Itching near injection site for 1 sold day) and VACCINATION SITE RASH (Horrible rash near injection site for 3 days and 4 nights). an unknown date, the patient experienced ERYTHEMA (Half side of breast beet red,Armpit became beet red). At the time of the report, FEAR (Frightened her) and ERYTHEMA (Half side of breast beet red,Armpit became beet red) outcome was unknown and VACCINATION SITE PRURITUS (Itching near injection site for 1 sold day) and VACCINATION SITE RASH (Horrible rash near injection site for 3 days and 4 nights) had resolved.            No concomitant medication was reported. Dates of vaccine administration, lot numbers and expiration dates were not reported. It was reported that horrible rash near injection site for 3 days and 4 nights and Itching near injection site for 1 sold day. No treatment medication was reported.   This case was linked to MOD-2022-592473 (Patient Link).   Reporter did not allow further contact