chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Hyperhidrosis, Illness, Loss of consciousness
Clinical narrative: Passed out cold/lost consciousness; violently ill; really sweating; Vomited; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood test: antibodies (Inconclusive) Had antibodies and donated plasma.         Company comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the non-serious expected events loss of consciousness, illness and hyperhidrosis and expected vomiting and chills. The events occurred the next day after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications were reported. Patient did not take any medications for the symptom relief. Patient stayed in bed for 2 days to recover.   This case was linked to MOD-2022-460285 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the non-serious expected events loss of consciousness, illness and hyperhidrosis and expected vomiting and chills. The events occurred the next day after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Passed out cold/lost consciousness; violently ill; really sweating; Vomited; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out cold/lost consciousness), ILLNESS (violently ill), HYPERHIDROSIS (really sweating), VOMITING (Vomited) and CHILLS (Shivering) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood test: antibodies (Inconclusive) Had antibodies and donated plasma.         Company comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the non-serious expected events loss of consciousness, illness and hyperhidrosis and expected vomiting and chills. The events occurred the next day after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications were reported. Patient did not take any medications for the symptom relief. Patient stayed in bed for 2 days to recover.   This case was linked to MOD-2022-460285 (Patient Link).; Sender's Comments: Company comment: This is a spontaneous case concerning a 75-year-old female patient with no relevant medical history, who experienced the non-serious expected events loss of consciousness, illness and hyperhidrosis and expected vomiting and chills. The events occurred the next day after the second dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Pain
Clinical narrative: Severe mid back pain slightly to the left (kidney) combined with urinary incontinence developed on day six after vaccine and continues now into day 10.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Renal pain, Urinary incontinence
Clinical narrative: Severe mid back pain slightly to the left (kidney) combined with urinary incontinence developed on day six after vaccine and continues now into day 10.
Age: 0.67
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; an expired dose of VARlVAX was inadvertently administered to a patient; Patient was vaccinated at 27-OCT-2004; This non-valid spontaneous report was received from a vaccine coordinator and refers to unspecified patient of unknown age. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided.  On 27-OCT-2021, the patient was inadvertently vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S033540, verified as valid, expiration date: 22-OCT-2021) in dose 0.5 milliliter for prophylaxis (dose number, route of administration and anatomical location were not reported) reconstituted with sterile diluent. The outcome of expired product administered was unknown. No additional adverse events reported.  This case was considered to be non-valid due to lack of patient's identifiers.  Follow-up information has been received from a nurse on 25-JAN-2022. The patient was 8-month-old female (born on 31-JAN-2004). Administration of expired varicella virus vaccine live (oka/merck)(VARIVAX) (lot# S033540, expiry date 22-OCT-2021) was confirmed to have been performed on 27-OCT-2004 (conflicting information, previously reported as 27-OCT-2021) (inappropriate age at vaccine administration), subcutaneously in patient's right arm. There was no adverse experience.  This report was considered to be valid, as the patient identifiers has been provided along with follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverese event; expired product administered; This spontaneous report was received from a medical assistant and refers to a patient of unknown age or gender.  The patient's concurrent conditions, medical history or concomitant medications were not provided.   On 20-JAN-2022, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 1ml injection once (lot #T014589 with expiration date: 25-OCT-2021; strength and route of administration were not reported) as prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional adverse event; VAQTA was administered after a temperature excursion; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 29-DEC-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, syringe, 0.5 milliliter (valid lot #U002749, expiration date: 04-MAY-2022), administered for prophylaxis (route of administration, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion (product storage error). The temperature, timeframe and if there was a previous temperature excursion was unknown by the reporter. No additional adverse effect reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This is a spontaneous report received from contactable consumer from License Party. Other Case identifier: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-123164 (Bristol-Myers Squibb Company).  This spontaneous case was reported by a patient and describes the occurrence of BACK PAIN in 80-year-old female patient who received apixaban (Eliquis) tablet for an unknown indication. On an unknown date, the patient started Eliquis (Oral), 5 milligram twice a day. On an unknown date, the patient experienced BACK PAIN. The action taken with Eliquis(Oral) was unknown. At the time of the report, BACK PAIN outcome was unknown. For Eliquis(Oral), the reporter did not provide any causality assessments.  Apixaban (ELIQUIS) is under agreement with Bristol-Myers Squibb.  Follow-up (06Jan2022): This is a spontaneous follow-up report received from a contactable nurse from License Party (Bristol-Myers Squibb). Other Case identifier: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-123164 (Bristol-Myers Squibb Company).  This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BACK PAIN in 80-year-old female patient who received apixaban (Eliquis) tablet for an unknown indication. CO-SUSPECT PRODUCTS included COVID-19 Vaccine for COVID-19 immunisation. On an unknown date, the patient started Eliquis (Oral), 5 milligram twice a day and Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced BACK PAIN. The action taken with Eliquis (Oral) was unknown. At the time of the report, BACK PAIN outcome was unknown. For Eliquis (Oral), the reporter considered BACK PAIN to be not related. Most recent follow up information was received from a nurse in response to query incorporated above includes: 06Jan2022: New reporter, co-suspect added, event attribute updated.  Apixaban (ELIQUIS) is under agreement with Bristol-Myers Squibb.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia, Thrombosis
Clinical narrative: PT STATED SHE HAD PNEUMONIA; BAD REACTION TO THE COVID VACCINE THAT CAUSED BLOOD CLOTS; This spontaneous case was reported by a consumer and describes the occurrence of pneumonia (PT STATED SHE HAD PNEUMONIA) and thrombosis (BAD REACTION TO THE COVID VACCINE THAT CAUSED BLOOD CLOTS) in 53-year-old female patient who received apixaban (ELIQUIS) tablet for an unknown indication. Co-suspect products included Covid-19 Vaccine for an unknown indication. On an unknown date, the patient started ELIQUIS (oral), 5 milligram twice a day and Covid-19 Vaccine (unknown route). On an unknown date, the patient experienced pneumonia (seriousness criterion medically significant) and thrombosis (seriousness criterion medically significant). The action taken with ELIQUIS (oral) was unknown. At the time of the report, pneumonia and thrombosis outcome was unknown. Patient stated she had pneumonia and a bad reaction to the COVID vaccine that caused blood clots. The strength of apixaban was 5 mg. For ELIQUIS (oral), the reporter did not provide any causality assessments.  Apixaban (ELIQUIS) is under agreement with Bristol-Myers Squibb.; Sender's Comments: BMS medical evaluation comment: This patient had pneumonia and thrombosis after apixaban therapy and COVID-19 vaccination. Based on the nature of the disease and its etiopathogenesis, the event pneumonia is considered not related to apixaban. Based on the limited information regarding the site of thrombosis and therapy details, it cannot be ascertained with the reasonable possibility that the apixaban could have caused the event.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Malaise, Ocular hyperaemia, Rash erythematous
Clinical narrative: side effects that included a rash on face and chest/redness on my chest; red mask across my eyes; ill; weak; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of red rash 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 red rash, eye red, unwell and weakness. On an unknown date, the outcome of the red rash, eye red, unwell and weakness were recovered/resolved.   It was unknown if the reporter considered the red rash, eye red, unwell and weakness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR011103  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient had received 1st dose of Shingles shot and experienced side effects that included a rash on his/her face and chest. Ever since then, every time he/she got ill or weak, he/she had the same symptoms as a red mask across eyes and redness on his/her chest. The follow-up could not be possible as no contact details were available. For tolerance to 2nd dose, refer case US2022AMR011103
Sex: U
Vaccine: VARZOS
Symptoms: Liver transplant
Clinical narrative: Liver transplant; This case was reported by a consumer via call center representative and described the occurrence of liver transplant in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Shingrix. On 21st November 2021, 6 days after receiving Shingrix, the patient experienced liver transplant. The patient was treated with immunosuppressants nos (Immunosuppressant Drug (Nos)). On an unknown date, the outcome of the liver transplant was unknown.   It was unknown if the reporter considered the liver transplant to be related to Shingrix.  Additional details were reported as follows: The reporter was the concerned patient. The age at vaccination was not reported. On 21st November 2021, the patient had liver transplant. The patient was on anti-rejection medications which lowered immune system protection. The patient asked if he/she need to be concerned about getting second Shingrix vaccine. Consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Muscle spasms, Peripheral coldness
Clinical narrative: Chills; leg cramps; cold feet and hands; headache; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, leg cramps, cold hands & feet and headache. On an unknown date, the outcome of the chills, leg cramps, cold hands & feet and headache were not recovered/not resolved.   It was unknown if the reporter considered the chills, leg cramps, cold hands & feet and headache to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and experienced chills, leg cramps, extremely cold feet and hands, headache. The patient did not experience fever. The reporter was just wondering if GlaxoSmithKline track side effects. Consent to follow up was requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 9/27/19,  not received 2nd; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th September 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 reporter was the patient. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked should repeat the first dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: felt as if it had been punched in the arm, sore; 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 Shingles vaccine with an associated reaction of no adverse event (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd 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.  Additional details provided as follows: The age at vaccination was unknown. The patient had no discomfort with the 1st shot. The 2nd dose felt as if the patient had been punched in the arm. It was very sore for 2 days, but patient hoping it was worth it.  The patient stated that one have to wait 2 months before getting the 2nd one. The follow up was not possible.
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Brain injury, Gait inability, Paralysis
Clinical narrative: paralyzed; unstable, brain will never fully recover; This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a female 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 paralysis (serious criteria hospitalization and GSK medically significant) and unsteadiness. On an unknown date, the outcome of the paralysis was unknown and the outcome of the unsteadiness was not recovered/not resolved.   It was unknown if the reporter considered the paralysis and unsteadiness to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient took the Shingles vaccine 3 years ago from reporting date and ended up in the hospital for two months paralyzed after months of rehab, the patient could walk again but she was unstable, her brain would never fully recover so now she was in an Alzheimer's research group.  The patient stated that she was alive but only because of her husband's non-stop care. The sad thing was the doctors and the hospitals did not turn the statistics into the CDC (Centers for disease control and prevention).  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Extra dose administered, Feeling abnormal, Herpes zoster, Pain
Clinical narrative: got 3 injections, still get shingles/ suspected vaccination failure; shingles; it doesn't hurt so bad; makes me miserable; got 3 injections; blisters; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, blister, feeling miserable and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain, feeling miserable and extra dose administered were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister and feeling miserable to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient got 3 injections of Shingles vaccine, which led to extra dose administered. The patient still get shingles at least once a year it did not hurt so bad and the blisters go away in about 2 weeks, so it was better.  It still makes patient miserable. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination failure
Clinical narrative: got 3 injections, still get shingles/ suspected vaccination failure; shingles; it doesn't hurt so bad; makes me miserable; got 3 injections; blisters; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine, the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, blister, feeling miserable and extra dose administered. On an unknown date, the outcome of the vaccination failure, shingles, pain, feeling miserable and extra dose administered were unknown and the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, blister and feeling miserable to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient got 3 injections of Shingles vaccine, which led to extra dose administered. The patient still get shingles at least once a year it did not hurt so bad and the blisters go away in about 2 weeks, so it was better.  It still makes patient miserable. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: killed my mother; This case was reported by a consumer via interactive digital media and described the occurrence of death in a adult female 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 death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   The reporter considered the death to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. This vaccine killed the patient's mother. The follow-up would not possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vaccinated, still got them/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient was vaccinated, and still got shingles. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shingles; Not fun very painful .; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had a shot for shingles, however the patient got the shingles. It was not fun very painful. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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.   On an unknown date, the patient received 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 recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and had sore arm for a few days but would take that over the shingles anytime. The patient prayed that the next one would be easier. The follow-up would not possible as no contact details were available. This case has been linked with US2022AMR014049, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR014049:Response to same post
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Loss of consciousness, Nervousness, Sleep disorder
Clinical narrative: passed out; sick to stomach; This case was reported by a consumer via interactive digital media and described the occurrence of passed out 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 day after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant) and stomach discomfort. On an unknown date, the outcome of the passed out and stomach discomfort were unknown.   It was unknown if the reporter considered the passed out and stomach discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient was getting the second shot of shingles vaccine the next day of reporting and was really nervous because he/she woke up during the night after getting the first shot and got really sick to the stomach and actually passed out in the bathroom the night of the shot. The patient stated that he/she was praying that would be the case for his/her second dose. The follow-up would not be possible as no contact details were available. This case has been linked to US2022AMR014021, response to same post.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR014021:Response to same post
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles despite being vaccinated/Suspected vaccination failure; Shingles; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient stated that the patient had an episode of shingles despite being vaccinated.  The patient was unsure of dates. The reporter did not agree to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had it despite being vaxed/suspected vaccination failure; had it, constant activation; pain that lingers; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient stated that the patient had shingles and suffering from the pain that lingers and constant activation, despite being vaccinated. This case was considered as suspected vaccination failure, since the details regarding completion of primary vaccination schedule, time to onset for event and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received adjuvant only; received adjuvant only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2022, the patient received the 2nd dose of Shingrix. On 14th January 2022, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received second dose of Shingrix where only AS01B Adjuvant was administered without the Lyophilized Antigen Component, which led to the inappropriate reconstitution technique and incorrect dose administered. Consent to follow up was granted.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Therapy non-responder
Clinical narrative: was not immune after receiving the 3 dose series; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In 1998, the patient received the 3rd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 2nd dose of Engerix B, Engerix B Pre-Filled Syringe Device, the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B, Engerix B Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder 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 reported as follows: Age at vaccination was not reported. The patient received 3 doses of Engerix B in 1998 and was found not immune at the time of reporting. The patient was recommended for re-starting the Engerix B series. Consent to follow up was granted.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles after first dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. In January 2022, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix and experienced Shingles. The patient was about to receive second dose no later than 8th February 2022 and the reporter wanted to know when the patient should receive second shot. The reporter wanted to know how long do he need to wait to give his second shot. The reporter abandoned the chat after reporting this when tried to collect the adverse event and his demographics. Consent to follow up was not possible as no contact details were available.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Gave powder reconstituted with sterile water; Gave powder reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA587A, expiry date 31st August 2022) for prophylaxis.   On 25th January 2022, the patient received Menveo. On 25th January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received Menveo dose in left deltoid. The patient inadvertently administered the Menveo lyophilized powder reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Electrocardiogram abnormal, Palpitations
Clinical narrative: Heart palpitations, irregular heart rhythm
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Maternal exposure during breast feeding, Menstruation irregular, Parosmia, Taste disorder
Clinical narrative: Period started up again baby is only 4.5 months along and breastfeeding  Smell and taste are distorted. Doing smell kit.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Fever.  (Also, muscle soreness at site of injection.) [ caused to miss a day of work ]
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Fatigue, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Arm soreness, runny nose, body aches, fatigue, lump in left arm pit
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood test normal
Clinical narrative: Four months to the day that I completed my Covid Vaccine series, my hair started falling out in massive chunks. I have never had hair thinning or Alopecia before. All blood tests have been ran and there is no other medical reason or event for the Alopecia to have been triggered. The only change in my life was the vaccine. I have never even had Covid. I was diagnosed by my PCP with Alopecia with no other diagnosis and was referred to a dermatologist. My hair has continued to fall out for 10 months. I have lost over 85% of my hair, despite early treatment with oral, topical and injection steroid treatments. I am now taking Methotrexate and folic acid and have some hair regrowth.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: received a third dose by accident; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA592A, expiry date 31st August 2022) for prophylaxis.   Previously administered products included Menveo (received 1st dose on an unknown date) and Menveo (received 2nd dose on an unkown date).   On 19th January 2022, the patient received the 3rd dose of Menveo. On 19th January 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Menveo by accident, which led to extra dose administered. The reporter consented to follow up.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting appx 5 hours after shot. No fever.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: Nerve pain in arms and hands
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: fever, aches
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest X-ray, Computerised tomogram head, Computerised tomogram neck, Dysarthria
Clinical narrative: Mini stroke (TIA) with slurred speech and facial droop or right cheek and lips, 219/97 BP on arrival at ER, testing and observation at ER for 36 hours, aspirin 81mg, atorvastatin 80mg, clopidogrel 75mg, BP 125/60 upon discharge from ER, speech normalized by time of discharge from ER, facial droop normalized within 3-4 days of discharge, continue taking aspirin and atorvastatin
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Facial paralysis, Magnetic resonance imaging head, Scan with contrast, Thrombosis
Clinical narrative: Mini stroke (TIA) with slurred speech and facial droop or right cheek and lips, 219/97 BP on arrival at ER, testing and observation at ER for 36 hours, aspirin 81mg, atorvastatin 80mg, clopidogrel 75mg, BP 125/60 upon discharge from ER, speech normalized by time of discharge from ER, facial droop normalized within 3-4 days of discharge, continue taking aspirin and atorvastatin
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Mini stroke (TIA) with slurred speech and facial droop or right cheek and lips, 219/97 BP on arrival at ER, testing and observation at ER for 36 hours, aspirin 81mg, atorvastatin 80mg, clopidogrel 75mg, BP 125/60 upon discharge from ER, speech normalized by time of discharge from ER, facial droop normalized within 3-4 days of discharge, continue taking aspirin and atorvastatin
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Pruritus, Rash, Urticaria
Clinical narrative: Itchiness all over my body about 10 or 11 days after the booster. Whenever I rub it slightly itch my skin anywhere on my body, it?ll become red and welt up. Sometimes I?ll get a rash there too. Much like dermatographia.  I went to a dermatologist after 4 days of having this condition. He thinks it?s likely to be an adverse reaction to the booster. He prescribed my prednisone.  I had no side effects from the first two vaccine shots.   Also of note, I had swollen lymph nodes under my armpits for about a week or so after the booster.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Pruritus, Urticaria
Clinical narrative: No reactions after the first 2 Moderna vaccines taken in March and April 2021.  But 8 days after the Moderna Booster shot (December 2021), I started getting very itchy skin and hives all over the body. I have never had hives or any allergies before ever in my life before.  4 weeks after the shot, I have joint pain and heart burns also. Zyrtec helps with hives (my primary physician's recommendation). Hives come back when I stop Zyrtec
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Ammonia decreased, Anti-GAD antibody negative, Anti-NMDA antibody negative, Asthenia, Blood creatinine increased
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood folate normal, Blood thyroid stimulating hormone decreased, CSF culture negative, CSF glucose increased, CSF lymphocyte count increased
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: CSF monocyte count decreased, CSF protein increased, CSF red blood cell count, CSF red blood cell count positive, CSF white blood cell count increased
Clinical narrative: Admitted to hospital 1/13/2022 with acute encephalopathy and generalized weakness with odd presentation. Initially blamed on a possible urinary tract infection, but subsequently the neurologic condition continued to worsen to a severe state not consistent with UTI. Symptoms of severe encephalopathy, generalized weakness, tremor and confusion. He required intubation and mechanical ventilation on 1/18/2022 due to such severe neurologic condition that he could not maintain an airway. He has been seen by multiple specialists (to include two neurologists, an infectious disease specialist, critical care physicians) without a clear diagnosis other than possibly aseptic meningitis based on minimal findings on a lumbar puncture (see below) possibly due to "autoimmune encephalitis" (per neurology assessment of all these findings). Patient continues in critical care in ICU and continues to worsen neurologically. No improvement after trial of IVIG. No obvious improvement with steroids (continuing to treat, most recent neurology assessment indicates they think patient may be plateau of symptoms).  No obvious improvement after broad spectrum antibiotics. Remains on mechanical ventilation in ICU.  Note: onset of symptoms (one week after vaccination) is based on a very lengthy conversation I had with wife the night of 1/18/2022.