chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Stomach upset; Back hurts; Neck hurts; Back of her leg hurts; Body aches/felt like every muscle in their body hurts; Typical gastro issue like nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts) and MYALGIA (Body aches/felt like every muscle in their body hurts) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery (She is a survival of three open heart surgery) and Heart valvular prosthesis user. Concomitant products included FLUDROCORTISONE, VITAMIN D [VITAMIN D NOS], WARFARIN SODIUM (JANTOVEN), PARACETAMOL (TYLENOL [PARACETAMOL]) and LIOTHYRONINE for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts), MYALGIA (Body aches/felt like every muscle in their body hurts), NAUSEA (Typical gastro issue like nausea) and CHILLS (Chills). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset), BACK PAIN (Back hurts), NECK PAIN (Neck hurts), PAIN IN EXTREMITY (Back of her leg hurts), MYALGIA (Body aches/felt like every muscle in their body hurts), NAUSEA (Typical gastro issue like nausea) and CHILLS (Chills) had resolved.            The patient stated after the 2nd dose within 4 hours, they started having side effects; these side effects were body aches, chills, stomach upset, their back hurts, the back of their leg hurts and felt like every muscle in their body hurts, neck hurts and typical gastro issue like Reportedly, the patient waited for 6 hours before using Tylenol and heat. The patient reported that the symptoms were all gone within a day and a-half and the patient was back to their normal lifestyle.   The patient also reported that they were a survivor of three open heart surgery and had artificial heart valve.   The patient used Heat and Tylenol to alleviate the events.   This case was linked to MOD-2021-395769, MOD-2021-395919 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine) had resolved.            No concomitant medications were reported. No treatment medications were reported.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Pain in extremity, Rash
Clinical narrative: Sore arm; She had a reaction; Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE REACTION (She had a reaction) and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel) in a 77-year-old female patient 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE REACTION (She had a reaction) and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INJECTION SITE REACTION (She had a reaction) outcome was unknown and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel) was resolving.            No Concomitant and Treatment medications were provided.  Patient stated that she was concerned that vaccine was not injected properly into the muscle.   This case was linked to MOD-2021-395969 (Patient Link).   Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; She had a reaction; Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), INJECTION SITE REACTION (She had a reaction) and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel) in a 77-year-old female patient 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), INJECTION SITE REACTION (She had a reaction) and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel). At the time of the report, PAIN IN EXTREMITY (Sore arm) and INJECTION SITE REACTION (She had a reaction) outcome was unknown and RASH (Rash/ rash is about size of half dollar on right arm/ rash size is now size of a nickel) was resolving.            No Concomitant and Treatment medications were provided.  Patient stated that she was concerned that vaccine was not injected properly into the muscle.   This case was linked to MOD-2021-395969 (Patient Link).   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Pain in extremity, Poor quality sleep, Skin discolouration
Clinical narrative: Fingertips are turning blue/different ones at different times/turn purple/different fingers at different times/started a week ago with just one finger; It hurts really bad/fingertips hurt really bad/hurts like heck/just the tip; Hurting; Strange; Index and middle finger woke me up in the middle of the night; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Fingertips are turning blue/different ones at different times/turn purple/different fingers at different times/started a week ago with just one finger), PAIN IN EXTREMITY (It hurts really bad/fingertips hurt really bad/hurts like heck/just the tip), POOR QUALITY SLEEP (Index and middle finger woke me up in the middle of the night), PAIN (Hurting) and FEELING ABNORMAL (Strange) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung disorder.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced POOR QUALITY SLEEP (Index and middle finger woke me up in the middle of the night). On an unknown date, the patient experienced SKIN DISCOLOURATION (Fingertips are turning blue/different ones at different times/turn purple/different fingers at different times/started a week ago with just one finger), PAIN IN EXTREMITY (It hurts really bad/fingertips hurt really bad/hurts like heck/just the tip), PAIN (Hurting) and FEELING ABNORMAL (Strange). At the time of the report, SKIN DISCOLOURATION (Fingertips are turning blue/different ones at different times/turn purple/different fingers at different times/started a week ago with just one finger), PAIN IN EXTREMITY (It hurts really bad/fingertips hurt really bad/hurts like heck/just the tip), POOR QUALITY SLEEP (Index and middle finger woke me up in the middle of the night), PAIN (Hurting) and FEELING ABNORMAL (Strange) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient got the first dose of Moderna COVID19 Vaccine around holiday and second dose about three weeks after that, which was around the first week of March.  No concomitant product information was provided. The patient reports that he runs his hands under water and it takes about 5 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Significant Follow up  received contains -patient details updated, Event added
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: reports to weird rashes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (reports to weird rashes) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (reports to weird rashes). At the time of the report, RASH (reports to weird rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-395739 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: No additional AE reported; a pregnant patient received a dose of GARDASIL 9 today/given in error; a pregnant patient received a dose of GARDASIL 9 today/given in error; This spontaneous prospective pregnancy report was received from a nurse and refers to a 34 years old female pregnant patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 01-NOV-2021, the patient received in error a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687293, verified as valid, expiration date: 30-APR-2022) for prophylaxis (exact dose, route of administration and anatomical location were not reported). The patient became pregnant with LMP of 17-MAY-2021 and EDD of 21-FEB-2022. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was at 28 weeks. The pregnancy outcome was pending. The patient experienced vaccination error and exposure during pregnancy. The patient was not currently experiencing any side effects. No additional adverse events reported. The outcome of the events was unknown.
Age: 1.58
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse events reported; admnistration of an adult dose of VAQTA admnistered to a 19 months old patient; This spontaneous report was received from a physician and refers to a 19 month old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  The physician reported that on 04-NOV-2021, the child patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) 1 milliliter,  lot number T034003 with expiration date 28-MAR-2022 (route of administration and anatomical location were not reported) for prophylaxis (Product use issue). No additional adverse event reported.
Sex: F
Vaccine: HPV9
Symptoms: Vaginal haemorrhage
Clinical narrative: she has also had abnormal pap smears with HPV in the past (dates unspecified); she has also had abnormal pap smears with HPV in the past (dates unspecified); Bleeding vaginal; This spontaneous report Was received from a pharmacist referring to herself, a female non-pregnant patient of unknown age. No patient's pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitant therapies were reported.     On an unspecified date in July 2021 (also reported as "beginning of July"), the patient was vaccinated with her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, by intramuscular route, (strength, frequency, anatomical location, lot number an expiration date were not reported), as human papillomavirus (HPV) prevention.  On an unspecified date in 2021, (also reported as "about two weeks after the secondo dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)), the patient began to experience vaginal bleeding (vaginal haemorrhage). Additionally, on an unknown date (also reported "in the past"), the patient had abnormal Papanicolaou smear with human papillomavirus (HPV) (papilloma viral infection and smear cervix abnormal). It was reported that on an unknown date, the patient sought medical attention, was treated with change the "birth control dosage" and would get unspecified bloodwork in a couple of days. At the time of reporting, the outcome of events was reported as not recovered. The reporter did not assess the causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).
Age: 1.0
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Expired product administered
Clinical narrative: No additional adverse event reported; Expire dose of PEDVAXHIB was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12-month-old female patient with none concurrent conditions, none allergies and none illness at the time of vaccination.   On 05-NOV-2021, the patient was vaccinated with an expired dose (expired product administered) of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB), intramuscularly, 0.5 milliliter, lot # R036178 expiration date 09-OCT-2021 for prophylaxis.    Concomitant therapies included measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) and pneumococcal vaccine conj 13v (crm197)(PREVNAR 13).     This error to administer expired vaccine occurred during storage in clinical practice, dispensing, preparation for administration and this was noticed after administration. The manufacturer was contacted, relayed in house data support potency but could not recommended re-administration dose. Also, this error was discussed with attending physician who advised re-administration not needed. Patient's mother was aware, and she did not want to pursue re-administration.  The nurse also reported, that no temperature excursions had occurred of the administered dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB). No additional adverse event and product quality complain were reported.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and referred to a currently 72 years old patient of unknown gender. Medical history, concurrent conditions, and concomitant medications were not provided. On 28-DEC-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for the long-term prevention and protection against shingles and zoster-related conditions. On an unknown date, the patient was treated for herpes zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: M
Vaccine: HPV9
Symptoms: Induration, Mass, Nodule, Peripheral swelling
Clinical narrative: hard swollen "knot" on thier shoulders; hard swollen mass on thier shoulders; Information has been received from a physician via a company representative, referring to two male patients of unknown ages. The patients' medical history, concurrent conditions and concomitant therapies were not reported.   On an unknown dates, the patients were vaccinated with doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (anatomical location, administration route, lot numbers and expiration dates were not reported) for prophylaxis.         On an unspecified date (reported as 3-4 weeks after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) administration), the two patients who are brothers both developed hard swollen "knot" on their shoulders with no evidence of infections.  The outcome of the hard swollen "knot" on their shoulders was unknown.  The casuality assessment between the aforementioned event and the vaccination with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Sex: F
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Vomiting projectile
Clinical narrative: immediately projectile vomited; This initial spontaneous report was received from a nurse refers concerning a 2 month and 5 days old infant female patient. The patient's pertinent medical history, concurrent conditions, allergy drugs/drug reactions and concomitant medications were not reported.  On 15-NOV-2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), per oral route, Lot # reported as 168825 and expiration date 24-NOV-2021 (strength, dose and frequency not provided) for prophylaxis.         It was reported that on the same day, on 15-NOV-2021, the patient immediately projectile vomited after receiving the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). It was reported that the patient did not seek medical attention. No additional events were reported.   The outcome of vomiting projectile was reported as recovered/resolved on 15-NOV-2021.     The causal relationship between the event and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was unknown at the time of the report.  Lot Number 168825 is invalid for rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and does not match any company product as confirmed by Lot Verification team.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Very red, very warm, very swollen and very painful; Very red, very warm, very swollen and very painful; Very red, very warm, very swollen and very painful; Very red, very warm, very swollen and very painful; This spontaneous report was received from a pharmacist via Pfizer referring to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, lot# and expiration date were not reported).  On an unknown date, the patient experienced erythema, feeling hot, pain and swelling (reported as "very red, very warm, very swollen and very painful"). The outcome of erythema, feeling hot, pain and swelling was unknown.  The causal assessment between all the events and the suspect therapy was not provided.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; temperature excursion for ROT ATEQ and notes the product has been administered today; This spontaneous report aas received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 22-NOV-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) oral, lot number 1742081, expiration date 18-JUL-2022 (dose not reported) for prophylaxis (product storage error).  No adverse event was reported.      The vaccine underwent a temperature excursion of 14.9 degrees Celsius for 62 hours. No previous temperature excursions were detected.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; ROTATEQ was administered following a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742080 experienced the temperature excursion of 48.5 degrees fahrenheit (F) for 30 minutes. On 22-NOV-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1742080, expiration date 14-JUL-2022 (formulation, concentration, exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error). There were no previous excursions reported. No adverse event was reported (no adverse event).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: the patient did not have any symptoms fro receiving an expired VAQTA dose; expired VAQTA administered; This spontaneous report was received from a doctor of osteopathy and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 23-NOV-2021, the patient was inadvertently vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) lot # T017179, expiration date 26-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). No adverse event was reported.  The reporter inquired was there any danger to the patient.  This is one of two reports from the same reporter. ; Sender's Comments:  US-009507513-2111USA009083:
Sex: U
Vaccine: FLUX
Symptoms: Back pain, Blister, Breast pain, Pain, Pruritus
Clinical narrative: Pains; Blisters started forming; The area is still itchy; Breast pain; Back pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 24th September 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, less than a day after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain, blister, pruritus, breast pain and back pain. On an unknown date, the outcome of the pain, blister, breast pain and back pain were unknown and the outcome of the pruritus was not recovered/not resolved.   It was unknown if the reporter considered the pain, blister, pruritus, breast pain and back pain to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age ta vaccination was not reported. The patient stated last year she/he got the flu shot in left arm that night she/he started getting pains and blisters started forming that night all on left side, all around under his/her left breast and across the middle of back. The patient also mentioned till today the area was still itchy, coincidence. The follow-up would not possible as no contact information was available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: It kicked my butt; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell 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 dose of Shingles vaccine and felt it kicked his/her butt too. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction for 10 days; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult female 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 allergic reaction. The patient was treated with allergy medication {nos} (Allergy Pill). On an unknown date, the outcome of the allergic reaction was recovered/resolved.   The reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The husband reported that his wife  patient had an allergic reaction to the shingrix vaccine, gone on for ten days. The reporter asked for information on what to do about a bad reaction that had gone on for twelve days now. Allergy pills had been helping. The call center representative provided all the relevant information to the reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sore on my bottom lip nose and the roof of my mouth; Cold sore on my bottom lip nose and the roof of my mouth; This case was reported by a consumer via interactive digital media and described the occurrence of cold sores 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 cold sores and sores roof of mouth. On an unknown date, the outcome of the cold sores and sores roof of mouth were recovered/resolved.   It was unknown if the reporter considered the cold sores and sores roof of mouth to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The patient got the first shot, and had every side effect possible,12 days of hell.  The patient had cold sore on bottom lip, in nose and the roof of the mouth. The patient was very very concerned about the second shot.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix vaccine over a year ago; 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 (1st dose received over a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable. Till the time of reporting the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter asked that If a person had their first Shingrix vaccine over a year ago, could they get their second dose now or did they need to start the series over. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction to the vaccine; This case was reported by a consumer via Shingrix GSK and described the occurrence of allergic reaction in a female 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 allergic reaction. On an unknown date, the outcome of the allergic reaction was recovered/resolved.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's husband. The age at vaccination was not reported. The reporter's wife had an allergic reaction to the vaccine, it had gone on for ten days. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had the shots be fore this last round of the shingles/suspected vaccination failure; I had the shots be fore this last round of the shingles; 2 times and they are Sooo painful; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient experienced shingles 2 times and they were soo painful. The patient had the shots before this last round of the shingles.  The reporter also said get the shot people. This case was considered as suspected vaccination failure as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243350:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and he got shingles/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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure 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 reported as follows: The patient was the reporter's co-worker. The age at vaccination was not reported. The patient got the vaccine and about a month or so later, he got shingles/ The reporter was just curious if it was related or not. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Multiple sclerosis, Neck pain, Vaccination failure
Clinical narrative: secondary multiple sclerosis.; have shingles, had the shingles vaccine/Suspected vaccination failure; shingles; sharp pain in neck; This case was reported by a consumer via  interactive digital media and described the occurrence of multiple sclerosis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced multiple sclerosis (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles and neck pain. The patient was treated with antibiotics nos (Antibiotic (Active Ingredient Unknown)). On an unknown date, the outcome of the multiple sclerosis, shingles and neck pain were not recovered/not resolved and the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the multiple sclerosis, vaccination failure, shingles and neck pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles vaccine 4 years ago from the date of reporting. At the time of reporting, the patient had shingles. The patient also had secondary multiple sclerosis. The patient was having a pretty regular sharp pain in neck. The patient was prescribed antibiotic. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after getting his shingles vaccine/suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male 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 reported as follows: The patient was the reporter's father. The age at vaccination was not reported. The patient got shingles after getting his shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. The case had been linked with US2021AMR202793, a tag post.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202793:tag at post
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: got both shots about 1 year ago, had a breakthrough case/suspected Vaccination failure; breakthrough case; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got both shots about 1 year ago. The patient experienced breakthrough cases. The patient had a breakthrough case last month from the date of reporting and it was not as severe as the others, refer case US2021AMR243458. This case was considered as suspected vaccination failure as time to onset and laboratory confirmation was unknown at the time of reporting. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243458:same reporter, other episode
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure, Varicella post vaccine
Clinical narrative: suspected vaccination failure; It wasn't as severe as the others; This case was reported by a consumer via (Facebook) 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received both the doses of Shingles vaccine, 1 year ago from the date of reporting. After receiving Shingles vaccine, the patient had a breakthrough case last month from the date of reporting. The patient stated that, it was not as severe as the others. This case was considered as suspected vaccination failure, since the details laboratory confirmation of herpes zoster was not provided.  This case had been linked with case US2021AMR243453, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243453:same reporter, other episode
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included immunodeficiency (the patient's immune system was compromised).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination as not reported. The patient had both Shingles vaccines several years ago and experienced shingles. The patient was recovering now. The physician told him it was a 1 percent chance of getting Shingles if you had both shots.  The follow-up would not possible as no contact details were available. The case was considered as suspected vaccination failure since the detail regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Mobility decreased, Pain, Vaccination failure
Clinical narrative: received this vaccine, had shingles/ suspected vaccination failure; shingles; painful; feel bad enough to stay in bed and feel yucky; This case was reported by a consumer via (Facebook) 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, pain and feeling bad. On an unknown date, the outcome of the vaccination failure, shingles, pain and feeling bad were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles. It was so painful.  The patient stated he/she had friendly suggestion, definitely felt like received this Shingles vaccine. The patient stated he/she, made feel bad enough to stay in bed for one day and feel Yucky another day. The patient stated he/she really did not ever want shingles again, so might be this would work. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot / had the shingles/ 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 male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In June 2021, 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: This case was reported for reporter's husband. The age at vaccination was not reported. The reporter stated the reporter and patient got the Shingles shot and the patient had the shingles in June 2021. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles a few years after I had the shot/ suspected vaccination failure; shingles / mild case; 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, several 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 details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got shingles a few years after the Shingles shot. Not terribly unusual, but it also was a very mild case. The patient stated he/she been told had no reason to expect another shingles episode. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.