chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Hard swelling; Painful; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Hard swelling) and PAIN (Painful) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs), Allergy to antibiotic (Ciprofloxacin), Allergy to antibiotic (Celebrex), Allergy to antibiotic (Betadyne), Soy allergy, Contrast media allergy (Contrast dye), Food allergy (Wheat), Fish allergy, Shellfish allergy and Bee sting.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced SWELLING (Hard swelling) and PAIN (Painful). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency; NAPROXEN (NAPROSYN E) for Adverse reaction, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse reaction, at an unspecified dose and frequency. On 10-Sep-2021, SWELLING (Hard swelling) was resolving. At the time of the report, PAIN (Painful) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant were provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: but tender at spot where vaccine was injected; Rash 6 days after injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (but tender at spot where vaccine was injected) and RASH (Rash 6 days after injection) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Previously sick with Covid). Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfa drugs), Allergy to antibiotic, Drug allergy, Drug allergy, Contrast media allergy, Soy allergy, Food allergy, Fish allergy, Shellfish allergy and Bee sting hypersensitivity.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced RASH (Rash 6 days after injection). On an unknown date, the patient experienced VACCINATION SITE PAIN (but tender at spot where vaccine was injected). At the time of the report, VACCINATION SITE PAIN (but tender at spot where vaccine was injected) outcome was unknown and RASH (Rash 6 days after injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported. Large red rash, measures 3 inches by 6 inches on left arm was reported.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site swelling, Pharyngeal swelling
Clinical narrative: Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache; Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache; Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache; Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache), HEADACHE (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache), CHILLS (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache) and INJECTION SITE SWELLING (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache) in a 33-year-old male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHARYNGEAL SWELLING (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache), HEADACHE (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache), CHILLS (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache) and INJECTION SITE SWELLING (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache). At the time of the report, PHARYNGEAL SWELLING (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache), HEADACHE (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache), CHILLS (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache) and INJECTION SITE SWELLING (Chills, swollen throat, baseball size swelling at injection site on right arm, throbbing headache) had not resolved. Not Provided          No concomitant medications were reported.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Decreased appetite, Depression, Interchange of vaccine products, Sleep disorder
Clinical narrative: Loss of appetite; mild stomach ache; disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11; disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11; Interchange of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), ABDOMINAL PAIN UPPER (mild stomach ache), DEPRESSION (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11), SLEEP DISORDER (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.    Co-suspect product included non-company product (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Hypertension (High blood pressure) and Allergy (Severe allergy with anaphylaxis).   On 06-Mar-2021, the patient started (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Mar-2021, (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and ABDOMINAL PAIN UPPER (mild stomach ache). 26-Aug-2021, the patient experienced DEPRESSION (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11), SLEEP DISORDER (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine). On 26-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine) had resolved. On 12-Sep-2021, DECREASED APPETITE (Loss of appetite) and ABDOMINAL PAIN UPPER (mild stomach ache) had not resolved and DEPRESSION (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11) and SLEEP DISORDER (disrupted sleep pattern sleep 10 hours a day (9/12/21) Severe depression (until 9/11) was resolving.        No concomitant medications were reported. No treatment medications were mentioned
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort
Clinical narrative: heavy headed en tired
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Electrocardiogram normal
Clinical narrative: The health dept came to my place of employment and gave the vaccines.  I took the first dose and within a couple days my chest began bothering me.  After 1 week i was concerned enough to go get an ECG which showed normal, but the discomfort continued for a couple weeks.  I have also felt tired since receiving it..  Because of this I did not and do not intend to get the second dose.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling hot, Urticaria
Clinical narrative: Hives episode: Torso, upper legs,  arms, scalp, eye lids came up in red raised blotches. Took an antihistamine tablet before going to bed, Hives nearly gone by morning. Inside ears, throat and down into body feels very hot.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Dyspnoea, Electrocardiogram, X-ray
Clinical narrative: 2 days after receiving the second dose I received shortness of breath and was heavy cheated.  I ended up at the hospital. I am now on a daily use inhaler to help my breathing during normal activity. I did not have asthma prior to the vaccine.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: No further Adverse event /No additional AEs reported; a patient inadvertently received a third dose of VAQTA instead of the recommended two doses; This spontaneous report was received from a medical assistant concerning to a 17 year old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.    On 23-AUG-2021, the patient was inadvertently vaccinated with the third dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported)  lot # T035720 expiration date: 15-APR-2022, 0.5 milliliter for prophylaxis; instead of the recommended two doses (extra dose administered).     For hepatitis a vaccine, inactivated(VAQTA SYRINGE (DEVICE)), the lot number was reported as T035720 and the serial number was not available. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE details or Pqc; administered expired vaccine of MMR II; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.   On 26-AUG-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot # S015961, expiration date: 23-MAY-2021, 0.5 milliliter (strength, dosing schedule and route of administration was not provided) for prophylaxis. Administered dose of vaccine was reconstituted in a sterile diluent, lot# S016862, expiration date reported as: 20-SEP-2022, but upon internal validation established as 09-FEB-2022. There was no previous temperature excursion noted. No additional adverse event details provided.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 shots in 2017 and received a dose of GARDASIL 9; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On unspecified dates in 2017, the patient possibly received the three doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (unidentified Merck hpv vaccine was administered (name and lot number not provided); dose, route, anatomical location, and expiration date were also not provided) for prophylaxis.  Then, on 10-SEP-2021 (reported as today), the patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (extra dose administered).
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 13-AUG-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, anatomical site of vaccination and vaccine scheme were not provided; lot number U013969 has been verified to be valid, expiration date reported and established as 06-FEB-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9°F) during a time frame of 90 hours (product storage error). There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003304: US-009507513-2109USA003305: US-009507513-2109USA003303: US-009507513-2109USA003302: US-009507513-2109USA003301:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: PROQUAD vaccine was administered 23AUG2021 following a supported temperature excursion; This spontaneous report has been received from a healthcare business professional, a chief executive officer, referring to a 4-year-old male patient. No information regarding the patient's medical history, concomitant medications or concurrent conditions was provided.  On 23-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, route of administration, vaccine scheme and anatomical site of vaccination were not reported; lot number T031603 has been verified to be valid, expiration date reported and established as 15-MAR-2022) as prophylaxis.   The vaccine was exposed to a temperature excursion of 8.4 degrees Fahrenheit, during a time frame of 1 hour and 30 minutes (product storage error). There was no previous temperature excursion.
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 13-AUG-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (lot number U013969 has been verified to be valid, expiration date reported and established as 06-FEB-2023) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T037642 has been verified to be valid, expiration date reported and established as 06-NOV-2022) as prophylaxis (doses, routes of administration, anatomical sites of vaccination and vaccine schemes were not reported).   The vaccine hepatitis A vaccine inactivated (VAQTA) was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9°F) during a time frame of 90 hours. The vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) was exposed to a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (32.9°F) for 90 hours (product storage error).  There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003185:
Sex: U
Vaccine: HEPA, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 16-AUG-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) (lot number U013969 has been verified to be valid, expiration date reported and established as 06-FEB-2023) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T037642 has been verified to be valid, expiration date reported and established as 06-NOV-2022) as prophylaxis (doses, routes of administration, anatomical sites of vaccination and vaccine schemes were not reported).   The vaccine hepatitis A vaccine inactivated (VAQTA) was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9°F) during a time frame of 90 hours. The vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) was exposed to a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (32.9°F) for 90 hours (product storage error).  There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA003185:
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: her fingertips are tingling; still has arm and shoulder joint pain; feels her hand go weak; she has arm soreness / the pain was more localized that day and the next day it was the whole arm.; she is worried about the finger tingling; She states the more she uses her arm the more cramping she has.; she's not comfortable with waiting around; This spontaneous report was received via Pfizer from a 38-year-old female patient who refers to herself. Her concurrent conditions included asthma. She had no concomitant medications.  On 28-JUL-2021, in the morning, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) in the left arm (dose number, dose, lot # and expiration date were not reported) for indication reported as "have asthma so they recommended it".  On the same day, she experienced arm soreness and by nighttime she felt the pain was more localized that day and the next day it was the whole arm. It was progressively gotten worse to the point that from 20-AUG-2021 her fingertips were tingling and from unspecified date in August 2021, the patient still had arm and shoulder joint pain. On an unknown date in August 2021 (reported as August 2020), she felt her hands go weak. On an unspecified date in 2021, the more the patient used her arm the more cramping she had. She also felt tingling-like pain was more intense. The patient was worried about the finger tingling and called her doctor, but her doctor was limited to what was on the Centers for Disease Control and Prevention (CDC) website, so there was not much they could tell her. It just said it was normal within two to three days but it did not say anything else. All they gave her was a flier that said it was normal to get soreness and that she could take acetaminophen (TYLENOL) if she had pain. It was not like a manufacturer card or anything. She confirmed the product was Pfizer (conflicting information, as it was reported as pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)) and was told to contact manufacturer for information by doctor. They said it did not sound like she was in danger, she did not need to run to the emergency room or an urgent care and said hopefully it resolved itself but she was not comfortable with waiting around so wanted to speak to somebody.   The outcome of arm soreness, arm and shoulder joint pain, fingertips were tingling and her hands go weak was reported as not recovered (ongoing). The outcome of was worried, was not comfortable and the more cramping she had was unknown. Action taken with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.  The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Age: 19.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; a patient received the first dose of GARDASIL 9 on 24 MAR 2016 and was 19 years old at the time. Caller reports that the second dose was administered today 14 SEP 2021; This spontaneous report was received from a pharmacist and refers to an adult patient of unknown exact age. There was no information regarding the patient's medical history, drug reactions/allergies or concomitant therapies provided.  On 24-MAR-2016, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. The patient was 19-year-old at that time. On 14-SEP-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, lot # T039467, expiration date 20-MAY-2023 (route of administration was not provided). It was considered to be an inappropriate schedule of vaccine administration. No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: T039467; expirationdate: 20-MAY-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported; Co-administration of PROQUAD and VARIVAX; This spontaneous report was received from a nurse concerning a 12 month old patient, gender not provided. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.      On 14-SEP-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter for prophylaxis (lot number T034615, has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date establish as 10-APR-2022) and with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter for prophylaxis (lot number T035401, has been determined to be valid for varicella virus vaccine live (oka/merck) , expiration date establish as 16-OCT-2022) (inappropriate schedule of product administration) (strength, route of administration and anatomical location were not provided for any vaccine) .      No adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; PROQUAD was administered after a temperature excursion; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 14-SEP-2021, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) 0.5 milliliters (mL) as prophylaxis (route of administration and anatomical site of vaccination were not reported; lot number T025509 has been verified to be valid, expiration date reported and established as 23-JAN-2022). The vaccine was exposed to a temperature excursion of 6.9 degrees Fahrenheit during a time frame of 48 minutes (product storage error). There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain primarily in my legs; This case was reported by a consumer via (Shingrix GSK and described the occurrence of myalgia of lower extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced myalgia of lower extremities. On an unknown date, the outcome of the myalgia of lower extremities was not recovered/not resolved.   It was unknown if the reporter considered the myalgia of lower extremities to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingrix vaccine and have had muscle pain primarily in his/her legs since getting the shingles vaccine (4 days ago). The reporter wanted to know how long could he/she expected this to last. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Syncope, Unresponsive to stimuli
Clinical narrative: syncope, found unresponsive/ second episode; sore arm; mild fatigue; This case was reported by a nurse via sales rep and described the occurrence of syncope in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2021, the patient received the 1st dose of Shingrix. In September 2021, 12 hrs after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant), pain in arm and fatigue. On an unknown date, the outcome of the syncope, pain in arm and fatigue were recovered/resolved.   It was unknown if the reporter considered the syncope, pain in arm and fatigue to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The nurse reported that a friend of wife called her to report that she received the Shingrix vaccine on 12th September 2021. The patient had sore arm but otherwise reasonably well except for mild fatigue until about 12 hours later when she had syncope, found unresponsive by husband (a physician) in bathroom. Followed by second episode as he was getting her back to bed, to which she was slow to recover from and he briefly considered calling ambulance but changed his mind after she awoke fully. The reporter stated that patient was willing to speak to GSK about this incident which she found to be very alarming. This case is linked with the case US2021AMR196420, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196420:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Tachycardia
Clinical narrative: felt tachycardic; This case was reported by a nurse and described the occurrence of tachycardia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced tachycardia. On an unknown date, the outcome of the tachycardia was recovered/resolved.   It was unknown if the reporter considered the tachycardia to be related to Shingrix.  Additional details provided were as follows: The case was reported by the wife of the patient. Age at vaccination was not reported. The patient received the 2nd dose of Shingrix vaccine and felt tachycardic afterwards. The reporter consented to follow-up. The case was linked with case US2021AMR196413, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR196413:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Skin discolouration
Clinical narrative: legs were discolored, black.; This case was reported by a consumer via interactive digital media and described the occurrence of skin discoloration 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 skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The reporter knew someone who got just the shingles shot years ago from the date of reporting and after that their legs were discolored, black.  That shot sure worked. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: Ended up in hospital; This case was reported by a consumer via (Facebook) interactive digital media and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received Shingles vaccine. In September 2021, less than 2 weeks after receiving Shingles vaccine, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was recovered/resolved.   It was unknown if the reporter considered the hospitalization 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 got 2 Van in shot and now went away. The patient got the Shingle shot last week and had a side effects ended up in hospital. The patient thanked that he/she was alright and good.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient got the shingles vaccine and felt so sick that  only lasted 5 years. The contact details were not reported hence follow-up not possible.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and still 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 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 case was reported by the patient. The age at vaccination was not reported. As per the patient even if you got the Shingles vaccine you could still get the shingles not as severe. The patient got the Shingles vaccine and still got the shingles. The follow up would not be 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 confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got both shingles shots last september, now shingles/suspecte vaccination failure; shingles; pain; 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.   In September 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine and more than a year 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 not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 the both the Shingles vaccine last year from our pharmacy. The patient got the last one last September and the patient was in his/her 7th week of shingles. As per the patient, one of the most painful thing and had to endure and hopes that did not happen to anyone. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot/ 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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 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 reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot and 3 years later still got shingles. The follow up would not be possible as no contact details were available.This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: outbreak of shingles from the vaccine/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 age at vaccination was not reported. The reporter said that well after reading his/her neighborhood paper. The patient's here were had an outbreak of shingles from the Shingles vaccine. This was in patient's from 13 on up. The follow up would not be 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 confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Pain, Urticaria
Clinical narrative: Hives; Allergic; Pain; This case was reported by a consumer and described the occurrence of hives in a female 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 hives, allergy to vaccine and pain. On an unknown date, the outcome of the hives and allergy to vaccine were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the hives, allergy to vaccine and pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the parents for her daughter . The age at vaccination was not reported. The reporter stated that the her daughter broke out with hives after the shot. The doctor said not get the second one. The reporter also stated that her daughter allergic to it and will be happy when pain was gone. The initial and follow-up processed together. For parents refer linked case US2021AMR190658,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190658:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: had shingles twice; Shingles hurt like heck; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received old vaccine of Shingles few years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient received a Shingles vaccine few years ago other than Shingrix and had shingles. The patient then received 1st dose of Shingrix and again had shingles. The patient also reported that the shingles hurt like heck. Due to the reaction after 1st Shingrix shot the patient was not allowed to take the second shot. The patient said that the problem would have been worst if he/she had not taken any vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: it hurt a lot; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case is self-reported by the patient. The age at vaccination was not reported. The patient received Shingles vaccine and it hurted a lot.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: herpes; This case was reported by a consumer via interactive digital media and described the occurrence of herpes virus infection 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 herpes virus infection. On an unknown date, the outcome of the herpes virus infection was unknown.   The reporter considered the herpes virus infection to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Shingles vaccine gave the patient herpes.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: one shot and neglected to get another; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported for the first dose and not applicable for the second dose. The patient got one shingle shot and 3 years later got shingles that lasted almost a year. The patient stated that he/ she neglected to get another, years later got shingles and had just got over them, lasted months.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product storage error
Clinical narrative: Pediarix that had previously been frozen.; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect product storage in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The pharmacist reported that the patient received dose of Pediarix that had previously been frozen, which led to incorrect product storage. The date of the dose, amount of dose, administration site, or which number dose within the series were not reported. The nurse that administered the dose stated that the dose had to be warmed up with her hands prior to administration, and the dose was thawed prior to administration.  The outcome of the patient receiving the dose of Pediarix was unknown. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Pain
Clinical narrative: 1st shot hurt too much; Got one shot because the 1st hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received 1st  dose of Shingles which hurt too much and therefore the patient did not receive next shot, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: severe injection site reaction with bruising and swelling; severe injection site reaction with bruising and swelling; This case was reported by a other health professional via sales rep and described the occurrence of injection site bruising in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site bruising and injection site swelling. On an unknown date, the outcome of the injection site bruising and injection site swelling were unknown.   It was unknown if the reporter considered the injection site bruising and injection site swelling to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced severe injection site reaction with bruising and swelling. No further information reported. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Vaccination site mass
Clinical narrative: 2nd shot not too painful, painful lump; Lump on arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles. Previously administered products included Shingles vaccine with an associated reaction of pain (1st dose received on an unknown date, for tolerance refer case US2021AMR197126).   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 and local swelling. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain and local swelling were unknown.   It was unknown if the reporter considered the pain and local swelling to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccines and was not too painful but had a lump on his/her arm. The patient stated shot was painful but worth it. The follow-up could not be possible as no contact details.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197126:Same reporter.