chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: TDAP
Symptoms: Oral mucosal eruption, Weight decreased
Clinical narrative: Vaccine given: Diphtheria, Tetanus, Pertussis ( VIS edition 1/2012 provided) symptoms: hard to breath, stopped eating, lost 10pounds on 2 weeks, swallow face, specially around the mouth, rush around the mouth, crying, not sleeping, agitate, etc.
Age: 0.92
Sex: M
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Abnormal behaviour, Blood test, Food intolerance, Gait inability, Gastrointestinal disorder
Clinical narrative: Patient was healthy. Then he got the MMR vaccine, the DTAP and the pneumococcal vaccine. On December 27th 2015, he was complaining of leg pain, had a fever, just wasn't acting right. We took him in and they said it was a common reaction. Well, it wasn't. That entire year patient was so sick. Constantly getting pneumonia, fevers, leg issues. Then come Halloween of 2016, he woke up and couldn't walk. Had a very high fever and wouldn't talk. I took him to his doctor. They ran a blood test. That night at 8:00 PM on 10/31/16, his doctor called me back and said his white blood cell count was extremely low and he was neutropenic. She said the hospital was waiting for us because his blood results were leukemic. We spent an entire week in the hospital with NO definite answers. They all kept saying it was "viral". I knew it had to do with the vaccines. His behavior has changed as well. I stopped vaccinating him. Ever since I stopped, his health has improved. But he still had horrible gut issues. Can't eat any dairy or soy. He never had any problems until he got the Dr vaccines. I want him safe. My oldest son too was vaccine injured but I didn't know it back then. I just want my children safe from this poison. I almost lost him. This has to stop.
Age: 0.92
Sex: M
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Injection site pain, Injection site reaction, Leukaemia, Malaise, Neutropenia
Clinical narrative: Patient was healthy. Then he got the MMR vaccine, the DTAP and the pneumococcal vaccine. On December 27th 2015, he was complaining of leg pain, had a fever, just wasn't acting right. We took him in and they said it was a common reaction. Well, it wasn't. That entire year patient was so sick. Constantly getting pneumonia, fevers, leg issues. Then come Halloween of 2016, he woke up and couldn't walk. Had a very high fever and wouldn't talk. I took him to his doctor. They ran a blood test. That night at 8:00 PM on 10/31/16, his doctor called me back and said his white blood cell count was extremely low and he was neutropenic. She said the hospital was waiting for us because his blood results were leukemic. We spent an entire week in the hospital with NO definite answers. They all kept saying it was "viral". I knew it had to do with the vaccines. His behavior has changed as well. I stopped vaccinating him. Ever since I stopped, his health has improved. But he still had horrible gut issues. Can't eat any dairy or soy. He never had any problems until he got the Dr vaccines. I want him safe. My oldest son too was vaccine injured but I didn't know it back then. I just want my children safe from this poison. I almost lost him. This has to stop.
Age: 0.92
Sex: M
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Pain in extremity, Pneumonia, Pyrexia, Speech disorder, White blood cell count decreased
Clinical narrative: Patient was healthy. Then he got the MMR vaccine, the DTAP and the pneumococcal vaccine. On December 27th 2015, he was complaining of leg pain, had a fever, just wasn't acting right. We took him in and they said it was a common reaction. Well, it wasn't. That entire year patient was so sick. Constantly getting pneumonia, fevers, leg issues. Then come Halloween of 2016, he woke up and couldn't walk. Had a very high fever and wouldn't talk. I took him to his doctor. They ran a blood test. That night at 8:00 PM on 10/31/16, his doctor called me back and said his white blood cell count was extremely low and he was neutropenic. She said the hospital was waiting for us because his blood results were leukemic. We spent an entire week in the hospital with NO definite answers. They all kept saying it was "viral". I knew it had to do with the vaccines. His behavior has changed as well. I stopped vaccinating him. Ever since I stopped, his health has improved. But he still had horrible gut issues. Can't eat any dairy or soy. He never had any problems until he got the Dr vaccines. I want him safe. My oldest son too was vaccine injured but I didn't know it back then. I just want my children safe from this poison. I almost lost him. This has to stop.
Age: 0.67
Sex: M
Vaccine: MMR
Symptoms: Erythema, Erythema of eyelid, Irritability
Clinical narrative: Kid's father statement- Friday night (36 hrs after vaccination) his cheeks seemed red and shiny.  Saturday morning (48 hrs) he still seemed to show more red in his nose and cheeks than normal.  His cheeks appeared better by Sunday (72 hrs) morning; however, his top/bottom eyelids seemed a little red for the next day or so.  He seemed especially irritable on Saturday, but maintained generally regular sleep and eating patterns.  We observed no localized swelling/irritation around the thigh injection site at any time.   All seemed resolved by Tuesday morning
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Headache, Lethargy, Nausea, Pain
Clinical narrative: Dizzy, Very sore arm, Nausea, Fever, Achiness, Lethargy, Headache.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Dizzy, Very sore arm, Nausea, Fever, Achiness, Lethargy, Headache.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Nausea, Pain, Pain in extremity
Clinical narrative: Dizzy, Very sore arm, Nausea, Fever, Achiness, Lethargy, Headache.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Dizzy, Very sore arm, Nausea, Fever, Achiness, Lethargy, Headache.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Headache, Lethargy, Nausea, Pain
Clinical narrative: About 7 hours after receiving the vaccination patient reports symptoms of a high body temperature, aches, dizziness, nausea, and a sore arm. The following morning patient reports waking up extremely warm with continued symptoms. Symptoms have seemed to improve slightly as time progressed.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: About 7 hours after receiving the vaccination patient reports symptoms of a high body temperature, aches, dizziness, nausea, and a sore arm. The following morning patient reports waking up extremely warm with continued symptoms. Symptoms have seemed to improve slightly as time progressed.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Feeling hot, Nausea, Pain, Pain in extremity
Clinical narrative: About 7 hours after receiving the vaccination patient reports symptoms of a high body temperature, aches, dizziness, nausea, and a sore arm. The following morning patient reports waking up extremely warm with continued symptoms. Symptoms have seemed to improve slightly as time progressed.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: About 7 hours after receiving the vaccination patient reports symptoms of a high body temperature, aches, dizziness, nausea, and a sore arm. The following morning patient reports waking up extremely warm with continued symptoms. Symptoms have seemed to improve slightly as time progressed.
Age: 90.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pt states pain at site of injection radiating down to lower part of same side of left arm. Advise pt to take OTC TYLENOL/ADVIL for pain and apply cold compress for 20 min.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: a lot of redness that came down the lower part of the arm and spread; Information has been received from a medical assistant via the company representative referring to a 67-year-old female patient. Information about concurrent condition, concomitant medication and medical history was unknown.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route and lot # were not reported) for prevention of pneumonia. After an unspecified amount of time later, the patient developed a lot of redness that came down the lower part of the arm and spread. She had sought medical attention due to the event. At the reported time, the event had already recovered.   The causal relationship between the event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post-herpetic neuralgia; Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 27-SEP-2012, at age 73 years, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (dosage, site and route of administration and lot number not provided). On an unknown date, the patient was treated by a family nurse practitioner (FNP) at a hospital for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster and  post-herpetic neuralgia respectively. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster and  post-herpetic neuralgia is unknown.  Additional information was received on 11-APR-2019 from a lawyer regarding a female patient.  The patient's address was updated as she had moved from one state to another state.  No other new information.  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received on 09-APR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2016, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a healthcare provider at a pain management center for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related.   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Information has been received on 09-APR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 25-OCT-2015, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related.   Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: This spontaneous report was received from a Registered Nurse via company representative regarding a 15 year old female patient. The patient's pertinent medical history, historical drugs, drug allergies/reactions, concurrent conditions and concomitant medications were unknown. On an unknown date, during the same office visit in 2018 the patient was vaccinated with a dose of GARDASIL 9 injection (dose, frequency, lot # and expiry date were not provided) intramuscularly for prophylaxis and other suspect therapy included DEPO-PROVERA (dose, frequency, lot # and expiry date were not provided). On an unknown date the patient experienced total hair loss. It was reported that patient was in office when event occurred. No treatment was given for the adverse event. The outcome of the event alopecia was unknown. Causality assessment was not provided. There was no PQC involved in the case.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; 2 patients received unspecified doses of ROTATEQ that were improperly stored; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 12-APR-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R016791, expiration date: 16-APR-2020, administered orally (dose was not provided) as prophylaxis. The vaccine underwent a temperature of 48.2 Fahrenheit (F) degrees during a time frame of 1 hour as recorded by a data logger. No previous temperature excursion was reported, as well as no adverse effects.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA006653:
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately 84 years of age, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer regarding a case in litigation concerning an elderly female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 13-OCT-2011, at age 71, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, MMRV
Symptoms: Blood test, Urticaria
Clinical narrative: had broken out in hives from "head to toe"; This spontaneous report was received from a the patient's mother, and refers to a 3 year old male patient. The patient concurrent condition included drug hypersensitivity to cefinir (OMNICEF) . The patient's medical history included eczema.     On an unknown date, in approximately 2009, when the patient had 3 years; he was vaccinated with an unspecified measles vaccine (dose, route of administration, manufacturer, lot number and expiration date were not reported) and then, on an unknown date, the patient broke out in hives from head to toe. No treatment was given but however unspecified blood work was performed with unspecified results and the patient saw a physician  On an unknown date, the patient recovered from the hives. The causal relationship between the unspecified measles vaccine and the event was not reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient inadvertently received an expired dose of MMR II; This spontaneous report was received from a pharmacist refers to a patient of unknown age. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.          On 15-APR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot number N009171 and expiration date 20-MAR-2019 for prophylaxis (dosage schedule, route, and anatomical location were not reported).     On the same day, the patient inadvertently received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered). No adverse effects reported.  The outcome of expired product administered and no adverse event was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Blood cortisol, Blood lactate dehydrogenase, Chest X-ray, Cough, Electrophoresis protein
Clinical narrative: cough; Overall sick feeling; sore arm; fever; This spontaneous report was received from a consumer concerning herself, a 67-year-old female patient with allergy to shellfish and hypertension which had been treated with non-specified hypertension medicine.      On 22-MAR-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 PFU (dose, routed, anatomical site, lot# and expiration date were unknown) for prevention of shingles.  On the same date, within minutes of receiving the vaccine, the patient's arm was sore down to the elbow (pain in extremity); the patient also reported that, in the evening of the same day,  she developed fever (pyrexia), cough and an overall sick feeling (malaise). The patient reported that pyrexia, cough and malaise became progressively worse causing her to make a physician visit and an unspecified treatment was given. Moreover, the patient underwent the following laboratory test: Complete blood count (CBC), "chem-panel," "mono-spot," "sed-rate," cortisol test, urinalysis, serum-protein electrophoresis, "GZP," Lactate dehydrogenase (LDH), thyroid testing and chest x-ray, with no results available at the reporting time.  The patient stated that she had had pyrexia, cough and malaise for more than three weeks and, at the reporting time, she still had not recovered; Furthermore, she reported that pain in extremity was also not recovered.  The causality between pain in extremity, pyrexia, cough and malaise and zoster vaccine live (ZOSTAVAX) was unknown.  The reporter considered that the reported events were no life-threatening.
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Laboratory test, Malaise, Mononucleosis heterophile test, Pain in extremity
Clinical narrative: cough; Overall sick feeling; sore arm; fever; This spontaneous report was received from a consumer concerning herself, a 67-year-old female patient with allergy to shellfish and hypertension which had been treated with non-specified hypertension medicine.      On 22-MAR-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 PFU (dose, routed, anatomical site, lot# and expiration date were unknown) for prevention of shingles.  On the same date, within minutes of receiving the vaccine, the patient's arm was sore down to the elbow (pain in extremity); the patient also reported that, in the evening of the same day,  she developed fever (pyrexia), cough and an overall sick feeling (malaise). The patient reported that pyrexia, cough and malaise became progressively worse causing her to make a physician visit and an unspecified treatment was given. Moreover, the patient underwent the following laboratory test: Complete blood count (CBC), "chem-panel," "mono-spot," "sed-rate," cortisol test, urinalysis, serum-protein electrophoresis, "GZP," Lactate dehydrogenase (LDH), thyroid testing and chest x-ray, with no results available at the reporting time.  The patient stated that she had had pyrexia, cough and malaise for more than three weeks and, at the reporting time, she still had not recovered; Furthermore, she reported that pain in extremity was also not recovered.  The causality between pain in extremity, pyrexia, cough and malaise and zoster vaccine live (ZOSTAVAX) was unknown.  The reporter considered that the reported events were no life-threatening.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Red blood cell sedimentation rate, Thyroid function test, Urine analysis
Clinical narrative: cough; Overall sick feeling; sore arm; fever; This spontaneous report was received from a consumer concerning herself, a 67-year-old female patient with allergy to shellfish and hypertension which had been treated with non-specified hypertension medicine.      On 22-MAR-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) 19400 PFU (dose, routed, anatomical site, lot# and expiration date were unknown) for prevention of shingles.  On the same date, within minutes of receiving the vaccine, the patient's arm was sore down to the elbow (pain in extremity); the patient also reported that, in the evening of the same day,  she developed fever (pyrexia), cough and an overall sick feeling (malaise). The patient reported that pyrexia, cough and malaise became progressively worse causing her to make a physician visit and an unspecified treatment was given. Moreover, the patient underwent the following laboratory test: Complete blood count (CBC), "chem-panel," "mono-spot," "sed-rate," cortisol test, urinalysis, serum-protein electrophoresis, "GZP," Lactate dehydrogenase (LDH), thyroid testing and chest x-ray, with no results available at the reporting time.  The patient stated that she had had pyrexia, cough and malaise for more than three weeks and, at the reporting time, she still had not recovered; Furthermore, she reported that pain in extremity was also not recovered.  The causality between pain in extremity, pyrexia, cough and malaise and zoster vaccine live (ZOSTAVAX) was unknown.  The reporter considered that the reported events were no life-threatening.
Sex: F
Vaccine: HEP
Symptoms: Injection site bruising, Injection site haemorrhage
Clinical narrative: Initial Report Received on 02-Apr-2019. A pharmacist reported that a female patient (age and race not provided) was administered with HEPLISAV-B for hepatitis B immunization and developed bleeding and bruising at the injection site, and reported that the HEPLISAV-B injection "may not be effective." Relevant medical history and concomitant medications were not provided. On 19-Mar-2019, the patient received the first dose of HEPLISAV-B from a pre-filled syringe (lot #, expiration date, and NDC # not provided). On 02-Apr-2019, a pharmacist reported that a female patient reported that she was concerned that the HEPLISAV-B injection may not be effective as she had a little blood from the injection site at the time of administration and she developed bruising a few days later. The patient requested to be administered a repeat first dose due to bleeding and bruising at the site. It was also reported that the caller (pharmacist), stated that the product was already discarded. No further information was provided. At the time of the report, the outcome of the events were unknown. The reporter did not provide a seriousness assessment for the event. Company comment: The company assessed the events of injection site haemorrhage, injection site bruising and lack of effect as non-serious. The events of injection site haemorrhage and injection site bruising are unlisted, and the event of lack of effect is listed per HEPLISAV-B USPI. Sender's Comments: The company assessed the events of injection site haemorrhage, injection site bruising and lack of effect as non-serious. The events of injection site haemorrhage and injection site bruising are unlisted, and the event of lack of effect is listed per HEPLISAV-B USPI.
Sex: M
Vaccine: VARZOS
Symptoms: Rash maculo-papular
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of maculopapular rash in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 1st April 2019, the patient received the 1st dose of SHINGRIX. On 3rd April 2019, 2 days after receiving SHINGRIX, the patient experienced maculopapular rash. On an unknown date, the outcome of the maculopapular rash was unknown. It was unknown if the reporter considered the maculopapular rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not provided, but it could be 60 or 61 years. The patient developed a maculopapular rash in the flank/hip area (not at the injection site).
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site rash, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever in a patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received SHINGRIX. On 4th April 2019, less than a day after receiving SHINGRIX, the patient experienced fever, chills, pain, injection site rash, rash and sickness. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the pain, injection site rash, rash and sickness were unknown. It was unknown if the reporter considered the fever, chills, pain, injection site rash, rash and sickness to be related to SHINGRIX. Additional details were provided as follows: On 4th and 5th April 2019 (Thursday and Friday), the patient had fever of 101 degree F, chills, aches and rash at injection site. On 7th April 2019 (Sunday), the rash spread to entire upper arm and was just keep spreading. Till the time of reporting, the patient was still sick.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of fever in a patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received SHINGRIX. On 4th April 2019, less than a day after receiving SHINGRIX, the patient experienced fever, chills, pain, injection site rash, rash and sickness. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the pain, injection site rash, rash and sickness were unknown. It was unknown if the reporter considered the fever, chills, pain, injection site rash, rash and sickness to be related to SHINGRIX. Additional details were provided as follows: On 4th and 5th April 2019 (Thursday and Friday), the patient had fever of 101 degree F, chills, aches and rash at injection site. On 7th April 2019 (Sunday), the rash spread to entire upper arm and was just keep spreading. Till the time of reporting, the patient was still sick.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of musculoskeletal pain in a adult patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced musculoskeletal pain. On an unknown date, the outcome of the musculoskeletal pain was unknown. It was unknown if the reporter considered the musculoskeletal pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. Age group was captured as adult as per SHINGRIX vaccine indication. The patient received SHINGRIX during the normal course of business. No additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On 29th March 2019, the patient received SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site erythema and injection site pain. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. Age group was captured as adult as per SHINGRIX vaccine indication. The patient received SHINGRIX during the normal course of business. No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of fever in a male patient who received 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 fever, pain, sweating and feels awful. On an unknown date, the outcome of the fever, pain, sweating and feels awful were recovered/resolved. It was unknown if the reporter considered the fever, pain, sweating and feels awful to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received the dose of SHINGRIX and experienced fever, sweating, aches and felt terrible for about 48 hours. The batch number was not reported. The reporter did not give permission for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Diarrhoea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received the 2nd dose of SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced upset stomach, stomach pain, pain in arm and diarrhea. On an unknown date, the outcome of the upset stomach was not recovered/not resolved and the outcome of the stomach pain, pain in arm and diarrhea were not reported. It was unknown if the reporter considered the upset stomach, stomach pain, pain in arm and diarrhea to be related to SHINGRIX. Additional information were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient got the shingle next shot on Thursday. In April 2019, the patient experienced very bad upset stomach, actual stomach pain, soreness of arm and diarrhea. The patient was curious and wanted to know how long would this last. The patient consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance of 1st dose of SHINGRIX, refer case US2019063718). 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 pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information were reported as follows: The age at vaccination was not reported. The patient was the caller's husband. The patient received SHINGRIX and experienced injection site pain that hurt when the area was touched. The pain went away in a few days. The patient did not consent to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Cough, Diarrhoea, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: cough; diarrhoea; injection site erythema; injection site induration; injection site sweeling; injection site warmth; pyrexia; rhinorrhoea; This case was reported by a consumer via other manufacturer and described the occurrence of cough in a adult patient who received HAV (Havrix) for prophylaxis.   On 29th March 2019, the patient received Havrix. On an unknown date, less than a month after receiving Havrix, the patient experienced cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea. On an unknown date, the outcome of the cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea were unknown.   It was unknown if the reporter considered the cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea to be related to Havrix.  Additional details were reported as follows: The age at vaccination was not provided. On 29th March 2019, Havrix was received by one of their associate during the normal course of business. No additional information was provided.
Sex: U
Vaccine: HEPA
Symptoms: Injection site warmth, Pyrexia, Rhinorrhoea
Clinical narrative: cough; diarrhoea; injection site erythema; injection site induration; injection site sweeling; injection site warmth; pyrexia; rhinorrhoea; This case was reported by a consumer via other manufacturer and described the occurrence of cough in a adult patient who received HAV (Havrix) for prophylaxis.   On 29th March 2019, the patient received Havrix. On an unknown date, less than a month after receiving Havrix, the patient experienced cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea. On an unknown date, the outcome of the cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea were unknown.   It was unknown if the reporter considered the cough, diarrhea, injection site erythema, injection site induration, injection site swelling, injection site warmth, fever and rhinorrhea to be related to Havrix.  Additional details were reported as follows: The age at vaccination was not provided. On 29th March 2019, Havrix was received by one of their associate during the normal course of business. No additional information was provided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 71-year-old female patient who received SHINGRIX for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, 5 hrs after receiving SHINGRIX and an unknown time after starting Valacyclovir, the patient experienced injection site swelling and injection site pain. On an unknown date, the patient experienced shingles. The patient was treated with Valacyclovir. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling, injection site pain and shingles to be related to SHINGRIX. Additional case details were provided as follows: The age at administration was not reported but it could be 71.5 or 71.6 years. The patient received the dose of SHINGRIX in left arm and experienced swelling and soreness at the injection site approximately 5-6 hours later. The patient could not sleep on her arm for 2-3 nights and then the issues was resolved. Since then the patient had a mild outbreak of shingles 3-4 weeks later. On 09th April 2019, the patient called back to report that the suspected shingles outbreak on 5th April 2019 was diagnosed by a physician and was not shingles. The patient gave the consent for follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 58-year-old male patient who received SHINGRIX (batch number X5XY4, expiry date 2nd July 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 10 days after receiving SHINGRIX, the patient experienced generalized rash and generalized pruritus. The patient was treated with prednisone. On an unknown date, the outcome of the generalized rash and generalized pruritus were not reported. It was unknown if the reporter considered the generalized rash and generalized pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient reacted to SHINGRIX, 10 days after, with rash on body and itching. The physician prescribed Prednisone due to reactions. The reporter gathered patient's information.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced chills and headache. On an unknown date, the outcome of the chills and headache were recovering/resolving. It was unknown if the reporter considered the chills and headache to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient did not wish to provide any demographics details. The patient received the dose of SHINGRIX approximately 6 months before the date of reporting and experienced every side effect listed in the Product Insert. The only events mentioned other than that generalized statement were chills, and headache. The patient reports that all events began to improve in about 3 days after the injection. The patient did not wish to specify her experience. The patient did not give the consent for follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Headache, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes mellitus, asthma, fibromyalgia and Sjogren's. Concomitant products included TYLENOL and ADVIL. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache and neck pain. On 13th March 2019, the patient experienced injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering and difficulty sleeping. On 15th March 2019, the patient experienced cough. On an unknown date, the outcome of the injection site pain, headache, neck pain, injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering, difficulty sleeping and cough were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, neck pain, injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering, difficulty sleeping and cough to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. One day after vaccination, the patient experienced injection site redness, injection site swelling, muscle pain, tiredness, feeling feverish, nausea, shivering and difficulty sleeping. Three days after vaccination, the patient experienced cough. The patient planned to continue follow up with her physician on an unknown date.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes mellitus, asthma, fibromyalgia and Sjogren's. Concomitant products included TYLENOL and ADVIL. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache and neck pain. On 13th March 2019, the patient experienced injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering and difficulty sleeping. On 15th March 2019, the patient experienced cough. On an unknown date, the outcome of the injection site pain, headache, neck pain, injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering, difficulty sleeping and cough were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, neck pain, injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering, difficulty sleeping and cough to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. One day after vaccination, the patient experienced injection site redness, injection site swelling, muscle pain, tiredness, feeling feverish, nausea, shivering and difficulty sleeping. Three days after vaccination, the patient experienced cough. The patient planned to continue follow up with her physician on an unknown date.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes mellitus, asthma, fibromyalgia and Sjogren's. Concomitant products included TYLENOL and ADVIL. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache and neck pain. On 13th March 2019, the patient experienced injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering and difficulty sleeping. On 15th March 2019, the patient experienced cough. On an unknown date, the outcome of the injection site pain, headache, neck pain, injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering, difficulty sleeping and cough were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, neck pain, injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering, difficulty sleeping and cough to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. One day after vaccination, the patient experienced injection site redness, injection site swelling, muscle pain, tiredness, feeling feverish, nausea, shivering and difficulty sleeping. Three days after vaccination, the patient experienced cough. The patient planned to continue follow up with her physician on an unknown date.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 12th March 2019, the patient received the 1st dose of SHINGRIX. On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The patient received SHINGRIX on the left arm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Nausea, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, neck pain, nausea and headache. On an unknown date, the outcome of the injection site erythema, neck pain, nausea and headache were recovered/resolved. It was unknown if the reporter considered the injection site erythema, neck pain, nausea and headache to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's sister.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional information were reported as follows: The age at vaccination was not reported. The patient was the caller's husband. The patient received SHINGRIX and experienced injection site pain that hurt when the area was touched. The pain went away in a few days. For tolerance of 2nd dose of SHINGRIX, refer case US2019GSK066313. The patient did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of itchy legs in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced itchy legs. On an unknown date, the outcome of the itchy legs was unknown. It was unknown if the reporter considered the itchy legs to be related to SHINGRIX. Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The patient experienced itching at one spot on his left thigh. No further details were provided.