chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. No patient's medical history, drug reactions/ allergies or concurrent conditions were reported.   On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot number R006220 with expiration date 29-FEB-2020,dosage number and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent. On unknown dates, the doses of VARIVAX were exposed to a temperature of of -11.3 °C(-14 °C to -10 °C) degrees Celsius for a time frame of 5 hours 5 minutes and -3.9 °C (-9 °C to 8 °C) for a time frame of 1 hour 44 minutes. The call was because a digital data logger. The previous temperature excursion was between -13 C° to -12 °C for a time frame of 15 hours 32 minutes.
Sex: U
Vaccine: RV5
Symptoms: Dehydration, Haematochezia, Salmonellosis
Clinical narrative: This spontaneous report was received from a healthcare worker referring to two infant patients of unknown age and gender. The patients did not have pertinent medical history, drug reactions or allergies and were not taking any concomitant medication. On 16-AUG-2018 and on 07-SEP-2018, respectively, the patients received the first dose, in the vaccination series, of ROTATEQ, orally, lot # N032569 with expiration date 18-JUN-2019, as "wellness visit" (prophylaxis). On an unspecified date in 2018, reported as shortly after receiving ROTATEQ, both patients were admitted to the hospital and both were diagnosed with salmonella with symptoms of bloody stools and dehydration. The patients sought medical attention and treatment was given for the adverse event. No laboratory diagnostics or studies were performed. At the time of reporting, the outcome of the patients was unknown. The causality assessment between ROTATEQ and the event was not reported. The reporter considered the salmonellosis to be life threatening and that caused the patients' significant disability, because both patients were hospitalized. Upon internal review, salmonellosis was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pelvic operation, Pelvic prolapse
Clinical narrative: This spontaneous report as received from a patient referring to herself a 76 year old female patient. The patient's concurrent conditions included low thyroid, high blood pressure and high cholesterol. She did not present any drug reactions or allergies. The concomitant therapies included unspecified blood pressure pill, cholesterol pill, thyroid medication and antidepressant (unspecified). On an unspecified date "over four years ago", the patient received an injection for the vaccination with ZOSTAVAX (strength, dose, route, frequency, lot # and expiration date were not provided) for prevention of shingles; diluted in 1 shot of sterile diluent (manufacturer unknown) (dose, route, frequency, lot # and expiration date were not provided). Additionally, the patient had "received both doses of SHINGRIX earlier in 2018 (reported as ''this year"). On 20-SEP-2018, the patient had been diagnosed with shingles. She sought medical attention and received treatment for the event (unspecified). The patient also mentioned that she had just had "pelvic prolapse surgery". The patient had not yet recovered from the events. No further adverse event (AE) information provided. The reporter did not provide a causal relationship between the events and the vaccination with ZOSTAVAX vaccine or the sterile diluent (manufacturer unknown). Upon internal review the event of pelvic prolapse was considered to be medically significant as the patient underwent a surgery.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Angioedema, Blood immunoglobulin E increased, Dyspnoea, Skin test positive
Clinical narrative: This literature marketed information has been received from a published literature article and refers to a 5-year-old boy with known preexisting alpha-gal allergy. Eight months before this episode he had been diagnosed with alpha-gal allergy (alpha-gal sIgE of 8.19 kU/L, total IgE of 149 kU/L) after several episodes of urticaria and facial angioedema 4 to 6 hours after ingestion of mammalian meat, following a tick bite, and was avoiding mammalian meat at the time of his vaccine reaction. He had no history of egg, latex, dairy, or gelatin allergy, and had uneventfully received all prior childhood vaccinations. Concomitant therapies included KINRIX. On an unknown date, the patient was vaccinated  with M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis, VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis and five minutes after receiving the vaccines, he developed shortness of breath, wheezing, disseminated urticaria, and angioedema of the face and oropharynx, prompting an emergency room visit where he received epinephrine, diphenhydramine, prednisone, and famotidine with relief of symptoms within 10 minutes. Diagnosed as anaphylaxis by treating physician. The patient was taken to emergency department, received intramuscular epinephrine with resolution of symptoms within 30-40 min. (recovered). The authors repeated his sIgE titers, demonstrating an increase in the galactose-a-1,3-galactose sIgE concentration to 26.9 kU/L, a beef sIgE of 14 kU/L, a lamb/mutton sIgE of 5.64 kU/L, a pork sIgE of 11.2 kU/L, porcine gelatin sIgE of 0.78 kU/L, and a bovine gelatin sIgE of 0.22 kU/L (reference for all <0.35 kU/L). The patient was skin tested to undiluted vaccines and gelatin. Skin prick tests were placed and read at 15 minutes, with appropriate controls. MMR was positive with a 5-mm wheal and 14-mm erythema, and varicella was positive with a 4-mm wheal and 12-mm erythema. Porcine gelatin was positive with a 6-mm wheal and 18-mm erythema. The histamine control had a 7-mm wheal and 20-mm erythema. DTaP/IPV and DTaP only vaccines were deemed negative on skin prick testing and at 1:100 intradermal testing. The authors concluded that based on agreement between skin and ex vivo testing, M-M-R II and/or VARIVAX appear to have been the cause of our alpha-gal allergic patient's vaccine-associated anaphylaxis. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156: Original Case : 1809USA011156.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria, Wheezing
Clinical narrative: This literature marketed information has been received from a published literature article and refers to a 5-year-old boy with known preexisting alpha-gal allergy. Eight months before this episode he had been diagnosed with alpha-gal allergy (alpha-gal sIgE of 8.19 kU/L, total IgE of 149 kU/L) after several episodes of urticaria and facial angioedema 4 to 6 hours after ingestion of mammalian meat, following a tick bite, and was avoiding mammalian meat at the time of his vaccine reaction. He had no history of egg, latex, dairy, or gelatin allergy, and had uneventfully received all prior childhood vaccinations. Concomitant therapies included KINRIX. On an unknown date, the patient was vaccinated  with M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis, VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis and five minutes after receiving the vaccines, he developed shortness of breath, wheezing, disseminated urticaria, and angioedema of the face and oropharynx, prompting an emergency room visit where he received epinephrine, diphenhydramine, prednisone, and famotidine with relief of symptoms within 10 minutes. Diagnosed as anaphylaxis by treating physician. The patient was taken to emergency department, received intramuscular epinephrine with resolution of symptoms within 30-40 min. (recovered). The authors repeated his sIgE titers, demonstrating an increase in the galactose-a-1,3-galactose sIgE concentration to 26.9 kU/L, a beef sIgE of 14 kU/L, a lamb/mutton sIgE of 5.64 kU/L, a pork sIgE of 11.2 kU/L, porcine gelatin sIgE of 0.78 kU/L, and a bovine gelatin sIgE of 0.22 kU/L (reference for all <0.35 kU/L). The patient was skin tested to undiluted vaccines and gelatin. Skin prick tests were placed and read at 15 minutes, with appropriate controls. MMR was positive with a 5-mm wheal and 14-mm erythema, and varicella was positive with a 4-mm wheal and 12-mm erythema. Porcine gelatin was positive with a 6-mm wheal and 18-mm erythema. The histamine control had a 7-mm wheal and 20-mm erythema. DTaP/IPV and DTaP only vaccines were deemed negative on skin prick testing and at 1:100 intradermal testing. The authors concluded that based on agreement between skin and ex vivo testing, M-M-R II and/or VARIVAX appear to have been the cause of our alpha-gal allergic patient's vaccine-associated anaphylaxis. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156: Original Case : 1809USA011156.
Age: 4.0
Sex: M
Vaccine: DTAP, HEP, HIBV, MMR, VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Flushing, Pruritus, Vomiting
Clinical narrative: This literature marketed information has been received from a published literature article and refers to a 4-year-old boy with known gelatin, beef, pork allergy. The patient developed on an unspecified date in approximately 2012, vomiting, itching, flushing, difficulty breathing within 5 min of vaccination with M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided) and VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. Concomitant vaccines, administered on the same date, included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and haemophilus influenza B (manufacturer unknown). The patient was diagnosed as anaphylaxis by treating physician. The patient was treated with antihistamines and 2 doses of intramuscular epinephrine. At the time of reporting, the outcome of the anaphylactic reaction was not reported. The author considered the event as a reaction associated to M-M-R II and VARIVAX. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156:
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUX, MMR, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: This literature marketed information has been received from a published literature article and refers to a 4-year-old boy who reported skin test positive pork allergy, no reports of other meat or alpha-gal allergy, no reported sIgE titers. The patient on an unspecified date in 2016, was diagnosed by the physician with anaphylaxis after vaccination with M-M-R II vaccination date, (dose, route, vaccination site, lot# and expiration date were not provided) and VARIVAX (vaccination date, dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. Concomitant vaccines included poliovirus vaccine inactivated (unspecified), diphtheria toxoid, pertussis acellular vaccine (unspecified) and tetanus toxoid and influenza virus vaccine. At the time of reporting, the outcome of anaphylactic reaction was not reported. The author considered the event as a reaction associated to M-M-R II and VARIVAX. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012066, US-009507513-1809USA012062).; Sender's Comments: US-009507513-1809USA011156:
Age: 16.0
Sex: M
Vaccine: DTAPIPV, HEP, MMR
Symptoms: Anaphylactic reaction, Dyspnoea, Respiratory distress, Urticaria
Clinical narrative: This literature marketed information has been received from a published literature article and refers to a 16-year-old boy with known beef, pork, milk allergy, no sIgE or alpha-gal results reported. The patient developed on an unspecified date in approximately 2016, disseminated urticaria, shortness of breath, respiratory distress within 20 min of M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis. Concomitant vaccines, administered on the same date, included hepatitis b vaccine (recombinant)(manufacturer unknown), poliovirus vaccine and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid. He was treated with antihistamines and steroids in emergency department. At the time of this report, the outcome of the events was unknown. The author considered the events as reactions associated to M-M-R II. Upon internal review the event respiratory distress was considered as medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012067, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012062).; Sender's Comments:  US-009507513-1809USA011156: Original Case : 1809USA011156.
Age: 2.0
Sex: M
Vaccine: DTAPH, MMR, VARCEL
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Urticaria
Clinical narrative: This literature marketed information has been received from a published literature article refers to a 2-year-old boy with  known beef, pork, and milk allergy. The patient developed on an unspecified date in approximately 2011, disseminated urticaria, shortness of breath, difficulty swallowing within an hour of receiving M-M-R II (dose, route, vaccination site, lot# and expiration date were not provided) and VARIVAX (dose, route, vaccination site, lot# and expiration date were not provided), for prophylaxis, and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) and haemophilus influenza B (manufacturer unknown).  Physician diagnosis of anaphylaxis. The patient received diphenhydramine hydrochloride (BENADRYL), prednisolone sodium phosphate (ORAPRED), and intramuscular 0.15 mg of epinephrine with resolution on an unspecified date. The author considered the event as a reaction associated to M-M-R II and VARIVAX. Upon internal review, anaphylactic reaction was determined to be medically significant. This is one of several reports from the same reporter (Case # US-009507513-1809USA011156, US-009507513-1809USA012060, US-009507513-1809USA012063, US-009507513-1809USA012064, US-009507513-1809USA012065, US-009507513-1809USA012066, US-009507513-1809USA012062); Sender's Comments:  US-009507513-1809USA011156:
Sex: F
Vaccine: HPV9
Symptoms: Abnormal loss of weight, Vomiting, Weight decreased
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to an 18 year old female patient. The patient's medical history included Helicobacter pylori (H. pylori) that was cleared. The patient's concurrent conditions, concomitant medications, and historical drugs were not reported. In approximately 2014 (reported as "about 4 years ago"), the patient was vaccinated with GARDASIL 9 (route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis. The physician reported that on an unknown date, the patient had been experiencing daily vomiting and also recently a significant weight loss. Also the patient saw an unspecified specialist in the psychiatric field on an unspecified date, and for an unknown reason. At the time of the report, the outcome of vomiting and weight decreased was reported as not resolved. The physician did not mention the causality assessment between the events and GARDASIL 9 vaccination, but the physician reported that the patient's mother saw information from an unspecified online source that said her daughter's symptoms could be related to her daughter receiving a dose of GARDASIL 9. The physician considered that the events of daily vomiting and the significant weight loss were disabling.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 32 year old female patient. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On an unknown date, in 2017, the patient was vaccinated with the first dose of VARIVAX on an unspecified physician's office and on 28-JUN-2018, the second dose at an unspecified facility subcutaneous for varicella vaccination (lot number and expiration date were not reported). On 27-SEP-2018, the patient informed the pharmacist that an unspecified lab test resulted in negative titers for varicella antibody (antibody test negative). The outcome of antibody test negative and the causal relationship between VARIVAX and the event antibody test negative were not reported.
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a consumer (the patient's parent) and refers to a female patient of unknown age. Her current conditions, medical history and concomitant therapies were not provided. On an unknown, date the patient was vaccinated with a dose of expired vaccination of VARIVAX injection, subcutaneously (dose, lot# and expiration date were not provided) for prevention of varicella.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistance concerning a patient of unknown age and gender. The patient's historical conditions, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On an unspecified date, the patient was vaccinated with an improperly stored ROTATEQ reported lot number N030364, expiry date 06-MAR-2019 (strength, dose, route and frequency were not reported) for prophylaxis. The administered dose of the vaccine ROTATEQ, experienced a temperature excursion of 9 degrees to 25 degrees Celsius for 13 minutes, with a previous temperature excursion of 9 degrees to 25 degrees Celsius for 15 hours, as recorded by a data logger. No adverse effects were reported. No product quality complaint was filed.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Irritability, Nausea, Pyrexia, Rash
Clinical narrative: This spontaneous report was received from the mother of a 12 month old female patient, regarding her daughter, a baby with no pertinent medical history, concurrent conditions or drug reaction/allergies. On 27-SEP-2018, the patient was vaccinated with an expired dose of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported) (expired product administered). There were no concomitant medications. On 27-SEP-2018, the patient experienced fever (pyrexia), irritability, mild rashes on cheek and back, and nausea. No treatment was given for the events. No lab diagnostic tests were performed. The patient's mother was on her way to hospital emergency room, at the time of the call. The outcome of the events was reported as not recovered. The reporter did not assess the causal relationship between therapy with M-M-R II and the events.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant medications was not provided. On an unknown date, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23, strength, dose and frequency were unknown (lot # N030987, expiration date 15-MAY-2019) intramuscular for prophylaxis. Administered dose experienced temperature of excursion of 47 degrees Celsius to 77 degrees Celsius for 100 hours. There was no previous temperature of excursion. Data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse, referring to an unspecified number of unspecified patients whose age and gender was unknown. Information about the patients' pertinent medical history, previous drug reactions and allergies was not provided. The nurse reported that, from 28-MAR-2018 until 28-SEP-2018, the patients were vaccinated with an unspecified number of improperly stored VARIVAX injection, for prophylaxis (doses number, frequency, route and anatomical location of vaccination were not provided; lot number N023956, expiration date 01-SEP-2019). The Merck sterile diluent (lot numbers R005481 [expiration date 30-NOV-2020], N029876 [expiration date 16-MAY-2018] and N030845 [expiration date 12-JUN-2020]) used concomitantly to reconstitute vaccines was properly stored according to reporter. The VARIVAX injections involved, were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (8.4F) for a time frame of 25 minutes, as was recorded by the Digital Data Logger. Previous temperature excursion was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: This spontaneous report was received from a pharmacist regarding to a patient of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On 26-SEP-2018, the patient was inadvertently vaccinated with 1 dose of ZOSTAVAX, lot # N025569, with expiration date 13-DEC-2018 (strength, anatomical location or route of administration were not provided), for prophylaxis; which was previously reconstituted with sterile diluent (MRK), lot # M044951 with expiration date 07-JUL-2019; instead of VARIVAX (wrong drug administered). No adverse effects were reported.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Influenza like illness, Injection site pain, Oral herpes
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Guillain Barre syndrome (in 2008) and rheumatoid arthritis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced cold sores, feeling miserable, influenza-like symptoms, headache and fever. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the cold sores, feeling miserable, influenza-like symptoms, headache and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, cold sores, feeling miserable, influenza-like symptoms, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. In the evening after receiving the SHINGRIX injection, the patient experienced soreness at the injection site that lasted for 3 to 4 days. In 2018, less than a year after receiving SHINGRIX, the patient experienced headaches, fever, and flu like symptoms that were still ongoing at the time of reporting, they came and go every few days. In 2018, less than a year after receiving SHINGRIX, these symptoms make her feel miserable. The patient reported that she has not a cold sore for years, however since less than 3 months after receiving SHINGRIX, she had several outbreaks. The patient reported that she had one cold sore that will not resolve. The patient had denied permission to contact their physician. Referred patient to her PCP.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included Guillain Barre syndrome (in 2008) and rheumatoid arthritis. On 18th July 2018, the patient received the 1st dose of SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced cold sores, feeling miserable, influenza-like symptoms, headache and fever. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the cold sores, feeling miserable, influenza-like symptoms, headache and fever were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, cold sores, feeling miserable, influenza-like symptoms, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm. In the evening after receiving the SHINGRIX injection, the patient experienced soreness at the injection site that lasted for 3 to 4 days. In 2018, less than a year after receiving SHINGRIX, the patient experienced headaches, fever, and flu like symptoms that were still ongoing at the time of reporting, they came and go every few days. In 2018, less than a year after receiving SHINGRIX, these symptoms make her feel miserable. The patient reported that she has not a cold sore for years, however since less than 3 months after receiving SHINGRIX, she had several outbreaks. The patient reported that she had one cold sore that will not resolve. The patient had denied permission to contact their physician. Referred patient to her PCP.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Gastrointestinal disorder, Hypersensitivity, Injection site erythema
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (old shingles vaccine received 2.5 to 3 years before the time of reporting). On 17th September 2018, the patient received SHINGRIX (intramuscular). In September 2018, 10 hrs after receiving SHINGRIX, the patient experienced allergic reaction, fever, nausea, diarrhea, loss of energy and gastrointestinal disorder. On 18th September 2018, the patient experienced injection site erythema and injection site rash. On 21st September 2018, the patient experienced rash. The patient was treated with Ice Pack (Nos), CORTIZONE 10 and BENADRYL Gel. In September 2018, the outcome of the fever, nausea, diarrhea, loss of energy and gastrointestinal disorder were recovered/resolved. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the injection site erythema, injection site rash and rash were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, fever, nausea, diarrhea, injection site erythema, injection site rash, rash, loss of energy and gastrointestinal disorder to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at around 12:30 in the left arm. About 10 to12 hours later she developed a fever of 100.9 degree Fahrenheit. The patient's normal body temperature 97.6 degree Fahrenheit, she also experienced no energy, nausea, a bout of diarrhea and her digestive system felt weird at an unknown date. The next day of receiving the injection she experienced redness at the injection site the size of a softball. The redness went down to her elbow. The patient used the terms redness and rash at the injection site to describe the events. The patient said that at the time reporting the rash was growing in size. The patient had put ice packs, CORTIZONE 10+ and BENADRYL gel and it did not help. On the day of reporting, the patient woke up with a rash on her face, and she was taking BENADRYL around the clock to treat it. The patient said that her pharmacist documented everything as an allergic reaction in their system. In the morning of the reporting day, the patient was visiting a Nurse practitioner. The patient did not have an assigned physician. The patient provided contact details of nurse practitioner that she was visiting.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (old shingles vaccine received 2.5 to 3 years before the time of reporting). On 17th September 2018, the patient received SHINGRIX (intramuscular). In September 2018, 10 hrs after receiving SHINGRIX, the patient experienced allergic reaction, fever, nausea, diarrhea, loss of energy and gastrointestinal disorder. On 18th September 2018, the patient experienced injection site erythema and injection site rash. On 21st September 2018, the patient experienced rash. The patient was treated with Ice Pack (Nos), CORTIZONE 10 and BENADRYL Gel. In September 2018, the outcome of the fever, nausea, diarrhea, loss of energy and gastrointestinal disorder were recovered/resolved. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the injection site erythema, injection site rash and rash were not recovered/not resolved. It was unknown if the reporter considered the allergic reaction, fever, nausea, diarrhea, injection site erythema, injection site rash, rash, loss of energy and gastrointestinal disorder to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX at around 12:30 in the left arm. About 10 to12 hours later she developed a fever of 100.9 degree Fahrenheit. The patient's normal body temperature 97.6 degree Fahrenheit, she also experienced no energy, nausea, a bout of diarrhea and her digestive system felt weird at an unknown date. The next day of receiving the injection she experienced redness at the injection site the size of a softball. The redness went down to her elbow. The patient used the terms redness and rash at the injection site to describe the events. The patient said that at the time reporting the rash was growing in size. The patient had put ice packs, CORTIZONE 10+ and BENADRYL gel and it did not help. On the day of reporting, the patient woke up with a rash on her face, and she was taking BENADRYL around the clock to treat it. The patient said that her pharmacist documented everything as an allergic reaction in their system. In the morning of the reporting day, the patient was visiting a Nurse practitioner. The patient did not have an assigned physician. The patient provided contact details of nurse practitioner that she was visiting.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a male patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm and general body pain. On an unknown date, the outcome of the swelling arm and general body pain were unknown. It was unknown if the reporter considered the swelling arm and general body pain to be related to SHINGRIX. Additional details were provided as follows: The caller reported adverse event for herself and her husband. The age at vaccination was not reported. The patient wanted to know if her reaction was common with SHINGRIX, and how long should she wait before getting the flu shot. The patient experienced swollen arm and body pain. The caller was driving, therefore very limited data was provided. This case has been linked with US2018172538, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin A increased, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of protein total increased in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 1st dose of SHINGRIX. On 7th September 2018, 1 days after receiving SHINGRIX, the patient experienced nausea. On 18th September 2018, the patient experienced protein total increased. On an unknown date, the outcome of the protein total increased was unknown and the outcome of the nausea was recovered/resolved. It was unknown if the reporter considered the protein total increased and nausea to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the right arm. The patient reported feeling slightly nauseous when she woke the next morning which was very mild. On 18th September 2018, she had laboratory work done with a slight increase in her IGA protein (blood immunoglobulin A).
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of headache in a 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 year after receiving SHINGRIX, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were recovered/resolved. It was unknown if the reporter considered the headache and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient experienced bad headache and fatigue for 38 hours after receiving SHINGRIX. The patient was a doctor who this healthcare professional worked with in the past. In order to explain what his question was he had to tell reporter about her adverse event. The reporter did not remember her initials and her date of birth.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Rash generalised
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of generalized rash in a 19-year-old male patient who received BEXSERO (batch number T66103, expiry date 31st December 2019) for prophylaxis. On 15th September 2018, the patient received BEXSERO. In September 2018, less than a week after receiving BEXSERO, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovering/resolving. It was unknown if the reporter considered the generalized rash to be related to BEXSERO. Additional details were provided as follows: The patient was experiencing rash all over his body.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 7th September 2018, the patient received the 1st dose of SHINGRIX. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching, injection site pain and rash. On 21st September 2018, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site itching, injection site pain and rash were recovering/resolving and the outcome of the pain in arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, pain in arm, injection site itching, injection site pain, rash and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. In the morning, the patient received SHINGRIX on the right. The symptoms of redness, sore and itchy presented at the site and also down her arm. Two weeks later, the patient began to have pain in her left arm so severe that she could not raise it. The physician's contact details were provided, however phone number was not available.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 7th September 2018, the patient received the 1st dose of SHINGRIX. On 7th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site itching, injection site pain and rash. On 21st September 2018, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the injection site erythema, injection site itching, injection site pain and rash were recovering/resolving and the outcome of the pain in arm and mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, pain in arm, injection site itching, injection site pain, rash and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. In the morning, the patient received SHINGRIX on the right. The symptoms of redness, sore and itchy presented at the site and also down her arm. Two weeks later, the patient began to have pain in her left arm so severe that she could not raise it. The physician's contact details were provided, however phone number was not available.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemorrhage, Platelet count decreased, Thrombocytopenia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of thrombocytopenia in a patient who received SHINGRIX (batch number H547E, expiry date unknown) for prophylaxis. On 14th September 2018, the patient received SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced thrombocytopenia (serious criteria hospitalization and GSK medically significant) and hemorrhage (serious criteria GSK medically significant). On an unknown date, the outcome of the thrombocytopenia and hemorrhage were unknown. It was unknown if the reporter considered the thrombocytopenia and hemorrhage to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The healthcare professional (HCP) reported that the patient received SHINGRIX on and developed severe thrombocytopenia. The patient were admitted to the hospital with bleeding and a platelet count of 8,000. In August, their platelet count was normal and this vaccine is the only thing that could have caused it because they had been on all their other medications prior as per the doctor. This information was left on the adverse event voicemail box. The voice mail escalated Vaccine MES to followup with the doctor. The doctor wanted to know if this reaction was reported with SHINGRIX because she was not sure if this occurred due to the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Malaise, Mobility decreased, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On 24th September 2018 15:00, the patient received SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced sickness, sore throat, mobility decreased and fever. On an unknown date, the outcome of the sickness, sore throat, mobility decreased and fever were unknown. It was unknown if the reporter considered the sickness, sore throat, mobility decreased and fever to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The patient stated almost immediately after having the vaccination, she felt sick. One side of her throat was sore and she couldn't physically move.
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of loss of consciousness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant). On an unknown date, the outcome of the loss of consciousness was recovered/resolved.  It was unknown if the reporter considered the loss of consciousness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional (HCP) said that her cousin received SHINGRIX and said she was knocked out for 2 days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received SHINGRIX (batch number L9CS4, expiry date unknown) for prophylaxis. On 11th September 2018, the patient received SHINGRIX. On 12th September 2018, 1 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter agreed to be contacted for follow up.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Dyspnoea, Rash generalised
Clinical narrative: Patient was in her nursing home room. Patient reported wanting a vaccination, but was having difficulty with her COPD acting up after her shower. She had asked that the pharmacist go into her room to administer. When going into room on 10/1/18 around 11:30 am I had her sign the consent form and asked if she had received the vaccination before. She reported she had received it for almost ~15 years now and that her healthcare provider wanted her to have it with her COPD. After administering the vaccination, I stayed and talked to her a little bit about her insurance and how she would be billed for the vaccination. She reported she was doing okay so I went ahead and left her room. ~30 minutes later the DON from the nursing home asked if we had an EPIPEN. She had called the nurse and LPN reported that she had a rash all over her body and was having labored breathing. Nurse reported trying to take a picture of the rash, but it was blurry. The nurse practioner was on site and gave order to administer the EPIPEN to patient. He was in the room with patient. Patient was also given BENADRYL, CLARITIN. Patient only needed one dose of Epi. Patient's rash went away and breathing became normal. She reported being okay. I checked back in on her before I left facility around 1:15 pm and she was doing okay. No rash remained.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint range of motion decreased, Pain, X-ray
Clinical narrative: When I got the shot I thought that the shot was given higher than I was accustomed to. I had left shoulder pain after injection which progressively got worse to the point it hurt to lift arm up, limited range of motion without pain, and chronic dull pain at rest. I took an NSAID around the clock since the vaccine was given but it had little affect on the pain.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth
Clinical narrative: Welt at injection site, redness, tenderness, and warmth.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Blood pressure increased, Flushing, Hyperhidrosis, Nausea
Clinical narrative: Within 10 minutes of injection, nausea, vomiting and stool. Diaphoretic and flush, had to be cooled with cold washcloths, immediately put to stretcher, BP slightly elevated, Blood glucose normal at 105--returned to feeling better within 30-45 minutes, but was driven home as a precaution, within 12 hours after sleeping 6-7 hours resumed normal work activities.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Within 10 minutes of injection, nausea, vomiting and stool. Diaphoretic and flush, had to be cooled with cold washcloths, immediately put to stretcher, BP slightly elevated, Blood glucose normal at 105--returned to feeling better within 30-45 minutes, but was driven home as a precaution, within 12 hours after sleeping 6-7 hours resumed normal work activities.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus, Injection site warmth
Clinical narrative: Erythema, warm to touch, edema and itchy at injection site. Took 2 Ibuprofen at 08:30. Spoke to Dr., physician at hospital clinic who examined arm and told patient to take BENADRYL. Physician told her that if the symptoms progress to notify her and to go to the Emergency Room.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient came back and her arm was very red and swollen at the site of injection. She never had this reaction before with SHINGRIX or the Flu shot but getting both of them gave her this side effect. We counseled her on how to manage the pain and called her next day to follow up and she said she was feeling better.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Employee reporting increased redness and swelling to left upper arm after receiving flu vaccine 2 days prior, evaluated by ER NP and provided with prescription for KEFLEX 500 mg four times a day and to apply warm compresses to area. Employee reported all symptoms resolved as of 9/29/2018.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site rash, Nausea
Clinical narrative: Large rash at injection site, nauseous, and dizziness.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient described feeling like something was "off " as soon as needle punctured her arm. She had a red, raised local reaction at the injection site, and developed a rash that spread all the way to her elbow. This resolved within a week of injection. She also described feeling like she was coming down with something, a general sickness feeling that kept her in bed. Approximately 11 days after injection she experienced a breakout of hives across her chest and forearm that she is still experiencing at 13 days post vaccine.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient described feeling like something was "off " as soon as needle punctured her arm. She had a red, raised local reaction at the injection site, and developed a rash that spread all the way to her elbow. This resolved within a week of injection. She also described feeling like she was coming down with something, a general sickness feeling that kept her in bed. Approximately 11 days after injection she experienced a breakout of hives across her chest and forearm that she is still experiencing at 13 days post vaccine.