chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Blood glucose increased, Blood ketone body increased, Gastroenteritis viral, Vomiting
Clinical narrative: STOMACH FLU; VOMITED; This spontaneous case report was received from a caregiver (PVX2019-130) on 15-Jan-2019 and a follow up report was received on 17-Jan-2019. The report describes a female consumer who vomited and experienced stomach flu following the intake of Vivotif for typhoid prophylaxis   The consumer's medical history included type 1 diabetes.  The consumer's medication included Novolog (insulin) for diabetes type I. The consumer had no history of unhygienic food or water intake.  It was reported by the caregiver that her daughter was halfway through her Vivotif course and had gotten stomach flu overnight; she vomited a couple times this morning (15-Jan-2019). She was due to take her third dose of Vivotif today. She had taken the first two doses on 11-Jan-2019 and 13-Jan-2019. On 15-Jan-2019, she had only vomited during the morning and she did not vomit anymore, and she was fine. The caregiver also stated that she had type 1 diabetes, and she sometimes vomited when she had ketones, so she was not sure what the vomiting was caused by. She was constantly taking insulin due to her type 1 diabetes.   The consumer completed the entire course of Vivotif.  The consumer's laboratory test included blood sugar level which was found to be 238 (the caregiver did not know the units) and two tests for ketones, one was taken right after she threw up, which showed moderate ketones and the second test was taken later that morning, before noon, which showed trace of ketones.  The action taken with Vivotif with respect to the events vomited and stomach flu was dosage maintained.  The clinical outcome of the events vomited, and stomach flu was resolved.  Company Comment: In this case, a female consumer developed vomiting and stomach flu following the intake of Vivotif. The consumer is a known patient of diabetes type 1 and showed moderate ketones in test after the events. Also, she has had similar history of vomiting in past when ketones were present. Due to the presence of confounding factors, the causality of the event vomiting and stomach flu was assessed as not related to Vivotif.; Sender's Comments: Company Comment: In this case, a female consumer developed vomiting and stomach flu following the intake of Vivotif. The consumer is a known patient of diabetes type 1 and showed moderate ketones in test after the events. Also, she has had similar history of vomiting in past when ketones were present. Due to the presence of confounding factors, the causality of the event vomiting and stomach flu was assessed as not related to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Influenza, Pyrexia
Clinical narrative: DID NOT COMPLETE VIVOTIF COURSE ONE WEEK PRIOR TO TRAVEL; FLU; This spontaneous case report was received from a pharmacist (PVX2019-589) on 06-Mar-2019. It described a 9-year-old female child consumer who had flu following the intake of oral Vivotif (one capsule every other day) for typhoid prophylaxis. The consumer was also "did not complete Vivotif course one week prior to travel".  The consumer's concurrent medical condition includes asthma. Also, she was allergic to amoxicillin (rash).  The consumer's concomitant medications included Proair (albuterol; 90 mcg; as needed), Flovent 110 HFA (fluticasone propionate; twice in a day) for asthma, and oral Zyrtec (loratadine; 10 mg; once in a day) in liquid form for allergies.  It was reported that the consumer took the first dose of Vivotif on 04-Mar-2019. On 06-Mar-2019, she was diagnosed with flu and had a fever of 100-degree Fahrenheit. On 05-Mar-2019, she had a fever of 103-degree Fahrenheit, which was reduced to 100-degree Fahrenheit on 06-Mar-2019. She was planning to leave for an endemic area on either 15-Mar-2019 or 17-Mar-2019.   The consumer was rotating between oral Tylenol (paracetamol; 360 mg) in every 6 hours and oral ibuprofen. Along with that she was taking oral Tamiflu (oseltamivir; 60 mg; twice in a day) for 5 days for flu.  The action taken with Vivotif with respect to the event flu was unknown while with respect to the event "did not complete Vivotif course one week prior to travel" was not applicable.  The clinical outcome of the events flu and "did not complete Vivotif course one week prior to travel" was unknown.  Company's Comment: In this case, it was reported that a 9-year-old female child consumer had flu following the intake of oral Vivotif. She also "did not complete Vivotif course one week prior to travel". There seems to be a temporal association between the intake of the vaccine and the event. However, flu is an infectious condition with most commonly viral etiology. Hence, the causality of the event was assessed as unlikely with Vivotif. The causality of the event "did not complete Vivotif course one week prior to travel" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 9-year-old female child consumer had flu following the intake of oral Vivotif. She  also "did not complete Vivotif course one week prior to travel". There seems to be a temporal association between the intake of the vaccine and the event. However, flu is an infectious condition with most commonly viral etiology. Hence, the causality of the event was assessed as unlikely with Vivotif. The causality of the event "did not complete Vivotif course one week prior to travel" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Cough, Influenza, Pyrexia, Respiratory symptom, Rhinorrhoea
Clinical narrative: INFLUENZA A; This spontaneous case report was received from a pharmacist (PVX2019-595) on 07-Mar-2019. It described a male child consumer who was diagnosed with influenza A following the intake of Vivotif for an upcoming trip.  The consumer was not taking any concomitant medication.  It was reported that the consumer took first two doses of Vivotif, probably 3 or 4 days ago. On 07-Mar-2019, he was diagnosed with Influenza A. He had a fever (approximately 100 degree Fahrenheit) and other upper respiratory symptoms like runny nose and cough.   The reporter did not think that Vivotif caused influenza A because the place where the consumer was located was an uptick of influenza A.  The action taken with Vivotif with respect to the event influenza A was unknown.  The clinical outcome of the event influenza A was not resolved.  Company's Comment: In this case, it was reported that a male child consumer was diagnosed with influenza A following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. However, influenza A is an infectious condition with most commonly viral etiology. Hence, the causality of the event was assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, it was reported that a male child consumer was diagnosed with influenza A following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. However, influenza A is an infectious condition with most commonly viral etiology. Hence, the causality of the event was assessed as unlikely with Vivotif.
Sex: U
Vaccine: TYP
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: FEVER; COMING DOWN WITH SOMETHING; This spontaneous case report was received from a pharmacist (PVX2019-645) on 13-Mar-2019. It described a 17-year-old adolescent consumer who had "fever" and "was coming down with something" following the intake of Vivotif for an unknown indication.  It was reported that the consumer took the first dose of Vivotif either on 11-Mar-2019 or 12-Mar-2019 and then, had a "mild fever" and "was coming down with something", may be flu.  The action taken with Vivotif with respect to the events "fever" and "coming down with something" was unknown.  The clinical outcome of the events "fever" and "was coming down with something" was unknown.  Company's Comment: In this case, it was reported that a 17-year-old adolescent consumer had "fever" and "coming down with something" following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a 17-year-old adolescent consumer who had fever and coming down with something following the intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever is labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP, UNK
Symptoms: Urinary tract infection
Clinical narrative: TOOK MACROBID WHILE TAKING VIVOTIF; URINARY TRACT INFECTION; This spontaneous case (PVX2019-876) was received from a nurse on 15-Apr-2019. It describes a 53-year-old adult female consumer who was diagnosed with urinary tract infection (UTI), after the administration of oral Vivotif (one capsule every other day; lot number: 3003215) for typhoid prophylaxis. She also "took Macrobid while taking Vivotif" for the treatment of UTI.   Case report: The consumer took 3 doses of Vivotif on 10-Apr-2019, 12-Apr-2019, and 14-Apr-2019 respectively. On 14-Apr-2019, she was diagnosed with UTI for which she started Macrobid (nitrofurantoin; 100 mg; twice a day) on 15-Apr-2019.   The consumer had no medical history.  Action taken with Vivotif and Macrobid with respect to the event urinary tract infection was unknown while with respect to the event "took Macrobid while taking Vivotif" was not applicable.  The clinical outcome of the event urinary tract infection and "took Macrobid while taking Vivotif" was unknown   The reporter considered the event urinary tract infection unrelated to vaccine.  Company's Comment: In this case, a 53-year-old adult female consumer developed urinary tract infection (UTI) following administration of Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Macrobid while taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, a 53-year-old adult female consumer developed urinary tract infection (UTI) following administration of Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Macrobid while taking Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP, UNK
Symptoms: Cystitis
Clinical narrative: BLADDER INFECTION; TOOK MACROBID WHILE TAKING VIVOTIF; This spontaneous case (PVX2019-895) was received from a consumer on 16-Apr-2019. It describes a female consumer who developed bladder infection, after the administration of Vivotif capsule for an unknown indication. She also "took Macrobid while taking Vivotif" for treatment of bladder infection.  Case report: The consumer took three doses of Vivotif. She took the third dose on 15-Apr-2019 and on the same day, she had bladder infection for which she took Macrobid (nitrofurantoin; twice a day for 5 days).  The consumer's concurrent medical condition included hypothyroidism and cholesterol.  Concomitant medication at the time of event included simvastatin (10 mg) for cholesterol, levothyroxine (37.5 mcg/ 0.0375 mg; 1.5 pill) for hypothyroidism.  Action taken with Vivotif and Macrobid with respect to the event bladder infection was unknown while with respect to the event "took Macrobid while taking Vivotif" was not applicable.   The consumer had not recovered from the event bladder infection while with the event "took Macrobid while taking Vivotif" was unknown.  Company's Comment: In this case, a female consumer developed bladder infection, after the administration of Vivotif. Since bladder infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Macrobid while taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, a female consumer developed bladder infection, after the administration of Vivotif. Since bladder infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif. The causality of the event "took Macrobid while taking Vivotif" was considered as not applicable.
Sex: F
Vaccine: TYP
Symptoms: Gingivitis
Clinical narrative: GUM INFECTION; This spontaneous case (PVX2019-1329) report was received from a caregiver on 24-May-2019. It describes a female consumer who had gum infection, after the administration of Vivotif for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 13-May-2019, on the same day she developed gum infection. She competed the Vivotif course and waiting to start clindamycin capsule (150 mg; three times a day), which was prescribed to her as a treatment medication. The gum infection was still present, but it was not as bad as before.   She had an oral surgery for wisdom teeth removal about three to four weeks ago from which she got gum infection.  The consumer did not take any concomitant medication.   Action taken with Vivotif was dosage maintained.  The consumer had been recovering from the event.  The reporter considered the event gum infection unrelated to vaccine.  Company's Comment: In this case, the patient developed gum infection after the administration of Vivotif. Since gum infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, the patient developed gum infection after the administration of Vivotif. Since gum infection is an infectious condition the causality of the event was assessed as unlikely with Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Chills, Vomiting
Clinical narrative: CHILLS; VOMITING; This spontaneous case was received from a nurse on 04-Jun-2019. It describes a female consumer who experienced chills and vomiting, after the administration of Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif at night. Then, at 2 am, she woke up with severe chills and vomited in every 30 minutes until 4:30 am. At 10:30 am, she was feeling fine.  Action taken with Vivotif was unknown.  The consumer had recovered from the events chills and vomiting.  Company's Comment: In this case, it was reported that a female consumer experienced chills and vomiting after intake of Vivotif. There seems to be a temporal association between the intake of vaccine and the events. Also, chills and vomiting are labelled as per agency. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer experienced chills and vomiting after intake of Vivotif. There seems to be a temporal association between the intake of vaccine and the events. Also, chills and vomiting are labelled as per agency. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Nasopharyngitis, Sinusitis
Clinical narrative: COLD; SINUS INFECTION; This spontaneous case (PVX2019-1469) was received from a physician on 07-Jun-2019. It describes a female consumer who experienced cold and sinus infection, while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer experienced cold and sinus infection on 06-Jun-2019, while taking Vivotif. Her last dose was due on 08-Jun-2019.  The consumer's medical history included cold and sinus infection.  The consumer's past medication included Augmentin (amoxicillin) for cold and sinus infection.  The consumer was not taking any other medication.  Action taken with Vivotif was unknown.  The clinical outcome of the events was unknown.  The reporter considered the events unrelated to vaccine.  Company's Comment: In this case, the consumer experienced cold and sinus infection while taking Vivotif. Since cold and sinus infection are infectious in etiology, the causality of the events is assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, the consumer experienced cold and sinus infection while taking Vivotif. Since cold and sinus infection are infectious in etiology, the causality of the events is assessed as unlikely with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Pain, Pyrexia
Clinical narrative: ACHING; FEVER; This spontaneous case report (PVX2019-2483) was received from a consumer on 01-Oct-2019. It described a male consumer who experienced "aching" (PT: Pain) and "fever" (PT: Pyrexia), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took third dose of oral Vivotif (one dose every other day) on 30-Sep-2019 and experienced aching with high fever of 101.5 degrees. He reported that he had a low fever all day around 100 and felt like his fever was coming back again. He also reported that the aching was more exacerbated at the night and the morning. He stated that this felt like the symptoms of a mild flu. He also reported that aching and fever was ongoing at the time of the report.   The consumer took Aleve (200 mg; every 5 hours) as treatment medication for the events. The consumer also received travel vaccines last week of Hepatitis A, yellow fever, and tetanus.  Action taken with Vivotif with respect to the event was unknown.  The consumer had not recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer had "aching" and "fever" after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, fever and abdominal pain are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had "aching" and "fever" after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible. Also, fever and abdominal pain are labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; This spontaneous case report (PVX2019-2551) was received from a nurse on 11-Oct-2019. It described a 61-year-old female consumer who developed urinary tract infection (PT: Urinary tract infection), while being on oral Vivotif for typhoid fever.  Case report: The consumer was on therapy of Vivotif and she had developed urinary tract infection, during therapy. She finished Vivotif course on 09-Oct-2019 and was just prescribed with Keflex (cephalexin; 500 mg; twice daily for 10 days) for urinary tract infection, which she has not started yet.  Action taken with Vivotif with respect to reported event was dosage maintained.  The clinical outcome of the reported event was unknown.  The reporter considered the event of urinary tract infection was not related to Vivotif.  Company's Comment: In this case, the patient developed a urinary tract infection (UTI) while on Vivotif vaccine. Since UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif.; Sender's Comments: Company's Comment: In this case, the patient developed a urinary tract infection (UTI) while on Vivotif vaccine. Due to the fact that UTI is an infectious condition the causality of the event was assessed as unlikely with Vivotif.
Sex: M
Vaccine: TYP
Symptoms: Cystitis
Clinical narrative: DIAGNOSED WITH BLADDER INFECTION A DAY AFTER COMPLETING VIVOTIF; This spontaneous case report (PVX2019-2963) was received from a pharmacist on 03-Dec-2019. Additional information was received on 04-Dec-2019. It described a male consumer who was diagnosed with bladder infection a day after completing Vivotif (PT: Cystitis). He was receiving Oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took all four doses of Vivotif from 25-Nov-2019 to 01-Dec-2019 according to schedule. It was reported that he was diagnosed with bladder infection on 02-Dec-2019. The pharmacist stated that he did not know the symptoms of bladder infection and onset date of symptoms. The pharmacist told the patient to wait for at least 3 days after completing Vivotif to start ciprofloxacin for bladder infection.  The patient did not take any concomitant medications while taking Vivotif.  Past medications included Ambien (zolpidem), azithromycin (500 mg), Valtrex (valacyclovir), Finacea (azelaic acid) for acne, and clarithromycin.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company Comment: A consumer was diagnosed with bladder infection a day after completing Vivotif course (Cystitis). Considering the infectious pathogenesis of cystitis, the causality of the event is assessed as unlikely with Vivotif.; Sender's Comments: A consumer was diagnosed with bladder infection a day after completing Vivotif course (Cystitis). Considering the infectious pathogenesis of cystitis, the causality of the event is assessed as unlikely with Vivotif.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Influenza like illness, Injection site pain, Pyrexia
Clinical narrative: injection site pain; fev; chills; received her 2nd dose of Shingrix 9 day earlier than the 2 month mark; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (For tolerance after 1st dose refer case US2020034256.).   On 22nd February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fev, chills and drug dose administration interval too short. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fev and chills were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fev and chills to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient experienced flu-like symptoms, but they were more intense and that lasted for 24 hours. The patient her 2nd dose of Shingrix 9 day earlier than the 2 month mark which led to drug dose administration interval too short.  Reporter did not consent to follow-up.  This case is linked to the case US2020AMR034881 and US2020AMR034882 husband's case.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Rash vesicular
Clinical narrative: developed an eruption on his arms and legs, and he thought it was related to the cold weather; itchy eryption; eruption kind of resembles a Shingles rash but not exactly; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (single dose received 2-3 years ago before reporting).   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a month after receiving Shingrix, the patient experienced painful rash, itchy rash and vesicular rash. The patient was treated with topical antibiotic (nos) (Antibacterial Cream). On an unknown date, the outcome of the painful rash, itchy rash and vesicular rash were not recovered/not resolved.   It was unknown if the reporter considered the painful rash, itchy rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient developed an eruption on his arms and legs, and he thought it was related to the cold weather. The eruption kind of resembles a Shingles rash but not exactly.  He said that the eruption is painful (the pain comes and goes), itchy and that he still had one area on the thigh that was 3 months old. He stated on that one, he has tried using a band-aid as it is below the pocket area of his pants.  He stated the eruptions range from being the size of a dime to the size of a quarter and that he had used three types of cream including an antibacterial cream.  He said that the eruption from December 2020 did not completely clear up. For tolerance with 2nd dose of Shingrix, refer linked case US2020054996.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Dermatitis allergic, Rash, Rash pruritic, Rash vesicular, Skin test positive
Clinical narrative: developed an eruption on his arms and legs, and he thought it was related to the cold weather; itchy eryption; eruption kind of resembles a Shingles rash but not exactly; This case was reported by a consumer via call center representative and described the occurrence of painful rash in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (single dose received 2-3 years ago before reporting).   In December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a month after receiving Shingrix, the patient experienced painful rash, itchy rash and vesicular rash. The patient was treated with topical antibiotic (nos) (Antibacterial Cream). On an unknown date, the outcome of the painful rash, itchy rash and vesicular rash were not recovered/not resolved.   It was unknown if the reporter considered the painful rash, itchy rash and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient developed an eruption on his arms and legs, and he thought it was related to the cold weather. The eruption kind of resembles a Shingles rash but not exactly.  He said that the eruption is painful (the pain comes and goes), itchy and that he still had one area on the thigh that was 3 months old. He stated on that one, he has tried using a band-aid as it is below the pocket area of his pants.  He stated the eruptions range from being the size of a dime to the size of a quarter and that he had used three types of cream including an antibacterial cream.  He said that the eruption from December 2020 did not completely clear up. For tolerance with 2nd dose of Shingrix, refer linked case US2020054996.
Sex: M
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Immune system disorder
Clinical narrative: lowering immune system; Side effects; This case was reported by a consumer and described the occurrence of immune system disorder in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced immune system disorder and adverse drug reaction. On an unknown date, the outcome of the immune system disorder and adverse drug reaction were unknown.   It was unknown if the reporter considered the immune system disorder and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was concerned with the side effects (which he had with the first shot) possibly lowering his immune system in such a way that if he contacted the coronavirus, it could be more harmful to him. The reporter wanted to know was it ok to get the second shot at a later date.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Vomiting
Clinical narrative: vomiting; feeling generally miserable; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting (serious criteria other: serious per reporter) and feeling miserable (serious criteria other: serious per reporter). On an unknown date, the outcome of the vomiting and feeling miserable were unknown.   It was unknown if the reporter considered the vomiting and feeling miserable to be related to Shingrix.  Additional details were provide as follows: This case was reported by the retired respiratory therapist. The age at vaccination was not reported. At another gathering of reporter's group another member stated that, she had reaction was one of vomiting and feeling generally miserable. The reporter consented to follow up. This case has been linked with case US2019083226, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: Neuropathic pain; This case was reported by a physician via call center representative and described the occurrence of neuropathic pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (episode 5 weeks before receiving Shingrix).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neuropathic pain. On an unknown date, the outcome of the neuropathic pain was unknown.   It was unknown if the reporter considered the neuropathic pain 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 it was captured as an adult as per vaccine indication. The reporter did not consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal distension, Asthenia, Chills, Decreased appetite
Clinical narrative: flu like symptoms; headache; tired; lack of appetite; blotted/ loud stomach with bloating; loud stomach; muscle aches / muscle aching; woke up feeling like I had been hit by a truck; weak; chills; queasy; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received the 1st dose of Shingrix. On 12th March 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th March 2020, the patient experienced influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy were recovering/resolving.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine on unknown arm and experienced injection site pain. The nurse told to patient that she might experience flu like symptoms and a sore arm for a few days after the vaccine. The patient worked that evening. On next morning, patient woke up feeling like she had been hit by a truck, weak, muscles aching, chills, headache, queasy, loud stomach with bloating. The patient also experienced influenza-like symptoms, , tiredness, appetite absent. This had been going on for a week but now patient felt somewhat better.  The patient stated that this would all be fine with her if we were not in the middle of a pandemic. The patient did not have any way of knowing what was actually going on with her and she wanted to know whether this vaccine caused this reaction in other people too. The patient planned to continue follow-up with her physician. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Injection site pain
Clinical narrative: flu like symptoms; headache; tired; lack of appetite; blotted/ loud stomach with bloating; loud stomach; muscle aches / muscle aching; woke up feeling like I had been hit by a truck; weak; chills; queasy; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received the 1st dose of Shingrix. On 12th March 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th March 2020, the patient experienced influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy were recovering/resolving.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine on unknown arm and experienced injection site pain. The nurse told to patient that she might experience flu like symptoms and a sore arm for a few days after the vaccine. The patient worked that evening. On next morning, patient woke up feeling like she had been hit by a truck, weak, muscles aching, chills, headache, queasy, loud stomach with bloating. The patient also experienced influenza-like symptoms, , tiredness, appetite absent. This had been going on for a week but now patient felt somewhat better.  The patient stated that this would all be fine with her if we were not in the middle of a pandemic. The patient did not have any way of knowing what was actually going on with her and she wanted to know whether this vaccine caused this reaction in other people too. The patient planned to continue follow-up with her physician. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: flu like symptoms; headache; tired; lack of appetite; blotted/ loud stomach with bloating; loud stomach; muscle aches / muscle aching; woke up feeling like I had been hit by a truck; weak; chills; queasy; pain at injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2020, the patient received the 1st dose of Shingrix. On 12th March 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 13th March 2020, the patient experienced influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy were recovering/resolving.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, headache, tiredness, appetite absent, bloating, upset stomach, muscle pain, feeling abnormal, weakness, chills and queasy to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine on unknown arm and experienced injection site pain. The nurse told to patient that she might experience flu like symptoms and a sore arm for a few days after the vaccine. The patient worked that evening. On next morning, patient woke up feeling like she had been hit by a truck, weak, muscles aching, chills, headache, queasy, loud stomach with bloating. The patient also experienced influenza-like symptoms, , tiredness, appetite absent. This had been going on for a week but now patient felt somewhat better.  The patient stated that this would all be fine with her if we were not in the middle of a pandemic. The patient did not have any way of knowing what was actually going on with her and she wanted to know whether this vaccine caused this reaction in other people too. The patient planned to continue follow-up with her physician. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Limb discomfort, Pyrexia
Clinical narrative: Fever; injection site was sore/it felt like he had been punched in the arm/ it hurt when he lifted his left arm; noted that when he rolled over on his left arm, discomfort made him jump; This case was reported by a consumer via call center representative and described the occurrence of fever in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 12th November 2019, refer case US2020AMR053599).   On 23rd March 2020 14:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In March 2020, 1 day after receiving Shingrix, the patient experienced arm discomfort. On 23rd March 2020, the patient experienced injection site pain. On 24th March 2020, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the injection site pain was recovering/resolving and the outcome of the arm discomfort was unknown.   It was unknown if the reporter considered the fever, injection site pain and arm discomfort to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. Less than a day after vaccination, the patient experienced a little soreness at injection site. At 5:00 pm that evening, he said it felt like he had been punched in the arm. On 24th March 2020, 1 day after vaccination, the reporter went for a pre-planned procedure and was told that he could not receive it because he had a fever of 100.4 degree F. Also on the same day, he said that it hurt when he lifted his left arm due to the vaccination. The patient reported that the injection was less sore on the day of reporting than it was, but he noted that when he rolled over on his left arm in the morning of 25th March 2020, the discomfort made him jump. The patient reported that he still had a fever today. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: recurring shingles outbreaks; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 07-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered recurring shingles outbreaks. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the recurring shingles outbreaks was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event recurring shingles outbreaks to be disability.
Sex: U
Vaccine: VARZOS
Symptoms: Flushing, Pruritus
Clinical narrative: once a day I get flushed and itchy for anywhere; once a day I get flushed and itchy for anywhere; This case was reported by a consumer and described the occurrence of pruritus in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pruritus and flushing. On an unknown date, the outcome of the pruritus and flushing were not recovered/not resolved.   It was unknown if the reporter considered the pruritus and flushing to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter wanted to know was it possible that he/she could still be feeling side effects from a Shingrix shot given in December 2019. About once a day he/she get flushed and itchy for anywhere from 5 to 15 minutes. The reporter was due the second dose but was reluctant to get it.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Cough, Diarrhoea, Dysphonia, Dyspnoea
Clinical narrative: White pustules on red spots; Diarrhea; red spots on the back of his throat; Sore throat; Coughing; Swelling in throat; Wheezing; tightness in throat; Trouble breathing; Hoarseness; Shivering; Ringing of the ears; Deep sleep; This case was reported by a consumer via call center representative and described the occurrence of sleep disorder in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th February 2020, 1 days after receiving Shingrix, the patient experienced sore throat, cough, throat swelling, wheezing, throat tightness, difficulty breathing, hoarseness and shivering. On 8th February 2020, the patient experienced red throat. On 10th February 2020, the patient experienced pustule and diarrhea. In February 2020, the patient experienced sleep disorder and ringing in ears. The patient was treated with prednisone and ambiguous medication nos (Cortisone (Nos)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sleep disorder, sore throat, cough, throat swelling, red throat, pustule, wheezing, throat tightness, difficulty breathing, hoarseness, diarrhea, shivering and ringing in ears were unknown.   It was unknown if the reporter considered the sleep disorder, sore throat, cough, throat swelling, pustule, wheezing, throat tightness, difficulty breathing, hoarseness, diarrhea, shivering and ringing in ears to be related to Shingrix. The reporter considered the red throat to be related to Shingrix.  Additional details were provided as follows: The patient Shingrix vaccine and came home sat in a chair and was in deep sleep in such a deep sleep that he did not even wake up to vacuum cleaner noise.  The patient experienced sore throat, coughing, and swelling in his throat it got worse.He experienced red spots in his throat on Saturday evening. The patient called his united health care nurse but she was of no help to him. The patient reached out to his pulmonologist via text about his adverse reaction. The patient also noticed the red spots on the back of his throat had white pustules. His doctor mentioned to him that the red spots on his throat are due to Shingrix vaccine. The patient started on prednisone and would be tapered down in the next few days.The patient was scheduled to get a cortisone shot once he was done with prednisone.  After starting the prednisone, his throat swelling and red spots are present but better. He also experienced wheezing, tightness in throat, trouble breathing, and hoarseness that are still present. He was making loud noises due to his wheezing and coughing at night. The patient had diarrhea and shivering. He has also been experiencing ringing in his ears, but he did not know when that started.  The reporter did not consent to follow up. No further details were provided.
Age: 67.0
Sex: U
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pharyngeal erythema, Pharyngeal swelling, Pustule, Sleep disorder
Clinical narrative: White pustules on red spots; Diarrhea; red spots on the back of his throat; Sore throat; Coughing; Swelling in throat; Wheezing; tightness in throat; Trouble breathing; Hoarseness; Shivering; Ringing of the ears; Deep sleep; This case was reported by a consumer via call center representative and described the occurrence of sleep disorder in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th February 2020, 1 days after receiving Shingrix, the patient experienced sore throat, cough, throat swelling, wheezing, throat tightness, difficulty breathing, hoarseness and shivering. On 8th February 2020, the patient experienced red throat. On 10th February 2020, the patient experienced pustule and diarrhea. In February 2020, the patient experienced sleep disorder and ringing in ears. The patient was treated with prednisone and ambiguous medication nos (Cortisone (Nos)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sleep disorder, sore throat, cough, throat swelling, red throat, pustule, wheezing, throat tightness, difficulty breathing, hoarseness, diarrhea, shivering and ringing in ears were unknown.   It was unknown if the reporter considered the sleep disorder, sore throat, cough, throat swelling, pustule, wheezing, throat tightness, difficulty breathing, hoarseness, diarrhea, shivering and ringing in ears to be related to Shingrix. The reporter considered the red throat to be related to Shingrix.  Additional details were provided as follows: The patient Shingrix vaccine and came home sat in a chair and was in deep sleep in such a deep sleep that he did not even wake up to vacuum cleaner noise.  The patient experienced sore throat, coughing, and swelling in his throat it got worse.He experienced red spots in his throat on Saturday evening. The patient called his united health care nurse but she was of no help to him. The patient reached out to his pulmonologist via text about his adverse reaction. The patient also noticed the red spots on the back of his throat had white pustules. His doctor mentioned to him that the red spots on his throat are due to Shingrix vaccine. The patient started on prednisone and would be tapered down in the next few days.The patient was scheduled to get a cortisone shot once he was done with prednisone.  After starting the prednisone, his throat swelling and red spots are present but better. He also experienced wheezing, tightness in throat, trouble breathing, and hoarseness that are still present. He was making loud noises due to his wheezing and coughing at night. The patient had diarrhea and shivering. He has also been experiencing ringing in his ears, but he did not know when that started.  The reporter did not consent to follow up. No further details were provided.