chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: TYP
Symptoms: Nausea, Oral administration complication, Vomiting
Clinical narrative: THREW UP A DOSE OF VIVOTIF; This spontaneous case report (PVX2019-1657) was received from a nurse on 26-Jun-2019. It describes a male consumer who threw up a dose of Vivotif, while being on Vivotif for an unknown indication.  Case report: The consumer took a dose of Vivotif and then, threw it. Afterwards, he took another dose on the same day. The consumer stated that he had not thrown up because he was nauseous, but because he had gagged while brushing his teeth.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that a male consumer who threw up a dose of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer who threw up a dose of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, vomiting is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: MISSED TO TAKE FOURTH DOSE ON TIME/ DID NOT COMPLETE HER IMMUNIZATION ONE WEEK PRIOR TO TRAVELING TO COUNTRY; STOMACH ACHE; TOOK DOSES WITH FOOD OR MILK; This spontaneous case report (PVX2019-1663) was received from a consumer on 25-Jun-2019. It describes a 15-year-old adolescent male consumer who had stomachache, after the administration of oral Vivotif for travelling to an endemic area (Country). He also "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to Country" and "took doses with food or milk."  Case report: The consumer took three doses of Vivotif with food or milk. The doses were taken on 19-Jun-2019, 21-Jun-2019, and 23-Jun-2019, respectively. He forgot to take fourth dose which was due on 25-Jun-2019. However, after the third dose he had bad stomachache. He had a planned trip to country on 27-Jun-2019.  Action taken with Vivotif with respect to the event stomachache was unknown while with respect to the events "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to Country" and "took doses with food or milk" was not applicable.  The consumer had recovered from the event stomachache on 24-Jun-2019 while the clinical outcome of the events "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to Country" and "took doses with food or milk" was unknown.  Company's Comment: In this case, it was reported that a 15-year-old adolescent male consumer had stomachache, after the administration of oral Vivotif. He also "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to country" and "took doses with food or milk". There seems to be a temporal association between the intake of the vaccine and the event. Also, stomachache is labeled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the events "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to Country" and "took doses with food or milk" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that a 15-year-old adolescent male consumer had stomach ache, after the administration of oral Vivotif. He also "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to country" and "took doses with food or milk". There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach ache is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the events "missed to take fourth dose on time/ did not complete her immunization one week prior to traveling to country" and "took doses with food or milk" was considered as not applicable.
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: ABDOMINAL PAIN; A spontaneous case report was received from a physician on 28-Jun-2019 for two consumers.  Based on the information obtained from the physician, two individual case safety reports PVX201907-000549 (husband) and PVX201907-000550 (wife) were created and cross-linked in the database.  This case describes a male consumer who had abdominal pain, after administration of first dose Vivotif for an unknown indication.  Action taken with Vivotif with respect to the event was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that a male consumer had abdominal pain after administration of first dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer had abdominal pain after administration of first dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201907-000550:
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain
Clinical narrative: ABDOMINAL PAIN; A spontaneous case report was received from a physician on 28-Jun-2019 for two consumers.  Based on the information obtained from the physician, two individual case safety reports PVX201907-000549 (husband) and PVX201907-000550 (wife) were created and cross-linked in the database.  This case describes a female consumer who had abdominal pain, after administration of first dose Vivotif for an unknown indication.  Action taken with Vivotif with respect to the event was unknown.  The clinical outcome of the event was unknown.  Company's Comment: In this case, it was reported that a female consumer had abdominal pain, after administration of first dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer had abdominal pain, after administration of first dose Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, abdominal pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201907-000549:
Sex: F
Vaccine: TYP
Symptoms: Nausea
Clinical narrative: NAUSEA; This spontaneous case report (PVX2019-1806) was received from a consumer on 13-Jul-2019. It describes a female consumer who felt nausea (PT: Nausea), after administration of Vivotif for an unknown indication.  Case report: The consumer started taking Vivotif and felt nauseous. She took her third dose on 13-Jul-2019 and again felt nauseous.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the event was not resolved.  Company's Comment: In this case, it was reported that a female consumer who felt nausea, after administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer who felt nausea, after administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Oral administration complication, Vomiting
Clinical narrative: THREW UP FIRST DOSE OF VIVOTIF; This spontaneous case report (PVX2019-1894) was received from a consumer on 22-Jul-2019. It described a 22-year-old female consumer who "threw up first dose of Vivotif" (PT: Vomiting), while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 19-Jul-2019 and after three to four hours, she threw up the Vivotif dose. She took second dose on 21-Jul-2019. She stated that she threw up due to her birth control pill, Sprintec (norgestimate and ethinyl estradiol), that she just started recently that makes her queasy. She also stated that she did not expose to any foreign or unhygienic food or drink.  Action taken with Vivotif was dosage maintained.  The clinical outcome of the reported event was unknown.  The reporter considered the event of "threw up first dose of Vivotif" was unrelated to vaccine.  Company's Comment: In this case, it was reported that the consumer "threw up first dose of Vivotif". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible. Also, vomiting is labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer  "threw up first dose of Vivotif". There seems to be a temporal association between the intake of the vaccine and the event. Hence, the causality of the event with Vivotif is assessed as possible.  Also, vomiting is labelled as per CCDS
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain upper
Clinical narrative: STOMACH PAINS; This spontaneous case report (PVX2019-1931) was received from a consumer on 25-Jul-2019. It described a 20-year-old male consumer who experienced stomach pains (PT: Abdominal pain upper), after administration of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer experienced stomach pains after taking the third and the fourth doses of Vivotif on 23-Jul-2019 and 25-Jul-2019, respectively. He took Tums (calcium carbonate) for treatment on 23-Jul-2019 which helped a little.   No action was taken with Vivotif with respect to the reported event.  The consumer had not recovered from the reported event.  Company's Comment: In this case, it was reported that a male consumer who experienced stomach pains, after administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a male consumer who experienced stomach pains, after administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, stomach pain is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: THREW UP; This spontaneous case report (PVX2019-2223) was received from a consumer on 30-Aug-2019. It described a female consumer who "threw up" (PT: Vomiting), after administration of third dose of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer threw up after taking the third dose on 26-Aug-2019. The fourth dose was taken on 28-Aug-2019.  The action taken with Vivotif with respect to the event was not applicable.  The consumer had recovered from the reported event on 26-Aug-2019.  Company's comment: In this case, a female consumer who "threw up" after administration of third dose of oral Vivotif. There is lack of information regarding medical history, concomitant medication and intake of any unhygienic food and water. Hence, the causality has been assessed as not assessable.; Sender's Comments: Company's comment: In this case, a female consumer who "threw up" after administration of third dose of oral Vivotif. There is lack of information regarding medical history, concomitant medication and intake of any unhygienic food and water. Hence, the causality has been assessed as not assessable.
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Abdominal pain upper
Clinical narrative: STOMACH IRRITATION; STOMACH CRAMPING; This spontaneous case report (PVX2019-2435) was received from a pharmacist on 25-Sep-2019. It described a 23-year-old adult female consumer who experienced stomach irritation (PT: Epigastric discomfort) and stomach cramping (PT: Abdominal pain upper), after administration of oral Vivotif capsule (took one dose every other day) for typhoid prophylaxis.  Case report: The consumer took the first two doses of Vivotif on 22-Sep-2019 and 24-Sep-2019, respectively and experienced stomach cramping and stomach irritation after taking it.  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 experienced stomach irritation and stomach cramping 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, stomach irritation and stomach cramping are labelled as per CCDS. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced stomach irritation and stomach cramping 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, stomach irritation and stomach cramping are labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Dysmenorrhoea, Muscle spasms, Vomiting
Clinical narrative: DIARRHEA; CRAMPS; THROWING UP; This spontaneous case report (PVX2019-2583) was received from a consumer on 16-Oct-2019. It described female consumer who had "diarrhea" (PT: Diarrhoea), "cramps" (PT: Abdominal pain) and "throwing up" (PT: Vomiting) while receiving oral Vivotif for typhoid fever.  Case report: The consumer reported to be fine after taking her first Vivotif dose. After the second dose, she experienced "real cramps, menstrual like cramps but they were only in her upper body part, under her breast". She reported that she had never experienced these cramps before, nor she had menstrual cramps in the past. She described the cramps as tightness and spasmodic. The cramps came in waves (of time). Last night, the consumer was "violently ill" which she clarified as throwing up twice and had diarrhea at the same time.   Action taken with Vivotif with respect to the events was unknown.  The clinical outcome of the reported events was unknown.  Company's Comment: In this case, it was reported that the consumer female consumer who had "diarrhea", "cramps" and "throwing up" while receiving oral 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, diarrhea, cramps and throwing up are labelled as per CCDS.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer female consumer who had "diarrhea", "cramps" and "throwing up" while receiving oral 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, diarrhea, cramps and throwing up are labelled as per CCDS.
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: SHARP PAIN IN HER STOMACH; NAUSEA; SHE WAS THROWING UP; This spontaneous case report (PVX2019-2703) was received from a consumer on 30-Oct-2019. Additional information was received on 01-Nov-2019. It described 25-year-old adult female consumer who had sharp pain in her stomach (PT: Abdominal pain upper), nausea (PT: Nausea) and she was throwing up (PT: Vomiting), while being on Vivotif (lot number: 3003279) for travel.  Case report: The consumer took three doses of Vivotif at midnight on 25-Oct-2019, 27-Oct-2019 and 29-Oct-2019. After her third dose, when she woke up on 29-Oct-2019, she threw up so much that she went to the emergency room (ER). In ER, she received nausea medicines and liquids and was told that it was because of Vivotif. On 30-Oct-2019, she was much better, and she had sharp pain in her stomach, but it was nothing compared to yesterday. On 01-Nov-2019, she reported that she did not take the last dose of Vivotif. She had nausea as well. It was reported that the ER thought it was because of Vivotif  The consumer had no medical history.  Concomitant medication included Yaz (Drospirenone/ Ethinyl estradiol) for birth control, which was received on 01-Nov-2019.  Action taken with Vivotif with respect to the reported events was vaccine discontinued.  The clinical outcome of the reported events sharp pain in her stomach and she was throwing up was resolving, while the clinical outcome of the event nausea was unknown.  Company's Comment: In this case, it was reported that the consumer had sharp pain in her stomach, nausea and she was throwing up 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.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had sharp pain in her stomach, nausea and she was throwing up 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.
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: SEVERE UNCONTROLLABLE DIARRHEA; A spontaneous case report was received from a nurse on 11-Nov-2019 for two consumer. Additional information was received on 13-Nov-2019.  Based on the information obtained from the nurse, two individual case safety report PVX201911-000856 (PVX2019-2787; female) and PVX201911-000857 (PVX2019-2788; male) were created and cross-linked in the database.  The case report (PVX2019-2787) described a 65-year-old elderly female consumer who developed severe uncontrollable diarrhea (PT: Diarrhoea), while being on oral Vivotif (took one capsule every other day) for typhoid fever prophylaxis.   Case report: The consumer took Vivotif doses on 16-Oct-2019, 18-Oct-2019, 20-Oct-2019, and 22-Oct-2019. It was reported that the consumer was still complaining severe uncontrollable diarrhea. As of 11-nov-2019, the event was ongoing which was interfering with her daily life.  Consumer's medical history included celiac disease.  Past medication included Yellow fever vaccine and a Tetanus vaccine, which were taken on 09-Oct-2019.  Action taken with Vivotif with respect to reported event was unknown.  The consumer had not recovered from the reported event.  Company's Comment: In this case, it was reported that a female consumer developed sever uncontrollable diarrhea following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The consumer's medical history of celiac disease is a significant confounding factor in the case.; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer developed sever uncontrollable diarrhea following administration of  of Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, diarrhoea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The consumer's medical history of celiac disease is a significant confounding factor in the case. US-PaxVax Berna GmbH-PVX201911-000857:
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Nausea
Clinical narrative: SEVERE DIARRHEA; NAUSEA; A spontaneous case report was received from a nurse on 11-Nov-2019 for two consumers. Additional information was received on 13-Nov-2019.  Based on the information obtained from the nurse, two individual case safety report PVX201911-000856 (PVX2019-2787; female) and PVX201911-000857 (PVX2019-2788; male) were created and cross-linked in the database.  The case report (PVX2019-2788) described a 77-year-old elderly male consumer who had nausea (PT: Nausea) and severe diarrhea (PT: Diarrhoea), while being on oral Vivotif (took one capsule every other day) for typhoid fever prophylaxis.   Case report: The consumer took Vivotif doses on 16-Oct-2019, 18-Oct-2019, 20-Oct-2019, and 22-Oct-2019. It was reported that the consumer was still complaining of nausea and severe diarrhea. As of 11-Nov-2019, the events were ongoing which were interfering with his daily life.  Past medication history included Yellow fever vaccine and a Tetanus vaccine, which were taken on 09-Oct-2019.  Action taken with Vivotif with respect to reported events was unknown.  The consumer had not recovered from the reported events.  Company's Comment: In this case, it was reported that a male consumer developed severe uncontrollable diarrhea and nausea following administration of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhoea and nausea are 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 male consumer developed severe uncontrollable diarrhea and nausea following administration of  of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, diarrhoea and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. US-PaxVax Berna GmbH-PVX201911-000856:
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Vomiting
Clinical narrative: STOMACH ACHE; NAUSEA; THROWING UP; DIARRHEA; This spontaneous case report (PVX2019-2796) was received from a consumer on 12-Nov-2019. It described a 32-years-old female consumer who started "throwing up" (PT: Vomiting) and also developed "stomach ache" (PT: Abdominal pain upper), "nausea" (PT: Nausea) and "diarrhoea" (PT: Diarrhoea), after administration of oral Vivotif for typhoid fever.  Case report: It was reported that the consumer did not experience any adverse event with first dose of Vivotif but after taking the second dose, she started throwing up. Eight to ten hours after taking the third dose, the event did not resolve. She also developed stomach ache, nausea and diarrhea. It was reported that these adverse events were not that bad after the second dose but got worse after taking the third dose of Vivotif.  Action taken with Vivotif with respect to the reported events was dosage maintained.  The clinical outcome of the events was unknown.  Company's Comment: In this case, it was reported that a female consumer started throwing up and developed "stomach ache", "nausea" and "diarrhoea", after administration of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, the vaccine has potential to cause these events. 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 started throwing up and also developed "stomach ache", "nausea" and "diarrhoea", after administration of oral Vivotiff. There seems to be a temporal association between the intake of the vaccine and the events. Also, the vaccine has potential to cause these events. Hence, the causality of the events with Vivotif is assessed as possible.
Age: 26.0
Sex: M
Vaccine: HEP
Symptoms: Injection site pain, Weight bearing difficulty
Clinical narrative: More painful than any other injection patient has received thus far. Patient still has issues with weight bearing with left arm.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information was received from a lawyer regarding a case in litigation and refers to a currently 68 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 09-NOV-2013 the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of her receipt of zoster vaccine live(ZOSTAVAX), in 2014, patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; the patient received an improperly stored dose of ROTATEQ on 3/13/2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 13-MAR-2020, the patient was vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # 1660112, expiration date 18-OCT-2020 (dose and frequency were not provided) for prophylaxis. Administered doses of the suspect vaccine experienced the temperature excursion above 47 Fahrenheit degrees (F) (52.1F) for 15 minutes. There was previous temperature excursion reported. The administered doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced the temperature excursion above 47F (55F) for 21 minutes. The digital data logger was involved to capture the temperature excursion. No adverse symptoms were reported. The outcome of the event was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information was received from a lawyer regarding a case in litigation and refers to a 61 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2007, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of her receipt of zoster vaccine live(ZOSTAVAX), in April 2007, patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are pennanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE information provided; the patient was administered an improperly stored dose of ROTATEQ; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 10-MAR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot number: 1660112, expiration date: 18-OCT-2020 (strength, exact dose and frequency were not provided) orally for prophylaxis. The suspect vaccine was exposed to a temperature above 47 degrees Fahrenheit (52.1 degrees Fahrenheit) for a duration of 15 minutes. There was a previous temperature excursion reported, at a temperature above 47 degrees Fahrenheit (55 degrees Fahrenheit) for a duration of 21 minutes. Data logger was involved. No additional adverse event information was provided.
Age: 79.0
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain
Clinical narrative: Pain under my left breast in the rib gage; This case was reported by a nurse via call center representative and described the occurrence of rib pain in a 79-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st February 2020, the patient received the 1st dose of Shingles vaccine. On 12th March 2020, 20 days after receiving Shingles vaccine, the patient experienced rib pain. On an unknown date, the outcome of the rib pain was unknown.   The reporter considered the rib pain to be possibly related to Shingles vaccine.  Additional details were provided as follows: The patient had pain under their left breast in the rib gage. The patient was wondering if the shingle shot could be a cause?
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Slight fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 23rd March 2020, the patient received Shingles vaccine. On 23rd March 2020, 1 hr after receiving Shingles vaccine, the patient experienced fever. On 23rd March 2020, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient had slight fever.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dry eye, Eye pain, Fatigue, Headache
Clinical narrative: Diagnosed with dry eyes; Sore in her eye; Diagnosed with lichen sclerosus / Severe case of lichen sclerosus; Itching in her crotch; Discomfort in her crotch; Arm became very swollen; Arm became hard as a rock; Arm became hot; Arm became achy; didn't feel well; headaches; tiredness; Couldn't move her arm; Felt like she had the flu; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased and influenza like illness. In February 2020, the patient experienced lichen sclerosus, localized itching and discomfort. On an unknown date, the patient experienced eye dryness and sore eye. The patient was treated with unknown steroid eyedrops (Steroid Eye Drop (Unknown)) and topical steroid nos (Steroid Cream). On an unknown date, the outcome of the swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased and sore eye were recovered/resolved and the outcome of the influenza like illness and eye dryness were unknown and the outcome of the lichen sclerosus, localized itching and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased, influenza like illness, eye dryness and sore eye to be related to Shingrix. The reporter considered the lichen sclerosus, localized itching and discomfort to be related to Shingrix.  Additional details were reported as follows: Caller reports that she received Shingrix and that day her arm became very swollen, hard as a rock, hot and achy. She also didn't feel well, with headaches and tiredness. She couldn't move her arm and felt like she had the flu. The symptoms lasted for over 1 week before resolving. A couple weeks after getting Shingrix she developed a sore in her eye. She saw her ophthalmologist and was diagnosed with dry eyes. She was given a steroid eye drop and the sore resolved and she now takes drops for dry eyes. About 3 weeks after getting Shingrix she developed itching and discomfort in her crotch. She thought it was a yest infection and treated it as such, but the symptoms did not resolve. She saw her gynecologist and was diagnosed with lichen sclerosus and is now using a steroid cream. It was a severe case of lichen sclerosus. She thoughts Shingrix caused the lichen sclerosus. Consented to follow up. ER Visit Required.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Influenza like illness, Lichen sclerosus, Malaise, Mobility decreased
Clinical narrative: Diagnosed with dry eyes; Sore in her eye; Diagnosed with lichen sclerosus / Severe case of lichen sclerosus; Itching in her crotch; Discomfort in her crotch; Arm became very swollen; Arm became hard as a rock; Arm became hot; Arm became achy; didn't feel well; headaches; tiredness; Couldn't move her arm; Felt like she had the flu; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased and influenza like illness. In February 2020, the patient experienced lichen sclerosus, localized itching and discomfort. On an unknown date, the patient experienced eye dryness and sore eye. The patient was treated with unknown steroid eyedrops (Steroid Eye Drop (Unknown)) and topical steroid nos (Steroid Cream). On an unknown date, the outcome of the swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased and sore eye were recovered/resolved and the outcome of the influenza like illness and eye dryness were unknown and the outcome of the lichen sclerosus, localized itching and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased, influenza like illness, eye dryness and sore eye to be related to Shingrix. The reporter considered the lichen sclerosus, localized itching and discomfort to be related to Shingrix.  Additional details were reported as follows: Caller reports that she received Shingrix and that day her arm became very swollen, hard as a rock, hot and achy. She also didn't feel well, with headaches and tiredness. She couldn't move her arm and felt like she had the flu. The symptoms lasted for over 1 week before resolving. A couple weeks after getting Shingrix she developed a sore in her eye. She saw her ophthalmologist and was diagnosed with dry eyes. She was given a steroid eye drop and the sore resolved and she now takes drops for dry eyes. About 3 weeks after getting Shingrix she developed itching and discomfort in her crotch. She thought it was a yest infection and treated it as such, but the symptoms did not resolve. She saw her gynecologist and was diagnosed with lichen sclerosus and is now using a steroid cream. It was a severe case of lichen sclerosus. She thoughts Shingrix caused the lichen sclerosus. Consented to follow up. ER Visit Required.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Diagnosed with dry eyes; Sore in her eye; Diagnosed with lichen sclerosus / Severe case of lichen sclerosus; Itching in her crotch; Discomfort in her crotch; Arm became very swollen; Arm became hard as a rock; Arm became hot; Arm became achy; didn't feel well; headaches; tiredness; Couldn't move her arm; Felt like she had the flu; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 1st dose of Shingrix. On 14th January 2020, less than a day after receiving Shingrix, the patient experienced swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased and influenza like illness. In February 2020, the patient experienced lichen sclerosus, localized itching and discomfort. On an unknown date, the patient experienced eye dryness and sore eye. The patient was treated with unknown steroid eyedrops (Steroid Eye Drop (Unknown)) and topical steroid nos (Steroid Cream). On an unknown date, the outcome of the swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased and sore eye were recovered/resolved and the outcome of the influenza like illness and eye dryness were unknown and the outcome of the lichen sclerosus, localized itching and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, induration, skin warm, pain in arm, feeling unwell, headache, tiredness, mobility decreased, influenza like illness, eye dryness and sore eye to be related to Shingrix. The reporter considered the lichen sclerosus, localized itching and discomfort to be related to Shingrix.  Additional details were reported as follows: Caller reports that she received Shingrix and that day her arm became very swollen, hard as a rock, hot and achy. She also didn't feel well, with headaches and tiredness. She couldn't move her arm and felt like she had the flu. The symptoms lasted for over 1 week before resolving. A couple weeks after getting Shingrix she developed a sore in her eye. She saw her ophthalmologist and was diagnosed with dry eyes. She was given a steroid eye drop and the sore resolved and she now takes drops for dry eyes. About 3 weeks after getting Shingrix she developed itching and discomfort in her crotch. She thought it was a yest infection and treated it as such, but the symptoms did not resolve. She saw her gynecologist and was diagnosed with lichen sclerosus and is now using a steroid cream. It was a severe case of lichen sclerosus. She thoughts Shingrix caused the lichen sclerosus. Consented to follow up. ER Visit Required.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Peripheral swelling, Skin warm
Clinical narrative: patient said his arm felt warm and hard and today (3/31)  it is swollen.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Post herpetic neuralgia, Rash, Rash vesicular
Clinical narrative: a painful, burning zoster-like rash; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-MAR-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a painful, burning zoster-like rash, she was ultimately diagnosed with post herpetic neuralgia. Besides, as a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX), the patient had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. In addition, she 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. The outcome of the events was considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   Rash vesicular and post herpetic neuralgia were considered to be disabling.
Sex: U
Vaccine: FLUX
Symptoms: Injection site reaction
Clinical narrative: injection site reactions are worse with this vaccine /injection site reactions are worse with this vaccine than with other flu vaccines; This case was reported by a other health professional via sales rep and described the occurrence of injection site reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not applicable for this report.. The reporter indicated the injection site reactions with the flu vaccines. The reporter was unable to obtain additional details. The reporter would not provide her any additional information. The reporter consented to follow up. This case had been linked to the case US2020019065, reported by same reporter.
Sex: M
Vaccine: FLUX
Symptoms: Chills, Injection site pain, Movement disorder
Clinical narrative: chills /get so chilly; pain in his arm for 24 hours at the injection site; difficulty lying; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced chills, injection site pain and movement disorder. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the injection site pain and movement disorder were unknown.   It was unknown if the reporter considered the chills, injection site pain and movement disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. He claims that he has had a flu shot every year and he would experience pain in his arm for 24 hours at the injection site but he described the pain and experience as negligible and infrequent. Occasionally, after receiving the flu shot it would be difficult for him to lie on his left shoulder to sleep but that experience only happened once or twice. He mentioned during the phone conversation that in the military he would receive 5 to 6 vaccinations in one day and he would get so chilly that he had to take a shower and the chills resolved. He didn't clarify which vaccinations he received in the military. The reporter consented to follow up.  This case has been linked with US2020021556, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Musculoskeletal pain, Neck pain
Clinical narrative: Injection site pain; redness; This case was reported by a consumer and described the occurrence of neck pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced neck pain, shoulder pain, injection site pain and injection site erythema. On an unknown date, the outcome of the neck pain, shoulder pain, injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the neck pain, shoulder pain, injection site pain and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient selected as an adult as per vaccine indication. Th patient stated that, had sever injection site pain and redness after vaccination. The patient did not experienced headache and muscle pain after 1st Shingrix vaccination. For tollerence of 2nd dose refer case US2020AMR033936, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: developed severe itching on arms and legs; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a 65-year-old 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 2 years after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix one and half year ago from reporting date and developed severe itching on arms and legs for 3 months.  The patient visited doctor for several times to get medicine to stop the itching. No other information was reported. This case has been linked with US2020AMR040809, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Myalgia
Clinical narrative: woke with the dry heavies; achy body; light headness; feel really bad today; Fever; tired; muscle pain; headache; This case was reported by a consumer via interactive digital media and described the occurrence of dry heaves in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pruritus (received 1st dose one nad half year ago from reporting date, refer case US2020AMR040791).   On 3rd March 2020, the patient received the 2nd dose of Shingrix. On 4th March 2020, 1 days after receiving Shingrix, the patient experienced dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache. On an unknown date, the outcome of the dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache were not recovered/not resolved.   It was unknown if the reporter considered the dry heaves, general body pain, light headedness, feeling bad, fever, tiredness, muscle pain and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but it could be 64 years or 65 years. The patient needed second shot but the patient was very nervous about getting it due to adverse events experienced after 1st dose, so the patient received 2nd dose late, a year and half after the 1st dose. On the day of reporting, the patient woke with the dry heavies, achy body and light headness. The patient felt very bad on the day of reporting, had fever, tired, muscle pain and headache. The patient wanted to know how long thses side effect might last.