chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MMR
Symptoms: Mumps, Oropharyngeal pain, Parotid gland enlargement, Polymerase chain reaction
Clinical narrative: mild sore throat; she had appearance of bull neck, but without fever. Swelling extends to midline over trachea--more tender over trachea than parotids; bilateral parotid swelling; mumps; This spontaneous report was received from a physician and refers to her daughter - female patient in her late 20s .The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), administered for prophylaxis (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided).  In August 2022, the patient experienced mumps. The patient returned from a trip. She then traveled. She returned home to visit parents on 15-AUG-2022. On 18-AUG-2022, the patient told the reporter by the phone she had swollen glands. On 19-AUG-2022, the reporter saw the patient and she had very painful bilateral parotid swelling-not swollen glands. On the same date in the evening, she had appearance of bull neck, but without fever. Swelling extended to midline over trachea-more tender over trachea than parotids at that time. On 20-AUG-2022, the patient experienced mild sore throat (reported as minimal systemic sx today - mild sore throat). The reporter got permission from department of health to send the buccal swab sample for mumps polymerase chain reaction (PCR). At the time of reporting, the outcome of the events was not provided.   The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  This is one of 2 linked reports.; Sender's Comments:  US-009507513-2208USA009009:
Sex: F
Vaccine: MMR
Symptoms: Headache, Lymphadenopathy, Mumps, Parotitis, Polymerase chain reaction positive
Clinical narrative: global headache; lymphadenopathy; bilateral parotid swelling; mumps; This spontaneous report was received from a consumer and refers to a 23-year-old female. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) administered for prophylaxis (strength, formulation, dose description, lot #, expiry date, and route of administration were not provided).  On an unknown date in August 2022, the patient was referred to the reporter for lymphadenopathy since early August. According to the reporter, she had spectacular bilateral parotitis and complained of global headache. Mucosal swab for mumps virus by reverse transcriptase polymerase chain reaction (RT-PCR) result was positive. On an unknown date in August 2022, the patient experienced mumps. At the time of reporting, the outcome of the events was not provided.   The causal relationship between the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.  This is one of 2 linked reports.; Sender's Comments:  US-009507513-2208USA008973:
Sex: F
Vaccine: PNC15
Symptoms: Vaccination site pain
Clinical narrative: A lot of pain at the injection site; This spontaneous report was received from a company representative concerning an elderly, female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On an unknown date, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) for prophylaxis (strength, dose, route of administration, anatomical location, lot number, expiration date and formulation were not provided).         On an unknown date, the patient experienced a lot of pain at the injection site (vaccination site pain), and after 15 minutes, the pain went away.      The outcome of vaccination site pain was reported as recovered.  The causal relationship between the suspect vaccine and the event occurrence was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: AFIB;  This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from License Party (Bristol-Myers Squibb). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2022-092533 (Bristol-Myers Squibb Company).  Information was received from a Consumer/other non health professional concerning a 63 Year(s) old Male patient, enrolled in the post marketing study who received Suspect product apixaban for Product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for covid-19 prophylaxis, lot number: Unknown. On an unknown date, the patient experienced atrial fibrillation(afib) which was considered serious due to the following criteria: life-threatening, hospitalization and medical significance. It is unknown if treatment was provided. The outcome of the event is unknown. The status of APIXABAN medication is unknown. The status of COVID-19 VACCINE medication is unknown. Concomitant medications were not reported. The reporter considered event atrial fibrillation not related to product APIXABAN. The reporter considered event atrial fibrillation related to product COVID-19 VACCINE. Patient's wife reported that her husband was in the ICU and went into AFIB after getting the COVID shot. No additional information reported Tracking of Changes: 18-Aug-2022: Initial information was received.  Eliquis is under agreement with BRISTOL-MYERS SQUIBB.  BMS Comments: This patient had life threatening atrial fibrillation after receiving apixaban therapy along with COVID - 19 vaccine. Atrial fibrillation is a cardiac electrophysiological disorder and it is considered not related to apixaban due to lack of pharmacological plausibility.; Sender's Comments: Based on the available information, a contributory role of suspect drug COVID - 19 vaccine cannot be entirely excluded for the reported event of atrial fibrillation. Patient's wife reported that her husband was in the ICU and went into AFIB after getting the COVID shot. Case will be reassessed upon receipt of additional information.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy, Protein total increased
Clinical narrative: Pregnant; Blood Screening "High Protein Level"; Initial Report Received on 27-May-2022 and 21-Jun-2022   An obstetric nurse  reported to the HEPLISAV-B pregnancy registry that a pregnant female  received one dose of HEPLISAV-B.  The patient reported that she had a titer test run by the obstetrician and was advised to get a vaccine as she did not have immunity.    On the same date the obstetric nurse contacted the HEPLISAV_B pregnancy registry, the husband of the pregnant patient also contacted the pregnancy registry and was transferred to medical information.    The husband also reported that his wife, a 28 year-old female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant and subsequently had high levels of protein in her blood.  No relevant medical history or concomitant medications were reported at the time of vaccination by the obstetric nurse and the husband.  The last menstrual period (LMP), estimated date of delivery (EDD), pregnancy history, and pregnancy risk factors were not reported.    On 14-Apr-2022, the pregnant patient (# of weeks of gestation unknown) received one dose of HEPLISAV-B (Lot # 937231, expiration date 14-Jan-2023, NDC # unknown) intramuscularly in the left arm.  The obstetric nurse additionally reported that on 26-May-2022, the pregnant patient returned to the pharmacy for her second dose and was advised that she would be given a different vaccine as she is pregnant.  The "RSS" provided information to the obstetric nurse about the pregnancy registry and informed her that her patient would be eligible to enroll.  The "RSS" was encouraged to provide the registry information to the patient.    The patient's husband reported that on an unknown date, after receiving the HEPLISAV-B injection, the patient had a blood screening and had a "high protein level." Therefore, she will be followed by a "high risk doctor." No other adverse reactions were reported.  No further information was provided.  Company Comment:  The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: Received 1st Dose of Heplisav-B and Received 2nd Dose from Another Manufacturer; Initial Report Received on 31-May-2022  A patient's mother reported that her daughter, a 23-year-old female patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization as the first dose and then a second dose of a hepatitis B vaccine from another manufacturer.   No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On 26-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route and injection site unknown).   On 31-May-2022, 36 days after having received the HEPLISAV-B injection, the patient received a second dose of hepatitis vaccine (unsure which one) from a different manufacturer. The patient had an appointment that day with her physician.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Injury associated with device, No adverse event
Clinical narrative: Needlestick; Initial Report Received on 07-Jun-2022  An adult nurse practitioner in the reported that 23-year-old female patient (race and ethnicity unknown) received a needlestick while emptying a garage can 2 weeks after her last dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On 07-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot # 937231, expiration date 30 Jan 2023, NDC # and route unknown) in the left deltoid.   On 25-May-2022, 49 days after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).   On an unspecified date in Jun-2022, approximately 2 weeks after the last dose of HEPLISAV-B, while emptying the garbage can, the patient received a needlestick.  The patient did not report any adverse effects.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and Having Welts; Itching and Having Welts; Initial Report Received on 08-Jun-2022  A registered nurse reported that male patient (age, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and experienced itching and welts all over his body afterwards.  No medical history at the time of vaccination was reported.   Concomitant medications at the time of vaccination were reported as unknown.  On an unspecified date, the patient received a dose of HEPLISAV-B (Lot # 935848, expiration date 02-Dec-2022, serial # 758765222631, NDC #, route, and injection site unknown).   On 06-Jun-2022, the patient complained of itching and having welts all over his body "after receiving vaccination".   No additional information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: TYP
Symptoms: Malaise, Product storage error
Clinical narrative: Feeling sick; Stored Vivotif incorrectly at room temperature for about 4 days; A spontaneous report was received from a pharmacist on 05AUG2022. It described a female patient (unknown age) who "stored Vivotif incorrectly at room temperature for about 4 days" (PT: Product storage error) and was "feeling sick" (PT: Malaise). The patient received the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient stored the Vivotif incorrectly at room temperature for about 4 days, then took the first and second dose of Vivotif on an unknown date. Reportedly, she was feeling sick after taking Vivotif. The outcome of the reported events was unknown.  Action taken with Vivotif with respect to "stored Vivotif incorrectly at room temperature for about 4 days" was not applicable and with the event of "feeling sick" was unknown.  Reportedly the reporter did not have any additional information.  Company comment: A consumer stored Vivotif incorrectly at room temperature for about 4 days (product storage error) and was feeling sick (malaise). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of malaise is assessed as possible. Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer stored Vivotif incorrectly at room temperature for about 4 days (product storage error) and was feeling sick (malaise). Further information regarding the events is limited. Considering the case information, the role of Vivotif cannot be ruled out and the causality of malaise is assessed as possible. Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error. The case is considered non- serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Incomplete course of vaccination, Malaise, Rash
Clinical narrative: Very sick; Horrible rash all over; Took one dose of Vivotif and stopped taking remaining doses; A spontaneous report was received from a nurse on 11AUG2022. It described a male patient (unknown age) who was "very sick" (PT: Illness) and developed a "horrible rash all over" (PT: Rash) following the administration of Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. Reportedly, the patient "took one dose of Vivotif and stopped taking remaining doses" (PT: Incomplete course of vaccination). It was reported that the patient took only one dose of Vivotif and felt very sick and had a horrible rash all over. Reportedly, the rash was so bad that his doctor recommended him to take oral steroids for the next three weeks. Additionally, it was confirmed that the patient was not going to take any more doses of Vivotif. Furthermore, it was stated that the patient never had any reaction to the typhoid vaccine. The outcome of the reported events was unknown.  Action taken with Vivotif with respect to the events "very sick" and "horrible rash all over" was vaccine withdrawn and for the event "took one dose of Vivotif and stopped taking remaining doses" it was not applicable.  No additional information was reported.  Company comment: A patient became very sick (illness) and developed a horrible rash all over (rash) following the administration of first dose of Vivotif. The patient took one dose of Vivotif and stopped taking remaining doses (incomplete course of vaccination). Further information regarding the events is limited. Considering a temporal association, the causality of illness and rash is assessed as possible with Vivotif. The causality of incomplete course of vaccination is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A patient became very sick (illness) and developed a horrible rash all over (rash) following the administration of first dose of Vivotif. The patient took one dose of Vivotif and stopped taking remaining doses (incomplete course of vaccination). Further information regarding the events is limited. Considering a temporal association, the causality of illness and rash is assessed as possible with Vivotif. The causality of incomplete course of vaccination is assessed as not applicable with Vivotif. The case is considered non-serious as per medical assessment.
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Consecutively took first and second dose of Vivotif on 1st and 2nd day; A spontaneous report was received from nurse on 12AUG2022. It described a male patient of unknown age who "consecutively took first and second dose of Vivotif on 1st and 2nd day" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient did not follow the recommended schedule to take Vivotif and consecutively took the first and second dose on first and the second day respectively.  Action taken with Vivotif with respect to the reported event was not applicable.  The outcome of the reported event was unknown.  No additional information was reported.  Company comment: It was reported that a patient consecutively took first and second dose of Vivotif on 1st and 2nd day (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a patient consecutively took first and second dose of Vivotif on 1st and 2nd day (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event.
Sex: M
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: Missed the third dose of the Vivotif on day 5; A spontaneous report was received from a caregiver on 16AUG2022. It described a male patient of unknown age who "missed the third dose of the Vivotif on day 5" (PT: Product dose omission issue). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunization. It was reported that the patient took the first dose of Vivotif on 12AUG2022. He missed the third dose of the Vivotif on day 5 as he forgot to take the drug this morning (at the time of the report) on empty stomach, he ate something. Now, two doses are left. Reportedly, the patient neither had any concurrent disease nor taking any medication. The patient had not undergone any kind of surgery in the past. The outcome of the reported event was not applicable.  Additionally, it was reported that the patient had no difficulty while having the vaccine.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer missed the third dose of Vivotif on day 5 (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer missed the third dose of Vivotif on day 5 (product dose omission issue). Vivotif dose should be taken every other day, and the causality of product dose omission issue is not applicable to Vivotif considering the nature of the event. The case is considered non-serious as per medical assessment.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles after her shingles shot/suspected vaccination failure; got shingles after her shingles shot.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comment: This case was reported by the patient's child via interactive digital media. The reporter stated that the patient got shingles a month after her Shingles shot, so the shot was pointless for her. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary immunization and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles vx ,I have a break out at least once a month/ suspected vaccination failure; Break out at least once a month, just a small patch; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 52-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had this since patient was 20 years age).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that he/she just found out that he/she had to have the Shingles vaccine again. The patient had a breakout at least once a month luckily it was just a small patch, but it sits directly on the patient's butt bone. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: have had the Shingrix shot and have shingles/ Suspected vaccination failure; currently have shingles; The pain is not for the faint of heart; The itching is not for the faint of heart; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGLES VACCINE (RECOMBINANT NON-LIVE)) for prophylaxis.   On an unknown date, the patient received Shingrix, Shingrix and SHINGLES VACCINE (RECOMBINANT NON-LIVE). In July 2022, unknown after receiving Shingrix, Shingrix and SHINGLES VACCINE (RECOMBINANT NON-LIVE), the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 12-Aug-2022 Reporter's Comments: The patient self reported the case via via interactive digital media. The patient currently had shingles. The patient had the Shingrix shot and the booster and the shingles vaccine prior to Shingrix. The pain and itching was not for the faint of heart. It had been 2 weeks then. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: HAD THE SHOTS GOT SCHINGLES ANAWAY/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received shots of Shingles vaccine and experienced shingles. The patient had shingles at the time of reporting. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Discomfort, Feeling abnormal, Herpes zoster, Neuralgia, Pain
Clinical narrative: Suspected vaccination failure; Still got the Shingles; Nerve pain; itching; Discomfort of Shingles; eased the pain; they about drove me nuts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia, pruritus, discomfort, pain and feeling abnormal. On an unknown date, the outcome of the vaccination failure, post herpetic neuralgia, pruritus, discomfort and feeling abnormal were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pruritus, discomfort, pain and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: This case was reported by a patient via   interactive digital media. The patient received the Shingles vaccine but still got the Shingle and they were a milder case. But the patient was just thankful that it was not any worse. Shingles had about drove patient's nuts. The patient experienced nerve pain and itching.  The patient had heard that pomifera healing oil would help with the discomfort of Shingles so patient ordered some and was amazed at how it helped.  The patient would rubbed it on shingles and it eased the pain.  The patient had recommended it to several and they said it worked for them. Follow-up would not possible, as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia, Pruritus, Vaccination failure
Clinical narrative: Suspected vaccination failure; Still got the Shingles; Nerve pain; itching; Discomfort of Shingles; eased the pain; they about drove me nuts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, post herpetic neuralgia, pruritus, discomfort, pain and feeling abnormal. On an unknown date, the outcome of the vaccination failure, post herpetic neuralgia, pruritus, discomfort and feeling abnormal were unknown and the outcome of the shingles was not recovered/not resolved and the outcome of the pain was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, post herpetic neuralgia, pruritus, discomfort, pain and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's comment: This case was reported by a patient via   interactive digital media. The patient received the Shingles vaccine but still got the Shingle and they were a milder case. But the patient was just thankful that it was not any worse. Shingles had about drove patient's nuts. The patient experienced nerve pain and itching.  The patient had heard that pomifera healing oil would help with the discomfort of Shingles so patient ordered some and was amazed at how it helped.  The patient would rubbed it on shingles and it eased the pain.  The patient had recommended it to several and they said it worked for them. Follow-up would not possible, as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: COVID-19, Herpes zoster, Vaccination failure
Clinical narrative: Had both vaccines/got both illnesses anyways/Suspected vaccination failure; got both illnesses anyways; got both illnesses anyways; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and covid-19. On an unknown date, the outcome of the vaccination failure, shingles and covid-19 were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient stated works about as well as the COVID vaccine.  The patient had both vaccines, got both illnesses anyways.  The patient stated that it was all a scam. It was unknown if the reporter considered the shingles and covid-19 to be related to COVID VACCINE.    Additional Supportive Information:This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming the targeted event were unknown at the time of reporting. The follow-up would not be possible as no contact details were available. In worst approach, the case was kept valid for events Suspected vaccination failure, shingles and covid-19 considering that the patient was reporting about target disease.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: had the vaccine and I've had the shingles twice/Suspected vaccination failure; had the shingles twice; only itching; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient had the Shingles vaccine and experienced shingles twice since, but very light cases and only itching not pain. The doctor told to the patient it was because of already having the vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the 2 shots, have had them 3 times since/Suspected vaccination failure; had them 3 times worse than before the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had them 3 times since, and they were far worse than before the shot).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 14-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient stated that right there with you all. The patient finally got the 2 shots, and was told he/she most likely would never had shingles again, well. The patient have had them 3 times since, and they were far worse than before the shot. The patient stated that he/she could not win. The patient stated good luck all. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test and time to onset, confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Pruritus, Swelling
Clinical narrative: swelling; itching; burning; This case was reported by a consumer via interactive digital media and described the occurrence of swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced swelling, pruritus and burning sensation. On an unknown date, the outcome of the swelling, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the swelling, pruritus and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's Comment: The patient self-reported this case via  interactive digital media. The patient took both the shingles shot and experienced reactions swelling, itching and burning. No shingles. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR118563:Case deleted
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Still in pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1 shot vaccine dose received 15 years ago.).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. The patient was treated with analgesic, nos (Pain Pills (Nos)). On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received Shingles vaccine and had pain. The physician put patient on 3 pain pills and patient still in a lot of pain. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Rash macular
Clinical narrative: Diarrhea; Big red blotch on arm; This case was reported by a consumer via other manufacturer and described the occurrence of diarrhea in a 78-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced diarrhea and red blotches. On an unknown date, the outcome of the diarrhea and red blotches were unknown.   It was unknown if the reporter considered the diarrhea and red blotches to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: The patient had diarrhea and big red blotch on arm.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling surrounding injection site; Erythma surrounding injection site; This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: The patient had symptoms which were centered around the injection site and started less than 24 hours after vaccination.  The patient had swelling and erythema surrounding injection site.
Sex: U
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: getting genital herpes after the vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of genital herpes in a 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 genital herpes. On an unknown date, the outcome of the genital herpes was unknown.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked was there a risk of getting genital herpes after getting the Shingrix vaccine it happened to him/her for the for the first time. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Dermatitis contact, Rash
Clinical narrative: I have a rash going now; Poison oak; has been a year since my 1st shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced rash, poison oak rash and incomplete course of vaccination. On an unknown date, the outcome of the rash and poison oak rash were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash and poison oak rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022  Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that received 1st shingles shot year ago.  The reporter wanted to know what will happened if he/she go for the second dose. The patient had rash going now but he/she was not sure if it was poison Oak. The follow-up could not be possible as no contact details were available. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 01-Aug-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got both the doses and just had a sore arm. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR119493:case deletion
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Skin lesion
Clinical narrative: severe allergic reaction; permanent damage to the veins in my legs; This case was reported by a consumer and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced allergic reaction and skin lesion. On an unknown date, the outcome of the allergic reaction was unknown and the outcome of the skin lesion was not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction and skin lesion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's comment: The case was self-reported by the patient. The patient received a dose of Shingles vaccine and experienced severe allergic reaction and reported last year (the day before the reporting). The patient asked what other steps were available. The patient just received the email where the Shingles vaccine was not a covered vaccine for reimbursement. The patient now had permanent damage to the veins in legs due to the change in the second vaccine. The patient asked advised what he/she was supposed to do.
Sex: U
Vaccine: HEPAB
Symptoms: Product storage error
Clinical narrative: temperature excursion; This case was reported by a pharmacist via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-Aug-2022 Reporter's comment: There was no transfer to medical information which was required. The report was not related to a study or program.  The other conditions was not provided. The investigations was not provided.  The Twinrix was not a Pfizer product.  The Twinrix manufacturer was GlaxoSmithKline. The national drug code number of Twinrix was not provided.  The reason for no lot number of Twinrix was not probed over the call. The expiry date of Twinrix was not provided.  The other products was not provided. The caller stated that he was calling from a pharmacy.  He asked if Twinrix was a Pfizer product, Twinrix was the Hepatitis A and B vaccine.  It was in regards to a temperature excursion.  The caller then stated that he just searched and that the manufacture was GlaxoSmithKline. The caller stated that he would call them.  There was no further information provided.  The call was ended. The reporter did not consent to follow-up.Additional Supportive Information: The patient received Twinrix vaccine which had a temperature excursion, which led to incorrect storage of vaccine.