chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Pollakiuria, Pyrexia, Vaccine positive rechallenge
Clinical narrative: upset stomach; severe lower left abdominal pain; increase urination; fever; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal discomfort (1st dose received on 4th March 2022, for tolerance refer case US2022AMR105297).   On 10th July 2022, the patient received the 2nd dose of Shingrix (intramuscular). In July 2022, 8 hrs after receiving Shingrix, the patient experienced upset stomach, abdominal pain, increased urinary frequency and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the upset stomach, abdominal pain, increased urinary frequency and fever were recovered/resolved.   It was unknown if the reporter considered the upset stomach, abdominal pain, increased urinary frequency and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 11th July 2022 Reporter's Comments: This case was reported by the patient. The patient received Shingrix in arm. The patient had exactly the same adverse effect after receiving the both Shingrix vaccine. About 8 hours after receiving the vaccines, the patient had an upset stomach, severe lower left abdominal pain and fever. The symptoms resolved by morning. The patient had increased urination about 10 hours after both doses and that also resolved by morning. The reporter did not consent to follow up. Additional supportive information The time to onset date for event upset stomach, abdominal pain, urine volume increased and fever as per event onset date and product start date was 1 day, however as per case narrative time to onset for upset stomach, abdominal pain, fever was 8 hours and urine volume increased was 10 hours.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105297:Same case
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Paraesthesia, Tongue discomfort
Clinical narrative: excessive swelling  injection site; tingling of whole body; Felt tongue was on fire.; This case was reported by a other health professional via sales rep and described the occurrence of injection site swelling in a female 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 a day after receiving Shingrix, the patient experienced injection site swelling, tingling and burning tongue. On an unknown date, the outcome of the injection site swelling, tingling and burning tongue were unknown.   It was unknown if the reporter considered the injection site swelling, tingling and burning tongue to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's comments: The patient woke up at night after dose of Shingrix. She had excessive swelling at site of injection, tingling of whole body and felt like tongue was on fire. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: took the first one and got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (more than once), rash (for the first time had a very mild) and nerve pain (lasted for 6 months).   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 sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient could only wear pants with a stretch waistline.  The second and third time it was very mild and short lived.  There were better antiviral medicines available.  The patient endured second and third case after vaccination, but patient was later informed that particular vaccine at that time was only 35 percentage effective, so patient needed to get the newer 2 shot preventative.  The patient took the first one and got so sick, so patient was never boostered.  The patient had kept the fingers crossed now.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   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 allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 9-July-2022 Reporter's comment:  This case was reported by a patient via Interactive digital media . The reporter stated that it was the worst things you would ever have. The patient had shingles and after the patient got over them, he or she took the first shot. The patient had an allergic reaction. The patient's doctor gave him/her medicine to take before he/she take the second one to keep from having a reaction. The reporter said that he/she rather had the reaction than the shingles.
Sex: M
Vaccine: MEN
Symptoms: Localised oedema, Migraine
Clinical narrative: Migraines; Ball of fluid where neck and skull met; This case was reported by a consumer via interactive digital media and described the occurrence of migraine in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, more than 2 years after receiving Meningococcal B vaccine, the patient experienced migraine and localized edema. On an unknown date, the outcome of the migraine was not recovered/not resolved and the outcome of the localized edema was unknown.   It was unknown if the reporter considered the migraine and localized edema to be related to Meningococcal B vaccine.     Additional Information: GSK receipt date :10 July 2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received Meningitis B vaccine  2.5 years ago had to get this for college.The consumer stated that patient had migraines for 6 months and  straight and a huge baseball sized ball of fluid where is neck and Skull met. He missed over a month of school. The patient still had migraines. Reporter warn anyone to know to not get this vaccine. Additional Supportive information: Follow up would not be possible since no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient got his/her 2 Shingles shots 2 months apart and his/her arm was sore for 3 days. The patient did not know needed 2 Shingles shot but it was over and done. The patient said his/her pneumonia shot in September (year unspecified). Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in an unknown number of patients 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 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 Shingrix.     Additional Information: GSK Receipt Date: 12-JUL-2022 Reporter's Comments:  The pharmacist mentioned patients experience a sore arm following a dose of Shingrix. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had Shingrix 4 yrs ago, scheduled for another; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years ago from reporting).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13th July 2022 Reporter's Comments: The patient self-reported this case. The patient's doctor's office could not get more (2nd dose) in the next 6 months. Now she was scheduled for another Shingrix vaccine. The patient asked did she need to start over and get two doses or just get one. The patient's physician said 1 dose and the pharmacist said to start again and have 2 doses and patient stated she would go with physician and the disease control and ignore the pharmacist even though she know him and he's going to be not nice about this. Reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19, UNK, VARZOS
Symptoms: Arthralgia, Back pain, Facial pain, Headache, Migraine
Clinical narrative: bad joint pain in hip, knee; pain in lower back; headache; new chronic migraines; concentrated pain above right eye; This case was reported by a pharmacist via other manufacturer and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included lenvatinib mesilate (Lenvima) unknown (batch number 11111111, expiry date unknown) for thyroid neoplasm and TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   The patient's past medical history included chronic migraine and hand and foot syndrome.   On an unknown date, the patient received Shingles vaccine. On 29th March 2022, the patient started Lenvima (oral) 20 mg at an unknown frequency. On an unknown date, the patient received COVID-19 VACCINE PFIZER. On 20th June 2022, less than 4 months after receiving Shingles vaccine, the patient experienced headache, chronic migraine and facial pain. On an unknown date, the patient experienced joint pain and low back pain. The patient was treated with paracetamol (Tylenol) and excedrin (nos) (Excedrin). The action taken with Lenvima was unknown. On 24th June 2022, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chronic migraine was recovered/resolved and the outcome of the facial pain, joint pain and low back pain were unknown.   It was unknown if the reporter considered the headache, chronic migraine, facial pain, joint pain and low back pain to be related to Shingles vaccine.      Additional Information: receipt date :12 July 2022 Reporters comment: The patient indicated they have been experiencing new chronic migraines that last for days after adjusting her dosing schedule of Lenvima. The patient indicated that about 6-8 weeks ago the patients specialist took patient off Lenvima for 3 weeks after she was recovering from hand and foot syndrome. After restarting the medication the specialist instructed the patient to take medication for 3 weeks on 1 week off. The patient advised that when starting back on the medication she had headache that lasted the entire week Monday through Friday with concentrated pain above right eye. The patient indicated no relief with Tylenol and Excedrin but the headache got better and went away by the end of the week. The patient also indicated she had been experiencing bad joint pain in hip, knee, and lower back while taking Lenvima and patient indicated these symptoms only began shortly after patient received Pfizer Covid 19 vaccinations and shingles vaccination. It was unknown if the reporter considered the headache, chronic migraine, eye pain, joint pain and low back pain to be related to COVID-19 VACCINE PFIZER and Lenvima. The patient stated that no relief with Tylenol and Excedrin but the headache got better and went away by the end of that week The patients prescriber was aware of all the patients side effects.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient inadvertently given 3rd dose; This case was reported by a nurse via sales rep and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 2 doses of Shingrix on an unknown date).   In June 2022, the patient received the 3rd dose of Shingrix. In June 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 13-Jul-2022 Reporter's comment: The nurse manager reported that the patient received 3 doses of Shingrix. The patient got the 3rd dose about a month ago. There were no side effects but should not have received a third dose. No further details provided on voicemail.  The reporter consented to follow up.  Additional supportive information: The patient received the 3rd dose of Shingrix, which led to extra dose administered. The case US2022106699 was identified as duplicate of case US2022AMR106530. All future correspondence would be added in case US2022AMR106530, which stands as case of record for this patient and the case US2022106699 would be deleted. As per the intake response, considering this case as valid with extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: headache; fever; severe body aches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2022 08:33, the patient received Shingrix. In July 2022, less than a day after receiving Shingrix, the patient experienced headache, fever and general body pain. On an unknown date, the outcome of the headache, fever and general body pain were unknown.   It was unknown if the reporter considered the headache, fever and general body pain to be related to Shingrix.     Additional Information: GSK receipt date :13 July 2022 Reporters comment: This case was reported by a patient via interactive digital media. The patient received shingrix vaccine the day before reporting in the afternoon and had  fever headache and severe body ache .
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix expired dose administration; This case was reported by a pharmacist via patient support programs and described the occurrence of expired vaccine used in a 65-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 14th July 2022, the patient received the 2nd dose of Havrix 1 dosage form(s). On 14th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-Jul-2022 Reporters comment: The patient received an expired dose of the Havrix vaccine on left deltoid. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Havrix vaccine, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: given sq instead of IM; This case was reported by a other health professional via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comments; This case was reported by a other health professional via interactive digital media. The patient received Shingrix via subcutaneous route instead of intramuscular route.  The reporter also asked that what should I feel the patient to expected as far as side effects were concerned. Additional supportive information: The patient received Shingrix via subcutaneous route instead of intramuscular route, which led to Intramuscular formulation administered by other route. Follow-up would not possible, as no contact, details were available.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Throat tightness
Clinical narrative: Within 20 minutes patient's throat was closing up; This case was reported by a physician via sales rep and described the occurrence of throat constriction in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date February 2023) for prophylaxis.   On 13th July 2022, the patient received Menveo. On 13th July 2022, less than an hour after receiving Menveo, the patient experienced throat constriction. The patient was treated with prednisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the throat constriction was recovered/resolved.   It was unknown if the reporter considered the throat constriction to be related to Menveo.     Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's comment: The patient was given Menveo in Doctor office and then within 20 minutes patient's throat was closing up.  It was then after hours so the patient went to urgent care, and was given prednisone and Benadryl.  As per the Doctor the patient was ok as of now.  Doctor originally was seeing patient for well visit when Menveo was given.  The patient originally was healthy with no other symptoms. Menveo was only vaccine given.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: received on 07/13/2022, expired on 06/30/2022; This case was reported by a nurse via patient support programs and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA571A, expiry date 30th June 2022) for prophylaxis.   On 13th July 2022, the patient received Menveo. On 13th July 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Linked case(s) involving the same patient:  US2022107247   Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's Comment: Nurse reported that the patient had received an expired dose of Menveo. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Menveo vaccine which was already expired in 30th June 2022, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022107247:FU1 - Deleted
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: A bit dizzy; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received Shingles vaccine. In July 2022, less than a day after receiving Shingles vaccine, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comments: This case was reported by a patient via interactive digital media. The patient recently had 2nd dose of Shingles vaccine few hours ago from reporting and felt a bit dizzy. The reporter had also asked if this could be a side effect. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Had 1st dose on  2020,  need to repeat  or just get 2nd?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comment: The patient reported this case via interactive digital media. The patient asked did he/she need to repeat 1st dose or could he/she just get 2nd dose now. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Myalgia, Pain
Clinical narrative: Feel achy; Mucle aches; Chills; Headache; Diarrhea; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2022 08:30, the patient received Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced pain, muscle pain, chills, headache and diarrhea. On an unknown date, the outcome of the pain, muscle pain, chills, headache and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the pain, muscle pain, chills, headache and diarrhea to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUL-2022 Reporter's comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix yesterday (day before reporting) at 8:30 and felt achy, muscle aches, chills, headache and diarrhea.  The patient asked that how long this would take to go away. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness
Clinical narrative: stiff neck; This case was reported by a consumer via interactive digital media and described the occurrence of stiff neck 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 stiff neck. On an unknown date, the outcome of the stiff neck was unknown.   It was unknown if the reporter considered the stiff neck to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient asked that was stiff neck a side effect. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: received the 1st dose in 2021 and did not get the 2nd due to COVID; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that he/she did not get the second shot because of Covid. The patient asked that did he/she need to restart the series. Additional supportive information: The patient did not get the second shot of Shingrix because of Covid, which led to Social problem. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: More than 6 months since 1st shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received in October (year unspecified)).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. It had been more than 6 months after 1st dose. The patient asked how that affected his/her second shot. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Neck pain, Pain in extremity, Rash erythematous
Clinical narrative: Red rash, looks like ox; Sore arm; Sore neck; Sore upper quarter back; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash, pain in arm, neck pain and back pain. On an unknown date, the outcome of the red rash, pain in arm, neck pain and back pain were unknown.   It was unknown if the reporter considered the red rash, pain in arm, neck pain and back pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-JUL-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced a red rash an what looked like a few ox. The patient also experienced a sore arm, neck and upper quarter back. The patient asked was that usual. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEP, HEP, HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: had a three dose, no longer have antibodies; This case was reported by a consumer via call center representative and described the occurrence of therapy non-responder in a 35-year-old patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 2nd dose of Hepatitis B vaccine and the 1st dose of Hepatitis B vaccine. On an unknown date, more than 2 years after receiving Hepatitis B vaccine, Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   Additional Information: GSK receipt date: 15-JUL-2022 Reporter's comment:  The patient had a three dose Hepatitis B vaccine back in 2001. The patient age was 35 years now and stated that it had been 21 years since they took the original vaccination. The patient had recently been tested negative for Hepatitis (Hep) B but that was uncovered that they know longer had the antibodies of that vaccine and they had need another Hepatitis (Hep) B vaccine. The patient received one dose of the Engerix vaccine for Hepatitis B yesterday (day before reporting). The patient also reported that there seemed to be a lot of confusion in the doctor's office about how many doses the patient was supposed to received. The doctor went back and forth asking each other. The doctor in their office had chatted and they had determined if the patient should only need the one dose and that it was not a three-dose regimen. The patient seeks confirmation if this was correct. The patient wanted to make sure that he/she were properly covered.  The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vax on 09/03/20, too much time elapsed for 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd September 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-Jul-2022 Reporter's comment: The patient received 1st dose of Shingrix vaccine and had too much time elapsed for him/her to get his/her 2nd dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 4 years later, 2nd not received; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked that the 1st dose of Shingrix was still valid 4 years later. The patient asked that he/she could get the 2nd vaccine. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 3 years ago, never got 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient never got the 2nd dose of Shingrix. The patient asked that he/she have to start the dosing schedule again. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shngrix, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 3 years ago, never got 2nd; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose 3 years ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Jul-2022 Reporter's comment: The patient never got the 2nd dose of Shingrix and asked that he/she had to start the dosing schedule again. The patient also asked that what should a patient do if their 2nd dose of Shingrix was later than six months after receiving the 1st dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I'm having fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever 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 fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient asked could he/she take Tylenol after the Shingles vaccine shot because patient was having fever. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: given by injection instead of orally; This case was reported by a physician via other manufacturer and described the occurrence of inappropriate route of vaccination in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (injection) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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: 20th July 2022 Reporter's Comments:  Reporter stated patient was given Rotarix by injection instead of orally. Additional supportive information: As patient was administered Rotarix by injection instead of oral route, which led to inappropriate route of vaccination. Reporter consented to follow up. This case has been linked with US2015103988 reported by same reporter.; Sender's Comments:  US-GSK-US2015103988:Same reporter
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Headache, Limb discomfort, Pain
Clinical narrative: fever; has red dots on his body; felt awful; discomfort in his arm; headache; body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th July 2022, the patient received Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, skin red, feels awful, arm discomfort, headache and general body pain. On an unknown date, the outcome of the fever, feels awful, arm discomfort, headache and general body pain were unknown and the outcome of the skin red was not recovered/not resolved.   It was unknown if the reporter considered the fever, skin red, feels awful, arm discomfort, headache and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09th July 2022, 11th July 2022 and 14th July 2022 Reporter's Comments: Reporter stated patient had Zoster vaccine and had red dots on body now, not itchy not hives not raised. Patient just got Shingles vaccine Thursday night. Patient felt awful with fever and discomfort in his arm, headache and body aches and now red dots were everywhere. Additional supportive information Reporter consented to follow up.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; has red dots on his body; felt awful; discomfort in his arm; headache; body aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th July 2022, the patient received Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced fever, skin red, feels awful, arm discomfort, headache and general body pain. On an unknown date, the outcome of the fever, feels awful, arm discomfort, headache and general body pain were unknown and the outcome of the skin red was not recovered/not resolved.   It was unknown if the reporter considered the fever, skin red, feels awful, arm discomfort, headache and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 09th July 2022, 11th July 2022 and 14th July 2022 Reporter's Comments: Reporter stated patient had Zoster vaccine and had red dots on body now, not itchy not hives not raised. Patient just got Shingles vaccine Thursday night. Patient felt awful with fever and discomfort in his arm, headache and body aches and now red dots were everywhere. Additional supportive information Reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain, Pollakiuria, Pyrexia
Clinical narrative: Upset stomach; severe lower left abdominal pain; Fever; increase urination; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd April 2022, the patient received the 1st dose of Shingrix (intramuscular). In April 2022, 8 hrs after receiving Shingrix, the patient experienced upset stomach, abdominal pain, fever and urinary frequency. On an unknown date, the outcome of the upset stomach, abdominal pain, fever and urinary frequency were recovered/resolved.   It was unknown if the reporter considered the upset stomach, abdominal pain, fever and urinary frequency to be related to Shingrix.     Linked case(s) involving the same patient:  US2022104933   Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comments:  This case was reported by the patient.  The patient received Shingrix in unknown arm.  About 8 hours after receiving the vaccines, the patient had an upset stomach, severe lower left abdominal pain and fever. The symptoms resolved by morning. The patient had increased urination about 10 hours after both doses and that also resolved by morning. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022104933:Same case
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: swelling and redness at the injection site; swelling and redness at the injection site; Nausea; overall flu-like symptoms; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 16-year-old male 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, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site swelling, injection site erythema, nausea and flu like symptoms. On an unknown date, the outcome of the injection site swelling, injection site erythema, nausea and flu like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema, nausea and flu like symptoms 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: 05-JUL-2022 Reporter's comment: The duration for events injection site swelling, injection site erythema, nausea and influenza like illness was reported as 3 days. Patient experienced swelling and redness at the injection site, nausea, and overall flu-like symptoms. Also reported all symptoms lasted approximately 3 days. The consent to follow up was given.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Herpes zoster, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Still (on and off) has Pain at the injection site and it is itchy and burns sometimes; Still (on and off) has Pain at the injection site and it is itchy and burns sometimes; Below injection site has red rash; GI symptoms (Abdominal pain) since getting the shot; Like a mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a elderly female 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 9 months after receiving Shingrix, the patient experienced injection site itching, injection site burning, red rash, abdominal pain and shingles. On an unknown date, the outcome of the injection site itching, injection site burning, red rash, abdominal pain and shingles were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site burning, red rash, abdominal pain and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's comment: The patient received the vaccine late October- early November, but did not remembered exact date.  The patient received Shingrix vaccine in right arm. Patient still had (on and off) pain at the injection site and it was itchy and burned sometimes.  Below injection site, the patient had a red rash like a mild case of shingles.  The patient had gastrointestinal symptoms (abdominal pain) since getting the shot.   The consent to follow up was given.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Still (on and off) has Pain at the injection site and it is itchy and burns sometimes; Still (on and off) has Pain at the injection site and it is itchy and burns sometimes; Below injection site has red rash; GI symptoms (Abdominal pain) since getting the shot; Like a mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a elderly female 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 9 months after receiving Shingrix, the patient experienced injection site itching, injection site burning, red rash, abdominal pain and shingles. On an unknown date, the outcome of the injection site itching, injection site burning, red rash, abdominal pain and shingles were not recovered/not resolved.   It was unknown if the reporter considered the injection site itching, injection site burning, red rash, abdominal pain and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's comment: The patient received the vaccine late October- early November, but did not remembered exact date.  The patient received Shingrix vaccine in right arm. Patient still had (on and off) pain at the injection site and it was itchy and burned sometimes.  Below injection site, the patient had a red rash like a mild case of shingles.  The patient had gastrointestinal symptoms (abdominal pain) since getting the shot.   The consent to follow up was given.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Restless legs syndrome
Clinical narrative: Condition aggravated; Flare up of RLS; This case was reported by a consumer via call center representative and described the occurrence of restless legs syndrome in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 42CM4, expiry date 11th June 2023) for prophylaxis.   Concurrent medical conditions included restless legs syndrome. Concomitant products included ropinirole hydrochloride (Requip), methadone and trazodone.   On 22nd March 2022, the patient received the 1st dose of Shingrix. On 22nd March 2022, less than a day after receiving Shingrix, the patient experienced restless legs syndrome. On an unknown date, the patient experienced condition aggravated. On an unknown date, the outcome of the restless legs syndrome was unknown and the outcome of the condition aggravated was recovering/resolving.   It was unknown if the reporter considered the restless legs syndrome and condition aggravated to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-Jul-2022 Reporter's comment: The patient received first dose of Shingrix vaccine in left deltoid.  After beginning the first dose of Shingrix, at night, patient experienced a flare up of restless legs syndrome, which did not calm down for 1 week.  More medicine was added to her medication protocol for restless legs syndrome when the flare up began.   Patient symptoms had improved. The consent to follow up was given. Patient gave consent to follow up with HCP.