chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Weakness in arm; This case was reported by a physician via sales rep and described the occurrence of weakness of arms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weakness of arms. On an unknown date, the outcome of the weakness of arms was unknown.   It was unknown if the reporter considered the weakness of arms to be related to Shingrix.     Additional Information: GSK receipt date: 17-Aug-2022 Reporter's comments: The reporter was a GSK staff employee. During a population based decision maker meeting and during a discussion of Shingrix, one of the medical directors or consultants shared that patient had a reaction after first dose of Shingrix injection. The patient experienced weakness in arm.  The patient delayed the second injection of the 2 dose series in hopes that arm weakness would abated.  The medical directors or consultants did not pursue the line of questioning further since this was during a formal meeting with multiple attendees. The reporter agrees to follow up from GlaxoSmithKline.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on face and neck; This case was reported by a nurse via sales rep and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the patient received 1st dose on 29th November 2021) and COVID 19 VACCINE PFIZER (received on 8th December 2021).   On 25th March 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced rash. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Aug-2022 Reporter's Comments: The reporter stated that the patient was seen by physician on 20th June 2022 for rash that the patient had on and off for 2 to 3 months, rash presented on face and neck. The reporter mentioned rash had been treated with steroids and steroid shot. Rash goes away and then comes when in the sun or it was triggered by heat. The reporter gave consent to follow up.; Sender's Comments:  US-GSK-US2022AMR120093:Same reporter, same patient
Age: 11.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero administered instead of HPV; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 11-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, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: The mother of the patient reported that the patient was given a dose of Bexsero instead of HPV at 11 years old. The reporter did not realize until she was reviewing her vaccine records. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Bexsero instead of HPV, which led to wrong vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pain, Peripheral swelling
Clinical narrative: Arm really red; Arm swollen; Arm hot; Aches, pains; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 erythema of extremities, swelling arm, extremities hot feeling of and pain. On an unknown date, the outcome of the erythema of extremities, swelling arm and extremities hot feeling of were recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, extremities hot feeling of and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR120549   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: The patient reported this case via interactive digital media. The patient stated that his/her first shot was very bad. The patient's arm really red, swollen and hot for weeks. The patient also experienced aches and pains. Additional supportive information: The follow-up would not possible as no contact details were available. For tolerance of 2nd dose refer case US2022AMR120549, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR120549:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: I had shingles twice on my face Very painful; They are so painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR120535   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient developed shingles twice on face and it was very painful. The first episode was on left side of face about 12 years ago and second episode on right side of face 4 years ago. The patient received first shingle shot before the first episode, then another shingles shot 4 years later. The patient already received two injections of the new shingles medication and hopefully it would not get them again. They (Shingles) were so painful.  Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR120535, reported by same patient. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR120535:Same patient, other dose
Sex: U
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: Arm is still swollen; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it 6 times).   In July 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced swelling arm. Shingles vaccine was discontinued. On an unknown date, the outcome of the swelling arm was not recovered/not resolved.   The reporter considered the swelling arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter was a consumer who stated that they had it 6 times and got the 1st dose of vaccination 6 week ago. The reporter had stated that their arm is still swollen and they had a bad reaction to it and stated that if they should not to get the second one. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain, Facial pain, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: They are so painful, shooting pains (like electric); forehead, including me eye and cheek since getting the shingles; forehead, including me eye and cheek since getting the shingles; forehead, including me eye and cheek since getting the shingles; another shingles shot 4 years later; 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.   The patient's past medical history included shingles (left side of face about 12 years ago, then on right side of face 4 years ago). Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1st dose received on an unknown date, for tolerance refer case US2022AMR120528).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, forehead headache, eye pain, facial pain and drug dose administration interval too long. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain, forehead headache, eye pain and facial pain were not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the pain, forehead headache, eye pain and facial pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR120528   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient developed shingles twice on face and it was very painful. The first episode was on left side of face about 12 years ago and second episode on right side of face 4 years ago. The patient received first shingle shot before the first episode, then another shingles shot 4 years later. The patient already received two injections of the new shingles medication and hopefully it would not get them again. They are so painful.  The patient experienced shooting pains (like electric) from forehead including eye and cheek after the shingles. Follow-up would not possible, as no contact details were available. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule  This case had been linked with US2022AMR120528, reported by same patient.; Sender's Comments:  US-GSK-US2022AMR120528:Same patient, other dose
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort
Clinical narrative: Shot tore my arm up; This case was reported by a consumer via interactive digital media and described the occurrence of arm discomfort 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 arm discomfort. On an unknown date, the outcome of the arm discomfort was unknown.   The reporter considered the arm discomfort 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 patient had shot tore his/her arm up. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Varicella
Clinical narrative: I have had chicken pox 3 times; sick for 3 weeks; 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.   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 and chickenpox. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the sickness and chickenpox to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Aug-2022 Reporter's Comments: The patient self-reported the case via via interactive digital media. The patient had the first shot of shingles vaccine and had every side effects and more. He/she was sick for 3 weeks. The patient stated that he/she would not get the second shot. The patient have had chicken pox 3 times and he/she would take chances. Additional Supportive Information: Follow-up could not be possible as no contact details were available. From the narrative it was not clear if the patient had chickenpox before or after vaccination, hence conservatively coded as a event.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling abnormal, Feeling hot, Pain, Peripheral swelling
Clinical narrative: First shot was very bad/ not as bad; Arm really red; Arm swollen; Arm hot; Aches, pains; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of erythema (1st dose received on an unknown date, refer case US2022AMR120491).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad, erythema of extremities, swelling arm, extremities hot feeling of and pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling bad, erythema of extremities, swelling arm, extremities hot feeling of and pain were unknown.   It was unknown if the reporter considered the feeling bad, erythema of extremities, swelling arm, extremities hot feeling of and pain to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR120491   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, his/her Shingles shot was not as bad. The patient's arm really red, swollen and hot. The patient also experienced aches and pains. Additional supportive information: The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR120491:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: First shot was very bad/ not as bad; Arm really red; Arm swollen; Arm hot; Aches, pains; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of erythema (1st dose received on an unknown date, refer case US2022AMR120491).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad, erythema of extremities, swelling arm, extremities hot feeling of and pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling bad, erythema of extremities, swelling arm, extremities hot feeling of and pain were unknown.   It was unknown if the reporter considered the feeling bad, erythema of extremities, swelling arm, extremities hot feeling of and pain to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR120491   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, his/her Shingles shot was not as bad. The patient's arm really red, swollen and hot. The patient also experienced aches and pains. Additional supportive information: The follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR120491:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pain, Paraesthesia
Clinical narrative: I had them/ got shingles on left side; awful painful; tingling; felt like committing Harry Carry; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 shingles, pain, tingling and feeling abnormal. The patient was treated with lidocaine (Lidocaine Patch). On an unknown date, the outcome of the shingles, pain and feeling abnormal were recovering/resolving and the outcome of the tingling was not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, tingling and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine and had worst, it was awhile, and the patient did not had the second one when the patient got shingles on left side it was awful painful felt like committing harry carry went to emergency room several times. In last emergency room visit patient's doctor put a lidocaine patch on patient's side and some went. The patient finally got better but still had some tingling for a while. The patient finally got the shots and stated so he/she did not get again they cost because most insurances did not pay so he/she paid for both around 200 dollar each but it was worth it if he/she never get again. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the liquid portion of menveo; received only the liquid portion of menveo; This case was reported by a nurse and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA673, expiry date March 2023) for prophylaxis.   On 18th July 2022, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 18th July 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The registered nurse reported that the medical assistant vaccinated patient with only the Menveo diluent. The reporter was unaware of the second vial that required reconstitution to provide patient with an effective vaccine dose. On 29th July 2022, the patient was re-vaccinated with properly reconstituted dose of Menveo and tolerated well.   No adverse reaction reported. Additional Supportive Information: The patient received only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with case US2022108245 reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022108245:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Pain in extremity
Clinical narrative: Arm aches; Was like I had the flu for 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 influenza and pain in arm. On an unknown date, the outcome of the influenza and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza and pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR120648   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that the patient received Shingles vaccine. The reporter stated that the patient never had Shingles. The patient received the shot that was not worst ever. The patient had the flu for 24 hours and then the arm aches for a few days. The follow-up could not be possible as no contact details were available. Additional supportive information: For tolerance of 2nd dose refer case US2022AMR120648.; Sender's Comments:  US-GSK-US2022AMR120648:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Pain in extremity
Clinical narrative: arm aches, didn't seem as bad; like I had the flu for 24 hours, didn't seem as bad; This case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of influenza (1st dose received on an unknown date, refer case US2022AMR120647).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the influenza and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza and pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR120647   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient never had Shingle and knock on wood. The patient opted to get the shot. It was one of if not the worst shot patient ever got. It was like patient had the flu for 24 hour and then the arm aches for a few days after that.  The second one did not seem as bad and patient guess because patient was more mentally prepared. Additional supportive information:  The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR120647:Same patient
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: FLUARIX was confused for KINRIX; This case was reported by a physician via other manufacturer and described the occurrence of wrong vaccine administered in a patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   Co-suspect products included flu seasonal tiv dresden pre-filled syringe device (Fluarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix and Fluarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix and Fluarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 Comments: The reporter was Merck field employee, who reported the case on behalf of both lead nurse and physician. The reporter mentioned that, the nurse and physician had stated how Fluarix prefilled syringe was confused for DTAP Kinrix prefilled syringe on unknown, previous date. The reporter unable to confirm if corresponding affected product was administered in place of other corresponding, separate affected product prior to or at the time of reporting. The reporter unable to further clarify these statements at the time of reporting. The reporter had limited information at the time of reporting.  No additional adverse events were reported. No further information provided. Additional Supportive Information: The patient received Fluarix instead of Kinrix, which led to wrong vaccine administered. Note: The case was kept valid conservatively, because it was not clear if affected product was administered to the patient or not.
Age: 1.67
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix in 20 month old; This case was reported by a consumer via sales rep and described the occurrence of inappropriate age at vaccine administration in a 20-month-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number ZL33B, expiry date 25th November 2024) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional Information: GSK Receipt Date: 17-Aug-2022. Reporter's comment: The 20 months old patient received Boostrix. Additional Supportive Information: The 20 months old patient received Boostrix, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose  06Nov2018, 2nd 17aug2022; This case was reported by a pharmacist via interactive digital media and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th November 2018).   On 17th August 2022, the patient received the 2nd dose of Shingrix. On 17th August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The pharmacist reported this case via interactive digital media. The patient received her first dose on 6th November 2018 but never got her second dose. The pharmacist gave the Shingrix shot to the patient on the day of reporting. The reporter asked what should be done after today's (day of reporting) dose or whether she should get another dose in 2-6 months. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt very bad, bad side effects; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles about 30 years ago from reporting).   On 16th August 2022, the patient received Shingles vaccine. On 17th August 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovering/resolving.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-Aug-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient got the Shingles shot on Tuesday and felt very bad the next day and some better on the day of reporting.  The patient asked whether the bad side effects be due to having shingles about 30 years ago. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: The shot made me 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 (Family History) (to sister).   On an unknown date, the patient received 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 recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient reported that he/she received Shingles vaccine because he/she saw how much pain it put to patient's sister through. The Shingles vaccine shot made the patient sick for 24 hours but well worth it.  Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out in shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: This case was reported by a patient's cousin via interactive digital media. The patient broke out in shingles a day after her doctor told her she needed the shingles vaccine.  The reporter stated stay away from it. Additional Supportive Information: Follow-up would not possible as no contact details were available. This case had been linked with US2022AMR121238 and US2022AMR121183, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR121238:Same reporter US-GSK-US2022AMR121183:Same reporter - Invalid case
Sex: U
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Probably broke out after their flu shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: This case was reported by a patient's cousin via interactive digital media. The patient probably broke out after having their flu shot. The reporter advised to stay away from it.  Additional supportive information: Follow-up would not possible, as no contact details were available. The case has been linked with the case US2022AMR121170 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR121170:Same reporter US-GSK-US2022AMR121183:Same reporter - Invalid case
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Fatigue, Pain in extremity
Clinical narrative: arm is very sore; exhausted!; 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.   The patient's past medical history included shingles. Previously administered products included Covid vaccine with an associated reaction of adverse drug reaction.   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 in arm and exhaustion. On an unknown date, the outcome of the pain in arm and exhaustion were unknown.   It was unknown if the reporter considered the pain in arm and exhaustion to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 17-AUG-2022.  Reporter's Comments: This case was reported by patient via interactive digital media. The patient had horrible reaction to this shot, much worse than Covid vaccine. However, Shingles pain was worse than labor so the reaction to the shot was better than that. The patient just got the first dose. The patient's arm was very sore, and he/she was exhausted. The patient had shingles and never wanted it again.  The follow up would not be possible as permission denied.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: horrible rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 17-AUG-2022 Reporter's comments: This case was reported by the patient's spouse via interactive digital media. The patient's spouse took both shots and had no problem whereas the patient took the first shot and in the year 2022 he had a horrible rash.  He went to the physician and he told him not to take the second shot. It had been going on for two months and patient was going to visit the dermatologist.  The reporter said that it was horrible and never thought this would happen and that everyone reacts differently.; Sender's Comments:  US-GSK-US2022AMR121367:Same reporter
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Needle issue, 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 elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th August 2022, the patient received Shingles vaccine. On 17th August 2022, 1 days after receiving Shingles vaccine, the patient experienced pain in arm. On 17th August 2022, 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: 17-AUG-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had the shot day before reporting.  The patient reported that the needle was bad and of course her arm was sore the next day of vaccination but the patient was fine.  It was well worth it.  A couple of years ago the patient saw some one who developed shingles and she remembered he was in agony for a couple of weeks.  That was why the patient took the shot and it would be worth it. Additional supportive information: The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR121378 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR121378:Same reporter
Age: 77.0
Sex: M
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 elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th August 2022, the patient received Shingles vaccine. On 17th August 2022, 1 days after receiving Shingles vaccine, the patient experienced pain in arm. On 17th August 2022, 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: 17-AUG-2022 Reporter's Comments: This case was reported by the patient's wife via interactive digital media. The patient had the shot day before reporting.  The patient's wife reported that the needle was bad and of course his arm was sore the next day of vaccination but the patient was fine. It was well worth it.  A couple of years ago the patient saw some one who developed shingles and she remembered he was in agony for a couple of weeks.  That was why the patient took the shot and it would be worth it. Additional supportive information: The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR121375 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR121375:Same reporter
Age: 89.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm was red for about 4 days; arm was swollen for 4 days; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included neuropathy and celiac disease.   In August 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.     Linked case(s) involving the same patient:  US2022121477   Additional Information: GSK Receipt Date: 19-AUG-2022 Reporter's Comments: The caller was the patient stating that she had the first Shingrix vaccine at the end of August 2021 and her arm was red and swollen for about 4 days. The patient received vaccine in left arm. The patient did not have any further information about the vaccine itself. The reporter consented to follow up. Health care professional for follow up. Additional Supportive Information: In 2021, the patient experienced erythema of extremities and swelling arm. In 2021, events erythema of extremities and swelling arm were recovered. For tolerance of 2nd dose refer linked case US2022121477.; Sender's Comments:  US-GSK-US2022121477:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: 2nd shot hurt going in, and coming out!; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain 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 reporter stated that the second dose was a doosie. The reporter reported that the patient experienced second dose hurt going in and coming out. The reporter stated so hold your breath and hold on to your seat when you get that one shot and do not forget to exercise your arm, right a way as well. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Thought I would never get over it; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient was totally agree that 2nd shot was very disrespectful. The patient thought he/she would never get over it. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: shoulder was slightly sore; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR122462   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 first dose of Shingles vaccine. The patient did not effect at all. The patient experienced shoulder slightly sore for 1 day. Follow-up would not possible, as no contact, details were available. Additional Supportive Information: This case had been linked with US2022AMR122462, reported by same patient.; Sender's Comments:  US-GSK-US2022AMR122462:Second dose case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Vaccine positive rechallenge
Clinical narrative: shoulder was slightly sore; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of arthralgia (For tolerance of 1st dose, refer case US2022AMR122458).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shoulder pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:US2022AMR122458   Additional Information: GSK Receipt Date:13-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that, sorry to hear that happened to you and he/she took the shots for shingle and it did not affect him/her at all might be his/her shoulder was slightly sore for 1 day only. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR122458:First dose case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Somnolence
Clinical narrative: being sleepy; I feel like I've been hit by a truck; This case was reported by a consumer via interactive digital media and described the occurrence of sleepiness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th August 2022, the patient received Shingles vaccine. On 13th August 2022, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the patient experienced sleepiness. On an unknown date, the outcome of the sleepiness and feeling abnormal were unknown.   It was unknown if the reporter considered the sleepiness and feeling abnormal to be related to Shingles vaccine.     Additional Information: GSK receipt date :13-AUG-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received Shingle vaccine shot and he/she was fine besides being sleepy. But next day he/she felt like hit by a truck. Additional Supportive information:As conservative approach Feeling abnormal was codeed as the patient mentioned I feel like I've been hit by a truck.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: shot caught up with me; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced feeling unwell. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that same here 2nd shot caught up with him/her the next day. The patient took 2 Motrin and slept for 6 hrs all was well and worth it for sure. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersomnia, Pain
Clinical narrative: it was very painful; slept about 3 hours; 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.   In August 2022, the patient received Shingles vaccine. In August 2022, less than a week after receiving Shingles vaccine, the patient experienced pain and sleep excessive. On an unknown date, the outcome of the pain and sleep excessive were unknown.   It was unknown if the reporter considered the pain and sleep excessive to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-AUG-2022 Reporter's Comments: This case was received from patient via interactive digital media. The patient had a Shingle shot this week and the patient thought it hit a bone as it was very painful.  The patient came home and slept about 3 hours. Additional Supportive Information: 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 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 the 1st dose of 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 unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2022AMR122534   Additional Information: GSK Receipt Date: 14-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient reported that he/she received first dose of Shingles vaccine and experienced sore arm. The patient reported that's called an immune response, which means they were producing antibodies to fight off a shingles infection. Additional Supportive Information: For tolerance of 2nd dose, refer case US2022AMR122534 reported by same reporter. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR122534:Same reporter