chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error, Underdose
Clinical narrative: No additional AE; HCP states that multiple patients have accidentally been given PEDVAXHIB vaccine that was diluted. HCP states that the person administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing up 0.5mL and administering; administering the product was diluting the PEDVAXHIB with 0.5mL of normal saline and then drawing; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender.  On 19-AUG-2022, it was stated that the patient have accidentally been given the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis, (lot # W002453 , has been verified to be a valid number; expiration date reported and established as: 24-JUN-2024), that was diluted with 0.5 milliter (ml) of normal saline and the drawing up 0.5 milliter (ml) and administered to the patients (product preparation error) (vaccine underdose).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA007866:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; The physician reported that a patient received improperly stored vaccine.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 08-SEP-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U024221, expiration date: 04-AUG-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (product storage error). Administered dose of vaccine underwent temperature excursion: -12.5 Celsius degrees for 1 hour. No previous temperature excursion was noted. No additional adverse event was report (no adverse event).
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event; Medical assistant reporting a vaccine was administered after a temperature excursion. No additional AE. No PQC.          ?    Names of vaccines involved (including lot/exp) VAXNEUVANCE U036156 5/25/2023        ?    Temperature 9.2C for 3 hours; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 28-SEP-2022, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) prefilled syringe, 0.5 milliliter, lot #U036156, expiration date: 25-MAY-2023, administered as prophylaxis (strength, and route of administration were not provided).  It was reported that the vaccine was administered after a temperature excursion at a temperature of 9.2 Celsius degrees (C) for 3 hours (product storage error). A previous temperature excursion was reported at a temperature of 15C for 1 hour. No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse event; A medical assistant reported that an expired dose of PROQUAD was administered to a patient.  No additional AE's and no PQC's were reported.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 06-SEP-2022, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, lot #U006311, expiration date: 24-AUG-2022, administered as prophylaxis to prevent measles, mumps, rubella and varicella infection (strength, and route of administration were not provided) (expired product administered). No additional adverse events were reported.
Age: 14.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller reports no additional AEs; administration of expired MMR II vaccine; This spontaneous report was received from an administrator and refers to a 14-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 11-OCT-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, 0.5 milliliter, lot #T034391, expiration date: 08-OCT-2022 (strength and route of administration were not provided) for prophylaxis (Expired product administered). No adverse events were reported (No adverse event).
Age: 16.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE events; Administration of expired MMR II vaccine; This spontaneous report was received from an administrator and refers to a 16-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 11-OCT-2022, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) rHA, 0.5 milliliter, lot #T034391, has been verified to be valid, expiration date: 08-OCT-2022, (strength and route of administration were not provided) for prophylaxis. No adverse events were reported (No adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2210USA004097: US-009507513-2210USA003600: US-009507513-2210USA003603: US-009507513-2210USA003897:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional Adverse Event; HCP reporting a patient was administered VAQTA that was improperly stored.; This spontaneous report has been received from a medical assistant referring a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 26-SEP-2022, the patient was vaccinated with an improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, once at a dose of 0,5 milliliter, lot number W003118 with expiration date 13-JUL-2023, administered for prophylaxis (route of administration and anatomical site of application were not provided) (product storage error), which had a temperature excursion of 32.29 fahrenheit (F) for 1 hour 32 minutes 0 seconds. No additional adverse event reported and there was no previous temperature excursion.
Sex: F
Vaccine: HPV9
Symptoms: Limb injury, Syringe issue
Clinical narrative: always seems like the syringes are out of place like the holder itself is not holding them in place; cut my finger; syringe flange broke into 3 different pieces/bottom glass part broke and cut my finger; broken syringe; This spontaneous report as received from a nurse and refers to a female patient (medical assistante) of unknown age. The patient concurrent condition and concomitant medicaitons were not reported. On 14-OCT-2022 (reported as" today"), the medical assistent was given to the patient (MARRS # 2210USA005747) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U031056, expiration date 16-JUN-2024 (dose and route of administration were not reported) and the bottom glass part broke and cut her finger. The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe flange broke into 3 different pieces. She was able to give the full dose and had gloves. It was also reported that when open a new package of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) "it always seems that the actually syringes in the packaging are always loose" and "seems like the syringes are out of place like the holder itself is not holding them in place". The causality assessment was not provided.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2210USA005747:MSD
Sex: U
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took second dose of Vivotif on day 5; A spontaneous report was received from a physician assistant on 26SEP2022. It described a patient (unknown age and gender) who "took second dose of Vivotif on day 5" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient took the first dose of Vivotif on 18SEP2022, and the second dose was taken on 22SEP2022. Reportedly the third and fourth dose of Vivotif was taken on 24SEP2022 and 26SEP2022 respectively. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient took the second dose of Vivotif on day 5 (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient took the second dose of Vivotif on day 5 (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Forgot to refrigerate the product and took 2 doses of the Vivotif; A spontaneous report was received from a consumer on 27SEP2022. It described a female patient of unknown age who "forgot to refrigerate the product and took 2 doses of the Vivotif" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) for immunisation. It was reported that the patient picked up Vivotif from her pharmacy on the 14SEP2022 and forgot to refrigerate the product. Reportedly, she took 2 doses of the Vivotif that were left unrefrigerated. Further, it was reported that the patient took the second dose of Vivotif on 27SEP2022 (today as per reporting). Additionally, the lot number of the product was provided as 3003687, 3003788 and the patient did not remember which lot number corresponds to her vaccine versus her husband's vaccine. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Based on the information available in the document two individual case safety reports 22000222 (wife) and 22000223 (husband) were created and cross-linked in the database.  Company comment: It was reported that a consumer forgot to refrigerate the product and took 2 doses of the Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer forgot to refrigerate the product and took 2 doses of the Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Age: 25.0
Sex: M
Vaccine: TYP
Symptoms: Product storage error
Clinical narrative: Forgot to refrigerate the product and took 2 doses of the Vivotif; A spontaneous report was received from a consumer on 27SEP2022. It described a male patient of unknown age who "forgot to refrigerate the product and took 2 doses of the Vivotif" (PT: Product storage error). The patient took the Vivotif (typhoid vaccine live oral Ty21A) for immunisation. It was reported that the patient picked up Vivotif from the pharmacy on the 16SEP2022 and forgot to refrigerate the product. Reportedly, he took 2 doses of the Vivotif that were left unrefrigerated. Further, it was reported that the patient took the second dose of Vivotif on 27SEP2022 (today as per reporting). Additionally, the lot number of the product was provided as 3003687, 3003788 and the reporter did not remember which lot number corresponds to her vaccine versus her husband's vaccine. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Based on the information available in the document two individual case safety reports 22000222 (wife) and 22000223 (husband) were created and cross-linked in the database.  Company comment: It was reported that a consumer forgot to refrigerate the product and took 2 doses of the Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.; Sender's Comments: It was reported that a consumer forgot to refrigerate the product and took 2 doses of the Vivotif (product storage error). Vivotif should always be stored in the refrigerator at the recommended temperature, and the causality of product storage error is assessed as not applicable to Vivotif due to the nature of the event which was due to human error.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif capsules daily; A spontaneous report was received from a pharmacist on 04OCT2022. It described a female patient (unknown age) who "took Vivotif capsules daily" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient got confused and took Vivotif capsules daily instead of every other day. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif capsules daily (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif capsules daily (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Malaise, Vaccination failure
Clinical narrative: had a horrible case of shingles for over 3 months now/ Suspected vaccination failure; Horrible case of Shingles; get him down; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and unwell. On an unknown date, the outcome of the vaccination failure and unwell were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and unwell to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 12-Oct-2022 Reporter's Comment: This case was reported by patient's wife via interactive digital media. The patient had the Shingles shot and booster shot in 2020.  The patient had horrible case of shingles for over 3 months now.  The reporter never seen anything got the patient down like this. Additional Supportive Information: This case was considered as vaccination failure since the detail regarding laboratory confirmation of shingles was unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got a shot 8 weeks ago, just got shingles/Suspected vaccination failure; Got shingles saturday morning; It (shingles) hurts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In October 2022, less than 2 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got a shot about 8 weeks ago and just shingles Saturday morning. The patient stated that they hurts. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was reported that just hot shingles Saturday morning it hurts, therefore conservatively onset for all events were captured as October 2022.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had vaccination but got shingles/Suspected vaccination failure; shingles; really hurts; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 13-Oct-2022 Reporter's comment: The case was received from the patient via Interactive digital media. The patient had the vaccination but got shingles. The patient stated really hurts. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 15 year old given Adult Hep A vaccine; 15 year old given Adult Hep A vaccine; This case was reported by a consumer via call center representative and described the occurrence of overdose in a 15-year-old patient who received Hepatitis A vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 07-OCT-2022 Reporter's Comments: The reporter stated that a patient was given the Adult Hepatitis A vaccine and the patient wanted to know any guidance. The reporter did not have any patient information.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Blister, Burning sensation, Chills, Fatigue, Herpes zoster
Clinical narrative: shingles; burning rash on right side; Blister on right side; Burning rash; residual fatigue; Woke up at night with tremors; chills; intense body aches; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 3rd October 2022, the patient received Shingles vaccine and Flu vaccine. On 5th October 2022, 2 days after receiving Shingles vaccine and Flu vaccine, the patient experienced fatigue. On 8th October 2022, the patient experienced shingles, burning sensation, blister and rash. In October 2022, the patient experienced tremor, chills and general body pain. On an unknown date, the outcome of the shingles, burning sensation, blister and rash were not recovered/not resolved and the outcome of the tremor, chills and general body pain were recovered/resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the shingles, tremor, chills, general body pain, fatigue, burning sensation, blister and rash to be related to Shingles vaccine and Flu vaccine.  Additional Information: GSK Receipt Date: 08-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient received a flu vaccine and a shingles vaccine on Monday.  After going to bed, the patient woke up in the middle of the night with tremors and chills along with intense body aches.  This lasted through the day with a return to normal with residual fatigue on Wednesday.  At the time of reporting, the patient developed a blister, burning rash on right side which had been diagnosed as shingles.
Sex: U
Vaccine: FLUX, VARZOS
Symptoms: Pain, Rash, Tremor
Clinical narrative: shingles; burning rash on right side; Blister on right side; Burning rash; residual fatigue; Woke up at night with tremors; chills; intense body aches; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 3rd October 2022, the patient received Shingles vaccine and Flu vaccine. On 5th October 2022, 2 days after receiving Shingles vaccine and Flu vaccine, the patient experienced fatigue. On 8th October 2022, the patient experienced shingles, burning sensation, blister and rash. In October 2022, the patient experienced tremor, chills and general body pain. On an unknown date, the outcome of the shingles, burning sensation, blister and rash were not recovered/not resolved and the outcome of the tremor, chills and general body pain were recovered/resolved and the outcome of the fatigue was unknown.   It was unknown if the reporter considered the shingles, tremor, chills, general body pain, fatigue, burning sensation, blister and rash to be related to Shingles vaccine and Flu vaccine.  Additional Information: GSK Receipt Date: 08-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient received a flu vaccine and a shingles vaccine on Monday.  After going to bed, the patient woke up in the middle of the night with tremors and chills along with intense body aches.  This lasted through the day with a return to normal with residual fatigue on Wednesday.  At the time of reporting, the patient developed a blister, burning rash on right side which had been diagnosed as shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain
Clinical narrative: back pain; This case was reported by a consumer via interactive digital media and described the occurrence of back pain in a 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 back pain. On an unknown date, the outcome of the back pain was unknown.   It was unknown if the reporter considered the back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-OCT-2022 Reporter's Comment: This case was reported by a patient via (Shingrix) interactive digital media. The patient had back pain next day after receiving shingles vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis
Clinical narrative: Enlarged knuckles; increased arthralgia in knuckles; This case was reported by a consumer via call center representative and described the occurrence of finger arthritis 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 finger arthritis and arthralgia. On an unknown date, the outcome of the finger arthritis and arthralgia were unknown.   It was unknown if the reporter considered the finger arthritis and arthralgia to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's Comments: The reported had a friend who reported experiencing same symptoms, except friend was still able to fit their rings over the middle knuckles. The reporter did not want to provide friend's information.  The reporter was advised to had friend call in to provide details. The reporter did not consent to follow-up. This case has been linked to the US2022144909 case reported by the same reporter.; Sender's Comments:  GSK-US2022144909:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site sore; injection site red; 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 Shingles vaccine. In October 2022, unknown after receiving Shingles vaccine, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were not recovered/not resolved.   The reporter considered the injection site pain and injection site erythema to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The patient self-reported this case via (Shingrix ) interactive digital media. It was stated that injection site from the shingles vaccine was still red and sore after 4 days. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: Sweating/was diaphoretic/experienced diaphoresis; felt was going to faint, Extreme lightheadedness; slightly nauseated feeling; This case was reported by a consumer via interactive digital media and described the occurrence of hyperhidrosis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, 14 hrs after receiving Shingles vaccine, the patient experienced hyperhidrosis, felt faint and nausea. On an unknown date, the outcome of the hyperhidrosis, felt faint and nausea were unknown.   It was unknown if the reporter considered the hyperhidrosis, felt faint and nausea to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that he/she had received Shingles vaccine on 10th October 2022 at approximately 11:30 am and at 02:00 am this morning (on reporting day) 14 hours later of vaccination woke and was diaphoretic/sweating, slightly nauseated and felt as though he/she was going to faint after going to the bathroom. The reporter had asked if this combination of symptomatic reactions were common or not. Additional supportive information: Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose pre Covid (2 years ago), 2nd dose on 19Jul2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine  (received a single dose pre covid).   On 19th July 2022, the patient received the 2nd dose of Shingles vaccine. On 19th July 2022, unknown after receiving Shingles vaccine, 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: 11-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient did not saw his/her physician for 2 years. The patient stated that they were not sure if this would be considered a first dose because of the duration of the initial or if this second. Additional supportive information: The patient received 2nd dose of Shingles vaccine later than the recommended interval, which led to lengthening of vaccine schedule. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Possible flu-like side effects; incredible body aches; headache, and other torture; This case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced influenza-like symptoms, general body pain and headache. On an unknown date, the outcome of the influenza-like symptoms, general body pain and headache were unknown.   The reporter considered the influenza-like symptoms, general body pain and headache to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt date: 12-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just got the shingles vaccine yesterday.  The patient sated that, he/she had possible flu-like side effects said by the nurse.  The patient further stated that, incredible body aches, headache and other torture. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles in head; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles one time ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 9-Oct-2022 Reporter's comment: The case was received from the patient's friend via interactive digital media. The patient (friend of reporter) tooks the vaccine once a year and now had shingles every year now in her head. Additional supportive information: The follow-up could not be possible as no contact details were available. As it was clear about the dose number and as pre the information it could confirm whether the patient was due for next dose or not as the patient was currently experiencing the adverse event, therefore in worst approach the case was processed with blank dose number and no medication error event was coded.
Age: 40.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Running a fever over 101; This case was reported by a consumer via call center representative and described the occurrence of fever in a 40-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 11th October 2022, the patient received the 1st dose of Shingrix. In October 2022, less than a week after receiving Shingrix, 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 Shingrix.     Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The day before reporting patient had Shingrix vaccine. The patient was 40's and immunocompromised and was running a fever over 101 degree Fahrenheit. The reporter asked was this normal. The fever was a lot of different degrees.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; 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 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.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient received a dose of Shingles vaccine and the only side effect were experienced was sore shoulder for few days. Additional Supportive Information: This case had been linked with US2022AMR146747 by same reporter. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR146747:Same reporter / master case
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder pain in an unspecified number of patients 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 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.     Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter reported that, the patients only had only side effect of sore shoulder for few days. The follow-up would not possible as no contact details were available. Additional Supportive Information: This case had been linked with US2022AMR146743,reporter by the same reporter, for different patient.; Sender's Comments:  US-GSK-US2022AMR146743:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose was given over a year ago; This case was reported by a other health professional 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 over a year ago in July 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-Oct-2022 Reporter's comment: The patient asked that if the first was given over a year ago, did the series need to be restarted. The patient wanted to be sure. Additional supportive information: Till the time of reporting, the patient did not receive second 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: Fatigue, Pyrexia
Clinical narrative: day of fever; felt tired; 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 the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and tiredness. On an unknown date, the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever and tiredness to be related to Shingles vaccine.    Additional Information: GSK Receipt Date: 08-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had a day of fever and felt tired after the shingles vaccine.  The patient stated that, minor compared to the agony described. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: was sore for day's; 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.   On 4th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 09-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingle vaccine a few days ago and it was sore for days and still kind of sore got it. The reporter stated that, Tuesday, so he/she was hoping that, he/she did not get shingles because people who had it said it was real painful. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles the 2nd time; 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 Shingles vaccine. On an unknown date, immediately 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.     Additional Information: GSK Receipt Date: 11-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had experienced shingles twice. The patient got the shingles vaccine and shortly after experienced shingles second time and was so painful. Additional Supportive Information: The follow up would not possible, as no contact, details were available. From the narrative it seems that the patient had shingles twice and shortly after vaccination the patient experienced shingles 2nd time, hence the case was not considered as suspected vaccination failure.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Achy feeling; Sore arm; 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.   On 7th October 2022, the patient received the 2nd dose of Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced pain and pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain and pain in arm were unknown.   It was unknown if the reporter considered the pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-OCT-2022 and 13-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got shingles vaccine yesterday this week.  The reporter stated that, just a little achy feeling. The patient only had sore arm.  The patient stated that, his/her father had the shingles shots and suffered really bad. The patient took Tylenol.  The patient further stated that, he/she believed in vaccines. The patient was glad to get the shingles shots. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Gastrooesophageal reflux disease
Clinical narrative: Acid reflux; stomach upset; This case was reported by a consumer via interactive digital media and described the occurrence of esophageal acid reflux in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10th October 2022, the patient received Shingles vaccine. On 11th October 2022, 1 days after receiving Shingles vaccine, the patient experienced esophageal acid reflux and upset stomach. On an unknown date, the outcome of the esophageal acid reflux and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the esophageal acid reflux and upset stomach to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 12-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingle vaccine on Monday.  Tuesday morning he/she woke up with acid reflux and had been having it since. The patient had never had this before.  The reporter wanted to know if this could be a side effect of vaccine. The patient saw where stomach upset was a symptom but did not mention reflux. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: worst side effects/shot make you really bad 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.   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: 12-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient said that this shot will make sick- it was the worst side effects. The patient was sick and was meant really bad sick for 3 days. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash sensation, nothing visible on skin; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received 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: 12-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient recently got the shingles vaccine and now he/she had what felt like a rash sensation for the last week with nothing visible on the surface of my skin yet. Additional supportive information: The follow-up could not be possible as no contact details were available.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 3rd October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 07-Oct-2022 Reporter's comment: A health care professional reported that the patient received a 3 days expired dose of Kinrix. The reporter consented to follow up. Additional Supportive Information: The patient was administered an expired dose of Kinrix, which led to expired vaccine used.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) 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 6th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 07-OCT-2022 Reporter's Comments: The reporter reported that a patient was inadvertently given a dose of Bexsero which expired on 30th September 2022.  No further details provided. The reporter consented to follow-up. Additional Supportive Information: The vaccine was already expired and was administered to the patient, which led to expired vaccine used.