chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: got the shot and I have had them even more. /18 times,suspected vaccination failure; had them even more/18 times.; This case was reported by a consumer  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (occurred in 1979).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was having shingles since 1979. The patient had got the shot and have had them (shingles) even more, in last year 18 times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have had both shots and just got over having shingles/Suspected Vaccination failure; just got over having shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had both shots and just got over having shingles.  The patient asked so this ad was false advertisement. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had first dose of Bexsero last July / second dose last week; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received in last July 2020).   In July 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. In July 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by the patient's parent. The age at vaccination was not reported The patient had 1st dose of Bexsero last July and the second dose last week which led to lengthening of vaccination schedule. The reporter said they were not aware it needed to be done closer together also asked should she need a booster. The follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Stress, Vaccination failure
Clinical narrative: Worse thing I ever had ,,,4 times ,I had them After the high priced singles shot / the shot didn't help at all/Suspected Vaccination failure; Worse thing I ever had ,,,4 times, I had them / caused from stress; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said worst thing he/she ever had, had 4 times shingles after the high priced shingles shot. The shingles things were caused from the stress and he/she did not care what they said and stated that the shot did not help at all. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow up would not be possible as no contact details were available.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: Numbness in both hands / getting worse; Swelling in both hands and both feet / getting worse; This case was reported by a pharmacist and described the occurrence of numbness in hand in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2021, the patient received the 1st dose of Shingrix. In February 2021, an unknown time after receiving Shingrix, the patient experienced numbness in hand and peripheral swelling. On an unknown date, the outcome of the numbness in hand and peripheral swelling were unknown.   It was unknown if the reporter considered the numbness in hand and peripheral swelling to be related to Shingrix.  Additional case details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix in unknown arm, 2 days later the patient felt numbness in both hands and swelling in both hands and both feet.  The symptoms had not resolved but were getting worse.  Both the reporter and patient gave permission to contact them.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Suspected Vaccination failure; got shingles; very painful disease; My back still itch every day; This case was reported by a consumer and described the occurrence of suspected 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, pain and pruritus. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The case reported by the patient herself/himself. The age at vaccination was not reported. The patient received the dose of Shingles vaccine and still got shingles. The reporter stated that it was very painful disease. The reporter mentioned that his/her back still itch every day. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain
Clinical narrative: constant pain.; locked my arm/shoulder; This case was reported by a consumer via media and described the occurrence of 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 pain and mobility decreased. The patient was treated with steroid shot (nos). On an unknown date, the outcome of the pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself/ herself. The age at vaccination was not reported. The patient had the vaccine and it had locked arm/shoulder for 7 months. The patient had constant pain. The patient had a steroid shot and it relieved the pain for about a month but again had a pain. The shot has worn off.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: terrible pain / never was OK; This case was reported by a consumer and described the occurrence of pain in a female 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, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's neighbor. The age at vaccination was not reported. The reporter stated that the patient's doctor talked her into the shot quite few years later, and for a couple years she was in terrible pain. No further information was provided. This case has been linked to US2021AMR138446 and US2021AMR092424, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138446:same reporter US-GLAXOSMITHKLINE-US2021AMR092424:same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination
Clinical narrative: I got very sick; didn't get the / second vaccine; This case was reported by a consumer via media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness and incomplete course of vaccination were unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/herself. The age at vaccination was not reported for the first dose and was not applicable for the second dose. The patient stated that he/she got very sick from the first dose of Shingrix. Till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: first vaccination in 1/2020 pre pandemic; This case was reported by a other health professional via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020 pre- pandemic).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provide are as follows: The age at vaccination was not reported. The patient received 1st Shingrix vaccination in January 2020 pre-pandemic and now wanted to get the 2nd shot which led to social problem. The reporter advised to get them both again or could he just get the 2nd shot.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Swelling face
Clinical narrative: face swelling on the left side of her jaw below her ear / taken to the emergency room; got her first / vaccine 6/22/2021 / got her second vaccine this morning; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on 22nd June 2021 and had swelling in arms, chills and redness for tolerance refer linked case US2021165601).   On 3rd August 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd August 2021, 20 min after receiving Shingrix, the patient experienced facial swelling and drug dose administration interval too short. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the facial swelling was not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient husband. The patient received 2nd dose of Shingrix vaccine and 20 minutes after developed face swelling on the left side of her jaw below her ear also  2nd dose of Shingrix received within a 2 month, which led to shortening of vaccine schedule. The patient was taken to the emergency room, given a 5 day course of steroids, and discharged. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021165601:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: got them on my / eye; got them on my face; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster 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 ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details provided were as follows: This case was reported by the patient. Age at vaccination was not reported. Patient received the Shingles vaccine and experienced shingles on face and eye. The patient stated that now get series of 2.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles 7th grade).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient reported that, he or she had shingles 7th grade and had received the shingles shot.  The patient still got the shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: doesn't prevent you 100% from developing shingles. I had the shingles 6 months after getting the second shot/ suspected vaccination failure; doesn't prevent you 100% from developing shingles. I had the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. The patient received Shingles vaccine and had the shingles 6 months after getting the second shot. The patient sated that the it doesn't prevent you 100 percent from developing shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Have shingles again now!; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (got shingles in 2015).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. After receiving 2 series Shingles shot in 2020, the patient got shingles again. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Dizziness, Motion sickness, Myalgia, Nausea
Clinical narrative: extensie saliva; dizziness/ motion sickness; nausea; Motion sickness; muscle aches; bone pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received Shingrix. On 25th July 2021, 2 days after receiving Shingrix, the patient experienced muscle pain, bone pain, dizziness and nausea. On 26th July 2021, the patient experienced motion sickness and increased salivation. The patient was treated with ondansetron (Zofran). On 27th July 2021, the outcome of the increased salivation was recovered/resolved. On an unknown date, the outcome of the muscle pain, bone pain, dizziness, nausea and motion sickness were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, bone pain, dizziness, nausea, motion sickness and increased salivation to be related to Shingrix.  Additional details were provided as follows: Pharmacist states patient received Shingrix last Friday. On Saturday she was ok, sunday she experienced muscle aches, bone pain.  Pharmacist is unsure of status of these symptoms. On Sunday, patient also experienced dizziness and nausea that persists.  On Monday, she still had bad dizziness and nausea. She felt like she had motion sickness. She went to the Urgent Care on tuesday and they prescribed Zofran which helped a bit but she is still having symptoms.  She also experienced extensie saliva on monday and tuesday but this symptom has resolved. No lot or expiration date available since patient got Shingrix at a pharmacy and the caller(Pharmacist) works at a MD office.
Sex: F
Vaccine: VARZOS
Symptoms: Salivary hypersecretion
Clinical narrative: extensie saliva; dizziness/ motion sickness; nausea; Motion sickness; muscle aches; bone pain; This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2021, the patient received Shingrix. On 25th July 2021, 2 days after receiving Shingrix, the patient experienced muscle pain, bone pain, dizziness and nausea. On 26th July 2021, the patient experienced motion sickness and increased salivation. The patient was treated with ondansetron (Zofran). On 27th July 2021, the outcome of the increased salivation was recovered/resolved. On an unknown date, the outcome of the muscle pain, bone pain, dizziness, nausea and motion sickness were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, bone pain, dizziness, nausea, motion sickness and increased salivation to be related to Shingrix.  Additional details were provided as follows: Pharmacist states patient received Shingrix last Friday. On Saturday she was ok, sunday she experienced muscle aches, bone pain.  Pharmacist is unsure of status of these symptoms. On Sunday, patient also experienced dizziness and nausea that persists.  On Monday, she still had bad dizziness and nausea. She felt like she had motion sickness. She went to the Urgent Care on tuesday and they prescribed Zofran which helped a bit but she is still having symptoms.  She also experienced extensie saliva on monday and tuesday but this symptom has resolved. No lot or expiration date available since patient got Shingrix at a pharmacy and the caller(Pharmacist) works at a MD office.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: shot #1 on 28-Jul-2021/ shot #2 on 30-Jul-2021.; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4N2ab, expiry date 10th February 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 30th July 2021, the patient received the 2nd dose of Shingrix .5 ml. On 30th July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provide are as follows: The case was reported by pharmacist. The reporter reported that a patient received 2nd dose of Shingrix  0.5 ml in unknown arm earlier than the recommend interval, which led to shortening of vaccination schedule. The Vaccine Administration Facility was the same as Primary reporter. The reporter consented to follow-up.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Rash macular, Speech disorder
Clinical narrative: Anaphylactic Reaction /ER Visit Required; red hive's spots; shortness of breath /could not breathe / could not talk; could not swallow; could not talk; This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) (batch number XN54L, expiry date unknown) for prophylaxis.   On 3rd October 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On 3rd October 2017, 10 min after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), erythema urticarial, shortness of breath, unable to swallow and speech disorder. The patient was treated with ambiguous medication nos (Epipen (Nos)), benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved and the outcome of the erythema urticarial, shortness of breath, unable to swallow and speech disorder were unknown.   It was unknown if the reporter considered the anaphylactic reaction, erythema urticarial, shortness of breath, unable to swallow and speech disorder to be related to Influenza vaccine Quadrivalent 2017-2018 season.  Additional details were provided as follows: The reporter was the patient. The patient received Flu vaccine without preservatives in left deltoid. She did not know the name of the vaccine, but known that it was manufactured by GSK. The patient had an anaphylactic reaction and had to be sent to the emergency room. The patient stated that in 10 minutes, she had red hives spots and after 20 minutes she had shortness of breath, where she could not breathe, could not swallow and could not talk. The patient was given an EpiPen, Benadryl and Steroids. The patient was provided with the date 27th July 2015. The reporter consented to follow up with health care professional.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Anaphylactic Reaction /ER Visit Required; red hive's spots; shortness of breath /could not breathe / could not talk; could not swallow; could not talk; This case was reported by a other health professional via call center representative and described the occurrence of anaphylactic reaction in a 32-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2017-2018 season) (batch number XN54L, expiry date unknown) for prophylaxis.   On 3rd October 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season. On 3rd October 2017, 10 min after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced anaphylactic reaction (serious criteria GSK medically significant), erythema urticarial, shortness of breath, unable to swallow and speech disorder. The patient was treated with ambiguous medication nos (Epipen (Nos)), benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the anaphylactic reaction was recovered/resolved and the outcome of the erythema urticarial, shortness of breath, unable to swallow and speech disorder were unknown.   It was unknown if the reporter considered the anaphylactic reaction, erythema urticarial, shortness of breath, unable to swallow and speech disorder to be related to Influenza vaccine Quadrivalent 2017-2018 season.  Additional details were provided as follows: The reporter was the patient. The patient received Flu vaccine without preservatives in left deltoid. She did not know the name of the vaccine, but known that it was manufactured by GSK. The patient had an anaphylactic reaction and had to be sent to the emergency room. The patient stated that in 10 minutes, she had red hives spots and after 20 minutes she had shortness of breath, where she could not breathe, could not swallow and could not talk. The patient was given an EpiPen, Benadryl and Steroids. The patient was provided with the date 27th July 2015. The reporter consented to follow up with health care professional.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number cm7ck, expiry date 29th July 2023) for prophylaxis.   On 17th July 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Boostrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported . The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number cm7ck, expiry date 29th July 2023) for prophylaxis.   On 17th July 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details provided were as follows: Physician reported that the patient was administered with Boostrix after a below freezing temperature excursion which led to incorrect storage of drug. No adverse event were reported. Reporter consented to follow-up. This case was 1 of 28 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Age: 63.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: mild dizziness / got worse; nausea; diarrhea / got worse; Pain at injection site; Sore arm; Headache; Fatigue; Muscle Pain; Neck pain; General joint pain; This case was reported by a pharmacist and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 29A05, expiry date 4th February 2023) for prophylaxis.   Co-suspect products included ibuprofen for pain in arm and headache and paracetamol (Tylenol) for pain in arm and headache.   On 31st July 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient started ibuprofen 200 mg at an unknown frequency and Tylenol 650 mg at an unknown frequency. On 31st July 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain and joint pain. On 2nd August 2021, the patient experienced dizziness, nausea and diarrhea. The action taken with ibuprofen was unknown. The action taken with Tylenol was unknown. On an unknown date, the outcome of the injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain, joint pain and dizziness were not recovered/not resolved and the outcome of the nausea and diarrhea were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain, joint pain, dizziness, nausea and diarrhea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received Shingrix on the left arm. The patient reported headache, sore arm, pain at injection site, fatigue, muscle pain, neck pain and general joint pain. The patient took 2 tablets of Tylenol 650 mg and 4 tablets of Ibuprofen 200 mg. On 2nd August 2021 afternoon, 2 days after receiving Shingrix and less than week after receiving Tylenol and Ibuprofen, the patient experienced mild dizziness, nausea and diarrhea. Diarrhea got worse during the evening. On 3rd August 2021, dizziness got worse. It was unknown if the reporter considered the dizziness, nausea and diarrhea to be related to Tylenol and Ibuprofen. The reporter also provided consent to follow up with health care professional (HCP). The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: UNK, UNK, VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Neck pain, Pain in extremity
Clinical narrative: mild dizziness / got worse; nausea; diarrhea / got worse; Pain at injection site; Sore arm; Headache; Fatigue; Muscle Pain; Neck pain; General joint pain; This case was reported by a pharmacist and described the occurrence of injection site pain in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 29A05, expiry date 4th February 2023) for prophylaxis.   Co-suspect products included ibuprofen for pain in arm and headache and paracetamol (Tylenol) for pain in arm and headache.   On 31st July 2021, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, the patient started ibuprofen 200 mg at an unknown frequency and Tylenol 650 mg at an unknown frequency. On 31st July 2021, less than a day after receiving Shingrix, the patient experienced injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain and joint pain. On 2nd August 2021, the patient experienced dizziness, nausea and diarrhea. The action taken with ibuprofen was unknown. The action taken with Tylenol was unknown. On an unknown date, the outcome of the injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain, joint pain and dizziness were not recovered/not resolved and the outcome of the nausea and diarrhea were unknown.   It was unknown if the reporter considered the injection site pain, pain in arm, headache, fatigue, muscle pain, neck pain, joint pain, dizziness, nausea and diarrhea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The patient received Shingrix on the left arm. The patient reported headache, sore arm, pain at injection site, fatigue, muscle pain, neck pain and general joint pain. The patient took 2 tablets of Tylenol 650 mg and 4 tablets of Ibuprofen 200 mg. On 2nd August 2021 afternoon, 2 days after receiving Shingrix and less than week after receiving Tylenol and Ibuprofen, the patient experienced mild dizziness, nausea and diarrhea. Diarrhea got worse during the evening. On 3rd August 2021, dizziness got worse. It was unknown if the reporter considered the dizziness, nausea and diarrhea to be related to Tylenol and Ibuprofen. The reporter also provided consent to follow up with health care professional (HCP). The reporter consented to follow up.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: No adverse event, Product storage error
Clinical narrative: administrated /after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number mk944, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that, the male patient was administrated with Pediarix vaccine after a below freezing temperature excursion on 26th July 2021, which led to incorrect storage of drug. No adverse event was reported . The reporter consented to follow up. This case is linked with one of the many cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164800: US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 19th July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The physician reported that the patient was administrated with Havrix after a below freezing temperature excursion which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter
Age: 0.92
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Administrated / after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-month-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 19th July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The physician reported that a male patient was administered with Havrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779: US-GLAXOSMITHKLINE-US2021164800: US-GLAXOSMITHKLINE-US2021164784: US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164801: US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164789: US-GLAXOSMITHKLINE-US2021164786:Same reporter. US-GLAXOSMITHKLINE-US2021164793:Same reporter. US-GLAXOSMITHKLINE-US2021164794:Same reporter. US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164804:Same reporter. US-GLAXOSMITHKLINE-US2021164805:Same reporter. US-GLAXOSMITHKLINE-US2021164806:Same reporter. US-GLAXOSMITHKLINE-US2021164808:Same reporter. US-GLAXOSMITHKLINE-US2021164793:same reporter
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Administrated / after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received HAV (Havrix) (batch number yl532, expiry date 9th September 2022) for prophylaxis.   On 23rd July 2021, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The physician reported that a patient was administrated with Havrix after a below freezing temperature excursion on 23rd July 2021.  No adverse event was reported The reporter consented to follow up. This case is one of 28 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164789: US-GLAXOSMITHKLINE-US2021164795:Same reporter. US-GLAXOSMITHKLINE-US2021164801: US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779: US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164784: US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164798:Same reporter. US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164797:Same reporter. US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164800: US-GLAXOSMITHKLINE-US2021164786:Same reporter. US-GLAXOSMITHKLINE-US2021164794:Same reporter. US-GLAXOSMITHKLINE-US2021164804:Same reporter. US-GLAXOSMITHKLINE-US2021164805:Same reporter. US-GLAXOSMITHKLINE-US2021164806:Same reporter. US-GLAXOSMITHKLINE-US2021164808:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter. US-GLAXOSMITHKLINE-US2021164799:Same reporter.