chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of RabAvert was administered on day one; Case reference number US-BN-2024-001772 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV24-0663) on 05-Apr-2024 and concerns an adult male patient.  The patient 's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of RabAvert (batch number: unknown) at an unknown dose, via unknown route and site of administration for pre-exposure.  On an unspecified date, one day after the first dose, the patient was vaccinated with the second dose of RabAvert (batch number: unknown) at an unknown dose, via unknown route and site of administration (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown whether the patient experienced any adverse event due to RabAvert.  No further information was provided.; Reporter's Comments: An adult male patient was vaccinated with the second dose of RabAvert, one day after the first dose, at an unknown dose, via unknown route and site of administration which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to RabAvert. Patient 's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: An adult male patient was vaccinated with the second dose of RabAvert, one day after the first dose, at an unknown dose, via unknown route and site of administration which is considered as inappropriate schedule of vaccine administered. Inappropriate schedule of product administration is considered listed per company convention. At this point, it was unknown whether the patient experienced any adverse event due to RabAvert. Patient 's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: RAB
Symptoms: Incorrect route of product administration
Clinical narrative: The patient received RabAvert intragluteally; Case reference number US-BN-2024-001787 is a spontaneous case report initially received from a health care professional via Med Communications (reference number USBAV24-0709) on 10-Apr-2024 and concerns a male patient of unspecified age.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was bitten on both arms by animal.  On an unspecified date, reported as yesterday the patient came to the hospital and received co suspect vaccine of HyperRab (immunoglobulin human anti-rabies, batch number: unknown), at unknown dose and route administration in both arms, for indication reported as rabies post exposure treatment.  On 09-Apr-2024, for unknown amount of time after animal exposure the patient received first RabAvert (batch number: unknown) intragluteally, at unknown dose and site administration for rabies post-exposure prophylaxis (explicitly coded as 'Inappropriate route of vaccination')  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A male patient of unspecified age received first RabAvert, intragluteally, for rabies post-exposure prophylaxis, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age received first RabAvert, intragluteally, for rabies post-exposure prophylaxis, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: The patient was vaccinated with an expired fourth dose of RabAvert vaccine; Case reference number US-BN-2024-001864 is a spontaneous case report initially received from a pharmacist via Agency (reference number: USBAV24-0886) on 30-Apr-2024 and concerns a 58-year-old male patient.   The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient had rabies exposure.  On 16-Apr-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at a dose of 2.5 units, administered intramuscularly at unknown site of administration, for post exposure.  On 19-Apr-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the second dose of RabAvert vaccine (batch number: unknown), at a dose of 2.5 units, administered intramuscularly at unknown site of administration.  On 23-Apr-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the third dose of RabAvert vaccine (batch number: unknown), at a dose of 2.5 units, administered intramuscularly at unknown site of administration.  On 30-Apr-2024, unknown amount of time after rabies exposure, the patient was vaccinated with the expired fourth dose of RabAvert (batch number: AD01A44B, expiration date: Jan-2024), at a dose of 2.5 units, administered intramuscularly at unknown site of administration (explicitly coded as 'expired vaccine used'). As reported today, the patient was treated with 8 mg of Zofran (ondansetron) orally.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A 58-year-old male patient was vaccinated with the expired fourth dose of RabAvert for post exposure, which is considered as expired vaccine used. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 58-year-old male patient was vaccinated with the expired fourth dose of RabAvert for post exposure, which is considered as expired vaccine used. It was unknown if the patient experienced any adverse event due to RabAvert vaccine. Expired product administered is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Fourth dose of RabAvert on day 14 for post-exposure was delayed; Case reference number US-BN-2024-001889 is a spontaneous case report initially received from a pharmacist via Med Communications (reference number: USBAV24-0971) on 08-May-2024 and concerns a 44-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient had rabies exposure, reported as a dog bite.  On unspecified date, unknown amount of time after the dog bite and reported as day zero, the patient was vaccinated with the first dose of RabAvert (batch number: unknown), at an unknown dose, administered intramuscularly at unknown site of administration, for post exposure rabies-dog bite.  On unspecified date, unknown amount of time after the dog bite, reported as day three, the patient was vaccinated with the second dose of RabAvert (batch number: unknown), at an unknown dose, administered intramuscularly at unknown site of administration.  On unspecified date, unknown amount of time after the dog bite, reported as day seven, the patient was vaccinated with the third dose of RabAvert (batch number: unknown), at an unknown dose, administered intramuscularly at unknown site of administration.  As reported, due to patient's situation and patient's going back and forth outside the facility and inside the facility, fourth dose on day 14 was delayed (explicitly coded as 'inappropriate schedule of vaccine administered').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to RabAvert vaccine.  No further information was provided.; Reporter's Comments: A 44-year-old female patient's fourth dose of RabAvert for post exposure rabies-dog bite on day 14 was delayed, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 44-year-old female patient's fourth dose of RabAvert for post exposure rabies-dog bite on day 14 was delayed, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event due to RabAvert. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-JUL-2024 The patient self-reported. She mentioned that she had developed shingles after having Shingrix immunizations. She had previously thought that her shingles shots were in 2023 but now her pharmacy was stated that the Shingrix shots were given in 2021. 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.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Sex: U
Vaccine: COVID19, HEPA, MEN, MENB
Symptoms: Pain in extremity
Clinical narrative: Pain in arm; This non-serious case was reported by a other health professional via other manufacturer and described the occurrence of pain in arm in a patient who received Hepatitis A vaccine (batch number X2598) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number 7H75N) for prophylaxis, Elasomeran (Moderna COVID-19 vaccine) (batch number AU5558B) for prophylaxis and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (TET TOX) (MENQUADFI) (batch number U7949AA) for prophylaxis.   On 05-MAR-2024, the patient received Hepatitis A vaccine, Bexsero (intramuscular), Moderna COVID-19 vaccine (intramuscular) and MENQUADFI (intramuscular). On 05-MAR-2024, less than a day after receiving Hepatitis A vaccine and Bexsero, the patient experienced pain in arm (Verbatim: Pain in arm). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Hepatitis A vaccine, Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the pain in arm to be related to Hepatitis A vaccine, Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUN-2024 Patient did not have any other side effects besides expected soreness in arms. No Medical History information was reported. It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication was not provided. Treatment information was not reported
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: made me sick; This non-serious case was reported by a consumer and described the occurrence of sickness in a 62-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine with an associated reaction of feeling abnormal (Received 1st dose on an unknown date and felt like crap refer case US2024079898).   On 28-MAY-2024, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: made me sick). The outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2024079898   Additional Information: GSK Receipt Date: 27-JUN-2024 The patient received second dose and dose made him sick.; Sender's Comments:  US-GSK-US2024079898:same patient
Sex: U
Vaccine: RVX
Symptoms: Herpes zoster
Clinical narrative: Outbreak of shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced shingles (Verbatim: Outbreak of shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to RSV vaccine.     It was unknown if the company considered the shingles to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 25-JUN-2024 An HCP reported that she recently had a 2 or 3 patient who had active shingles after receiving the RSV vaccine but it was not known whether it was the GSK arexvy or the Pfizer vaccine. This case was linked with case US2024079191 with same reporter.; Sender's Comments:  US-GSK-US2024079191:Different patient/ same event
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity, Tachycardia
Clinical narrative: arm was slightly sore; did not feel right vaccination; tachycardia; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tachycardia. Concurrent medical conditions included infection parasitic.   On 02-APR-2024, the patient received the 1st dose of Shingrix (unknown arm). On 02-APR-2024, immediately after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: did not feel right vaccination) and tachycardia (Verbatim: tachycardia). On an unknown date, the patient experienced pain in arm (Verbatim: arm was slightly sore). On 02-APR-2024, the outcome of the feeling abnormal and tachycardia were resolved (duration 10 min). The outcome of the pain in arm was unknown.   It was unknown if the reporter considered the feeling abnormal, tachycardia and pain in arm to be related to Shingrix.   It was unknown if the company considered the feeling abnormal, tachycardia and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2024 and 25-JUN-2024 The patient self-reported this case for herself. The reporter stated Shingrix vaccine was administered to her and almost immediately after receiving her dose she stated she did not feel right and experienced tachycardia. Both events resolved within approximately 10 minutes. She also reported that her arm was slightly sore in 2024. The consumer could not remember which arm she was vaccinated in. The reporter reported that she was currently being treated for parasites and tick-borne diseases.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 44HD4, expiry date 30-MAY-2024) and (batch number 4N9PF, expiry date 12-DEC-2025) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date lot number: 44HD4, expiration date: 30th May 2024).   On 02-APR-2024, the patient received the 2nd dose of Shingrix. On 02-APR-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-JUN-2024 Pharmacist had a 75 year old male patient who was late for his second Shingrix dose. Patient's wife was no records on the first appointment on her calendar so she insisted that the shot has never happened. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule.
Age: 8.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: he's eight, and he was given the Kinrix vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: he's eight, and he was given the Kinrix vaccine). The outcome of the inappropriate age at vaccine administration 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: 25-JUN-2024 The health care professional reported that, they had a kiddo (patient) that came in and he was eight and he was given the Kinrix vaccine which was indicated for four through six years old, which led to an inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Inappropriate route of administration/was administered a dose of Menveo on 25Jun2024 by subcutaneous route instead of intramuscular; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number 4293K, expiry date 31-JUL-2025) for prophylaxis.   On 25-JUN-2024, the patient received Menveo (subcutaneous, left arm). On 25-JUN-2024, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: Inappropriate route of administration/was administered a dose of Menveo on 25Jun2024 by subcutaneous route instead of intramuscular). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 25-JUN-2024 The pharmacist reported that Menveo was administered to a patient by subcutaneous route instead of intramuscular, which led to intramuscular formulation administered by other route. The vaccine administration facility was the same as primary reporter.
Sex: U
Vaccine: RSV
Symptoms: Incorrect dose administered
Clinical narrative: Less than 5 mL once is reconstitute; Product Complaint; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: Less than 5 mL once is reconstitute) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 25-JUN-2024 The reported stated that she was giving Arexvy vaccine, just recently, and this happened before but never called about it, so when reporter was withdrawing the diluent, to reconstitute it, it was not enough solution, like it barely made 0.3 mL of the vaccine to give. The reporter questioned should she just give the patient that because they give the hole amount vaccine that was in the bottle with the vaccine or was there a problem. The reporter was not getting the 0.5 mL dose. In order to see if there is a QCP, the HCP was asked how she reconstitute the vaccine, and she said that she first use one syringe to withdrawn the adjuvant, latter with other syringe she take the reconstitute vaccine. The reporter was asked if by any chance, she dropped something or loose the liquid while she change this 2 syringes, she said that maybe she loose a drop, but that was not a significant amount. At the end, the HCP said that she will not get worry about it, she needs to leave, and that she will just deal with it latter, and HCP ended up the call. Also, related about what she said, it seemed that in the previous situation she mentioned, she did administrate only the 0.3 mL, as maybe she administrate less than 0.5 mL which led to incomplete dose administered and pharmaceutical product complaint.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: a patient received a dose of Arexvy on January 9th 2024 and they accidentally gave a second dose on May 14th 2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number J7G32, expiry date 09-MAY-2026) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 9th January 2024 with batch number J7G32 and expiry 9th May 2026).   On 14-MAY-2024, the patient received the 2nd dose of Arexvy. On 14-MAY-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a patient received a dose of Arexvy on January 9th 2024 and they accidentally gave a second dose on May 14th 2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 26-JUN-2024 The pharmacist reported that a patient received 1st dose of Arexvy and accidently received 2nd dose, which led to extra dose administered. The reporter did not feel comfortable for providing patient initials.
Age: 0.33
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old patient was given Kinrix by accident; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received DTPa-IPV (Kinrix) (batch number 5H95B, expiry date 16-FEB-2026) for prophylaxis.   On 11-JUN-2024, the patient received Kinrix. On 11-JUN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month old patient was given Kinrix by accident). The outcome of the inappropriate age at vaccine administration 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: 27-JUN-2024 A reporter reported that a 4 month old patient was given Kinrix by accident which led to Inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: part of tongue swollen last night; felt sick; Pain at injection site; redness at injection site; Swelling at injection site; overall pain in muscles; pain in bones; got more sick with this vaccine; headaches on and off; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included covid 19 vaccine. Concurrent medical conditions included fibromyalgia. Concomitant products included ibuprofen (Advil) and cyclobenzaprine hydrochloride (Flexeril).   On 24-JUN-2024 17:00, the patient received the 1st dose of Shingrix (left arm). In JUN-2024, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: Swelling at injection site), muscle pain (Verbatim: overall pain in muscles), bone pain (Verbatim: pain in bones), sickness (Verbatim: got more sick with this vaccine) and intermittent headache (Verbatim: headaches on and off). On 25-JUN-2024 05:00, the patient experienced feeling unwell (Verbatim: felt sick). On 26-JUN-2024, the patient experienced swollen tongue (Verbatim: part of tongue swollen last night). The outcome of the injection site pain, injection site erythema and injection site swelling were not resolved and the outcome of the muscle pain and intermittent headache were unknown and the outcome of the bone pain, sickness, swollen tongue and feeling unwell were resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, bone pain, sickness, intermittent headache, swollen tongue and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, muscle pain, bone pain, sickness, intermittent headache, swollen tongue and feeling unwell to be related to Shingrix.   Additional Information: GSK receipt date: 27-MAY-2024 The patient stated that she received dose 1 of Shingrix on Monday.  She stated at the next morning she wok up and felt sick.  The patient had redness, swelling and pain at the injection site, left arm, that she has been using ice on it.  She also stated that she had been taking Advil and flexeril and had a history of fibromyalgia.   She stated that, she got more sick with this vaccine than with COVID vaccine.  She also experienced overall pain in muscles and bones (recovered) and has had headaches on and off.  She mentioned that part of her tongue was swollen last night but it was better now (at the time of reporting).  She stated that she did not thought she would get dose 2. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Swollen tongue
Clinical narrative: part of tongue swollen last night; felt sick; Pain at injection site; redness at injection site; Swelling at injection site; overall pain in muscles; pain in bones; got more sick with this vaccine; headaches on and off; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included covid 19 vaccine. Concurrent medical conditions included fibromyalgia. Concomitant products included ibuprofen (Advil) and cyclobenzaprine hydrochloride (Flexeril).   On 24-JUN-2024 17:00, the patient received the 1st dose of Shingrix (left arm). In JUN-2024, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain at injection site), injection site erythema (Verbatim: redness at injection site), injection site swelling (Verbatim: Swelling at injection site), muscle pain (Verbatim: overall pain in muscles), bone pain (Verbatim: pain in bones), sickness (Verbatim: got more sick with this vaccine) and intermittent headache (Verbatim: headaches on and off). On 25-JUN-2024 05:00, the patient experienced feeling unwell (Verbatim: felt sick). On 26-JUN-2024, the patient experienced swollen tongue (Verbatim: part of tongue swollen last night). The outcome of the injection site pain, injection site erythema and injection site swelling were not resolved and the outcome of the muscle pain and intermittent headache were unknown and the outcome of the bone pain, sickness, swollen tongue and feeling unwell were resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, muscle pain, bone pain, sickness, intermittent headache, swollen tongue and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site erythema, injection site swelling, muscle pain, bone pain, sickness, intermittent headache, swollen tongue and feeling unwell to be related to Shingrix.   Additional Information: GSK receipt date: 27-MAY-2024 The patient stated that she received dose 1 of Shingrix on Monday.  She stated at the next morning she wok up and felt sick.  The patient had redness, swelling and pain at the injection site, left arm, that she has been using ice on it.  She also stated that she had been taking Advil and flexeril and had a history of fibromyalgia.   She stated that, she got more sick with this vaccine than with COVID vaccine.  She also experienced overall pain in muscles and bones (recovered) and has had headaches on and off.  She mentioned that part of her tongue was swollen last night but it was better now (at the time of reporting).  She stated that she did not thought she would get dose 2. Did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given subcutaneously by accident; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 4935H, expiry date 17-MAY-2026) for prophylaxis.   On 19-JUN-2024, the patient received the 1st dose of Shingrix (subcutaneous). On 19-JUN-2024, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: Vaccine was given subcutaneously by accident). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 27-JUN-2024 The reporter was a Medical Assistant. The reporter reported that the patient received their first dose of Shingrix but the vaccine was given subcutaneously by accident which led to intramuscular formulation administered by other route. The vaccine administration facility was the same as primary reporter. This case is linked with US2024080434, same reporter, different patient.; Sender's Comments:  US-GSK-US2024080434:Same reporter/different patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first dose of Shingrix before the pandemic and wanted to know how to proceed with the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose before the pandemic ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: received their first dose of Shingrix before the pandemic and wanted to know how to proceed with the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2024 A pharmacist reported that a patient received their first dose of Shingrix before the pandemic and wanted to know how to proceed with the series.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.75
Sex: M
Vaccine: RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 21 months old male patient received Rotarix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 21-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 5F7L2) for prophylaxis.   On 07-JUN-2024, the patient received Rotarix lyophilized formulation. On 07-JUN-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate age at vaccine administration (Verbatim: a 21 months old male patient received Rotarix). The outcome of the inappropriate age at vaccine administration 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: 28-JUN-2024 The physician reported there was a maladministration of Rotarix in a patient above the age studied, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: chills; generalized myalgia; flu-like symptoms for 48 hours; lower limb pain; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms for 48 hours), PAIN IN EXTREMITY (lower limb pain), CHILLS (chills) and MYALGIA (generalized myalgia) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms for 48 hours), PAIN IN EXTREMITY (lower limb pain), CHILLS (chills) and MYALGIA (generalized myalgia). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms for 48 hours), PAIN IN EXTREMITY (lower limb pain), CHILLS (chills) and MYALGIA (generalized myalgia) had resolved.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   Concomitant medication was not reported. Approximately 24 to 48 hours after vaccination, patient had chills, flu-like symptoms for 48 hours, generalized myalgia and then only lower limb pain that disappears after 48 hours. No fever. Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.       Concomitant medication was not provided. Reporter approached our booth and shared about her husband receiving the COVID vaccine sometime in early 2021. She mentioned that approximately five days after the injection, he had a heart attack. She said he has since recovered. Treatment information was not reported.; Reporter's Comments: Company comment: This spontaneous case concerns an adult male patient with no medical history information reported, who experienced the unexpected serious (life threatening, hospitalization and medically significant) AESI of myocardial infarction. The event occurred approximately 5 days after a dose of mRNA-1273. The event resolved. No further information about the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: have taken paxlovid before; have taken paxlovid before; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 75-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2024 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "pulmonary heart disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (PRIMARY IMMUNIZATION COMPLETED), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "have taken paxlovid before". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course Caller stated have taken paxlovid before. Patient has hypertension and pulmonary heart disease took booster shot this year. Caller stated has had every vaccine and booster pfizer has given.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400088679 Same Patient/drug, different dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Myocardial fibrosis
Clinical narrative: partially Resolving Myocardial Fibrosis Five Months following the mRNA COVID-19 Vaccine; This is a literature report.  A 30-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL FIBROSIS (hospitalization, medically significant), 5 months after the suspect product(s) administration, outcome "recovering", described as "partially Resolving Myocardial Fibrosis Five Months following the mRNA COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: Unknown result.; Sender's Comments: As there is limited information in the case provided, the causal association between the event myocardial fibrosis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Achy Joins; This is a spontaneous report received from a Pharmacist.  A 51-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Achy Joins". Additional information: achy joints occurs per patient with each vaccine dose.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Rash
Clinical narrative: rash; Initial information received on 02-Jul-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant patient of an unknown gender who experienced rash after receiving diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On 02-Jul-2024, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot number; strength; expiry date not reported) via intramuscular route in unknown administration site for routine vaccination (Immunisation). Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested.  On 02-Jul-2024 the patient developed rash (latency: same day).  Patient did not experience any additional symptoms/events.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Sex: U
Vaccine: YF
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: some of the vaccines just leaked on the patient's arm with no reported adverse event; administered yf-vax to a patient. when her colleague gave it, it was defective and some of the vaccines just leaked on the patient's arm with no reported ae; administered yf-vax to a patient. when her colleague gave it, it was defective and some of the vaccines just leaked on the patient's arm with no reported adverse event; Initial information received on 01-Jul-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who experienced some of the vaccines just leaked on the patient's arm with no reported adverse event, administered yellow fever vaccine - [YF-Vax] to a patient, when her colleague gave it, it was defective.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect yellow fever vaccine - Solution for injection lot number not reported via unknown route in unknown administration site (strength, and expiration date: not provided) for Immunisation (exposure via skin contact), (incorrect dose administered) and (accidental exposure to product) (latency- same day). Information regarding batch number and expiration date corresponding to the one at a time of event occurrence was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: YF
Symptoms: Inappropriate schedule of product administration
Clinical narrative: YF-vax was given 4-days after another live vaccine with no reported adverse event; Initial information received on 02-Jul-2024 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 56-year-old female patient whom yellow fever vaccine - [YF-VAX] was given 4-days after another live vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 20-Apr-2024, the patient received a 0.5 ml dose of suspect Yellow Fever Vaccine - Solution for injection of lot UK032AB and expiry date: 31-Mar-2025 (Frequency :once, Strength: standard) via unknown route in unknown administration site as Immunization and was given 4-days after another live vaccine with no reported adverse event (inappropriate schedule of product administration) (latency: on same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.