chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.58
Sex: U
Vaccine: PNC15, PNC15, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperaturer excursion; temperaturer excursion; This spontaneous report was received from an other health professional and referred to an 8-month-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 22-NOV-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X019438, expiration date was reported as 07-NOV-2025 (also reported 30-AUG-2025, conflicting information), administered intramuscularly for prophylaxis (strength, dose and anatomical site of administration was not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, batch #U7423AA (also reported as U753SAA), expiration date: 23-SEP-2025 (also reported as 30-SEP-2025), administered intramuscularly for prophylaxis (strength, dose, anatomical site of administration were not provided). On 20-DEC-2023, the patient received pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X019438, expiration date was reported as 07-NOV-2025 (also reported 30-AUG-2025, conflicting information), administered intramuscularly for prophylaxis (strength and anatomical site of administration were not provided). All vaccines were found experiencing multiple temperature excursions (TE) from 19-OCT-2023 to 22-JAN-2024 (product storage error, twice, onset date of 22-NOV-2023 and 20-DEC-2023). Healthcare professional (HCP) requested stability information for vaccine products. No additional adverse event (AE) reported (no adverse event).  This is one of several reports received from the same reporter.
Age: 0.58
Sex: U
Vaccine: PNC15, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; temperaturer excursion; This spontaneous report was received from an other health professional and referred to an 7-month-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 08-JAN-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, lot #X019438, expiration date was reported as 07-NOV-2025 (also reported 30-AUG-2025, conflicting information), administered intramuscularly for prophylaxis (strength, dose and anatomical site of administration was not provided); and diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (V419) injection, batch # U753SAA (also reported as U7423AA), expiration date: 23-SEP-2025 (also reported as 30-SEP-2025), administered intramuscularly for prophylaxis (strength, dose, anatomical site of administration were not provided). All vaccines were found experiencing multiple times of temperature excursion (TE) from19-OCT-2023 to 22-JAN-2024 (product storage error). Healthcare professional (HCP) requested stability information for vaccine products. No additional adverse event (AE) reported (no adverse event).  This is one of several reports received from the same reporter.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller is a nurse who reports PEDVAX HIB product that experienced temperature excursion was administered to a patient. See excursion details below. Product administered 3/13/2024. Please be advised most recent "excursion" was within recommended range; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 18-FEB-2024, the haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) underwent temperature in temperature above 9 Celsius degrees (C) (18.1C) and length of 17 hours 0 minutes and 0 seconds. Then it was stored in temperature from 2 C to 8 C (1.5C) and of length 15 hours 43 minutes and 0 seconds. On 13-MAR-2024 the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # W028532 and expiration date 09-MAY-2025 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event).
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration, Underdose
Clinical narrative: Patient received Jynneos vaccine 0.5 ml intradermally instead of subcutaneously; Patient received Jynneos vaccine 0.5 ml intradermally instead of subcutaneously; Case reference number US-BN-2024-000177 is a spontaneous case report initially received from a nurse via Communication (reference number: USBAV24-0310) on 13-Feb-2024 and concerns a 55-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 13-Feb-2024, the patient was vaccinated with the first dose of Jynneos (batch number: FDP00020) intradermally at a dose of 0.5 milliliter, at unknown site of administration, for unknown indication (explicitly coded as 'intradermal injection' and 'vaccine overdose').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  No further information was provided.; Reporter's Comments: A 55-year-old male patient was vaccinated with the first dose of Jynneos, intradermally at a dose of 0.5 milliliter, for unknown indication, which is considered as intradermal injection and vaccine overdose. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Intradermal injection and vaccine overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and vaccine overdose have 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 55-year-old male patient was vaccinated with the first dose of Jynneos, intradermally at a dose of 0.5 milliliter, for unknown indication, which is considered as intradermal injection and vaccine overdose. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Intradermal injection and vaccine overdose are considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Intradermal injection and vaccine overdose have been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Infection, Monkeypox
Clinical narrative: The patient experienced a breakthrough infection of mpox in October 2023 after being vaccinated with Jynneos in August 2022.; The patient experienced a breakthrough infection of mpox in October 2023 after being vaccinated with Jynneos in August 2022.; Case reference number US-BN-2024-000627 is a spontaneous case initially received from a consumer via Bavarian Nordic (BN_2024_01411) on 13-Mar-2024 and concerns a male patient in his 30s.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date in Aug-2022, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose, via an unknown route and site of administration, for an unknown indication.  On an unspecified date in Aug-2022, an unknown amount of time after the first dose of Jynneos, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), at an unknown dose, via an unknown route and site of administration.  On an unspecified date in Oct-2023, an unknown amount of time after the second dose of Jynneos, the patient experienced a breakthrough infection of monkeypox.   At the time of the initial report, the outcome of the events monkeypox and breakthrough infection were unknown.  The reporter did not provide seriousness assessment for the events monkeypox and breakthrough infection, however, the events monkeypox and breakthrough infection were assessed as serious due to medically significant criteria. Causality assessment was not provided.  No further information was provided.; Reporter's Comments: A male patient in his 30s experienced a serious events of breakthrough infection and monkeypox (both medically significant), unknown time after the second dose of Jynneos. Monkeypox and infection are both unlisted and unexpected according to CCDS v6 and PI for Jynneos. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, causality for both reported events is assessed as not related to Jynneos. As with any other vaccine, vaccination with MVA-BN may not result in protection in all cases (as stated in CCDS v6). The case is serious due to medical significance.; Sender's Comments: A male patient in his 30s experienced a serious events of breakthrough infection and monkeypox (both medically significant), unknown time after the second dose of Jynneos. Monkeypox and infection are both unlisted and unexpected according to CCDS v6 and PI for Jynneos. The outcome was unknown. The patient's medical history and concomitant medication details were not provided. Considering that Jynneos is a non-replicating vaccine which does not contain the monkeypox, causality for both reported events is assessed as not related to Jynneos. As with any other vaccine, vaccination with MVA-BN may not result in protection in all cases (as stated in CCDS v6). The case is serious due to medical significance.
Sex: F
Vaccine: RSV
Symptoms: Injection site necrosis
Clinical narrative: Necrosis injection site; This serious case was reported by a other health professional via patient support programs and described the occurrence of injection site necrosis in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79428, expiry date 02-MAR-2025) for prophylaxis.   Concurrent medical conditions included chronic obstructive pulmonary disease.   On 18-OCT-2023, the patient received the 1st dose of Arexvy (right arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site necrosis (Verbatim: Necrosis injection site) (serious criteria GSK medically significant). The outcome of the injection site necrosis was not resolved.   The reporter considered the injection site necrosis to be related to Arexvy.     The company considered the injection site necrosis to be related to Arexvy.   Additional Information: GSK Receipt Date: 14-MAR-2024 This report was submitted via the online direct entry reporting system. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles after vaccination/Suspected vaccination failure; Shingles; Pain was terrible; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients 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 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Pain was terrible). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported via (social media) interactive digital media. The reporter stated that the side effects were horrible and lasted 3 or 4 days with the first and second dose, but with shingles they said the pain was terrible. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after the shot/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles after the shot/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 Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a reporter via (social media) interactive digital media. The reporter stated that he/she had Shingles when he/she was 22. Anyway, spoke with a woman who said she and her sister both got Shingles after the shot. Reporter was staying away from anything sharp.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case has been linked to the case US2024AMR033150 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR033150:Same reporter, woman's case
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Vaccination failure
Clinical narrative: I have gotten a shot when it came out a few years ago and I have them now/ Suspected vaccination failure; I have them now; it not fun very painful on my shoulder; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I have gotten a shot when it came out a few years ago and I have them now/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have them now) and shoulder pain (Verbatim: it not fun very painful on my shoulder). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the shoulder pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and shoulder pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and shoulder pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2024 This case was reported by a patient via (social media) interactive digital media. The patient had gotten a shot when it came out a few years ago and had them at the time fo reporting and it was not fun very painful on his/her shoulder after getting the shot. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: RSV, RSV
Symptoms: Malaise
Clinical narrative: multiple physical ailments; This serious case was reported by a lawyer and described the occurrence of physically unwell in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced physically unwell (Verbatim: multiple physical ailments) (serious criteria hospitalization). The outcome of the physically unwell was not reported.   It was unknown if the reporter considered the physically unwell to be related to Arexvy.     It was unknown if the company considered the physically unwell to be related to Arexvy.   Additional Information: GSK receipt date - 12-Mar-2024 As per legal complaints the plaintiff administration Arexvy (PF) and as a result of use of above medication the plaintiff developed multiple physical ailments resulting in hospitalization.
Sex: U
Vaccine: RSV, RSV
Symptoms: Dysphagia, Dyspnoea, Epistaxis, Haemoptysis, Productive cough
Clinical narrative: multiple physical ailments; This serious case was reported by a lawyer and described the occurrence of physically unwell in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced physically unwell (Verbatim: multiple physical ailments) (serious criteria hospitalization). The outcome of the physically unwell was not reported.   It was unknown if the reporter considered the physically unwell to be related to Arexvy.     It was unknown if the company considered the physically unwell to be related to Arexvy.   Additional Information: GSK receipt date - 12-Mar-2024 As per legal complaints the plaintiff administration Arexvy (PF) and as a result of use of above medication the plaintiff developed multiple physical ailments resulting in hospitalization.
Sex: U
Vaccine: RSV, RSV
Symptoms: Sputum discoloured, Throat tightness
Clinical narrative: multiple physical ailments; This serious case was reported by a lawyer and described the occurrence of physically unwell in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy .5 ml. On an unknown date, an unknown time after receiving Arexvy, the patient experienced physically unwell (Verbatim: multiple physical ailments) (serious criteria hospitalization). The outcome of the physically unwell was not reported.   It was unknown if the reporter considered the physically unwell to be related to Arexvy.     It was unknown if the company considered the physically unwell to be related to Arexvy.   Additional Information: GSK receipt date - 12-Mar-2024 As per legal complaints the plaintiff administration Arexvy (PF) and as a result of use of above medication the plaintiff developed multiple physical ailments resulting in hospitalization.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye inflammation, Eye irritation, Pain in extremity, Pyrexia, Rash
Clinical narrative: left arm was sore; my eyes are inflamed; eyes started burning/ eyes were still irritated; developed a rash above the lip/ rash spread all over; Fever/fever came back; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (had years ago from wearing dang mask). Previously administered products included Shingrix with an associated reaction of pyrexia (received 1st dose on 09-DEC-2023 in the left arm, for tolerance refer linked case US2024019968).   On 10-FEB-2024, the patient received the 2nd dose of Shingrix (left arm). On 12-FEB-2024, 2 days after receiving Shingrix, the patient experienced eye irritation (Verbatim: eyes started burning/ eyes were still irritated) and rash (Verbatim: developed a rash above the lip/ rash spread all over). On 14-FEB-2024, the patient experienced eye inflammation (Verbatim: my eyes are inflamed). In FEB-2024, the patient experienced fever (Verbatim: Fever/fever came back) and pain in arm (Verbatim: left arm was sore). Rechallenge with Shingrix was positive. On 14-FEB-2024, the outcome of the fever was resolved. In FEB-2024, the outcome of the pain in arm was resolved. The outcome of the eye irritation, rash and eye inflammation were not resolved.   It was unknown if the reporter considered the fever, pain in arm, eye irritation, rash and eye inflammation to be related to Shingrix.     It was unknown if the company considered the fever, pain in arm, eye irritation, rash and eye inflammation to be related to Shingrix.   Linked case(s) involving the same patient: US2024019968   Additional Information: GSK Receipt Date: 14-FEB-2024 The patient self-reported this case. The reporter wanted to know was there any information on Shingrix regarding rash and eye burning. The patient just got his second dose this past weekend on Saturday (from the date of reporting), his left arm was sore for several hours and the fever lasted longer this time, it went from 102.2 Fahrenheit down to 99.5 F.  On Monday 2 days after, the fever came back, his eyes started burning and he developed a rash above the lip.  Today 4 days after (on the day of reporting) the fever worked its way out but the rash was the concern. The rash spread all over, his eyes were burning, and inflamed, still today it was irritated. The patient did not want to go to the ER (emergency room) so he went to the pharmacy and the pharmacist told him to use cortisone cream. But he had some prescribed cream from years ago when he had a rash from wearing those dang mask. That helped a little. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2024019968:Original Case : US2024019968
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity
Clinical narrative: Allergic reaction/After effects; Broke out all over the body 5 days after shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergic reaction (Verbatim: Allergic reaction/After effects) and shingles (Verbatim: Broke out all over the body 5 days after shot). The outcome of the allergic reaction and shingles were not resolved.   It was unknown if the reporter considered the allergic reaction and shingles to be related to Shingles vaccine.     It was unknown if the company considered the allergic reaction and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2024 and 14-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had shingles shot  in July and had a severe allergic reaction.  The patient was still dealing with the after effects. 5 days after shots, the patient had broke out all over the body. The patient stated that it would be taking any more of the shingles, covid or any more of those shots that they did not no the effects later on.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Loss of personal independence in daily activities, Rash vesicular
Clinical narrative: rash with blisters; shingles; I didn't go out for a month; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles). On an unknown date, the patient experienced blistery rash (Verbatim: rash with blisters) and activities of daily living impaired (Verbatim: I didn't go out for a month). The outcome of the shingles was not reported and the outcome of the blistery rash was resolved and the outcome of the activities of daily living impaired was resolved (duration 1 month).   It was unknown if the reporter considered the shingles, blistery rash and activities of daily living impaired to be related to Shingles vaccine.     It was unknown if the company considered the shingles, blistery rash and activities of daily living impaired to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR032638   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the 1st vaccine and then went to get the 2nd one but they did not administer it because patient had a rash with blisters.  The patient cured it, then he/she got shingles in June 2023, patient did not go out for a month. For tolerance of 2nd dose refer case US2024AMR032638.; Sender's Comments:  US-GSK-US2024AMR032638:Same reporter, different dose (2nd dose)
Sex: M
Vaccine: VARZOS
Symptoms: Dry skin, Feeling abnormal, Neuralgia, Pain of skin, Paraesthesia
Clinical narrative: nerve pain; Back was very tingly; itchy; Very dry skin; very dry skin/it became painful; He is so miserable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: nerve pain), tingling (Verbatim: Back was very tingly), pruritus (Verbatim: itchy), dry skin (Verbatim: Very dry skin), skin pain (Verbatim: very dry skin/it became painful) and feeling miserable (Verbatim: He is so miserable). The patient was treated with pregabalin (Lyrica). The outcome of the nerve pain was resolving and the outcome of the tingling, pruritus, dry skin, skin pain and feeling miserable were not reported.   It was unknown if the reporter considered the nerve pain, tingling, pruritus, dry skin, skin pain and feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain, tingling, pruritus, dry skin, skin pain and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024 This case was reported by a patient's spouse via interactive digital media. The reporter stated that reporter's husband had the shingles vaccine about 5 years ago (from the reporting date). Then a couple months ago, he told his back was very tingly and itchy. The reporter did not check it out but told him that when he went to the doctor next, got her check it out. The reporter looked and said he had very dry skin and used moisturizer on it. But it did not help. And it became painful and moved to his upper abdomen. No rash just pain. It spread across his whole upper abdomen and even up his sides towards his armpits. Went back to the doctor, she referred him to a gastroenterologist or surgeon. He said it must be nerve pain. He was so miserable. The patient said it was the worst pain ever. It was minimally relieved with Narcotics and Lyrica. But he was always sleepy with the medications. They had desperately been trying to research the causes or diagnosis. So the reporter was wondering if it could be shingles. The reporter thought might be the rash was small and went unnoticed since it was on the back. And now he just had the pain.  The reporter stated, might be because patient had the vaccine, he did not get the rash.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: nerve pain; Back was very tingly; itchy; Very dry skin; very dry skin/it became painful; He is so miserable; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: nerve pain), tingling (Verbatim: Back was very tingly), pruritus (Verbatim: itchy), dry skin (Verbatim: Very dry skin), skin pain (Verbatim: very dry skin/it became painful) and feeling miserable (Verbatim: He is so miserable). The patient was treated with pregabalin (Lyrica). The outcome of the nerve pain was resolving and the outcome of the tingling, pruritus, dry skin, skin pain and feeling miserable were not reported.   It was unknown if the reporter considered the nerve pain, tingling, pruritus, dry skin, skin pain and feeling miserable to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain, tingling, pruritus, dry skin, skin pain and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2024 This case was reported by a patient's spouse via interactive digital media. The reporter stated that reporter's husband had the shingles vaccine about 5 years ago (from the reporting date). Then a couple months ago, he told his back was very tingly and itchy. The reporter did not check it out but told him that when he went to the doctor next, got her check it out. The reporter looked and said he had very dry skin and used moisturizer on it. But it did not help. And it became painful and moved to his upper abdomen. No rash just pain. It spread across his whole upper abdomen and even up his sides towards his armpits. Went back to the doctor, she referred him to a gastroenterologist or surgeon. He said it must be nerve pain. He was so miserable. The patient said it was the worst pain ever. It was minimally relieved with Narcotics and Lyrica. But he was always sleepy with the medications. They had desperately been trying to research the causes or diagnosis. So the reporter was wondering if it could be shingles. The reporter thought might be the rash was small and went unnoticed since it was on the back. And now he just had the pain.  The reporter stated, might be because patient had the vaccine, he did not get the rash.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: pain throughout my body all day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Additional patient notes included patient's historical drug included Shingles vaccine for prophylaxis with reaction shingles, reference case US2024AMR031901.   In MAR-2024, the patient received the 2nd dose of Shingles vaccine. In MAR-2024, 1 day after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: pain throughout my body all day). In MAR-2024, the outcome of the general body pain was resolved.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     It was unknown if the company considered the general body pain to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR031901   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient went to regular appointment now in March 2024 and they gave him/her the 2nd dose of Shingles vaccine.  In the end that day patient felt better, the next day patient was experiencing pain throughout body all day. The patient was fine. This case had been link with US2024AMR031901, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR031901:Same patient, different dose (1st dose)
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Havrix (Hepatitis A vaccine) injectable suspension was administered to a patient instead of Hepatitis B vaccine; currently 7-month-old patient received Havrix pediatric; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a infant male patient who received HAV (Havrix pediatric) (batch number g79c4, expiry date 20-SEP-2025) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced wrong vaccine administered (Verbatim: Havrix (Hepatitis A vaccine) injectable suspension was administered to a patient instead of Hepatitis B vaccine) and inappropriate age at vaccine administration (Verbatim: currently 7-month-old patient received Havrix pediatric). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 07-MAR-2024 The health care professional reported that Havrix (Hepatitis A Vaccine) injectable suspension was administered to a patient instead of Hepatitis B vaccine, which led to wrong vaccine administered. No information was provided as to what Hepatitis B vaccine was supposed to had been administered to the patient. An infant patient received Havrix pediatric earlier than the recommended age, which led to an inappropriate age at vaccine administration. The reporter consent to follow up.
Sex: U
Vaccine: DTAP, HIBV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: vaccine error duplicate; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a patient who received Hib UNK (Hib vaccine) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received Hib vaccine and DTaP vaccine. On an unknown date, an unknown time after receiving Hib vaccine and DTaP vaccine, the patient experienced wrong vaccine administered (Verbatim: vaccine error duplicate). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 08-MAR-2024 It was reported that practice had a vaccine error duplicate on 18 month vaccines given, Hib and Dtap which led to wrong vaccine administered.
Age: 47.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was inadvertently administered with 2nd dose of Twinrix 7 days before due date; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 47-year-old female patient who received HAB (Twinrix) (batch number H3SG9, expiry date 03-JAN-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE INACT;HEPATITIS B VACCINE RHBSAG (YEAST) (TWINRIX).   On 07-MAR-2024, the patient received the 2nd dose of Twinrix. On 07-MAR-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too short (Verbatim: patient was inadvertently administered with 2nd dose of Twinrix 7 days before due date). The outcome of the drug dose administration interval too short 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: 11-MAR-2024 The nurse reported that a patient was inadvertently administered with 2nd dose of Twinrix 7 days before due date, which led to shortening of the vaccine schedule. The first dose of Twinrix administered on 15-FEB-2024 from batch number H3SG9 with expiry date 03-JAN-2025. Both vaccines had same lot number and were given in the same facility.  The vaccine administration facility was the same as primary reporter.
Age: 32.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy
Clinical narrative: Drug Exposure During Pregnancy; We gave Infanrix to a 32-year-old patient; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 32-year-old female patient who received DTPa (Infanrix) (batch number 9R2D7, expiry date 23-MAY-2025) for prophylaxis.   On 12-MAR-2024, the patient received Infanrix. On 12-MAR-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: We gave Infanrix to a 32-year-old patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Infanrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   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: 12-MAR-2024 The medical assistant informed that they gave Infanrix to a patient who was currently pregnant with a high-risk pregnancy. The vaccine administration facility was the same as primary reporter. The patient received Infanrix vaccine above than the recommended age limit, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: incidence of shingles after the series of Shingrix / Suspected vaccination failure; incidence of shingles after the series of Shingrix; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 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: incidence of shingles after the series of Shingrix / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: incidence of shingles after the series of Shingrix). 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 Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 13-MAR-2024 The healthcare professional requested data about the incidence of shingles after the series of Shingrix.  Possible adverse event collected. The vaccine administration facility was the same as primary reporter. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: CLAIMS TO HAVE NOT BEEN THE SAME SINCE THE COVID-19 VACCINE; This spontaneous report received from a patient via social media site concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1) ((suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced claims to have not been the same since the covid-19 vaccine (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of claims to have not been the same since the covid-19 vaccine was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Neck pain, Vaccination site pain
Clinical narrative: intense muscle pain at the neck; intense muscle pain at the injection site; intense muscle pain at the shoulders; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (intense muscle pain at the neck), VACCINATION SITE PAIN (intense muscle pain at the injection site) and ARTHRALGIA (intense muscle pain at the shoulders) in a 51-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031707) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included COVID-19 on 18-Dec-2023.   On 21-Feb-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 50 microgram and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 23-Feb-2024, the patient experienced NECK PAIN (intense muscle pain at the neck), VACCINATION SITE PAIN (intense muscle pain at the injection site) and ARTHRALGIA (intense muscle pain at the shoulders). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NECK PAIN (intense muscle pain at the neck), VACCINATION SITE PAIN (intense muscle pain at the injection site) and ARTHRALGIA (intense muscle pain at the shoulders) had resolved.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that, the patient experienced intense muscle pain at the injection site, shoulders, and neck, lasting for three weeks following the shot. He had to resort to taking ibuprofen for relief. The patient did not experience any additional symptoms or events.
Age: 0.42
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Extra dose administered
Clinical narrative: Patient was inadvertently given two doses of Vaxelis at the same visit
Age: 64.0
Sex: M
Vaccine: RSV
Symptoms: Urticaria
Clinical narrative: Patient reports that beginning the day after vaccination, he experienced widespread hives after eating and drinking. The rash lasted about 6 hours each time. This continued for about one week.
Age: 2.0
Sex: M
Vaccine: DTAPIPVHIB, HEPA, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Left thigh swelling developed one day after vaccine and increased by the third day. No pain
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine was administered after the beyond use date of 3/16/24.  No adverse effects reported by patient at time of this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 52-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccination and did not receive other medication in 2 weeks. Paxlovid was given as treatment for COVID-19 from 05Mar2024 to 10 Mar2024.  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: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile and temporal association.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza
Clinical narrative: get sick; felt like she had the flu; This is a spontaneous report received from a Nurse.  A 70-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Aortic aneurysm" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "severe arthritis" (unspecified if ongoing); "cardiac issues" (unspecified if ongoing); "Lung mass", start date: 2007 (unspecified if ongoing), notes: has not changed since 2007. Guesses she is sitting pretty good.; "Hypertension" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "triglycerides" (unspecified if ongoing); "Depression" (unspecified if ongoing); "extreme anxiety" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "spina bifida" (unspecified if ongoing), notes: L4, L5. The patient's concomitant medications were not reported. Past drug history included: Pneumovax, start date: 2000. Vaccination history included: Moderna (DOSE NUMBER UNKNOWN, SINGLE; Lot number: unknown), for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "get sick"; INFLUENZA (non-serious), outcome "unknown", described as "felt like she had the flu".  Additional information: First, this whole Covid thing. Had been receiving Moderna products. At one point, was due for update, her pharmacy only had Pfizer so, she took Pfizer. Had side effects, did get sick.  Never got sick with Moderna, not once. Had 1 Pfizer Covid vaccine because it was all the pharmacy had available, did not want to take the risk. Clarified, after the one time Pfizer Covid vaccine, went right back to Moderna. Just had the one dose Pfizer.  The next day after the Pfizer Covid vaccine, felt like she had the flu. Never felt that with Moderna.   Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Wellbutrin, reaction(s): "Known allergies: Wellbutrin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid with treatment start date on 06Mar2024 and treatment stop date on 11Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.