chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: The first one made me a little sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: The first one made me a little sick). The outcome of the sickness was not reported.   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.   Additional Information: GSK Receipt Date: 06-MAR-2024 This case was reported by a patient via interactive digital media. The patient was so glad he/she got the doses. The first dose made him/her a little sick, but the second dose was no problem at all. The reporter was very grateful that they exist to avoid this horrible sickness.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza, Pyrexia
Clinical narrative: Slight fever; Flu symptoms; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-MAR-2024, the patient received the 1st dose of Shingles vaccine. In MAR-2024, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: Slight fever) and flu symptoms (Verbatim: Flu symptoms). The outcome of the fever and flu symptoms were resolving.   It was unknown if the reporter considered the fever and flu symptoms to be related to Shingles vaccine.     It was unknown if the company considered the fever and flu symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 07-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the first dose two days ago (from the reporting date). The patient ran a slight fever, and felt flu symptoms.  The patient felt like it was almost gone then. Not really bad or anything.  The patient heard that second shot made you feel bad as well.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: allergy reaction; itching; 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: allergy reaction) and pruritus (Verbatim: itching). The patient was treated with diphenhydramine hydrochloride (Benadryl). The outcome of the allergic reaction and pruritus were not reported.   It was unknown if the reporter considered the allergic reaction and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the allergic reaction and pruritus to be related to Shingles vaccine.   Additional Information: GSK received date: 07-Mar-2024 This case was reported by a patient via interactive digital media. Patient took Benadryl for the allergy reaction. Patients head took spells itching but no breakout since and patient prayed that he/she did not.
Sex: U
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Pain, Subcutaneous abscess
Clinical narrative: I have developed abscesses (2) in the armpit of the arm in which i received that shot; painful; limiting my activities; This non-serious case was reported by a consumer via call center representative and described the occurrence of abscess limb in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced abscess limb (Verbatim: I have developed abscesses (2) in the armpit of the arm in which i received that shot), pain (Verbatim: painful) and activities of daily living impaired (Verbatim: limiting my activities). The outcome of the abscess limb, pain and activities of daily living impaired were not reported.   It was unknown if the reporter considered the abscess limb, pain and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the abscess limb, pain and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2024 The patient self-reported this case. The patient recently had his/her second Shingles shot in the series and he/she had developed abscesses (2) in the armpit of the arm in which patient received that shot. The reporter asked, did the 2nd Shingles shot cause abscesses and could Shingrix cause chickenpox. The patient received reply via visitor chatbot agent. The patient said that he/she tried to find out if the 2nd Shingrix shot could cause abscess. The patient researched this on the internet and some articles indicated that the side effects for the 2nd dose could be more severe. The patient further said that he/she was going to see his/her CRNP (certified registered nurse practitioner) later and try to get these drained, they were painful and limiting his/her activities.
Sex: U
Vaccine: RSV
Symptoms: Confusional state
Clinical narrative: confusion; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of confusion in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced confusion (Verbatim: confusion). The outcome of the confusion was not reported.   It was unknown if the reporter considered the confusion to be related to Arexvy.     It was unknown if the company considered the confusion to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-MAR-2024.  This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The reporter asked that did the RSV could cause confusion.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: So painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced pain (Verbatim: So painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK received date: 09-Mar-2024 This case was reported by a patient via interactive digital media. Patient had a small case with shingles. It was so painful. Patient got the shot and it felt like he/she got hit by a bus the 2nd day. The follow-up could not be possible as no contact details were available. This case had been linked with US2024GSK035587, reported by same reporter.; Sender's Comments:  US-GSK-US2024GSK035587:Same patient (case for 2nd dose)
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm was sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK received date: 09-Mar-2024 This case was reported by a patient via interactive digital media. Patient had shingles and it was rough. The newer vaccine came out and patient got the 2 shots. Patient's arm was sore a bit but compared to shingles.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: broke out in rashes on my neck; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced rash (Verbatim: broke out in rashes on my neck). The outcome of the rash was not reported.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.   It was unknown if the company considered the rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and broke out in rashes on his/her neck. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK received date: 09-Mar-2024 This case was reported by a patient via interactive digital media. Patient stated, be very careful with the shot. Patient got very sick when he/she got the Shingrix shot. This case had been linked with US2024AMR032486, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR032486:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: in bed for three days after getting the shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of bedridden 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 bedridden (Verbatim: in bed for three days after getting the shot). The outcome of the bedridden was resolved (duration 3 days).   It was unknown if the reporter considered the bedridden to be related to Shingles vaccine.     It was unknown if the company considered the bedridden to be related to Shingles vaccine.   Additional Information: GSK received date: 09-Mar-2024 This case was reported via interactive digital media. Reporter knew of someone (patient) that was in bed for three days after getting the shot. This case had been linked with US2024AMR032482, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR032482:Same reporter, reporter's case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; Pain; 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 Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and pain (Verbatim: Pain). The outcome of the shingles was not reported and the outcome of the pain was resolved (duration 2 months).   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the shot and next day had shingles. Pain lasted for 2 months. Terrible. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Vaccine positive rechallenge
Clinical narrative: sick with both shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: sick with both shots). Rechallenge with Shingles vaccine was positive. The outcome of the sickness was not reported.   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: US2024AMR029463   Additional Information: GSK Receipt Date: 05-MAR-2024 This case was reported by a patient via interactive digital media. The patient was glad that he/she got the shingles vaccination, however it was not easy.  The patient was so sick with the shot.; Sender's Comments:  US-GSK-US2024AMR029463:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Illness, Influenza like illness
Clinical narrative: Really sick; Flu / felt like she had the flu; Shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced sickness (Verbatim: Really sick), influenza like illness (Verbatim: Flu / felt like she had the flu) and shingles (Verbatim: Shingles). The outcome of the sickness, influenza like illness and shingles were unknown.   It was unknown if the reporter considered the sickness, influenza like illness and shingles to be related to Shingrix.     It was unknown if the company considered the sickness, influenza like illness and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2024 The patient friend reported that that the patient received her first dose only of the shingles vaccine in the fall of 2023. The reported that within a week of receiving the first dose, felt like she had the flu, was really sick, and had shingles. The reporter did not had an exact date of when the patient received the first dose and did not know the name of the vaccine as Shingrix itself when she called. The reported that the product was not confirmed. The reporter had reported all that was provided for this adverse event. The patient was not on the phone, so consent to follow up with healthcare professional was not asked.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix - Late second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago).   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: Shingrix - Late second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 08-MAR-2024 The reporter was concerned if the patient needed to re start the series of Shingrix. The permission to follow up was not requested. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case had been linked to US2024031103, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024031103:2nd patient case
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong product administered
Clinical narrative: inadvertently administered Fluarix instead of a Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 46-year-old male patient who received Flu Seasonal TIV Dresden (Fluarix) for prophylaxis.   On 07-MAR-2024, the patient received Fluarix. On 07-MAR-2024, an unknown time after receiving Fluarix, the patient experienced wrong vaccine administered (Verbatim: inadvertently administered Fluarix instead of a Boostrix). The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-MAR-2024 The reporter called to inquired that how to processed and asked for recommendation. Reporter reported that a patient was inadvertently administered Fluarix instead of a Boostrix day before of reporting day, which led to wrong vaccine administered. The reporter consented to follow-up.
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix + older than recommended age; 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 9-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 08-MAR-2024, the patient received Kinrix. On 08-MAR-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix + older than recommended age). 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: 08-Mar-2024 The reporter reported that the Kinrix vaccine was administered to a 9 years old. The lot number was not reported. The patient received Kinrix vaccine who was older than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received their first dose of Shingrix two years ago at age 48 years.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 48-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Patient received their first dose of Shingrix two years ago at age 48 years.). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 11-MAR-2024 The health care professional (HCP) reported on behalf of patient.  The patient was now 50 and would take the 2nd dose. Patient received their first dose of Shingrix two years ago at age 48 years, which led to inappropriate age at
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: diluting the lyophilized component with sterile solution instead of the right adjuvant suspension; used unapproved diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 06-MAR-2024, the patient received the 1st dose of Shingrix. On 06-MAR-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: diluting the lyophilized component with sterile solution instead of the right adjuvant suspension) and inappropriate dose of vaccine administered (Verbatim: used unapproved diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 11-MAR-2024 The nurse explained that a medical assistant administered 1 dose of Shingrix diluting the lyophilized component with sterile solution instead of the right adjuvant suspension, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The caller did not have patient initials, lot number or expiration date on hand.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Maladministration of shingrix after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients 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 incorrect storage of drug (Verbatim: Maladministration of shingrix after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 11-MAR-2024 The Shingrix vials were storage in the freezer because healthcare professional's provider told her to do so.  The vaccines were out of range for 3 hours and 17 minutes and lowest temperature was -12.2 degree C and Shingrix vials were administered to patients between November 2023 to January 2024, which led to incorrect storage of vaccine. The reporter needed time to run the report and have additional details on this case. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received a first dose 7 months ago can receive a late second dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately 7 months ago prior to the reporting).   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 a first dose 7 months ago can receive a late second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-Mar-2024 The reporter reported that the patient received a first dose 7 months ago the approximate date, pharmacist does not know exact date. The reporter wanted to know if patient can receive a late second dose of Shingrix vaccine. The vaccine administration facility was the same as primary reporter. The reporter declined to provide adverse event information since she stated that no adverse event was present for this inquiry and requested to had information verbally. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal disorder, Neuropathy peripheral, Pain, Pain in extremity
Clinical narrative: neuropathy like shingles in both hands; Patient reports pain in both hands; I am in a lot of pain; hands are very dysfunctional; This serious case was reported by a nurse via call center representative and described the occurrence of peripheral neuropathy in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis and fibromyalgia.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced peripheral neuropathy (Verbatim: neuropathy like shingles in both hands) (serious criteria GSK medically significant), pain in hand (Verbatim: Patient reports pain in both hands), pain (Verbatim: I am in a lot of pain) and upper extremity dysfunction (Verbatim: hands are very dysfunctional). The outcome of the peripheral neuropathy, pain in hand and pain were not resolved and the outcome of the upper extremity dysfunction was not reported.   It was unknown if the reporter considered the peripheral neuropathy, pain in hand, pain and upper extremity dysfunction to be related to Shingrix.     It was unknown if the company considered the peripheral neuropathy, pain in hand, pain and upper extremity dysfunction to be related to Shingrix.   Additional Information: GSK Receipt date: 12-MAR-2024 The reporter was a patient. Patient reported that she received her Shingrix vaccine several weeks ago from reporting day, sometime at the end of January or the beginning of February 2024. Patient reported that the vaccine was administered at local pharmacy, and after administration of vaccine patient developed neuropathy like shingles in both hands. Patient reported that pain in hand. Patient reported that her hand are very dysfunctional and she was in a lot of pain. Patient reported that it hurts so much that even she holding the phone get hurts. Patient reported that the pain was worse in the left hand. Patient was also a nurse and inquired was it possible that the vaccine caused it. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number 4N9PSS, expiry date 12-DEC-2025) for prophylaxis.   On 12-MAR-2024, the patient received Shingrix. On 12-MAR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component)) and inappropriate dose of vaccine administered (Verbatim: Maladministration of AS01B Adjuvant of Shingrix (without the Lyophilized Antigen Component)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-MAR-2024 The pharmacist reported that the patient was received only the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was same the same as primary reporter. The reporter consent to follow up via email.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Underdose; Engerix - B Misadministration  of pediatric dose to an adult patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2025) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Underdose) and adult use of a child product (Verbatim: Engerix - B Misadministration  of pediatric dose to an adult patient.). The outcome of the underdose and adult use of a child product were 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: 12-MAR-2024 The medical assistant reported that administration of pediatric dose to an adult, which led to adult use of a child product and underdose. The reporter was asked if patient was still on the clinic and she answered yes. The vaccine administration facility was same the same as primary reporter. The reporter consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation
Clinical narrative: COVID-19; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient experienced drug allergy when treated with tozinameran (dose number in series 1) for covid-19 prophylaxis, drug allergy when treated with amoxicillin, and codeine. The patient received covid-19 vaccine ad26.cov2.s(dose umber in series 1 (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 17-SEP-2021 13:00 to Left Arm for covid-19 prophylaxis. The batch  number was not reported. we are unable to perform follow to request batch/lot numbers. Concomitant medications included ibuprofen. On 05-MAR-2024 , the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). On 05-MAR-2024, the patient experienced covid-19 (dose number in series 2). Treatment medications (dates unspecified) included: nirmatrelvir/ritonavir. After taking Paxlovid for 5 days, Patient test results were a faint second line. Four days later, patient test result is a vivid second line. Some additional coughing and back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis atopic, Headache
Clinical narrative: Dermatitis atopic aggravated; Headache; This spontaneous case was reported by a patient and describes the occurrence of DERMATITIS ATOPIC (Dermatitis atopic aggravated) and HEADACHE (Headache) in a 62-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis.    Concurrent medical conditions included Headache (had headache since college) and Dermatitis atopic.   On 17-Nov-2020, the patient DUPILUMAB (DUPIXENT) (Subcutaneous use) dosage was changed to 600 milligram once a day. On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and DUPILUMAB (DUPIXENT) (Subcutaneous use) 300 milligram every three weeks. On an unknown date, the patient experienced DERMATITIS ATOPIC (Dermatitis atopic aggravated) and HEADACHE (Headache). At the time of the report, DERMATITIS ATOPIC (Dermatitis atopic aggravated) and HEADACHE (Headache) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No past drugs or family history was reported.  It was reported that, since starting the Dupixent medication, about 8 hours after each injection, the patient experienced a headache that lasted for approximately 12 hours (onset given as Nov 2020) and headaches did not happen immediately after the injections.  The patient's doctor told her to take regular headache medicine if she needed as treatment. The patient was due for second dose of Moderna vaccine. The patient reported that, she was forced to go without medication for approximately 5 months and her condition became worse (dermatitis atopic) (onset: unknown).  Action taken for Dupixent was given as no action taken for headache and not applicable for dermatitis atopic aggravated.  Causality of Dupixent was given as related for dermatitis atopic aggravated and not reported for headache.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Tinnitus
Clinical narrative: Ringing in Ear; Tingling in Hands and Feet; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Ringing in Ear) and PARAESTHESIA (Tingling in Hands and Feet) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) .5 milliliter. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to .5 milliliter. On 15-May-2021, the patient experienced TINNITUS (Ringing in Ear) and PARAESTHESIA (Tingling in Hands and Feet). At the time of the report, TINNITUS (Ringing in Ear) and PARAESTHESIA (Tingling in Hands and Feet) had not resolved.            No concomitant medications were reported. Patient received 0.5 ml of MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 13-Oct-2022 Intramuscularly. Batch number of the vaccine was reported as 053D22A. It was unknown if the patient experienced any additional symptoms/events. Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 38-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: "Asthma" (unspecified if ongoing); "insulin resistance" (unspecified if ongoing); "known allergies: coffee" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: Iodine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Mar2024 to 05Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a healthcare professional.  A 60-year-old female patient (not pregnant) received BNT162b2 OMI XBB.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Oct2023 as dose 1, single (Batch/Lot number: unknown) at the age of 59 years for COVID-19 immunisation. The patient's relevant medical history included: "Allergies to sulfa" (unspecified if ongoing); "Chronic allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "recovered with sequelae" (Mar2024) and all described as "COVID-19". Therapeutic measures were taken as a result of the events which included nirmatrelvir/ ritonavir (PAXLOVID) from 06Mar2024 to 11Mar2024 as antiviral.  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: Based on the information currently available, a lack of efficacy with BNT162b2 OMI XBB.1.5 in this patient cannot be completely excluded.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non-HCP. The patient is the reporter.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 at 16:00 as DOSE 3 (BOOSTER), SINGLE (batch/lot number: unknown) at the age of 68 years for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as DOSE 1, SINGLE (batch/lot number: unknown) and as DOSE 2, SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Prostate CA" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Known allergies: Muscle relaxants" (unspecified if ongoing), notes: Known allergies: Muscle relaxants. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19." Therapeutic measures were taken as a result of Drug ineffective, Covid-19. Patient received Paxlovid from 08Mar2024 to 13Mar2024.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.
Sex: M
Vaccine: PNC20
Symptoms: Bone pain, Mobility decreased
Clinical narrative: Felt like his bones all filled with crushed glass; most painful thing; Could not move; could barely get out of bed or move around; This is a spontaneous report received from a nurse.  A male patient received pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BONE PAIN (non-serious), outcome "unknown", described as "Felt like his bones all filled with crushed glass; most painful thing"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "Could not move; could barely get out of bed or move around".  Additional Information: On13Mar2024 (Wednesday), the reporting nurse spoke to the patient (counselor) about her own adverse reaction with the product and the patient said the same thing happened to him. The patient felt like his bones all filled with crushed glass, and he could not move. The patient had the same feeling the nurse had. They did not know what this is, this side effect if anybody knows about it or what. It was the most painful thing ever. The patient could barely get out of bed or move around, spent the whole entire day on the couch, and never felt anything like this before.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (Diphtheria CRM 197 Protein) will be requested and submitted if and when received.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Inflammation, Neuralgia, Pain in extremity
Clinical narrative: Guillain-Barre disease which is a nerve disease caused by Pfizer; Nerves are screaming with pain; Had this for a whole months and spreading to his right arm and nerves; Arms being in pain so terrible, the nerves; Pfizer shot is affected his nerves; Inflammation; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 91-year-old male patient received BNT162b2 (BNT162B2 NOS), in Sep2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 90 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre disease which is a nerve disease caused by Pfizer"; NEURALGIA (non-serious), outcome "unknown", described as "Nerves are screaming with pain; Had this for a whole months and spreading to his right arm and nerves"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arms being in pain so terrible, the nerves; Pfizer shot is affected his nerves"; INFLAMMATION (non-serious), outcome "unknown". The events "nerves are screaming with pain; had this for a whole months and spreading to his right arm and nerves", "arms being in pain so terrible, the nerves; pfizer shot is affected his nerves" and "inflammation" required physician office visit. Therapeutic measures were taken as a result of neuralgia, pain in extremity, inflammation.  Clinical courses: Patient received a COVID-19 Pfizer shot in his arms, the nerves are screaming with pain and he went to the doctor and they give him some reliever pain relieve Inflammation but now he had this for a whole months and spreading to his right arm and nerves and he had been reading about just Guillain-Barre disease caused by Pfizer shot and he wondered do we have any recommendation what he should do about his arms being in pain so terrible, the nerves. The Pfizer shot is affected his nerves. Treatment: Pill for Inflammation. No previous immunization with Pfizer Vaccine. No any vaccine administered on the same date. No other vaccinations four weeks prior to COVID Vaccine.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Guillain-Barre syndrome, Neuralgia, Pain in extremity
Clinical narrative: Guillain Barre syndrome; shoulder at the back side had pain; nerve pain; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 92-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain Barre syndrome"; ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder at the back side had pain"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain". Clinical course:  Caller got the RSV (Abrysvo vaccine). He woke up then his left shoulder at the back side had pain. It was terrible. The next day, it was his front side, then it went all the way down his arm, the nerve pain. It lasted for about 10 days. Now it's in his right arm that his nerves are in pain. Caller wonders if this is because of the Guillain Barre syndrome. The patient asked whether the nerves in arm pain terrible. It said it is possibly spread through the brain. Caller wants to know if there's any treatment he can get for the nerve damage.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain in jaw, Transient ischaemic attack
Clinical narrative: Severe Headache, sore throat, TMJ pain since administration of vaccine and headache and TMJ pain  getting worse. on March 19th had one episode of mini stroke.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: wanted to report that 2 inches on each side of where she got the Covid shot on 03/12/24 on right arm. hot to touch and red.  no limitation with moving no fever/chills a little bit uncomfortable/discomfort. feels like she just got a vaccine. no rash whole body no itching no swelling
Age: 18.0
Sex: F
Vaccine: YF
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine was given intramuscular route instead of subcutaneous route
Age: 65.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Pancreatitis acute
Clinical narrative: acute pancreatitis; 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 17Dec2023 at 10:45 as dose 1, single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 17Dec2023 as dose 1, single, in left arm for immunisation. The patient's relevant medical history included: "iodine contrast agent allergy" (unspecified if ongoing). The patient did not have COVID-19 prior to vaccination. Concomitant medication(s) included: HYZAAR; SIMVASTATIN; PHENYTOIN; VIT D3. The patient also took other concomitant therapy with an unspecified multi-vitamin. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: PANCREATITIS ACUTE (hospitalization) with onset 23Dec2023 at 07:30, outcome "recovering", described as "acute pancreatitis". The patient was hospitalized for pancreatitis acute (hospitalization duration: 6 day(s)). The event "acute pancreatitis" required emergency room visit. The clinical course was reported as follows: The patient was diagnosed with acute pancreatitis 6 days after the vaccine was hospitalized for 6 days. All the usual causes of pancreatitis were ruled out in the hospital and still investigating what may have caused this. Therapeutic measures were taken as a result of pancreatitis acute with pain medication and fluid therapy. The patient was not tested for COVID-19 post vaccination.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had 3 covid shots, all of them from Pfizer and still got covid; had 3 covid shots, all of them from Pfizer and still got covid; This is a spontaneous report received from a Consumer or other non HCP.  A 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: "sinus infection", start date: Feb2022 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "recovered" (05Mar2024) and all described as "had 3 covid shots, all of them from Pfizer and still got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Mar2024) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 25Feb2024 to 01Mar2024. Clinical course: The reporter reported that patient had 3 covid shots, all of them from Pfizer and still got covid.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.