chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Inadequate aseptic technique in use of product
Clinical narrative: Patient came in to get a flu shot. Per patient, when staff prepared to give the shot, her needle lid fell on the floor and she bent to pick it up and screamed. The Pharmacist on duty ran to administration site to see what happened and if staff was okay. She said she was fine and had things handled. Staff did not change the needle topper after this and still continued to give the patient the shot.  The patient felt uncomfortable and felt slighted/endangered. She was given paperwork to have tests performed courtesy of pharmacy. An apology was rendered. Per staff, she pricked her finger after trying to re-cap the needle.
Age: 1.92
Sex: F
Vaccine: IPV, UNK
Symptoms: Fatigue, Gait disturbance, Gait inability, Inflammation, Joint swelling
Clinical narrative: Side effects post vaccines - swollen left knee, stiff, inflammation, unable to walk, climb stairs. Feeling fatigued more than unusual. Limping  2-3 weeks post vaccines. Noticed swelling in knee. Still showing side effects 3 months post vaccines
Age: 1.92
Sex: F
Vaccine: IPV, UNK
Symptoms: Musculoskeletal stiffness
Clinical narrative: Side effects post vaccines - swollen left knee, stiff, inflammation, unable to walk, climb stairs. Feeling fatigued more than unusual. Limping  2-3 weeks post vaccines. Noticed swelling in knee. Still showing side effects 3 months post vaccines
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion
Clinical narrative: congestion x 5 days, felt better after
Age: 33.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory tract congestion
Clinical narrative: congestion x 1 week, felt better after
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Eye pain, Eye pruritus, Eyelid pain, Lacrimation increased, Photophobia
Clinical narrative: Slight fever, very bad watering of the eyes, couldn't open my eyes when exposed to bright light like my phone screen, pain in the eye ducts, slight pain by eye lashes, itching around the eyes, and swelling of the eyelids.
Age: 25.0
Sex: M
Vaccine: FLUC4
Symptoms: Pyrexia, Swelling of eyelid
Clinical narrative: Slight fever, very bad watering of the eyes, couldn't open my eyes when exposed to bright light like my phone screen, pain in the eye ducts, slight pain by eye lashes, itching around the eyes, and swelling of the eyelids.
Age: 12.0
Sex: F
Vaccine: TD
Symptoms: Wrong product administered
Clinical narrative: RECEIVED TD INSTEAD OF TDAP
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Disorientation, Dizziness, Immediate post-injection reaction, Loss of consciousness, Pallor
Clinical narrative: Patient received boostrix vaccine in left arm first, was responsive and talking. Then was given the engerix-b vaccine and after injection immediately passed out. She was out for around 2 minutes and unresponsive to shouting,  pale in the face, and also voided during this time. The patient then became conscious and was disorientated so my other technician stated that she was at the pharmacy getting the vaccine. Patient was still very dizzy after passing out and was given skittles and an apple juice. After around 5-10 minutes was still not feeling good enough to walk so we called in a family medicine doctor from across the hallway. She evaluated her and said she should be okay. Patient's husband picked up the patient because she was not capable of driving. When she left 1 hr and 1/2 later she was feeling much better.
Age: 28.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Patient received boostrix vaccine in left arm first, was responsive and talking. Then was given the engerix-b vaccine and after injection immediately passed out. She was out for around 2 minutes and unresponsive to shouting,  pale in the face, and also voided during this time. The patient then became conscious and was disorientated so my other technician stated that she was at the pharmacy getting the vaccine. Patient was still very dizzy after passing out and was given skittles and an apple juice. After around 5-10 minutes was still not feeling good enough to walk so we called in a family medicine doctor from across the hallway. She evaluated her and said she should be okay. Patient's husband picked up the patient because she was not capable of driving. When she left 1 hr and 1/2 later she was feeling much better.
Age: 52.0
Sex: U
Vaccine: COVID19-2, FLU4
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Did not feel well after vaccination; body ache, fever but states did get flu shot same day
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Pain, Rash, Rash erythematous
Clinical narrative: Patient noticed a red rash on injection site that spread up the arm and to the neck. Rash was not hot to the touch. Patient also complained about muscle pain in the right arm where IMZ was given, and the pain was spreading as well.
Age: 24.0
Sex: F
Vaccine: RSV, TDAP, RSV, TDAP
Symptoms: Cervical dilatation, Exposure during pregnancy, Premature delivery, Premature rupture of membranes
Clinical narrative: Patient received both the Abrysvo and Boostrix vaccines on 02-23-2024. The due date for the baby was 03-24-2024; however, the time of birth was early after having received the Abrysvo (RSV) vaccine. Patient is concerned by the information regarding possibility of pre-term due to the vaccine. After birth, the baby experienced brain bleeds and seizures, which resulted in hydrocephalus and brain damage. Treatment is ongoing for baby at this time. Baby's birth weight was 6 pounds 5 ounces. Patient describes having lost mucus plug week prior to delivery date 3-7-24; water breaking without having contractions.
Age: 18.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Blood pressure decreased, Dizziness, Hyperhidrosis, Pallor, Presyncope
Clinical narrative: Approximately 10 minutes after Afluria was administered, the patient started blacking out, becoming pale and sweating profusely.  She remained conscious and stated she was not having difficulty breathing.  We sat her down and drank some water and had a snack.  Within 5 minutes she was visibly less pale and not sweating as much.  Upon the arrival of EMT after another 5 minutes, her blood pressure was noted to be "low" and by this time she was fully awake and feeling better though still a little dizzy.  Her mother stated they would go to the hospital for further evaluation.
Age: 17.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 66.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 14.0
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine given past used by date, no reaction
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gave vaccine on day 28 instead of day 30. Not given within time frame (dose is still valid and doesn't need repeated)
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, MMRV, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Injection site redness and warmth
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: vaccine past used by date, no reaction
Sex: F
Vaccine: MMR
Symptoms: Areflexia, Autonomic nervous system imbalance, Cerebral atrophy, Death, Imaging procedure abnormal
Clinical narrative: receiving a dose of MMR vaccine with subsequent T cell harvest for donor lymphocyte infusion;   This literature marketed report has been received from the authors of a published literature article, titled as stated above, and refers to a 1-year-old female patient with no significant past medical history. Concomitant medications were not provided. Concurrent condition included acute myeloid leukemia. On an unknown date, the patient attended her 1-year well-child visit and received age-appropriate vaccinations.  The patient's medical history included: blood stem cell transplant. The patient's concurrent conditions included: hypogammaglobulinaemia, drug eruption,  measles post vaccine, hospitalisation, encephalitis viral, and acute myeloid leukaemia. Historical drugs included:  (PROQUAD) vitamin a,  immunoglobulin, and methylprednisolone. Concomitant medications included: ribavirin, interferon alfa and inosine pranobex.  On an unknown date, her father consented to receiving a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection,  (strength, dose, lot#, expiration date, indication,  route of administration and anatomical site of vaccination were not provided), vaccine with subsequent T cell harvest for donor lymphocyte infusion. (Product use in unapproved indication). Despite these interventions, she had persistent respiratory failure, dysautonomia, elevated opening pressure and bilateral upper extremity myoclonus with nonreactive pupils and lack of gag reflex. Repeat imaging showed progressive findings and brain atrophy. Following multidisciplinary discussion with family, the patient was discharged for compassionate extubation at home surrounded by her family, outcome of event encephalitis viral was fatal. MeV immunohistochemistry was performed with 1 scant block, there was no immunohistochemical evidence of MeV.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of 2 reports derived from the same literature article (cross referenced with 2403USA003613).  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-MLMSERVICE-20240304-4863795-1:
Sex: F
Vaccine: MMR
Symptoms: Immunohistochemistry, Intracranial pressure increased, Myoclonus, Pupil fixed, Respiratory failure
Clinical narrative: receiving a dose of MMR vaccine with subsequent T cell harvest for donor lymphocyte infusion;   This literature marketed report has been received from the authors of a published literature article, titled as stated above, and refers to a 1-year-old female patient with no significant past medical history. Concomitant medications were not provided. Concurrent condition included acute myeloid leukemia. On an unknown date, the patient attended her 1-year well-child visit and received age-appropriate vaccinations.  The patient's medical history included: blood stem cell transplant. The patient's concurrent conditions included: hypogammaglobulinaemia, drug eruption,  measles post vaccine, hospitalisation, encephalitis viral, and acute myeloid leukaemia. Historical drugs included:  (PROQUAD) vitamin a,  immunoglobulin, and methylprednisolone. Concomitant medications included: ribavirin, interferon alfa and inosine pranobex.  On an unknown date, her father consented to receiving a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), injection,  (strength, dose, lot#, expiration date, indication,  route of administration and anatomical site of vaccination were not provided), vaccine with subsequent T cell harvest for donor lymphocyte infusion. (Product use in unapproved indication). Despite these interventions, she had persistent respiratory failure, dysautonomia, elevated opening pressure and bilateral upper extremity myoclonus with nonreactive pupils and lack of gag reflex. Repeat imaging showed progressive findings and brain atrophy. Following multidisciplinary discussion with family, the patient was discharged for compassionate extubation at home surrounded by her family, outcome of event encephalitis viral was fatal. MeV immunohistochemistry was performed with 1 scant block, there was no immunohistochemical evidence of MeV.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of 2 reports derived from the same literature article (cross referenced with 2403USA003613).  Lot # is being requested and will be submitted if received.; Sender's Comments:  US-MLMSERVICE-20240304-4863795-1:
Age: 3.0
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; IMPROPER STORAGE; This spontaneous report has been received from a Medical Assistant, regarding to a 3-year-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.  On 15-JUN-2024, the patient was vaccinated (at the age of 3-years-old) with an improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) subcutaneous injection, in the Left Arm (lot  number x019104, expiration date: 16-JUL-2025); varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous Injection, in the Right Arm (lot number y003893, expiration date: 06-FEB-2026) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) in the Right Arm (lot number: y003893, expiration date: 06-FEB-2026) all administered subcutaneously as prophylaxis (Doses was not provided).   Administered doses were stored at a temperature of 46.6 degrees Fahrenheit (F), during a time frame of 33 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.  This is one of two reports from same report.
Age: 17.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects or symptoms reported.; PROQUAD inadvertently administered to a 17-year-old patient on 08/19/2024.; This spontaneous report has been received by a nurse regarding a 17-years-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 19-AUG-2024, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) formulation as default: injection (strength, dose, frequency, route of administration, vaccination scheme, site of administration, lot #, and expiration date were not reported) as prophylaxis (product administered to patient of inappropriate age). No side effects or symptoms reported. No further information provided.  Lot # were being requested and will be submitted if received.
Age: 1.25
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC; HCP called to report inadvertent administration of one dose of GARDASIL 9 to a 15-month-old patient on 13AUG2024; This spontaneous report was received from a nurse regarding to a 15-month-old patient of unknown gender. The patient's medical history, concomitant therapies, dug reactions or allergies were not reported.  On 13-AUG-2024, the patient was inadvertent vaccinated with human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (strength, dose, frequency, route of administration, anatomical injection site, lot number and expiration date were not provided) for prophylaxis (product administered to patient of inappropriate age).   No additional information was provided. No additional adverse event (AE)/product quality complaint (PQC) (no adverse event).  Lot number is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain, Skin erosion, Sleep disorder
Clinical narrative: Suspected vaccination failure; Shingles; pain; headache; Hard to sleep; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: pain), headache (Verbatim: headache) and trouble falling asleep (Verbatim: Hard to sleep). The patient was treated with diphenhydramine hydrochloride (Benadryl) and ibuprofen. The outcome of the vaccination failure was not reported and the outcome of the shingles, pain, headache and trouble falling asleep were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, headache and trouble falling asleep to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. It was unknown if the company considered the shingles, pain, headache and trouble falling asleep to be related to Shingrix.   Additional Information: GSK receipt date: 13-AUG-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine about 7 years ago and now had shingles on scalp on the left side. The patient had horrible pain and so hard to sleep since head was raw. Ice packs, Benadryl at night and ibuprofen had been the most blue semi- relief. The shooting headache pain was indescribable. The patient prayed for all who were suffering with this affliction. 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.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; pain; headache; Hard to sleep; 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 (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: pain), headache (Verbatim: headache) and trouble falling asleep (Verbatim: Hard to sleep). The patient was treated with diphenhydramine hydrochloride (Benadryl) and ibuprofen. The outcome of the vaccination failure was not reported and the outcome of the shingles, pain, headache and trouble falling asleep were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, headache and trouble falling asleep to be related to Shingrix.     The company considered the vaccination failure to be related to Shingrix. It was unknown if the company considered the shingles, pain, headache and trouble falling asleep to be related to Shingrix.   Additional Information: GSK receipt date: 13-AUG-2024 This case was reported by a patient via interactive digital media. The patient got the vaccine about 7 years ago and now had shingles on scalp on the left side. The patient had horrible pain and so hard to sleep since head was raw. Ice packs, Benadryl at night and ibuprofen had been the most blue semi- relief. The shooting headache pain was indescribable. The patient prayed for all who were suffering with this affliction. 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.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got shingles/ 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 male 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/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-AUG-2024 This case was reported by consumer via interactive digital media. The reporter reported that the patient got the shots of vaccine and got the shingles which was lasted about a week and half and cleared up with the oral medications that were given. This case was considered as suspected vaccination failure as details regarding completion of primary series, time to onset and laboratory details were unknown at a time of reporting. The case had been linked with the case US2024AMR104605, reported by same reporter.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine. US-GSK-US2024AMR104605:same reporter but case created for grandchild.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 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: suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles). The outcome of the vaccination failure was not reported and the outcome of the shingles was resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-AUG-2024  This case was reported by patient via interactive digital media. He/she got all the shots and still got shingles, all the shot did was help make a more mild case. He/she stated that the shingles lasted about a week and a half and cleared up with the oral meds we were given. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting. This case was linked with case US2024AMR104602 with same reporter.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK is a listed event which is considered related to GSK Shingles vaccine. US-GSK-US2024AMR104602:same reporter but case created for grandchild.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vacination failure; shingles; hurts like heck; 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: suspected vacination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and pain (Verbatim: hurts like heck). The outcome of the vaccination failure, 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.     The company considered the vaccination failure to be unrelated 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: 17-AUG-2024 The case was received from the patient via interactive digital media. The patient reported that yes he/she did and hurt like heck and took forever to clear up. The reporter mentioned that this response was to the following question from they got the vaccine but still got them. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccine schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the completion of primary vaccine schedule, clinical description,medical history and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
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 (Shingles vaccine) for prophylaxis.   Previously administered products included COVID vaccine with an associated reaction of coronavirus infection and Shingles vaccine (in 2008).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was resolved (duration 1 week).   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: 13-AUG-2024 The patient got the new Shingles shot and was sick for over a week.
Sex: U
Vaccine: COVID19, RSV
Symptoms: Headache, Nasal congestion
Clinical narrative: stuffy nose; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nasal stuffiness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   On 15-AUG-2024, the patient received Arexvy and COVID-19 vaccine. On 15-AUG-2024, less than a day after receiving Arexvy, the patient experienced nasal stuffiness (Verbatim: stuffy nose) and headache (Verbatim: headache). The outcome of the nasal stuffiness and headache were not reported.   It was unknown if the reporter considered the nasal stuffiness and headache to be related to Arexvy.     It was unknown if the company considered the nasal stuffiness and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 15-AUG-2024 This case was reported by a patient via interactive digital media. The patient received Covid booster and an RSV shot on the day of reporting and had stuffy nose and headache. It was unknown if the reporter considered the nasal stuffiness and headache to be related to COVID-19 vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: after administering a dose of Shingrix, the box with the remaining vaccine was left out at room temperature for 23 hours; 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 a patient who received Herpes zoster (Shingrix) (batch number MS245, expiry date 16-JUN-2026) for prophylaxis.   Previously administered products included Shingrix (received a dose on an unknown date).   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: after administering a dose of Shingrix, the box with the remaining vaccine was left out at room temperature for 23 hours). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 13-AUG-2024 The other health professional reported that after administering a dose of Shingrix, the box with the remaining vaccine was left out at room temperature for 23 hours, which led to an incorrect storage of drug.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: accidentally administered an expired dose of Shingrix to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 51-year-old female patient who received Herpes zoster (Shingrix) (expiry date 05-AUG-2024) for prophylaxis.   On 14-AUG-2024, the patient received the 1st dose of Shingrix. On 14-AUG-2024, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: accidentally administered an expired dose of Shingrix to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 14-AUG-2024 A nurse reported that they accidentally administered an expired dose of Shingrix to a patient on 14 August 2024 which led to expired vaccine used.  The diluent portion was not expired but the powder expired on 05 August 2024. This was the first dose of Shingrix for the patient.  The vaccine administration facility was the same as primary reporter.
Age: 10.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 10 year old was given a dose of KINRIX as their 5th DTAP vaccine; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 10-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 10 year old was given a dose of KINRIX as their 5th DTAP vaccine). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2024 The patient was given a dose of Kinrix as their 5th DTAP vaccine.  No identifiers were available for child except that child turned 10 years old in June of 2024. No identifiers of the vaccine or information concerning the administration or location of injection were available at the time of call. The reporter stated that no harm to the minor child had been reported. The patient received Kinrix above than the recommended age limit, which led to inappropriate age at vaccine administration.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: A dose of expired Energix-B was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received HBV (Engerix B pediatric) (expiry date 12-MAY-2024) for prophylaxis.   On 16-AUG-2024, the patient received the 1st dose of Engerix B pediatric. On 16-AUG-2024, an unknown time after receiving Engerix B pediatric, the patient experienced expired vaccine used (Verbatim: A dose of expired Energix-B was administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-AUG-2024 The registered nurse reported that an expired dose of Engerix B10 vaccine was administered to the patient, which led to expired vaccine used. The reporter asked was there a great potential for potency loss and will the individual need re-vaccinated.  The reporter stated the expiration date was June 2024 but upon checking in the batch number identifier, the expiry date was 12th May 2024 (as entered with the suspect vaccine). The Vaccine Administration Facility was the same as Primary Reporter. This case is linked with US2024104007, reporter by same reporter.; Sender's Comments:  US-GSK-US2024104007:Same reporter/different patient
Sex: U
Vaccine: COVID19
Symptoms: Dependence on oxygen therapy
Clinical narrative: Because as of two vaccinations of Moderna, patient was on oxygen 24/7, it was done by patient.; This spontaneous case was reported by a patient and describes the occurrence of DEPENDENCE ON OXYGEN THERAPY (Because as of two vaccinations of Moderna, patient was on oxygen 24/7, it was done by patient.) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPENDENCE ON OXYGEN THERAPY (Because as of two vaccinations of Moderna, patient was on oxygen 24/7, it was done by patient.) (seriousness criterion medically significant). At the time of the report, DEPENDENCE ON OXYGEN THERAPY (Because as of two vaccinations of Moderna, patient was on oxygen 24/7, it was done by patient.) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant and treatment medication were reported.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) event of dependence on oxygen therapy that occurred unknown days after receiving two doses of SPIKEVAX COVID-19 VACCINE NOS vaccine, which were unknown doses of COVID-19 vaccination schedule. The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. It was reported that after two vaccinations of Moderna, patient was on oxygen 24/7. The outcome of the event was reported as unknown. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS vaccine is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Pyrexia, Raynaud's phenomenon
Clinical narrative: Caller reports the flair-ups are now more frequent and more severe then prior to the most recent dose of Spikevax/both hands were totally freezing, white and with blue finger tips; light shakes; Low Fever; chills; pretty bad joint pain; feels exhausted; This spontaneous case was reported by a patient and describes the occurrence of RAYNAUD'S PHENOMENON (Caller reports the flair-ups are now more frequent and more severe then prior to the most recent dose of Spikevax/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (Low Fever), CHILLS (chills) and ARTHRALGIA (pretty bad joint pain) in a 67-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Raynaud's syndrome (Reynaud's Syndrome first diagnosed "30 years ago." Reports the flair-ups and symptoms would be "very rare" usually only felt in the winter or if it was very cold and rainy).   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RAYNAUD'S PHENOMENON (Caller reports the flair-ups are now more frequent and more severe then prior to the most recent dose of Spikevax/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (Low Fever), CHILLS (chills), ARTHRALGIA (pretty bad joint pain) and FATIGUE (feels exhausted). At the time of the report, RAYNAUD'S PHENOMENON (Caller reports the flair-ups are now more frequent and more severe then prior to the most recent dose of Spikevax/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (Low Fever), CHILLS (chills), ARTHRALGIA (pretty bad joint pain) and FATIGUE (feels exhausted) had resolved.      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had Raynaud's Syndrome and it was exacerbated after her last dose of Moderna.   Patient had the most recent dose in September or October of 2023.  However, she reported the symptoms were immediately exacerbated following the most recent dose in Fall of 2023. She reported both hands were totally freezing, white and with blue fingertips.  She reported feeling common symptoms after every Covid vaccine ever received i.e., low fever, light shakes, chills, feels exhausted, pretty bad joint pain.  She stated symptoms always subsided after one or two days.  Treatment information was not provided.   This case was linked to MOD-2024-772800 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Caller reports the flair-ups are now more frequent and more severe then prior to the most recent dose of Spikevax/both hands were totally freezing, white and with blue finger tips; light shakes; Low Fever; chills; pretty bad joint pain; feels exhausted; This spontaneous case was reported by a patient and describes the occurrence of RAYNAUD'S PHENOMENON (Caller reports the flair-ups are now more frequent and more severe then prior to the most recent dose of Spikevax/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (Low Fever), CHILLS (chills) and ARTHRALGIA (pretty bad joint pain) in a 67-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Raynaud's syndrome (Reynaud's Syndrome first diagnosed "30 years ago." Reports the flair-ups and symptoms would be "very rare" usually only felt in the winter or if it was very cold and rainy).   On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RAYNAUD'S PHENOMENON (Caller reports the flair-ups are now more frequent and more severe then prior to the most recent dose of Spikevax/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (Low Fever), CHILLS (chills), ARTHRALGIA (pretty bad joint pain) and FATIGUE (feels exhausted). At the time of the report, RAYNAUD'S PHENOMENON (Caller reports the flair-ups are now more frequent and more severe then prior to the most recent dose of Spikevax/both hands were totally freezing, white and with blue finger tips), TREMOR (light shakes), PYREXIA (Low Fever), CHILLS (chills), ARTHRALGIA (pretty bad joint pain) and FATIGUE (feels exhausted) had resolved.      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had Raynaud's Syndrome and it was exacerbated after her last dose of Moderna.   Patient had the most recent dose in September or October of 2023.  However, she reported the symptoms were immediately exacerbated following the most recent dose in Fall of 2023. She reported both hands were totally freezing, white and with blue fingertips.  She reported feeling common symptoms after every Covid vaccine ever received i.e., low fever, light shakes, chills, feels exhausted, pretty bad joint pain.  She stated symptoms always subsided after one or two days.  Treatment information was not provided.   This case was linked to MOD-2024-772800 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I started suffering great pain in both upper arms. After a period of time the pain in my right arm diminished. However, my left upper arm-devastating,horrible pain. I am barely able to lift the arm.; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I started suffering great pain in both upper arms. After a period of time the pain in my right arm diminished. However, my left upper arm-devastating,horrible pain. I am barely able to lift the arm.) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In November 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I started suffering great pain in both upper arms. After a period of time the pain in my right arm diminished. However, my left upper arm-devastating,horrible pain. I am barely able to lift the arm.). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I started suffering great pain in both upper arms. After a period of time the pain in my right arm diminished. However, my left upper arm-devastating,horrible pain. I am barely able to lift the arm.) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.     No Concomitant medications provided by the reporter. Patient received booster dose.  Post vaccination patient suffered from pain in both upper arms and after a period pain in right arm diminished for patient. Patient experienced left upper arm-devastating, horrible pain. Patient was unable to lift the arm. Patient went through physical therapy, but it was not helped. Patient visited with rheumatologist and received an injection for treatment. Patient also tried for acupuncture. Due to symptom patient was unable to swim.  Patient had limited relief with treatment medication.   This case was linked to US-MODERNATX, INC.-MOD-2024-772831 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772831:Same Reporter other case
Sex: U
Vaccine: COVID19
Symptoms: Complex regional pain syndrome
Clinical narrative: complex regional pain syndrome  CRPS; This spontaneous case was reported by a patient and describes the occurrence of COMPLEX REGIONAL PAIN SYNDROME (complex regional pain syndrome  CRPS) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Fibroids, Complex regional pain syndrome and Hysterectomy (To remove fibroid).    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COMPLEX REGIONAL PAIN SYNDROME (complex regional pain syndrome  CRPS) (seriousness criterion medically significant). The patient was treated with LIDOCAINE at a dose of lidocaine pacth. At the time of the report, COMPLEX REGIONAL PAIN SYNDROME (complex regional pain syndrome  CRPS) 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 provided by the reporter. Patient had mottled and shiny skin. Patient had symptom of myoclonic jerking, boils, affected taste buds, smells, ringing in ears, falling on the floor and clumsiness. Patient experienced complex regional pain syndrome from twelve year or more.  Patient had remission for about five years now. Due to complex regional pain syndrome patient one leg and her mouth paralyzed. Also, patient body turned as purple, patient experienced bleeding gums, hyper mobility disorder, bradykinesia and muscle twitching. Patient used treatment medication to reduce pain. Company comment-This spontaneous case concerns a patient of unknown gender and age with medical history of complex regional pain syndrome (in remission) who experienced the serious (due to medically significant) unexpected event complex regional pain syndrome. An unknown dose number of mRNA-1273 vaccine (on an unknown date) was given. It was reported that patient experienced complex regional pain syndrome for twelve years or more, in remission for about five years now. Due to complex regional pain syndrome one leg and mouth was paralyzed. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: she was non-responsive and was put in the hospital for 6 days, 3 of which were in the ICU; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of LOSS OF CONSCIOUSNESS (she was non-responsive and was put in the hospital for 6 days, 3 of which were in the ICU) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 2) in 2021, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose 3, Booster) and Moderna (Dose 1); for Product used for unknown indication: RSV VACCINE. Past adverse reactions to the above products included No adverse event with RSV VACCINE; and Vaccination adverse reaction with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna and Moderna.    In October 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced LOSS OF CONSCIOUSNESS (she was non-responsive and was put in the hospital for 6 days, 3 of which were in the ICU) (seriousness criteria hospitalization and medically significant). In 2023, LOSS OF CONSCIOUSNESS (she was non-responsive and was put in the hospital for 6 days, 3 of which were in the ICU) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter.  It was reported that patient received other vaccines in the four weeks prior to COVID-19 vaccine.  It was reported that for patient past vaccination, patient took nausea medication before vaccines. Further for past covid-19 vaccination patient always has some kind of reaction but nowhere near what put her in the hospital.  Patient was recommended for Shingles vaccine.  No treatment medications provided by the reporter.  Company Comments: This is a spontaneous case concerning a 77-year-old female patient with no medical history reported who experienced the unexpected serious (due to hospitalization and medically significant) event of Loss of consciousness that occurred on unknow date. The patient was vaccinated with fourth dose mRNA-1273.815 (SPIKEVAX 2023-2024 PFS). As reported the patient was non-responsive and was put in the hospital for 6 days, 3 of which were in the ICU. The event resolved the same year as started but on unknown date. Apart of Moderna vaccines the patient was also vaccinated with RSV VACCINE with no adverse events. The event is assessed as not related due to unknow temporal association. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2024-772708, US-MODERNATX, INC.-MOD-2024-772710 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-772710:Same patient , different product US-MODERNATX, INC.-MOD-2024-772708:Same reporter, different product