chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Electroencephalogram, Illness, Musculoskeletal stiffness, Tremor
Clinical narrative: Upper body tremors and stiffening of legs began 1 week post vaccination. Tremors did not stop when arms were held down. Tremors occur when falling asleep, when going through developmental growth spurts, or when becoming ill. Tremors occur 2 or more times a week and have continued to current date
Age: 0.33
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5, DTPPVHBHPB, PNC13, RV5
Symptoms: Electroencephalogram, Musculoskeletal stiffness, Tremor
Clinical narrative: Upper body tremors and stiffening of legs began 1 week post vaccination. Tremors did not stop when arms were held down. Tremors occur when falling asleep, when going through developmental growth spurts, or when becoming ill. Tremors occur 2 or more times a week and have continued to current date
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Amnesia
Clinical narrative: Significant short term memory loss
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Injection site bruising, Injection site reaction, Injection site urticaria, Puncture site bruise, Skin lesion
Clinical narrative: Pt received vaccine on 7/31/23. On morning of 8/2/23, he was noted to have a bruise on his Right upper thigh, surrounded by welts. Parent thought patient maybe had been bitten by older sister, but no event witnessed, and sister denies biting. Seen in clinic. Had a 2.5 cm bruise medially adjacent to Right upper thigh puncture site. There was a border of urticarial lesions about 8mm-1cm each surrounding the bruise. No other findings of angioedema on the body, nor other urticarial lesions noted. No respiratory or gastrointestinal symptoms.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB, PNC15
Symptoms: Urticaria
Clinical narrative: Pt received vaccine on 7/31/23. On morning of 8/2/23, he was noted to have a bruise on his Right upper thigh, surrounded by welts. Parent thought patient maybe had been bitten by older sister, but no event witnessed, and sister denies biting. Seen in clinic. Had a 2.5 cm bruise medially adjacent to Right upper thigh puncture site. There was a border of urticarial lesions about 8mm-1cm each surrounding the bruise. No other findings of angioedema on the body, nor other urticarial lesions noted. No respiratory or gastrointestinal symptoms.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest pain, Decreased appetite, Hallucination, Headache
Clinical narrative: Fevers, sweats, hallucinations, chest pains, malaise for many days, loss of appetite, headache, anxiety, body aches, unable to work for several days.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Impaired work ability, Malaise, Pain, Pyrexia
Clinical narrative: Fevers, sweats, hallucinations, chest pains, malaise for many days, loss of appetite, headache, anxiety, body aches, unable to work for several days.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Joint swelling, Laboratory test, Pain in extremity, Peripheral swelling
Clinical narrative: Left arm appeared red with increasing swelling, largest noted about 12 cm.  Left upper extremity was hot, painful. Joint swelling developed in left shoulder and left elbow. Rash appears under eyes and both cheeks. Arm still remains red.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Skin warm
Clinical narrative: Left arm appeared red with increasing swelling, largest noted about 12 cm.  Left upper extremity was hot, painful. Joint swelling developed in left shoulder and left elbow. Rash appears under eyes and both cheeks. Arm still remains red.
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product administration duration
Clinical narrative: none.  vaccine administered after BUD.  just reporting for posterity
Age: 22.0
Sex: F
Vaccine: RAB
Symptoms: Induration, Nodule, Tenderness, Urticaria
Clinical narrative: Hives, urticaria, Tender Indurated Nodules of B/L lower extremities Treatment with Benadryl PRN
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, MENB, MNQ, TDAP, VARCEL
Symptoms: Dyskinesia, Face injury, Fall, Head injury, Hyporesponsive to stimuli
Clinical narrative: After receiving all vaccinations, patient was asked if okay to stand up. He stood up and walked about 5ft, standing there after 3-4 minutes, patient fell forward in a stiff/muscle tension position. Resulting in falling on his face/head. Patient did not show any symptoms before fall. After the fall, both mom and I turned him around, laying on his back. Provider did assist with helping patient gain conscious. We then noticed patient was bleeding from his mouth. We gave mom gauze for some pressure on childs lip. As then, we noticed more blood coming from his mouth and a missing from tooth. Patient also had an open wound underneath his chin. As patient was trying to gain conscious, there was some uncommon body movement and yelling come from him. As we all patiently helped with assisting our provider to make patient feel ok. He slowly responded with answering he was ok. Then paramedics where called by this time. As patient was still laying on his back, mother was not letting his head from hitting the floor. Blood pressure was taken a few times while patient was on the floor. Reading was taken around 11:20am. 1st 100/55 and 2nd reading 105/71, pulse 82, Sat 100%. Paramedics responded around 11:25, Care was then handed over to paramedics.
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, MENB, MNQ, TDAP, VARCEL
Symptoms: Loss of consciousness, Mouth haemorrhage, Muscle tightness, Musculoskeletal stiffness, Screaming
Clinical narrative: After receiving all vaccinations, patient was asked if okay to stand up. He stood up and walked about 5ft, standing there after 3-4 minutes, patient fell forward in a stiff/muscle tension position. Resulting in falling on his face/head. Patient did not show any symptoms before fall. After the fall, both mom and I turned him around, laying on his back. Provider did assist with helping patient gain conscious. We then noticed patient was bleeding from his mouth. We gave mom gauze for some pressure on childs lip. As then, we noticed more blood coming from his mouth and a missing from tooth. Patient also had an open wound underneath his chin. As patient was trying to gain conscious, there was some uncommon body movement and yelling come from him. As we all patiently helped with assisting our provider to make patient feel ok. He slowly responded with answering he was ok. Then paramedics where called by this time. As patient was still laying on his back, mother was not letting his head from hitting the floor. Blood pressure was taken a few times while patient was on the floor. Reading was taken around 11:20am. 1st 100/55 and 2nd reading 105/71, pulse 82, Sat 100%. Paramedics responded around 11:25, Care was then handed over to paramedics.
Age: 17.0
Sex: M
Vaccine: HEPA, IPV, MENB, MNQ, TDAP, VARCEL
Symptoms: Tooth loss, Wound
Clinical narrative: After receiving all vaccinations, patient was asked if okay to stand up. He stood up and walked about 5ft, standing there after 3-4 minutes, patient fell forward in a stiff/muscle tension position. Resulting in falling on his face/head. Patient did not show any symptoms before fall. After the fall, both mom and I turned him around, laying on his back. Provider did assist with helping patient gain conscious. We then noticed patient was bleeding from his mouth. We gave mom gauze for some pressure on childs lip. As then, we noticed more blood coming from his mouth and a missing from tooth. Patient also had an open wound underneath his chin. As patient was trying to gain conscious, there was some uncommon body movement and yelling come from him. As we all patiently helped with assisting our provider to make patient feel ok. He slowly responded with answering he was ok. Then paramedics where called by this time. As patient was still laying on his back, mother was not letting his head from hitting the floor. Blood pressure was taken a few times while patient was on the floor. Reading was taken around 11:20am. 1st 100/55 and 2nd reading 105/71, pulse 82, Sat 100%. Paramedics responded around 11:25, Care was then handed over to paramedics.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Blood test, Discomfort, Dizziness, Gait disturbance
Clinical narrative: PATIENT CLAIMED TO HAVE DIZZINESS, BLURRED VISION, UNCOMFORTABLE TO WALK AND ANXIETY AFTER SHOT.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Vision blurred
Clinical narrative: PATIENT CLAIMED TO HAVE DIZZINESS, BLURRED VISION, UNCOMFORTABLE TO WALK AND ANXIETY AFTER SHOT.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: -Swelling on R 3rd finger the next day after injection -All fingers & B palm swelling on 8/9/2023 -Both knees, B feet most swollen & B elbow - feet swollen.
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Feeling cold, Feeling hot, Hypokinesia, Illness, Loss of consciousness
Clinical narrative: shortly after (a month or so.. I got covid and was very ill for 3 weeks); shortly after (a month or so.. I got covid and was very ill for 3 weeks); ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "I may have long covid" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "scarring in lung" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "get very tired" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "shortness of breathoverall off." (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off. 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 "shortly after (a month or so.. I got covid and was very ill for 3 weeks)"; ILLNESS (non-serious), outcome "unknown", described as "ill". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300274675 Same product, patient, different event, different dose;
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: Palpitations, Pulmonary fibrosis, Syncope
Clinical narrative: shortly after (a month or so.. I got covid and was very ill for 3 weeks); shortly after (a month or so.. I got covid and was very ill for 3 weeks); ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "I may have long covid" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "scarring in lung" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "get very tired" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "shortness of breathoverall off." (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off. 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 "shortly after (a month or so.. I got covid and was very ill for 3 weeks)"; ILLNESS (non-serious), outcome "unknown", described as "ill". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300274675 Same product, patient, different event, different dose;
Sex: F
Vaccine: COVID19, FLUX, COVID19, FLUX
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: shortly after (a month or so.. I got covid and was very ill for 3 weeks); shortly after (a month or so.. I got covid and was very ill for 3 weeks); ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "I may have long covid" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "scarring in lung" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "get very tired" (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off.; "shortness of breathoverall off." (unspecified if ongoing), notes: I may have long covid/scarring in lung/get very tired, shortness of breathoverall off. 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 "shortly after (a month or so.. I got covid and was very ill for 3 weeks)"; ILLNESS (non-serious), outcome "unknown", described as "ill". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Nasal Swab.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300274675 Same product, patient, different event, different dose;
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, C-reactive protein, Chest pain, Headache
Clinical narrative: Previously well 69 year old female received Shingrix vaccine in left arm. Starting 1 day after receiving vaccination, patient developed progressively worsening pain in her left upper extremity that progressed to widespread pain throughout her body, associated with fatigue and headache.  Reports significant, persistent pain and stiffness in neck, shoulders, hips, and legs.   Patient was seen at urgent care, in PCP office, and by Rheumatology.  Treated with multiple courses of NSAIDs and corticosteroids.  Diagnosed with possible polymyalgia rheumatica by Rheumatology, still on prednisone therapy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Laboratory test, Neck pain, Pain in extremity, Rheumatoid factor
Clinical narrative: Previously well 69 year old female received Shingrix vaccine in left arm. Starting 1 day after receiving vaccination, patient developed progressively worsening pain in her left upper extremity that progressed to widespread pain throughout her body, associated with fatigue and headache.  Reports significant, persistent pain and stiffness in neck, shoulders, hips, and legs.   Patient was seen at urgent care, in PCP office, and by Rheumatology.  Treated with multiple courses of NSAIDs and corticosteroids.  Diagnosed with possible polymyalgia rheumatica by Rheumatology, still on prednisone therapy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Joint stiffness, Musculoskeletal stiffness, Neck pain
Clinical narrative: Previously well 69 year old female received Shingrix vaccine in left arm. Starting 1 day after receiving vaccination, patient developed progressively worsening pain in her left upper extremity that progressed to widespread pain throughout her body, associated with fatigue and headache.  Reports significant, persistent pain and stiffness in neck, shoulders, hips, and legs.   Patient was seen at urgent care, in PCP office, and by Rheumatology.  Treated with multiple courses of NSAIDs and corticosteroids.  Diagnosed with possible polymyalgia rheumatica by Rheumatology, still on prednisone therapy.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Previously well 69 year old female received Shingrix vaccine in left arm. Starting 1 day after receiving vaccination, patient developed progressively worsening pain in her left upper extremity that progressed to widespread pain throughout her body, associated with fatigue and headache.  Reports significant, persistent pain and stiffness in neck, shoulders, hips, and legs.   Patient was seen at urgent care, in PCP office, and by Rheumatology.  Treated with multiple courses of NSAIDs and corticosteroids.  Diagnosed with possible polymyalgia rheumatica by Rheumatology, still on prednisone therapy.
Sex: F
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 32-year old patient received haemophilus influenzae type B vaccine; This literature marketed report has been received from the authors in a  published literature article titled as stated below, concerning a 32-year-old female patient, with medical history that included occasional ingrown hairs and folliculitis, family history of cardiovascular disease. Information regarding the patient's concurrent conditions included hypertension, tobacco smoking of 10 pack a year, she rarely consumed alcohol and did not use illicit drugs. Concomitant medications included diphtheria vaccine toxoid (+) pertussis vaccine (+) tetanus vaccine toxoid (DPT VACCINE).  On an unknown date, the patient received a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) intramuscular injection, administered for unclear reasons (Product used for unknown indication)(strength, dose description, lot #, expiry date, and route of administration were not provided) (drug use in unapproved population).  A copy of the published article is attached as further documentation of the patient's experience.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No event; Improperly stored vaccine; This spontaneous report was received from a physician and refers to a 2 month old female patient. Patient had none concurrent conditions or medical history. Concomitant medications included hepatitis b vaccine (manufacturer unknown), diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) and PEPCID (unspecified component).     On 06-JUN-2023, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1968386, expiration date: 23-MAY-2024, oral (po) (strength not provided) as prophylaxis, which underwent a temperature excursion and there was a concern about vaccine viability. It was reported that it was believed that there was sensory issue in the alarm; therefore, temperatures were monitored with a back up logger. It was seen that temperature was in range, and the new data logger was kept using. Vaccines that underwent the temperature excursion were returned. No adverse effects were seen.
Age: 0.17
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No event; dose administered at 2 months old; This spontaneous report was received from a physician and refers to a 2 month old female patient. Patient had none concurrent conditions or medical history. Concomitant medications included of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2307USA009420), diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 7V (crm197)(PREVNAR) and PEPCID (unspecified component).     On 06-JUN-2023, the patient was vaccinated with a dose of included hepatitis b vaccine (manufacturer unknown) (lot #, expiration date, strength, route of administration, anatomical location not provided) as prophylaxis, when she was 2 months old (inappropriate schedule of product administration). No adverse effects reported.  This is one of 2 reports from the same patient.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Hepatitis B vaccine was administered on 13-DEC-2021, 08-FEB-2022 and 06-SEP-2022; Hepatitis B vaccine was administered on 13-DEC-2021, 08-FEB-2022 and 06-SEP-2022; This spontaneous report was received from a nurse and refers to an 8-weeks-old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant vaccines included diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), and rotavirus vaccine, live, oral, pentavalent (ROTATEQ).  On 13-DEC-2021, the patient was vaccinated with the first dose of Hepatitis B Vaccine (manufacturer unknown) administered as prophylaxis (Strength, dose, route of administration, vaccination scheme, anatomical location, lot umber and expiration date were not reported). On 08-FEB-2022, she was vaccinated with the second dose of Hepatitis B Vaccine (manufacturer unknown) (Strength, dose, route of administration, vaccination scheme, anatomical location, lot umber and expiration date were not reported) (Inappropriate schedule of product administration), and on 06-SEP-2022, the patient was vaccinated with the third dose of Hepatitis B Vaccine (manufacturer unknown) (Strength, dose, route of administration, vaccination scheme, anatomical location, lot umber and expiration date were not reported) (Inappropriate schedule of product administration).  This is one of several reports from the same reporter. This is one of two reports for the same patient.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No side effects reported; HCP calling to report VAQTA was administered after it experienced a temperature excursion; This spontaneous report has been received from a medical assistance referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2023, the patient was vaccinated with an impropered storage dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, at a dose of 0.5 milligram, lot number 1971534 hat was verified to be valid for syringe with an expiration date established as 06-OCT-2024, administered for prophylaxis (strength, anatomical location, and route of administration were not provided) (improper storage of product in use). The excursion occurred with a temperature of 50 Grades Farenheit (F) for 1 hour, 40 minutes, and 0 seconds. There was no previous temperature excursion reported. No additional adverse event provided.  No side effects were reported (no adverse event).
Age: 17.0
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Pharmacist called stating a patient received their 2nd MMR II dose only 2 weeks after the 1st dose. Caller stated the first dose was administered 7/14/2023 and the 2nd was administered 7/31/2023. Caller stated the patient has had no symptoms. No addi; This spontaneous report was received from a pharmacist concerning a 17-year-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.     On 14-JUL-2023 the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the second dose was administered on 31-JUL-2023 (also reported as 2 weeks after) (Inappropriate schedule of product administration) (doses, routes of administration, anatomical locations, lot numbers, and expiry dates were not provided) as prophylaxis.  It was reported that the patient had no symptoms. No additional adverse event (AE) (no adverse event).
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Feeling abnormal, Immediate post-injection reaction
Clinical narrative: immediately after giving the dose the patient began to feel dizzy; he was not feeling good; This spontaneous report has been received from other health professional via company representative concerning a 16-year-old male patient.  The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On an unknown date in 2023 (reported as "on an unknown date last week"), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter (ml), once, administered intramuscularly (IM) in the left deltoid, (lot # X005044, has been verified to be a valid lot number, expiration date reported and upon internal validation established as 02-JAN-2025) for human papillomavirus (HPV) prophylaxis.  On an unknown date in 2023, immediately after the vaccine dose was given, the patient began to feel dizzy and was not feeling good. He sat and rest in the office for a few minutes and recovered. Additionally, he received water. The patient said he was "ok" and then left the office. This was the 3rd of 3 similar cases that have occurred in the office. In all 3 instances, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was the only vaccine given with the same lot number.  The causal relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was unknown.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2308USA003657:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Facial paralysis, Lip discolouration, Malaise
Clinical narrative: facial paleness/ patient's lips went a white hue; dizziness/ woozy feeling; do not feel good.; This spontaneous report was received from a medical assistant, via Company representative, referring to a 13-year-old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not reported.   On an unspecified day in 2023 (reported as "on an unknown date this past week"), the patient was administered the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliters administered intramuscularly in the left deltoid (lot number X005044 has been verified to be valid, expiration date reported and established as 02-JAN-2025) for human papillomavirus (HPV) prevention.   The patient was laying down when the vaccine was given, and after giving the dose she was on the way to sit in the waiting room. Then, she began to have symptoms of facial paleness, her lips wen a white hue (pallor), she had dizziness, and woozy feeling (dizziness). In addition, the patient stated that she did not feel good (malaise). Hence, she was given water as a treatment. Once she was feeling better, her vital signs were checked, and all were within normal limits. At the time of the report, the patient had recovered from the events.  The reporter's causality assessment was not provided.   This is one of three reports received from the same reporter. ; Sender's Comments:  US-009507513-2308USA003477: US-009507513-2308USA003553:
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Headache, Influenza, Nausea
Clinical narrative: They are light pink and dark red patches; hives on legs, arms, back and abdomen; flu type symptoms; shivering; headache; nausea; buzzing in ears; This non-serious case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUL-2023, the patient received the 1st dose of Shingrix (right arm). In JUL-2023, 2 days after receiving Shingrix, the patient experienced flu symptoms (Verbatim: flu type symptoms), shivering (Verbatim: shivering), headache (Verbatim: headache), nausea (Verbatim: nausea) and ear buzzing (Verbatim: buzzing in ears). On 26-JUL-2023, the patient experienced hives (Verbatim: hives on legs, arms, back and abdomen). On an unknown date, the patient experienced skin red (Verbatim: They are light pink and dark red patches). In JUL-2023, the outcome of the flu symptoms, shivering, headache, nausea and ear buzzing were resolved (duration 3 days). The outcome of the hives and skin red were not resolved.   It was unknown if the reporter considered the flu symptoms, shivering, headache, nausea, ear buzzing, hives and skin red to be related to Shingrix.     It was unknown if the company considered the flu symptoms, shivering, headache, nausea, ear buzzing, hives and skin red to be related to Shingrix.   Additional Information: Receipt Date: 02-AUG-2023 The consumer was the reporter stated that he had his 1st Shingrix vaccination. Two days after vaccination he started experiencing flu like symptoms, shivering, headache, nausea and buzzing in his ears, which lasted for 3 days. On 26 July 2023 he stated that he had one hive on his abdomen.   On 2 August 2023 the reporter reported having hives on his legs, arms, abdomen and back. The hives were of different sizes and shapes with the largest being the size of a lemon.   They were light pink and dark red patches.   The consumer had an appointment with a dermatologist on 2 August 2023 (on the day reporting). The reporter did not consent for follow up. The case is linked with US2023105231, by same reporter.; Sender's Comments:  US-GSK-US2023105231:Same reporter
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus, Urticaria
Clinical narrative: They are light pink and dark red patches; hives on legs, arms, back and abdomen; flu type symptoms; shivering; headache; nausea; buzzing in ears; This non-serious case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21-JUL-2023, the patient received the 1st dose of Shingrix (right arm). In JUL-2023, 2 days after receiving Shingrix, the patient experienced flu symptoms (Verbatim: flu type symptoms), shivering (Verbatim: shivering), headache (Verbatim: headache), nausea (Verbatim: nausea) and ear buzzing (Verbatim: buzzing in ears). On 26-JUL-2023, the patient experienced hives (Verbatim: hives on legs, arms, back and abdomen). On an unknown date, the patient experienced skin red (Verbatim: They are light pink and dark red patches). In JUL-2023, the outcome of the flu symptoms, shivering, headache, nausea and ear buzzing were resolved (duration 3 days). The outcome of the hives and skin red were not resolved.   It was unknown if the reporter considered the flu symptoms, shivering, headache, nausea, ear buzzing, hives and skin red to be related to Shingrix.     It was unknown if the company considered the flu symptoms, shivering, headache, nausea, ear buzzing, hives and skin red to be related to Shingrix.   Additional Information: Receipt Date: 02-AUG-2023 The consumer was the reporter stated that he had his 1st Shingrix vaccination. Two days after vaccination he started experiencing flu like symptoms, shivering, headache, nausea and buzzing in his ears, which lasted for 3 days. On 26 July 2023 he stated that he had one hive on his abdomen.   On 2 August 2023 the reporter reported having hives on his legs, arms, abdomen and back. The hives were of different sizes and shapes with the largest being the size of a lemon.   They were light pink and dark red patches.   The consumer had an appointment with a dermatologist on 2 August 2023 (on the day reporting). The reporter did not consent for follow up. The case is linked with US2023105231, by same reporter.; Sender's Comments:  US-GSK-US2023105231:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the patients were getting scheduled too early; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a unspecified number of patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patients received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced drug dose administration interval too short (Verbatim: the patients were getting scheduled too early). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 03-AUG-2023 The reporter reported that their facility used a scheduling system to schedule Shingrix 2nd dose appointments, but there was a malfunction, and the patients were getting schedule too early. The reporter reported that few patients received second dose one month after the first dose. The reporter was unsure of how many patients were affected, but he knows at least two patients. The reporter did not have any patient information, dates of administration, or lot numbers available at time of call. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The reporter reported that the time interval between the first and second dose of Shingrix vaccine was less than 2 months, which led to shortening of vaccination schedule.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Antiviral treatment, Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; 6 months ago, the patient had a mild case of shingles.; this week had shingles on his right arm, right chest, and left leg; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax with an associated reaction of herpes zoster.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: 6 months ago, the patient had a mild case of shingles.) and shingles (Verbatim: this week had shingles on his right arm, right chest, and left leg). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). The outcome of the vaccination failure and shingles were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 03-AUG-2023 The patient received Shingrix about 5 to 6 years ago and confirmed he received 2 doses, 6 months apart. About 6 months ago, the patient had a mild case of shingles. This week, the patient experienced shingles on his right arm, right chest, and left leg. The patient was prescribed antiviral medication ( for 7 days) for the shingles. The patient was vaccinated with Zostavax (date not given). After receiving Zostavax, the patient experienced shingles twice. The reporter/patient gave consent to follow up. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Possible Underdose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number MZ7M5, expiry date 25-OCT-2024) for prophylaxis.   On 05-AUG-2023, the patient received the 1st dose of Shingrix. On 05-AUG-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Possible Underdose administration). The outcome of the incomplete dose administered was unknown.   Additional Information: Receipt date: 07-AUG-2023 A patient received Shingrix first dose and after the injection they saw some drops on his pants, so patient was worried about received Shingrix less than recommended volume however pharmacist did not believed the vaccine was leaked. The reporter consented to follow up.  The patient received Shingrix possibly less than recommended volume, which led to incomplete dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient accidentally received a second dose of Shingrix at less than the recommended interval.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number 33a2z, expiry date 25-OCT-2024) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 02-AUG-2023, the patient received the 2nd dose of Shingrix. On 02-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient accidentally received a second dose of Shingrix at less than the recommended interval.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: Receipt date: 07-AUG-2023 The reporter called in to report that a patient accidentally received a second dose of Shingrix at less than the recommended interval. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. The patient received 2nd dose of Shingrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: fingers, except her thumbs, were numb; This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in fingers in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included carpal tunnel syndrome.   In JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, 1 day after receiving Shingrix, the patient experienced numbness in fingers (Verbatim: fingers, except her thumbs, were numb). The outcome of the numbness in fingers was not resolved.   It was unknown if the reporter considered the numbness in fingers to be related to Shingrix.     It was unknown if the company considered the numbness in fingers to be related to Shingrix.   Additional Information: Receipt date: 07-AUG-2023 The reporter was the patient's husband, he reported the patient received her first dose of Shingrix about 3 weeks ago.  The next day all of her fingers, except her thumbs were numb.  She saw a specialist who determined her carpal tunnel syndrome was minimal and was not causing the numbness.  The reporter did not consent to follow-up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo only liquid given; Menveo only liquid given; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31-AUG-2023) for prophylaxis.   On 26-JUL-2023, the patient received Menveo. On 26-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo only liquid given) and inappropriate dose of vaccine administered (Verbatim: Menveo only liquid given). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 07-AUG-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.   The patient received only the diluent portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: received another dose of MENVEO; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 31-MAR-2024) for prophylaxis.   Previously administered products included Menactra (received a dose in 2017). Concomitant products included MENVEO.   On 08-AUG-2023, the patient received the 2nd dose of Menveo. On 08-AUG-2023, an unknown time after receiving Menveo and an unknown time after receiving MENVEO, the patient experienced extra dose administered (Verbatim: received another dose of MENVEO). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 08-AUG-2023 The reporter was a Nurse Practitioner (NP).   The HCP/Reporter (NP) gave consent to follow up.  The patient received an extra dose of Menveo, which led to extra dose administered
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: BOOSTRIX was given to a 4 year old boy; This non-serious case was reported by a medical representative via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: BOOSTRIX was given to a 4 year old boy). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023. Office Manager for clinic reported that Boostrix was given to a 4-year old boy, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Apr-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 24-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    No concomitant medications were reported.  On 13-Oct-2022, the patient received first dose of 25 microgram of monovalent Moderna vaccine (batch/lot number: AR9236B). Patient did not receive the third dose.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Same reporter