chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Candida infection, Lethargy, Loss of personal independence in daily activities, Pain
Clinical narrative: PATIENT REPORTED DEVELOPING BELL'S PALSEY 8 DAYS AFTER RECEIVING THE SHINGLES VACCINE. PATIENT REPORTS NO OTHER SIGNNIFICANT CHANGES TO HIS DAILY ROUTINE AND EXPERIENCED FEVER, LETHARGY, AND SORENESS THE DAY FOLLOWING THE VACCINE. PATIENT ALSO REPORTS DEVELOPING THRUSH 4 DAYS AFTER RECEIVING VACCINE.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: PATIENT REPORTED DEVELOPING BELL'S PALSEY 8 DAYS AFTER RECEIVING THE SHINGLES VACCINE. PATIENT REPORTS NO OTHER SIGNNIFICANT CHANGES TO HIS DAILY ROUTINE AND EXPERIENCED FEVER, LETHARGY, AND SORENESS THE DAY FOLLOWING THE VACCINE. PATIENT ALSO REPORTS DEVELOPING THRUSH 4 DAYS AFTER RECEIVING VACCINE.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Rash, Rash morbilliform, Rhinorrhoea
Clinical narrative: Rash, cough, runny nose 12 days after vaccine .  No fever.  Rash is morbilliform on trunk, arms, legs
Age: 8.0
Sex: M
Vaccine: HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Paraesthesia, Pruritus, Skin discolouration, Skin hypopigmentation
Clinical narrative: Said experienced an adverse reaction following administration of five vaccines at his last well-child visit. Symptoms included immediate onset (within 2 hours) of generalized pruritus lasting 1-2 days, tingling sensation persisting for 4-5 days, and development of white spots on his face. Physical examination revealed a 1x2 cm hypopigmented region collateral to the right nostril. The reaction's specific cause is unclear due to multiple vaccines being administered simultaneously.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Cellulitis, Injection site swelling, Injection site vesicles, Ultrasound scan, X-ray
Clinical narrative: Seen at  ER on 6/22/2025  left upper arm became swollen and  blisters had xray and ultrasound; had ID evalaution was admitted for 24 hours, diagnosed with Left Arm  Cellulitis and prescribed Cephalexin 500 MG Antibiotics Orally daily no fever or tenderness.
Age: 37.0
Sex: F
Vaccine: HPV9
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Patient received first dose on 2/26, second dose on 3/31/25, and last dose on 6/25/25. According to ACIP guidelines, patient meets 2/3 requirements for the minimal intervals between doses. She meets the 4 week requirement between dose 1 and 2, and the 12 week requirement between dose 2 and 3. However, she does not meet the 5 month requirement between dose 1 and 3.
Age: 68.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Major pain in left shoulder.  10 out of10!  Extremely painful at certain times in the upper left arm.  Always painful, but pain varied.  Treatment:  Meloxicam, Pregabalin Steroid 7-day course, and steroid injection.  Methocarbamol and Tylenol.  Lots of ice.
Age: 65.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient came to the pharmacy and reported that her left arm  around the injection site started to swell, feeling hot like inflamed and itchy, sore to the touch . The side effects started 4 days  after administered Capvaxive. Patient didn't take anything but Tylenol. She cannot take Benadryl due to working , doesn't want to get drowsy from Benadryl. I advised patient to seek help or go to the doctor if it doesn't go away.
Age: 20.0
Sex: F
Vaccine: YF
Symptoms: No adverse event
Clinical narrative: There were no adverse effects from the vaccine in the 20 minute waiting period. The patient was absolutely fine and we will be checking on her daily for the next several days and if there are adverse effects. we will report them.
Age: 1.42
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: mom noticed Red area on thigh where vaccine was administered.  Site still has pea size knot at this time
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse event; the consumer inadvertently received the adult dose of the RECOMBIVAX HB vaccine rather than another pediatric dose; This spontaneous report was received from a nurse referring to an 18-year-old patient of unknown gender.   The patient's medical history, concurrent conditions, concomitant therapies, and drug reactions/allergies were not reported. In May 2025, the patient received a pediatric dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB).   On 20-Jun-2025, the patient inadvertently received the adult dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (lot #Y006509, expiration date: 11-Feb-2027) rather than another pediatric dose, 1.0 ml administered as prophylaxis by health professional (accidental overdose). No adverse event was reported (no adverse event).   Lot # is being requested and will be submitted if received.
Age: 54.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling
Clinical narrative: HBP calling to report AE for PNEUMOVAX 23. Patient was administered the vaccine twice within the same month.; Patient experienced swelling and redness at the  injection site.; Patient experienced swelling and redness at the  injection site.; This spontaneous report was received from a consumer referring to a 54-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.  On 03-JUN-2025, the patient received a dose of Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) for vaccination, (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y016291, with expiration date on 06-DEC-2026).   On 19-JUN-2025, she received an extra dose of Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) for vaccination, (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number Y016291, with expiration date on 06-DEC-2026) (Extra dose administered).   On an unknown date, the patient experienced swelling and redness at the injection site (Vaccination site swelling) (Injection site erythema). On an unknown date, she recovered from the events of vaccination site swelling and injection site erythema.   The causal relationship between the events occurrence and Pneumococcal Vaccine, Polyvalent (23-valent) Solution for injection (PNEUMOVAX 23) was not reported.
Sex: F
Vaccine: RVX
Symptoms: Cardiac operation
Clinical narrative: undergo open heart surgery; This serious case was reported by a consumer via interactive digital media and described the occurrence of open heart surgery in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. In MAY-2025, an unknown time after receiving RSV vaccine, the patient experienced open heart surgery (Verbatim: undergo open heart surgery) (serious criteria clinically significant/intervention required). The outcome of the open heart surgery was not reported.   It was unknown if the reporter considered the open heart surgery to be related to RSV vaccine.     The company considered the open heart surgery to be unrelated to RSV vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2025 The patient got vaccinated with Respiratory Syncytial Virus vaccine and had undergo open heart surgery last month of reporting.; Sender's Comments: Cardiac operation is an unlisted event which is considered unrelated to GSK RSV vaccine. US-GSK-US2025AMR077284:same reporter different patient
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Pyrexia
Clinical narrative: Patient felt bad; Tired; Fever;  This non-serious case was reported by a nurse via sales rep and described the occurrence of feeling bad in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: Patient felt bad), tiredness (Verbatim: Tired) and fever (Verbatim: Fever). The outcome of the feeling bad, tiredness and fever were resolved (duration 4 days).   The reporter considered the feeling bad, tiredness and fever to be related to Shingrix.     The company considered the feeling bad, tiredness and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUN-2025 The nurse reported that a patient received Shingrix vaccine and had felt bad, tired, and had fever for approximately 4 days. The patient would not receive second Shingrix dose.
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; Got shingles and was very painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 70-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In JUN-2025, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles and was very painful). The outcome of the vaccination failure was not reported and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 18-JUN-2025 This case was reported by a patient via interactive digital media. The patient was 70 years old. The patient had both shingles shots and still got shingles. It was very painful. The doctor gave some medicines and cream to put on it. The patient was on the second week of the shingles. The patient believed that if the patient hadn't got the shots, the shingles would have been worse. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding 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 regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK's Shingles vaccine (Dose 1 & 2).
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: She reports injection site pain and soreness after both doses; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: She reports injection site pain and soreness after both doses). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR077808   Additional Information: GSK receipt date: 12-JUN-2025 The patient has had both doses of Shingrix.  She reported that injection site pain and soreness after both doses.  She did not report how long the pain and soreness lasted. For tolerance of 2nd dose refer case US2025AMR077808.; Sender's Comments:  US-GSK-US2025AMR077808:same patient dose 2
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: She reports injection site patient and soreness after both doses; This non-serious case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose and had injection site pain and soreness, refer case US2025AMR077805).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: She reports injection site patient and soreness after both doses). Rechallenge with Shingrix was positive. The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2025AMR077805   Additional Information: GSK receipt date: 12-JUN-2025 The patient has had both doses of Shingrix.  She reported that injection site pain and soreness after both doses.  She did not report how long the pain and soreness lasted.; Sender's Comments:  US-GSK-US2025AMR077805:same patient dose 2
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: My child got vaccinated with engerix-B using adult dose; My child got vaccinated with engerix-B using adult dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of adult product administered to child in a child patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: My child got vaccinated with engerix-B using adult dose) and overdose (Verbatim: My child got vaccinated with engerix-B using adult dose). The outcome of the adult product administered to child and overdose were not applicable.   Additional Information: GSK receipt date: 17-JUN-2025 child got vaccinated with Engerix-B using adult dose, which led to adult product administered to child and overdose.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache; fatigue; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In OCT-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache) and fatigue (Verbatim: fatigue). The outcome of the headache and fatigue were resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.     It was unknown if the company considered the headache and fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUN-2025 Patient received his first dose on 23rd or 24th October 2024.    Patient had fatigue and a headache and stated that he does not remember how long it lasted after the first dose.; Sender's Comments:  US-GSK-US2025073371:same patient
Vaccine: VARZOS
Symptoms: Herpes zoster, Sensory disturbance
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles 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: 19-JUN-2025 This case was reported by a patient via interactive digital media. Patient went to get his/her second shot and told the physician his/her hip felt strange.  Physician looked at it, chuckled, and said patient already had shingles.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Administration of expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-month-old female patient who received DTPa (Infanrix) (batch number Z53J4, expiry date 07-JUN-2025) for prophylaxis.   On 14-JUN-2025, the patient received Infanrix. On 14-JUN-2025, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Administration of expired dose). The outcome of the expired vaccine used was not applicable.   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: 16-JUN-2025 The patient received an expired dose of Infanrix, which led expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Joint swelling, Oedema peripheral, Paraesthesia
Clinical narrative: Tingling, pain on inner side of knees; pain on inner side of knees; swelling extended to her thighs, had hard lumps behind knees and up to top of thighs; swelling extended to her thighs, had hard lumps behind knees and up to top of thighs; Discomfort continued; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling, pain on inner side of knees), ARTHRALGIA (pain on inner side of knees), JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) and OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 29-Apr-2025, the patient experienced PARAESTHESIA (Tingling, pain on inner side of knees) (seriousness criterion medically significant) and ARTHRALGIA (pain on inner side of knees) (seriousness criterion medically significant). In 2025, the patient experienced JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) (seriousness criterion medically significant), OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) (seriousness criterion medically significant) and DISCOMFORT (Discomfort continued). At the time of the report, PARAESTHESIA (Tingling, pain on inner side of knees) outcome was unknown, ARTHRALGIA (pain on inner side of knees), JOINT SWELLING (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) and OEDEMA PERIPHERAL (swelling extended to her thighs, had hard lumps behind knees and up to top of thighs) had resolved and DISCOMFORT (Discomfort continued) had not resolved.        The action taken with mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) was unknown.       No Concomitant medication was reported.  A reporter reporting that patient suffered side effects after vaccinated with Moderna vaccine on 19-Apr-2025. It was mentioned the following: Tingling, pain on inner side of knees, around 29-Apr-2025. Discomfort continued and swelling extended to her thighs, had hard lumps behind knees and up to top of thighs.  Reporter added that similar symptoms happened around 3 years ago, after Moderna vaccine. it was started manual lymphatic drainage for lymphedema after first episode. Patient contacted GP 3rd week in May for pain relief, and started manual lymphatic drainage again as was successful after 18 months.   It was unknown if the patient experienced any additional symptoms/events.  No treatment drug was reported.   This case was linked to MOD-2025-787686 (Patient Link).; Reporter's Comments: The benefit -risk relationship of product is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: Reemergence of stroke symptoms, facial droop and slight speech issues; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) in a 73-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046732) for COVID-19 prophylaxis.     The patient's past medical history included Carotid artery dissection (Prior stroke 2016 due to dissection of carotid). Previously administered products included for COVID-19 prophylaxis: Moderna vaccine. Past adverse reactions to the above products included No adverse effect with Moderna vaccine. Concurrent medical conditions included Stroke (Prior stroke 2016 due to dissection of carotid).    On 22-May-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On 22-May-2025,  after starting mRNA-1273.712 (SPIKEVAX 2024-2025 PFS), the patient experienced CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) (seriousness criterion medically significant). On 23-May-2025, CEREBROVASCULAR ACCIDENT (Reemergence of stroke symptoms, facial droop and slight speech issues) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: (Negative) negative for stroke. On an unknown date, Magnetic resonance imaging: (Negative) negative for stroke.         No concomitant medication was reported. The patient had reemergence of stroke symptoms, facial droop, and slight speech issues. Prior stroke 2016 due to dissection of carotid. The patient went to ER had CAT scan and follow up MRI all results were negative for stroke. The patient had previous Moderna covid vaccines with no adverse effects. All vaccines were administered at local pharmacy.  It was unknown if the patient experienced any additional symptoms or events. Reporter causality was not reported. No treatment medication was reported.; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue
Clinical narrative: It was confusion and then like extreme like fatigue to the point where the patient like, they ended up not attending an important meeting that they had; It was confusion and then like extreme like fatigue to the point where the patient like, they ended up not attending an important meeting that they had; This is a spontaneous report received from a Nurse.  A 70-year-old female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for hyperlipidaemia. The following information was reported: CONFUSIONAL STATE (non-serious), FATIGUE (non-serious) all with onset 2025, outcome "unknown" and all described as "It was confusion and then like extreme like fatigue to the point where the patient like, they ended up not attending an important meeting that they had".  Additional information: The patient is reaching out from a doctor's office, internal medicine. We do have patient that recently completed one of the Pfizer like the vaccines for COVID (Later clarified as Pfizer COVID-19 vaccine) and so, the next day, the patient had some side effects that doctor wanted to report. So, it was confusion and then like extreme like fatigue to the point where the patient like, they ended up not attending an important meeting that they had. Reporter stated, it has been about a month since the start date of side effects.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old female patient received BNT162b2 omicron (kp.2) (COVID-19 VACCINE OMICRON KP.2-MANUFACTURER UNKNOWN), on 11Jun2025 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: The consumer stated that she is sick. She thinks they gave her a vaccination of COVID . When paraphrased the above concern, consumer stated, "I never had COVID, but they gave me a vaccination on June 11th after I got those vaccination, I started getting sick, every day I got sicker. I am not getting any better. I feel like I am dying." The patient stated that she was on blood pressure medication  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: EW0161) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, Lot number: ER8734), administration date: 01Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FJ1620) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot number: ER8734), administration date: 01Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 2, lot number: EW0161), administration date: 22Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), single (Lot number: GJ5342) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE  1, lot number: ER8734), administration date: 01Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 2, lot number: EW0161), administration date: 22Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 3 (BOOSTER), lot number: FJ1620), administration date: 07Dec2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 28Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, lot number: ER8734), administration date: 01Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 2, lot number: EW0161), administration date: 22Apr2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2 (DOSE 3 (BOOSTER), lot number: FJ1620), administration date: 07Dec2021, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days"; BNT162b2;BNT162b2 omi ba.4-5 (DOSE 4 (BOOSTER), lot number: GJ5342), administration date: 04Nov2022, for covid-19 immunisation, reaction(s): "The first five doses had minimal side effects, causing only minor discomfort for a couple of days". The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: The first five doses had minimal side effects, causing only minor discomfort for a couple of days; This is a spontaneous report received from a Consumer or other non HCP.  An elderly patient received BNT162b2 (BNT162B2), on 01Apr2021 as dose 1, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "The first five doses had minimal side effects, causing only minor discomfort for a couple of days".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500122789 same patient and reporter, different dose and event;
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: administration of Ipol after Temperature excursion not viable for use which reached 47.03F for 41 mins due to a failure of battery backup  with no adverse event; Initial information received on 19-Jun-2025 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old male patient (36 cm and 18.64 kg) for whom administration of IPV (VERO) [IPOL] after temperature excursion not viable for use which reached 47.03f for 41 mins due to a failure of battery backup with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a Dose 1 (0.5ml) of suspect IPV (VERO); Suspension for injection with unknown strength (lot W1B511M with expiry date 08-SEP-2025) via intramuscular route in unknown administration site for Immunization; after temperature excursion not viable for use which reached 47.03f for 41 mins due to a failure of battery backup  with no adverse event (poor quality product administered) (latency: same day)  Reportedly: patient was advising and scheduled to repeat. No previous excursion reported.   Action taken was not applicable.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  2025SA164290:IT-00537292
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; A HCP called and reported that an expired dose of RECOMBIVAX HB was administered to a patient on 6/23/2025 with expiry date of 5/23/2025. The caller confirmed the dose has never been stored outside of the recommended range. No symptoms reported. Call; Primary Product Identification: Primary Product Name: RECOMBIVAX HB INJ 10/1.0 mcrg/ml ------------------------- Product Details #1 (Primary Product) : Product Name: RECOMBIVAX HB INJ 10/1.0 mcrg/ml Lot Number: w036624 Expiration Date: 5/23/2025 Operator of Device: Health Professional Obtain: False Hazardous Product?: False  ------------------------- Adverse Event Details: Description: A HCP called and reported that an expired dose of RECOMBIVAX HB was administered to a patient on 6/23/2025 with expiry date of 5/23/2025. The caller confirmed the dose has never been stored outside of the recommended range. No symptoms reported. Caller declined to report the AE at this time. Consent was obtained to follow up with the HCP. No additional AE reported. No PQC. AE Onset Date/Date PQC First Identified: 6/23/2025 ------------------------- PQC Details: PQC Present?: false QIR Requested?: False -------------------------
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had it twice even though got the shots; 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: Had it twice even though got the shots). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2025 This case was reported by a patient via interactive digital media. The patient mentioned that they had shingles twice even though had got the shots of Shingles vaccine.  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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK Shingles vaccine.  Herpes zoster is an unlisted event which is considered unrelated to GSK Shingles vaccine.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Missing second and third dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 23-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received first dose of Engerix b somewhere last June 2024).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Missing second and third dose). The outcome of the incomplete course of vaccination was not applicable.   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: 17-JUN-2025 The pharmacist reported that a patient that received only a first dose of Engerix b somewhere last June twenty-twenty four. The pharmacist wanted some advice about the patient´s schedule for the second and third dose.  No specific vaccination date, no vaccine detail and patient demographics were obtained in this call (no initials provided from the Pharmacist´s end in this call).  No further information was obtained. Till the time of reporting the patient did not receive the second dose of Engerix b which led to incomplete course of vaccination.
Vaccine: RSV
Symptoms: Product container issue
Clinical narrative: Had a defect; It broke; The person was not able to use the vaccine; The vial broke; The initial case was missing the following minimum criteria: not reportable product complaint. Upon receipt of follow-up information on 23Jun2025, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Physician from product quality group.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE BREAKAGE (non-serious), described as "Had a defect; It broke; The person was not able to use the vaccine; The vial broke". Additional information: a sales representative reported that a customer that had the rsv vaccine prot.subunit pref 2v and when they were about to administer it, however, they had a defect with the vaccine. When they were reconstituting one of their rsv vaccine prot.subunit pref 2v vaccines, it did not reconstitute, and it messed up the bottle. The customer was unable to administer, as they thought it broke. The reporter stated that was the defect that happened, and the person was not able to use the vaccine. It was further reported, "while they were administering it, there occurred an issue, where the vial broke. She was with the customer that time." It was clarified that the defective product was not given to any patient.   The reporter considered "had a defect; it broke; the person was not able to use the vaccine; the vial broke" not related to rsv vaccine prot.subunit pref 2v. Causality for "had a defect; it broke; the person was not able to use the vaccine; the vial broke" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  Product Quality Group provided investigational results on 03Mar2025 for rsv vaccine prot.subunit pref 2v (device constituent): Investigation Summary and Conclusion: (withheld) 03Mar2025. No further investigation was required as no valid lot number or returned sample was available. This complaint will continue to be trended. If additional information becomes available, this complaint will be reopened.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness postural, Dyspnoea, Dyspnoea exertional, Fatigue
Clinical narrative: Shortness of breath without exertion, chest tightness, constantly exhausted, dizziness when I would stand up. These symptoms lasted for a little over two weeks but were still noticed very mildly for a few weeks following. I would get exhausted and completely out of breath when climbing my home stairs to my bedroom. This is only one flight of stairs and I never have these symptoms when climbing them. I am an active person. I also had to sit down after extremely short walks to my car and back.  My doctor instructed me to take Benadryl 1 hour before receiving the COVID vaccine on my second round, which was on 04/12/2021, but I had the same reaction, just milder.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Felt extreme pain in arm when injection was given.  Injection site continued to be painful for weeks and then the pain started spreading down the arm and then up the arm.  Now having muscular pain from shoulder to elbow with limited mobility.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Incorrect dosage given. Patient received the pediatric/adolescent dosage of 0.5ml instead of 1ml full adult dose. No signs and symptoms of adverse reaction at this time.
Age: 35.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: TWELVE HOURS AFTER INJECTION, PATIENT EXPERIENCED HIGH FEVER, ARTHRALGIA, HEADACHE, MYALGIAS AND FATIGUE.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Anaphylactic reaction, Dyspnoea, Rash, Swelling of eyelid
Clinical narrative: Patient had anaphylaxis, swelling eyelids, difficulty breathing, rash on upper torso and arms that started about 15 minutes after vaccine. She was given 10ml oral benadryl and one dose of epipen 0.3 and squad was called to transport her to ER.
Age: 58.0
Sex: F
Vaccine: HEPAB, PNC20, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: First night I had fever, chills, joint pain, and ached all over.  Took ibuprofen in the middle of the night but still felt awful.  Fatigued all day and too tired to think, unable to work.  Two days later, left arm injection site is red and warm to touch.  Feels like I've been punched in the deltoid.
Age: 58.0
Sex: F
Vaccine: HEPAB, PNC20, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Mental impairment, Pain
Clinical narrative: First night I had fever, chills, joint pain, and ached all over.  Took ibuprofen in the middle of the night but still felt awful.  Fatigued all day and too tired to think, unable to work.  Two days later, left arm injection site is red and warm to touch.  Feels like I've been punched in the deltoid.
Age: 58.0
Sex: F
Vaccine: HEPAB, PNC20, VARZOS
Symptoms: Pyrexia
Clinical narrative: First night I had fever, chills, joint pain, and ached all over.  Took ibuprofen in the middle of the night but still felt awful.  Fatigued all day and too tired to think, unable to work.  Two days later, left arm injection site is red and warm to touch.  Feels like I've been punched in the deltoid.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Noticed redness to site, warm to the touch the next day, some swelling observed as well. Came in on 06/25/25 to show medical staff. Site observed and did notice redness, warm to touch and some swelling. She was instructed to do cool compress and to take Claritin to help with reaction. Was also instructed to go to ER should the site start getting very painful and not feeling well.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal distension, Erythema, Pain, Skin plaque
Clinical narrative: Erythematous plaque circular in nature, minimal swelling and pain
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Med error child too young for Kinrix should have had individual vaccines  no adverse reaction or event
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site discomfort, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: I noticed a lot of redness and swelling on the thigh where two shots were given.  The skin was hard and warm to the touch.  It started about 24 hours after the injections were given and was approximately 4? in diameter. That quickly changed to covering my child?s entire thigh, up to the buttocks and into the diaper area/inner thigh. He was itching and wincing in discomfort, but had no other symptoms. I was told by phone triage that this was not anything to be too concerned about and that it should clear up by day 3. It has continued to spread and doesn?t appear to be resolving.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC20
Symptoms: Injection site warmth
Clinical narrative: I noticed a lot of redness and swelling on the thigh where two shots were given.  The skin was hard and warm to the touch.  It started about 24 hours after the injections were given and was approximately 4? in diameter. That quickly changed to covering my child?s entire thigh, up to the buttocks and into the diaper area/inner thigh. He was itching and wincing in discomfort, but had no other symptoms. I was told by phone triage that this was not anything to be too concerned about and that it should clear up by day 3. It has continued to spread and doesn?t appear to be resolving.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Sleep disorder, Tenderness
Clinical narrative: pt states their arm was red and painful following injection but the pain has continued a couple of weeks after administration. pt states their arm still hurts when they lay on it to sleep or touch it.  Did advise tylenol, ibuprofen, cold compress, and to follow up with their pcp.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site redness and swelling 3in x 3in. Treated with Augmentin x 10 days. Has f/u on 6/25/25.
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Antinuclear antibody negative, Arthralgia, Body temperature increased, Borrelia test negative, C-reactive protein normal
Clinical narrative: nausea and Fever 103.2 for 2 days, polyarthritis 2 weeks later for 5 days
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Full blood count normal, Headache, Myalgia, Peripheral swelling, Polyarthritis
Clinical narrative: nausea and Fever 103.2 for 2 days, polyarthritis 2 weeks later for 5 days
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor negative, Streptococcus test negative, Vomiting
Clinical narrative: nausea and Fever 103.2 for 2 days, polyarthritis 2 weeks later for 5 days
Age: 16.0
Sex: F
Vaccine: MENB, MENB, MNQ
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, C-reactive protein normal, Full blood count normal, Nausea
Clinical narrative: nausea and Fever 103.2 for 2 days, polyarthritis 2 weeks later for 5 days