chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Rash, Sensory disturbance, Somnolence
Clinical narrative: face had a rash all over it; not feel good; sleepy all the time; feel insides moving around by buttocks and around lower area; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 1, for covid-19 prophylaxis. Non-company products included: moderna covid-19 vaccine (form of admin and route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 2, for covid-19 prophylaxis; pfizer biontech covid-19 vaccine (form of admin and route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: Dose series 3, for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.    On an unspecified date, the patient experienced face had a rash all over it, not feel good, sleepy all the time, and feel insides moving around by buttocks and around lower area.  It was reported that the patient's face had a rash all over it and wouldn't go away and could also feel insides moving around by buttocks and around my lower area. Patient had over 30 vaccines whole life since 1994. The patient do not feel good all the time and was sleepy all the time as well. Dose series 1. The action taken with janssen covid-19 vaccine, moderna covid-19 vaccine and pfizer biontech covid-19 vaccine was not applicable.  The patient had not recovered from face had a rash all over it. The outcome of not feel good, sleepy all the time and feel insides moving around by buttocks and around lower area was not reported.  This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: last booster was very itchy, more than ever before; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (last booster was very itchy, more than ever before) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included HRT. Previously administered products included for Drug use for unknown indication: Penicillin. Past adverse reactions to the above products included No adverse effect with Penicillin. Concurrent medical conditions included Asthma (needed to carry an inhaler for a rare use), Penicillin allergy (as a young child), Hypothyroidism (Mild) and Menopause. Concomitant products included Levothyroxine sodium for Hypothyroidism.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (last booster was very itchy, more than ever before). At the time of the report, PRURITUS (last booster was very itchy, more than ever before) outcome was unknown.            Patient had to see a pulmonologist annually as he's carrier for Alpha 1. Patient was not allergic to bee stings or any other injections. Patient always had Moderna, and because of asthma he had faithfully gotten his boosters in a timely fashion. The patient stated that he had Moderna injections for every single Covid booster. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-779524 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2025: Live significant follow-up received with patient initial, narrative and reference ID was added; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-779524:Same patient and different dose
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Liver disorder, Pneumonia, Respiratory syncytial virus infection
Clinical narrative: developed pneumonia; asthma; liver problems; developed RSV; This spontaneous case was reported by a patient and describes the occurrence of PNEUMONIA (developed pneumonia) in a 72-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (developed pneumonia) (seriousness criterion medically significant), ASTHMA (asthma), LIVER DISORDER (liver problems) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (developed RSV). At the time of the report, PNEUMONIA (developed pneumonia) had not resolved and ASTHMA (asthma), LIVER DISORDER (liver problems) and RESPIRATORY SYNCYTIAL VIRUS INFECTION (developed RSV) outcome was unknown.            Concomitant product use was not provided by the reporter. Patient had 5 doses of Moderna vaccines and had asthma, liver problems, developed RSV, developed pneumonia and it had taken 15 months for lungs but still not fully healed. Reporter causality was not reported. Treatment information was not provided.   This case was linked to MOD-2025-782183 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2025: Live significant follow-up received: Patient age, event verbatim and outcome updated and reference ID added.; Reporter's Comments: Company comment: Pneumonia and respiratory syncytial virus infection were assessed as not related due to lack of biological plausibility. The benefit-risk relationship of product is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular disorder
Clinical narrative: Patient now had 3 testicles.; This spontaneous case was reported by a patient and describes the occurrence of TESTICULAR DISORDER (Patient now had 3 testicles.) in a 75-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced TESTICULAR DISORDER (Patient now had 3 testicles.). At the time of the report, TESTICULAR DISORDER (Patient now had 3 testicles.) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Ventricular tachycardia
Clinical narrative: ventricular tachycardia; uncontrollable hypertension; This is a spontaneous report received from a Physician from medical information team.  A male 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 and concomitant medications were not reported. The following information was reported: VENTRICULAR TACHYCARDIA (medically significant), outcome "unknown"; HYPERTENSION (medically significant), outcome "unknown", described as "uncontrollable hypertension". Therapeutic measures were taken as a result of ventricular tachycardia, hypertension. The patient was the reporter's colleague who had received the COVID-19 vaccine and had similar symptoms...uncontrollable hypertension and ventricular tachycardia. He had a pacemaker placed. Despite that, the patient and reporter both agree that having the vaccine was critical.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on the implied temporal association, the contributory role of suspect drug BNT162B2 OMICRON (KP.2) cannot be excluded for the reported events. Information on details surrounding patient complete medical history and concomitant medications would aid in comprehensive medical assessment. Case will be reassessed should additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: He cannot use his arm/cannot move his right arm; Arm is in continuous pain/From his shoulder to elbow it hurts like hell; This is a spontaneous report received from a Consumer or other non HCP.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (disability), outcome "unknown", described as "He cannot use his arm/cannot move his right arm"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Arm is in continuous pain/From his shoulder to elbow it hurts like hell". The events "he cannot use his arm/cannot move his right arm" and "arm is in continuous pain/from his shoulder to elbow it hurts like hell" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of joint range of motion decreased, pain in extremity. Additional information: He cannot use his arm. He was crippled with the covid shot and he cannot use his arm and is in continuous pain. He was angry and from that shot he cannot move his right arm and was having a hard time washing his hair. From his shoulder to elbow, it hurts like hell. He wants the spike protein put in his body to be removed. It was a couple of years ago and he is not sure how old he was. He has been having pain which started a couple weeks later after the covid shot. He thought its like a twisted muscle or something. He thought he perhaps twisted his arm but he didn't and a muscle does not take a couple years to heal. Treatment includes ointment prescribed by doctor and nothing is happening. He is a very healthy individual.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective
Clinical narrative: COVID; COVID; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 74-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The clinical course was reported as follows: The patient wanted desperately to take the COVID 19 VACCINE, however, every time she got the shot, she got COVID and got terribly sick with a fever of 102, so she had stopped getting the vaccine and stopped getting the FLU shot because the same thing happened to her, she got the flu. The patient wanted to be protected and she was scared to take the shots and vaccine. The patient underwent the following laboratory tests and procedures: Body temperature: 102.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal mass
Clinical narrative: lump in her throat - like on the side of neck; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A 69-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PHARYNGEAL MASS (non-serious), outcome "unknown", described as "got a lump in my throa--like on the side of my neck".  Additional information: The patient took the first injection, the first vaccination, and got a lump in her throat - like on the side of her neck.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500036790 same patient and drug, different dose and event;
Sex: M
Vaccine: UNK
Symptoms: Cough, Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: Vaccination failure; Lingering cough; Tested positive for Flu A; This spontaneous case initially received on 03-Feb-2025, was reported by a non health professional and concerns a child male patient.  At the time of the event the patient had allergy to Peanuts. No concomitant medications were reported. There was no product complaint associated with this case.  Administration of company suspect drug: On 26-Oct-2024, the patient received Flucelvax (TIV) for Active immunization against influenza disease, dose and route of administration: not reported, anatomical location: Left Deltoid,  Lot number: 946624.  No additional suspect drugs.  Adverse reactions/events and outcomes: On 31-Jan-2025, the patient experienced Tested positive for Flu A (Medically Significant, outcome: Recovered / Resolved, stop date: 03-Feb-2025). Associated symptoms included: Lingering cough. On an unknown date, the patient experienced Vaccination failure (Medically Significant, outcome: Not Reported).  The reporter informed that the vaccination was given on a clinic, flu was verified by nasal swab and the source of infection was school or wrestling. The patient Recovered as of 03-Feb-2025 with lingering cough.  Case was upgraded to serious upon company assessment of the reported event (Tested positive for Flu A) clinical significance.  Flucelvax (TIV) action taken: Not Applicable Treatment medication: Ibuprofen, Oscillococcinum  Reporter assessment:  The reporter assessed the event Tested positive for Flu A as non serious and did not provide seriousness for Vaccination failure and did not provide a causality assessment for the events.; Reporter's Comments: Causality:  Related. Due to the spontaneous nature of the case, it is considered related for reporting purposes. Vaccination failure and Influenza is assessed as related due to provided approximate time frame from the date of vaccine which is plausible.
Sex: U
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: Experienced an allergic reaction to the immunization; This spontaneous case, initially received on 15-Oct-2024, was reported by a non health professional and concerns a patient of unknown age/gender.  Concomitant Medications and Medical History was reported as Unknown.  Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for immunization, Dose regimen: 5 ml, Route of Administration: Not Reported, Lot number: No batch number available, and would not be requested due to no consent for follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Experienced an allergic reaction to the immunization (outcome: Unknown).  Reporter stated the individual (patient) experience an allergic reaction to the immunization.  Treatment measures associated with event was reported as Unknown.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter provides a seriousness and hospitalization for the event as unknown and causality was reported as related.; Reporter's Comments: The causality of events was assessed related to the administration of Flucelvax TIV
Sex: U
Vaccine: UNK
Symptoms: Hypersensitivity
Clinical narrative: Experienced an allergic reaction to the immunization; This spontaneous case, initially received on 15-Oct-2024, was reported by a non health professional and concerns a patient of unknown age/gender.  Concomitant Medications and Medical History was reported as Unknown. Administration of company suspect drug: On an unknown date, the patient received Flucelvax (TIV) for immunization, Dose regimen: 5 ml, Route of Administration: Not Reported, Lot number: No batch number available, and would not be requested due to no consent to follow-up.  No additional suspect drugs.  Adverse reactions/events and outcomes: On an unknown date, the patient experienced Experienced an allergic reaction to the immunization (outcome: Unknown).  Reporter stated the individual (patient) experience an allergic reaction to the immunization.  Treatment measures associated with event was reported as Unknown.  Flucelvax (TIV) action taken: Not Applicable  Reporter's assessment:  The reporter provides a seriousness and hospitalization for the event as unknown and causality was reported as related.; Reporter's Comments: The causality of event was assessed related to the administration of Flucelvax
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reported AE on behalf of a patient who was administered improperly stored PEDVAXHIB on 2/4/2025 that experienced a TE on 1/31/2025. No symptoms reported. No additional AE details reported. Obtained consent to contact HCP. TE Filed (Case; This spontaneous report was received from a nurse referring to a patient, age and gender not provided.  Information regarding the patient's pertinent medical history, drug allergies or reactions, or concomitant medications was not provided. On 04-FEB-2025, the patient was vaccinated with an improperly stored dose of  Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PEDVAX) injection, 0.5 ml for prophylaxis (route of administration, vaccination scheme frequency, anatomical location were not reported, lot number Y006392 with and expiration date on 08-NOV-2025). The administered dose of the vaccine experienced a temperature excursion  10.22 degrees Celsius for 22 hours and  50 minutes. It was not reported if the information was recorded by a data logger or not. There was no adverse effect reported.
Age: 73.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Gait inability, Peripheral swelling
Clinical narrative: leg swelling, unable to walk
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient mother noticed swelling and warm to the touch the next day on both sites. Mother dosed with Benadryl with some improvement. mother then called clinic the next day to inform clinic that reaction was twice as big and continued to give Benadryl. Provider did go ahead and prescribe antibiotic to pharmacy.
Age: 64.0
Sex: M
Vaccine: PNC20
Symptoms: Hypoaesthesia
Clinical narrative: Patient complaints that his fingers on left hand was numbed when he was waking up in the morning after he got a shot about 3 days. He said he will go to family doctor for checking it up.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC20
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient states her arm was still sore days after her injections.  She presented to her MD, and MD told her it was due to vaccine being administered in the incorrect location.  Pharmacist states the vaccine was administered according to protocol in the correct location and that MD is speculating since they would not be able to see the injection site days after the injection.  Patient states that she has needed physical therapy after her injections.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills, fatigue and headache, lasting 36 hrs
Age: 27.0
Sex: F
Vaccine: RSV
Symptoms: Autopsy, Exposure during pregnancy, Foetal heart rate abnormal, Premature delivery, Stillbirth
Clinical narrative: Two days after shot baby had no heartbeat. Baby was born 24 hours later stillborn. 4lbs13oz. her name on birth cert. Born at hospital.
Age: 79.0
Sex: M
Vaccine: RSV, UNK
Symptoms: Extra dose administered
Clinical narrative: Patient received two doses of Arexvy RSV vaccine when only one dose is indicated. The first dose was on 12/06/2023 and the second dose was on 09/12/2024 (listed as date of adverse reaction on item 5).
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Blood test normal, Chest pain, Feeling abnormal, Injection site pain, Pain
Clinical narrative: Pain began radiating deep into my left shoulder from injection site. I work in health care, have had many vaccines, and never thought twice. Figured it was just a painful vaccine. the pain continued to spread over the course of the next few hours into my chest, other arm, fingers. I went to bed after telling my spouse I felt off but just wanted to sleep. I woke in the night screaming in pain. Upon arrival to the hospital my entire body ached and pulsated. I was in excruciating pain. I sat in the ER lobby for 2 hours. By the time I was actually seen by a physician another hour later, the pain had some what subsided.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, X-ray normal
Clinical narrative: Pain began radiating deep into my left shoulder from injection site. I work in health care, have had many vaccines, and never thought twice. Figured it was just a painful vaccine. the pain continued to spread over the course of the next few hours into my chest, other arm, fingers. I went to bed after telling my spouse I felt off but just wanted to sleep. I woke in the night screaming in pain. Upon arrival to the hospital my entire body ached and pulsated. I was in excruciating pain. I sat in the ER lobby for 2 hours. By the time I was actually seen by a physician another hour later, the pain had some what subsided.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blindness, Menstruation irregular, Pain in extremity, Visual impairment
Clinical narrative: I began having pain and swelling in my arm, vaginal bleeding, then blurry vision.  The symptoms progressed and my left arm became swollen and could not be touched or used without great pain/difficulty. I began having nose bleeds. I lost vision in my right eye, and I began a complete menstrual cycle.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Bell's palsy, Blindness unilateral, Cellulitis, Epistaxis, Injected limb mobility decreased
Clinical narrative: I began having pain and swelling in my arm, vaginal bleeding, then blurry vision.  The symptoms progressed and my left arm became swollen and could not be touched or used without great pain/difficulty. I began having nose bleeds. I lost vision in my right eye, and I began a complete menstrual cycle.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pain in extremity, Peripheral swelling, Tenderness, Vaginal haemorrhage
Clinical narrative: I began having pain and swelling in my arm, vaginal bleeding, then blurry vision.  The symptoms progressed and my left arm became swollen and could not be touched or used without great pain/difficulty. I began having nose bleeds. I lost vision in my right eye, and I began a complete menstrual cycle.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Vision blurred
Clinical narrative: I began having pain and swelling in my arm, vaginal bleeding, then blurry vision.  The symptoms progressed and my left arm became swollen and could not be touched or used without great pain/difficulty. I began having nose bleeds. I lost vision in my right eye, and I began a complete menstrual cycle.
Age: 73.0
Sex: F
Vaccine: PNC20, UNK, PNC20, RSV
Symptoms: Eyelids pruritus, Pain in extremity, Pruritus, Rash erythematous, Sensitive skin
Clinical narrative: patient reports onset about 8-12 hours post-administration. Started with full body itching progressing to a rash on the chest and neck. Specifically not hives. Doctor advised her to take an antihistamine, which helped (diphenhydramine at first, then loratadine). Continuing to take loratadine and itching has improved but not yet subsided at about 7 days post-onset.
Age: 73.0
Sex: F
Vaccine: PNC20, UNK, PNC20, RSV
Symptoms: Pruritus, Rash
Clinical narrative: patient reports onset about 8-12 hours post-administration. Started with full body itching progressing to a rash on the chest and neck. Specifically not hives. Doctor advised her to take an antihistamine, which helped (diphenhydramine at first, then loratadine). Continuing to take loratadine and itching has improved but not yet subsided at about 7 days post-onset.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse event; HCP calling to report an AE regarding the GARDASIL 9 vaccine. HCP reported that an 19 year old male patient received his first dose of the vaccine on 12/21/2023 at 17 years of age. HCP stated that the patient received his second dose of the vaccine o; This spontaneous report has been received from a pharmacist, regarding to a 19-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported. On 21-DEC-2023, the patient was vaccinated with the first dose (at the age of 17-years old) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) suspension for injection as prophylaxis (Lot No., expiration date, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). On 10-FEB-2025, 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) suspension for injection as prophylaxis (Lot No., expiration date, exact dose quantity volume, route and anatomical location of administration and vaccination scheme frequency were not provided). It was stated that the pharmacist did not know the reason for the delay between the first and second doses of the mention vaccine.  (Inappropriate schedule of product administration).  No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: My arm got really sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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 pain in arm (Verbatim: My arm got really sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-JAN-2025 This case was reported by a patient via interactive digital media. The patient just had his/her first shot of Shingles vaccine and his/her arm got really sore but patient would go and get the second shot in 2 months.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: administration of only the diluent portion; administration of only the diluent portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: administration of only the diluent portion) and inappropriate dose of vaccine administered (Verbatim: administration of only the diluent portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 28-JAN-2025 The pharmacist asked if it was problematic to administer only the diluent portion of Shingrix. The pharmacist was administered only diluent portion of Shingrix which led to, inappropriate preparation of medication and inappropriate dose of vaccine administered. The pharmacist was not sure if a patient received the diluent portion without the lyophilized component.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test normal, Computerised tomogram normal, Magnetic resonance imaging normal, Neurological symptom, Paralysis
Clinical narrative: Pt present 3 weeks post vaccination to ER with Guillen-Barre like symptoms. Paralysis to waist. Pt reuiring continued IV immunotherapy and rehab. No prior medical history
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: X-ray normal
Clinical narrative: Pt present 3 weeks post vaccination to ER with Guillen-Barre like symptoms. Paralysis to waist. Pt reuiring continued IV immunotherapy and rehab. No prior medical history
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: interval between first dose and second dose was too short; vesicles; This non-serious case was reported by a other health professional and described the occurrence of vesicles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17-DEC-2024, the patient received the 1st dose of Shingrix. On 28-JAN-2025, the patient received the 2nd dose of Shingrix. On 24-DEC-2024, 7 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced vesicles (Verbatim: vesicles). On 28-JAN-2025, the patient experienced drug dose administration interval too short (Verbatim: interval between first dose and second dose was too short). On 28-JAN-2025, the outcome of the vesicles was resolved (duration 1 month 4 days). The outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the vesicles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vesicles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 03-FEB-2025 The reporter reported that the patient had received Shingrix vaccine and experienced autoimmune disease diagnosed (Vesicles). The reporter mentioned that the expiry date of Shingrix was unknown. The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of the vaccination scheduled.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt bad on bath shots; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a 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 feeling bad (Verbatim: felt bad on bath shots). The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Linked case(s) involving the same patient: US2025AMR013535   Additional Information: GSK Receipt Date: 18-JAN-2025 This case was reported by patient itself. The patient felt bad upon receiving Shingrix vaccine..
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Injection site erythema, Injection site swelling
Clinical narrative: She still has not received Shingrix dose 2; red injection site; and swollen injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient did not receive the 2nd dose of Shingrix. In MAY-2024, the patient received the 1st dose of Shingrix. In MAY-2024, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: red injection site) and injection site swelling (Verbatim: and swollen injection site). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: She still has not received Shingrix dose 2). The outcome of the injection site erythema and injection site swelling were resolved (duration 10 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix and Shingrix.     It was unknown if the company considered the injection site erythema and injection site swelling to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 05-FEB-2025 The reporter stated that she received dose 1 Shingrix in May 2024. She stated that within 24 hours her arm was red and swollen. That lasted 10 days and then resolved. The reporter stated that as per her PCP and her neurologist had different ideas on getting dose 2. The patient still had not received Shingrix dose 2 and will speak to her HCP again. Information provided per content. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash pruritic, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; developed a rash on her right side yesterday; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In FEB-2022, the patient received the 1st dose of Shingrix. On 04-FEB-2025, 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: shingles) and itchy rash (Verbatim: developed a rash on her right side yesterday). The patient was treated with triamcinolone and valaciclovir. The outcome of the vaccination failure and itchy rash were not reported and the outcome of the shingles was unknown.   It was unknown if the reporter considered the vaccination failure, shingles and itchy rash to be related to Shingrix and Shingrix.     The company considered the vaccination failure, shingles and itchy rash to be unrelated to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 05-FEB-2025 The patient who received 2 doses of Shingrix in 2022 and she thought she got her first dose in February 2022 and her second dose 6 months later. She developed a rash on her right side and one day before the reporting day that itches and went to the doctor. The doctor thought she had shingles and prescribed triamcinolone cream and valacyclovir.  This case was considered as suspected vaccination failure as details regarding 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,  and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix.  Herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix.  Rash pruritic  is a listed event which, due to the following criteria (concurrent herpes zoster) is considered unrelated to GSK vaccine Shingrix.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, IPV, PNC20
Symptoms: Extra dose administered
Clinical narrative: Patient was given extra ipol vaccine at visit on 2/18/2025.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Pyrexia, Vomiting
Clinical narrative: cough, fever, chills, vomiting
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Antinuclear antibody positive, Anxiety, Arthralgia, Asthenia
Clinical narrative: Initial symptoms were mild flu like symptoms for 1 week. Sudden onset of anxiety and depression in 03/2021 through 11/2021. 04/2022 sudden onset of debilitating anxiety. 11/2022 developed extreme fatigue, joint and muscle pain, brain fog, headaches, activity intolerance and heat intolerance. 03/2023 +ANA and CRP. Diagnosed with autoimmune disease/connective tissue disease, pseudo dementia and fibromyalgia. Symptoms persist despite treatment from rheumatologist. Approved for SSDI 10/25/2024. I believe my symptoms are due to the Covid vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Blood test normal, Brain fog, C-reactive protein, Cardiac stress test
Clinical narrative: Initial symptoms were mild flu like symptoms for 1 week. Sudden onset of anxiety and depression in 03/2021 through 11/2021. 04/2022 sudden onset of debilitating anxiety. 11/2022 developed extreme fatigue, joint and muscle pain, brain fog, headaches, activity intolerance and heat intolerance. 03/2023 +ANA and CRP. Diagnosed with autoimmune disease/connective tissue disease, pseudo dementia and fibromyalgia. Symptoms persist despite treatment from rheumatologist. Approved for SSDI 10/25/2024. I believe my symptoms are due to the Covid vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram thorax, Condition aggravated, Connective tissue disorder, Depression, Echocardiogram
Clinical narrative: Initial symptoms were mild flu like symptoms for 1 week. Sudden onset of anxiety and depression in 03/2021 through 11/2021. 04/2022 sudden onset of debilitating anxiety. 11/2022 developed extreme fatigue, joint and muscle pain, brain fog, headaches, activity intolerance and heat intolerance. 03/2023 +ANA and CRP. Diagnosed with autoimmune disease/connective tissue disease, pseudo dementia and fibromyalgia. Symptoms persist despite treatment from rheumatologist. Approved for SSDI 10/25/2024. I believe my symptoms are due to the Covid vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Fibromyalgia, Headache, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Initial symptoms were mild flu like symptoms for 1 week. Sudden onset of anxiety and depression in 03/2021 through 11/2021. 04/2022 sudden onset of debilitating anxiety. 11/2022 developed extreme fatigue, joint and muscle pain, brain fog, headaches, activity intolerance and heat intolerance. 03/2023 +ANA and CRP. Diagnosed with autoimmune disease/connective tissue disease, pseudo dementia and fibromyalgia. Symptoms persist despite treatment from rheumatologist. Approved for SSDI 10/25/2024. I believe my symptoms are due to the Covid vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphocyte count increased, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Myalgia, Pseudodementia
Clinical narrative: Initial symptoms were mild flu like symptoms for 1 week. Sudden onset of anxiety and depression in 03/2021 through 11/2021. 04/2022 sudden onset of debilitating anxiety. 11/2022 developed extreme fatigue, joint and muscle pain, brain fog, headaches, activity intolerance and heat intolerance. 03/2023 +ANA and CRP. Diagnosed with autoimmune disease/connective tissue disease, pseudo dementia and fibromyalgia. Symptoms persist despite treatment from rheumatologist. Approved for SSDI 10/25/2024. I believe my symptoms are due to the Covid vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell count increased, Temperature intolerance, Ultrasound scan, White blood cell count increased, X-ray limb normal
Clinical narrative: Initial symptoms were mild flu like symptoms for 1 week. Sudden onset of anxiety and depression in 03/2021 through 11/2021. 04/2022 sudden onset of debilitating anxiety. 11/2022 developed extreme fatigue, joint and muscle pain, brain fog, headaches, activity intolerance and heat intolerance. 03/2023 +ANA and CRP. Diagnosed with autoimmune disease/connective tissue disease, pseudo dementia and fibromyalgia. Symptoms persist despite treatment from rheumatologist. Approved for SSDI 10/25/2024. I believe my symptoms are due to the Covid vaccine.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Adverse reaction
Clinical narrative: The nurse gave a full dose .5cc intradermally. She had given the eua version before.  The pt had a roubst rxn-he sent me a picture-but he was fine.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, PNC20, RV5
Symptoms: Rash
Clinical narrative: Mom messaged the office via the patient portal at 1840 on 2/18/2025 with concerns of a rash on patient's trunk area. Per mom, this is the first time she has seen this rash after immunizations.  No fever at this time.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Eye swelling, Ocular hyperaemia
Clinical narrative: Mom reports Left eye red and swollen almost shut 2 hours after taking the shot
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac ablation, Cold sweat, Dyspnoea, Electrocardiogram
Clinical narrative: I RECEIVED 2 COVID-19 SHOTS 1(EN6201 4/9/21) 2(EN6198 4/30/21) ON JUNE 30,2021 AROUND 8 PM I WOKE WITH A COLD SWEAT, A POUNDING HEART THAT FELT IN MY CHEST AND LEFT RIBCAGE WITH SOB I WENT TO THE EMERGENCY ROOM WHERE I WAS DIAGNOSED WITH AFIB. THIS WAS THE FIRST OF MANY VISITS WHICH ALSO INVOLVED HAVING AN ABLATION TO CORRECT THE AFIB. NOW I AM ON PERMANENT MEDICATION FOR THIS CONDITION, ELIQUIS, SOTOLOL AND A BABY ASPIRIN
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram, Palpitations, Ultrasound scan
Clinical narrative: I RECEIVED 2 COVID-19 SHOTS 1(EN6201 4/9/21) 2(EN6198 4/30/21) ON JUNE 30,2021 AROUND 8 PM I WOKE WITH A COLD SWEAT, A POUNDING HEART THAT FELT IN MY CHEST AND LEFT RIBCAGE WITH SOB I WENT TO THE EMERGENCY ROOM WHERE I WAS DIAGNOSED WITH AFIB. THIS WAS THE FIRST OF MANY VISITS WHICH ALSO INVOLVED HAVING AN ABLATION TO CORRECT THE AFIB. NOW I AM ON PERMANENT MEDICATION FOR THIS CONDITION, ELIQUIS, SOTOLOL AND A BABY ASPIRIN
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Atrioventricular block, Cardiac pacemaker evaluation, Cardiac pacemaker insertion, Death, Loss of consciousness
Clinical narrative: loss of consciousness, heart block AV block, death, emergency room temporary external pacemaker connected, procedural pneumothorax, permanent pacemaker procedure, breathing cessation during surgery i.e another death
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Procedural pneumothorax, Respiratory arrest, Transcutaneous pacing
Clinical narrative: loss of consciousness, heart block AV block, death, emergency room temporary external pacemaker connected, procedural pneumothorax, permanent pacemaker procedure, breathing cessation during surgery i.e another death
Age: 17.0
Sex: F
Vaccine: IPV
Symptoms: Wrong product administered
Clinical narrative: Patient came for TB skin test but 0.1 of polio administered. Nurse recognized mistake, informed patient and administered tuberculin. Patient informed to watch for allergic reaction.
Age: 25.0
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received a 3rd dose, patient reports no side effects.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient had already received annual influenza vaccine on 12/03/2024.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Computerised tomogram abdomen, Laboratory test, Magnetic resonance imaging abdominal, Mesenteric vein thrombosis
Clinical narrative: Portal, mesenteric, and splenic vein thrombosis
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Portal vein thrombosis, Splenic vein thrombosis, Ultrasound scan
Clinical narrative: Portal, mesenteric, and splenic vein thrombosis
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Dizziness, Electrocardiogram normal, Laboratory test normal, Scan with contrast normal
Clinical narrative: pt says on Feb 8th he was taken to the ER. because  the room was violently spinning and he was vomiting. They did multiple test which were all negative. He had a head and neck CT with contrast. Had an EKG and cardiac marker lab work. His DX was vertigo. They prescribed him Zofran and meclizine. He followed up with PCP Dr. on Feb 14th. He DX was vestibular neuritis. His recommendation was to continue the meds that he was given in the ER since this is a virus caused by varicella which is the active ingredient from the Shingrix vaccine. He is still having the symptoms and dizziness from the virus and will discuss having the second dose with his PCP.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Varicella, Vertigo, Vestibular neuronitis, Vomiting
Clinical narrative: pt says on Feb 8th he was taken to the ER. because  the room was violently spinning and he was vomiting. They did multiple test which were all negative. He had a head and neck CT with contrast. Had an EKG and cardiac marker lab work. His DX was vertigo. They prescribed him Zofran and meclizine. He followed up with PCP Dr. on Feb 14th. He DX was vestibular neuritis. His recommendation was to continue the meds that he was given in the ER since this is a virus caused by varicella which is the active ingredient from the Shingrix vaccine. He is still having the symptoms and dizziness from the virus and will discuss having the second dose with his PCP.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: The patient was seen in our clinic for a school physical when mom mentioned his right arm. The injection site has a localized reaction with swelling, erythema, and very hard to touch. This vaccine was given at County Health Department on 02/11/2025 and this patient was seen in our office on 02/17/2025. Mom has been using ice packs to minimize swelling but not given any oral medications such as Benadryl or Tylenol to prevent rash. His arm has been like this for almost a week. The school was contacted because they are trying to get the patient caught up on vaccines but no more was given due to the reaction he has had. Mom is concerned about any further vaccinations due to the fact the patient has had reactions  with other vaccines in the past. We explained to mom we would report this and get further information regarding the info. she has given us in the clinic on 02/17/2025.
Age: 74.0
Sex: M
Vaccine: PNC21
Symptoms: Chills, Headache, Myalgia, Pain, Pyrexia
Clinical narrative: About 12 hours after injection, awaken with high fever and chills, body aches, sever headache, muscle aches
Age: 13.0
Sex: M
Vaccine: TYP
Symptoms: Dyspnoea, Loss of consciousness, Urticaria, Vomiting
Clinical narrative: Reported to RN that took call stating that after the client took his second dose of Oral Typhoid, had a severe reaction that presented as vomiting (threw up the pill), followed by hives, more vomiting, passing out, loss of consciousness for a minute or two and some trouble breathing. Client's mother did not seek medical care but was monitored throughout the night. No lingering effects the morning after this episode. Instructed to reach out to their PCP