chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Migraine, Mobility decreased, Scan with contrast
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: venous damage per pt-Medium, Systemic: Hypertension-Mild, Additional Details: pt reported md has diagnosed him with "long covid" associated with vaccine-venous damage , Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: ; LotNumber: 2724l; Route: im; BodySite: arm; Dose: ; VaxDate: 10/11/2024
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Hypertension, Injection site pain, Post-acute COVID-19 syndrome, Venous injury
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: venous damage per pt-Medium, Systemic: Hypertension-Mild, Additional Details: pt reported md has diagnosed him with "long covid" associated with vaccine-venous damage , Other Vaccines:  VaccineTypeBrand: Flulaval; Manufacturer: ; LotNumber: 2724l; Route: im; BodySite: arm; Dose: ; VaxDate: 10/11/2024
Age: 1.0
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; the 12 month old patient was administered  MMR II on 1/20/2025 (1st dose) and on 2/3/2025 the 12 month old patient was administered VARIVAX (1st dose).; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 20-Jan-2025, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), dose number 1, then, on 03-Feb-2025, the patient was vaccinated with Varicella Virus Vaccine Live (Oka-Merck) (VARIVAX), dose number 1, both as prophylaxis, the vaccines were reconstituted with sterile diluent (dose, route of administration lot # and expiration date were not reported) (Inappropriate schedule of product administration). No other information was provided. No additional adverse event.  Lot # is being requested and will be submitted if received.
Age: 18.0
Sex: F
Vaccine: MMRV, MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; HCP called to report PROQUAD was given to an 18 year old female on 3/26/2025. No side effects or symptoms. HCP gave the combination accidentally instead of MMRII and VARIVAX separate. No additional AE/no PQC.; This spontaneous report was received from a Licensed Nurse Practitioner and refers to a 18-year-old female patient.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 26-Mar-2025, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), (lot #Y008283, expiration date: 21-Oct-2025) 0.5 mL administered by Unknown route for prophylaxis. The vaccine was prepared with a Sterile Diluent (lot# and expiration date not reported). The healthcare professional gave the combination accidentally instead of Measles, Mumps, and Rubella (MMRII) and varicella virus vaccine life (VARIVAX) separate. No side effects or symptoms.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Immediate syncope; This spontaneous report was received from a Physician Assistant and refers to an 18-year-old male patient. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Concomitant medications included Diphtheria tetanus pertussis vaccine (TDAP) and Meningococcal vaccine ("GFK").  On 06-May-2025, the patient was vaccinated with the first dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) 0.5 mL (lot #Y007197 confirmed as valid, expiration date: 18-Aug-2026), administered Intramuscularly (anatomical location not provided) as human papillomavirus (HPV) prevention.  On the same date after vaccination, the patient experienced Immediate syncope. Therefore, the patient was laid down and the event recovered within 15 minutes. It was reported that the aforementioned concomitant vaccines were administered few minutes before Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), and the patient did not experience any immediate symptoms. Also, it was stated that there was a brand-new box of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) and so far, they had given 3 doses out of this box and had had the same issue with each patient. Patient had not experienced any other issues.    The causal relationship between Immediate syncope and Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) was not reported.  Upon internal review, the event of Immediate syncope was determined to be medically significant.   This is one of several cases reported by the same reporter.; Sender's Comments: Priority : 2 , Is case serious : Yes , Index user : , Index date : 2025-05-08 , MNSC number : 02802186 , CLIC number : , ESTAR number : , IRMS number : 02802186 , Central date : 2025-05-08 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administering pentacel but only the dtap-ipv dose was given with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case was linked to US-SA-2025SA135316 and US-SA-2025SA138691  This case involves an unknown age female patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but only the DTAP-IPV dose was given with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Apr-2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) via unknown route in unknown administration site for Immunization but only the DTAP-IPV dose was given with no reported adverse event (single component of a two-component product administered) (latency- same day).  Information on the batch number was requested corresponding to the one at time of event occurrence.    Reportedly, the nurse called to ask if the dose given to a patient is valid- only the liquid part of Pentacel was administered. She further asked if they had to revaccinate or when can they give the Hib component.   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:  US-SA-2025SA135316: US-SA-2025SA138691:
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Nurse reported administering pentacel but only the Dtap-IPV dose was given with no reported adverse event; Initial information received on 08-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age male patient who was administered with diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] but only the DTAP-IPV dose was given with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 10-Apr-2025, the patient received an unknown dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(Vero)/HIB(PRP/T) vaccine, Powder and suspension for suspension for injection with standard strength (expiry date and lot number not reported) via unknown route in unknown administration site for Immunization but only the DTAP-IPV dose was given with no reported adverse event (single component of a two-component product administered) (latency- same day).  Reportedly, the nurse called to ask if the dose given to a patient is valid- only the liquid part of Pentacel was administered. She further asked if they had to revaccinate or when can they give the Hib component.   Information on the batch number was requested corresponding to the one at time of event occurrence.    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:  US-SA-2025SA138519:
Age: 0.58
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was administered the liquid DTaP-IPV component of Pentacel without mixing it with the Hib component of the vaccine with no reported adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 months old patient with unknown gender who was administered with the liquid dtap-ipv component of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] without mixing it with the hib component of the vaccine with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 09-May-2025, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine, Suspension for injection (lot number, expiry date and strength not reported) via unknown route in unknown administration site for Immunization (Immunisation) and was administered the liquid dtap-ipv component of pentacel without mixing it with the hib component of the vaccine with no reported adverse event (single component of a two-component product administered).  Information on the batch number was requested corresponding to the one at time of event occurrence.   Reportedly, caller stated that she accidentally gave only the liquid DTaP-IPV component of the Pentacel vaccine to a 7-month-old baby, without first mixing it with the Hib component of the vaccine, and she is asking for information on that.  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.
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: product administered after the excursion with no reported adverse event; Initial information received on 09-May-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who received after the excursion with no reported adverse event IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect IPV (VERO) Suspension for injection (Unknown strength, lot and expiry date) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation) after the excursion with no reported adverse event (poor quality product administered) (Latency same day)  Information on the batch number was requested corresponding to the one at time of event occurrence.  Reportedly, Max/low temperature reached: Lowest temperature reached was 21.7F and maximum was 43.2F. Duration out of labelled range: 15 minutes. Human error not involved, but caller is unsure which vaccines were administered and will follow up if they decide to deem the products not viable. Caller stated that their back up log showed a 43.5 F maximum temperature and a 39.0F minimum temperature.  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.
Age: 1.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Crying, Extra dose administered, No adverse event
Clinical narrative: pentacel was administered twice (in one day),the first vaccination, only the diluent was administered,in the second vaccination, the fully reconstituted pentacel was administered with no reported adverse event; Initial information received on 13-May-2025 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who was administered  an extra dose of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] twice (in one day),during the first vaccination, only the diluent was administered, in the second vaccination, the fully reconstituted pentacel was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine conj 15v (CRM197) for Immunisation.   On 07-May-2025, the patient received an extra (dose 3)  of 0.5 ml of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine, Powder and suspension for suspension for injection, lot UKO15AA,expiry date: 31-May2025, Frequency = once, Strength:Standard, via intramuscular route in the left thigh for prophylactic vaccination (immunization) which was administered twice (in one day),during the first vaccination, only the diluent was administered, in the second vaccination, the fully reconstituted pentacel was administered with no reported adverse event (extra dose administered) (latency:same day).  Reportedly,patient was reported waking up crying and was holding his head and no treatment given.  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.
Age: 2.0
Sex: F
Vaccine: PNC21
Symptoms: Gait inability, Injection site rash, Injection site reaction, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Injection was done at 9:50a on Tuesday morning. within 15 minutes of her injection a very thick puffy rash along her leg beginning from injection site up towards her mid belly began. Leg stiffness, leg pain, and inability to walk due to her leg not being able to have weight on it happened immediately following her rash appearing. We placed warm compresses and gentle circular motions to the leg, gave Benadryl and a topical antihistamine to her leg. At 9:15pm that night, she spike a high fever of 104.1 that was not responsive for several hours to tylenol or ibuprofen to drop the fever. It took several hours of cold baths and rags to get the fever down. She had a blank stare in her face and didn't seem as though she was hearing us. At 2:30a her fever finally dropped to 102.6 and stayed there the remaining of the day (even with around the clock ibuprofen and tylenol in her system). She began vomiting off and on until 5pm that Wednesday night.  Her rash spread and her leg remained stiff and painful to touch. By day 3 (Thursday) her fever is completely gone and despite the rash and her leg having a hard time walking from the vaccine site, she is otherwise okay.
Age: 2.0
Sex: F
Vaccine: PNC21
Symptoms: Pyrexia, Rash, Staring, Vomiting, Weight bearing difficulty
Clinical narrative: Injection was done at 9:50a on Tuesday morning. within 15 minutes of her injection a very thick puffy rash along her leg beginning from injection site up towards her mid belly began. Leg stiffness, leg pain, and inability to walk due to her leg not being able to have weight on it happened immediately following her rash appearing. We placed warm compresses and gentle circular motions to the leg, gave Benadryl and a topical antihistamine to her leg. At 9:15pm that night, she spike a high fever of 104.1 that was not responsive for several hours to tylenol or ibuprofen to drop the fever. It took several hours of cold baths and rags to get the fever down. She had a blank stare in her face and didn't seem as though she was hearing us. At 2:30a her fever finally dropped to 102.6 and stayed there the remaining of the day (even with around the clock ibuprofen and tylenol in her system). She began vomiting off and on until 5pm that Wednesday night.  Her rash spread and her leg remained stiff and painful to touch. By day 3 (Thursday) her fever is completely gone and despite the rash and her leg having a hard time walking from the vaccine site, she is otherwise okay.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chronic fatigue syndrome, Condition aggravated, Dyspnoea, Gastrooesophageal reflux disease, Hypertension
Clinical narrative: ?????????????????? (Post-COVID)  5. Migraines  6. POTS  7. HTN  8. GERD  9. MIS-A  10. L4-S1 stenosis, bulging discs  11. N/V prn  12. Intermittent Sob  13. Myalgic Encephalomyelitis
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intervertebral disc protrusion, Laboratory test, Lumbar spinal stenosis, Migraine, Multisystem inflammatory syndrome in adults
Clinical narrative: ?????????????????? (Post-COVID)  5. Migraines  6. POTS  7. HTN  8. GERD  9. MIS-A  10. L4-S1 stenosis, bulging discs  11. N/V prn  12. Intermittent Sob  13. Myalgic Encephalomyelitis
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Post-acute COVID-19 syndrome, Postural orthostatic tachycardia syndrome, Vomiting, X-ray
Clinical narrative: ?????????????????? (Post-COVID)  5. Migraines  6. POTS  7. HTN  8. GERD  9. MIS-A  10. L4-S1 stenosis, bulging discs  11. N/V prn  12. Intermittent Sob  13. Myalgic Encephalomyelitis
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypoaesthesia, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; I have no feeling on side where I had it bad; 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.   The patient's past medical history included shingles (patient had it bad out of the blue, but once he/she got over it).   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), shingles (Verbatim: Shingles) and numbness (Verbatim: I have no feeling on side where I had it bad). The outcome of the vaccination failure, shingles and numbness were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and numbness to be related to Shingles vaccine.     The company considered the vaccination failure, shingles and numbness to be unrelated to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAY-2025 This case was reported by a patient via interactive digital media  Patient had it bad out of the blue. Once he/she was over it, he/she got the shots and later ended up getting it again.  The second time was at least mild.  He/she lost feeling on the side where he/she had it bad. 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  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 and Hypoaesthesia are unlisted events which are considered unrelated to GSK Shingles vaccine"
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a dose of Kinrix vaccine was administered to a 2-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 05-MAY-2025, the patient received Kinrix. On 05-MAY-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a dose of Kinrix vaccine was administered to a 2-year-old patient). The outcome of the inappropriate age at vaccine administration 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 :05-MAY-2025 Nurse called to report a dose of Kinrix vaccine was administered to a 2-year-old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: Menveo, Administration of only the diluent portion; Menveo, 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 dose of vaccine administered in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 07-MAY-2025, the patient received Menveo. On 07-MAY-2025, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: Menveo, Administration of only the diluent portion) and inappropriate preparation of medication (Verbatim: Menveo, Administration of only the diluent portion). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were not applicable.   Additional Information: GSK receipt date: 07-MAY-2025 Other HCP reported about administration of only the diluent portion of Menveo (2 vial) to a patient, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The pharmacist asked if the patient should be re vaccinated. The pharmacist did not provide patient identifiers (initials, age), and did not had the information about Menveo dose(lot number, expiration date). Consented to follow up.
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   This case contains information for the 2nd of 5 patients described by the reporter.   No concomitant medication was reported.  The reporter checked to see if Spikevax lot 3043838 had any quality issues or concerns.   It was unknown if the patient experienced any additional symptoms/events.   No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786107 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live follow-up received that contains non-significant information includes reference numbers were added. On 07-May-2025: Live follow-up received that contains non-significant information includes reference numbers were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786107:Master case
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient experienced arm pain after receiving the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3043838) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Patient experienced arm pain after receiving the Moderna vaccine) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   This case contains information for the 1st of 5 patients described by the reporter.   No concomitant medication was reported.  The reporter checked to see if Spikevax lot 3043838 had any quality issues or concerns.   It was unknown if the patient experienced any additional symptoms/events.   No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2025-786120, US-MODERNATX, INC.-MOD-2025-786122, US-MODERNATX, INC.-MOD-2025-786123, US-MODERNATX, INC.-MOD-2025-786125 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2025: Live follow-up received that contains non-significant information includes reference numbers were added. On 07-May-2025: Live follow-up received that contains non-significant information includes reference numbers were added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-786120:Patient 2 US-MODERNATX, INC.-MOD-2025-786122:Patient 3 US-MODERNATX, INC.-MOD-2025-786125:Patient 5 US-MODERNATX, INC.-MOD-2025-786123:Patient 4
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling, Swelling face
Clinical narrative: Swelling on left side of face and neck.
Age: 1.42
Sex: F
Vaccine: COVID19
Symptoms: Hiccups, Respiration abnormal
Clinical narrative: Hiccupping and belly breathing from 10am-4pm about 6 hours after receiving vaccine.
Age: 1.0
Sex: M
Vaccine: MMR, PNC20, VARCEL
Symptoms: Decreased appetite, Injection site erythema, Poor quality sleep
Clinical narrative: Redness to back of R arm x 4 days, Tx w/ Tylenol / Motrin, poor appetite / sleep.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient was diagnosed by prescriber as cellulitis. the injection site is red and swollen. patient is in a course of antibiotics and is unresponsive. she recieved a antibiotic shot today and might have to visit md again for another shot. she was also recommened to take alletgy medication otc.
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient was diagnosed by prescriber as cellulitis. the injection site is red and swollen. patient is in a course of antibiotics and is unresponsive. she recieved a antibiotic shot today and might have to visit md again for another shot. she was also recommened to take alletgy medication otc.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Systemic: COVID-19 VIRUS-Medium, Additional Details: Patient has COVID-19 now. Patient says it's been 3 weeks since she had COVID-19 virus.
Age: 70.0
Sex: M
Vaccine: PNC21
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pt received vaccine at 10 am and called the pharmacy back at 3 pm and said he was experiencing itchiness from the waste up and was red in the face and neck but no swelling. Pt had already left so told him to take benadryl and to go to urgent care or ER if it got any worse. Called the next day on 4/30 to follow up and left a message but have not heard back to see if pt actually ended up going to get extra help
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: No adverse event or administration error occurred. Documentation error due to clicking "no" instead of "yes" to reconstitution question. Vaccine was given as directed and was reconstituted correctly before administering.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: No adverse event/administration error occurred. Clicked "no" instead of "yes" when documenting if vaccine was reconstituted. Vaccine was administered as directed and was reconstituted correctly before administration.
Age: 58.0
Sex: M
Vaccine: MMR
Symptoms: Injection site pain, Muscle discomfort
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: pt trains at boxing gym, claims 1 week after the vaccine he feels an uncomfortable sensation under his tricep muscle.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Flushing, Hyperhidrosis, Hypotension, Seizure like phenomena, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure like symptoms-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Additional Details: Patient fainted twice in seated position and seemed to have seizure like activity in eyes, mouth, and hands. 911 responded and took all vitals, pt had regained consciousness and signed waiver with EMTs to leave on own accord with spouse.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure like symptoms-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Systemic: Shakiness-Medium, Additional Details: Patient fainted twice in seated position and seemed to have seizure like activity in eyes, mouth, and hands. 911 responded and took all vitals, pt had regained consciousness and signed waiver with EMTs to leave on own accord with spouse.
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Hypoacusis
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: patient experienced impaired vision and hearing 10 minutes after immunization was provided. patient was asked to remain seated for 15 minutes. patient still complained he could not see or hear. rescue was called,mother verbally consented, to call rescue. rescue assessed vitals they were in normal range. patient vision and hearing was restored. Patient did not leave with rescue symptoms  dissipated with the exception of residual headache., Other Vaccines:  VaccineTypeBrand: priorix; Manufacturer: gsk; LotNumber: 955e2; Route: subcutaneous; BodySite: left arm; Dose: 1; VaxDate: 05/01/2025
Age: 48.0
Sex: M
Vaccine: MMR
Symptoms: Injection site bruising, Visual impairment
Clinical narrative: Site: Bruising at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: patient experienced impaired vision and hearing 10 minutes after immunization was provided. patient was asked to remain seated for 15 minutes. patient still complained he could not see or hear. rescue was called,mother verbally consented, to call rescue. rescue assessed vitals they were in normal range. patient vision and hearing was restored. Patient did not leave with rescue symptoms  dissipated with the exception of residual headache., Other Vaccines:  VaccineTypeBrand: priorix; Manufacturer: gsk; LotNumber: 955e2; Route: subcutaneous; BodySite: left arm; Dose: 1; VaxDate: 05/01/2025
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Systemic: Low Platelet count-Severe, Additional Details: Patient says she has low platelet count, but this may also be due to oncology treatment.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Additional Details: patient was feeling faint. advised to lie down but did not want to lie down on floor -propped up feet/legs to allow for circulation. advised to call 911 patient refused/ took initial bp 70/50 temp 95 .  monitored patient for 1/2 hour . bp 120/74 before leaving ., Other Vaccines:  VaccineTypeBrand: shingrix /shingles; Manufacturer: gsk; LotNumber: ; Route: im; BodySite: deltoid rt; Dose: ; VaxDate: UNKNOWN
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Blood pressure increased
Clinical narrative: Systemic: elevated blood pressure-Mild, Other Vaccines:  VaccineTypeBrand: shingles shingrix; Manufacturer: glaxosmithkline; LotNumber: 75gz7; Route: im; BodySite: left deltoid; Dose: ; VaxDate: UNKNOWN
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Injection site erythema, Lethargy, Malaise
Clinical narrative: Site: Redness at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Additional Details: Patient stated to the technician that she was really sick and did not elaborate any further.
Age: 76.0
Sex: F
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: rash on arm that spread/moved to bicep-Medium
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: Systemic: Patient has Long COVID-Severe, Additional Details: Patient has Long COVID
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Flushing, Headache, Hyperhidrosis
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild, Additional Details: Patient stated was like a light switch were lasted for about a day then was fine, but when experiencing symptoms stated it felt like he had covid
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild, Additional Details: Patient stated was like a light switch were lasted for about a day then was fine, but when experiencing symptoms stated it felt like he had covid
Age: 59.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient called back two days after receiving vaccine to inform us that his arm was red and irritated. He then came in on 5/5/25 (4 days after receiving vaccine) to show us his arm and how red it was- there was redness about 4 inches wide and almost 6 inches in height. He also said that it felt warm to the touch. Called his doctor's office on 5/6/25 to inform them of his reaction and the nurse said she will follow up with patient.
Age: 59.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Arthralgia, Influenza like illness, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient called back two days after receiving vaccine to inform us that his arm was red and irritated. He then came in on 5/5/25 (4 days after receiving vaccine) to show us his arm and how red it was- there was redness about 4 inches wide and almost 6 inches in height. He also said that it felt warm to the touch. Called his doctor's office on 5/6/25 to inform them of his reaction and the nurse said she will follow up with patient.
Age: 59.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Injection site pruritus, Injection site swelling, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Additional Details: Patient called back two days after receiving vaccine to inform us that his arm was red and irritated. He then came in on 5/5/25 (4 days after receiving vaccine) to show us his arm and how red it was- there was redness about 4 inches wide and almost 6 inches in height. He also said that it felt warm to the touch. Called his doctor's office on 5/6/25 to inform them of his reaction and the nurse said she will follow up with patient.
Age: 59.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Describes generalized symptoms as joint pain & flu like symptoms-Mild, Systemic: Joint Pain-Mild, Additional Details: As of 05/05/2025: large raised red area around the injection site on the left deltoid measuring 4"x 5.5".  Hot to the touch.  pain and discomfort self managed bypatien using scheduled tylenol
Age: 59.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Arthralgia, Influenza like illness, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Describes generalized symptoms as joint pain & flu like symptoms-Mild, Systemic: Joint Pain-Mild, Additional Details: As of 05/05/2025: large raised red area around the injection site on the left deltoid measuring 4"x 5.5".  Hot to the touch.  pain and discomfort self managed bypatien using scheduled tylenol
Age: 59.0
Sex: M
Vaccine: PNC21, PNC21
Symptoms: Injection site pruritus, Injection site swelling, Pain, Pyrexia
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Mild, Systemic: Fever-Mild, Systemic: Describes generalized symptoms as joint pain & flu like symptoms-Mild, Systemic: Joint Pain-Mild, Additional Details: As of 05/05/2025: large raised red area around the injection site on the left deltoid measuring 4"x 5.5".  Hot to the touch.  pain and discomfort self managed bypatien using scheduled tylenol
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Eye movement disorder, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: incontinent of urine-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Patient became unresponsive, incontinent of urine, eyes rolling and pale approximately 5 minutes after vaccine administration. EMS called and vitals obtained while on call with EMS. Patient unresponsive for approximately a minute. Patient came too and able to answer questions appropriately after but remained, diaphoretic.
Age: 41.0
Sex: M
Vaccine: TD
Symptoms: Pallor, Syncope, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: incontinent of urine-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Additional Details: Patient became unresponsive, incontinent of urine, eyes rolling and pale approximately 5 minutes after vaccine administration. EMS called and vitals obtained while on call with EMS. Patient unresponsive for approximately a minute. Patient came too and able to answer questions appropriately after but remained, diaphoretic.
Age: 34.0
Sex: M
Vaccine: PNC21
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: couple days after the vaccine, patient develops swelling and redness from deltoid down the arm
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Confusional state, Fatigue, Lethargy
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: sleep walking/driving, in and out of consciousness-Severe, Systemic: Weakness-Medium, Additional Details: Pt got the moderna covid vaccine and capvaxive at the same appointment, pt reported being weak and tire. Pt says she sleeped walked during the middle of the night and sleep drove during the middle of the night with no specific place in mind. she realized what she was doing and drove back home. Pt says she was in and out of consciousness while driving, Other Vaccines:  VaccineTypeBrand: capvaxive; Manufacturer: merck sharp; LotNumber: y019158; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Somnambulism
Clinical narrative: Systemic: Chills-Medium, Systemic: Confusion-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: sleep walking/driving, in and out of consciousness-Severe, Systemic: Weakness-Medium, Additional Details: Pt got the moderna covid vaccine and capvaxive at the same appointment, pt reported being weak and tire. Pt says she sleeped walked during the middle of the night and sleep drove during the middle of the night with no specific place in mind. she realized what she was doing and drove back home. Pt says she was in and out of consciousness while driving, Other Vaccines:  VaccineTypeBrand: capvaxive; Manufacturer: merck sharp; LotNumber: y019158; Route: im; BodySite: left arm; Dose: ; VaxDate: UNKNOWN
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Lethargy, Malaise
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: Weakness-Mild, Additional Details: Not feeling well, flu like symptoms
Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient got her prevnar 20 on 04/30/2025, after 3 days she started having redness and swelling on the injection site and down to here lbow.
Age: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: stiff arm, has some difficulty raising arm, feels locked in-Medium
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Injection site erythema, Injection site pain, Wheezing
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: rash went from injection site to elbow. noticed the rash tues am, down to elbow. when she came in on 5/7/25 at 11am she stated rash has receded a little. monday night slight wheezing/chest pain/shortness of breath.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Loss of personal independence in daily activities, Malaise
Clinical narrative: Systemic: Exhaustion / Lethargy-Severe, Systemic: Feeling unwell.-Mild, Additional Details: Patient stated she had to cancel plans due to the extreme tiredness/fatigue., Other Vaccines:  VaccineTypeBrand: Influenza Vaccine; Manufacturer: Fluzone High dose; LotNumber: U8499AA; Route: IM; BodySite: Right Arm; Dose: 1; VaxDate: 09/23/2024
Age: 68.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Confusional state, Dizziness, Fatigue, Lethargy
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Weakness-Medium
Age: 70.0
Sex: M
Vaccine: RSV
Symptoms: Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Weakness-Medium