chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administration to an patient under the age (3 YO); 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 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number Y49BZ, expiry date 17-MAY-2026) for prophylaxis.   On 10-APR-2025, the patient received Kinrix. On 10-APR-2025, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to an patient under the age (3 YO)). 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: 02-MAY-2025 The reporter reported on 02-May-2025 a the nurse gave an 8 month old baby the Kinrix.  The Vaccine Administration Facility is the same as Primary Reporter. The Healthcare professional reported that the patient was 8 month at the moment of the vaccination, but as we escalated this to 2nd line, HCP mentioned to my coworker that the real age of the patient was 3 years old which led to the inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: received an extra Hep A/Extra Dose Administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-year-old male patient who received HAV (Havrix) (batch number A3X2K, expiry date 07-SEP-2026) for prophylaxis.   Previously administered products included havrix (Patient received first dose on an unknown date) and Havrix (Patient received booster dose and completed the schedule for the first time on 06-SEP-2022).   On 01-MAY-2025, the patient received the 3rd dose of Havrix. On 01-MAY-2025, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: received an extra Hep A/Extra Dose Administered). The outcome of the extra dose administered 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: 02-MAY-2025 Nurse stated that they had a patient that received a vaccine error.  The patient received Hep A vaccine, Havrix and the patient had already received a Hep initial doses, the patient actually received an extra Hep A. Patient completed the schedule for the first time on September 6th, 2022. Patient received third dose of Havrix , which led to extra dose administered.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Boostrix incomplete dose administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 47-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number Y3Z9P, expiry date 27-AUG-2027) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incomplete dose administered (Verbatim: Boostrix incomplete dose administration). The outcome of the incomplete dose administered 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: 02-MAY-2025 The registered nurse reported that the patient received incomplete dose of Boostrix. The nurse wanted to know how to proceed (like repeat the dose in two or four weeks or wait at al) after a patient received an incomplete dose of Boostrix.  The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: MMR
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administration of Priorix via intramuscular route in a 61 year old; administration of Priorix via intramuscular route; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 61-year-old female patient who received MMR (Priorix) (batch number 4n222, expiry date 13-SEP-2026) for prophylaxis.   On 02-MAY-2025, the patient received the 1st dose of Priorix (intramuscular). On 02-MAY-2025, an unknown time after receiving Priorix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Priorix via intramuscular route in a 61 year old) and subcutaneous injection formulation administered by other route (Verbatim: administration of Priorix via intramuscular route). The outcome of the inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route were 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: 02-MAY-2025 The pharmacist contacted GlaxoSmithKline to request information about the administration of Priorix via intramuscular route in a 61 year old patient, which led to the inappropriate age at vaccine administration and subcutaneous injection formulation administered by other route. The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: it had been four years does this patient need third vaccine; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Men B NVS (Bexsero) for prophylaxis.   Previously administered products included Bexsero (patient received 1st dose on an unknown date) and Bexsero (patient received 2nd dose on an unknown date).   On an unknown date, the patient did not receive the 3rd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incomplete course of vaccination (Verbatim: it had been four years does this patient need third vaccine). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 02-MAY-2025 Other HCP reported that a patient who according to the former guideline got two Bexsero´s 2021, and it had been four years does this patient get a third vaccine? Reporter indicated that at age twenty five was a cut-off and don´t want to give a third dose. Till the time of reporting patient did not receive 3rd dose of Bexsero which led to incomplete course of vaccination.
Age: 47.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: A 47 years old male patient received Priorix IM instead of subcutaneous; A 47 years old male patient received Priorix; This non-serious case was reported by a consumer via call center representative and described the occurrence of subcutaneous injection formulation administered by other route in a 47-year-old male patient who received MMR (Priorix) (batch number 4N222, expiry date 13-SEP-2026) for prophylaxis.   On 23-APR-2025, the patient received Priorix (intramuscular, unknown deltoid). On 23-APR-2025, an unknown time after receiving Priorix, the patient experienced subcutaneous injection formulation administered by other route (Verbatim: A 47 years old male patient received Priorix IM instead of subcutaneous) and inappropriate age at vaccine administration (Verbatim: A 47 years old male patient received Priorix). The outcome of the subcutaneous injection formulation administered by other route and inappropriate age at vaccine administration were 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 On 23rd April 2025, a 47 year old male received Priorix intramuscularly in the deltoid instead of subcutaneously, which led to Subcutaneous injection formulation administered by other route and Inappropriate age at vaccine administration. The patient/reporter was not certain if he had received prior MMR injections in the past as a child, though he assumed that he had.  However, since he was preparing for international travel, it was recommended that he receive a Priorix dose before his departure.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the second dose on February 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 93KK4, expiry date 31-JAN-2027) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix vaccine in 2018).   In FEB-2025, the patient received Shingrix. In FEB-2025, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: the second dose on February 2025). The outcome of the drug dose administration interval too long was not applicable.   Additional Information: GSK Receipt Date: 06-MAY-2025 The pharmacist called to verify if an extra Shingrix dose would be needed if patient received the first dose on 2018 and the second dose on February 2025, which led to drug dose administration interval too long. The Vaccine Administration Facility is the same as Primary Reporter.
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: hasn't received a second dose yet). The outcome of the incomplete course of vaccination was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-MAY-2025 The pharmacist called on 6th May 2025, to report a patient received a first dose of Twinrix in 2023 and had not received a second dose yet which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. Exact vaccination date and adverse event details were asked and declined. Only information provided was that the Twinrix was administered during year 2023.
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 15 month old patient received Boostrix on November 8th 2024 instead of the 4th Dtap dose; received at 15 months of age; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (Dtap) for prophylaxis.   Previously administered products included Dtap (received 3 doses on an unknown date).   On 08-NOV-2024, the patient received Boostrix. On an unknown date, the patient received the 4th dose of Dtap. On 08-NOV-2024, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: 15 month old patient received Boostrix on November 8th 2024 instead of the 4th Dtap dose) and inappropriate age at vaccine administration (Verbatim: received at 15 months of age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: The nurse reported that a 15 month old patient received Boostrix on November 8th 2024 instead of the 4th Dtap dose (previously vaccinated with 3 Dtap doses), which led to wrong vaccine administered. The patient received a dose of Boostrix at an inappropriate age, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter.
Age: 50.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: dose administered was the 2nd dose of Engerix-B, and that it had expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HBV (Engerix B) (batch number NT9X3, expiry date 09-SEP-2024) for prophylaxis.   On 08-MAY-2025, the patient received the 2nd dose of Engerix B. On 08-MAY-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: dose administered was the 2nd dose of Engerix-B, and that it had expired). The outcome of the expired vaccine used was not applicable.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-MAY-2025 The nurse reported that she had administered a HepB vaccination, and it is expired which led to, expired vaccine used.
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: accidentally administered an expired hepatitis A pediatric vaccine (Havarix); This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix pediatric) (expiry date MAY-2025) for prophylaxis.   On 07-MAY-2025, the patient received Havrix pediatric. On 07-MAY-2025, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: accidentally administered an expired hepatitis A pediatric vaccine (Havarix)). The outcome of the expired vaccine used was not applicable.   Additional Information: GSK Receipt Date: 08-MAY-2025 Reporter stated that their clinic accidentally administered an expired hepatitis A pediatric vaccine (Havrix) to a patient, it was expired by 2 days, which led to expired vaccine used. Also wanted to know if any known risks/concerns of receiving an expired vaccine and if this vaccine is still valid (like if it is still ok up to a few days).
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis.    No Medical History information was reported.   On 29-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. Not Provided      For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   This case contains information for the 2nd patient out of 4 patients described by the reporter. Concomitant medication information was not reported.  HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem.   This case was linked to US-MODERNATX, INC.-MOD-2025-785794 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live follow up received that non-significant information. References added. On 29-Apr-2025: Live follow up received that non-significant information; reference ID added; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785794:Patient 2 of 4
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis.    No Medical History information was reported.   On 29-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown. Not Provided      For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   This case contains information for the 3rd patient out of 4 patients as described by the reporter.  Concomitant medication was not reported. HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem.   This case was linked to US-MODERNATX, INC.-MOD-2025-785794 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live follow up received that non-significant information. References added. On 29-Apr-2025: Live follow up received that non-significant information; reference ID added; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785794:Patient 3
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis.    No Medical History information was reported.   On 29-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   This case was created for 4th out of 4 patients reported.  Concomitant medication was not reported. HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem.   This case was linked to US-MODERNATX, INC.-MOD-2025-785794 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live non-significant follow-up received. References added. On 29-Apr-2025: Live non-significant follow-up received. Reporter details and reference ID added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785794:Patient 4
Vaccine: COVID19
Symptoms: Device issue, No adverse event
Clinical narrative: HCP stated that a few of her PFS have been having issues with the plunger; No adverse effect; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) in a  patient of an unknown age and gender who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3046731) for COVID-19 prophylaxis.    Suspect product included Pre-filled Syringe injection (batch no. 3046731) for COVID-19 prophylaxis.    No Medical History information was reported.   On 23-Apr-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) .5 milliliter. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect). At the time of the report, DEVICE ISSUE (HCP stated that a few of her PFS have been having issues with the plunger) and NO ADVERSE EVENT (No adverse effect) outcome was unknown.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   This case was created for 1st patient out of 4 patients as described by the reporter.  Concomitant medication information was not reported.  HCP stated that, whenever the needle is attached to the PFS, the plunger rod becomes stuck, almost like there was too much pressure. HCP stated that the nurse was able to push the plunger up and down before she attached the needle onto it. HCP stated that she did clarify with the nurse about the needle. She stated that the nurse tried taking off the needle to see if that was the issue and the plunger still would not move. HCP stated that the nurse encountered this issue upon administering the vaccine to the patient. She stated that it was administered in the patient's arm. This happened to 1 patient on 23-Apr-2025 and 3 patients on 29-Apr-2025. Treatment medication was not reported. The Device problem code for Spikevax syringe include FDA code 1670, IMDRF code A23 which included Use of Device Problem.   This case was linked to US-MODERNATX, INC.-MOD-2025-785803, US-MODERNATX, INC.-MOD-2025-785807, US-MODERNATX, INC.-MOD-2025-785810 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2025: Live non-significant follow-up received. References added. On 29-Apr-2025: Live non-significant follow-up received. Reporter details and reference ID added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2025-785810:Patient 4 US-MODERNATX, INC.-MOD-2025-785807:Patient 3 US-MODERNATX, INC.-MOD-2025-785803:Patient 2
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Tinnitus
Clinical narrative: I wound up getting tinnitus; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (I wound up getting tinnitus) in an elderly female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine (Flu) for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (had received "6 or 7" doses of Spikevax already). Past adverse reactions to the above products included No adverse effect with Spikevax NOS.   In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient received dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (I wound up getting tinnitus). At the time of the report, TINNITUS (I wound up getting tinnitus) outcome was unknown.      No concomitant medications were reported.  It was reported that the patient received 6 or 7 doses of Spikevax throughout her life, with the most recent Spikevax 24-25 administered in Sep-2024. The patient received high-dose flu vaccine, whose manufacturer and date were not reported. The patient developed tinnitus following flu shot. The patient emphasized that the event was related to the flu shot and not the COVID vaccine, which she had received multiple times. She also reported the event tinnitus to the company responsible for administering the flu shot, clarifying that it was not related to Spikevax.   No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: Experiencing prolonged healing at the injection site; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE REACTION (Experiencing prolonged healing at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. In 2021, the patient experienced INJECTION SITE REACTION (Experiencing prolonged healing at the injection site). At the time of the report, INJECTION SITE REACTION (Experiencing prolonged healing at the injection site) had not resolved.            Concomitant medication was not provided.  Patient called to report that the injection site from her Moderna COVID-19 vaccine, received in 2021, had not healed. She had been experiencing prolonged healing at the injection site. Despite consulting multiple doctors over the years, she had not received a satisfactory explanation. She expressed concern about the unusual duration for healing and inquired if others experienced similar issues.  One doctor mentioned mercury from the needle, while another ordered blood tests, which she recently completed, but results are pending.  It was unknown if the patient experienced any additional symptoms or events.  Treatment information was not reported.
Age: 32.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Vaccine administered 5/12/2025, it expired the day before on 5/11/2025.  No adverse affects noted.
Age: 1.25
Sex: F
Vaccine: DTAP, PNC20, VARCEL
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Mom reports swelling to injection site left thigh the following day after receiving 3 vaccines. Tender to touch. Dr examined patient. Treatment Cephalexin 125 mg/5ml take 150 mg = 6 ml by mouth every 8 hours x 5 days.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Confusional state, Dizziness, Dysstasia, Gait disturbance
Clinical narrative: About fifteen minutes after, as I was outside waiting for my  ride I experienced a series of alarming side effects: first it was a vision problem, then severe dizziness and confusion that lasted for several hours. I had trouble seeing the ramp to access  the bus  and finding the seat belt. Thanks to the caring driver I could safely return home.   Next morning I woke up to severe pain in my left arm, that extended to all the left side of my body. I had trouble standing as my left hip and left knee seem very wobbly and unable to sustain my weight. This condition as remained like that to this day, and seems to be permanent. No pain reliever was able to allow me recover the complete use of my left leg and hip.   What worries me is that it has affected my ability to walk already somehow a little diminish due to my age. I am eighty seven and experience the normal decline in the agility that I had before.  I had the Moderna vaccine before twice without any side effects. I feel that I have the duty to report my reaction to warn other elderly person about possible severe side effects of the new vaccine.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity, Visual impairment
Clinical narrative: About fifteen minutes after, as I was outside waiting for my  ride I experienced a series of alarming side effects: first it was a vision problem, then severe dizziness and confusion that lasted for several hours. I had trouble seeing the ramp to access  the bus  and finding the seat belt. Thanks to the caring driver I could safely return home.   Next morning I woke up to severe pain in my left arm, that extended to all the left side of my body. I had trouble standing as my left hip and left knee seem very wobbly and unable to sustain my weight. This condition as remained like that to this day, and seems to be permanent. No pain reliever was able to allow me recover the complete use of my left leg and hip.   What worries me is that it has affected my ability to walk already somehow a little diminish due to my age. I am eighty seven and experience the normal decline in the agility that I had before.  I had the Moderna vaccine before twice without any side effects. I feel that I have the duty to report my reaction to warn other elderly person about possible severe side effects of the new vaccine.
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 71.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: patient reported itching, pudging on the back of arm, and small rash around the injection site. Took benadryl which helped the itching
Age: 24.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Pruritus, Rash
Clinical narrative: Rash, itching, soreness, redness
Age: 42.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination. The outcome was uneventful, with no symptoms or signs of reactions reported.
Age: 18.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Rash
Clinical narrative: Pt has rash and itching. Pt was given Benadryl and Ibuprofen
Age: 53.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the second of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 43.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of any reactions reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Injection site paraesthesia, Injection site reaction, Mass, Pain
Clinical narrative: Injection given at the County Medical Center Kidney Transplant Clinic on 4/14/25. Developed local reaction a few hours after the injection with lump, pain, swelling that persisted for several days. 2 weeks later, begin to notice tingling sensation intermittently that started near injection site & then radiates down arm and forearm in radial nerve distribution, including tingling in thumb, index, and third fingers. Intermittently feeling a tight squeezing sensation of the upper arm now for the past few days that she describes as feeling as if a blood pressure cuff is intermittently tightening and squeezing her upper arm. Presented today, 5/12/25, for evaluation as symptoms seem to be worsening. No other explanation for symptoms other than the vaccination.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling
Clinical narrative: Injection given at the County Medical Center Kidney Transplant Clinic on 4/14/25. Developed local reaction a few hours after the injection with lump, pain, swelling that persisted for several days. 2 weeks later, begin to notice tingling sensation intermittently that started near injection site & then radiates down arm and forearm in radial nerve distribution, including tingling in thumb, index, and third fingers. Intermittently feeling a tight squeezing sensation of the upper arm now for the past few days that she describes as feeling as if a blood pressure cuff is intermittently tightening and squeezing her upper arm. Presented today, 5/12/25, for evaluation as symptoms seem to be worsening. No other explanation for symptoms other than the vaccination.
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-seried vaccination; the outcome was uneventful, with no symptoms or sighs of reaction reported.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Brachial plexus injury, Immediate post-injection reaction, Muscle twitching, Muscular weakness, Nerve injury
Clinical narrative: Disgnosed with brachial plexus injury/ neuritis pain was immediate and had nerve injury including muscle weakness and twitching down to hand.
Age: 39.0
Sex: F
Vaccine: UNK
Symptoms: Neuritis, Pain, X-ray
Clinical narrative: Disgnosed with brachial plexus injury/ neuritis pain was immediate and had nerve injury including muscle weakness and twitching down to hand.
Age: 21.0
Sex: M
Vaccine: SMALLMNK
Symptoms: No adverse event
Clinical narrative: The treatment was the first of a two-series vaccination; the outcome was uneventful, with no symptoms or signs of reaction reported.
Age: 60.0
Sex: F
Vaccine: PNC21, RSV, VARZOS
Symptoms: Injection site pain, Injection site rash, Urticaria
Clinical narrative: Per patient, localized injection site pain in both arms following administration.  Urticaria on right arm same day.  Rash developed around right arm at injection area. approximately 2 days after vaccine administration. Patient took Benadryl to manage symptoms with success. Rash lessened and eventually went away after a few days.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, C-reactive protein increased, Complement factor C3, Impaired work ability, Joint stiffness
Clinical narrative: Received first shot in series on 31 Jan 2025. Soon started noticing stiffness in finger joints but I didn't make the connection to the vaccine. Received second shot on March 5 2025. Symptoms worsened. Pain and stiffness in finger joints, wrists, toes and and one point knees. Pain sufficient to interfere with work and prevent sleep.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Sleep disorder
Clinical narrative: Received first shot in series on 31 Jan 2025. Soon started noticing stiffness in finger joints but I didn't make the connection to the vaccine. Received second shot on March 5 2025. Symptoms worsened. Pain and stiffness in finger joints, wrists, toes and and one point knees. Pain sufficient to interfere with work and prevent sleep.
Age: 0.42
Sex: M
Vaccine: DTAP, HIBV, PNC15, RV5
Symptoms: Product administered at inappropriate site
Clinical narrative: DATACEL vaccination was given in the same vaccination site as another vaccine.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered
Clinical narrative: Pt was given 2 doses of MMR vaccine
Age: 62.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Injection site discomfort, Injection site pain, Musculoskeletal discomfort, Pain
Clinical narrative: THE PATIENT COMPLAINED THAT HIS RIGHT ARM IN THE DELTOID AND/OR SHOULDER AREA HAD SOME PAIN AND DISCOMFORT WHEN HE RAISED HIS ARM UP HALF WAY UP.  HE ALSO MENTIONED THAT THIS ARM( RIGHT ARM)  IN THE SHOULDER AREA WAS INJURED FORM SNOW SHOVELING AND THAT SOME TIME IT SILL HURTS. ON 5/12/25 HE CAME IN FOR HIS SECOND SHINGRX VACCINE. IT WAS PUT IN HIS LEFT DELTOID.  I INSTRUCTED HIM TO CHECK WITH HIS PROVIDER IF HIS RIGHT ARM CONTINUED TO BOTHER HIM.
Age: 29.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Eye movement disorder, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Patient was getting 2 vaccines at the pharmacy. Patient got the first vaccine (flu shot) on the right arm and the patient fainted during the 2nd shot (meningitis vaccine) on the left arm. Patient was seated in a chair with arm rests. During the vaccine administration, he said that he felt dizzy. Immediately after, he fainted. His head tilted back and his eyes rolled back. Father and Pharmacist restrained the patient to keep him from falling. Patient was passed out for about 30 seconds and woke up. He was also sweating.  Initial blood pressure was 108/53 with a pulse of 58. We called 911 and paramedics came. Paramedics examined. Vitals were all good. On the consent form, he stated that he had never fainted or felt dizzy after receiving an immunization. After the incident, the father and patient then mentioned that he fainted about 3 months ago during a blood draw.  Patient had meal(s) during the day and was hydrated.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Flushing, Injection site erythema, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Rash, large welt running down tricep that vaccine was administer in, flushed skin, bright red skin color, itchy,
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Rash, large welt running down tricep that vaccine was administer in, flushed skin, bright red skin color, itchy,
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine injection sites - red, warm, swollen. Non-tender.
Age: 50.0
Sex: F
Vaccine: PNC21, PNC20
Symptoms: Headache, Swelling face, Urticaria
Clinical narrative: Hives on face and trunk within 2-3 hours post vaccination. No airway involvement
Age: 50.0
Sex: F
Vaccine: PNC21, PNC20
Symptoms: Urticaria
Clinical narrative: Hives on face and trunk within 2-3 hours post vaccination. No airway involvement
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Deafness bilateral, Laboratory test, Pain in extremity, Scan, Vertigo
Clinical narrative: Shortly after receiving the pneumonia and shingrix vaccine on 3/18/025, I began experiencing the following symptoms:  1 . Sudden hearing loss in my right ear 2. Persistent and distressing ringing  3. Dizziness, especially when standing for extended periods  4. Nerve tingling on my face 5. Generalized fatigue and weakness   These symptoms have not improved and I am mostly bedridden due to the constant dizziness and instability. My ability to work, socialize, and perform basic daily activities has been severely been limited. Prior to the vaccination i was in good health and led an active lifestyle. This reaction has had a devastating impact on my physical well-being.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Vomiting
Clinical narrative: Shortly after receiving the pneumonia and shingrix vaccine on 3/18/025, I began experiencing the following symptoms:  1 . Sudden hearing loss in my right ear 2. Persistent and distressing ringing  3. Dizziness, especially when standing for extended periods  4. Nerve tingling on my face 5. Generalized fatigue and weakness   These symptoms have not improved and I am mostly bedridden due to the constant dizziness and instability. My ability to work, socialize, and perform basic daily activities has been severely been limited. Prior to the vaccination i was in good health and led an active lifestyle. This reaction has had a devastating impact on my physical well-being.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Asthenia, Audiogram abnormal, Deafness unilateral, Dizziness, Fatigue
Clinical narrative: Shortly after receiving the pneumonia and shingrix vaccine on 3/18/025, I began experiencing the following symptoms:  1 . Sudden hearing loss in my right ear 2. Persistent and distressing ringing  3. Dizziness, especially when standing for extended periods  4. Nerve tingling on my face 5. Generalized fatigue and weakness   These symptoms have not improved and I am mostly bedridden due to the constant dizziness and instability. My ability to work, socialize, and perform basic daily activities has been severely been limited. Prior to the vaccination i was in good health and led an active lifestyle. This reaction has had a devastating impact on my physical well-being.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Gait disturbance, Impaired work ability, Loss of personal independence in daily activities, Mixed deafness, Mobility decreased
Clinical narrative: Shortly after receiving the pneumonia and shingrix vaccine on 3/18/025, I began experiencing the following symptoms:  1 . Sudden hearing loss in my right ear 2. Persistent and distressing ringing  3. Dizziness, especially when standing for extended periods  4. Nerve tingling on my face 5. Generalized fatigue and weakness   These symptoms have not improved and I am mostly bedridden due to the constant dizziness and instability. My ability to work, socialize, and perform basic daily activities has been severely been limited. Prior to the vaccination i was in good health and led an active lifestyle. This reaction has had a devastating impact on my physical well-being.
Age: 66.0
Sex: F
Vaccine: PNC21, VARZOS, PNC21, VARZOS
Symptoms: Paraesthesia, Sudden hearing loss, Tinnitus, Tympanometry abnormal, Vertigo
Clinical narrative: Shortly after receiving the pneumonia and shingrix vaccine on 3/18/025, I began experiencing the following symptoms:  1 . Sudden hearing loss in my right ear 2. Persistent and distressing ringing  3. Dizziness, especially when standing for extended periods  4. Nerve tingling on my face 5. Generalized fatigue and weakness   These symptoms have not improved and I am mostly bedridden due to the constant dizziness and instability. My ability to work, socialize, and perform basic daily activities has been severely been limited. Prior to the vaccination i was in good health and led an active lifestyle. This reaction has had a devastating impact on my physical well-being.
Age: 1.5
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Circumstance or information capable of leading to medication error, Scratch, Underdose
Clinical narrative: the needle of the syringe to scrape the patient's leg; remaining volume of the VAQTA dose was then "squirted out of the syringe and landed on the mother's clothes; This spontaneous report was received from a Medical Assistant and refers to a 1-year-old female patient.   The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.   On 22-APR-2025, the patient received the second dose of Hepatitis A Vaccine, Inactivated (VAQTA) (lot #Y015910, expiration date: 06-Feb-2026) (0.5 mL / single or two dose series), intramuscularly, for the treatment of Hepatitis A vaccination.  The Medical Assistant stated that during the vaccination, the patient moved their leg during the attempt to administer the product, causing the needle of the syringe to scrape the patient's leg (Skin abrasion) and the remaining volume of the vaccine dose was then "squirted out of the syringe and landed on the mother's clothes" (Accidental underdose). Medical Assistant confirmed there have been no medical concerns or reactions reported regarding this event.   The patient did not seek medical attention. As treatment for the event the patient received a bandage. The patient recovered from the event of the needle of the syringe to scrape the patient's leg on an unspecified date. At the reporting time, the outcome of remaining volume of the VAQTA dose was then squirted out of the syringe and landed on the mother's clothes was unknown.   The action taken with Hepatitis A Vaccine, Inactivated was reported as not applicable.   The causal relationship between the event of the needle of the syringe to scrape the patient's leg and Hepatitis A Vaccine, Inactivated was not provided.