chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: arm still hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: arm still hurts).  The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 23-SEP-2023 This case was reported by patient via (social media) interactive digital media. The patient got his/her, and arm still hurts 5 days later. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: FLUX, RVX
Symptoms: Arthralgia, Musculoskeletal discomfort
Clinical narrative: shoulder was quite sore; discomfort; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shoulder soreness in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included influenza vaccine (Flu Vaccine (Name Unknown)) for prophylaxis.   In SEP-2023, the patient received RSV vaccine. On an unknown date, the patient started Flu Vaccine (Name Unknown). In SEP-2023, less than a week after receiving RSV vaccine, the patient experienced shoulder soreness (Verbatim: shoulder was quite sore) and discomfort (Verbatim: discomfort). The outcome of the shoulder soreness was resolving and the outcome of the discomfort was not resolved.   It was unknown if the reporter considered the shoulder soreness and discomfort to be related to RSV vaccine.     It was unknown if the company considered the shoulder soreness and discomfort to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 23-SEP-2023 The case was received from the patient via interactive digital media. The patient got RSV vaccination this week (reporting week) when he/she went to the pharmacy to get flu shot.  The patient stated the second night shoulder was quite sore. It seems to be getting better. The patient thought any discomfort would go away by the fifth day. It was unknown if the reporter considered the shoulder soreness and discomfort to be related to FLU vaccine.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RVX
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included pneumonia (in hospital 10 days with pneumonia) and respiratory syncytial virus infection.   On 25-SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 26-SEP-2023 This case was reported by patient via (social media) interactive digital media. The patient reported that he or she got our RSV vaccination yesterday, sore arm but he/she got RSV last year, in hospital 10 days with pneumonia. Follow up was not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Arthritis
Clinical narrative: Arthritis in shoulder; This non-serious case was reported by a consumer and described the occurrence of shoulder arthritis in a adult male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shoulder arthritis (Verbatim: Arthritis in shoulder).The outcome of the shoulder arthritis was not reported.   The reporter considered the shoulder arthritis to be related to Shingles vaccine.  The company considered the shoulder arthritis to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-SEP-2023 The patient self-reported this case. The patient experienced arthritis in shoulder caused by Shingles vaccine. The consent to follow up granted.
Age: 25.0
Sex: U
Vaccine: MNQ
Symptoms: Interchange of vaccine products
Clinical narrative: patient received a dose of Menveo after having received a dose of MenQuadfi; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 25-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included MENQUADFI.   On 24-SEP-2023, the patient received Menveo. On 24-SEP-2023, an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: patient received a dose of Menveo after having received a dose of MenQuadfi).  The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK Receipt Date: 25-Sep-2023 The pharmacist reported a patient received a dose of Menveo after having received a dose of MenQuadfi, which led to interchange of vaccine products. The pharmacist could not provide lot numbers or expiration dates.  No additional information provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose a couple of years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the second dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-Oct-2023 The pharmacist stated that she would sometimes had patients come into the pharmacy stating they received first dose of Shingrix a couple of years ago but never got the second dose.   She would estimate 10 patients.  At the time of reporting, she did not have any patient specific information. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. This is 1 of 10 linked reports reported by the same reporter. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: a patient received a dose of Shingrix reconstituted with sterile water instead of the accompanying adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-SEP-2023, the patient received Shingrix. On 25-SEP-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: a patient received a dose of Shingrix reconstituted with sterile water instead of the accompanying adjuvant). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023. The reporter reported a patient received a dose of Shingrix reconstituted with sterile water instead of the accompanying adjuvant. The reporter consented to follow up. The reporter did not provide patient demographics or lot number and expiration date.  No additional information was provided. The patient accidentally received a dose of Shingrix which had been reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Hernia, Intervertebral disc protrusion, Oropharyngeal pain, Pruritus
Clinical narrative: herniated/bulging discs; itching on stomach; developed a small group of blisters; developed a little sore throat; tendonitis in leg; This non-serious case was reported by a other health professional via call center representative and described the occurrence of blister in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUN-2023, more than 2 years after receiving Shingrix, the patient experienced tendonitis (Verbatim: tendonitis in leg). On 20-SEP-2023, the patient experienced blister (Verbatim: developed a small group of blisters) and sore throat (Verbatim: developed a little sore throat). On an unknown date, the patient experienced hernia (Verbatim: herniated/bulging discs) and pruritus (Verbatim: itching on stomach).  The patient was treated with ambiguous medication nos (Cortisone (Nos)) and medication unknown (Epidural Injections (Trade Name/Ingredients Unknown)). The outcome of the blister and hernia were resolving and the outcome of the sore throat and pruritus were resolved and the outcome of the tendonitis was unknown.   It was unknown if the reporter considered the blister, sore throat, hernia, tendonitis and pruritus to be related to Shingrix.     It was unknown if the company considered the blister, sore throat, hernia, tendonitis and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2023 The patient was a retired health care professional. The patient was fully vaccinated with Shingrix for about 2 years ago. The reporter enquire that do you keep data on break through symptomatology ? Trying to understand my current symptoms, as she wanted guidance. She stated she recently developed a small group of blisters 1 to 1.5 inches long and 0.5 inches wide to right of spinal cord on her back that act and felt like shingles blisters. They are located just under bra latch.  At the time she also developed a little sore throat that was now resolved (resolved 24 to 36 hours later). As of now, the blisters were scabbed over and drying.  She had not been treating them with anything.   She had not spoken to an HCP about her symptoms.  She stated she also was recovering from 2 lumbar herniated bulging discs (L4 AND L5). She had 4 courses of cortisone, 2 epidural injections L4 and L5  also 2 injections of cortisone in her leg for tendonitis in her leg.  This was in addition to 3 courses of oral cortisone.  She was been dealing with this since June 2023.  The last cortisone injection she had was on 13th September 2023 in tendons and muscles that were being affected in her leg. Additionally, HCP reported that after about 24 to 48 hours after received her 2nd dose of Shingrix she developed itching on her stomach and she stated it was gone as quickly as it came. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Scab, Tendonitis
Clinical narrative: herniated/bulging discs; itching on stomach; developed a small group of blisters; developed a little sore throat; tendonitis in leg; This non-serious case was reported by a other health professional via call center representative and described the occurrence of blister in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular, left arm). In JUN-2023, more than 2 years after receiving Shingrix, the patient experienced tendonitis (Verbatim: tendonitis in leg). On 20-SEP-2023, the patient experienced blister (Verbatim: developed a small group of blisters) and sore throat (Verbatim: developed a little sore throat). On an unknown date, the patient experienced hernia (Verbatim: herniated/bulging discs) and pruritus (Verbatim: itching on stomach).  The patient was treated with ambiguous medication nos (Cortisone (Nos)) and medication unknown (Epidural Injections (Trade Name/Ingredients Unknown)). The outcome of the blister and hernia were resolving and the outcome of the sore throat and pruritus were resolved and the outcome of the tendonitis was unknown.   It was unknown if the reporter considered the blister, sore throat, hernia, tendonitis and pruritus to be related to Shingrix.     It was unknown if the company considered the blister, sore throat, hernia, tendonitis and pruritus to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2023 The patient was a retired health care professional. The patient was fully vaccinated with Shingrix for about 2 years ago. The reporter enquire that do you keep data on break through symptomatology ? Trying to understand my current symptoms, as she wanted guidance. She stated she recently developed a small group of blisters 1 to 1.5 inches long and 0.5 inches wide to right of spinal cord on her back that act and felt like shingles blisters. They are located just under bra latch.  At the time she also developed a little sore throat that was now resolved (resolved 24 to 36 hours later). As of now, the blisters were scabbed over and drying.  She had not been treating them with anything.   She had not spoken to an HCP about her symptoms.  She stated she also was recovering from 2 lumbar herniated bulging discs (L4 AND L5). She had 4 courses of cortisone, 2 epidural injections L4 and L5  also 2 injections of cortisone in her leg for tendonitis in her leg.  This was in addition to 3 courses of oral cortisone.  She was been dealing with this since June 2023.  The last cortisone injection she had was on 13th September 2023 in tendons and muscles that were being affected in her leg. Additionally, HCP reported that after about 24 to 48 hours after received her 2nd dose of Shingrix she developed itching on her stomach and she stated it was gone as quickly as it came. The reporter consented to follow up.
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Product storage error
Clinical narrative: Fluarix, Boostrix, 23.4 Celsius for 1 month; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season and Boostrix. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: Fluarix, Boostrix, 23.4 Celsius for 1 month).  The outcome of the incorrect storage of drug was unknown.   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: 25-Sept-2023 Clinic Manager called to check stability of vaccines, Fluarix and Boostrix at 23.4 Celsius for 1 month. No prior. The reporter inquired that what if vaccines were administered. The reporter reported that he or she thought that the vaccines were administered.  The reporter unable to provide any vaccine or patient details due to still investigating. Did not consent to follow-up. The patient received Fluarix and Boostrix after temperature excursion, led to incorrect storage of drug.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: patients received FluLaval QIV today after a temperature excursion; This non-serious case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2023-2024 season) (batch number 39PF2, expiry date 30-JUN-2024) for prophylaxis.   On 25-SEP-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced incorrect storage of drug (Verbatim: patients received FluLaval QIV today after a temperature excursion).  The outcome of the incorrect storage of drug was unknown.   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: 25-Sept-2023 Doctor of medicine called and reported that 6 patients received FluLaval QIV on the day of reporting after a temperature excursion (total time of excursion was 112 hours). The reporter had no details regarding patients but gave consent for follow up. This is 1 of 6 linked patients reported by the same reporter. The patient received a dose of Flulaval QIV after temperature excursion, which led to incorrect storage of drug.
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Received only the lyophilized powder portion of shingrix after being reconstituted with normal saline; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 25-year-old female patient who received Herpes zoster (Shingrix) (batch number 259GZ, expiry date 15-MAY-2025) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Received only the lyophilized powder portion of shingrix after being reconstituted with normal saline).  The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 25-SEP-2023 The reporter reported that a patient that was immunocompromised received only the lyophilized powder portion of shingrix after being reconstituted with normal saline. No reactions were reported.  The reporter consented to follow up. The patient received only the lyophilized powder portion of shingrix after being reconstituted with normal saline, which led to wrong solution used in drug reconstitution.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on forehead, legs and arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 07-SEP-2023, the patient received the 1st dose of Shingrix (left arm). In SEP-2023, 1 week after receiving Shingrix, the patient experienced itchy rash (Verbatim: Itchy rash on forehead, legs and arms).  The outcome of the itchy rash was not resolved.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.     It was unknown if the company considered the itchy rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-SEP-2023 The caller reported he received Shingrix dose 1 and a week later he experienced an itchy rash on his forehead, legs and arms.  Some of the rash went away, some was still there on all areas.   The reporter was referred to HCP. The reporter consented to follow up.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, Exposure during pregnancy
Clinical narrative: expired dose of FluLaval QIV to pregnant female patient; expired dose of FluLaval QIV on 25Sep2025 to pregnant female patient; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number CA52L, expiry date 30-JUN-2023) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 25-SEP-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 25-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: expired dose of FluLaval QIV on 25Sep2025 to pregnant female patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: expired dose of FluLaval QIV to pregnant female patient).  The outcome of the expired vaccine used and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (FluLaval Quadrivalent 2022-2023 season): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   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: 25-Sept-2023 The case was reported by Obstetrics and gynecology office supervisor.   The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. This is 2 of 2 linked patient report reported by the same reporter. A medical assistant administered an expired dose of FluLaval QIV  to pregnant patient, which led to expired vaccine used and vaccine exposure during pregnancy.; Sender's Comments:  US-GSK-US2023131819:Same reporter, different patient
Age: 72.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired vaccine was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received HAB (Twinrix adult) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Twinrix adult. On 26-SEP-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: expired vaccine was administered).  The outcome of the expired vaccine used was unknown.   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: 26-SEP-2023 The reporter stated that an expired Twinrix was administered which led to expired vaccine used. The reporter consented to follow up via postal The vaccine administration facility is the same as primary reporter.
Age: 36.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix dose that had already expired on 22/Sep/2023 was administered to a patient.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 36-year-old female patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 23-SEP-2023, the patient received Twinrix. On 23-SEP-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix dose that had already expired on 22/Sep/2023 was administered to a patient.).  The outcome of the expired vaccine used was unknown.   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: 26-SEP-2023 It was reported that a Twinrix dose that had already expired was administered to a patient which led to expired vaccine used. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: adult dose of Havrix to a 14 year old; adult dose of Havrix to a 14 year old; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 14-year-old male patient who received HAV (Havrix adult) (batch number 55M72, expiry date 13-DEC-2024) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: adult dose of Havrix to a 14 year old) and inappropriate age at vaccine administration (Verbatim: adult dose of Havrix to a 14 year old).  The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 A nurse called to ask for information about the administration of an adult dose of Havrix to a 14 year old male patient which led to overdose and inappropriate age at vaccine administration. The Healthcare professional asked for guidance on this situation. The reporter consented to follow up.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; Shivers; headache; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), CHILLS (Shivers), HEADACHE (headache) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J on 17-Mar-2021 and J&J on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J&J and J&J.    On 17-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), CHILLS (Shivers), HEADACHE (headache) and PYREXIA (fever). At the time of the report, PAIN (body aches), CHILLS (Shivers), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received bivalent booster on 16-Oct-2022 and 27-May-2023. patient received Spikevax 2023-2024 Formula on 22-Sep-2023. Concomitant medication was not reported. Treatment medication was not reported.   This case was linked to MOD-2023-742520 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse event; Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use) 1 dosage form. On 27-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route).    Treatment medications were not reported.   This case was linked to MOD-2023-742833 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: appetite loss; fatigue; headache; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (appetite loss), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 20-Sep-2023, the patient experienced FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills). On 25-Sep-2023, the patient experienced DECREASED APPETITE (appetite loss). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (appetite loss), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. On 21Sep2023, patient reported that her joints were painful in the morning. Patient took 2 Tylenol went back to bed for an hour and a half and felt fine the rest of the day.   This case was linked to US-MODERNATX, INC.-MOD-2023-742800, US-MODERNATX, INC.-MOD-2023-742929 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742800:Same patient, monovalent moderna vaccine US-MODERNATX, INC.-MOD-2023-742929:Husband's case
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in an adult patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that patient best friend's relative received the Moderna COVID-19 vaccine and was knocked out cold after getting it. They had to go to the ER to get their head checked.  Treatment medications were not reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: No adverse event; inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch nos. 3030536 and 3030536) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer in April 2022, Pfizer in May 2022 and Pfizer in May 2023. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concomitant products included INFLUENZA VACCINE and RSV VACCINE for an unknown indication.   On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 28-Sep-2023, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) dosage was changed to .5 milliliter. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced ACCIDENTAL OVERDOSE (inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (inadvertently adminsitered 2 doses of the Spikevax (PFS) to one patient today).    They want to know if there would be any adverse events or if they need to watch out for anything on the patient. Treatment medications were not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Tenderness
Clinical narrative: sore; joint pain; could hardly walk; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (sore), ARTHRALGIA (joint pain) and GAIT DISTURBANCE (could hardly walk) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENDERNESS (sore), ARTHRALGIA (joint pain) and GAIT DISTURBANCE (could hardly walk). At the time of the report, TENDERNESS (sore), ARTHRALGIA (joint pain) and GAIT DISTURBANCE (could hardly walk) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient received the Moderna COVID-19 vaccine, was sick for 2 days after receiving the vaccine. Patient was sore and had joint pain for 2 days. Patient could hardly walk the day after receiving the vaccine. Patient did not have any additional details for her best friend. Treatment medications were not reported.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse event; Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route) and NO ADVERSE EVENT (no adverse event) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205E23A) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE from 27-Sep-2023 to an unknown date for an unknown indication.    On 27-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use) 1 dosage form. On 27-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Subcutaneous use), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Spikevax PFS was administered to 2 patients, over 65 yrs in the back of the arm likely in the subcutaneous tissue instead of recommended route).    Treatment medications were not reported.   This case was linked to MOD-2023-742767 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: felt real rotten; sweating; nausea; chills; Bad headache; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills) and HEADACHE (Bad headache) in a 39-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (Bad headache) and FATIGUE (Really tired). At the time of the report, FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (Bad headache) and FATIGUE (Really tired) outcome was unknown.        SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) dosing remained unchanged.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742748 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742748:Master case (spikevax 2023-2024)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: felt real rotten; sweating; nausea; chills; Bad headache; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills) and HEADACHE (Bad headache) in a 39-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (Bad headache) and FATIGUE (Really tired). At the time of the report, FEELING ABNORMAL (felt real rotten), HYPERHIDROSIS (sweating), NAUSEA (nausea), CHILLS (chills), HEADACHE (Bad headache) and FATIGUE (Really tired) outcome was unknown.        SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) dosing remained unchanged.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742748 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742748:Master case (spikevax 2023-2024)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Headache, Pain
Clinical narrative: dry mouth; aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (dry mouth), PAIN (aches) and HEADACHE (headache) in a 37-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2021.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 28-Sep-2023, the patient experienced DRY MOUTH (dry mouth), PAIN (aches) and HEADACHE (headache). The patient was treated with IBUPROFEN (ANADVIL) at an unspecified dose and frequency. At the time of the report, DRY MOUTH (dry mouth), PAIN (aches) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       Concomitant medications were not reported. The patient did not experience any additional symptoms/events. There were no lab data/results available.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema
Clinical narrative: I noticed my injection site was itchy and looked in the mirror to see a large red mark; I noticed my injection site was itchy and looked in the mirror to see a large red mark; General aches; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of PAIN (General aches), VACCINATION SITE PRURITUS (I noticed my injection site was itchy and looked in the mirror to see a large red mark), VACCINATION SITE ERYTHEMA (I noticed my injection site was itchy and looked in the mirror to see a large red mark), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Sep-2023, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 29-Sep-2023, the patient experienced PAIN (General aches). On 30-Sep-2023, the patient experienced VACCINATION SITE PRURITUS (I noticed my injection site was itchy and looked in the mirror to see a large red mark) and VACCINATION SITE ERYTHEMA (I noticed my injection site was itchy and looked in the mirror to see a large red mark). At the time of the report, PAIN (General aches), VACCINATION SITE PRURITUS (I noticed my injection site was itchy and looked in the mirror to see a large red mark), VACCINATION SITE ERYTHEMA (I noticed my injection site was itchy and looked in the mirror to see a large red mark), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Patient received flu and COVID shot on Thursday at the clinic at around 9:30 A.M.  Patient had fever and chills on Thursday night and general aches on Friday. On that Saturday, the patient went to take a shower and noticed that the injection site was itchy and looked in the mirror to see a large red mark in there.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: sore arm; maybe a mild fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (maybe a mild fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had a couple of stents in the heart.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (maybe a mild fever). At the time of the report, PAIN IN EXTREMITY (sore arm) and PYREXIA (maybe a mild fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that he was taking blood thinners and had a couple stents in his heart, so he can not take anything stronger than that.  Patient stated that he received all the Moderna doses and it was a big mistake to get three vaccines at once on 09-Oct-2022. The patient began, every single one he had side effects such as sore arm, maybe a mild fever.  The only thing he took was acetaminophen and no other treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-743089, US-MODERNATX, INC.-MOD-2023-743016 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-743089:bivalent case US-MODERNATX, INC.-MOD-2023-743016:
Age: 67.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: Rash; fevers; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PYREXIA (fevers) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.  Patient had no known allergies.    On 21-Sep-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In September 2023, the patient experienced RASH (Rash), PYREXIA (fevers) and CHILLS (chills). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Rash, Fever and Chills, at an unspecified dose and frequency. On 25-Sep-2023, RASH (Rash) had resolved. At the time of the report, PYREXIA (fevers) and CHILLS (chills) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: as high 101.0.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient reported side effects such as rash and fevers for about 2-3 days and chills. Rash had cleared, and the fever seems to be going away. Fevers were as high 101.0.  Patient reported that she was taking Aspirin for the symptoms.