chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Cardiac stress test normal, Chest pain, Hypoaesthesia, Palpitations
Clinical narrative: Patient reports that 8 days after receiving this 2023-24 Spikevax vaccination at pharmacy, he experienced: syncope, palpitations, left chest pain left and one-sided facial numbness. He saw his cardiologist, Dr, who found he had a negative stress test and not likely due to vaccination. Patient claims he has Bell's Palsy.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient reports that 8 days after receiving this 2023-24 Spikevax vaccination at pharmacy, he experienced: syncope, palpitations, left chest pain left and one-sided facial numbness. He saw his cardiologist, Dr, who found he had a negative stress test and not likely due to vaccination. Patient claims he has Bell's Palsy.
Age: 1.92
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Skin induration, Skin swelling
Clinical narrative: per MOC: a red spot and large hard bump noted the day after vaccine was received; 2 days after vaccine received the ball/bump had resolved and gone down but redness remained and spread all over whole thigh; pt was able to walk/run and no complaints of pain; no fever noted.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Tendon disorder
Clinical narrative: Patient complained of sore arm the day of getting this spikevax vaccine. He complained of muscle pain, indicated that he had to go to emergency room because of the pain. He said there was tendon damage.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: Shingrix vaccine was administered without mixing the two components( diluent and powder). Only the diluent was administered so the patient did not receive the active ingredient. Both vials were pulled from the refrigerator with the intention of reconstituting, but only the solution was drawn into the syringe and administered. The vial with powder remaining was noticed by the administering pharmacist after coming back into the pharmacy from the vaccination room. Manufacture was contacted and they assured that there is no potential harm and the patient must wait 4 weeks before she can receive the correct vaccine. Patient has no adverse reactions to the diluent administered and her provider was informed on the incident.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Varivax was administered merely 5 days after MMR vaccine.
Age: 67.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: adult female patient received a 10 mcg dose of Engerix B; adult female patient received a 10 mcg dose of Engerix B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 67-year-old female patient who received HBV (Engerix B 10 mcg) (batch number FB9RH, expiry date 21-JAN-2024) for prophylaxis.   On 07-DEC-2023, the patient received the 1st dose of Engerix B 10 mcg .5 ml. On 07-DEC-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: adult female patient received a 10 mcg dose of Engerix B) and adult use of a child product (Verbatim: adult female patient received a 10 mcg dose of Engerix B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 08-DEC-2023 A practice manager reported that the adult patient received a 10-mcg dose of Engerix vaccine which led to underdose and adult use of child product. The reporter consented to follow up via email. This case was linked with US2023172471, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023172471:2nd patient
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: an adult female patient received a 10 mcg dose of Engerix; an adult female patient received a 10 mcg dose of Engerix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 45-year-old female patient who received HBV (Engerix B 10 mcg) (batch number FB9RH, expiry date 21-JAN-2024) for prophylaxis.   On 06-DEC-2023, the patient received the 2nd dose of Engerix B 10 mcg .5 ml. On 06-DEC-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: an adult female patient received a 10 mcg dose of Engerix) and adult use of a child product (Verbatim: an adult female patient received a 10 mcg dose of Engerix). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 08-DEC-2023 A practice manager reported that the adult patient received a 10-mcg dose of Engerix vaccine which led to adult use of child product and underdose. The reporter consented to follow up via email. This case was linked with US2023172469 as reported by same reporter.; Sender's Comments:  US-GSK-US2023172469:2nd patient
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Insomnia
Clinical narrative: pain at the injection site; hard time sleeping; tiredness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psychiatric disorder nos (psychiatric condition) and blood pressure high (HBP). Concomitant products included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (Vitamins), olanzapine (Zyprexa) and valproate semisodium (Depakote).   On 07-DEC-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). In DEC-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), difficulty sleeping (Verbatim: hard time sleeping) and tiredness (Verbatim: tiredness). The outcome of the injection site pain, difficulty sleeping and tiredness were not resolved.   It was unknown if the reporter considered the injection site pain, difficulty sleeping and tiredness to be related to Shingrix.     It was unknown if the company considered the injection site pain, difficulty sleeping and tiredness to be related to Shingrix.   Additional Information: RA Receipt Date: 08-DEC-2023 The patient self-reported this case. Patient reported that he takes medications for blood pressure, psychiatric medications, Depakote, Zyprexa and vitamins.  The patient got the 1st dose of Shingrix vaccine at a local pharmacy and had a hard time sleeping last night (on vaccination night). Consent to follow up with healthcare professional was denied.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: patient had 2 cases of shingles /Suspected vaccination failure; The patient had 2 cases of shingles after receiving the vaccines; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: patient had 2 cases of shingles /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: The patient had 2 cases of shingles after receiving the vaccines). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 11-DEC-2023. The health care professional reported that he/she had a patient, that had gotten both doses of the Shingrix vaccine.  The patient had 2 cases of shingles after receiving the vaccines.  The reporter just wanted to know if there was any evidence for a booster after the 2 doses. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter did not consent to follow up.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Employee states an expired dose of Boostrix was administered to a patient today.; 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 62-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7ZD7L, expiry date 09-FEB-2023) for prophylaxis.   On 11-DEC-2023, the patient received Boostrix. On 11-DEC-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Employee states an expired dose of Boostrix was administered to a patient today.). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 11-DEC-2023 The Vaccine Administration Facility was the same as Primary Reporter Employee stated an expired dose of Boostrix was administered to a patient today, led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: vaccine administer to pregnant patients; This non-serious prospective pregnancy case was reported by a other health professional via sales rep and described the occurrence of vaccine exposure during pregnancy in a female patients who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patients received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: vaccine administer to pregnant patients). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 11-Dec-2023 The reporter reported that he received an email from CMA at the physician's office. The reporter stated that the multiple pregnant patients received Arexvy vaccine, which led to vaccine exposure during pregnancy. The reporter did not provided distinguishing factors, no pregnancy registry questions were asked.   The reporter did not provided lot number, expiry dates, patient information initials, gender, date of birth or dates of administration. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Fibrosis, Inappropriate schedule of product administration
Clinical narrative: Fibrosis of hand; harmacy administered 2nd dose early and patient is experiencing fibrosis of the hand.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fibrosis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fibrosis (Verbatim: Fibrosis of hand) and drug dose administration interval too short (Verbatim: harmacy administered 2nd dose early and patient is experiencing fibrosis of the hand.). The outcome of the fibrosis and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the fibrosis to be related to Shingrix.     It was unknown if the company considered the fibrosis to be related to Shingrix.   Additional Information: RA Receipt Date: 11-DEC-2023 The pharmacist reported that pharmacy administered 2nd dose early, which led to shortening of vaccination schedule and patient was experiencing fibrosis of the hand.  The reporter asked had this been seen with patients who were administered early 2nd doses of Shingrix and requested RA to call back or email with any data (email address not provided). Permission for Safety follow-up not obtained.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Pharmacist reporting an expired dose of Engerix-B was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HBV (Engerix B) (batch number pb3kn, expiry date 03-DEC-2023) for prophylaxis.   On 09-DEC-2023, the patient received Engerix B. On 09-DEC-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Pharmacist reporting an expired dose of Engerix-B 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:12-DEC-2023 The pharmacist reported an expired dose of Engerix-B was administered, which led to expired vaccine used. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. No additional adverse event information available per healthcare professional.
Age: 32.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: administered a dose of Twinrix that 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 32-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 12-DEC-2023, the patient received Twinrix. On 12-DEC-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: administered a dose of Twinrix that had expired). 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:12-DEC-2023 A nurse called to inform that earlier that day, a patient had been administered a dose of Twinrix that had expired, which led to expired vaccine used. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: a patient intravenously received a dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 12-DEC-2023, the patient received Boostrix (intravenous). On 12-DEC-2023, an unknown time after receiving Boostrix, the patient experienced intramuscular formulation administered by other route (Verbatim: a patient intravenously received a dose of Boostrix). The outcome of the intramuscular formulation administered by other route 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: 12-DEC-2023 A pharmacy student called to inform that earlier that day, a patient intravenously received a dose of Boostrix, which led to intramuscular formulation administered by other route. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient came in to get a Shingrix dose but the patient received the Shingrix first dose 2 years ago.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 2 years ago in 2021).   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: a patient came in to get a Shingrix dose but the patient received the Shingrix first dose 2 years ago.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: RA Receipt Date: 14-DEC-2023 The reporter asked how to proceed, would the patient need to start over or could they get the second dose. The reporter unable to provide any prior vaccine details due to not being administered at their facility. The reporter did not consent to follow-up. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menveo Expired dose administered; 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 15-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA749A, expiry date 30-NOV-2023) for prophylaxis.   On 14-DEC-2023, the patient received Menveo. On 14-DEC-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo Expired dose administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-DEC-2023 The reporter asked for information regarding the administration of an expired Menveo dose to a patient, which led to expired vaccine used. The HCP (healthcare professional) asked for guidance on this situation. During the call permission to follow up was not requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Lethargy, Malaise
Clinical narrative: Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise; Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise; Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise; Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FEELING ABNORMAL (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), LETHARGY (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), MALAISE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) and FATIGUE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), LETHARGY (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), MALAISE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) and FATIGUE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise). At the time of the report, FEELING ABNORMAL (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), LETHARGY (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise), MALAISE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) and FATIGUE (Felt lousy with fatigue, lethargy, feeling spaced out, and just feeling crummy in general, general malaise) had resolved.            Concomitant medications were not reported.  It was reported that the patient started treatment with 5 doses of Moderna COVID-19 vaccine. It was reported that the patient experienced the same symptoms for 2 days following each dose.  Treatment information was not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Device leakage, No adverse event, Underdose
Clinical narrative: No adverse event; A patient received half a dose of the vaccine because some of the vaccine leaked out from the syringe.; He explains that the issue is in the hub where the needle needs to be attached to the syringe. It just doesn´t go on very well. It didn´t look like it was loose or anything, the needle was fully on; Some of the vaccine leaked out from the syringe.; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (A patient received half a dose of the vaccine because some of the vaccine leaked out from the syringe.), DEVICE CONNECTION ISSUE (He explains that the issue is in the hub where the needle needs to be attached to the syringe. It just doesn´t go on very well. It didn´t look like it was loose or anything, the needle was fully on), DEVICE LEAKAGE (Some of the vaccine leaked out from the syringe.) and NO ADVERSE EVENT (No adverse event) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032679) for COVID-19 prophylaxis.    Co-suspect product included Pre-filled Syringe injection (batch no. 3032679) for COVID-19 prophylaxis.    No Medical History information was reported.   On 11-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 11-Dec-2023, the patient experienced UNDERDOSE (A patient received half a dose of the vaccine because some of the vaccine leaked out from the syringe.), DEVICE CONNECTION ISSUE (He explains that the issue is in the hub where the needle needs to be attached to the syringe. It just doesn´t go on very well. It didn´t look like it was loose or anything, the needle was fully on) and DEVICE LEAKAGE (Some of the vaccine leaked out from the syringe.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (A patient received half a dose of the vaccine because some of the vaccine leaked out from the syringe.), DEVICE CONNECTION ISSUE (He explains that the issue is in the hub where the needle needs to be attached to the syringe. It just doesn´t go on very well. It didn´t look like it was loose or anything, the needle was fully on), DEVICE LEAKAGE (Some of the vaccine leaked out from the syringe.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments. For Pre-filled Syringe, the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not reported.  The Device problem code for Spikevax syringe include code 1670, IMDRF code A23 which include Use of Device Problem and code 1250, IMDRF code A050401 which include Fluid Leak.   Most recent FOLLOW-UP information incorporated above includes: On 11-Dec-2023: Live follow-up received and added references.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: We have been sick ever since getting the vaccine and would never get another.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (We have been sick ever since getting the vaccine and would never get another.) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced ILLNESS (We have been sick ever since getting the vaccine and would never get another.). At the time of the report, ILLNESS (We have been sick ever since getting the vaccine and would never get another.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       In a marketing research study a verbatim response told that, we had been sick ever since getting the vaccine and would never get another. It was unknown if the patient experienced any additional symptoms/events. Concomitant medications were not reported.  No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: She started having watery Diarrhea on 02DEC2023 through 06DEC2023; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (She started having watery Diarrhea on 02DEC2023 through 06DEC2023) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Underlying GI problems and immune problems way before the vaccination.  Concurrent medical conditions included GI upset and Immune disorder (NOS).    On 30-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 02-Dec-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIARRHOEA (She started having watery Diarrhea on 02DEC2023 through 06DEC2023). At the time of the report, DIARRHOEA (She started having watery Diarrhea on 02DEC2023 through 06DEC2023) had not 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 medication was not reported.  Treatment medication was not reported.  The patient started having watery diarrhea on 02-Dec-2023 through 06-Dec-2023  December 5th was the worst day with watery diarrhea. It's not pathogens.  On 07-DEC-2023, the patient woke up in the middle of the night with wet pads and throughout the day she had wet panties. The patient states, by watery diarrhea she means the stool character changed from pasty to runny from sticking to the toilet to watery for six days. The patient states that the watery diarrhea was still going on. It was not pathogen.   This case was linked to US-MODERNATX, INC.-MOD-2023-753542 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-753542:Other people case (invalid case)
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: having pain from the Moderna shot, its only being 7 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (having pain from the Moderna shot, its only being 7 hours) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) 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 PAIN (having pain from the Moderna shot, its only being 7 hours). At the time of the report, PAIN (having pain from the Moderna shot, its only being 7 hours) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site haemorrhage
Clinical narrative: Her arm started to bleed so much that they had to change the bandage; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (Her arm started to bleed so much that they had to change the bandage), HEADACHE (headache) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (She had 6 previous doses of Pfizer COVID-19 vaccine and she had no problem.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 09-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Dec-2023, the patient experienced INJECTION SITE HAEMORRHAGE (Her arm started to bleed so much that they had to change the bandage), HEADACHE (headache) and CHILLS (chills). At the time of the report, INJECTION SITE HAEMORRHAGE (Her arm started to bleed so much that they had to change the bandage) outcome was unknown and HEADACHE (headache) and CHILLS (chills) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       The concomitant medication was not reported by reporter. It was reported that patient was not taking any blood thinner.  The treatment medication was not reported by reporter.   Reporter did not allow further contact
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Extreme fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Extreme fatigue) and CHILLS (Chills) in a 44-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) 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) (Intramuscular use) 1 dosage form. On 12-Dec-2023, the patient experienced PYREXIA (Fever), FATIGUE (Extreme fatigue) and CHILLS (Chills). On 13-Dec-2023, PYREXIA (Fever), FATIGUE (Extreme fatigue) and CHILLS (Chills) had resolved.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: The patient reports that a Co Worker reports that Spikevax did not have the same reactions as to the first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (The patient reports that a Co Worker reports that Spikevax did not have the same reactions as to the first Moderna Covid-19 vaccine) 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 IMMUNISATION REACTION (The patient reports that a Co Worker reports that Spikevax did not have the same reactions as to the first Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (The patient reports that a Co Worker reports that Spikevax did not have the same reactions as to the first Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient reports that a Co Worker reports that Spikevax did not have the same reactions as to the first Moderna Covid-19 vaccine.
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Cancer. Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE on 28-Jan-2021, MODERNA COVID-19 VACCINE on 25-Feb-2021, MODERNA COVID-19 VACCINE on 05-Nov-2021, MODERNA COVID-19 VACCINE on 05-Apr-2022 and MODERNA COVID-19 VACCINE on 07-Oct-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE and MODERNA COVID-19 VACCINE.    On 07-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 5 dosage form. On 04-Sep-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Covid-19). On 22-Sep-2023, COVID-19 (Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Sep-2023, SARS-CoV-2 test: Negative.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  He has cancer problems and is taking chemotherapy. He had a covid infection starting 4SEP2023. He was not feeling well and coughing up phlegm. He took a medication to try and help with that but does not remember the name. He had a negative COVID-19 test on 22SEP2023.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: pt had received a dose of spikevax in september 2023 and came by pharmacy to get 2nd dose of shingrix. tech processed it as spikevax instead and pt received a 2nd dose of spikevax instead of shingrix.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: pt asked for 2nd dose of shingrix and tech processed it as covid spikevax and pt received the dose. pt had received a dose of spikevax in 9/2023
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Chest pain, Dyspnoea, Tachycardia
Clinical narrative: 30 MINUTES AFTER ADMINISTRATION OF AREXVY, PATIENT DEVELOPED SHORTNESS OF BREATH AND STABBING PAIN IN CHEST. SHE CALLED ME FROM HOME AND I ADVISED HER TO SEEK MEDICAL ATTENTION. SHE SELF-TREATED WITH AT-HOME OXYGEN BEFORE GOING TO HERE PCP OFFICE WHERE IT WAS FOUND SHE WAS EXPERIENCING TACHYCARDIA. AT 5PM, I FOLLOWED UP WITH HER. SHE WAS RESTING AND FEELING BETTER.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives over entire body Treated with benadryl and Allegra Hives
Age: 17.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Fall, Syncope
Clinical narrative: The patient went to the bathroom following the vaccine, and when they came out they fainted, falling down. We helped the patient into a chair and gave them cold water to sip on. We advised the patient to wait, and when they felt better they left with no immediate complications. There was no bleeding, and the patient was oriented to person and place.
Age: 80.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Contusion, Injection site bruising, Pain in extremity
Clinical narrative: Patient received the 2 vaccines in the left arm, has reported significant bruising of the entire arm that started the next day and pain in the arm that started about an hour after the vaccinations we given.  Bruising is improving per patient encounter.
Age: 40.0
Sex: F
Vaccine: PNC20
Symptoms: Anxiety, Confusional state, Crying, Fear, Irritability
Clinical narrative: My arm hurt all day after the shot and I was drowsy and achy.  Then about 24 hours after the shot, I became tearful and couldn't be consoled, I had a high level of irritability and and crying to the point where I could not function.  My family called EMS they were so worried about me.  About 48 hours after the shot, I became extremely anxious with a sense of dread, confused, and couldn't stop crying and screaming, saying I was afraid and I couldn't be left alone.  My family again called for help but first responders did not offer any help and said the hospital could not doing anything to make the side effects of the vaccine go away.  I laid on the floor and cried for hours.  Doing a little better now.  I have never felt like that or acted like that in my entire life until I had this vaccine.
Age: 40.0
Sex: F
Vaccine: PNC20
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Screaming, Somnolence
Clinical narrative: My arm hurt all day after the shot and I was drowsy and achy.  Then about 24 hours after the shot, I became tearful and couldn't be consoled, I had a high level of irritability and and crying to the point where I could not function.  My family called EMS they were so worried about me.  About 48 hours after the shot, I became extremely anxious with a sense of dread, confused, and couldn't stop crying and screaming, saying I was afraid and I couldn't be left alone.  My family again called for help but first responders did not offer any help and said the hospital could not doing anything to make the side effects of the vaccine go away.  I laid on the floor and cried for hours.  Doing a little better now.  I have never felt like that or acted like that in my entire life until I had this vaccine.
Age: 40.0
Sex: F
Vaccine: PNC20
Symptoms: Tearfulness
Clinical narrative: My arm hurt all day after the shot and I was drowsy and achy.  Then about 24 hours after the shot, I became tearful and couldn't be consoled, I had a high level of irritability and and crying to the point where I could not function.  My family called EMS they were so worried about me.  About 48 hours after the shot, I became extremely anxious with a sense of dread, confused, and couldn't stop crying and screaming, saying I was afraid and I couldn't be left alone.  My family again called for help but first responders did not offer any help and said the hospital could not doing anything to make the side effects of the vaccine go away.  I laid on the floor and cried for hours.  Doing a little better now.  I have never felt like that or acted like that in my entire life until I had this vaccine.
Age: 84.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Bell's palsy
Clinical narrative: Developed Bell's Palsy on right side of face
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Blood test, Decreased appetite, Diarrhoea, Immediate post-injection reaction, Infant irritability
Clinical narrative: Patient was instantly sleepy, fussy, and not eating as much as usual after her vaccines on Wednesday. Those same behaviors continued until Sunday morning. On Sunday, she threw up her 3 oz of formula and refused all formula from then on. Her last regular feeding was at 2:30 AM that same morning. By 2 PM, we took her to the ER because she still wouldn?t eat and her color was very pale. She was admitted and given IV fluids. While in the hospital, she developed diarrhea as well. She didn?t eat again until Monday night and didn?t eat as much as normal until the following Sunday.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20, RV5
Symptoms: Pallor, Somnolence, Spinal X-ray, Urine analysis, Vomiting
Clinical narrative: Patient was instantly sleepy, fussy, and not eating as much as usual after her vaccines on Wednesday. Those same behaviors continued until Sunday morning. On Sunday, she threw up her 3 oz of formula and refused all formula from then on. Her last regular feeding was at 2:30 AM that same morning. By 2 PM, we took her to the ER because she still wouldn?t eat and her color was very pale. She was admitted and given IV fluids. While in the hospital, she developed diarrhea as well. She didn?t eat again until Monday night and didn?t eat as much as normal until the following Sunday.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Fatigue, Headache, Injection site mass, Injection site pain
Clinical narrative: severe headache and pain in injection site. This started an hour and a half after shot. I laid down and had joint pains in my legs. i was very fatigued the rest of the day and my arm pain worsened and the headache continued. The arm pain and headache contined the next day. when I touched the injection site there was a lump the size of a dime. i massaged it for two days and it finally went away. I took no tylenol because I wanted to make sure the vaccine worked.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity
Clinical narrative: severe headache and pain in injection site. This started an hour and a half after shot. I laid down and had joint pains in my legs. i was very fatigued the rest of the day and my arm pain worsened and the headache continued. The arm pain and headache contined the next day. when I touched the injection site there was a lump the size of a dime. i massaged it for two days and it finally went away. I took no tylenol because I wanted to make sure the vaccine worked.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Product administered at inappropriate site
Clinical narrative: The pharmacist administered the Tdap vaccine almost halfway down my right arm. I was unaware until later that night when I saw that the band-aid she had placed was not on the injection site, but several inches above. The next 3 days the injection site became incredibly swollen, red, hot, and painful to the touch. After about 10 days the swelling had decreased. There continues to be pain at the injection site that has gotten worse as time has gone on. Pain occurs when lifting objects over 10 pounds, weighted flexion of the elbow, turning a steering wheel when backing out of parking spaces, etc. I will be having my first doctor's visit in regards to the pain next week.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt reports that two days after flu shot, he started developing radiating L arm pain.  The pain has been increasing every day, and range of motion has become more limited every day.  At this time, can abduct arm about 30 degrees.  Reports 8-9/10 radiating pain while on ibuprofen and prednisone.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Asthenia, Chills, Diarrhoea, Fatigue, Pain
Clinical narrative: 6 hours after the vaccine, I experienced chills.  This was followed by body aches and profound fatigue and weakness.  I had one episode of loose stool.  The symptoms lasted all through the next day, and I spent the entire day in bed sleeping.   The following day which was December 2, I continued to feel weak and tired and achy.  I was able to resume normal activities on December 3.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Somnolence
Clinical narrative: 6 hours after the vaccine, I experienced chills.  This was followed by body aches and profound fatigue and weakness.  I had one episode of loose stool.  The symptoms lasted all through the next day, and I spent the entire day in bed sleeping.   The following day which was December 2, I continued to feel weak and tired and achy.  I was able to resume normal activities on December 3.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Patient received 2 doses of the Moderna Spike Vax for 6months to 11y instead of the one single adult dose.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody negative, C-reactive protein decreased, Condition aggravated, Full blood count normal, Metabolic function test
Clinical narrative: Since first covid vaccine in Feb 2021, mild achiness persists through the present with some stiffness, to slightly greater degree with each dose, 7 vaccines in all. Participated in V-Safe and mentioned this each time. Vaccine granted by CDC for more info one time.  Doesn?t require medication except occasional Tylenol 500mg, one pill only.  Last week, asked medical provider for rheumatologic screening tests. No treatment planned. Perhaps Rheumatology consult in future. Observe for now.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Red blood cell sedimentation rate normal, Rheumatoid factor negative, SARS-CoV-2 antibody test positive
Clinical narrative: Since first covid vaccine in Feb 2021, mild achiness persists through the present with some stiffness, to slightly greater degree with each dose, 7 vaccines in all. Participated in V-Safe and mentioned this each time. Vaccine granted by CDC for more info one time.  Doesn?t require medication except occasional Tylenol 500mg, one pill only.  Last week, asked medical provider for rheumatologic screening tests. No treatment planned. Perhaps Rheumatology consult in future. Observe for now.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chillblains, Erythema, Pain in extremity, Skin discolouration, Skin erosion
Clinical narrative: I developed chillblains on 3 of my toes 4 days after vaccination. They started as red lesions but have progressed to darker purple now (day 6 after vaccination). They are painful and feel raw.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: I developed chillblains on 3 of my toes 4 days after vaccination. They started as red lesions but have progressed to darker purple now (day 6 after vaccination). They are painful and feel raw.
Age: 65.0
Sex: M
Vaccine: FLUA4
Symptoms: Haematochezia
Clinical narrative: Blood in stool next day after receiving vaccine. Only 1 time. No more blood in stool following bowel movement.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Pfizer Covid vaccine- anaphylactic reaction
Age: 60.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Audiogram, Computerised tomogram, Tinnitus
Clinical narrative: I received the Covid 19 SpikeVax by Moderna, my first time getting Moderna.  I've always had the Pfizer booster.  Within 2 days of getting the injection, both my ears started ringing with signs of tinnitus.  Over the next few days, the ringing never going away but increasing in intensity in both ears. By 5 days after, the ringing became intense not allowing me to sleep, relax or function property. After the first week, without any relief from the serious tinnitus, migraines starting with vertigo.  I went to Urgent Care where I was prescribed Valium to sleep, with no avail.  10 days later, my body started to shutdown, where I believe I had a TIA, not my first.  Have no relief yet with tinnitus increasing in severity.  Worried that depression is taking over.
Age: 60.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Acoustic stimulation tests, Loss of personal independence in daily activities, Migraine, Sleep disorder, Tinnitus
Clinical narrative: I received the Covid 19 SpikeVax by Moderna, my first time getting Moderna.  I've always had the Pfizer booster.  Within 2 days of getting the injection, both my ears started ringing with signs of tinnitus.  Over the next few days, the ringing never going away but increasing in intensity in both ears. By 5 days after, the ringing became intense not allowing me to sleep, relax or function property. After the first week, without any relief from the serious tinnitus, migraines starting with vertigo.  I went to Urgent Care where I was prescribed Valium to sleep, with no avail.  10 days later, my body started to shutdown, where I believe I had a TIA, not my first.  Have no relief yet with tinnitus increasing in severity.  Worried that depression is taking over.