chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Blister rupture, Herpes zoster, Rash, Scab
Clinical narrative: Shingles outbreak times two/I broke out in a rash/I am breaking out on my back; blisters; then small scabs; Patient spine bruised; itches but does not hurt; Patient spine felt sore; rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles outbreak times two/I broke out in a rash/I am breaking out on my back), blister (Verbatim: blisters), scab (Verbatim: then small scabs) and contusion of back (Verbatim: Patient spine felt sore, bruised). The outcome of the shingles was not resolved and the outcome of the blister was resolving and the outcome of the scab was unknown and the outcome of the contusion of back was not reported.   It was unknown if the reporter considered the shingles, blister, scab and contusion of back to be related to Shingrix.     It was unknown if the company considered the shingles, blister, scab and contusion of back to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2023 The patient self-reported this case. The patient got shingle vaccine and shortly after she broke out in rash. When the patient went into get her booster, the patient showed the nurse. She said it was shingles. Two weeks after vaccination the patient broke out with presumed shingles. The patient described had blisters appeared between her breasts and on her chest. The reported that her pharmacist declined to give her second dose of Shingrix in July 2023 as the patient still had active shingles. The patient broke out in presumed shingles again on back about 3 days ago from reporting. The patient stated that her blisters were start beginning to pop and scab over. The patient stated that no outbreak was painful but itich. The first thing the patient noticed, was her spine felt sore, bruised. Then she broke out.  The patient asked was this shingles, a mild case due to vaccination, the patient did not know what to do about it. was there any cream or prescription for this. The patient was not sure if she should call her doctor or not. The reporter consent to follow up granted.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Spinal pain
Clinical narrative: Shingles outbreak times two/I broke out in a rash/I am breaking out on my back; blisters; then small scabs; Patient spine bruised; itches but does not hurt; Patient spine felt sore; rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles outbreak times two/I broke out in a rash/I am breaking out on my back), blister (Verbatim: blisters), scab (Verbatim: then small scabs) and contusion of back (Verbatim: Patient spine felt sore, bruised). The outcome of the shingles was not resolved and the outcome of the blister was resolving and the outcome of the scab was unknown and the outcome of the contusion of back was not reported.   It was unknown if the reporter considered the shingles, blister, scab and contusion of back to be related to Shingrix.     It was unknown if the company considered the shingles, blister, scab and contusion of back to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-NOV-2023 The patient self-reported this case. The patient got shingle vaccine and shortly after she broke out in rash. When the patient went into get her booster, the patient showed the nurse. She said it was shingles. Two weeks after vaccination the patient broke out with presumed shingles. The patient described had blisters appeared between her breasts and on her chest. The reported that her pharmacist declined to give her second dose of Shingrix in July 2023 as the patient still had active shingles. The patient broke out in presumed shingles again on back about 3 days ago from reporting. The patient stated that her blisters were start beginning to pop and scab over. The patient stated that no outbreak was painful but itich. The first thing the patient noticed, was her spine felt sore, bruised. Then she broke out.  The patient asked was this shingles, a mild case due to vaccination, the patient did not know what to do about it. was there any cream or prescription for this. The patient was not sure if she should call her doctor or not. The reporter consent to follow up granted.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient received a dose of Fluarix QIV on 30Oct2023 and then inadvertently was administered a second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 7Z423, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 14-NOV-2023, the patient received the 2nd dose of Fluarix Quadrivalent 2023-2024 season .5 ml. On 14-NOV-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: patient received a dose of Fluarix QIV on 30Oct2023 and then inadvertently was administered a second dose). The outcome of the extra dose administered 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: 16-NOV-2023 A nurse reported that a patient received a dose of Fluarix QIV and then inadvertently was administered a second dose, which led to extra dose administered.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: RVX
Symptoms: Product preparation error, Underdose
Clinical narrative: A  pharmacist called to inform that a patient had just been administered the adjuvant only of Arexvy.; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) (batch number 72S24) for prophylaxis.   On an unknown date, the patient received RSV vaccine (intramuscular). On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced inappropriate preparation of medication (Verbatim: A  pharmacist called to inform that a patient had just been administered the adjuvant only of Arexvy.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-NOV-2023 The patient received only adjuvant of Arexvy vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Did not consent to follow up.
Age: 45.0
Sex: M
Vaccine: HEP, MMR, VARCEL, MMR, VARCEL, FLU4
Symptoms: Guillain-Barre syndrome, Intensive care
Clinical narrative: Guillain Barre/GBS symptoms; This serious case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a 45-year-old male patient who received HBV (Engerix B) (batch number 7MH25, expiry date 07-DEC-2025) for prophylaxis.   Co-suspect products included Mmr ii for prophylaxis and Aesculus hippocastanum (Varivax) for prophylaxis.   On 18-OCT-2023, the patient received Engerix B (intramuscular, left deltoid), Mmr ii (subcutaneous, left arm) and Varivax (right arm). On 11-NOV-2023, 24 days after receiving Engerix B, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre/GBS symptoms) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the guillain barre syndrome to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   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: 15-NOV-2023 The reporter called to report that a patient received Engerix B along with MMR and Varivax on same day, and developed GBS symptoms. The patient was admitted to the hospital and currently was in the ICU. Reporter was uncertain what dose in the 3 dose series of Engerix B the patient received. On 11th November 2023, 24 days after receiving Varivax and MMR2, the patient experienced guillain barre syndrome. The MMR2 was administered subcutaneously in the back of the left arm (not deltoid) and the Varivax was administered in the right arm. MA was uncertain what dose in the 3 dose series of Engerix-B the patient received. It was unknown if the reporter considered the guillain barre syndrome to be related to Varivax and MMR2 vaccine. The reporter consented to follow up.
Age: 45.0
Sex: M
Vaccine: HEP, MMR, VARCEL, MMR, VARCEL, FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre/GBS symptoms; This serious case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a 45-year-old male patient who received HBV (Engerix B) (batch number 7MH25, expiry date 07-DEC-2025) for prophylaxis.   Co-suspect products included Mmr ii for prophylaxis and Aesculus hippocastanum (Varivax) for prophylaxis.   On 18-OCT-2023, the patient received Engerix B (intramuscular, left deltoid), Mmr ii (subcutaneous, left arm) and Varivax (right arm). On 11-NOV-2023, 24 days after receiving Engerix B, the patient experienced guillain barre syndrome (Verbatim: Guillain Barre/GBS symptoms) (serious criteria hospitalization and GSK medically significant). The outcome of the guillain barre syndrome was not resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Engerix B and Engerix B Pre-Filled Syringe Device.     It was unknown if the company considered the guillain barre syndrome to be related to Engerix B and Engerix B Pre-Filled Syringe Device.   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: 15-NOV-2023 The reporter called to report that a patient received Engerix B along with MMR and Varivax on same day, and developed GBS symptoms. The patient was admitted to the hospital and currently was in the ICU. Reporter was uncertain what dose in the 3 dose series of Engerix B the patient received. On 11th November 2023, 24 days after receiving Varivax and MMR2, the patient experienced guillain barre syndrome. The MMR2 was administered subcutaneously in the back of the left arm (not deltoid) and the Varivax was administered in the right arm. MA was uncertain what dose in the 3 dose series of Engerix-B the patient received. It was unknown if the reporter considered the guillain barre syndrome to be related to Varivax and MMR2 vaccine. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: DIED SUDDENLY; This spontaneous report received from a consumer via communication (other source) via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 19-OCT-2023, the patient  died suddenly from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20231149954-Died suddenly. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: One kid took it and had a reaction and caller says it depends on the batch number; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (One kid took it and had a reaction and caller says it depends on the batch number) in a 3-decade-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 third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (One kid took it and had a reaction and caller says it depends on the batch number). At the time of the report, IMMUNISATION REACTION (One kid took it and had a reaction and caller says it depends on the batch number) outcome was unknown.            Patient was 20 something years old. No relevant concomitant medications were reported. Patient had 3 shots which were all Moderna. No treatment medication reported.   Reporter did not allow further contact.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Dizziness
Clinical narrative: She started experiencing dizziness; her heart was fluttering a little bit; This spontaneous case was reported by a patient and describes the occurrence of ARRHYTHMIA (her heart was fluttering a little bit) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient was never diagnosed with COVID-19.  Concurrent medical conditions included Penicillin allergy (Patient was allergic to penicillin and does receive a shot every month for allergies).    On 10-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 11-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIZZINESS (She started experiencing dizziness). In November 2023, the patient experienced ARRHYTHMIA (her heart was fluttering a little bit) (seriousness criterion medically significant). In November 2023, ARRHYTHMIA (her heart was fluttering a little bit) had resolved. At the time of the report, DIZZINESS (She started experiencing dizziness) had not resolved.            No concomitant medications were reported.  On 11-Nov-2023, she started experiencing dizziness. She told that even on that morning of reporting day, when she woke up, she felt a little dizzy, but it was on and off now.  In addition, her heart was fluttering a little bit. She felt that it was beating kind of fast, but that resolved by itself and she felt fine now. She did not think that it had anything to do with the vaccine. She had received all Moderna COVID-19 shots in the past.   No treatment information was provided by the reporter. Company comment:  This spontaneous case concerns a 74-year-old female patient, with no relevant medical history reported, who experienced the unexpected, serious (medically significant) AESI of arrhythmia (reported as heart as fluttering a little bit) which occurred in context of SPIKEVAX 2023-2024 dose administration, which was 4th dose of COVID-19 vaccination schedule. Latency cannot be calculated due to exact event onset date unknown, however it was provided that it occurred during the same month of vaccination.  The patient was previously vaccinated with Moderna vaccine (primary series and 3rd booster dose) on unknown dates in the past and the patient experienced nausea and dizziness after 2nd dose and dizziness after 3rd dose. The event was accompanied by dizziness, which started the next day after vaccination; it as on and off. In addition, the patient felt that heart was beating kind of fast, but that resolved by itself and she felt fine now. No further clinical information or details on clinical course, medical history, etiologic and diagnostic work up with treatment were provided for medical review. Event outcome was recovered at the time of the report. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.   This case was linked to MOD-2023-750145 (Patient Link).   Reporter did not allow further contact
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Sore arm; Tired; : 1st dose - 05Apr2021, lot number - 025B21A 2nd dose- 27May2021, lot number - 005C21A; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (: 1st dose - 05Apr2021, lot number - 025B21A 2nd dose- 27May2021, lot number - 005C21A) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A, 005C21A, 021H12B and 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (: 1st dose - 05Apr2021, lot number - 025B21A 2nd dose- 27May2021, lot number - 005C21A). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (: 1st dose - 05Apr2021, lot number - 025B21A 2nd dose- 27May2021, lot number - 005C21A) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to MOD-2023-750219, MOD-2023-750230 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Patient had minimal side effects including sore arm; Patient had minimal side effects including tired; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Patient had minimal side effects including sore arm) and FATIGUE (Patient had minimal side effects including tired) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Patient had minimal side effects including sore arm) and FATIGUE (Patient had minimal side effects including tired). At the time of the report, PAIN IN EXTREMITY (Patient had minimal side effects including sore arm) and FATIGUE (Patient had minimal side effects including tired) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-750219, MOD-2023-750226 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Oropharyngeal pain
Clinical narrative: She states that the effectiveness of the last booster that she had was only 7% effective; She is gradually getting a sore throat. At this point it is very sore.; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.) and DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective) in a 75-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 15-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.). On an unknown date, the patient experienced DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective). At the time of the report, OROPHARYNGEAL PAIN (She is gradually getting a sore throat. At this point it is very sore.) had not resolved and DRUG INEFFECTIVE (She states that the effectiveness of the last booster that she had was only 7% effective) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient stated that the effectiveness of the last booster that she had was only 7% effective. She was calling to find out if that is correct. The last vaccine she received was on 15 Oct 2023, and she confirmed it was Spikevax. She read that information from a political email. She was gradually getting a sore throat. At this point it was very sore. She was concerned that the booster was not effective.  Company Comment This spontaneous case concerns a 75-year-old female patient with no medical history reported who experienced the unexpected events of sore throat and drug ineffective unknown days after a dose of mRNA-1273.815 vaccine. Concomitant medication details nor Treatment details were reported. She was calling to find out if that is correct, concerned that the booster was not effective.  The benefit-risk relationship of mRNA-1273.815 vaccine is not affected by this report.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Joint aches; Chills; nausea; Muscle aches; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches) and VOMITING (Vomiting) in a 58-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 13-Nov-2023, the patient experienced ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches), VOMITING (Vomiting) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Joint aches; Chills; nausea; Muscle aches; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches) and VOMITING (Vomiting) in a 58-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 13-Nov-2023, the patient experienced ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches), VOMITING (Vomiting) and FATIGUE (Fatigue). At the time of the report, ARTHRALGIA (Joint aches), CHILLS (Chills), NAUSEA (nausea), MYALGIA (Muscle aches), VOMITING (Vomiting) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm) in a 25-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient had no medical history, concomitant disease or risk factor.     On 28-Jan-2023, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) 1 dosage form. On 28-Jan-2023,  after starting SPIKEVAX NOS (SPIKEVAX NOS), the patient experienced PAIN IN EXTREMITY (soreness in the arm). On 29-Jan-2023, PAIN IN EXTREMITY (soreness in the arm) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       Concomitant medications were not reported.  The patient had not experienced any additional symptoms/events.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscles aches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscles aches) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscles aches). At the time of the report, MYALGIA (muscles aches) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.  Patient states that she had the 1st 2 vaccines and 2 booster doses. She is getting the new vaccine and would like to know how long does the protection last for the new vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Nasopharyngitis, Oral herpes
Clinical narrative: cold; cold sore; canker sore; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (cold), ORAL HERPES (cold sore) and APHTHOUS ULCER (canker sore) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth 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, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), ORAL HERPES (cold sore) and APHTHOUS ULCER (canker sore). At the time of the report, NASOPHARYNGITIS (cold), ORAL HERPES (cold sore) and APHTHOUS ULCER (canker sore) outcome was unknown.            No concomitant medication was reported. It was reported that patient had canker sore in her mouth and wanted to know if she can receive the new Spikevax 2023-2024 vaccine while she had this symptom. No treatment information was provided.   Reporter did not allow further contact
Age: 76.0
Sex: M
Vaccine: COVID19, RVX
Symptoms: Blood glucose increased
Clinical narrative: Today his blood sugar is elevated; This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE INCREASED (Today his blood sugar is elevated) in a 76-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: COVID-19 vaccines (Dose 1), COVID-19 vaccines (Dose 4), COVID-19 vaccines (Dose 3) and COVID-19 vaccines (Dose 2). Past adverse reactions to the above products included No adverse event with COVID-19 vaccines, COVID-19 vaccines, COVID-19 vaccines and COVID-19 vaccines. Concurrent medical conditions included Type 2 diabetes mellitus.   On 13-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On 17-Nov-2023, the patient experienced BLOOD GLUCOSE INCREASED (Today his blood sugar is elevated). At the time of the report, BLOOD GLUCOSE INCREASED (Today his blood sugar is elevated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2023, Blood glucose increased: increased.         No concomitant medication was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Nausea, Overdose, Syringe issue
Clinical narrative: first syringe used malfunctioned; chest tightness; nausea; dizziness; It therefore seems likely that I did receive some of the first vaccine and therefore was injected with a higher dose than recommended; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest tightness), NAUSEA (nausea), DIZZINESS (dizziness), OVERDOSE (It therefore seems likely that I did receive some of the first vaccine and therefore was injected with a higher dose than recommended) and SYRINGE ISSUE (first syringe used malfunctioned ) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 23-Dec-2022. Previously administered products included for COVID-19 prophylaxis: Moderna vaccines. Past adverse reactions to the above products included No adverse event with Moderna vaccines.   On 15-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 15-Nov-2023, received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) dosage was changed to 1 dosage form. On 15-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced OVERDOSE (It therefore seems likely that I did receive some of the first vaccine and therefore was injected with a higher dose than recommended). On 16-Nov-2023, the patient experienced CHEST DISCOMFORT (chest tightness), NAUSEA (nausea) and DIZZINESS (dizziness). On an unknown date, the patient experienced SYRINGE ISSUE (first syringe used malfunctioned ). At the time of the report, CHEST DISCOMFORT (chest tightness), NAUSEA (nausea) and DIZZINESS (dizziness) had not resolved and OVERDOSE (It therefore seems likely that I did receive some of the first vaccine and therefore was injected with a higher dose than recommended) and SYRINGE ISSUE (first syringe used malfunctioned ) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  It was reported that the first syringe used malfunctioned, and it was unclear how much of the vaccine was transmitted. The provider switched arms and administered a full dose of a second vaccine. The provider assured that none or 'little' of the first vaccine was transmitted. Since the vaccination the patient had significant side effects - chest tightness, ongoing nausea, dizziness, that were never experienced with previous Moderna covid vaccines. The patient thought she likely received some of the first vaccine and therefore was injected with a higher dose than recommended. The patient did not experience any additional symptoms/events.  Treatment medication was not reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Chills, Decreased appetite, Headache, Hypersomnia
Clinical narrative: foggy head; sleeping 12-14 hours; Circular Rash at injection site.; swollen, and hot to touch.; head ache; swollen, and hot to touch; lethargic; chills; fever; loss of appetite; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 15-Nov-2023, the patient experienced LETHARGY (lethargic) (seriousness criterion life threatening), CHILLS (chills) (seriousness criterion life threatening), PYREXIA (fever) (seriousness criterion life threatening), DECREASED APPETITE (loss of appetite), VACCINATION SITE RASH (Circular Rash at injection site.), VACCINATION SITE SWELLING (swollen, and hot to touch.), HEADACHE (head ache) and VACCINATION SITE WARMTH (swollen, and hot to touch). On an unknown date, the patient experienced BRAIN FOG (foggy head) and HYPERSOMNIA (sleeping 12-14 hours). The patient was treated with PARACETAMOL (TYLENOL) in November 2023 at a dose of 600 milligram. At the time of the report, LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (loss of appetite), VACCINATION SITE RASH (Circular Rash at injection site.), VACCINATION SITE SWELLING (swollen, and hot to touch.), HEADACHE (head ache) and VACCINATION SITE WARMTH (swollen, and hot to touch) had not resolved and BRAIN FOG (foggy head) and HYPERSOMNIA (sleeping 12-14 hours) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Company Comment: This is a case concerning a 45-year-old female patient with no medical history, who experienced the serious (due life-threatening) unexpected, events of lethargy, chills and pyrexia, together with other non-serious events, which occurred on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. It was reported that the patient was treated with paracetamol. The outcome of the events was reported as not recovered. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Pyrexia, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: foggy head; sleeping 12-14 hours; Circular Rash at injection site.; swollen, and hot to touch.; head ache; swollen, and hot to touch; lethargic; chills; fever; loss of appetite; This spontaneous case was reported by an other health care professional and describes the occurrence of LETHARGY (lethargic), CHILLS (chills) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 15-Nov-2023, the patient experienced LETHARGY (lethargic) (seriousness criterion life threatening), CHILLS (chills) (seriousness criterion life threatening), PYREXIA (fever) (seriousness criterion life threatening), DECREASED APPETITE (loss of appetite), VACCINATION SITE RASH (Circular Rash at injection site.), VACCINATION SITE SWELLING (swollen, and hot to touch.), HEADACHE (head ache) and VACCINATION SITE WARMTH (swollen, and hot to touch). On an unknown date, the patient experienced BRAIN FOG (foggy head) and HYPERSOMNIA (sleeping 12-14 hours). The patient was treated with PARACETAMOL (TYLENOL) in November 2023 at a dose of 600 milligram. At the time of the report, LETHARGY (lethargic), CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (loss of appetite), VACCINATION SITE RASH (Circular Rash at injection site.), VACCINATION SITE SWELLING (swollen, and hot to touch.), HEADACHE (head ache) and VACCINATION SITE WARMTH (swollen, and hot to touch) had not resolved and BRAIN FOG (foggy head) and HYPERSOMNIA (sleeping 12-14 hours) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Company Comment: This is a case concerning a 45-year-old female patient with no medical history, who experienced the serious (due life-threatening) unexpected, events of lethargy, chills and pyrexia, together with other non-serious events, which occurred on the same day after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. It was reported that the patient was treated with paracetamol. The outcome of the events was reported as not recovered. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Injection site pain, Nausea, Pyrexia
Clinical narrative: she had a little nausea, sore arm at the injection and fever; she had a little nausea, sore arm at the injection and fever; she had a little nausea, sore arm at the injection and fever; He stated his wife had similar side effects she was terribly tired; He stated his wife and him got sick after receiving the Spikevax vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He stated his wife and him got sick after receiving the Spikevax vaccine), INJECTION SITE PAIN (she had a little nausea, sore arm at the injection and fever), PYREXIA (she had a little nausea, sore arm at the injection and fever), NAUSEA (she had a little nausea, sore arm at the injection and fever) and FATIGUE (He stated his wife had similar side effects she was terribly tired) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032707) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Caller stated his wife has type 2 Diabetes and he does not believe she had COVID-19.  The patient's past medical history included Type 2 diabetes mellitus. Previously administered products included for Drug use for unknown indication: Moderna COVID-19 vaccine (1st dose: lot number 011L20A) on 08-Jan-2021, Moderna COVID-19 vaccine (2nd Dose: lot number 030L20A) on 04-Feb-2021, Moderna COVID-19 vaccine (3rd dose: lot number 039B21A) on 10-Nov-2021 and Moderna COVID-19 vaccine (4th dose: lot number AS7146B) on 05-Oct-2022. Past adverse reactions to the above products included No adverse reaction with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 08-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 11-Nov-2023, the patient experienced ILLNESS (He stated his wife and him got sick after receiving the Spikevax vaccine) and FATIGUE (He stated his wife had similar side effects she was terribly tired). On an unknown date, the patient experienced INJECTION SITE PAIN (she had a little nausea, sore arm at the injection and fever), PYREXIA (she had a little nausea, sore arm at the injection and fever) and NAUSEA (she had a little nausea, sore arm at the injection and fever). On 11-Nov-2023, ILLNESS (He stated his wife and him got sick after receiving the Spikevax vaccine), INJECTION SITE PAIN (she had a little nausea, sore arm at the injection and fever), PYREXIA (she had a little nausea, sore arm at the injection and fever), NAUSEA (she had a little nausea, sore arm at the injection and fever) and FATIGUE (He stated his wife had similar side effects she was terribly tired) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750207 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750207
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chest pain, Fatigue, Headache
Clinical narrative: extreme body aches (mostly neck/spine); Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.; heart palpitations; occasional chest pain; extreme fatigue; headache; fever; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain) and FATIGUE (extreme fatigue) in a 32-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic asthma (Allergy induced asthma).  On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Nov-2023, the patient experienced PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain), FATIGUE (extreme fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain), FATIGUE (extreme fatigue), HEADACHE (headache) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102° F.  The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.  Concomitant product use was not provided by the reporter.  The patient experienced extreme fatigue, headache, fever (102° F), extreme body aches (mostly neck/spine), bee stinging sensations that wake her from sleep (normally in hand or leg), hands, fingers, and toes felt very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain. The patient did not experience any additional symptoms/events.  The patient did not have any additional medical history, concomitant disease or risk factor.  There were no lab data/results available.  Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: extreme body aches (mostly neck/spine); Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.; heart palpitations; occasional chest pain; extreme fatigue; headache; fever; This spontaneous case was reported by a non-healthcare professional and describes the occurrence of PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain) and FATIGUE (extreme fatigue) in a 32-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic asthma (Allergy induced asthma).  On 17-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 17-Nov-2023, the patient experienced PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain), FATIGUE (extreme fatigue), HEADACHE (headache) and PYREXIA (fever). At the time of the report, PAIN (extreme body aches (mostly neck/spine)), ASTHENIA (Hands, fingers, and toes feel very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain.), PALPITATIONS (heart palpitations), CHEST PAIN (occasional chest pain), FATIGUE (extreme fatigue), HEADACHE (headache) and PYREXIA (fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102° F.  The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.  Concomitant product use was not provided by the reporter.  The patient experienced extreme fatigue, headache, fever (102° F), extreme body aches (mostly neck/spine), bee stinging sensations that wake her from sleep (normally in hand or leg), hands, fingers, and toes felt very weak and numb, and high heart rate (even at rest) as well as heart palpitations and occasional chest pain. The patient did not experience any additional symptoms/events.  The patient did not have any additional medical history, concomitant disease or risk factor.  There were no lab data/results available.  Treatment information was not provided.