chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: HEPAB, HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, Product administered to patient of inappropriate age
Clinical narrative: would now like to get the 3rd dose; received the 1st dose of Twinrix at 17 years old on 20Aug2008 and the 2nd dose at 20 years old on 20 Oct 2011; received the 1st dose of Twinrix at 17 years old; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 17-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis and HAB (Twinrix) for prophylaxis.   On 20-OCT-2011, the patient received the 2nd dose of Twinrix. On 20-AUG-2008, the patient received the 1st dose of Twinrix. On an unknown date, the patient did not receive the 3rd dose of Twinrix. On 20-AUG-2008, not applicable after receiving Twinrix and Twinrix and an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received the 1st dose of Twinrix at 17 years old). On 20-OCT-2011, the patient experienced drug dose administration interval too long (Verbatim: received the 1st dose of Twinrix at 17 years old on 20Aug2008 and the 2nd dose at 20 years old on 20 Oct 2011). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: would now like to get the 3rd dose). The outcome of the inappropriate age at vaccine administration, drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 26-Oct-2023 The patient received 1st dose of Twinrix at an inappropriate age, which led to inappropriate age at vaccine administration. The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule. Till the time of reporting, the patient did not receive 3rd dose of Twinirx, which led to incomplete course of vaccination. The reporter did not have the lot/expiry date as the vaccine was given at a different clinic. The reporter consented to follow-up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia
Clinical narrative: sick to his stomach; chills; now experiencing fever, chills, and is sick to his stomach; This non-serious case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 79-year-old male 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 upset stomach (Verbatim: sick to his stomach), chills (Verbatim: chills) and fever (Verbatim: now experiencing fever, chills, and is sick to his stomach). The outcome of the upset stomach, chills and fever were not resolved.   It was unknown if the reporter considered the upset stomach, chills and fever to be related to Shingrix.     It was unknown if the company considered the upset stomach, chills and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-OCT-2023  The reporter was a patient. Patient received the Shingrix and at the reporting time experiencing fever, chills and was sick to his stomach. No further information was known. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Nausea, Pain
Clinical narrative: Nausea; Sore body/Hurt body; This non-serious case was reported by a other health professional via call center representative and described the occurrence of nausea in a unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patients received the 1st dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patients experienced nausea (Verbatim: Nausea) and general body pain (Verbatim: Sore body/Hurt body). The outcome of the nausea and general body pain were unknown.   It was unknown if the reporter considered the nausea and general body pain to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the nausea and general body pain to be related to Bexsero and Bexsero 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: 25-OCT-2023  The reporter reported that less than 5 people (patients) had bad reactions of sore body, hurt body and nausea after the Bexsero. The reporter had no further information about the event. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak this week; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included aciclovir (Acyclovir).   On 30-JUN-2023, the patient received the 1st dose of Shingrix. In OCT-2023, between 3 and 4 months after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles outbreak this week). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-OCT-2023  The reporter was a patient. Concomitant product included steroid shot (unknown name) for unknown reason. Patient received the Shingrix and diagnosed with shingles outbreak in the reporting week. The reporter consented to follow up.
Age: 0.42
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5-month-old patient received a dose of FluLaval QIV on 21/Sep/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number 4MM2J, expiry date 30-JUN-2024) for prophylaxis.   On 21-SEP-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 21-SEP-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced inappropriate age at vaccine administration (Verbatim: 5-month-old patient received a dose of FluLaval QIV on 21/Sep/2023). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-OCT-2023 The reporter was a medical assistant. The reporter called to inform that a 5-month-old patient received a dose of FluLaval QIV, which led to inappropriate age at vaccine administration. Such patient was 14 days apart from turning 6 months. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not yet received the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 20-OCT-2020).   On an unknown date, the patient did not receive Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2023 The reporter was a pharmacist. The pharmacist reported a patient received the first dose of Shingrix on October 20, 2020 and not yet received the second dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination.
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: child born in 2015 was given a KINRIX Vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 7-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   On an unknown date, the patient received Kinrix (injection, left thigh). On an unknown date, an unknown time after receiving Kinrix, the patient experienced inappropriate schedule of vaccine administered (Verbatim: child born in 2015 was given a KINRIX Vaccine). The outcome of the inappropriate schedule of vaccine 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: 26-OCT-2023 The reporter was a medical Assistant.   Health care professional (HCP) called today (on the day of reporting) to report that a child born in 2015 was given a Kinrix vaccine.   She stated the child had never had vaccines since birth and the reason was unknown.   HCP stated MMR, Kinrix, and Varicella were given at the same visit. The patient received Kinrix as a 1st vaccine, which led to inappropriate vaccine schedule.  The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old patient received a dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 19-OCT-2023, the patient received Kinrix. On 19-OCT-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 4 month old patient received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-OCT-2023 The reporter informed that a 4 month old patient received a dose of Kinrix which led to inappropriate age at vaccine administration. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the 1st dose of Shingrix over a year ago/ did not receive 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 08-JUN-2022).   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: patient received the 1st dose of Shingrix over a year ago/ did not receive 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-OCT-2023 The pharmacist stated that, a patient received the 1st dose of Shingrix over a year ago and wanted to know, did the patient need to start the series over. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Electric shock sensation, Myalgia, Paraesthesia
Clinical narrative: Paresthesia/ tingling; the muscle is a little sore; electric shock-like down the right arm in the ulna nerve distribution; This non-serious case was reported by a physician via call center representative and described the occurrence of paresthesia in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (right arm). On an unknown date, 3 weeks after receiving Shingrix, the patient experienced paresthesia (Verbatim: Paresthesia/ tingling), muscle soreness (Verbatim: the muscle is a little sore) and electric shock sensation (Verbatim: electric shock-like down the right arm in the ulna nerve distribution). The outcome of the paresthesia, muscle soreness and electric shock sensation were not resolved.   It was unknown if the reporter considered the paresthesia, muscle soreness and electric shock sensation to be related to Shingrix.     It was unknown if the company considered the paresthesia, muscle soreness and electric shock sensation to be related to Shingrix.   Additional Information: GSK receipt date 26 Oct 2023: The reporter is the patient.  The patient received the first dose of SHINGRIX at the end of July / beginning of August 2023 in the right arm. Three weeks later, the patient began to experience tingling, paresthesia, electric shock-like down the right arm in the ulna nerve distribution.  To this day, when the patient presses on the right deltoid, the muscle was a little sore, and it reproduces the tingling sensation in the hand. The reporter consented to follow up with HCP (pharmacy).
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Blood cholesterol, Blood cholesterol increased, Glycosylated haemoglobin, Glycosylated haemoglobin increased
Clinical narrative: PARALYSIS; TREMORED FOR ALMOST THREE MONTH; DID NOT WORK FOR TEN MONTHS; NUMEROUS SIDE EFFECTS; CHOLESTEROL HAVE GONE UP; A1C (HEMOGLOBIN) LEVEL HAVE GONE UP; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, expiry were not reported) dose was not reported, 1 total administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, three days after receiving the vaccine patient presented to emergency room as patient was felt having a stroke. The patient had mention having paralysis. The patient's cholesterol and A1C (hemoglobin) level have gone up. The patient stated that having tremor for almost three months like patient had Parkinson's disease. The patient was not able work for ten months. The patient had a numerous side effect since vaccine. The patient stated that after 2.5 years still recovering and has a lot of side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremored for almost three month, and did not work for ten months, and was recovering from paralysis, numerous side effects, cholesterol have gone up, and a1c (hemoglobin) level have gone up. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231078595-Paralysis. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Paralysis, Tremor
Clinical narrative: PARALYSIS; TREMORED FOR ALMOST THREE MONTH; DID NOT WORK FOR TEN MONTHS; NUMEROUS SIDE EFFECTS; CHOLESTEROL HAVE GONE UP; A1C (HEMOGLOBIN) LEVEL HAVE GONE UP; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number, expiry were not reported) dose was not reported, 1 total administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in APR-2021, three days after receiving the vaccine patient presented to emergency room as patient was felt having a stroke. The patient had mention having paralysis. The patient's cholesterol and A1C (hemoglobin) level have gone up. The patient stated that having tremor for almost three months like patient had Parkinson's disease. The patient was not able work for ten months. The patient had a numerous side effect since vaccine. The patient stated that after 2.5 years still recovering and has a lot of side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremored for almost three month, and did not work for ten months, and was recovering from paralysis, numerous side effects, cholesterol have gone up, and a1c (hemoglobin) level have gone up. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20231078595-Paralysis. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Pyrexia
Clinical narrative: Loss of appetite; high fever; chills; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (high fever) and CHILLS (chills) in a 70-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient had no history of COVID-19 diagnosis.  Concurrent medical conditions included Type 2 diabetes mellitus, Mitral regurgitation, Irritable bowel syndrome, Blood pressure high, Drug allergy (codeine allergy), Drug allergy (Miralax allergy) and Drug allergy (magnesium citrate allergy).    On 27-Oct-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (high fever) and CHILLS (chills). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (high fever) and CHILLS (chills) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient received previous Moderna doses first Dose: 17-FEB-2021 Lot 071F21A, second Dose: 17-MAR-2021, Lot 044A21A. It was reported that the patient had received all Moderna COVID-19 vaccines so far and her reactions have been high fever, chills, loss of appetite. She would only have to stay at home for a couple of days after which she was able to return to work. With one of the doses, her fever went to 104F. She would stay at home and in bed when she did not feel well after the vaccinations. Patient received fourth dose on 20OCT2022, Lot: 049D22A and fifth dose on 26-OCT-2023, Lot A02920B. No treatment medication reported.   This case was linked to MOD-2023-747880 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Moderna COVID-19 vaccine (original formulation) as primary series). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. In March 2023, the patient experienced COVID-19 (It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick). At the time of the report, COVID-19 (It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick) had resolved.            No concomitant medication was reported.  Reportedly, a patient started treatment on unreported dates with Moderna COVID-19 vaccine (original formulation) for his primary series, and 2 updated bivalent booster doses. It was reported the patient came down with COVID-19 twice this year, the first week of MAR-2023 and the 3rd week of MAY-2023. The patient reportedly didn't get very sick. His last booster dose was reported to be about 6 months prior to when he got sick in March with COVID.  No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she was very tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (she was very tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 prophylaxis.     Patient had no COVID-19 diagnosis.  The patient's past medical history included Metastatic breast cancer (metastatic triple positive breast cancer) in 2011. Concurrent medical conditions included Allergy to chemicals (sulfa and hexchlorine).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (she was very tired). At the time of the report, FATIGUE (she was very tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. It was reported that patient received second dose on 3-APR-2021, Lot no 039A21A, third dose on 24-SEP-2021, Lot no 038R21A and fourth dose on 22-MAR-2023, Lot number AS7171B. Patient received her flu shot on 06-Oct-2023. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747939 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Aches; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Aches) and FATIGUE (Fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 031M20A, 027H14B and 027L20A) for COVID-19 prophylaxis.     The patient's past medical history included Aortic stenosis (since about 5 years ago pretty stable during that time). Concurrent medical conditions included Post-traumatic stress disorder and Mood swings. Concomitant products included SERTRALINE for Post-traumatic stress disorder and Mood swings, METOPROLOL TARTRATE, OMEPRAZOLE, ROSUVASTATIN and MIRABEGRON for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Aches) and FATIGUE (Fatigue). At the time of the report, PAIN (Aches) and FATIGUE (Fatigue) outcome was unknown.            No treatment information was reported.   This case was linked to MOD-2023-748020, MOD-2023-747981 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Pain
Clinical narrative: aches; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN (aches) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Metoprolol Tartrate, Mirabegron, Omeprazole and Rosuvastatin; for Post-traumatic stress disorder: Sertraline; for Mood swings: Sertraline. Past adverse reactions to the above products included No adverse event with Metoprolol Tartrate, Mirabegron, Omeprazole, Rosuvastatin, Sertraline and Sertraline. Concurrent medical conditions included Aortic stenosis (since about 5 years ago, pretty stable during that time.), Post-traumatic stress disorder and Mood swings.    On 14-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 (aches) and FATIGUE (fatigue). At the time of the report, PAIN (aches) and FATIGUE (fatigue) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-747981, US-MODERNATX, INC.-MOD-2023-747999 (Linked Report). This case was linked to MOD-2023-747981, MOD-2023-747999 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747981:Same patient, master case (Spikevax 2023-2024 PFS) US-MODERNATX, INC.-MOD-2023-747999:Same patient monovalet dose
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Vaccination site pain
Clinical narrative: Every year in October and always on a Friday to help with "flu-ish" symptoms; pain in the injection site that tends to both her for 24-36 hours after vaccination; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Every year in October and always on a Friday to help with "flu-ish" symptoms) and VACCINATION SITE PAIN (pain in the injection site that tends to both her for 24-36 hours after vaccination) 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 dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Every year in October and always on a Friday to help with "flu-ish" symptoms) and VACCINATION SITE PAIN (pain in the injection site that tends to both her for 24-36 hours after vaccination). At the time of the report, INFLUENZA LIKE ILLNESS (Every year in October and always on a Friday to help with "flu-ish" symptoms) and VACCINATION SITE PAIN (pain in the injection site that tends to both her for 24-36 hours after vaccination) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown whether the patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. It was reported that the patient takes moderna vaccine every year in October and always on a friday to help with "flu-ish" symptoms and pain in the injection site that tends to both her for 24-36 hours after vaccination.  No treatment medication was reported.   This case was linked to MOD-2023-747870 (Patient Link).
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Eye contusion, Feeling abnormal, Pain, Pruritus
Clinical narrative: painful; black eye; at the time of the shot she felt "off-centered; itchy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (painful), EYE CONTUSION (black eye), FEELING ABNORMAL (at the time of the shot she felt "off-centered) and PRURITUS (itchy) in a 79-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: Pneumococcal vaccine. Past adverse reactions to the above products included No adverse event with Pneumococcal vaccine.    On 28-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced PRURITUS (itchy). On 28-Oct-2023, the patient experienced PAIN (painful), EYE CONTUSION (black eye) and FEELING ABNORMAL (at the time of the shot she felt "off-centered). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (painful), EYE CONTUSION (black eye), FEELING ABNORMAL (at the time of the shot she felt "off-centered) and PRURITUS (itchy) had not resolved.            It was reported that patient had received other vaccines four weeks prior to Covid-19.  Concomitant product use was not provided by the reporter.  Patient receives total of five doses of mdoerna covid-19 vaccine, previous four doses were first dose on 12-Jan-2021 (Lot number-013L20A), second dose on 09-Feb-2021(Lot number- 030M20A), third dose on 27-Oct-2021 (Lot number- 012F21A), fourth dose on 18-Apr-2022 (Lot number- 057M21A).  It was reported that 30 minutes after receiving the most recent dose of the vaccine she noted her eyelid started to turn black. This spot was slightly painful, and at the time of the shot she felt off-centered. It got worse over the weekend, moving to her eye and her face. She talked to a pharmacist who recommended she take an antihistamine, so she took a Zyrtec. At the time of report black eye as it was still ongoing today, but was also itchy.
Age: 65.0
Sex: F
Vaccine: FLUX, RVX, UNK
Symptoms: Hypersomnia
Clinical narrative: Patient slept after the first one and came home and passed on and slept all day and patient is sleeping a lot.; This spontaneous case was reported by a physician and describes the occurrence of HYPERSOMNIA (Patient slept after the first one and came home and passed on and slept all day and patient is sleeping a lot.) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect products included non-company products RSV VACCINE for an unknown indication and INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 28-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form, dose of RSV VACCINE (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 28-Oct-2023, the patient experienced HYPERSOMNIA (Patient slept after the first one and came home and passed on and slept all day and patient is sleeping a lot.). At the time of the report, HYPERSOMNIA (Patient slept after the first one and came home and passed on and slept all day and patient is sleeping a lot.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment information was reported.  Company comment: This spontaneous case concerns a 65-year-old, female patient with no medical history information reported, who experienced the unexpected non serious AESI of hypersomnia. The event occurred on the same day after a dose of SPIKEVAX 2023-2024). As reported, patient got three shots on the same day RSV, flu, and Spikevax and slept a lot after the first one. Reportedly patient came home and passed on and slept all day. Patient reported that she never takes naps and now is sleeping a lot. No further information about the events was provided. Concurrent administration of RSV and influenza vaccines remains a confounder for the event. The benefit-risk relationship of SPIKEVAX 2023-2024 is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Extra dose administered, Feeling abnormal, Pruritus
Clinical narrative: gave her a flu shot and another SPIKEVAX shot inadvertently; The last two nights she has had prickly itching; She felt a little funny but otherwise she was fine; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (The last two nights she has had prickly itching), FEELING ABNORMAL (She felt a little funny but otherwise she was fine) and EXTRA DOSE ADMINISTERED (gave her a flu shot and another SPIKEVAX shot inadvertently) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3917B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 (it was mild. She took the other drug that was Paxlovid. She tested positive for two weeks but she was better in a day.) from 01-Feb-2023 to February 2023. Concurrent medical conditions included Seasonal allergy.   On 20-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 26-Oct-2023, received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2023, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. In October 2023, the patient experienced PRURITUS (The last two nights she has had prickly itching) and FEELING ABNORMAL (She felt a little funny but otherwise she was fine). On 26-Oct-2023, the patient experienced EXTRA DOSE ADMINISTERED (gave her a flu shot and another SPIKEVAX shot inadvertently). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (The last two nights she has had prickly itching) had not resolved and FEELING ABNORMAL (She felt a little funny but otherwise she was fine) and EXTRA DOSE ADMINISTERED (gave her a flu shot and another SPIKEVAX shot inadvertently) outcome was unknown.            It was reported that patient had received other vaccines in the four weeks prior to Covid-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that patient receives a Spikevax vaccine on 20-Sep-2023. On 26-Oct-2023 patient receives a flu shot and another SPIKEVAX shot inadvertently. She felt a little funny but otherwise she was fine. The last two nights she had prickly itching and took Benadryl which had helped. She had not changed her diet or done laundry so she was wondering if this was from the second shot. This morning she still felt it in her lower legs and a little on her belly. Her doctor told her to keep taking the Benadryl. She did have the other lot numbers for her previous vaccinations.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Gingival disorder, SARS-CoV-2 test
Clinical narrative: little red part on her gums; Cough; This spontaneous case was reported by a patient and describes the occurrence of GINGIVAL DISORDER (little red part on her gums) and COUGH (Cough) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 00A21A and 005M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced GINGIVAL DISORDER (little red part on her gums) and COUGH (Cough). On 09-Feb-2021, GINGIVAL DISORDER (little red part on her gums) and COUGH (Cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Chest X-ray: diagnosed her with IOD (she thinks). In 2023, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GINGIVAL DISORDER (little red part on her gums) to be related. No further causality assessment was provided for COUGH (Cough).    No relevant concomitant medications were reported.  She had not had any trouble. When she went to the doctor in September he told her it was early to get SPIKEVAX, flu shot or RSV vaccines. She recently went to urgent care and got tested for COVID-19 and was negative. They did a chest X-ray and diagnosed her with IOD (she thinks). She wont be able to get with a lung doctor for a while. Her doctor told her not to get the vaccine until her cough was better. Patient administered fourth vaccine of Moderna bivalent on 01 OCT 2022 with lot no. 055F22B. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747785 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747785:Bivalent Dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Pyrexia
Clinical narrative: Flu-like symptoms: aches in joints, low grade fever, fatigue, chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms: aches in joints, low grade fever, fatigue, chills) in a 49-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 30-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms: aches in joints, low grade fever, fatigue, chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms: aches in joints, low grade fever, fatigue, chills) had not resolved.            Concomitant medication was not provided. Patient experienced flu-like symptom which include aches in joints, low grade fever, fatigue, chills. Treatment information was not reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Rash, Rash pruritic, Skin reaction
Clinical narrative: Itching like crazy; she experienced a bad skin reaction; rash that was not only at the injection site but on both arms; Bad skin reaction or rash that was not only at the injection site but on both arms; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Itching like crazy), SKIN REACTION (she experienced a bad skin reaction), VACCINATION SITE RASH (rash that was not only at the injection site but on both arms) and RASH PRURITIC (Bad skin reaction or rash that was not only at the injection site but on both arms) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030372) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In October 2023, the patient experienced VACCINATION SITE PRURITUS (Itching like crazy), SKIN REACTION (she experienced a bad skin reaction), VACCINATION SITE RASH (rash that was not only at the injection site but on both arms) and RASH PRURITIC (Bad skin reaction or rash that was not only at the injection site but on both arms). At the time of the report, VACCINATION SITE PRURITUS (Itching like crazy), SKIN REACTION (she experienced a bad skin reaction), VACCINATION SITE RASH (rash that was not only at the injection site but on both arms) and RASH PRURITIC (Bad skin reaction or rash that was not only at the injection site but on both arms) had not resolved.            No relevant concomitant medications were reported. It was reported that the patient had been receiving Moderna vaccines since the beginning of COVID.  She saw a dermatologist on the day of report who recommended a topical steroid treatment and oral antihistamines. She was planning on taking Benadryl at night on the day of the report.   This case was linked to MOD-2023-748128 (Patient Link).
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: itching; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and RASH (Rash) in a 75-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) from 31-Oct-2023 to an unknown date for an unknown indication.    On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Oct-2023, the patient experienced PRURITUS (itching) and RASH (Rash). At the time of the report, PRURITUS (itching) and RASH (Rash) 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.   The patient got Spikevax at noon time, she just broken out into a rash under her waist and on her back. The patient received 3 original shots and 2 or 3 boosters after, and she reported all the doses were Moderna, the patient drank a ton of water concomitant supplements and vitamins.
Age: 54.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 54-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for Influenza immunisation.    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 and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Patient had received Spikevax along with flu shot approximately 3 weeks ago and. Patient only had a bit sore arm and next day he was fine.   This case was linked to US-MODERNATX, INC.-MOD-2023-710279 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710279:Wife case
Age: 65.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Headache, Hyperhidrosis, Malaise, Mobility decreased
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; sweating; feeling absolutely terrible; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING ABNORMAL (feeling absolutely terrible), HEADACHE (headache), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) in a 65-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for Influenza immunisation.    The patient's past medical history included COVID-19 (2 months ago). Previously administered products included for COVID-19 immunisation: Johnson and Johnson (had 2 Johnson and Johnson COVID-19 Vaccines previously.). Past adverse reactions to the above products included No adverse event with Johnson and Johnson. Concurrent medical conditions included CLL.   On 30-Oct-2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 30-Oct-2023 at 10:30 AM, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 30-Oct-2023, the patient experienced HYPERHIDROSIS (sweating), FEELING ABNORMAL (feeling absolutely terrible) and HEADACHE (headache). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating) and HEADACHE (headache) had not resolved and FEELING ABNORMAL (feeling absolutely terrible), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Reported that patient was feeling absolutely terrible. He has been in bed since Monday night. He was sweating, had headache and he just felt terrible. His oncologist recommended to get the vaccine. Patient had lot of water. He felt like he had COVID-19 again.