chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: fainting after receiving a dose of Bexsero; This serious case was reported by a nurse via sales rep and described the occurrence of fainting in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced fainting (Verbatim: fainting after receiving a dose of Bexsero) (serious criteria GSK medically significant).  The outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the fainting 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: 12-OCT-2023 The nurse called to ask if there were instances of fainting after receiving a dose of Bexsero.  She stated she had several in the past year. She would also like to know was if there was there any data on increase of adverse events with Bexsero being given with another vaccine, especially Meningitis ACWY. The reporter consented to follow up. The case is linked with US2023140658, reported by same reporter.; Sender's Comments:  US-GSK-US2023140658:same reporter
Age: 75.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: MA stated that a 75 year old patient inadvertently received Pediarix instead of Tdap; MA stated that a 75 year old patient inadvertently received Pediarix instead of Tdap; 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 75-year-old patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: MA stated that a 75 year old patient inadvertently received Pediarix instead of Tdap) and wrong vaccine administered (Verbatim: MA stated that a 75 year old patient inadvertently received Pediarix instead of Tdap).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 12-OCT-2023 Medical Assistant (MA) stated that a 75 year old patient inadvertently received Pediarix instead of Tdap. Caller declined to provide additional information, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site discolouration, Injection site erythema, Pyrexia
Clinical narrative: Injection site turned purple red; Big blush around injection site; severe headache; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site discoloration in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site discoloration (Verbatim: Injection site turned purple red), injection site erythema (Verbatim: Big blush around injection site), headache (Verbatim: severe headache) and fever (Verbatim: Fever).  The outcome of the injection site discoloration, injection site erythema, headache and fever were resolved.   It was unknown if the reporter considered the injection site discoloration, injection site erythema, headache and fever to be related to Shingrix.     It was unknown if the company considered the injection site discoloration, injection site erythema, headache and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient self-reported this case. The patient stated that she received Shingrix and developed a reaction. The patient had fever, severe headache, injection site turned purple red and also had a big blush at the injection site. The reporter reported that all symptoms went away 4 to 5 days later. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-OCT-2023, the patient received Shingrix. On 13-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique) 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: 13-OCT-2023 The health care professional (HCP) unable to provide any patient or vaccine details.  The reporter confirmed the patient was administered the Shingrix AS01b Liquid component without the lyophilized component today (on the day of reporting). HCP mentioned unsure but thought the physician advised to administer a complete dose after diluent only dose. The patient received only diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient not received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 2022 received 1st dose.).   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 not received the 2nd dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 13-OCT-2023 A pharmacist reported that the patient received dose one of Shingrix in 2022 and was now presenting for dose two of the series.  Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Glycosylated haemoglobin, Therapeutic response unexpected
Clinical narrative: PAIN IN HIS FEET CURED AND LESSENED NEUROPATHY; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 209 pounds, and height was 68 inches. The patient's past medical history included: cardiac arrest (at 67 years old while playing sports), and blood in urine, and concurrent conditions included: neuropathy, diabetes (diagnosed last year (2022) and stated that statins caused the diabetes), sleep apnea, hypertension (which came from the war), social alcohol drinker, and non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and no drug abuse or illicit drug usage. The patient was a heavy sugar eater (15 to 20 candy bars, cake, cookies) but looks 60 years old. The patient did not get a blood test for three years due to COVID. The patient has had a sleep problem since his cardiac arrest. The patient was a veteran and was waking up every half hour to hour because of visions of war. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 8 decade old. The batch number was not reported and has been requested. Concomitant medications included metoprolol tartrate for blood pressure, atorvastatin for cholesterol, metformin for sugar, amlodipine, and trazodone.  On an unspecified date, the patient experienced pain in his feet cured and lessened neuropathy. Laboratory data (dates unspecified) included: HbA1C good. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in his feet cured and lessened the neuropathy was not reported. This report was non-serious. This case, involving the same patient is linked to 20231019877.
Age: 64.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: husband got breakthrough COVID after receiving the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BREAKTHROUGH COVID-19 (husband got breakthrough COVID after receiving the vaccine) in a 64-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included COVID-19 (COVID-19 positive on 15-APR-2022) on 15-Apr-2022.   In September 2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 16-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced BREAKTHROUGH COVID-19 (husband got breakthrough COVID after receiving the vaccine). On 07-Oct-2023, BREAKTHROUGH COVID-19 (husband got breakthrough COVID after receiving the vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Patient had previously received Moderna vaccines first dose on 13-MAR-2021, Lot no. 001B21A, second Dose on 10-APR-2021, Lot no. 038B21A third Dose on 12DEC2021, Lot no. 031H21A fourth Dose on 7-MAR-2022, Lot no. 004M21A fifth Dose on 17-NOV-2022, Lot no. 020H22A. It was reported that patient received flu shot one week after Spikevax 2023-2024.  Question 9 was left unanswered since the applicable option was not available in the decision tree.   This case was linked to US-MODERNATX, INC.-MOD-2023-745333 (E2B Linked Report). This case was linked to MOD-2023-745962 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2023: Live significant follow up received. Reference numbers added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745333:Wife case
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Tenderness
Clinical narrative: tenderness; headache; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. 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 TENDERNESS (tenderness), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills). At the time of the report, TENDERNESS (tenderness), HEADACHE (headache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient received new Moderna formulation 2023-2024 on 09-Oct-2023 (batch no: 3030535).  Patient had received booster dose last year and other previous doses. Patient had headache, tenderness, fever, chills with previous doses of the COVID-19 vaccines. Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745395 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745395:Spikevax 2023-24 case (Same patient)
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for 1 day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm for 1 day) in a 49-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU Shot . Past adverse reactions to the above products included No adverse event with FLU Shot .    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 PAIN IN EXTREMITY (sore arm for 1 day). At the time of the report, PAIN IN EXTREMITY (sore arm for 1 day) had resolved.            No concomitant medication was reported.   No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745549 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745549:
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Illness, Pain in extremity
Clinical narrative: they got a little ill for a couple of days, couldn't get out of bed; it was the first time other than arm being sore; tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (they got a little ill for a couple of days, couldn't get out of bed), PAIN IN EXTREMITY (it was the first time other than arm being sore) and FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049022A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-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 ILLNESS (they got a little ill for a couple of days, couldn't get out of bed), PAIN IN EXTREMITY (it was the first time other than arm being sore) and FATIGUE (tired). At the time of the report, ILLNESS (they got a little ill for a couple of days, couldn't get out of bed), PAIN IN EXTREMITY (it was the first time other than arm being sore) and FATIGUE (tired) outcome was unknown.            Concomitant medication not reported.   The patient had all Moderna vaccines 1 st dose on 29 Jan 2021 with lot number 041L20A, 2nd dose on 27 Feb 2021 with lot number 023M20A, 3rd dose on 1 Nov 2021 with lot number 033F21A and 4th dose on 18 Jan 2022 with lot number 001M21A.  Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745579 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745579:Wife case (Master case)
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Was tired that night/ I'm exhausted still; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Was tired that night/ I'm exhausted still) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   In 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2022, the patient experienced PAIN IN EXTREMITY (Sore arm). 2022, the patient experienced FATIGUE (Was tired that night/ I'm exhausted still). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and FATIGUE (Was tired that night/ I'm exhausted still) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  It was reported that the patient took Moderna and flu shot last year and was tired that night and had a sore arm, the next day. The patient was in bed since Wednesday and went to bed early on Tuesday evening. At the time of report the patient was exhausted, except when Motrin was taken.
Sex: F
Vaccine: COVID19-2
Symptoms: Accidental underdose, COVID-19
Clinical narrative: So there are five of us that were infected.; No one else in the family had received a full dose for their booster.; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (So there are five of us that were infected.) and ACCIDENTAL UNDERDOSE (No one else in the family had received a full dose for their booster.) in an adult female 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 (Dose 1), Moderna COVID-19 Vaccine (Dose 4), Moderna COVID-19 Vaccine (Dose 3) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On an unknown date, 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, the patient experienced ACCIDENTAL UNDERDOSE (No one else in the family had received a full dose for their booster.). In December 2022, the patient experienced COVID-19 (So there are five of us that were infected.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (So there are five of us that were infected.) had resolved and ACCIDENTAL UNDERDOSE (No one else in the family had received a full dose for their booster.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Reported that patient has received Moderna boosters around October November.  Reported that patient was sick and did not got seriously ill and sick.   This case was linked to US-MODERNATX, INC.-MOD-2023-745748 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-Oct-2023: Live Follow-up received that contains significant information: Reporter, patient detail, medical history, treatment medication, event details and Refence Ids updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745748:Father's or Reporter's case
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe anaphylaxis reaction; This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (severe anaphylaxis reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (severe anaphylaxis reaction) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (severe anaphylaxis reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Hashimoto's disease (Hashimoto's hypothyroidism).    In 2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The patient stated he was in clinical trials for the Moderna COVID-19 Vaccine back in 2020. The other Moderna vaccines that he took in the trials he had a reaction.  His reactions from the original vaccines consisted of a little temperature and after a day or two it went away.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745290 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745290:Same patient, different vaccine (monovalent)
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Mar-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient had previously received Moderna vaccines first dose on 13-MAR-2021, Lot no. 001B21A, second Dose on 10-APR-2021, Lot no. 038B21A third Dose on 12DEC2021, Lot no. 031H21A. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745332, US-MODERNATX, INC.-MOD-2023-745333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745332:Husband case (MASTER CASE) US-MODERNATX, INC.-MOD-2023-745333:Wife case
Age: 48.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vitiligo
Clinical narrative: Vitiligo; This spontaneous case was reported by a patient and describes the occurrence of VITILIGO (Vitiligo) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis.     The patient had never been tested positive for COVID-19. The patient no acute illness at the time of vaccination or up to one month before. The patient no chronic illness.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (First Dose LOT: 04A21A) on 12-Mar-2021, Moderna Covid-19 Vaccine (Second dose LOT:036B21A) on 09-Apr-2021 and Moderna Covid-19 Vaccine (Third Dose LOT:065FC21A) on 20-Nov-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna Covid-19 Vaccine and Moderna Covid-19 Vaccine. Concurrent medical conditions included Drug allergy (sulfa drugs).    On 03-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced VITILIGO (Vitiligo). At the time of the report, VITILIGO (Vitiligo) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered VITILIGO (Vitiligo) to have an unknown relationship.    It was reported that the patient always wore masks. The patient had not experienced similar events in the past. No concomitant medication was reported.  Due to the event the patient visited the dermatologist on 01-Nov-2022. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Oct-2023: Significant follow-up received. Reporter details updated. Patient details updated. Current condition added. Previous doses batch number updated. Suspect administration date was updated. Reporter causality updated.
Age: 57.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Pruritus, Syncope
Clinical narrative: Faint; Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over; headache; swelling on her arm; redness; itchiness; cold; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Faint) in a 57-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    No Medical History information was reported.   On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant) and DIZZINESS (Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over). In October 2023, the patient experienced PERIPHERAL SWELLING (swelling on her arm), ERYTHEMA (redness), PRURITUS (itchiness), NASOPHARYNGITIS (cold) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SYNCOPE (Faint), PERIPHERAL SWELLING (swelling on her arm), ERYTHEMA (redness), PRURITUS (itchiness), NASOPHARYNGITIS (cold), DIZZINESS (Dizzy/ Lightheaded like a balloon/ / Feeling like she was going to fall over) and HEADACHE (headache) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  Halfway through the night after receiving the most recent dose of the vaccine she felt dizzy, lightheaded like a balloon, and faint. She went to work, where she felt she got worse. Feeling like she was going to fall over, was dizzy, cold, and had a headache. She also had some swelling on her arm, itchiness, and redness. She called her doctor who recommended ice on her arm, Tylenol, rest, and drinking lots of fluids. She had attempted these treatments. Company comment: This spontaneous case concerns a 57-year-old female patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of SYNCOPE, halfway through the night after receiving an unspecified dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine, among other non-serious events. Vaccination with influenza vaccine on the same day remains as a confounder for the event. She took paracetamol, rest, and drank fluids as treatment. No further clinical information was available for medical review. She reported having received previous doses of the COVID-19 vaccines without any specifications. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-745400 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745400:Spikevax NOS case (Same patient)
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Induration
Clinical narrative: flu like symptoms; aches; joint pain; Heavy chills; low grade fever; headache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (aches), ARTHRALGIA (joint pain), CHILLS (Heavy chills) and PYREXIA (low grade fever) in a 48-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's past medical history included COVID-19 (Patient was diagnosed with Covid 19) on 20-Mar-2023 and Lupus vulgaris. Previously administered products included for Product used for unknown indication: Flu shot on 13-Sep-2023 and Flu shot on 10-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot and Flu shot. Concurrent medical conditions included Fibromyalgia, Rheumatoid arthritis and Asthma. Concomitant products included PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 11-Oct-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (aches), ARTHRALGIA (joint pain), CHILLS (Heavy chills), PYREXIA (low grade fever), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (aches), ARTHRALGIA (joint pain), CHILLS (Heavy chills), PYREXIA (low grade fever), HEADACHE (headache) and FATIGUE (fatigue) was resolving.            It was reported that hard knot under the skin 3 inches wide and slightly raised. First 38 hrs had flu like symptoms of severe body aches, joint pain, heavy chills, low grade fever, headache, fatigue. It was unknown if the patient experienced any additional symptoms/events. The treatment medication was not reported by reporter.   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Nodule, Pain, Pyrexia
Clinical narrative: flu like symptoms; aches; joint pain; Heavy chills; low grade fever; headache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (aches), ARTHRALGIA (joint pain), CHILLS (Heavy chills) and PYREXIA (low grade fever) in a 48-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's past medical history included COVID-19 (Patient was diagnosed with Covid 19) on 20-Mar-2023 and Lupus vulgaris. Previously administered products included for Product used for unknown indication: Flu shot on 13-Sep-2023 and Flu shot on 10-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu shot and Flu shot. Concurrent medical conditions included Fibromyalgia, Rheumatoid arthritis and Asthma. Concomitant products included PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for an unknown indication.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 11-Oct-2023, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (aches), ARTHRALGIA (joint pain), CHILLS (Heavy chills), PYREXIA (low grade fever), HEADACHE (headache) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN (aches), ARTHRALGIA (joint pain), CHILLS (Heavy chills), PYREXIA (low grade fever), HEADACHE (headache) and FATIGUE (fatigue) was resolving.            It was reported that hard knot under the skin 3 inches wide and slightly raised. First 38 hrs had flu like symptoms of severe body aches, joint pain, heavy chills, low grade fever, headache, fatigue. It was unknown if the patient experienced any additional symptoms/events. The treatment medication was not reported by reporter.   Reporter did not allow further contact
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: His arm is swollen; his arm is swollen and sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (His arm is swollen) and PAIN IN EXTREMITY (his arm is swollen and sore) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 14-Oct-2023, the patient experienced PERIPHERAL SWELLING (His arm is swollen) and PAIN IN EXTREMITY (his arm is swollen and sore). At the time of the report, PERIPHERAL SWELLING (His arm is swollen) and PAIN IN EXTREMITY (his arm is swollen and sore) had not resolved.            Concomitant medication not reported.   Treatment medication not reported.
Age: 42.0
Sex: M
Vaccine: FLUX, UNK
Symptoms: Gaze palsy, Injection site pain
Clinical narrative: sore arm from where patient received his injection; mild headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm from where patient received his injection) and HEADACHE (mild headache) in a 42-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 15-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 microgram. On 16-Oct-2023, the patient received dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On 16-Oct-2023, the patient experienced INJECTION SITE PAIN (sore arm from where patient received his injection) and HEADACHE (mild headache). At the time of the report, INJECTION SITE PAIN (sore arm from where patient received his injection) and HEADACHE (mild headache) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter. treatment medication also not reported.  Patient woken up with a mild headache and a sore arm from where he received his injection The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 14-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2023, SARS-CoV-2 test: Positive.         Concomitant medication was not provided.  Patient only had Moderna vaccines and have had every vaccine available. Up until this vaccine, she would get very ill within about 8 hours of the shot(s) including fever, bone pain, and headaches. The last shot she had had no reaction whatsoever. She even commented to someone that she wondered if she got a "dud" shot. Exactly 2 weeks later, on October 10, 2023, She was exposed to Covid. At about 2 am 5 days later on Saturday, October 14, she tested positive for Covid and started taking Paxlovid. Her partner 87y old who had the Pfizer recent vaccine on Sept. 19, 2023, had so far, remained negative with no symptoms.   This case was linked to US-MODERNATX, INC.-MOD-2023-745824 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745824:Same patient, different vaccine
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Pain in extremity
Clinical narrative: Strong arm pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Strong arm pain) and HEADACHE (headache) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Breast cancer (past). Concurrent medical conditions included Blood pressure high.    On 16-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Strong arm pain) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Strong arm pain) and HEADACHE (headache) was resolving.            Concomitant medication was not provided. Treatment information was not reported.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Eye swelling
Clinical narrative: eye is swelled up; This spontaneous case was reported by a patient and describes the occurrence of EYE SWELLING (eye is swelled up) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (3rd dose  and batch-012H21B) on 04-Dec-2021; for Product used for unknown indication: Pfizer (4th dose) on 07-Nov-2022. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Pfizer.    On 16-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced EYE SWELLING (eye is swelled up). On 17-Oct-2023, EYE SWELLING (eye is swelled up) had resolved.            No concomitant medication was reported. The patient had received Spikevax vaccine and her left eye was swelled up. This was the first time that something like this was happening to her. The patient received the vaccine in the afternoon and this didn´t start until 10 PM that same night. The patient woke up and it´s gone down on the next day, it´s better. It started so soon after receiving the shot.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745842 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Vaccine was given at approximately 0930. 30 minutes after vaccine injection (10:00am) patient noticed her face starting to itch.  This eventually progressed to a rash on the anterior, upper legs.  At 12:50pm patient returned to speak to RN who gave the injection.  Pt stated the rash on legs had subsided but face still felt slightly itchy.  At 12:55pm patient was given 25mg Benadryl with water.
Age: 77.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Decreased appetite, Dyspnoea exertional, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Patient reports extreme pain and swelling at injection sites for 4-5 days, dyspnea on exertion, extreme fatigue, loss of appetite, and body aches. Symptoms started the day after immunization and lasted 4-5 days.
Age: 77.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Pain
Clinical narrative: Patient reports extreme pain and swelling at injection sites for 4-5 days, dyspnea on exertion, extreme fatigue, loss of appetite, and body aches. Symptoms started the day after immunization and lasted 4-5 days.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Pruritus, Tenderness
Clinical narrative: the following day, my left arm turned red about the size of a tennis ball.  the area itched a lot, didn't scratch but it was tender.  then a few days later the itching stopped and the area only looked bruised.  there was never any pain, only itching and it is just about gone as of this date, almost 2 weeks later.  did seek medical assistance from family doctor, as it wasn't an emergency and I knew it would go away.
Age: 66.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Electrocardiogram, Paraesthesia oral, Rash, Urticaria
Clinical narrative: 66-year-old male patient came in for seasonal flu vaccine and covid-19 vaccine appointment on 10/19/2023 at 10:00am. Patient received both doses, covid (left deltoid) at 10:01am and flulaval (right deltoid) at 10:04am and returned to his car where he decided to wait 30 mins before leaving. At 10:30am patient returned to the flu clinic to report rashes on both arms and tingling in his mouth/tongue. Patient was assessed by RN, RN, and myself RN Rashes were visible on both arms, two distinct areas of hives on his left elbow and hand. He also had one area of hives on his right wrist. Due to the ?tingling on tongue? as reported by the patient, we collectively decided to administer 0.3 mg of epinephrine injection per policy for administering epinephrine for anaphylaxis; given by RN at 10:40am in patients right thigh, patient remained stable. RN called urgent care and spoke to charge nurse, who informed me to ?call 911 per protocol.?  Per the RN?s in the flu clinic it was recommended to the patient that we call 911 due to protocol. Patient agreed, 911 was called by RN and the ambulance arrived around 11:00am to the flu clinic. Patient report and snapshot of his chart was given to the paramedics by RN. Patient was assessed by paramedics where vitals were taken as well as two EKG?s.  One paramedic called their base to inform their Dr. of situation. Dr. requested to speak with patient over the phone. Paramedic spoke with the Dr. to double check that patient needs to be transported to the hospital because he was given epinephrine. Paramedic informed patient that he will need to go to the emergency room for further monitoring. Patient declined ambulance transportation and opted to have his wife pick him up and bring him to nearest emergency room. Paramedics had patient sign a liability waiver that he was declining transportation via ambulance. RN signed waiver as a witness.  Patient was brought via wheelchair to main entrance of the clinic by RN and was safely transferred to his wife?s car.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash macular, Rash pruritic
Clinical narrative: hypersensitvity reaction/macular pruritic rash without angioedema
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Second dose of Arexvy was administered to patient on 10/19/23. Patient thought he had previously received influenza vaccine but had been given an RSV vaccine (Arexvy) on 10/9/23 instead. Patient asked for RSV vaccine and RPh did not double check to make sure patient had not already received the vaccine. No insurance reject. Patient received the second dose and later reported he had found the paperwork from the first RSV vaccine.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Vaccine was administered to an ineligible patient during an off-site immunization clinic. Patient was contacted to ensure no adverse events and patient's PCP was contacted to inform of incorrect vaccination given. Patient is 49 years old and does not meet the minimum age requirement of 50 years old to receive this vaccine.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Nausea, Presyncope
Clinical narrative: During an office visit with a provider, patient had vaccines administered. After the vaccination, patient was getting up to leave when she had a vasovagal episode. Patient was also slightly nauseous without vomiting. Staff gave juice, snacks, an ice pack, and had patient lay down with legs elevated. Reported to the provider who was seeing the patient. Provider then re-examined patient. Patient started feeling better. After having patient stay for at least 15 more minutes, patient was able to recover and leave the clinic without any symptoms.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Dysstasia, Gait disturbance, Vertigo
Clinical narrative: Patient received a high dose flu shot, then experienced vertigo when she tried to stand up. Patient is a resident at an assisted living facility and has a history of vertigo, as well as some level of disability. An aide from the facility was with her at the time of the vaccine and the adverse effects. We gave her a bottle of water and an ice pack to place on the back of her neck, which helped. After sitting for about 20 minutes, she was feeling a little better, but was still unable to stand and walk out on her own. She declined transport to the hospital, and the aide went out to the transport van to get a wheelchair to get her to the van and into the facility. She also called the facility nurse, who said that she would check the patient over when she gets back to the facility. The aide said that the patient is prone to dizziness and vertigo, and said that they would watch her closely for the rest of today. Patient was coherent and talking fine, moving fine, no shakiness, no fever, just vertigo. Patient was able to get into the wheelchair and left with the aide.
Age: 76.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Cerebrovascular accident
Clinical narrative: Hospitalized for stroke 2 days after vaccination
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received Comirnaty for 12 and older instead of pediatric COVID 19 vaccine
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS STORED IN AN UNAPPROVED STORAGE UNIT
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Confusional state, Feeling abnormal, Hallucination, Malaise
Clinical narrative: Fever, chills, malaise, generalized muscle pain, moderate to severe, confusion, felt like a zombie. Had to lie in bed for duration of night. Tylenol extra strength seemed to help. Had a hallucination while lying in bed. Felt better next day but then, late in day same symptoms  came back, not as severe. Back in bed.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever, chills, malaise, generalized muscle pain, moderate to severe, confusion, felt like a zombie. Had to lie in bed for duration of night. Tylenol extra strength seemed to help. Had a hallucination while lying in bed. Felt better next day but then, late in day same symptoms  came back, not as severe. Back in bed.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Blood iron, C-reactive protein, Full blood count, Iron binding capacity total, Metabolic function test
Clinical narrative: Within 4-5 hours post-IM he developed severe upper posterior torso muscle aches/pains that were worse with movement.  Pain initially was about 5/10 (0=nothing/10=worst), increased to 9/10 by 9am the following morning, interfering with sleep entire interval.  Several hours later pain diminished to about 6-7/10.   IV EGCG and Methylprednisolone treatment initiated ~3pm, which will take a few hours to see notable response.