chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Erythema, Hypersensitivity, Swelling
Clinical narrative: after shingrix administration swelled up like large bump; after shingrix administration big red mark; after shingrix administration allergic rxn; might be having allergic to shingles shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced swelling (Verbatim: after shingrix administration swelled up like large bump), erythema (Verbatim: after shingrix administration big red mark), allergic reaction (Verbatim: after shingrix administration allergic rxn) and allergy to vaccine (Verbatim: might be having allergic to shingles shot).  The outcome of the swelling was unknown and the outcome of the erythema, allergic reaction and allergy to vaccine were not reported.   It was unknown if the reporter considered the swelling, erythema, allergic reaction and allergy to vaccine to be related to Shingrix.     It was unknown if the company considered the swelling, erythema, allergic reaction and allergy to vaccine to be related to Shingrix.   Additional Information: GSK receipt date: 11-Oct-2023 The patient stated that after shingrix administration swelled up like large bump big red mark allergic reaction and might be having allergic to shingles shot. The reporter consented to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Miliaria, Rash, Rash pruritic, Rash vesicular
Clinical narrative: heat rash; itchy rash consisting of small intact blisters all over his back, legs and arms; small intact blisters all over his back, legs and arms; This non-serious case was reported by a consumer via call center representative and described the occurrence of heat rash in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). In SEP-2023, between 1 and 2 months after receiving Shingrix, the patient experienced heat rash (Verbatim: heat rash), itchy rash (Verbatim: itchy rash consisting of small intact blisters all over his back, legs and arms) and blister (Verbatim: small intact blisters all over his back, legs and arms).  The patient was treated with ambiguous medication nos (Cortisone (Nos)). The outcome of the heat rash, itchy rash and blister were not resolved.   It was unknown if the reporter considered the heat rash, itchy rash and blister to be related to Shingrix.     It was unknown if the company considered the heat rash, itchy rash and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-OCT-2023 The patient self-reported this case. He received his first Shingrix dose about 2 months ago from reporting.  About 3 weeks ago he developed an itchy rash consisting of small intact blisters all over his back, legs and arms.  The rash started while he was on vacation in a very hot area. He saw two doctors and was told it was a heat rash. He used a cortisone cream to treat the rash. The cream did not help.  Nothing else was reported. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the 2nd dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 07-NOV-2019 and no reactions reported).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never received the 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter consented to follow up, email preferred. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: patient got a dose of expired Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number J9B25, expiry date 14-SEP-2023) for prophylaxis.   On 12-OCT-2023, the patient received Shingrix. On 12-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient got a dose of expired Shingrix).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 Nurse reported the patient got a dose of expired Shingrix, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: nurse gave a patient just the diluent; nurse gave a patient just the diluent; uses another diluent to reconstitute and administer it; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number 2Z9N3, expiry date 26-SEP-2025) for prophylaxis.   On 11-OCT-2023, the patient received Shingrix. On 11-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: nurse gave a patient just the diluent), inappropriate dose of vaccine administered (Verbatim: nurse gave a patient just the diluent) and wrong solution used in drug reconstitution (Verbatim: uses another diluent to reconstitute and administer it).  The outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and wrong solution used in drug reconstitution were unknown.   Additional Information: GSK Receipt Date: 11-OCT-2023 The nurse requested data that can Shingrix be reconstituted with anything other than the diluent it comes with as she was short 1 diluent because another nurse gave a patient just the diluent then uses another diluent to reconstitute and administer it which led to Wrong solution used in drug reconstitution, inappropriate preparation of medication and inappropriate dose of vaccine administered. He got a correct dose as well. Patient received Shingrix adjuvant only followed by a complete Shingrix dose on the same day. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: She had SHINGRIX shot #1 on an unknown date in September 2022. She was never told that she needed shot #2 to complete the series; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 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: She had SHINGRIX shot #1 on an unknown date in September 2022. She was never told that she needed shot #2 to complete the series).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient self-reported this case. She was never told that she needed shot 2 to complete the series. She did not have the lot number of the injected product. She did not recall which pharmacy she went to get the immunization. The VAERS details was reported for 1st dose of Shingrix. The reporter consented to follow up. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer through other manufacturer (Pfizer Inc.) concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, and drug allergy (fosomax and arthrotec). The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total, dose 1, was administered on 10-MAR-2021 to left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included levothyroxine sodium (Synthroid).  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received 2 doses (second and third dose) of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin were not reported, batch number: 017F21A, expiry: unknown) administered on 02-NOV-2021 to left arm and (form of admin, route of admin were not reported, batch number: 005M21A, expiry: unknown), administered on 20-APR-2022 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with 2 doses (second and third dose) of non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2). The patient also received fourth dose with Non-company suspect vaccine Moderna covid-19 vaccine, (elasomeran), (Dose number in series 3), (form of admin, route of admin were not reported, batch number: AS7162B, expiry: unknown) dose was not reported, administered on 20-SEP-2022 to left arm for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (Dose number in series 3). On an unspecified date in 2023, the patient experienced suspected covid-19 infection (Dose number in series 3). The patient started taking treatment with non-company drug Paxlovid (nirmatrelvir/ritonavir) (form of admin, route of admin, batch number and expiry date were not reported) dose and frequency were not reported from 27-SEP-2023 to 01-OCT-2023 for suspected covid-19 infection. On 07-OCT-2023, after 5 days of last dose with treatment with Paxlovid, the patient experienced covid-19 rebound (suspected covid-19 infection) (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (Dose number in series 2), and elasomeran (Dose number in series 3) was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Pain in extremity
Clinical narrative: headache; soreness in the arm; hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN IN EXTREMITY (soreness in the arm) and HYPERSENSITIVITY (hypersensitivity reaction) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030371) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine  (Dose 3, batch lot no 8FF2590) on 27-Oct-2021, Pfizer vaccine  (Dose 4, batch lot no FM0658) on 22-Mar-2022, Pfizer vaccine  (Dose 5, batch lot no GH9694) on 12-Sep-2022, Pfizer vaccine  (Dose 6, batch lot no GJ3268) in April 2023, RSV VACCINE on 05-Sep-2023 and Influenza on 05-Sep-2023. Past adverse reactions to the above products included Headache with Pfizer vaccine , Pfizer vaccine , Pfizer vaccine  and Pfizer vaccine ; and No adverse event with Influenza and RSV VACCINE.    On 16-Sep-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PAIN IN EXTREMITY (soreness in the arm) and HYPERSENSITIVITY (hypersensitivity reaction). At the time of the report, HEADACHE (headache) and PAIN IN EXTREMITY (soreness in the arm) had resolved and HYPERSENSITIVITY (hypersensitivity reaction) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 15Jan2021, patient received first Moderna dose (lot number 041L20A). On 12Feb2021, patient received second Moderna dose (lot number 030D20A). Patient received the injection from a 1-inch needle instead of a 1.5-inch needle. Patient read that for his weight he was supposed to receive the vaccine from a 1.5-inch needle to prevent this from becoming a subcutaneous injection. Stated that there may be the potential for an additional dose in the future to manage the dosing administration error.  Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Syringe issue
Clinical narrative: Product apparently leaked out of a Covid-19 prefilled syringe; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe) and NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe).    Concomitant medications were not reported.  The Device problem code for Spikevax syringe include FDA code, code A050401 which include Fluid Leak. The Spikevax syringe device was malfunctioned and the type.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: It was reported the patient, who has many allergies, reacted badly.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (It was reported the patient, who has many allergies, reacted badly.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple allergies.    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 IMMUNISATION REACTION (It was reported the patient, who has many allergies, reacted badly.). At the time of the report, IMMUNISATION REACTION (It was reported the patient, who has many allergies, reacted badly.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Patient had reacted badly to Moderna vaccine. Treatment medication was not reported.
Age: 68.0
Sex: F
Vaccine: UNK
Symptoms: Injection site haemorrhage
Clinical narrative: The pharmacy technician stated that they were able to inject the vaccine but when the syringe was pulled out, the patient bled profusely from the site of the injection.; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE HAEMORRHAGE (The pharmacy technician stated that they were able to inject the vaccine but when the syringe was pulled out, the patient bled profusely from the site of the injection.) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3835E) for COVID-19 prophylaxis.     Concurrent medical conditions included Osteoporosis. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 12-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 12-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE HAEMORRHAGE (The pharmacy technician stated that they were able to inject the vaccine but when the syringe was pulled out, the patient bled profusely from the site of the injection.). At the time of the report, INJECTION SITE HAEMORRHAGE (The pharmacy technician stated that they were able to inject the vaccine but when the syringe was pulled out, the patient bled profusely from the site of the injection.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Age: 0.67
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Staff member gave pt 0.3mL of undiluted covid vaccine. Should have been diluted with 1.1mL of 0.9% sodium chloride (multi dose vial with 3 doses).
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: CSF myelin basic protein, CSF oligoclonal band, CSF protein increased, Computerised tomogram head normal, Demyelinating polyneuropathy
Clinical narrative: Presented with progressive weakness in the lower extremities with numbness and paresthesias in his lower extremities.  Eventually admitted to hospital on 10/12/2023 and had lumbar puncture demonstrating high proteins with oligoclonal band and myelin basic protein pending. NCS/EMG of the lower extremities demonstrated demyelinating polyneuropathy.  He received 5 days of IV IG and presently receiving IV pulse steroids as well and receiving Aggressive PT/OT. Awaiting transfer to rehab facility
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Electromyogram abnormal, Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Nerve conduction studies abnormal
Clinical narrative: Presented with progressive weakness in the lower extremities with numbness and paresthesias in his lower extremities.  Eventually admitted to hospital on 10/12/2023 and had lumbar puncture demonstrating high proteins with oligoclonal band and myelin basic protein pending. NCS/EMG of the lower extremities demonstrated demyelinating polyneuropathy.  He received 5 days of IV IG and presently receiving IV pulse steroids as well and receiving Aggressive PT/OT. Awaiting transfer to rehab facility
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Paraesthesia
Clinical narrative: Presented with progressive weakness in the lower extremities with numbness and paresthesias in his lower extremities.  Eventually admitted to hospital on 10/12/2023 and had lumbar puncture demonstrating high proteins with oligoclonal band and myelin basic protein pending. NCS/EMG of the lower extremities demonstrated demyelinating polyneuropathy.  He received 5 days of IV IG and presently receiving IV pulse steroids as well and receiving Aggressive PT/OT. Awaiting transfer to rehab facility
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia, Pyrexia
Clinical narrative: Patient received Spikevax vaccine at 830 AM on 10/16, and reported to ED at 3:30 PM complaining of SOB. Also Hypoxemia and felt feverish. She was admitted on 10/16/23 to the hospital. Her physician contacted the pharmacy at 3:00 PM on 10/17 to inform us of the admission--He states she is currently stable and expected discharge is tomorrow, 10/18.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 71.0
Sex: F
Vaccine: COVID19, FLU4, RSV
Symptoms: Cough, Injection site erythema, Injection site rash, Pain in extremity
Clinical narrative: Patient stated that she received all three vaccines on 10/13/23 the next day she had a high fever, extremely sore arm, redness and rash near injection site, and is developing a cough.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Patient started feeling pain in arm 3 weeks after vaccination in 2021. In April 2023 patient is getting pains in the arm again. in July 2023 patient has tingling in her arm.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 47.0
Sex: M
Vaccine: COVID19, FLU4, HEP, MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt received Spike Moderna 23-24 formula 4 weeks early. Patient did not have any reaction to vaccine administer early, patient was fine after 15 post vaccination observation.
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Back pain, Blood pressure increased, Fatigue, Injection site pain
Clinical narrative: Pt had pneumo 20 vaccine 12 d ago and developed constant L sharp pain lateral to shot area with radiation to neck and back along with weakness and fatigue. Pt at times has to lift L arm up with R arm. Not redness no swelling Pt ween in AUC x 2 and given prednisone 10 mg x 4 d. Pt with neg L arm u/s with no DVT and L shoulder xray was negative. Pt taking motrin 600mg alternating with tylenol . Ice can help. No hx of neck pain prior to vaccination Pt with elevated BP since L arm has been painful
Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Mobility decreased, Neck pain, Pain, Ultrasound Doppler normal, X-ray limb normal
Clinical narrative: Pt had pneumo 20 vaccine 12 d ago and developed constant L sharp pain lateral to shot area with radiation to neck and back along with weakness and fatigue. Pt at times has to lift L arm up with R arm. Not redness no swelling Pt ween in AUC x 2 and given prednisone 10 mg x 4 d. Pt with neg L arm u/s with no DVT and L shoulder xray was negative. Pt taking motrin 600mg alternating with tylenol . Ice can help. No hx of neck pain prior to vaccination Pt with elevated BP since L arm has been painful
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Diarrhoea, Dizziness, Fluid intake reduced, Hypertension, Hypophagia
Clinical narrative: Fever Cold like symptoms Abnormal high BP (normal BP is 114/68, BP registered st emergency room at 148/90) Dizzy spells Lightheaded Fainting Struggling to eat and drink Diarrhea
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Nasopharyngitis, Pyrexia, Syncope
Clinical narrative: Fever Cold like symptoms Abnormal high BP (normal BP is 114/68, BP registered st emergency room at 148/90) Dizzy spells Lightheaded Fainting Struggling to eat and drink Diarrhea
Age: 79.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bells palsy
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms, fever, and weakness for a few days after the vaccines; flu-like symptoms, fever, and weakness for a few days after the vaccines; flu-like symptoms, fever, and weakness for a few days after the vaccines; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms, fever, and weakness for a few days after the vaccines), PYREXIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) and ASTHENIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 014M20A, 035C21A and 005M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-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 INFLUENZA LIKE ILLNESS (flu-like symptoms, fever, and weakness for a few days after the vaccines), PYREXIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) and ASTHENIA (flu-like symptoms, fever, and weakness for a few days after the vaccines). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms, fever, and weakness for a few days after the vaccines), PYREXIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) and ASTHENIA (flu-like symptoms, fever, and weakness for a few days after the vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient reported having flu like symptoms, fever, and weakness for a few days after the vaccines.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745568 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745568:Same patient (Bivalent case)
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered, Fatigue, Pain, Pyrexia
Clinical narrative: patient also received covid states normal side effects from when she receives covid(fever, aches, fatigue) believes to be from covid not from flucelvax which was  incorrect formulation given 2022-2023 flucelvax given expired 6/30/23
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 84.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Back pain, Cold sweat, Headache, Nausea
Clinical narrative: Patient complained of headache, back pain, nausea, and cold sweats about 5 minutes after getting 2 vaccines listed above.  Patient was told to sit down.  Her BP and pulse was monitored for about 15 minutes after onset of symptoms.  Patient gradually began feeling better after about five minutes with all symptoms resolving within 30 minutes
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: none-inadvertently given 2022-2023 formulation expiring 6/30/23
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 52.0
Sex: F
Vaccine: FLUC4
Symptoms: Expired product administered
Clinical narrative: none- inadvertently gave 2022-2023 flucelvax expiring 6/30/23
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered, Product administration error
Clinical narrative: Vaccine administered past vaccination date (expired 10/01/23 and administered in error on 10/17/23)
Age: 57.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Expired product administered
Clinical narrative: Vaccine administered past vaccination date (expired 10/01/23 and administered in error on 10/17/23)
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: VACCINE WAS  STORED IN AN UNAPPROVED STORAGE UNIT
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pyrexia, Throat irritation
Clinical narrative: Headache; Throat irritation; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Throat irritation), PYREXIA (fever), CHILLS (chills) and HEADACHE (Headache) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030342) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 07-Oct-2023, the patient experienced PYREXIA (fever) and CHILLS (chills). On 08-Oct-2023, the patient experienced THROAT IRRITATION (Throat irritation). On 09-Oct-2023, the patient experienced HEADACHE (Headache). At the time of the report, THROAT IRRITATION (Throat irritation) and HEADACHE (Headache) had not resolved and PYREXIA (fever) and CHILLS (chills) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had no longer has fever or chills. Throat irritation still persists. He previous doses were Pfizer. This was the first time she took Moderna.  No treatment information was reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: She then got home and decided to read a book but instead fell asleep for 4 hours; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (She then got home and decided to read a book but instead fell asleep for 4 hours) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (She then got home and decided to read a book but instead fell asleep for 4 hours). On 24-Feb-2021, SOMNOLENCE (She then got home and decided to read a book but instead fell asleep for 4 hours) 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.   No concomitant drug was reported.  On 24-Mar-2021, patient took Moderna monovalent dose 2; lot number 007B21A. On 03-Nov-2021, patient took Moderna monovalent dose 3; lot number 071F21A. On 06-Apr-2022, patient took Moderna monovalent dose 4; lot number 048L21A. On 31-Oct-2022, patient took Moderna bivalent dose 5; lot number 059F22A.  With the first Moderna shot she went to run errands afterwards. She then got home and decided to read a book but instead fell asleep for 4 hours. That was very unlike her. No additional symptoms or side effects. No medications or treatments.   Patient was asking about which symptoms she can expect with the new vaccine and what makes this vaccine different than previous Moderna vaccines.
Age: 87.0
Sex: F
Vaccine: UNK
Symptoms: Nausea, Pain in extremity, Presyncope
Clinical narrative: arm is sore; she almost passed out; nauseous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (arm is sore), PRESYNCOPE (she almost passed out) and NAUSEA (nauseous) in an 87-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced PAIN IN EXTREMITY (arm is sore), PRESYNCOPE (she almost passed out) and NAUSEA (nauseous). On 10-Oct-2023, PAIN IN EXTREMITY (arm is sore) and NAUSEA (nauseous) had resolved. At the time of the report, PRESYNCOPE (she almost passed out) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. It had been reported that patient arm was sore and she was a little nauseous at morning once she got breakfast but patient was ok at the time of reporting but she almost passed out. Treatment information was not provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Pain in extremity
Clinical narrative: I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination; my left arm was super sore; This spontaneous case was reported by a patient and describes the occurrence of HAEMATURIA (I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination) and PAIN IN EXTREMITY (my left arm was super sore) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 07-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced PAIN IN EXTREMITY (my left arm was super sore). On 09-Oct-2023, the patient experienced HAEMATURIA (I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination). At the time of the report, HAEMATURIA (I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination) had not resolved and PAIN IN EXTREMITY (my left arm was super sore) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered HAEMATURIA (I noticed really small, streak of blood, a spot or 2 or red blood when I wiped myself after urination) to be related. No further causality assessment was provided for PAIN IN EXTREMITY (my left arm was super sore).    No relevant concomitant medications were reported. On the night of 09 Oct 2023, she noticed really small, streak of blood, a spot or 2 or red blood when she wiped herself after urination. It was like when a needle was pricked and see a small blood. On 10 Oct 2023 she saw small dots. It was not getting worse and patient has not spoken with doctor. She went online and saw that this was a side effect of Covid vaccine, Spikevax. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745140 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Oct-2023: Follow up included non-significant information and references updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745140:Monovalent Dose
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Decreased appetite, Facial pain, Fatigue, Loss of personal independence in daily activities
Clinical narrative: everything was sore, specially her face; everything was sore, specially her face; didn't eat all day; feeling sick really sick; shivering; extreme fatigue/ she couldn't do anything; This spontaneous case was reported by a patient and describes the occurrence of FACIAL PAIN (everything was sore, specially her face), PAIN (everything was sore, specially her face), FEEDING DISORDER (didn't eat all day), MALAISE (feeling sick really sick) and CHILLS (shivering) in a 59-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.     Previously administered products included for Product used for unknown indication: Pfizer (Received 2 doses). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for an unknown indication.    On 08-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Oct-2023, the patient experienced FACIAL PAIN (everything was sore, specially her face), PAIN (everything was sore, specially her face), FEEDING DISORDER (didn't eat all day), MALAISE (feeling sick really sick), CHILLS (shivering) and FATIGUE (extreme fatigue/ she couldn't do anything). At the time of the report, FACIAL PAIN (everything was sore, specially her face), PAIN (everything was sore, specially her face), FEEDING DISORDER (didn't eat all day), MALAISE (feeling sick really sick), CHILLS (shivering) and FATIGUE (extreme fatigue/ she couldn't do anything) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient got new COVID vaccine which made her very, very sick. Instead of having a normal reaction patient had a severe reaction. Patient previously received Moderna but the second time was worse than the first time. She could have received more doses in the past, but she was unsure about the number of doses she received.  Patient experienced the following: she received the vaccine on that afternoon and on the same night was shivering, feeling really sick, everything was sore, especially her face, she could not do anything, patient was still not well but better, did not eat all day, extreme fatigue.  Treatment received was reported as none.   This case was linked to US-MODERNATX, INC.-MOD-2021-013254 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-013254:Same patient, Different moderna vaccine
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Pain
Clinical narrative: everything was sore, specially her face; everything was sore, specially her face; didn't eat all day; feeling sick really sick; shivering; extreme fatigue/ she couldn't do anything; This spontaneous case was reported by a patient and describes the occurrence of FACIAL PAIN (everything was sore, specially her face), PAIN (everything was sore, specially her face), FEEDING DISORDER (didn't eat all day), MALAISE (feeling sick really sick) and CHILLS (shivering) in a 59-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.     Previously administered products included for Product used for unknown indication: Pfizer (Received 2 doses). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for an unknown indication.    On 08-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Oct-2023, the patient experienced FACIAL PAIN (everything was sore, specially her face), PAIN (everything was sore, specially her face), FEEDING DISORDER (didn't eat all day), MALAISE (feeling sick really sick), CHILLS (shivering) and FATIGUE (extreme fatigue/ she couldn't do anything). At the time of the report, FACIAL PAIN (everything was sore, specially her face), PAIN (everything was sore, specially her face), FEEDING DISORDER (didn't eat all day), MALAISE (feeling sick really sick), CHILLS (shivering) and FATIGUE (extreme fatigue/ she couldn't do anything) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient got new COVID vaccine which made her very, very sick. Instead of having a normal reaction patient had a severe reaction. Patient previously received Moderna but the second time was worse than the first time. She could have received more doses in the past, but she was unsure about the number of doses she received.  Patient experienced the following: she received the vaccine on that afternoon and on the same night was shivering, feeling really sick, everything was sore, especially her face, she could not do anything, patient was still not well but better, did not eat all day, extreme fatigue.  Treatment received was reported as none.   This case was linked to US-MODERNATX, INC.-MOD-2021-013254 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-013254:Same patient, Different moderna vaccine
Age: 32.0
Sex: F
Vaccine: UNK
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: Patch is warm to touch and sore; Her arm has a red rash/patch; Patch is warm to touch and sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Patch is warm to touch and sore), RASH ERYTHEMATOUS (Her arm has a red rash/patch) and PAIN IN EXTREMITY (Patch is warm to touch and sore) in a 32-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced FEELING HOT (Patch is warm to touch and sore), RASH ERYTHEMATOUS (Her arm has a red rash/patch) and PAIN IN EXTREMITY (Patch is warm to touch and sore). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) (oral use) on 10-Oct-2023 at an unspecified dose and frequency. At the time of the report, FEELING HOT (Patch is warm to touch and sore), RASH ERYTHEMATOUS (Her arm has a red rash/patch) and PAIN IN EXTREMITY (Patch is warm to touch and sore) was resolving.            Concomitant medication was not provided. Patient received Flu shot and COVID shot. The area below where recipient received the vaccine, she had a large red rash or patch on arm. That patch was warm to touch and sore. Patient took treatment with Nyquil on the night of 10-Oct.
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Fatigue, Myalgia, Pyrexia
Clinical narrative: fever; muscle pain; dizziness; fatigue; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever), MYALGIA (muscle pain), DIZZINESS (dizziness) and FATIGUE (fatigue) in a 24-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 09-Oct-2023, the patient experienced PYREXIA (fever), MYALGIA (muscle pain), DIZZINESS (dizziness) and FATIGUE (fatigue). At the time of the report, PYREXIA (fever), MYALGIA (muscle pain), DIZZINESS (dizziness) and FATIGUE (fatigue) was resolving.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient had an intense fever for three nights. It was unknown if the patient experienced any additional symptoms/events. No treatment medications were reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever, spike in temp; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever, spike in temp) and CHILLS (chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Jan-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 PYREXIA (fever, spike in temp) and CHILLS (chills). At the time of the report, PYREXIA (fever, spike in temp) and CHILLS (chills) 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.   No concomitant medication was reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reporter stated that her husband took Spikevax on a day before reporting and stated that with the previous doses, both she and he had experienced a fever, spike in temp, and chills with all doses which lasted a short while but did not last. Patient reported that with Spikevax, he did not.  The patient did not have lot number information for their Moderna vaccines: initial doses and all boosters.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745401 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745401:Wife case (Same reporter diferrent patients)
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever, spike in temp; chills; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever, spike in temp) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever, spike in temp) and CHILLS (chills). At the time of the report, PYREXIA (fever, spike in temp) and CHILLS (chills) 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.   No concomitant medication was reported.  Patient received Moderna vaccines Initial doses in 2021 and Boosters in 2022.  Patient stated that she was scheduled to take her Spikevax on the reporting day. She stated that the doctor told them that there was a new vaccine. Patient reported that with the previous doses they both had, they experienced a fever, spike in temp, and chills with all doses which lasted a short while but did not last.  The patient did not have lot number information for their Moderna vaccines: initial doses and all boosters.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-745394 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745394:husband case (Same reporter diferrent patients)