chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Peripheral swelling
Clinical narrative: My arm was swollen; My arm was red; Discomfort; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced discomfort (Verbatim: Discomfort), swelling arm (Verbatim: My arm was swollen) and erythema of extremities (Verbatim: My arm was red). The outcome of the discomfort was resolved (duration 1 day) and the outcome of the swelling arm and erythema of extremities were not reported.   It was unknown if the reporter considered the discomfort, swelling arm and erythema of extremities to be related to Shingles vaccine.     It was unknown if the company considered the discomfort, swelling arm and erythema of extremities to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-NOV-2023 This case was reported by a patient via interactive digital media. The reporter was patient. The patient received shingles vaccine. The reporter reported that The patient experienced discomfort lasted one day and his arm was swollen and red. Patient's daughter had worse experienced of adverse events, but it's still better to get vaccinated. This case had been link with US2023AMR162032  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR162032:Case created for Child
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: had the 2 doses but it hurt a lot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: had the 2 doses but it hurt a lot). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-NOV-2023 This case was reported by a patient's wife via (web site) interactive digital media. She reported that her husband already had the 2 doses of shingles vaccine, but it had hurt a lot to him, that's why she did not want to have them, However, with the things they said when she would get shingles, so she thought she had to go and get them. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: had the 2 doses but it hurt a lot; Reason-case created in error.; Sender's Comments:  US-GSK-US2023AMR162882:Same patient/ First dose
Sex: U
Vaccine: VARZOS
Symptoms: Erythromelalgia
Clinical narrative: Eryrthomelalgia; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of erythromelalgia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced erythromelalgia (Verbatim: Eryrthomelalgia). The outcome of the erythromelalgia was not reported.   It was unknown if the reporter considered the erythromelalgia to be related to Shingles vaccine.     It was unknown if the company considered the erythromelalgia to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-NOV-2023 The reporter reported that a patient developed erythromelalgia after shingles vaccine, with big flares after Covid shots and boosters (just putting the pieces together now). No more vaccines. The follow up could not be possible, as no contact details were available.
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Dizziness, Electric shock sensation
Clinical narrative: Dizziness; Electric shock sensation; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of dizziness in a 44-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) for prophylaxis.   Co-suspect products included COVID-19 vaccine for prophylaxis.   Concurrent medical conditions included fibromyalgia (patient has Fibromyalgia). Concomitant products included duloxetine hydrochloride (Cymbalta).   On 19-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season (intramuscular, left arm) and COVID-19 vaccine (intramuscular, right arm) .5 ml. On 20-OCT-2023, 1 days after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced dizziness (Verbatim: Dizziness) and electric shock sensation (Verbatim: Electric shock sensation). The outcome of the dizziness and electric shock sensation were not resolved.   It was unknown if the reporter considered the dizziness and electric shock sensation to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the dizziness and electric shock sensation to be related to Fluarix Quadrivalent 2023-2024 season and Fluarix Tetra 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-21-NOV-2023 The reporter reported that the patient experienced electric shock sensation and dizziness after 1 days of vaccination. The patient received Fluarix Quadrivalent vaccine and COVID-19 vaccine at same time. The reporter considered the electric shock sensation and dizziness possible related to Covid19 vaccine. The consent to follow up requested.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: received Arexvy vaccine first dose on Sep 2023, but on 11/21/2023 received by error another dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number PR7R5, expiry date 05-MAR-2025) for prophylaxis.   Concurrent medical conditions included parkinsonism (with Parkinson). Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 21-NOV-2023, the patient received the 2nd dose of Arexvy. On 21-NOV-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: received Arexvy vaccine first dose on Sep 2023, but on 11/21/2023 received by error another dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 21-NOV-2023 A pharmacist reported that a patient received arexvy vaccine first dose on september 2023 and another dose on the day of reporting, which led to extra dose administered. Permission to storage personal information on medical Information database was declined. The reporter consented to follow-up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis allergic, Neuralgia
Clinical narrative: having neuralgia; hypersensitivity in the skin; This non-serious case was reported by a consumer via call center representative and described the occurrence of neuralgia in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2023, the patient received the 1st dose of Shingrix. In NOV-2023, an unknown time after receiving Shingrix, the patient experienced neuralgia (Verbatim: having neuralgia) and cutaneous hypersensitivity (Verbatim: hypersensitivity in the skin). The outcome of the neuralgia and cutaneous hypersensitivity were not resolved.   It was unknown if the reporter considered the neuralgia and cutaneous hypersensitivity to be related to Shingrix.     It was unknown if the company considered the neuralgia and cutaneous hypersensitivity to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-NOV-2023 The reporter was the patient who stated that he received the 1st Shingrix shot 2 weeks ago (from the day of reporting) and started having neuralgia and also hypersensitivity in the skin around the waist and back. According to the patient the symptoms were getting worse. The reporter did not consent to follow-up.
Age: 0.5
Sex: F
Vaccine: HEPA, HEPA, HEPA
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered a third dose of Havrix; The child previously had doses on 08Dec2022 and 25May2023.; Inappropriate age at vaccination; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 6-month-old female patient who received HAV (Havrix) (batch number L9R92, expiry date 26-SEP-2025) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis and HAV (Havrix) for prophylaxis.   On 21-NOV-2023, the patient received the 3rd dose of Havrix. On 25-MAY-2023, the patient received the 2nd dose of Havrix. On 08-DEC-2022, the patient received the 1st dose of Havrix. On 08-DEC-2022, not applicable after receiving Havrix and Havrix and an unknown time after receiving Havrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccination). On 25-MAY-2023, the patient experienced drug dose administration interval too short (Verbatim: The child previously had doses on 08Dec2022 and 25May2023.). On 21-NOV-2023, the patient experienced extra dose administered (Verbatim: inadvertently administered a third dose of Havrix). The outcome of the extra dose administered, drug dose administration interval too short and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 21-NOV-2023 The nurse reported that, a 18 month old patient was inadvertently administered a third dose of havrix on 21st November 2023 which led to extra dose administered. The nurse reported, the patient previously had 2nd dose dose of havrix on 25th may 2023 which led to drug dose administration interval too short. The nurse reported that, the patient had 1st dose of havrix on 8th December 2022 which led to inappropriate age at vaccination. The vaccine administration facility was same as the primary reporter. The reporter consented to follow up.
Age: 5.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of Pediarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date 17-NOV-2023) for prophylaxis.   On 20-NOV-2023, the patient received Pediarix. On 20-NOV-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: received an expired dose of Pediarix). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:21-NOV-2023 The registered nurse reported that the patient received an expired dose of Pediarix which was expired on Friday. The patient received Pediarix beyond the expiration date, which led to expired vaccine used. The healthcare professional stated that they had plan to report to VAERS as well. The reporter consented to follow up.
Sex: M
Vaccine: RSV
Symptoms: Cough, Nasal congestion, Productive cough, Upper respiratory tract congestion
Clinical narrative: Cough; phlegm; throat congestion; nasal congestion; This non-serious case was reported by a consumer via call center representative and described the occurrence of cough in a 70-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 10-NOV-2023, the patient received the 1st dose of Arexvy. On 15-NOV-2023, 5 days after receiving Arexvy, the patient experienced cough (Verbatim: Cough), phlegm (Verbatim: phlegm), upper respiratory tract congestion (Verbatim: throat congestion) and nasal congestion (Verbatim: nasal congestion). The outcome of the cough, phlegm, upper respiratory tract congestion and nasal congestion were not resolved.   It was unknown if the reporter considered the cough, phlegm, upper respiratory tract congestion and nasal congestion to be related to Arexvy.     It was unknown if the company considered the cough, phlegm, upper respiratory tract congestion and nasal congestion to be related to Arexvy.   Additional Information: GSK receipt date: 22-NOV-2023 The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: rash is on both her hips going towards her knees; shingles; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-OCT-2023, the patient received the 1st dose of Shingrix (left arm). In NOV-2023, between 1 and 2 months after receiving Shingrix, the patient experienced shingles (Verbatim: shingles). On an unknown date, the patient experienced rash (Verbatim: rash is on both her hips going towards her knees). The patient was treated with calamine;glycerol;zinc oxide (Calamine Lotion) and valaciclovir hydrochloride (Valtrex). The outcome of the shingles was unknown and the outcome of the rash was not reported.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.     It was unknown if the company considered the shingles and rash to be related to Shingrix.   Additional Information: GSK receipt date: 22-NOV-2023 The patient self-reported this case. The patient developed shingles about a week ago from the reporting day. The rash was on both her hips gone towards her knees. It was on her buttocks and outside section of her legs. She had been taken Valtrex and calamine lotion to treat shingles. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo Reconstitution with a different diluent.; 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 wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo Reconstitution with a different diluent.) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-NOV-2023 An health care professional called to ask for information about the administration of a Menveo vaccine that was reconstituted with a different diluent other than the meningococcal CYW-135 (MenCYW-135) liquid conjugate vaccine component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health care professional asked if the patient had to be re vaccinated. The reporter did not provide patient information and declined permission to store her contact information in our database.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Arexvy was inadvertently administered to 5 pregnant patients; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: Arexvy was inadvertently administered to 5 pregnant patients). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 22-NOV-2023 The reporter stated that Arexvy was inadvertently administered to pregnant patient. The reporter consented to follow up via mail. This was 1 of 5 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR164802:Same reporter/deifferent patient US-GSK-US2023AMR164803:Same reporter/deifferent patient US-GSK-US2023AMR164804:Same reporter/deifferent patient US-GSK-US2023AMR164805:Same reporter/deifferent patient
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of Twinrix on October 3rd 2023 and the 2nd dose has not been administered 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 73-year-old female patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact, Hepatitis b vaccine rHBsAg (yeast) (Twinrix).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of Twinrix on October 3rd 2023 and the 2nd dose has not been administered yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Nov-2023 Pharmacist reported that the patient had not been administered 2nd dose yet. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: a patient that took the 1st shot of the Shingrix vaccine and never received the second shot over a year ago.; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date 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: a patient that took the 1st shot of the Shingrix vaccine and never received the second shot over a year ago.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-NOV-2023 The vaccine administration facility was the same as primary reporter The health care professional (HCP) stated that she had a patient that took the 1st shot of the Shingrix vaccine and never received the second shot over a year ago, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Muscle contractions involuntary
Clinical narrative: mild pain in left knee; constriction in hamstring; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE CONTRACTIONS INVOLUNTARY (constriction in hamstring) and ARTHRALGIA (mild pain in left knee) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral use) 11 milligram once a day. On 14-Nov-2023, TOFACITINIB CITRATE (XELJANZ XR) (Oral use) dosage was changed to 11 milligram once a day. On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (constriction in hamstring). In November 2023, the patient experienced ARTHRALGIA (mild pain in left knee). At the time of the report, MUSCLE CONTRACTIONS INVOLUNTARY (constriction in hamstring) and ARTHRALGIA (mild pain in left knee) outcome was unknown.            Concomitant medication was not provided.  The patient reports starting Xeljanz XR in 2021, exact date unknown. reports were without Xeljanz XR "for about 1 month" due to issues with previous pharmacy, about a week ago noted some mild pain in left knee, resumed Xeljanz XR 14 Nov 2023, patient was doing well at this time, unclear if back to baseline, md not aware of missed doses. Patient reports "constriction in hamstring," since having a recent Moderna covid vaccine, exact duration unknown, exact date of vaccine unknown, unclear if this was resolved at present, patient reports was able to run as normal, unknown if md aware.  Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Caller had no reaction except for an extremely black and blue area maybe 2 by 3 inches.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Caller had no reaction except for an extremely black and blue area maybe 2 by 3 inches.) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058876) for COVID-19 prophylaxis.     Patient was body sensitive.  The patient's past medical history included DVT in 2022, Pulmonary embolism in 2022 and Arthritis. Previously administered products included for Product used for unknown indication: Flu Shot or Pneumonia shot (Patient does not get a reaction when she had flu shot or pneumonia shot.); for Deep vein thrombosis: Eliquis (Patient was on Eliquis for DVT and Pulmonary Emboli which they hopefully have resolved and last time in the hospital for it was 2022.) in 2022. Past adverse reactions to the above products included No adverse effect with Eliquis and Flu Shot or Pneumonia shot. Concurrent medical conditions included Allergy to antibiotic, Allergy to NSAIDs, Hypothyroidism and Fibromyalgia. Concomitant products included METHYLPREDNISOLONE for Arthritis.    On 12-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced IMMUNISATION REACTION (Caller had no reaction except for an extremely black and blue area maybe 2 by 3 inches.). At the time of the report, IMMUNISATION REACTION (Caller had no reaction except for an extremely black and blue area maybe 2 by 3 inches.) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient received previous Moderna doses include first dose on 20Jan2021 with Lot#028L20A, second dose on 17Feb2021 with Lot#004M20A, third dose on 28Nov2021 with Lot#013F21A, fourth dose on12Dec2022 with Lot#043422A. Caller called the pharmacist and asked if there was possibility that they had a bad injection since they had no reaction.  Every time patient got the initial and second booster, patient had very sore area, very hot area, and it drained down to the elbow. The injection site was hot, hard, sore. Caller has had 4 boosters since the initial two. Treatment information was not reported.   This case was linked to MOD-2023-751596 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2023: Live follow-up received and added reporter details, added patient details.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Pruritus
Clinical narrative: The doctor told him that she had a reaction; I took the vaccine and again, it causes me to itch um in a very profuse way; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (The doctor told him that she had a reaction) and PRURITUS (I took the vaccine and again, it causes me to itch um in a very profuse way) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (The doctor told him that she had a reaction) and PRURITUS (I took the vaccine and again, it causes me to itch um in a very profuse way). At the time of the report, IMMUNISATION REACTION (The doctor told him that she had a reaction) and PRURITUS (I took the vaccine and again, it causes me to itch um in a very profuse way) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  Suspect product dosage text was reported as unknown. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-750233, US-MODERNATX, INC.-MOD-2023-751283 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750233:Different patient same moderna vaccine US-MODERNATX, INC.-MOD-2023-751283:Different patient same product
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Rash, Swelling
Clinical narrative: Large red swollen sore rash on arm; Large red swollen sore rash on arm; Large red swollen sore rash on arm; Large red swollen sore rash on arm; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (Large red swollen sore rash on arm), ERYTHEMA (Large red swollen sore rash on arm), RASH (Large red swollen sore rash on arm) and PAIN IN EXTREMITY (Large red swollen sore rash on arm) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 26-Nov-2023, the patient experienced SWELLING (Large red swollen sore rash on arm), RASH (Large red swollen sore rash on arm) and PAIN IN EXTREMITY (Large red swollen sore rash on arm). On an unknown date, the patient experienced ERYTHEMA (Large red swollen sore rash on arm). At the time of the report, SWELLING (Large red swollen sore rash on arm), ERYTHEMA (Large red swollen sore rash on arm), RASH (Large red swollen sore rash on arm) and PAIN IN EXTREMITY (Large red swollen sore rash on arm) had not resolved.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   Concomitant product use was not provided by the reporter.  The patient experienced large red swollen sore rash on arm. Still the size of tennis ball 76 hours later. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she had tested positive for COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (she had tested positive for COVID) in a 47-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.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 25-Nov-2023, the patient experienced COVID-19 (she had tested positive for COVID). At the time of the report, COVID-19 (she had tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's mother reported that, about in the middle of October (on 16-OCT-2023 or 17-OCT-2023), her daughter received a vaccine. She had all the other boosters. She was well off the two-week period for immune response.  It was reported that, the patient was running a slight fever. Not a lot and felt like a cold. On Friday, 25-NOV-2023, the patient had a home test and had tested positive for COVID. This was the first time she had COVID. She took the Moderna vaccine right through all the boosters. And she never got it.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2023: Live follow-up received with significant information. References added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nasal congestion, Pain, Pain in extremity
Clinical narrative: She has the nose stuffy; sore arm; low grade fever; chills; aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching), NASAL CONGESTION (She has the nose stuffy), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 01-Jun-2022. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot number 039K20A) on 27-Dec-2020, Moderna COVID-19 Vaccine (Dose 2, Lot number 028L20A) on 24-Jan-2021, Moderna COVID-19 Vaccine (Dose 3, 045C21A) on 29-Oct-2021, Moderna COVID-19 Vaccine (Dose 4, 049L21A) on 25-May-2022, Spikevax Bivalent (Dose 5 and 057F22A) on 13-Oct-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Spikevax Bivalent.    On 28-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Nov-2023, the patient experienced PAIN (aching), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever) and CHILLS (chills). On an unknown date, the patient experienced NASAL CONGESTION (She has the nose stuffy). At the time of the report, PAIN (aching), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever) and CHILLS (chills) had not resolved and NASAL CONGESTION (She has the nose stuffy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99°F, highest of 100.4°F and 99.4°F.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that patient's temperature got to 99°F and highest of 100.4°F during the night. And had temperature about 99.4°F at the time of reporting. She had no chills anymore. She had to use lots of blankets and sweaters. She has the nose stuffy. She had no cough and no sore throat. Dosage text was reported as unknown. The treatment medication was not reported by reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She has the nose stuffy; sore arm; low grade fever; chills; aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching), NASAL CONGESTION (She has the nose stuffy), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 01-Jun-2022. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot number 039K20A) on 27-Dec-2020, Moderna COVID-19 Vaccine (Dose 2, Lot number 028L20A) on 24-Jan-2021, Moderna COVID-19 Vaccine (Dose 3, 045C21A) on 29-Oct-2021, Moderna COVID-19 Vaccine (Dose 4, 049L21A) on 25-May-2022, Spikevax Bivalent (Dose 5 and 057F22A) on 13-Oct-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Spikevax Bivalent.    On 28-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Nov-2023, the patient experienced PAIN (aching), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever) and CHILLS (chills). On an unknown date, the patient experienced NASAL CONGESTION (She has the nose stuffy). At the time of the report, PAIN (aching), PAIN IN EXTREMITY (sore arm), PYREXIA (low grade fever) and CHILLS (chills) had not resolved and NASAL CONGESTION (She has the nose stuffy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99°F, highest of 100.4°F and 99.4°F.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that patient's temperature got to 99°F and highest of 100.4°F during the night. And had temperature about 99.4°F at the time of reporting. She had no chills anymore. She had to use lots of blankets and sweaters. She has the nose stuffy. She had no cough and no sore throat. Dosage text was reported as unknown. The treatment medication was not reported by reporter.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypokinesia
Clinical narrative: She could barely raise her arm up; she started having so much pain in the shoulder area; This spontaneous case was reported by a patient and describes the occurrence of HYPOKINESIA (She could barely raise her arm up) and ARTHRALGIA (she started having so much pain in the shoulder area) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 80777-0102-93) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023 at 3:22 PM, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023, the patient experienced HYPOKINESIA (She could barely raise her arm up) and ARTHRALGIA (she started having so much pain in the shoulder area). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOKINESIA (She could barely raise her arm up) and ARTHRALGIA (she started having so much pain in the shoulder area) had resolved.            No concomitant medication was reported. The patient had taken Moderna vaccines on 1st dose on 24-Mar-2021, 2nd dose on 21-Apr-2021, 3rd dose on 26-Nov-2021, 4th dose on 15-Apr-2022 and 5th dose on 14-Oct-2022.  The patient received Spikevax and had a bad reaction. The patient never had a problem with Moderna before. In the evening the patient started having so much pain in the shoulder area. The reaction really scared the patient. The patient could barely raise the arm up. It lasted for a long time. This was from the armpit up, area of the shoulder. It was horrible. The patient was afraid to take anything.  She was feeling better after taking Tylenol. It took a while but she was fine.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (passed away) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. Death occurred on 29-Nov-2023 The patient died on 29-Nov-2023. The cause of death was not reported. An autopsy was not performed.            No concomitant medication was reported. No treatment medication was reported.  Company comment: This fatal spontaneous case concerns a patient (unknown age and unknown gender), with no medical history reported, who received a dose with Spikevax 2023-2024 Formula vaccine (Andusomeran - unspecified dose number) and experienced the unexpected, serious (medically significant and death) event of death. Latency cannot be properly assessed since vaccination date was not provided. The cause of death was unknown. The report stated that the patient passed away after "they got the shot". As per the report autopsy was not performed. No further information regarding the event and cause of death have been provided. The benefit-risk relationship of Spikevax 2023-2024 Formula vaccine (Andusomeran) is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Age: 73.0
Sex: M
Vaccine: COVID19, FLUX, RVX
Symptoms: Extra dose administered, Myalgia
Clinical narrative: HCP states that patient reported the regular muscle aches and pains; Patient received 1st Spikevax on 21Sep2023, 2nd Spikevax - 27Nov2023; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (HCP states that patient reported the regular muscle aches and pains) and EXTRA DOSE ADMINISTERED (Patient received 1st Spikevax on 21Sep2023, 2nd Spikevax - 27Nov2023) in a 73-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch nos. 3031897 and 202F23A) for COVID-19 prophylaxis.    Co-suspect products included non-company products RSV VACCINE for an unknown indication and INFLUENZA VACCINE (FLU VACCINE VII) for COVID-19 prophylaxis.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (lot number 058E21A) on 03-Sep-2021 and Spikevax Bivalent (lot number AS7164B) on 30-May-2023. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Spikevax Bivalent.   On 21-Sep-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 27-Nov-2023, received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2023, the patient received dose of RSV VACCINE (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 27-Nov-2023, the patient experienced MYALGIA (HCP states that patient reported the regular muscle aches and pains) and EXTRA DOSE ADMINISTERED (Patient received 1st Spikevax on 21Sep2023, 2nd Spikevax - 27Nov2023). At the time of the report, MYALGIA (HCP states that patient reported the regular muscle aches and pains) and EXTRA DOSE ADMINISTERED (Patient received 1st Spikevax on 21Sep2023, 2nd Spikevax - 27Nov2023) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Vaccination site pain
Clinical narrative: A general feeling of mild not quite like the flu; Soreness for 2 days in the injection site arm.; I had chills but no fever or nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (A general feeling of mild not quite like the flu), VACCINATION SITE PAIN (Soreness for 2 days in the injection site arm.) and CHILLS (I had chills but no fever or nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy (Penicillin allergy from 50 years ago) and Breast cancer (survivor of 5 years ago which was before her first Covid-19 vaccine and is currently in remission.).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (A general feeling of mild not quite like the flu), VACCINATION SITE PAIN (Soreness for 2 days in the injection site arm.) and CHILLS (I had chills but no fever or nausea). At the time of the report, FEELING ABNORMAL (A general feeling of mild not quite like the flu), VACCINATION SITE PAIN (Soreness for 2 days in the injection site arm.) and CHILLS (I had chills but no fever or nausea) had resolved.        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. Treatment information was not provided.  The patient generally experienced the following after each of her Moderna Covid-19 vaccines. 2 days of symptoms to the vaccine.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Super tingly all over body, my hair line, hands, back, feet everywhere feels Like pins and needles; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Super tingly all over body, my hair line, hands, back, feet everywhere feels Like pins and needles) in a 40-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 20-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PARAESTHESIA (Super tingly all over body, my hair line, hands, back, feet everywhere feels Like pins and needles). At the time of the report, PARAESTHESIA (Super tingly all over body, my hair line, hands, back, feet everywhere feels Like pins and needles) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reported that patient experience super tingly all over body, her hair line, hands, back, feet everywhere felt Like pins and needles, lasting over one week without going away. Started right after vaccine and subsided but then restarted again about 20 days later. It was unknown if the patient experienced any additional symptoms/events.   No treatment medications were reported.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red itchy rash on chest, back, arms and legs; Red itchy rash on chest, back, arms and legs; Red itchy rash on chest, back, arms and legs; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (Red itchy rash on chest, back, arms and legs), RASH ERYTHEMATOUS (Red itchy rash on chest, back, arms and legs) and RASH (Red itchy rash on chest, back, arms and legs) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 09-Nov-2023, the patient experienced RASH PRURITIC (Red itchy rash on chest, back, arms and legs), RASH ERYTHEMATOUS (Red itchy rash on chest, back, arms and legs) and RASH (Red itchy rash on chest, back, arms and legs). At the time of the report, RASH PRURITIC (Red itchy rash on chest, back, arms and legs) had not resolved and RASH ERYTHEMATOUS (Red itchy rash on chest, back, arms and legs) and RASH (Red itchy rash on chest, back, arms and legs) outcome was unknown.            Concomitant and treatment medications were not reported.  Reported Red itchy rash on chest, back, arms and legs on day 4 after vaccine It was unknown if the patient experienced any additional symptoms/events.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Pericarditis
Clinical narrative: Reporter was convinced he had pericarditis, doctors didn't diagnose him with pericarditis; Chest pain; starting to go up to his neck; This serious, initial spontaneous safety report was received by Novavax on 28-NOV-2023 from a physician via the contact center.  A 76-year-old male was vaccinated with intramuscular Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter suspect COVID-19 vaccine dose 1 (booster) in the left arm on 17-NOV-2023 14:30 at a pharmacy.  Medical history included COVID-19 (tested positive via antibody and rapid antigen tests on unreported dates) and Drug hypersensitivity to penicillin. The individual was previously vaccinated with "4 or 5 doses" of Pfizer BioNTech COVID-19 vaccine (tozinameran) on unreported dates.  Concomitant medications included valsartan and Lipitor (atorvastatin calcium).  On an unreported day in NOV-2023, after vaccination, the individual experienced chest pain (PT: Chest pain). On 23-NOV-2023, the individual woke up about 5 am, reporting he had chest pain all night for about 5 hours and that it was starting to go up to his neck. The individual was brought to the emergency room on that day, where it was determined he did not have a heart attack. The reporter believed the individual had pericarditis (PT: Pericarditis) (Serious: Medically Significant), but the doctors at the ER didn't diagnose him with pericarditis and no tests were run to confirm the diagnosis. It was reported the chest pain lasted a couple of days, and the individual was waiting to see a cardiologist.   At the time of reporting, the event outcome of Chest pain was recovered/resolved, and the event outcome of Pericarditis was unknown.; Sender's Comments: This 76-year-old male experienced: Pericarditis and Chest pain after vaccination with Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) 0.5 milliliter. The event Pericarditis was assessed as serious. The event Chest pain was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted (2023-2024 Formula) and the reported events is considered Possible.