chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Very sore arm/ pain and soreness at the injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had many times in the past 5 years).   On an unknown date, the patient received the 1st dose of Shingrix (left arm). On an unknown date, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: Very sore arm/ pain and soreness at the injection site). The outcome of the injection site pain was resolved (duration 6 days).   The reporter considered the injection site pain to be possibly related to Shingrix.     The company considered the injection site pain to be possibly related to Shingrix.   Additional Information: GSK Receipt Date: 02-OCT-2023 and 04-OCT-2023  The patient was self-reported this case. The patient reported that she received first dose of Shingrix vaccine and it only gave her a very sore arm for 6 days. The patient experienced pain and soreness at the injection site immediately after received Shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Nasopharyngitis, Tremor
Clinical narrative: Chills/shivers; cold; shaking; could not get out of bed; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of chills in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine and postmenopausal symptoms (post-menopausal urticaria).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Chills/shivers), cold (Verbatim: cold), tremor (Verbatim: shaking) and bedridden (Verbatim: could not get out of bed).  The outcome of the chills, cold, tremor and bedridden were resolving.   It was unknown if the reporter considered the chills, cold, tremor and bedridden to be related to Shingrix.     It was unknown if the company considered the chills, cold, tremor and bedridden to be related to Shingrix.   Linked case(s) involving the same patient:  US2023135785   Additional Information: GSK Receipt Date: 03-OCT-2023 The customer reported that she got her 1st dose in October or November 2019. Patient reported that the 1st dose gave her chills, was cold, had shivers and was shaking. The patient could not get out of bed. The symptoms last for about 30 minutes and then subsided. Patient reported she had 10 years of post-menopausal urticaria. The patient reported that she was afraid of taking the Prednisone. Not all information is available. Customer was asked twice for demographic but did not provide during the call. Customer provided consent to follow up with her and her Healthcare professional. Lot and expiration dates of vaccines were unknown. The reporter consented to follow up. This case is linked with US2023135785, same patient 2nd dose.; Sender's Comments:  US-GSK-US2023135785:Same patient, 2nd dose
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: reported a child dose of Engerix-B was given to an adult (55 years); reported a child dose of Engerix-B was given to an adult (55 years); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult use of a child product in a 55-year-old patient who received HBV (Engerix B pediatric) for prophylaxis.   On 02-OCT-2023, the patient received Engerix B pediatric. On 02-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: reported a child dose of Engerix-B was given to an adult (55 years)) and underdose (Verbatim: reported a child dose of Engerix-B was given to an adult (55 years)).  The outcome of the adult use of a child product and underdose were unknown.   Additional Information: GSK receipt date 2 Oct 2023 The pharmacist reported a child dose of Engerix-B was given to an adult on 2nd October 2023, which led to adult use of a child product and underdose. The reporter consented to follow up.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix was administered by mistake to a 13-year-old patient; Infanrix was administered by mistake to a 13-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 13-year-old female patient who received DTPa (Infanrix) (batch number HH443) for prophylaxis.   On 10-NOV-2022, the patient received Infanrix. On 10-NOV-2022, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was administered by mistake to a 13-year-old patient) and wrong vaccine administered (Verbatim: Infanrix was administered by mistake to a 13-year-old patient).  The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 2 Oct 2023: Nurse reported that in 2022 a dose of Infanrix was administered by mistake to a 13-year-old patient who was supposed to receive Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up via email agreed.
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient 1 month of age received by mistake Bexsero; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old female patient who received Men B NVS (Bexsero) (batch number Z39XM, expiry date 31-OCT-2026) for prophylaxis.   On 02-OCT-2023, the patient received the 1st dose of Bexsero. On 02-OCT-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: patient 1 month of age received by mistake Bexsero).  The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 2 Oct 2023 Medical assistant reported that a patient 1 month of age received by mistake Bexsero, which led to inappropriate age at vaccine administration. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Product administered at inappropriate site, Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient received a pediatric dose; adult patient received a pediatric dose of ENGERIX-B in the thigh on Friday; adult patient received a pediatric dose of ENGERIX-B in the thigh on Friday; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number 32M5G, expiry date 14-SEP-2025) for prophylaxis.   On 29-SEP-2023, the patient received Engerix B pediatric (unknown thigh) 10 ug. On 29-SEP-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: adult patient received a pediatric dose), adult use of a child product (Verbatim: adult patient received a pediatric dose of ENGERIX-B in the thigh on Friday) and vaccine administered at inappropriate site (Verbatim: adult patient received a pediatric dose of ENGERIX-B in the thigh on Friday).  The outcome of the underdose, adult use of a child product and vaccine administered at inappropriate site were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-OCT-2023 Adult patient received a pediatric dose of Engerix-B in the thigh, which led to underdose, adult use of a child product and vaccine administered at inappropriate site. The reporter consented to follow up.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: male patient received Bexsero on 9/7/2023 instead of HPV vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number XX33P, expiry date 31-JAN-2026) for prophylaxis.   On 07-SEP-2023, the patient received Bexsero. On 07-SEP-2023, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: male patient received Bexsero on 9/7/2023 instead of HPV vaccine).  The outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Oct-2023 The medical assistant reported that treating physician is not aware yet or the patient's parent.  According to reporter she will notify parents and PCP.  Reporter stated patient was doing fine. The reporter consented to follow-up. The patient received Bexsero instead of HPV vaccine, which led wrong vaccine administered.
Sex: U
Vaccine: FLU4
Symptoms: Device leakage, Incorrect dose administered, Underdose, Wrong technique in product usage process
Clinical narrative: patient received an incomplete dose of Fluarix since it leaked; have not attached the needle correctly causing the leakage; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   On 03-OCT-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On 03-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced incomplete dose administered (Verbatim: patient received an incomplete dose of Fluarix since it leaked) and wrong technique in product usage process (Verbatim: have not attached the needle correctly causing the leakage).  The outcome of the incomplete dose administered and wrong technique in product usage process were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Oct-2023 No patient/vaccines identifiers were available. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up. The patient received an incomplete dose of Fluarix since it leaked (they had not attached the needle correctly causing the leakage), which led to incomplete dose administered and wrong technique in product usage.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: painful, itchy rash on the side of his chest; painful, itchy rash on the side of his chest; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 03-OCT-2023, 8 days after receiving Shingrix, the patient experienced itchy rash (Verbatim: painful, itchy rash on the side of his chest) and pain (Verbatim: painful, itchy rash on the side of his chest).  The outcome of the itchy rash and pain were not resolved.   It was unknown if the reporter considered the itchy rash and pain to be related to Shingrix.     It was unknown if the company considered the itchy rash and pain to be related to Shingrix.   Additional Information: GSK receipt date: 03-OCT-2023 The reporter was the health care professional (pharmacist).  A patient developed a painful, itchy rash on the side of his chest.  Nothing else was reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Blurry Vision; This serious case was reported by a consumer via call center representative and described the occurrence of blurred vision in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rheumatoid arthritis (history of rheumatoid arthritis with sardosis).   On 29-AUG-2023, the patient received the 2nd dose of Shingrix (left arm). On 07-SEP-2023, 9 days after receiving Shingrix, the patient experienced blurred vision (Verbatim: Blurry Vision) (serious criteria hospitalization).  The outcome of the blurred vision was not resolved.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.     It was unknown if the company considered the blurred vision to be related to Shingrix.   Additional Information: GSK receipt date: 4-Oct-2023 The caller states she had a dose of Shingrix and had blurry vision and was admitted to hospital overnight to run tests.  Referred to health care professional, medical information, phone number were provided. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received Menveo lyophilized men-A component after it was reconstituted with a non-GSK inactive diluent; received Menveo lyophilized men-A component after it was reconstituted with a non-GSK inactive diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA983A, expiry date 30-SEP-2024) for prophylaxis.   On 28-SEP-2023, the patient received Menveo. On 28-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Menveo lyophilized men-A component after it was reconstituted with a non-GSK inactive diluent) and inappropriate dose of vaccine administered (Verbatim: received Menveo lyophilized men-A component after it was reconstituted with a non-GSK inactive diluent).The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The reporter stated that a patient received Menveo lyophilized men-A component after it was reconstituted with a non-GSK inactive diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.
Age: 8.0
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Boostrix - Use in patient younger than 10 years of age; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 11-APR-2016, the patient received Boostrix. On 11-APR-2016, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix - Use in patient younger than 10 years of age). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-SEP-2023 The reporter reported that the 8 years old patient received Tdap vaccine. The reporter asked why the state immunization information system recommends Tdap vaccination to this patient since a booster dose was recommended every 10 years. On 3rd October 2023 after a follow up call with the reporter she confirmed that Boostrix was administered. The reporter did not shared patient information patient initials, gender nor data about the Boostrix dose given in 2016 like lot number and expiry date. The patient received Boostrix who was younger than the indicated age which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: by mistake, the patient got a third dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose was given in Feb 2023) and Shingrix (the second dose was given in May 2023).   On 04-OCT-2023, the patient received the 3rd dose of Shingrix. On 04-OCT-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: by mistake, the patient got a third dose).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 04-OCT-2023 The nurse called to report the administration of a third dose to a 50 year old female patient. The healthcare professional mentioned that by mistake, the patient got a third dose, which led to extra dose administered. The reporter asked for safety information regarding this situation. The healthcare professional did not provide information about the third dose administered (lot number, exp date). The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Therapeutic response unexpected
Clinical narrative: HARD NIGHT SLEEP; HAD GOOD LUCK WITH IT / HELPED WITH NEUROPATHY AND FEET DID A LITTLE BETTER / HAD PAIN IN LEFT KNEE AND THAT WENT AWAY ALSO; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: neuropathy (pain in left knee). The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient reported that he was happy with getting the vaccines and did not want to receive Moderna's. Per the consumer, he had good luck with it. He mentioned the Vaccine helped with his neuropathy and feet did a little better. He state he had pain in his left knee and that went away also (coded as unexpected therapeutic benefit) (dose number in series 2). The patient stated when he got the booster he had a hard night's sleep but his feet were still doing better (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had good luck with it / helped with neuropathy and feet did a little better / had pain in left knee and that went away also and hard night sleep was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DIED; BLOOD CLOTS; This spontaneous report received from a consumer via Agency via a company representative concerned a 30 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was a man with a new baby. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had blood clots and died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of blood clots was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20231022488.; Sender's Comments: V0: 20231022451-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable. 20231022451-blood clots. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: UNK
Symptoms: Asthma
Clinical narrative: patient experienced Asthma Attack; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (patient experienced Asthma Attack) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Arrhythmia, COVID-19, Gastroesophageal reflux disease, Iron deficiency anemia and Supraventricular tachycardia. Concurrent medical conditions included Anxiety, Arthritis, Asthma (uncomplicated), Hyperlipidemia, Hypertension and Hepatocellular carcinoma. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]), ALPRAZOLAM, AMIODARONE, AMITRIPTYLINE, AMLODIPINE, APIXABAN, BUDESONIDE;FORMOTEROL, CALCIUM CARBONATE, CELECOXIB, CHOLECALCIFEROL, CYANOCOBALAMIN, CYANOCOBALAMIN (VITAMIN B-12), DICLOFENAC SODIUM, EPINEPHRINE, ERGOCALCIFEROL, ESTRADIOL, EZETIMIBE, BENRALIZUMAB (FASENRA PEN), FLUTICASONE PROPIONATE, FUROSEMIDE, GABAPENTIN, IPRATROPIUM, MELATONIN, METOPROLOL TARTRATE, MONTELUKAST, DRONEDARONE HYDROCHLORIDE (MULTAQ), MUPIROCIN, INOSITOL NIACINATE, NIACIN, OMEGA-3-ACID ETHYL ESTER (OMEGA 3 ACID ETHYL ESTERS), OMEPRAZOLE, POTASSIUM CHLORIDE, TELMISARTAN, VITAMIN C [ASCORBIC ACID] and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) for an unknown indication.    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 ASTHMA (patient experienced Asthma Attack). The patient was treated with OMALIZUMAB (XOLAIR) for Asthma, at an unspecified dose and frequency. At the time of the report, ASTHMA (patient experienced Asthma Attack) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication included as gluc sulchondro, Hydrocodone acetaminophen.
Sex: M
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: the patient got  COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain,  which was not the usual joint achiness.; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (the patient got  COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain,  which was not the usual joint achiness.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced POLYMYALGIA RHEUMATICA (the patient got  COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain,  which was not the usual joint achiness.) (seriousness criterion medically significant). At the time of the report, POLYMYALGIA RHEUMATICA (the patient got  COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain,  which was not the usual joint achiness.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   It was reported that within an hour of vaccination, the patient got COVID-19 induced PMR (polymyalgia rheumatica) that came with excruciating pain, which was not the usual joint achiness. It was reported patient was a very typical case. It was reported the disease had lasted 2 years and the patient was in horrible shape, and his state was worse at the time of reporting . The patient was being treated with a specialist.  No treatment medications were provided. Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced unexpected serious (medically significant) event of Polymyalgia rheumatica which occurred in context of receiving a dose of mRNA-1273 vaccine, which was the patient's unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to exact vaccination date unknown and exact event onset date unknown, however based on provided information it has started within an hour of vaccination and lasted for 2 years. Event has started with excruciating pain, which was not the usual arthralgia. It was provided that during these 2 years the patient was in horrible shape, and his state was worse at the time of reporting. Further details regarding clinical course and symptoms, concomitant medications and concurrent diseases, accompanying circumstances with potential alternative causalities, etiologic and diagnostic work up with treatment details are not available in the report. Event's outcome was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Left arm pain from my shoulder the elbow; injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm pain from my shoulder the elbow) and VACCINATION SITE PAIN (injection site arm hurt) in a 78-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. AS76428 and AS746B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Apr-2023, the patient received sixth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 02-Jun-2023, received seventh dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2023, the patient experienced PAIN IN EXTREMITY (Left arm pain from my shoulder the elbow) and VACCINATION SITE PAIN (injection site arm hurt). At the time of the report, PAIN IN EXTREMITY (Left arm pain from my shoulder the elbow) and VACCINATION SITE PAIN (injection site arm hurt) outcome was unknown.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 30Sep2022, patient received his fifth Moderna booster dose (lot number AS7146B). The patient received the vaccine in his left arm. On 06Oct2023, patient received his 8th overall Moderna booster dose on (lot number 3032264, expiration date not known). Patient received the vaccine in his left arm. The patient did not feel anything and has no side effects. The patient wonders if he actually goes the vaccine.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744772 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744772:Monovalent case
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Swelling
Clinical narrative: Slight swelling; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Slight swelling) and PAIN IN EXTREMITY (Pain in the arm) 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 06-Oct-2023, the patient experienced SWELLING (Slight swelling) and PAIN IN EXTREMITY (Pain in the arm). At the time of the report, SWELLING (Slight swelling) and PAIN IN EXTREMITY (Pain in the arm) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-744800 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744800:Husband case
Age: 25.0
Sex: F
Vaccine: FLUX, UNK
Symptoms: Chills, Muscle fatigue, Myalgia, Pyrexia, Tremor
Clinical narrative: muscle fatigue; shaking; muscle soreness; temperature increase; chills; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE FATIGUE (muscle fatigue), TREMOR (shaking), MYALGIA (muscle soreness), PYREXIA (temperature increase) and CHILLS (chills) in a 25-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032218) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    The patient's past medical history included Coughing (Took Mucinex DM for coughing.) and COVID-19 (Once around Mar-2022 during 3 to 5 days) in March 2022. Previously administered products included for Coughing: Mucinex DM. Past adverse reactions to the above products included No adverse event with Mucinex DM.   On 04-Oct-2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 04-Oct-2023 at 11:30 AM, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 04-Oct-2023, the patient experienced MUSCLE FATIGUE (muscle fatigue), TREMOR (shaking), MYALGIA (muscle soreness), PYREXIA (temperature increase) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MUSCLE FATIGUE (muscle fatigue), TREMOR (shaking), PYREXIA (temperature increase) and CHILLS (chills) was resolving and MYALGIA (muscle soreness) had not resolved.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  On 03-Jan-2021, the patient received first dose of Pfizer and the lot number was EJ1686. On 20-Jan-2021, the patient received second dose of Pfizer and the lot number was EL3248. On 20-Nov-2021, the patient received third dose of Pfizer and the lot number was FD0809. On 05-Nov-2022, the patient received fourth dose of Pfizer and the lot number was GJ6738.  The patient has received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient had her Spikevax appointment at her work at 11:30 AM and started feeling symptoms when she was driving home approximately at 5 or 6 PM, initially felt muscle fatigue and then headedness, later on she felt temperature increase and chunk chills, she was shaking a lot, and feeling muscle soreness.  Caller took Tylenol and Excedrin. Muscle soreness was still ongoing. The patient got flu vaccine at same time than Spikevax but in a different arm.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The patient also states she had COVID in December 2022; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient also states she had COVID in December 2022) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (she is allergic to thimerosal).    On 01-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2022, the patient experienced COVID-19 (The patient also states she had COVID in December 2022). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient also states she had COVID in December 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient stated that she had Moderna all the way through. She wants to know if the new vaccine had thimerosal because she was allergic to thimerosal. The patient also states she had COVID in December 2022. She ended up taking Paxlovid at the time. She wants to make sure that it was ok to take Spikevax.  The patient was unsure whether her Moderna dose on 1Jul2022 was monovalent or bivalent vaccine.  Patient had Moderna on 12Feb2021, Moderna on 12Mar2021, and Moderna on 21Nov2021 Moderna on 01Jul2022 (lot number 014B22A). Concomitant medications were not reported.
Age: 86.0
Sex: F
Vaccine: RVX, UNK
Symptoms: Rhinorrhoea, Sinus pain
Clinical narrative: She had pained in her sinus in the right side; after receiving the Spikevax her nose started running; This spontaneous case was reported by a nurse and describes the occurrence of SINUS PAIN (She had pained in her sinus in the right side) and RHINORRHOEA (after receiving the Spikevax her nose started running) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 202F23A) for COVID-19 prophylaxis.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    Patient did not report any medical history or condition.    On 21-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced SINUS PAIN (She had pained in her sinus in the right side) and RHINORRHOEA (after receiving the Spikevax her nose started running). On 02-Oct-2023, SINUS PAIN (She had pained in her sinus in the right side) and RHINORRHOEA (after receiving the Spikevax her nose started running) had resolved.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  On 03-Feb-2021, the patient received first dose and the lot number was 010M20A.  On 03-Mar-2021, the patient received second dose and the lot number was 003A21A.  On 25-Oct-2021, the patient received third dose and the lot number was 004F21A.  On 30-Mar-2022, the patient received fourth dose and the lot number was 002M21A. On 24-Sep-2022, the patient received fifth dose and the lot number was AS7145B.  The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient recently got the RSV and the Spikevax together. She never got the Pfizer vaccine. Patient got 6 doses, and she did not have any reaction. However, 10 days after receiving the Spikevax her nose started running. She had pained in her sinus in the right side. Then the next day everything was gone. She stated she was not sure if it was a side effect or if she should report it.   Treatment medication use information was not provided by reporter.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction
Clinical narrative: received one moderna vaccine and 1 pfizer vaccine he has about the same side effects with both; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (received one moderna vaccine and 1 pfizer vaccine he has about the same side effects with both) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (received one moderna vaccine and 1 pfizer vaccine he has about the same side effects with both). At the time of the report, IMMUNISATION REACTION (received one moderna vaccine and 1 pfizer vaccine he has about the same side effects with both) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Reporter son had received one moderna vaccine and 1 pfizer vaccine he had about the same side effects with both. Concomitant medications were not reported.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2023: Live follow-up received include no new information.
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: weakness; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea). At the time of the report, ASTHENIA (weakness), DIZZINESS (dizziness) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient asked "did have something to recommend that he could take for the side effects of the booster dose he took yesterday.  No treatment information was reported.
Age: 87.0
Sex: M
Vaccine: UNK
Symptoms: Asthenia, Diarrhoea, Hypophagia, Mobility decreased, Vomiting
Clinical narrative: can't move; has not been eating or drinking anything; been week; diarrhea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (can't move), FEEDING DISORDER (has not been eating or drinking anything), ASTHENIA (been week), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 87-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Oct-2023, the patient experienced MOBILITY DECREASED (can't move), FEEDING DISORDER (has not been eating or drinking anything), ASTHENIA (been week), DIARRHOEA (diarrhea) and VOMITING (throwing up). At the time of the report, MOBILITY DECREASED (can't move), FEEDING DISORDER (has not been eating or drinking anything) and ASTHENIA (been week) outcome was unknown and DIARRHOEA (diarrhea) and VOMITING (throwing up) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  Patient has received 3 doses of the Moderna COVID-19 vaccines before receiving a dose of the SPIKEVAX vaccine on either 26-SEP-2023 or 27-SEP-2023. Lot number unknown. Since yesterday he has been throwing up, had diarrhea, been week, can't move, and has not been eating or drinking anything.   He has not taken any medications or treatments for his symptoms. He has not spoken to his healthcare professional.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 complication; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19 complication) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Pneumonia (Double pneumonia) in 2021, Unable to walk and COVID-19 in 2020. Concurrent medical conditions included Amyotrophic lateral sclerosis.   In March 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, received 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 COVID-19 (COVID-19 complication) (seriousness criterion death). The patient died on 29-Jun-2022. The reported cause of death was covid-19 complication. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not reported. Patient was a healthy person until he caught covid. The patient was passed away due to complications of COVID-19.  The patient had suspected signs of Lou Gehrig's disease in 2021, but did not received the diagnosis untill june 2021.  Company comment:  This is a spontaneous case concerning a 69-year-old, male patient with Amyotrophic lateral sclerosis and COVID-19 one year before first vaccination, who died after the administration of three doses of mRNA-1273 vaccine due to COVID-19 complications. No further information on clinical course, investigations and autopsy was available in the report. Her wife stated that the patient was healthy before COVID-19 disease and died due to COVID-19 complications. The patient died about 15 months after the first dose, but latency could not be assessed in regards of the third dose due to lack of information on vaccination date. The company causality for the event COVID-19 was assessed as not applicable, since mRNA-1273 vaccine is a nucleoside modified vaccine that does not contain any virus capable of causing viral infection. COVID-19 is the confounder of event and patient underlying condition of Amyotrophic lateral sclerosis a risk factor to developed COVID-19 complications. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-744264 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744264:Wife case; Reported Cause(s) of Death: COVID-19 complication
Sex: F
Vaccine: UNK
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: achiness; headache; fever; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (achiness), HEADACHE (headache) and PYREXIA (fever) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness), HEADACHE (headache) and PYREXIA (fever). At the time of the report, PAIN (achiness), HEADACHE (headache) and PYREXIA (fever) 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. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient stated that she had reactions like headache 1 hour after getting the vaccines and she would feel great and then it would come back. Patient also experienced the symptoms of normal fever and achiness. Patient worried about Covid-19 vaccination and opined that COVID-19 vaccine alters own body frequency and for those that have had Covid shots. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-744256 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2023: Live follow-up has been appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-744256:Husband case
Age: 77.0
Sex: F
Vaccine: UNK
Symptoms: Drug interaction, Pain in extremity
Clinical narrative: She has had a sore arm after the dose yesterday as usual; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She has had a sore arm after the dose yesterday as usual) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for an unknown indication.    No Medical History information was reported.   On 05-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (She has had a sore arm after the dose yesterday as usual). At the time of the report, PAIN IN EXTREMITY (She has had a sore arm after the dose yesterday as usual) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. She has received 7 doses of the Moderna COVID-19 vaccines, on 3MAR2021 with lot number 027A21A, on 31MAR2021 with lot number 039A21A, on18AUG2021 with lot number unknown, on 24FEB2022 with lot number 022521A, on 29SEP2022 with lot number A57146B, on 25APR2023 with lot number unknown, on 5OCT2023 with lot number unknown. Patient had a sore arm after the dose that day as usual. She was concerned for reduced efficacy because of the medication interaction. Nurse noted that with this medication the vaccine may have a diminished effect reducing the efficacy of the Moderna vaccine. At her 7th dose, nurse told that because she was taking the medication Jakafi she would have a diminished efficacy from the vaccine. Treatment information was not reported.