chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix reconstituted with sterile water instead of with adjuvant; Shingrix reconstituted with sterile water instead of with adjuvant; 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 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-OCT-2023, the patient received Shingrix. On 02-OCT-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix reconstituted with sterile water instead of with adjuvant) and inappropriate dose of vaccine administered (Verbatim: Shingrix reconstituted with sterile water instead of with adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter stated that a patient was accidently given a dose of Shingrix which was not properly reconstituted. The dose was reconstituted with sterile water instead of with the Shingrix adjuvant which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Havrix adult dose administered to a child; Overdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of adult product administered to child in a patient who received HAV (Havrix adult) (batch number 772YT) for prophylaxis.   On an unknown date, the patient received the 1st dose of Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced adult product administered to child (Verbatim: Havrix adult dose administered to a child) and overdose (Verbatim: Overdose). The outcome of the adult product administered to child and overdose were unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The pharmacist called MI to see which formulation was the following Havrix.  HCP requested information about how to proceed with Havrix second dose if a kid patient receive Havrix adult first dose. Health care professional (HCP) was in doubt about if there was a patient involved in this possible scenario. The child patient received adult Havrix dose, which led to overdose and adult product used by the child. The HCP accepted follow up by Safety Team to his personal  email.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number X54CN, expiry date 27-MAY-2023) for prophylaxis.   On 27-OCT-2023, the patient received the 1st dose of Shingrix. On 27-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient was administered an expired dose of Shingrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-OCT-2023 The pharmacist reported a patient was administered an expired dose of Shingrix which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: who received her first dose of Shingrix 7 years ago. She has not received her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received her first dose of Shingrix 7 years ago). Concomitant products included valaciclovir (Valacyclovir).   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: who received her first dose of Shingrix 7 years ago. She has not received her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The reporter was the patient, who received her 1st dose of Shingrix 7 years ago.  The patient stated that she was currently taking valacyclovir. The patient had not received her 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Acne, Dry eye, Induration, Ocular rosacea, Swelling
Clinical narrative: dry eyes; ocular rosacea; hard bumps; hard bumps; acne; This non-serious case was reported by a consumer via call center representative and described the occurrence of eye dryness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received one Shingles injection before on an unknown date from different manufacturer).   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced eye dryness (Verbatim: dry eyes), ocular rosacea (Verbatim: ocular rosacea), local swelling (Verbatim: hard bumps), induration (Verbatim: hard bumps) and acne (Verbatim: acne). The patient was treated with doxycycline. Shingrix was discontinued. The outcome of the eye dryness, ocular rosacea, local swelling, induration and acne were unknown.   It was unknown if the reporter considered the eye dryness, ocular rosacea, local swelling, induration and acne to be related to Shingrix.     It was unknown if the company considered the eye dryness, ocular rosacea, local swelling, induration and acne to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-OCT-2023 The patient self-reported this case. The patient reported that, she had one injection of the Shingrix and then experienced the noted issues. She had dry eyes, ocular rosacea, hard bumps and acne, this happened about 3 to 5 months ago in 2023 (from the date of reporting), she really not sure about the timeline. She further stated she had seen eye doctor and dermatologist.  She was receiving Doxycycline for her eyes. She did not receive the second dose of Shingrix.  The patient stated these events were still occurring on and off. They resolve then reappear. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue, Single component of a two-component product administered
Clinical narrative: inappropriate reconstitution technique; patient was administered a dose of Shingrix adjuvant without reconstituting with the antigen vial; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-OCT-2023, the patient received Shingrix. On 27-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: inappropriate reconstitution technique) and inappropriate dose of vaccine administered (Verbatim: patient was administered a dose of Shingrix adjuvant without reconstituting with the antigen vial). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The state department of health regional consultant reported a site reached out to them regarding a patient that was administered a dose of Shingrix adjuvant without reconstituting with the antigen vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The dose was given today, on the date of reporting.  The reporter did not have/declined to provide any further details. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive 2nd Shingles shot; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (shingles outbreaks every 9 months). Previously administered products included Shingles vaccine (1st dose received on 31st March 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: did not receive 2nd Shingles shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date : 27-OCT-2023 The reporter stated that they had regular shingles outbreak every 9 months, but had seen improvement in symptoms and severity since receiving first dose of Shingles shot. The reporter stated that they did not receive 2nd Shingles shot within 6 months of March when they got the first. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: RSV
Symptoms: Product preparation issue
Clinical narrative: one vial of Arexvy was administered to a patient without reconstitution; last week an Arexvy vaccine was administered without reconstitution; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In OCT-2023, the patient received Arexvy. In OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: one vial of Arexvy was administered to a patient without reconstitution) and inappropriate dose of vaccine administered (Verbatim: last week an Arexvy vaccine was administered without reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 27-OCT-2023 The pharmacist called to report only one vial of Arexvy was administered to a patient without reconstitution but was unsure which one. Information about patient and vaccine were asked but caller stated had no details about event. During call HCP (health care professional) stated last week (from the date of reporting) an Arexvy vaccine was administered without reconstitution and when asked which vial was administered or if an unapproved diluent was used to reconstitute the antigen powder HCP answered did not have any information and requested medical information for both scenarios, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient received an extra dose of Fluarix by accident; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number 7Z423, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 27-OCT-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On 27-OCT-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: patient received an extra dose of Fluarix by accident). The outcome of the extra dose 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: 27-OCT-2023 The medical assistant stated that a patient received an extra dose of Fluarix by accident (October 18 and today), which led to extra dose administered. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Retching
Clinical narrative: Shingrix around 5 months ago and for 24 hours was dry heaving; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry heaves in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced dry heaves (Verbatim: Shingrix around 5 months ago and for 24 hours was dry heaving). The outcome of the dry heaves was resolved (duration 24 hrs).   It was unknown if the reporter considered the dry heaves to be related to Shingrix.     It was unknown if the company considered the dry heaves to be related to Shingrix.   Additional Information: GSK receipt date: 30-OCT-2023 The patient self-reported this case. The reporter stated he had his first dose of Shingrix around 5 months ago (from the date of reporting) in 2023 and for 24 hours was dry heaving. The event only lasted 24 hours and was resolved. The consent to follow up requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity, Tendon pain
Clinical narrative: JOINT PAIN, MUSCLE, TENDON PAIN, VERY SEVERE. SEEEMS TO BE SLOWLY RESOLVING, BUT SEVERE PAIN CONTINUES IN SHOUJLDERS AND BACKS OF LEGS. PAIN CONTROLLED WITH ADVIL AND TYLENOL EVERY DAY.  PATIENT HAS HAD ALL MODERNA COVID VACCINES OFFERED WITH NO ABNORMAL REACTIONS. ALSO HAS HAD PNEUMONIA, SHINGLES, FLU, TDAP AS APPROPRIATE WITH NO ADVERSE REACTIONS.
Age: 57.0
Sex: F
Vaccine: COVID19, PNC20
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: patient states arm red and swollen from injection site
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Injection site reaction, Injection site warmth, Rash, Rash erythematous, Rash macular
Clinical narrative: 2 days after vaccine, pt's mom noted that pt woke up with a pink splotchy rash to backs of knees, chest, warmth around L thigh injection site, abdomen, back, axilla, bilateral arms
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUC4, MMRV
Symptoms: Skin warm
Clinical narrative: 2 days after vaccine, pt's mom noted that pt woke up with a pink splotchy rash to backs of knees, chest, warmth around L thigh injection site, abdomen, back, axilla, bilateral arms
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Device connection issue, Needle issue, No adverse event, Underdose
Clinical narrative: there was needle leakage; patient did not receive full dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 75-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number FH3BB, expiry date 23-MAR-2025) for prophylaxis.   On 30-OCT-2023, the patient received Arexvy. On 30-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: patient did not receive full dose). On an unknown date, the patient experienced needle leak (Verbatim: there was needle leakage). The outcome of the incomplete dose administered and needle leak were unknown.   Additional Information: GSK receipt date: 30-OCT-2023 The HCP (health care professional) reported that patient received the Arexvy after the syringe was loose and there was needle leakage, so patient did not receive full dose, which led to incomplete dose administered. No reactions reported. The reporter consented to follow up.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient states noticing red bumps that look like bites along back, thighs, and now going down legs toward feet.  Does not look like in a particular pattern.  States they are not itchy but starting to have some pain.  Didn't notice them until the morning after the shot.  Doesn't look like shingles (not following dermatomes and not one side of trunk nor blistering) and patients states wasn't out where could have chiggers nor believes it is from bed bug bites.  Patient states no having reactions to flu shots in past.  Has not had any new medications, no changes to clothing/detergent/soap.  When they talked to dr they advised pt to use hydrocortisone and observe for now and follow up if they are still there.
Age: 66.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: CSF test normal, Computerised tomogram normal, Disorientation, Electrocardiogram normal, Electroencephalogram normal
Clinical narrative: Initial reaction in first few days- muscle pain. 7 days post vaccination- neurological issue, disoriented, requiring > 2 weeks ICU testing, diagnosis, treatment-  No other indicators of any other cause.
Age: 66.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Intensive care, Lumbar puncture normal, Magnetic resonance imaging normal, Myalgia, Nervous system disorder
Clinical narrative: Initial reaction in first few days- muscle pain. 7 days post vaccination- neurological issue, disoriented, requiring > 2 weeks ICU testing, diagnosis, treatment-  No other indicators of any other cause.
Age: 72.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site discolouration, Injection site nodule, Injection site pain, Injection site scar, Injection site thrombosis
Clinical narrative: Pt had to go to ER, had severe pain, big knot, blood clot and scar at injection site. After 2 months still got black spot at injection site.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Patient broke out  in a whole body rash.
Age: 76.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Injection site swelling
Clinical narrative: SWELLING AT INJECTION SITE OF RIGHT ARM AFTER COMIRNATY INJECTION
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus, Skin abrasion, Swelling
Clinical narrative: swollen to baseball size, hot, red, itchy
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Patient came to pharmacy next day with Left arm red, inflamed and warm to the touch. parents were very concerned so he was referred to local after hours pediatric office.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; had 4 episodes of Shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis, cholecystitis, psoriasis, vocal cord paralysis, episcleritis, thyroiditis and immunocompromised. Additional patient notes included Current condition was reported as crones.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 4 episodes of Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 30-OCT-2023 Reporter was a healthcare professional calling as a customer. The reporter stated that after receiving the Shingrix Vaccine she had 4 episodes of Shingles. Shingrix vaccine series was given as per PI instructions in the year 2021. Concomitant product included tumor necrosis factor Medication. The reporter was an immunocompromised patient who called today to inquire about clinical study information and how to become a participant in clinical studies. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 76.0
Sex: F
Vaccine: RSV
Symptoms: Exposure via skin contact, Needle issue, Underdose
Clinical narrative: the administration of Arexvy 4 drops leaked through the needle; drops were in contact with patient´s arm; drops were in contact with patient´s arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 76-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 324NX) for prophylaxis.   On 31-OCT-2023, the patient received Arexvy. On 31-OCT-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: the administration of Arexvy 4 drops leaked through the needle), exposure via skin contact (Verbatim: drops were in contact with patient´s arm) and inadvertent exposure to vaccine (Verbatim: drops were in contact with patient´s arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 31-OCT-2023 The pharmacist called to report during the administration of Arexvy 4 drops leaked through the needle, so the volume of vaccine administered was unknown, which led to incomplete dose administered. The reporter mentioned drops were in contact with patient's arm, which led to exposure via skin contact and inadvertent exposure to vaccine. The reporter did not consent to follow-up.
Sex: F
Vaccine: FLUX, RSV
Symptoms: Hallucination
Clinical narrative: Hallucinations; This serious case was reported by a nurse via sales rep and described the occurrence of hallucination in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received Arexvy and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant). The outcome of the hallucination was resolved (duration 1 hr).   It was unknown if the reporter considered the hallucination to be related to Arexvy.     It was unknown if the company considered the hallucination to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter reported that the patient received Arexvy vaccine accompanied with an unspecified flu vaccine and experienced hallucinations. The reporter stated that she did not know when the hallucinations started after administration of Arexvy vaccine.   The reporter stated that the patient thought she was on fire for an hour and then hallucinations resolved. It was unknown if the reporter considered the hallucination to be related to Influenza vaccine. This case was 1 of 3 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023152424:Same reporter( 2 Of 3) US-GSK-US2023152427:same reporter( 3of 3)
Sex: F
Vaccine: FLUX, RSV
Symptoms: Hallucination
Clinical narrative: Hallucinations; This serious case was reported by a nurse via sales rep and described the occurrence of hallucination in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received Arexvy and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant). The outcome of the hallucination was resolved (duration 1 hr).   It was unknown if the reporter considered the hallucination to be related to Arexvy.     It was unknown if the company considered the hallucination to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter reported that the patient received Arexvy vaccine accompanied with an unspecified flu vaccine and experienced hallucinations. The reporter stated that she did not know when the hallucinations started after administration of Arexvy vaccine.   The reporter stated that the patient thought she was on fire for an hour and then hallucinations resolved. It was unknown if the reporter considered the hallucination to be related to Influenza vaccine. This case was 2 of 3 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023152427:Same reporter US-GSK-US2023152421:Same reporter
Sex: F
Vaccine: FLUX, RSV
Symptoms: Hallucination
Clinical narrative: Hallucinations; This serious case was reported by a nurse via sales rep and described the occurrence of hallucination in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On an unknown date, the patient received Arexvy and INFLUENZA VACCINE. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant). The outcome of the hallucination was resolved (duration 1 hr).   It was unknown if the reporter considered the hallucination to be related to Arexvy.     It was unknown if the company considered the hallucination to be related to Arexvy.   Additional Information: GSK Receipt Date: 02-NOV-2023 The reporter reported that the patient received Arexvy vaccine accompanied with an unspecified flu vaccine and experienced hallucinations. The reporter stated that she did not know when the hallucinations started after administration of Arexvy vaccine.   The reporter stated that the patient thought she had snakes on her for an hour and then hallucinations resolved. It was unknown if the reporter considered the hallucination to be related to Influenza vaccine. This case was 3 of 3 cases for the patient reported by same reporter. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023152421:same reporter( 1of 3) US-GSK-US2023152424:Same reporter (2 of 2)
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: HIGH BLOOD SUGAR; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient had a allergy to pain medication (vomiting). The patients blood sugar level was 5.2 and weight was great before vaccination. The patient was previously treated with covid-19 vaccine ad26. cov2 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: OH3A214 expiry: UNKNOWN), dose was not reported, 1 total administered on 09-APR-2021 for covid-19 prophylaxis (dose number in series 1). No adverse events reported following vaccination (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: UNKNOWN) dose was not reported,1 total administered on 05-DEC-2021 to left Arm for covid-19 prophylaxis. Concomitant medications included metformin for drug used for unknown indication.  On an unspecified date, the patients blood sugar level increased 6.9 (Dose number in series 2). The patient doctor gave Ozempic for treatment. After stopped taking Ozempic patients blood sugar level again increased. The patient stated that after taking two medications blood sugar level was only 6.2. The patient took Jardiance and had horrible side effects, gave her E.coli (Escherichia). The patient-maintained sugar level by eating 30 carbs per meal. The patient visited gynecologist. The patient was upset because doing everything still side effect are same. Laboratory data (dates unspecified) included: Blood sugar increased 6.9, 6.2. Treatment medications (dates unspecified) included: semaglutide, and empagliflozin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood sugar. This report was non-serious. This case, from the same reporter is linked to 20231105443.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Pyrexia
Clinical narrative: Loss of appetite; High fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 071F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus, Irritable bowel syndrome, Blood pressure high, Mitral regurgitation and Drug allergy (codeine, Miralax, magnesium citrate.).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (High fever) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient had received all Moderna COVID-19 vaccines so far and her reactions have been high fever, chills, loss of appetite. She would only have to stay at home for a couple of days after which she was able to return to work. With one of the doses, her fever went to 104F.   This case was linked to US-MODERNATX, INC.-MOD-2023-747880 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747880:Same patient (Different vaccine)
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: I react to the Covid shots; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I react to the Covid shots) 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 TOZINAMERAN (COMIRNATY) for COVID-19 immunization.    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 TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I react to the Covid shots). At the time of the report, IMMUNISATION REACTION (I react to the Covid shots) outcome was unknown.     Concomitant medication was not provided. Patient reacted to both COVID shots, i.e., both Pfizer and Moderna.  Treatment information was not reported.   Reporter did not allow further contact.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Pulmonary fibrosis
Clinical narrative: Pulmonary fibrosis; We still got Covid; This spontaneous case was reported by a nurse and describes the occurrence of PULMONARY FIBROSIS (Pulmonary fibrosis) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna (First dose and Lot no: 012M20A.) on 02-Feb-2021. Past adverse reactions to the above products included No adverse event with Moderna.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY FIBROSIS (Pulmonary fibrosis) (seriousness criterion medically significant) and COVID-19 (We still got Covid). At the time of the report, PULMONARY FIBROSIS (Pulmonary fibrosis) and COVID-19 (We still got Covid) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient received all the doses of Moderna vaccines until now. Patient had less severe Pulmonary fibrosis.  Treatment information was not reported.  Company Comment: This is a Spontaneous case reported by a nurse, concerning a female patient of unknown age, with no relevant medical history, who experienced the unexpected and serious (due to medically significant) event of Pulmonary fibrosis, and the unexpected and non-serious event of COVID-19, which occurred on an unknown date after an unspecified dose of mRNA-1273.222 vaccine. Previous doses were administered with mRNA-1273 vaccine. No information disclosed about diagnostic tests performed, clinical course or treatments received. COVID-19 could be a confounding factor for Pulmonary fibrosis. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-747938 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747938:Case for Husband
Sex: U
Vaccine: COVID19
Symptoms: Chills, Immunisation reaction
Clinical narrative: Chills and everything; Chills and everything; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Chills and everything) and CHILLS (Chills and everything) in a  patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jan-2021, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 20-Feb-2021, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Chills and everything) and CHILLS (Chills and everything). At the time of the report, IMMUNISATION REACTION (Chills and everything) and CHILLS (Chills and everything) outcome was unknown.            No relevant concomitant medications were reported. The patient received Pfizer BioNTech covid-19 Bivalent vaccine on 21-Oct-2022. Patient received Moderna vaccines and developed "Chills and everything" similar to that the patient experienced with the flu shot before receiving the Pfizer bivalent vaccine. No treatment medication reported.
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Body ache; Sore injection site; Swollen lymph nodes; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), VACCINATION SITE PAIN (Sore injection site), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Fever) and HEADACHE (Headache) 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN (Body ache), VACCINATION SITE PAIN (Sore injection site), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PAIN (Body ache), VACCINATION SITE PAIN (Sore injection site), LYMPHADENOPATHY (Swollen lymph nodes), PYREXIA (Fever) and HEADACHE (Headache) had resolved.            Concomitant and treatment medications were not reported.  The patient had sore injection site, slightly swollen lymph nodes under the arm used for injection, fever (for 2 days), body ache, headache. It was unknown if the patient experienced any additional symptoms or events.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: her vaccinated right arm hurt; slight headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 040A21A and 031R21A) for COVID-19 prophylaxis.     The patient's past medical history included Cancer in 2019, Chemotherapy in 2019 and Radiation therapy in 2019. Concurrent medical conditions included Epilepsy (since teenage years). Concomitant products included PRIMIDONE (MYSOLINE) for Epilepsy, COLECALCIFEROL (VIT D3) for an unknown indication.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, 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 VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache). At the time of the report, VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache) outcome was unknown.            Patient has had Epilepsy, and she stated the Epilepsy medication makes her whole body slow. That's why she was slow to respond. Patient's whole system was like that, just in general without a vaccination, that's just from every day. She stated that part didn't change after vaccination. She took Vit D3, and the doctor had asked her to monitor her High Blood Pressure. Patient did mention that they were monitoring her blood pressure and have not prescribed any medication for it.   No treatment information was reported.   This case was linked to MOD-2023-748135, MOD-2023-748129 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Headache, Vaccination site pain
Clinical narrative: her vaccinated right arm hurt; slight headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache) in an 8-decade-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     The patient's past medical history included Cancer in 2019, Chemotherapy in 2019 and Radiotherapy in 2019. Concurrent medical conditions included Epilepsy (since teenage years). Concomitant products included PRIMIDONE (MYSOLINE) for Epilepsy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 14-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache). At the time of the report, VACCINATION SITE PAIN (her vaccinated right arm hurt) and HEADACHE (slight headache) outcome was unknown.            It was reported that because of the cancer treatment in 2019, sometimes she tried to say something, and it doesn't always come out the way she intended. She has had Epilepsy since teenage years & takes Mysoline. She stated that the Epilepsy medication makes her whole body slow. That was why she was slow to respond. Her whole system was like that, just in general without a vaccination, that's just from every day. She stated that part didn't change after vaccination. She takes Vit D3, and the doctor had asked her to monitor her High Blood Pressure. She mentioned that they are monitoring her blood pressure and have not prescribed any medication for it. No treatment information was provided.   This case was linked to MOD-2023-748129 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: chills light; Headache; chills; Headache; chills; low fever; body aches; This spontaneous case was reported by a patient and describes the occurrence of the first episode of HEADACHE (Headache), the first episode of CHILLS (chills), PYREXIA (low fever), MYALGIA (body aches) and the second episode of HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A, 022M2DA, 033F21A and 014B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had never been tested positive or diagnosed with COVID-19.  Concurrent medical conditions included Diabetes since 2008, Hypertension (HBP), Thyroid disorder (Thyroid), Drug allergy (Ceclor) and Sleep disorder (Sleep aid). Concomitant products included FEXOFENADINE for Allergy, PRAVASTATIN for Cholesterol, METFORMIN for Diabetes, VALSARTAN and NIFEDIPINE for Hypertension, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMIN & MINERAL, MAGNESIUM and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced the first episode of HEADACHE (Headache), the first episode of CHILLS (chills), PYREXIA (low fever) and MYALGIA (body aches). On 18-Feb-2021 at 5:00 PM, the patient experienced the second episode of HEADACHE (Headache) and the second episode of CHILLS (chills). On 07-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills light). On 22-Jan-2021, PYREXIA (low fever) and MYALGIA (body aches) had resolved. On 19-Feb-2021, last episode of HEADACHE (Headache) and the last episode of CHILLS (chills) had resolved. On 07-Jul-2022, CHILLS (chills light) had resolved.            On 21-Jan-2021, at 03:00 A.M and 03:00 P.M, the patient experienced the first episode of HEADACHE (Headache), the first episode of CHILLS (chills), PYREXIA (low fever) and MYALGIA (body aches).  The events did not cause the patient to seek medical care.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741758 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A, 025A21A and 030L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Vegetable allergy (mushroom allergy), Penicillin allergy and Drug allergy (Paxel).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2022, 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 PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine) outcome was unknown. Not Provided          No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-748145 (Patient Link).
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Patient was not diagnose with COVID-19.  Concurrent medical conditions included Blood pressure high, Food allergy, Penicillin allergy and Drug allergy (Paxil).    On 12-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (She includes that she usually had a soreness in her arms after receiving the previous Moderna COVID-19 vaccine) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-748145 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748145:Same patient (SPIKEVAX 2023-2024), master case
Age: 89.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain
Clinical narrative: his arm is extremely sore at the site of the injection; He is also running a fever (100F); This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (his arm is extremely sore at the site of the injection) and PYREXIA (He is also running a fever (100F)) in an 89-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 01-Nov-2023, the patient experienced VACCINATION SITE PAIN (his arm is extremely sore at the site of the injection) and PYREXIA (He is also running a fever (100F)). At the time of the report, VACCINATION SITE PAIN (his arm is extremely sore at the site of the injection) and PYREXIA (He is also running a fever (100F)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2023, Body temperature: 100 F.         No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-046502 (Patient Link).