chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthropod bite, Fatigue, Rash, Sensitive skin
Clinical narrative: he started feeling tired, developed pain on the abdomen, developed sensitive skin, patches of rash, and developed what it looked like a spider bite.; he started feeling tired, developed pain on the abdomen, developed sensitive skin, patches of rash, and developed what it looked like a spider bite.; he started feeling tired, developed pain on the abdomen, developed sensitive skin, patches of rash, and developed what it looked like a spider bite.; pain on the abdomen; feeling tired; This non-serious case was reported by a consumer via call center representative and described the occurrence of spider bite in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced spider bite (Verbatim: he started feeling tired, developed pain on the abdomen, developed sensitive skin, patches of rash, and developed what it looked like a spider bite.), patchy rash (Verbatim: he started feeling tired, developed pain on the abdomen, developed sensitive skin, patches of rash, and developed what it looked like a spider bite.), sensitive skin (Verbatim: he started feeling tired, developed pain on the abdomen, developed sensitive skin, patches of rash, and developed what it looked like a spider bite.), abdominal pain (Verbatim: pain on the abdomen) and tiredness (Verbatim: feeling tired). The outcome of the spider bite, patchy rash, sensitive skin, abdominal pain and tiredness were unknown.   It was unknown if the reporter considered the spider bite, patchy rash, sensitive skin, abdominal pain and tiredness to be related to Shingrix.     It was unknown if the company considered the spider bite, patchy rash, sensitive skin, abdominal pain and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2024 The reporter was patient itself. The patient received the Shingrix vaccine he started feeling tired, developed pain on the abdomen, developed sensitive skin, patches of rash, and developed what it looked like a spider bite.  The reporter consented to follow up.
Sex: M
Vaccine: MENB, MNQ
Symptoms: Product preparation error
Clinical narrative: dose were Bexsero and Menveo were mixed together; dose were Bexsero and Menveo were mixed together; 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 16-year-old male patient who received Men B NVS (Bexsero) (batch number Z39XM, expiry date 31-OCT-2026) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMXA986A, expiry date 31-OCT-2024) for prophylaxis.   On 20-FEB-2024, the patient received Bexsero and Menveo. On 20-FEB-2024, an unknown time after receiving Bexsero and Menveo, the patient experienced inappropriate preparation of medication (Verbatim: dose were Bexsero and Menveo were mixed together) and inappropriate dose of vaccine administered (Verbatim: dose were Bexsero and Menveo were mixed together). The outcome of the inappropriate preparation of medication and inappropriate dose of 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: 21-FEB-2024 Vaccine coordinator called to report that it was intended to administer 1 dose of Bexsero and 1 dose of Menveo to the same patient. After the vaccines were administered it was detected that 1 Bexsero syringe was empty and a second was only half empty, 1 of the 2-vial presentation of Menveo was empty and another had only 1 vial used (diluent empty and lyophilized unused). Vaccine coordinator was not sure what dose, or a dose were Bexsero and Menveo were mixed, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Health care provider reported that they asked the medical assistant that administrated the vaccines who stated that did not remember what was given to the patient. The reporter consented to follow-up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: potential administration of Infanrix to an 11-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 11-year-old female patient who received DTPa (Infanrix) (batch number 3MY97, expiry date 03-MAR-2024) for prophylaxis.   On 22-JAN-2024, the patient received Infanrix. On 22-JAN-2024, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: potential administration of Infanrix to an 11-year-old patient). 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: 21-FEB-2024 The nurse informed about the potential administration of Infanrix to an 11-year-old patient, which led to an inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 97.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: received Fluzone vaccine on 25-SEP-2023 and then administered a FluLaval vaccine on 26-DEC-2023; 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 97-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) (batch number J9HA9, expiry date 30-JUN-2024) for prophylaxis.   Concomitant products included Fluconazole (Fluzone).   On 26-DEC-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 26-DEC-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced extra dose administered (Verbatim: received Fluzone vaccine on 25-SEP-2023 and then administered a FluLaval vaccine on 26-DEC-2023). 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: 21-FEB-2024 The medical assistant reported that the patient received Fluzone vaccine and then was administered a FluLaval vaccine, which led to extra dose administered. The staff had since called the patient and reported that she had no issues. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Cyanosis, Mobility decreased, Pain in extremity, Peripheral swelling, Skin discolouration
Clinical narrative: fingers started swelling/hard to move his fingers due to the swelling; turning black and blue; fingers are painful; turning black and blue; hard to move fingers; This non-serious case was reported by a consumer via call center representative and described the occurrence of swelling of fingers in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In DEC-2023, the patient received the 1st dose of Shingrix. In DEC-2023, 4 days after receiving Shingrix, the patient experienced swelling of fingers (Verbatim: fingers started swelling/hard to move his fingers due to the swelling), skin discoloration (Verbatim: turning black and blue), pain in fingers (Verbatim: fingers are painful), blue skin (Verbatim: turning black and blue) and mobility decreased (Verbatim: hard to move fingers). The outcome of the swelling of fingers, skin discoloration, pain in fingers, blue skin and mobility decreased were unknown.   It was unknown if the reporter considered the swelling of fingers, skin discoloration, pain in fingers, blue skin and mobility decreased to be related to Shingrix.     It was unknown if the company considered the swelling of fingers, skin discoloration, pain in fingers, blue skin and mobility decreased to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-FEB-2024 The patient received a Shingrix vaccine first dose about 2 months ago (from the day of reporting) and approximately 4 days later, his fingers started swelling and turning black and blue.  The patient stated it was hard to move his fingers due to the swelling, his fingers were painful. The patient reported that it began gradually and had built up over time to be severe. The patient stated that his physician did not know what was causing it.  The patient declined and said would call us if he has additional information.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered a dose of expired Boostrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number E3594, expiry date 18-JAN-2024) for prophylaxis.   On 21-FEB-2024, the patient received Boostrix. On 21-FEB-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: administered a dose of expired Boostrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-FEB-2024 The nurse reported she administered a dose of Boostrix on 21 February 2024 afterward she realized the vaccine had an expiration date of 18 January 2024 which led to expired vaccine used. At the time of reporting, a repeat dose had not been administered.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: accidentally given only the adjuvant portion; accidentally given only the adjuvant portion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number D5934, expiry date 11-DEC-2025) for prophylaxis.   On 21-FEB-2024, the patient received the 1st dose of Shingrix. On 21-FEB-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally given only the adjuvant portion) and inappropriate dose of vaccine administered (Verbatim: accidentally given only the adjuvant portion). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-FEB-2024 A pharmacist called in to report that a patient was accidentally given only the adjuvant portion of Shingrix and wished to know how to proceed which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They gave information about the patient, vaccine and event.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site exfoliation, Injection site pruritus, Injection site swelling, Joint stiffness, Myalgia
Clinical narrative: skin itchy at injection site; skin flakey at injection site; swelling at injection site; sleepy; feverish; couldn't bend her knee; knee felt like she had a Baker's cyst; grueling pain in the muscle of her leg, sharp and mundane; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose administered on 08-NOV-2023). Concurrent medical conditions included necrosis (Necrosis of the Jaw), rheumatoid arthritis, sjogren's and memory disturbance.   On 15-FEB-2024, the patient received the 2nd dose of Shingrix (left arm). In FEB-2024, 4 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: skin itchy at injection site), injection site exfoliation (Verbatim: skin flakey at injection site), injection site swelling (Verbatim: swelling at injection site), sleepiness (Verbatim: sleepy), fever (Verbatim: feverish), stiff knees (Verbatim: couldn't bend her knee), baker's cyst (Verbatim: knee felt like she had a Baker's cyst) and muscle pain (Verbatim: grueling pain in the muscle of her leg, sharp and mundane). The outcome of the injection site itching, injection site exfoliation, injection site swelling, sleepiness, fever, stiff knees and baker's cyst were unknown and the outcome of the muscle pain was resolved.   It was unknown if the reporter considered the injection site itching, injection site exfoliation, injection site swelling, sleepiness, fever, stiff knees, baker's cyst and muscle pain to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site exfoliation, injection site swelling, sleepiness, fever, stiff knees, baker's cyst and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-FEB-2024 Consumer was the reporter. The reporter stated that she had her second Shingrix vaccination and after the vaccination she felt feverish and sleepy. Four days later, at the end of the night, she was itching and her arm started to swell at the injection site. The reporter stated her skin looked flakey. When she went to bed she felt like she had a Baker's cyst in her knee and she couldn't bend her knee. The muscle in her leg felt like grueling pain, sharp and mundane. The consumer reported that now the pain wastotally gone. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Somnolence, Synovial cyst
Clinical narrative: skin itchy at injection site; skin flakey at injection site; swelling at injection site; sleepy; feverish; couldn't bend her knee; knee felt like she had a Baker's cyst; grueling pain in the muscle of her leg, sharp and mundane; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose administered on 08-NOV-2023). Concurrent medical conditions included necrosis (Necrosis of the Jaw), rheumatoid arthritis, sjogren's and memory disturbance.   On 15-FEB-2024, the patient received the 2nd dose of Shingrix (left arm). In FEB-2024, 4 days after receiving Shingrix, the patient experienced injection site itching (Verbatim: skin itchy at injection site), injection site exfoliation (Verbatim: skin flakey at injection site), injection site swelling (Verbatim: swelling at injection site), sleepiness (Verbatim: sleepy), fever (Verbatim: feverish), stiff knees (Verbatim: couldn't bend her knee), baker's cyst (Verbatim: knee felt like she had a Baker's cyst) and muscle pain (Verbatim: grueling pain in the muscle of her leg, sharp and mundane). The outcome of the injection site itching, injection site exfoliation, injection site swelling, sleepiness, fever, stiff knees and baker's cyst were unknown and the outcome of the muscle pain was resolved.   It was unknown if the reporter considered the injection site itching, injection site exfoliation, injection site swelling, sleepiness, fever, stiff knees, baker's cyst and muscle pain to be related to Shingrix.     It was unknown if the company considered the injection site itching, injection site exfoliation, injection site swelling, sleepiness, fever, stiff knees, baker's cyst and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-FEB-2024 Consumer was the reporter. The reporter stated that she had her second Shingrix vaccination and after the vaccination she felt feverish and sleepy. Four days later, at the end of the night, she was itching and her arm started to swell at the injection site. The reporter stated her skin looked flakey. When she went to bed she felt like she had a Baker's cyst in her knee and she couldn't bend her knee. The muscle in her leg felt like grueling pain, sharp and mundane. The consumer reported that now the pain wastotally gone. The reporter consented to follow up.
Age: 0.75
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Administered by accident a Boostrix dose to patient instead of Pediarix; Administered by accident a Boostrix dose to patient instead of Pediarix; 9 month old patient received Boostrix vaccine; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in a 9-month-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21-FEB-2024, the patient received Boostrix. On 21-FEB-2024, an unknown time after receiving Boostrix, the patient experienced accidental underdose (Verbatim: Administered by accident a Boostrix dose to patient instead of Pediarix), wrong vaccine administered (Verbatim: Administered by accident a Boostrix dose to patient instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: 9 month old patient received Boostrix vaccine). The outcome of the accidental underdose, wrong vaccine administered and inappropriate age at vaccine administration 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: 22-FEB-2024 The pediatrician reported that a medical assistant administered by accident a Boostrix dose to an underage patient instead of Pediarix, which led to an accidental underdose, wrong vaccine administered and inappropriate age at vaccine administration.   The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This case had been linked with US2024023947, reported by the same reporter.; Sender's Comments:  US-GSK-US2024023947:Different patient
Age: 0.17
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose, Wrong product administered
Clinical narrative: Administered by accident a Boostrix dose to patient instead of Pediarix; Administered by accident a Boostrix dose to patient instead of Pediarix; Boostrix dose recived by to a 2 month; This non-serious case was reported by a physician via call center representative and described the occurrence of accidental underdose in a 2-month-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 21-FEB-2024, the patient received Boostrix. On 21-FEB-2024, an unknown time after receiving Boostrix, the patient experienced accidental underdose (Verbatim: Administered by accident a Boostrix dose to patient instead of Pediarix), wrong vaccine administered (Verbatim: Administered by accident a Boostrix dose to patient instead of Pediarix) and inappropriate age at vaccine administration (Verbatim: Boostrix dose recived by to a 2 month). The outcome of the accidental underdose, wrong vaccine administered and inappropriate age at vaccine administration 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: 22-FEB-2024 The pediatrician reported that a medical assistant administered by accident a Boostrix dose to a underage patient instead of Pediarix, which led to accidental underdose, wrong vaccine administered and inappropriate age at vaccine administration.   The vaccine administration facility was the same as primary reporter. This case had been link with US2024023946, reported by the same reporter.; Sender's Comments:  US-GSK-US2024023946:Different patient
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: accidentally administered a 10 mcg dose of Engerix-B (pediatric) to an adult patient; accidentally administered a 10 mcg dose of Engerix-B (pediatric) to an adult patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 9K74F, expiry date 27-OCT-2025) for prophylaxis.   On 22-FEB-2024, the patient received Engerix B pediatric 10 µg. On 22-FEB-2024, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: accidentally administered a 10 mcg dose of Engerix-B (pediatric) to an adult patient) and adult use of a child product (Verbatim: accidentally administered a 10 mcg dose of Engerix-B (pediatric) to an adult patient). The outcome of the accidental underdose and adult use of a child product 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: 22-FEB-2024 The registered nurse reported they accidentally administered a 10 mcg dose of Engerix-B pediatric to an adult patient, which led to accidental underdose and adult use of a child product.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: reconstituted with a sterile saline diluent different from what accompanies Rotarix; staff member administered Rotarix wrong diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 422GF, expiry date 24-FEB-2025) for prophylaxis.   On 09-DEC-2023, the patient received Rotarix lyophilized formulation. On 09-DEC-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with a sterile saline diluent different from what accompanies Rotarix) and inappropriate dose of vaccine administered (Verbatim: staff member administered Rotarix wrong diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of 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: 22-FEB-2024 The MA (medical assistant) reported that the staff member administered Rotarix to a patient that was reconstituted with a sterile saline diluent different from what accompanies Rotarix, which led to, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to the follow up.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Maladministration of Engerix-B after the expiration date; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HBV (Engerix B) (batch number 9255P, expiry date 15-FEB-2024) for prophylaxis.   On 22-FEB-2024, the patient received the 3rd dose of Engerix B. On 22-FEB-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Maladministration of Engerix-B after the expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-FEB-2024 The pharmacist reported that on the day of reporting a patient received Engerix-B expired dose, which led to an expired vaccine used. The reporter consented to follow up.
Age: 47.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose of Twinrix after the recommended interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 47-year-old male patient who received HAB (Twinrix) (batch number H7RF2, expiry date 17-JAN-2026) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on an unknown date).   On 22-FEB-2024, the patient received the 2nd dose of Twinrix. On 22-FEB-2024, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received the second dose of Twinrix after the recommended interval). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-FEB-2024  The healthcare professional reported that a patient had received the second dose of Twinrix after the recommended interval, which led to lengthening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, Thrombosis
Clinical narrative: THREE BLOOD CLOTS; TWO STROKES; This spontaneous report received from a patient via another company (Pfizer Inc: 202400043965) on 21-FEB-2024 was received on 21-FEB-2024 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: allergy. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number: 1808 980) dose was not reported, administered on 07-MAY-2021 10:30 to Left Arm for covid-19 prophylaxis. No concomitant medications were reported. On 14-SEP-2021 01:00, the patient experienced three blood clots, and two strokes (dose series 1). Patient received blood thinner for the adverse events. On 16-FEB-2024, Laboratory data included: COVID-19 virus test results not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from three blood clots, and two strokes. This report was serious (Disability Or Permanent Damage).; Sender's Comments: V0:  Thrombosis, Cerebrovascular accident. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: Basal cell carcinoma, Nasal discomfort
Clinical narrative: basal skin cell cancer; consistent left nasal passage interior and the nostril and exterior problems since the last booster shot in 2021; This spontaneous case was reported by a patient and describes the occurrence of BASAL CELL CARCINOMA (basal skin cell cancer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced NASAL DISCOMFORT (consistent left nasal passage interior and the nostril and exterior problems since the last booster shot in 2021). On an unknown date, the patient experienced BASAL CELL CARCINOMA (basal skin cell cancer) (seriousness criterion medically significant). At the time of the report, BASAL CELL CARCINOMA (basal skin cell cancer) and NASAL DISCOMFORT (consistent left nasal passage interior and the nostril and exterior problems since the last booster shot in 2021) had not resolved.            No concomitant medication was reported. It was reported that patient had an aggressive dermatologist who scraped off part of nose on the outside currently and told him it was basal skin cell cancer. No treatment medication was reported.  Company comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) event of basal cell carcinoma which occurred after the administration of mRNA-1273 vaccine, used as a third dose. Latency could not be assessed due to a lack of information about the onset date. The causality for the event of basal cell carcinoma is assessed as not related due to inconsistency in the safety profile of the drug and the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Head discomfort, Headache, Musculoskeletal stiffness
Clinical narrative: Arm getting hard and starting to hurt; Arm starting to hurt; a little head spacy-ness; Chills; feeling tired; mild headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm getting hard and starting to hurt), PAIN IN EXTREMITY (Arm starting to hurt), HEAD DISCOMFORT (a little head spacy-ness), CHILLS (Chills) and FATIGUE (feeling tired) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine on 05-Nov-2021, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 19-Sep-2022, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 19-Apr-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) and Moderna covid-19 vaccine. Concurrent medical conditions included Scoliosis and Kidney disorder.    On 21-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 21-Sep-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm getting hard and starting to hurt), PAIN IN EXTREMITY (Arm starting to hurt), HEAD DISCOMFORT (a little head spacy-ness), CHILLS (Chills), FATIGUE (feeling tired) and HEADACHE (mild headache). On 22-Sep-2023, MUSCULOSKELETAL STIFFNESS (Arm getting hard and starting to hurt), PAIN IN EXTREMITY (Arm starting to hurt), HEAD DISCOMFORT (a little head spacy-ness), CHILLS (Chills), FATIGUE (feeling tired) and HEADACHE (mild headache) had resolved.            No concomitant medication was reported.  Client stated that she spaced out having received her flu and RSV immunizations but spaces them all out by 2-3-4 weeks along with the COVID vaccine. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-762082, US-MODERNATX, INC.-MOD-2023-716451, US-MODERNATX, INC.-MOD-2023-716240 (Linked Report). This case was linked to MOD-2021-304545 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-762082:Son case US-MODERNATX, INC.-MOD-2023-716240:SPIKEVAX 2023-2024 Case US-MODERNATX, INC.-MOD-2023-716451:Husband case
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm getting hard and starting to hurt; Arm starting to hurt; a little head spacy-ness; Chills; feeling tired; mild headache; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Arm getting hard and starting to hurt), PAIN IN EXTREMITY (Arm starting to hurt), HEAD DISCOMFORT (a little head spacy-ness), CHILLS (Chills) and FATIGUE (feeling tired) in a 74-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: Moderna covid-19 vaccine on 05-Nov-2021, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 19-Sep-2022, MODERNA COVID-19 VACCINE and BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) on 19-Apr-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) and Moderna covid-19 vaccine. Concurrent medical conditions included Scoliosis and Kidney disorder.    On 21-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 21-Sep-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (Arm getting hard and starting to hurt), PAIN IN EXTREMITY (Arm starting to hurt), HEAD DISCOMFORT (a little head spacy-ness), CHILLS (Chills), FATIGUE (feeling tired) and HEADACHE (mild headache). On 22-Sep-2023, MUSCULOSKELETAL STIFFNESS (Arm getting hard and starting to hurt), PAIN IN EXTREMITY (Arm starting to hurt), HEAD DISCOMFORT (a little head spacy-ness), CHILLS (Chills), FATIGUE (feeling tired) and HEADACHE (mild headache) had resolved.            No concomitant medication was reported.  Client stated that she spaced out having received her flu and RSV immunizations but spaces them all out by 2-3-4 weeks along with the COVID vaccine. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-762082, US-MODERNATX, INC.-MOD-2023-716451, US-MODERNATX, INC.-MOD-2023-716240 (Linked Report). This case was linked to MOD-2021-304545 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-762082:Son case US-MODERNATX, INC.-MOD-2023-716240:SPIKEVAX 2023-2024 Case US-MODERNATX, INC.-MOD-2023-716451:Husband case
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle spasms; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle spasms) in a 61-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031894) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: SHINGRIX (SHINGRIX VIAL (10-PK) KIT) on 07-Feb-2024. Past adverse reactions to the above products included No adverse effect with SHINGRIX.    On 17-Feb-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 18-Feb-2024, after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced MUSCLE SPASMS (muscle spasms). The patient was treated with CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for Muscle spasms, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Muscle spasms, at an unspecified dose and frequency and CORTISONE for Muscle spasms, at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (muscle spasms) was resolving.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  The patient had muscle spasms that went on all week. Patient went to a chiropractor then an orthopedic Dr and by the falling Sunday patient went to hospital. Patient started physical therapy. On an Unknown date, urine test, CT scan, MRI were performed; however, there were no additional lab data/results available. Patient was given Flexeril, in the hospital was given an anti-inflammatory and Advil, and Orthopedic Dr gave her a cortisone shot.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Heart rate, Palpitations
Clinical narrative: swelling of face and throat; dizziness and weakness; Trouble breathing; swelling of face and throat; fast heart beat; dizziness and weakness; rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of face and throat), ASTHENIA (dizziness and weakness), DYSPNOEA (Trouble breathing), PHARYNGEAL SWELLING (swelling of face and throat) and PALPITATIONS (fast heart beat) in a 47-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19.) on 26-May-2022. Concurrent medical conditions included Allergy.    On 08-Feb-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 08-Feb-2024, the patient experienced SWELLING FACE (swelling of face and throat), ASTHENIA (dizziness and weakness), DYSPNOEA (Trouble breathing), PHARYNGEAL SWELLING (swelling of face and throat), PALPITATIONS (fast heart beat), DIZZINESS (dizziness and weakness) and RASH (rash all over body). At the time of the report, SWELLING FACE (swelling of face and throat), ASTHENIA (dizziness and weakness), DYSPNOEA (Trouble breathing), PHARYNGEAL SWELLING (swelling of face and throat), PALPITATIONS (fast heart beat), DIZZINESS (dizziness and weakness) and RASH (rash all over body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2024, Heart rate: fast heart beat.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Concomitant product use was not provided by the reporter.  Vaccine was given by shot. Patient was given at the facility.  It was unknown if the patient experienced any additional symptoms or events. He still had not been sent to a hospital for recovery and had been worsening. This could be malpractice.  There were no other lab data or results were available.  Treatment information was not provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Rash, Swelling face
Clinical narrative: swelling of face and throat; dizziness and weakness; Trouble breathing; swelling of face and throat; fast heart beat; dizziness and weakness; rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling of face and throat), ASTHENIA (dizziness and weakness), DYSPNOEA (Trouble breathing), PHARYNGEAL SWELLING (swelling of face and throat) and PALPITATIONS (fast heart beat) in a 47-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was diagnosed with Covid 19.) on 26-May-2022. Concurrent medical conditions included Allergy.    On 08-Feb-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 08-Feb-2024, the patient experienced SWELLING FACE (swelling of face and throat), ASTHENIA (dizziness and weakness), DYSPNOEA (Trouble breathing), PHARYNGEAL SWELLING (swelling of face and throat), PALPITATIONS (fast heart beat), DIZZINESS (dizziness and weakness) and RASH (rash all over body). At the time of the report, SWELLING FACE (swelling of face and throat), ASTHENIA (dizziness and weakness), DYSPNOEA (Trouble breathing), PHARYNGEAL SWELLING (swelling of face and throat), PALPITATIONS (fast heart beat), DIZZINESS (dizziness and weakness) and RASH (rash all over body) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2024, Heart rate: fast heart beat.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  Concomitant product use was not provided by the reporter.  Vaccine was given by shot. Patient was given at the facility.  It was unknown if the patient experienced any additional symptoms or events. He still had not been sent to a hospital for recovery and had been worsening. This could be malpractice.  There were no other lab data or results were available.  Treatment information was not provided.
Age: 32.0
Sex: F
Vaccine: HPV9
Symptoms: Skin reaction
Clinical narrative: allergic skin reaction
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Shoulder injury related to vaccine administration, Sleep disorder, Spinal pain
Clinical narrative: Pt called to state that she has been suffering from SIRVA (shoulder injury related to vaccine administration) since date of administration.  She is certain that RPh who administered vaccine gave the dose too high on her shoulder.   Pt claims she has been suffering from a painful shoulder since date of admin, and keeps her awake at night. Also states it has been 1 month and condition is not resolving. Oncologist would like to do steroid shot but pt is unable at this time due to current cancer condition.  Is in process of making appt with primary dr for further treatment.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product administration error
Clinical narrative: No adverse reaction or event was noted. However, Adacel was given to an 8yr old patient and the indicated age for adacel is age 10-64. After research, it was found that no dose was needed for patient, due to her previous Dtap doses.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dry mouth, Headache, Injection site pain, Nausea
Clinical narrative: Patient received Shingrix dose #1 @12:05PM on 2.28.24 and called the pharmacy around 5PM on 2.28.24 to inquire about the reaction to the vaccine. Patient reported nausea, headache, pain at the injection site, dizziness and dry mouth.  Patient denied shortness of breath, swelling on the face/throat.  Patient was informed about usual side effect and advised to seek medical help if the reaction gets worse. Patient saw MD on 2.29.24 and MD reassured patient that it's a normal side effect to vaccine and continue hydration and rest.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: REDNESS, SWELLING AND WARM IN THE AREA WHERE THE VACCINE WAS ADMINISTERED (LEFT DELTOID). TREATED WITH PAIN MEDICATION AND WARM COMPRESSES
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group. A 70-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023- 2024 FORMULA)), on 23Sep2023 at 14:30 as dose 1, single (Lot number: HG4629) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 at 13:30 as dose 1, single (Lot number: EL3249), on 24Feb2021 at 13:30 as dose 2, single (Lot number: EL9265), on 24Sep2021 at 14:30 as dose 3 (booster), single (Lot number: 3014SBA) and on 11Apr2022 at 14:30 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "plaque in left side of heart" (unspecified if ongoing); "Wool/lanolin" (unspecified if ongoing); "Wool/lanolin" (unspecified if ongoing); "sun dried tomatoes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rosouvastatin for plaque in left side of heart. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 71-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Nov2023 as dose 1 (toppac), single (Lot number: HJ7224) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications for thyroid. No known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. clinical course: Patient reported that, patient took COVID-19 treatment from 16Feb2024 to 20Feb2024, and her COVID-19 symptom rebound on 25Feb2024.
Age: 79.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Bone pain, Fatigue, Headache, Myalgia
Clinical narrative: Headache; Muscle ache; Low-grade temperature/fever up to 101.4 F; fatigued; bone aches; Arm was sore; joints were sore; Body ache; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 80-year-old female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 20Oct2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 79 years intramuscular, in left arm for immunisation. The patient's relevant medical history included: "COPD" (ongoing). Concomitant medication(s) included: ADVAIR taken for chronic obstructive pulmonary disease; SPIRIVA [TIOTROPIUM BROMIDE MONOHYDRATE] taken for chronic obstructive pulmonary disease; PROAIR HFA. The following information was reported: HEADACHE (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "Muscle ache"; PYREXIA (non-serious), outcome "recovered", described as "Low-grade temperature/fever up to 101.4 F"; FATIGUE (non-serious), outcome "recovered", described as "fatigued"; BONE PAIN (non-serious), outcome "recovered", described as "bone aches"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Arm was sore"; ARTHRALGIA (non-serious), outcome "recovered", described as "joints were sore"; PAIN (non-serious), outcome "recovered", described as "Body ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, myalgia, pyrexia, fatigue, bone pain, pain in extremity, arthralgia, pain.  Additional information: The patient had a very strong reaction to the Pfizer RSV vaccine consistent of fever up to 101.4 F for three days, bone aches, muscle ache, fatigue, very strong headache, vey fatigued and, a low-grade temperature. Her symptoms lasted for two weeks. The caller asks if she should get the RSV vaccine again. The patient believed the route of administration was intramuscular because her arm was sore, joints were sore. No other investigations. Took Codeine aspirin as treatment.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.