chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Connective tissue disorder" (unspecified if ongoing), notes: took immunosuppressants. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid on 25May2023 to 25May2023  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diverticulitis, Feeding disorder, Illness, Night sweats, Pain
Clinical narrative: diverticulitis; sick; can't eat or drink; side pain; night sweats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 18Apr2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEEDING DISORDER (non-serious) with onset 2023, outcome "unknown", described as "can't eat or drink"; DIVERTICULITIS (medically significant) with onset 2023, outcome "unknown"; NIGHT SWEATS (non-serious) with onset 2023, outcome "unknown"; ILLNESS (non-serious) with onset 2023, outcome "unknown", described as "sick"; PAIN (non-serious) with onset 2023, outcome "unknown", described as "side pain".   Clinical course: Caller was asking how far apart the first Pfizer COVID-19 monovalent vaccine and the Pfizer COVID -19 bivalent vaccine should be administered? Caller provided that she received her first Pfizer COVID-19 monovalent vaccine on 18Apr2023 and then received the Pfizer COVID-19 bivalent vaccine three weeks later on 09May2023. Caller stated that the healthcare provider told her that during this time period between vaccines, the authorization had changed and only bivalent was available to be administered. Caller provided that she was "real sick from it, so sick that she can't eat or drink." Caller stated that she had "high fever, night sweats, chills, side pain, and what she eats comes right back out." Caller provided that her doctor stated she "has diverticulitis because of the COVID shot."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300198955 same patient/vaccine,different dose/AE;
Sex: M
Vaccine: COVID19
Symptoms: Alopecia, Incorrect route of product administration
Clinical narrative: alopecia; Inappropriate route of vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  An adult male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intravenous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Inappropriate route of vaccination".  Additional information: Reporter stated so both reporter (daughter) and her father developed what appears to be alopecia after being vaccinated. Now Pfizer was introducing a new drug for alopecia. Just curious if anyone else developed this after being vaccinated, patient wants to know exposure. Reporter considered event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Crying, Dysgraphia, Gait disturbance, Hypersomnia, Pain in extremity
Clinical narrative: having trouble walking; legs hurt/hands hurt/Her legs and her hands worsen every week, every month; crying; She can't write now anyway; They go to sleep all the time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 13Jan2022 as dose 3 (booster), single (Lot number: FJ5682), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EP7533, Anatomical location: right arm), administration date: 29Mar2021, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE, Lot Number: EP7533, Anatomical location: left arm), administration date: 19Apr2021, for Covid-19 immunization. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "having trouble walking"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "legs hurt/hands hurt/Her legs and her hands worsen every week, every month"; CRYING (non-serious), outcome "unknown"; DYSGRAPHIA (non-serious), outcome "unknown", described as "She can't write now anyway"; HYPERSOMNIA (non-serious), outcome "unknown", described as "They go to sleep all the time".  Additional information: She said that she took the COVID Pfizer vaccine booster, and since she received it her health became worse. She was having trouble walking and getting out of bed, including sitting up. She was crying. Her legs hurt all the time. She cannot write any-way. Her hands hurt too bad. They go to sleep all the time. This is all since the vaccine. Before the vaccine she was able to paint her walls with a brush. Now she cannot even paint a fingernail now. After the booster, she started to experience it within 30 days. Her problems were bilateral, and more in her legs than her arms. She has had no other vaccines. Prior Vaccinations within 4 weeks were none.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Symptomatic Covid 19 Infection confirmed by at home test.; Symptomatic Covid 19 Infection confirmed by at home test.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2022 as dose 4 (booster), single (Lot number: EL3248) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatric Arthritis" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jun2023 at 15:00, outcome "recovering" and all described as "Symptomatic Covid 19 Infection confirmed by at home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2023) Positive, notes: at 15:00 Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with PAXLOVID.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Overdose, Product preparation error, Wrong product administered
Clinical narrative: allergies; a patient is given an undiluted vaccine dose; a patient is given an undiluted vaccine dose; Patient has had no previous doses of Covid vaccine.; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 6-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jun2023 as dose 1 (orange cap), 0.2 ml single (Lot number: GK1657, Expiration Date: 29Aug2023) at the age of 6 years, in right deltoid for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Atopic dermatitis" (ongoing); "cough" (unspecified if ongoing); "wheezing" (unspecified if ongoing); "shortness of breath" (unspecified if ongoing); "allergy to eggs" (unspecified if ongoing). Concomitant medication(s) included: VENTOLIN HFA taken for cough, wheezing, dyspnoea (ongoing); EPINEPHRINE taken for food allergy (ongoing). The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 06Jun2023, outcome "unknown", described as "Patient has had no previous doses of Covid vaccine."; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 06Jun2023, outcome "unknown" and all described as "a patient is given an undiluted vaccine dose"; HYPERSENSITIVITY (non-serious) with onset 06Jun2023, outcome "unknown", described as "allergies". Additional information: The event a patient is given an undiluted vaccine dose was reported as serious (hospitalization). The patient was prescribed Fluticasone nasal spray for allergies and Acetaminophen to take as needed for fever.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 25Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 15Nov2021 as dose 3 (booster), single (Lot number: FD0809), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19. COVID 19 Treatment start date was on 22May2023 and stop date was on 26May2023. The patient has no known allergies and no other medical history.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on a home test for covid about one month ago/ Pain/ Bad cold; tested positive on a home test for covid about one month ago/ Pain/ Bad cold; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9269) intramuscular, in left arm, on 11Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 02Sep2021 as dose 3 (booster), single (Lot number: FF8841) and on 05May2022 as dose 4 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "tested positive on a home test for covid about one month ago/ Pain/ Bad cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2023) Positive, notes: Covid Home Test; It was either 01May2023 or 06May2023 somewhere around there. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: It was reported initially that the patient had three previous doses of Pfizer COVID 19 vaccine; patient is aware that there is another dose of the covid vaccine from Pfizer, does not know specifically which formulation he had had. The patient reported that he tested positive on a home test for Covid about one month ago. The patient asked when he may receive another dose of the vaccine. The Covid test was done either on 01May2023 or 06May2023 somewhere around there (as reported). The treatment received was Over the Counter stuff for Pain, it was like bad cold. Patient could not tell if the lot number was  FK9596 or FK9598, but he thought it was FK9596.The vaccination time for first, second and third vaccination was reported as sometime during day time. The prior vaccinations (within 4 weeks) was reported as None. The Adverse event did not require visit to Physician office or Emergency room. The patient's thought process was if got bad, where to read about it and he felt it was like allergies too. It was not bad enough to go, therefore he stayed home. The patient stated he was calling to determine if he has had covid and according to the testing he did he wants to know if there is a waiting period; asked if he kept getting notified about getting the booster thing for someone his age, he asked if he should wait.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness in the arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Echocardiogram, Electrocardiogram, Urticaria, Vaccination site reaction
Clinical narrative: very severe site reaction; it swelled up very significant swelling; incredible welt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 14Mar2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1998 (ongoing); "Immunosupressed" (unspecified if ongoing), notes: has an underlying condition and is immune suppressed. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot#: EL9263), administration date: 25Jan2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "sore arm", "did not feel 100 percent but felt ok"; BNT162b2 (DOSE 2; Lot#: EN6201), administration date: 15Feb2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "typical sore arm", "did not feel 100 percent"; BNT162b2 (DOSE 3; Lot#: FC3184), administration date: 06Sep2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "typical sore arm", "did not feel 100 percent". The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "very severe site reaction"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "it swelled up very significant swelling"; URTICARIA (non-serious), outcome "unknown", described as "incredible welt". The events "very severe site reaction", "it swelled up very significant swelling" and "incredible welt" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site reaction, vaccination site swelling, urticaria.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300214232 Same product, patient, different event, different dose;US-PFIZER INC-202300215225 Same product, patient, different event, different dose;US-PFIZER INC-202300215226 Same product, patient, different event, different dose;US-PFIZER INC-202300215227 Same product, patient, different event, different dose;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, X-ray
Clinical narrative: very severe site reaction; it swelled up very significant swelling; incredible welt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 14Mar2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 69 years for covid-19 immunisation. The patient's relevant medical history included: "MS", start date: Aug1998 (ongoing); "Immunosupressed" (unspecified if ongoing), notes: has an underlying condition and is immune suppressed. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1; Lot#: EL9263), administration date: 25Jan2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "sore arm", "did not feel 100 percent but felt ok"; BNT162b2 (DOSE 2; Lot#: EN6201), administration date: 15Feb2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "typical sore arm", "did not feel 100 percent"; BNT162b2 (DOSE 3; Lot#: FC3184), administration date: 06Sep2021, when the patient was 68-year-old, for COVID-19 immunization, reaction(s): "typical sore arm", "did not feel 100 percent". The following information was reported: VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "very severe site reaction"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "it swelled up very significant swelling"; URTICARIA (non-serious), outcome "unknown", described as "incredible welt". The events "very severe site reaction", "it swelled up very significant swelling" and "incredible welt" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site reaction, vaccination site swelling, urticaria.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300214232 Same product, patient, different event, different dose;US-PFIZER INC-202300215225 Same product, patient, different event, different dose;US-PFIZER INC-202300215226 Same product, patient, different event, different dose;US-PFIZER INC-202300215227 Same product, patient, different event, different dose;
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Pulmonary embolism, Thrombosis
Clinical narrative: blood clots; pulmonary embolism; trouble breathing; The initial case was missing the following minimum criteria: ICH-Unidentifiable reporter. Upon receipt of follow-up information on 06Jun2023, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1), for covid-19 immunisation; Bnt162b2 (dose 2), for covid-19 immunisation. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "blood clots"; PULMONARY EMBOLISM (medically significant), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "trouble breathing". The patient had blood clotting since the patient got 3 jabs of Pfizer vaccine Covid Vaccine - BNT162b2. After pulmonary embolism the patient have trouble breathing. Therapeutic measures were taken as a result of thrombosis, Pulmonary embolism.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC13
Symptoms: Blood immunoglobulin G, Drug ineffective, Laboratory test, Pneumonia necrotising
Clinical narrative: necrotizing pneumonia; necrotizing pneumonia; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 3-year-old patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA NECROTISING (medically significant), outcome "unknown" and all described as "necrotizing pneumonia". The patient underwent the following laboratory tests and procedures: lab work: IGG protection for 5 of the 13 serotypes, notes: IGG protection for 5 of the 13 serotypes in Prevnar 13. Additional information: A 03-year-old had necrotizing pneumonia and the physician had lab work performed which showed IGG protection for 5 of the 13 serotypes in Prevnar 13. Event took place after use of product.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine PREVENAR 13 administration.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pyrexia, Trigger finger
Clinical narrative: Trigger Thumb; Low fever; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230515000035 (Moderna).  A 71-year-old female patient received BNT162b2 (BNT162B2), on 17May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 71 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Feb2021 as dose 1, single (Lot number: 029L20A), on 03Mar2021 as dose 2, single (Lot number: 011A21A) and on 09Nov2021 as dose 3 (booster), single (Lot number: 066F21A) for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 23Sep2022 as dose 5 (booster), single (Lot number: AS7140C) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Flu" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Flu vaccine (she received her flu shot last year but waited after a few weeks after the bivalent dose.), administration date: 2022, for Flu vaccination. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17May2022, outcome "unknown"; TRIGGER FINGER (medically significant), outcome "unknown", described as "Trigger Thumb"; PYREXIA (non-serious), outcome "unknown", described as "Low fever". The event "trigger thumb" required physician office visit. Clinical course: Patient wanted to get her 2nd bivalent Moderna shot but she would also be needing to get a steroid shot for her trigger thumb. She had her trigger thumb 6 weeks ago and she thought this was due to over use and not due to the vaccine. All were Moderna except for the 4th dose. The 1st 3 doses were administered at [Withheld] (drive through event) and the last 2 at the [withheld]. Caller stated that she received her flu shot last year but waited after a few weeks after the bivalent dose. She mentioned that she received the Bivalent dose like a month ago and the only symptom she experienced with this and all the other vaccines was low fever someday after. Patient mentioned that because of her trigger thumb the doctor advised her to wait 2 weeks after the bivalent to get a steroid shot, and she wanted to know if Moderna could confirm if it was  recommended to wait for her steroid shot 2 weeks. The vaccine recipient's Age information was unknown. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Therapeutic response unexpected
Clinical narrative: work on Scleroderma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Scleroderma" (ongoing), notes: I say reversed my chronic condition which presumably is Scleroderma. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "work on Scleroderma". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that since started getting COVID vaccine shots, it improved. The patient said reversed chronic condition which presumably was Scleroderma. Other part of the patient protocol was Neem. Getting a booster every few weeks together with caps/oil seem remarkably appear to actually work on Scleroderma, which was a nasty incurable condition. The patient wanted to share this in case you want to explore new applications for your mRNA products. In terms of bloodwork I have antibodies.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: horrible joint pain in my hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "horrible joint pain in my hands".  Additional information: Reported as, patient now have horrible joint pain in hands and was told it was from the vaccine. patient received two vaccines and a booster. patient hands were in constant pain like patient had never had before. patient was a surgical technologist and patient hands were patient job and now patient can barely use them. patient was 43, patient was barely able to use hands to work anymore. patient was going to lose job because of vaccine that patient was convinced and pressured and forced to take or lose my job.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: I just know that this particular shot has some bad side effect your arm swells and hurt; I just know that this particular shot has some bad side effect your arm swells and hurt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "I just know that this particular shot has some bad side effect your arm swells and hurt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter's Comments: ~~~
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: occurrence of chest pain following the second Covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "occurrence of chest pain following the second Covid vaccine". Additional information: Patient would like to know the occurrence of chest pain following the second Covid vaccine as he/she have has recurring chest pain ever since his/her second vaccination 2 years ago.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: FLUR4
Symptoms: Immunisation reaction
Clinical narrative: had a reaction to Flublok; Initial information was received on 05-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age female patient who had a reaction to influenza quadrivalent recombinant vaccine [Flublok QIV] after receiving it.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in Sep-2022, the patient received 0.5 ml, total dose of suspect influenza quadrivalent recombinant vaccine (prefilled) (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization. The information on the batch number was requested.  On an unknown date the patient had a reaction to flublok (immunisation reaction) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  It was reported The health-care professional reported it but now the patient wants information on the inactive ingredients in the vaccine. Provided the inactive ingredients per the PI. The health-care professional wanted the ingredient information be emailed to her.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: both vaccines were given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end; Initial information received on 05-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 73 years old male patient who was administered vaccines Influenza Quadrival A-B High dose HV vaccine [Fluzone High-Dose Quadrivalent] given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Tozinameran (Pfizer Biontech Covid-19 vaccine) for Prophylactic vaccination.  On an unknown date in Oct-2022, the patient received 0.7ml dose (frequency: once; strength: standard) of suspect Influenza Quadrival A-B High dose HV vaccine of lot UG919AC and expiry: 30-Jun-2023 via intramuscular route in the left arm for immunization.  On an unknown date in Oct-2022, the patient developed both vaccines were given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end (peripheral swelling) (latency: 1 day) following the administration of Influenza Quadrival A-B High dose HV Vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (both vaccines were given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end).  At time of reporting, the outcome was Unknown for the event both vaccines were given into the left arm; on the next day had swelling left arm, swell 3 times the normal size, began at the top portion and then extended to the fingertip end.
Age: 5.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adacel was administered to a 5 year old patient by mistake, with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 years old female patient who had adacel was administered to a 5 year old patient by mistake, with no reported adverse event after receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's past medical history, medical treatment(s), and family history were not provided. No concomitant vaccines were given.   On 02-Jun-2023, the patient received a 0.5 ml once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection,  unknown strength, expiration date, lot U47461AA via intramuscular route in unknown administration site for Immunization.  On 02-Jun-2023 the patient developed a non-serious adacel was administered to a 5 year old patient by mistake, with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  Outcome: Unknown for the event adacel was administered to a 5 year old patient by mistake, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.42
Sex: M
Vaccine: IPV
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: the Ipol was exposed to 8.2 C for 5 mins with no reported adverse event; the Ipol was administered to 5 month old child with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old male patient and the IPV (VERO) [IPOL] was exposed to 8.2 c for 5 mins with no reported adverse event and administered. .  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Prophylactic vaccination.  On 31-May-2023, the patient received a 0.5 ml dose of suspect IPV (VERO) suspension for injection (strength: not reported; expiry date: 16-Jun-2025, lot W1A191M) via subcutaneous route in the left thigh for Immunization and administered to 5 month old child with no reported adverse event (poor quality product administered) (same day latency)  On an unknown date the ipol was exposed to 8.2 c for 5 mins with no reported adverse event (product storage error) (unknown latency).  Human error: YES; product administered to a patient: YES  Action taken:  not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: YF
Symptoms: No adverse event, Product preparation error
Clinical narrative: YF-Vax was mixed with sterile water instead of the diluent and administered to a patient with no reported adverse event; Initial information received on 06-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient where yellow fever vaccine [YF-vax] mixed with sterile water instead of the diluent and administered to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect yellow fever vaccine. Solution for injection lot number not reported via unknown route in unknown administration site (dose, frequency, strength and expiration date: not provided) for prophylactic vaccination, Information on the batch number was requested and YF-Vax was mixed with sterile water instead of the diluent and administered to a patient with no reported adverse event (product preparation error) (latency- same day) following the administration of yellow fever vaccine.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Insomnia, Muscular weakness, Myalgia
Clinical narrative: Extreme muscular pain, muscle weakness, fever, swelling of entire upper arm, nausea, chills, sweating , insomnia
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Extreme muscular pain, muscle weakness, fever, swelling of entire upper arm, nausea, chills, sweating , insomnia
Sex: U
Vaccine: HPV4, HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: approximately 20 years ago but did not complete the series/Patient has now come in and would like to complete the 3 dose series; No AE/PQC reported; This spontaneous report has been received from a healthcare professional and refers to a 44-year-old patient of unknown gender.  The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date (also reported as approximately 20 years ago), the patient was vaccinated with two doses of either hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and anatomical site of administration were not provided) but did not complete the series and wanted to complete the 3-dose series (Inappropriate schedule of product administration). No other adverse events were reported.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Boostrix + Administration of expired dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 10-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 4N2EZ, expiry date 03-JUN-2023) for prophylaxis.   On 06-JUN-2023, the patient received Boostrix. On 06-JUN-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix + Administration of expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Jun-2023 The nurse asked that the dose was valid. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received an expired dose of Boostrix, which led to expired vaccine used. The case was linked with case US2023080436, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023080436:same reporter, different patient
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received vaccine after its expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after its expiration date).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. Treatment medications were not provided.  This case was reported for patient 3 of 7.   This case was linked to US-MODERNATX, INC.-MOD-2023-727965 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727965:Master Case of Patient 1
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Vaccination site pain
Clinical narrative: sore right arm of injection; covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) and VACCINATION SITE PAIN (sore right arm of injection) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included Blood pressure high and Cardiac disorder (cardiac issues since befor his first dose of the Modern Covid-19 vaccine.).    On 30-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right arm of injection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) and VACCINATION SITE PAIN (sore right arm of injection) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received the vaccine in his right arm. Patient reported no adverse reactions. The patient received his extra Moderna booster dose on 30-NOV-2022, Lot number 050D22A. The patient and his wife had Covid-19 the week of 09-MAY-2023. It was a mild case of Covid-19 vaccine. Like having the flu for a couple of days and then started to get better. The patient and his wife were prescribed Paxlovid and felt worse after day 1 of the Paxlovid regimen They felt so bad from the Paxlovid worse from Paxlovid than from the Covid-19 infection. Patient's wife and he stopped the Paxlovid after 1 day.   This case was linked to MOD-2023-727713 (Patient Link).