chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Idiopathic urticaria
Clinical narrative: Entire body covered in hives/Diagnosed with chronic idiopathic hives; Angioedema; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa meds" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 04Aug2021, when the patient was 34-year-old, for Covid-19 Immunization. The following information was reported: ANGIOEDEMA (medically significant) with onset 17Mar2023 at 12:00, outcome "not recovered"; IDIOPATHIC URTICARIA (medically significant) with onset 17Mar2023 at 12:00, outcome "not recovered", described as "Entire body covered in hives/Diagnosed with chronic idiopathic hives". The events "entire body covered in hives/diagnosed with chronic idiopathic hives" and "angioedema" required physician office visit.  The adverse event detail information included entire body covered in hives; angiodema and seen rheumatoid arthritis doctor, regular doctor, and allergist, and dermatologist; Diagnosed with chronic idiopathic hives; Nothing gave relief. Therapeutic measures were taken as a result of idiopathic urticaria, angioedema included Xolair shot, zyrtec, Pepcid, atarax, Benadryl, sin.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Lot number: EP7534), in right arm, on 06Apr2021 as dose 2, single (Lot number: ER8729), in left arm and on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 34 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 22Jul2022 as dose 4 (booster), single (Lot number: 017B22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Cardiac Arrhythmia" (unspecified if ongoing); "Palpitations" (unspecified if ongoing); "AV Block 2° Type 1" (unspecified if ongoing); "PVC" (unspecified if ongoing); "PAC" (unspecified if ongoing); "Hypokalemia" (unspecified if ongoing); "Bipolar Disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "PTSD" (unspecified if ongoing); "OCD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Substance Abuse Disorder" (unspecified if ongoing); "Opiate Dependence Disorder" (unspecified if ongoing); "known allergies: Bee Venom" (unspecified if ongoing), notes: known allergies: Bee Venom. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine, Cephalexin, Bee Venom; Cymbalta, reaction(s): "known allergies: Cymbalta", notes: known allergies: Cymbalta; Cephalexin, reaction(s): "known allergies: Cephalexin", notes: known allergies: Cephalexin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 22Jul2022, outcome "unknown"; 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 including paxlovid.; Sender's Comments: Based on available information, a lack of efficacy under interchange of vaccine products with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 42 years, 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergy. Concomitant medication(s) included: SYNTHROID, start date: 15Sep2012, stop date: 06Aug2023; OMEPRAZOLE, start date: 12Feb2022, stop date: 06Aug2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included paxlovid from 22Jul2023-26Jul2023, and had bitter taste rebound after testing negative.  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.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 46-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. COVID-19 Treatment included Paxlovid from 28Jul2023 to 02Aug2023.  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.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, 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: "RA" (unspecified if ongoing); "OA" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Discoid Lupus" (unspecified if ongoing); "Rosacea" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: CT dye" (unspecified if ongoing); "Known allergies: tomatoes" (unspecified if ongoing); "Known allergies: onions" (unspecified if ongoing); "Known allergies: pork" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine"; Biaxin, reaction(s): "Known allergies: Biaxin".The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. 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.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 as dose 5 (booster), single (Lot number: GJ6739) for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3248), on 08Feb2021 as dose 2, single (Lot number: EM9810), on 02Nov2021 as dose 3 (booster), single (Lot number: FF2590) and on 11May2022 as dose 4 (booster), single (Lot number: FP4554) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "Graves Disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperlipidemia" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydroxychloridine, reaction(s): "Known allergies: Hydroxychloridine"; Morphine, reaction(s): "Known allergies: Morphine"; Codeine, reaction(s): "Known allergies: Codeine"; Iodine, reaction(s): "Known allergies: Iodine"; Plaquenil, reaction(s): "Known allergies: Plaquenil"; Tramadol, reaction(s): "Known allergies: Tramadol"; Amitriptyline, reaction(s): "Known allergies: Amitriptyline". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient started the first dose of Paxlovid since 31Jul2023.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Apr2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: sulfa antibiotics" (unspecified if ongoing), notes: known allergies: sulfa antibiotics. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin", notes: known allergies: Amoxicillin; Keflex, reaction(s): "known allergies: keflex", notes: known allergies: keflex. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: positive test 5 days after turning negative; Positive, notes: positive test 5 days after turning negative. Therapeutic measures with Paxlovid from 22Jul2023 to 26Jul2023 were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (DRUG INEFFECTIVE, COVID-19) and BNT162B2.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 62 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: other medical history: High cholesterol; "osteoporosis" (unspecified if ongoing), notes: other medical history: osteoporosis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. 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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Paxlovid treats the covid-19; Paxlovid treats the 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 54-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown). The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid treats the covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "idiopathic thrombocytopenic purpura" (unspecified if ongoing); "asthma" (unspecified if ongoing). No Known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Aug2023) Positive, notes: tested positive a week after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient take Paxlovid from 27Jul2023 to 01Aug2023 as Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 12:30 as dose 4 (booster), single (Lot number: Unknown), 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: "Known allergies: opioids and opiates" (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 05Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19".  On 05Aug2023 the patient came down with very similar symptoms to first Covid infection (sinus, body aches, headache, cough) and test positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Aug2023) negative; (05Aug2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient treated with PAXLOVID from 26Jul2023 to 31Jul2023. 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.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose: 1-3 / Pfizer, Dose: 4; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 49 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Lot number: 040A21A), in left arm, on 13Apr2021 as dose 2, single (Lot number: 016B2VA), in left arm and on 20Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Graves' disease" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "known allergies: Kiwi" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Sep2022, outcome "unknown", described as "Moderna, Dose: 1-3 / Pfizer, Dose: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment from 27Jul2023 to 31Jul2023.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Muscle spasms, Myalgia, Nausea, Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting, muscle cramps/ spasms Narrative:
Age: 50.0
Sex: F
Vaccine: ANTH
Symptoms: Muscle swelling, Pruritus, Skin warm
Clinical narrative: Swollen deltoid muscle large area. Area is warm erythema and itching. There no pain or knot at the injection site.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Cough, Laboratory test, Parosmia
Clinical narrative: Altered loss of taste and smell, prolonged chronic cough
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Taste disorder
Clinical narrative: Altered loss of taste and smell, prolonged chronic cough
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Post herpetic neuralgia
Clinical narrative: Patient says that after the first shot her post herpetic neuralgia became more severe; Patient says that after the first shot her post herpetic neuralgia became more severe; This non-serious case was reported by a nurse via sales rep and described the occurrence of post herpetic neuralgia in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles(shingles rash) in 2017). Concurrent medical conditions included post herpetic neuralgia.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced post herpetic neuralgia (Verbatim: Patient says that after the first shot her post herpetic neuralgia became more severe) and condition aggravated (Verbatim: Patient says that after the first shot her post herpetic neuralgia became more severe). The outcome of the post herpetic neuralgia and condition aggravated were not reported.   It was unknown if the reporter considered the post herpetic neuralgia and condition aggravated to be related to Shingrix.     It was unknown if the company considered the post herpetic neuralgia and condition aggravated to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-AUG-2023 The patient had shingles and reported on and off post herpetic neuralgia after shingles rash cleared.  The patient recently received first shot of Shingrix and did not had an active rash at time of vaccine, question was asked and reporter said no. The patient said that after the first shot her post herpetic neuralgia became more severe. The reporter asked if this was caused by the vaccine and wondered if it was ok for patient to receive the second shot. The reporter did not agree to follow up from GlaxoSmithKline (GSK).
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: he developed a red, rough patchy rash from left foot, up both ankles, up both legs to both hips; This non-serious case was reported by a consumer via call center representative and described the occurrence of red rash in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atopic dermatitis (atopic dermatitis on both hands). Concomitant products included hydrocortisone (Hydrocortisone Cream).   On 15-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, several weeks after receiving Shingrix, the patient experienced red rash (Verbatim: he developed a red, rough patchy rash from left foot, up both ankles, up both legs to both hips). The patient was treated with prednisone. The outcome of the red rash was not resolved.   It was unknown if the reporter considered the red rash to be related to Shingrix.     It was unknown if the company considered the red rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-AUG-2023 The patient had a history of atopic dermatitis on both hands that he used topical and injectable steroids. The patient stated he received Shingrix dose and a few weeks later he developed a red, rough patchy rash from left foot, up both ankles, up both legs to both hips (not yet resolved). The patient went to Primary care physician (PCP) who prescribed prednisone and referred to dermatologist.  The patient was referred to HCP. The reporter consented to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid portion of Menveo was administered; only the liquid portion of Menveo was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA903A, expiry date 31-JAN-2024) for prophylaxis.   On 02-AUG-2023, the patient received Menveo. On 02-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo was administered) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 The reporter was a medical assistant. The reporter stated that patient was administered with only liquid portion of Menveo. The reporter stated there was one powder vial left in the box due to which the event was discovered. The reporter was unsure to which patient the incomplete dose was given. The patient received only adjuvant of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email.
Sex: U
Vaccine: COVID19, PPV, VARZOS
Symptoms: Illness
Clinical narrative: got very sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis and PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, COVID-19 VACCINE and PNEUMONIA VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine and an unknown time after receiving COVID-19 VACCINE, the patient experienced sickness (Verbatim: got very sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: Receipt date: 01-AUG-2023 This case was reported by patient via interactive digital media. The patient reported that he/she received the first dose of Shingles vaccine with the pneumonia and Covid-19 vaccines, he/she got very sick, with the second dose, he/she did not have any negative reactions. It was unknown if the reporter considered the sickness to be related to Covid-19 vaccine and Pneumonia vaccine.     Follow up was not possible, as no contact details were available.
Age: 0.83
Sex: U
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: baby received two doses of Kinrix instead of DTaP and Polio; the second dose was given on 6/8/2023; baby received two doses of Kinrix instead of DTaP and Polio; Dose one was given on 4/27/2023 (age 9 months and 5 days); This non-serious case was reported by a other health professional via sales rep and described the occurrence of wrong product administered in a 10-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included DTPa-IPV (Kinrix) for prophylaxis.   On 08-JUN-2023, the patient received the 2nd dose of Kinrix (intramuscular). On 27-APR-2023, the patient received the 1st dose of Kinrix (intramuscular). On 27-APR-2023, not applicable after receiving Kinrix and an unknown time after receiving Kinrix, the patient experienced wrong product administered (Verbatim: baby received two doses of Kinrix instead of DTaP and Polio) and inappropriate age at vaccine administration (Verbatim: Dose one was given on 4/27/2023 (age 9 months and 5 days)). On 08-JUN-2023, the patient experienced wrong product administered (Verbatim: baby received two doses of Kinrix instead of DTaP and Polio) and inappropriate age at vaccine administration (Verbatim: the second dose was given on 6/8/2023). The outcome of the wrong product administered, inappropriate age at vaccine administration, wrong product 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: 02-AUG-2023 GlaxoSmithKline (GSK) field representative called response center to report that she read an email from a physician's office. She may forward the email to safety.  She reported that a patient received two doses of Kinrix instead of DTaP and Polio .  Dose one was given at age 9 months and 5 days and the second dose was given at age 10 months and 17 days. Not all information is available. Patient's sex and DOB are unknown and initials were not provided. The consent to follow up with health care professional (HCP) office. The patient received 2 doses of Kinrix instead of DTaP and Polio at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Poor quality product administered
Clinical narrative: prepared a vial for patient use on 01AUG2023 but the patient did not come and the product was administered on 02AUG2023 to another patient (with no reported adverse event); Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old male patient for whom a vial of meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] was prepared for use on 01aug2023 but the patient did not come and the product was administered on 02aug2023 to another patient (with no reported adverse event) while receiving vaccine   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine VLP RL1 4V (Yeast) (Gardasil) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (Boostrix) for Prophylactic vaccination.  On 02-Aug-2023, the patient received 0.5 ml (dose 1) of suspect meningococcal A-C-Y-W135 (T CONJ) Vaccine, Solution for injection lot U7643AB via intramuscular route in the left deltoid for immunization,a vial was prepared for patient use on 01aug2023 but the patient did not come and the product was administered on 02aug2023 to another patient (with no reported adverse event) (poor quality product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event poor quality product administered.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.   Additional information was received on 04-Aug-2023: Case upgraded from non case to valid case and narrative amended accordingly.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: dry portion (ActHIB) reconstituted with sterile water and separated from the liquid portion (DTAP-IPV) with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patients who was given dry portion (acthib) reconstituted with sterile water and separated from the liquid portion (dtap-ipv) with no reported adverse event after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength, expiry date: unknown) (lot: UJ791AA) via unknown route in unknown administration site for Immunization.  On an unknown date the patients had an event of dry portion (acthib) reconstituted with sterile water and separated from the liquid portion (dtap-ipv) with no reported adverse event (product preparation error) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  Outcome: Unknown    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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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: 29.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Fall, Headache, Myalgia
Clinical narrative: Fever over 100 degrees F / Headaches/ Chills / Muscle Aches /  Fell on the ground on 8/8/23 at 8:45pm after trying to get something from the Kitchen. May have hit my head on ground unsure due to the side effects. I did not seek medical help as felt fine.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Severe spreading redness and soreness  and warm to touch at injection site of my right arm
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Dysphagia, Dyspnoea
Clinical narrative: Presented to the ED c/o SOB/dysphagia; admitted for pna d/t COVID-19; tx w/O2, singulair, zinc, steroids, abx; weaned to RA, dc'd home
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19, Palpitations
Clinical narrative: Presented to ED with palpitations, found to be in rapid ventricular response, likely due to symptomatic COVID-19 infection; tx w/O2, steroids, singulair, zinc; weaned to RA; dc'd to HHC.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Impaired work ability, Musculoskeletal stiffness
Clinical narrative: Headache, Arthralgia, Fever, stiff neck, back pain Narrative: onset of s/s in late afternoon day of shot missed two days of work.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, Arthralgia, Fever, stiff neck, back pain Narrative: onset of s/s in late afternoon day of shot missed two days of work.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: no additional ae; expired STERILE DILUENT that was used to reconstitute VARIVAX; Product preparation issue; This spontaneous report was received from a nurse, referring to a patient of unknown age. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 01-JUN-2023, the patient was inadvertently administered with expired STERILE DILUENT (lot #T029529 was valid, expiration date 16-APR-2023) that was used to reconstitute varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) for prophylaxis. No temperature excursion. No symptoms reported. (Expired product administered, Product preparation issue, No adverse event); Sender's Comments:  US-009507513-2307USA005044:MSD
Sex: F
Vaccine: PNC13, PPV
Symptoms: Asthenia, Brain fog, Erythema, Fatigue, Feeling abnormal
Clinical narrative: wrong vaccine administered; Foggy feeling; Severe pain on her where the injection site was higher up on shoulder; Felt cold then felt hot then felt cold; arm was swollen and hard to touch; She had big red mark exact straight line right over bicep and back of triceps that encompassed half triceps and half bicep; Could feel cold feeling in back of arm like stuck there; felt weak and fatigued; felt weak and fatigued; had not a a pleasant reaction; arm was hard to touch; This spontaneous report was received from a consumer and refers to a 69-year-old female patient with osteoporosis, arthritis, bundle branch block left and asthma. The patient's medical history included pneumonia. Concomitant therapies included alprazolam (XANAX) and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). Historical vaccines included PFIZER BIONTECH COVID-19 VACCINE.  On 30-JUN-2023 the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W001100 and expiration date, 0.5 milliliter, intramuscularly in the left arm for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered).  On 30-JUN-2023, 6 hours after injection, the patient had not had a pleasant reaction (ill-defined disorder). First thing she felt was foggy feeling (feeling abnormal). Went to bed because she didn't feel comfortable moving about the house. Felt as if getting cold. Felt cold then hot then felt cold (feeling of body temperature change). Hot one second cold the next. Next thing was severe pain on her where the injection site was higher up on shoulder (vaccination site pain). Pain down top of rotator cuff and that pain was all on her upper arm and it was so painful she could not move her arm, she felt like neurological problem in a way. Pain was off the chart, and she could stand a lot of pain. Took 2 advil. Couldn't use or raise arm above straight out. This was caused by injection. Top of arm in front, not triceps, left of biceps it was hard and swollen, arm was swollen and hard to touch (Peripheral swelling) (Induration). Then more strangely she got like when you wear a t-shirt and get line from sunburn it's opposite that she had big red mark exact straight line right over biceps and back of triceps that encompassed half triceps and half bicep (Erythema). Could feel cold feeling in back of arm like stuck there (Peripheral coldness). Also felt weak and fatigued and like she had to go to bed and control (Asthenia) (Fatigue). The outcome of induration, ill-defined disorder, fatigue, asthenia, peripheral coldness, erythema, peripheral swelling, feeling of body temperature change, vaccination site pain and feeling abnormal was unknown. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events was not applicable.   The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Feeling of body temperature change, Ill-defined disorder, Induration, Injected limb mobility decreased, Injection site erythema
Clinical narrative: wrong vaccine administered; Foggy feeling; Severe pain on her where the injection site was higher up on shoulder; Felt cold then felt hot then felt cold; arm was swollen and hard to touch; She had big red mark exact straight line right over bicep and back of triceps that encompassed half triceps and half bicep; Could feel cold feeling in back of arm like stuck there; felt weak and fatigued; felt weak and fatigued; had not a a pleasant reaction; arm was hard to touch; This spontaneous report was received from a consumer and refers to a 69-year-old female patient with osteoporosis, arthritis, bundle branch block left and asthma. The patient's medical history included pneumonia. Concomitant therapies included alprazolam (XANAX) and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). Historical vaccines included PFIZER BIONTECH COVID-19 VACCINE.  On 30-JUN-2023 the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W001100 and expiration date, 0.5 milliliter, intramuscularly in the left arm for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered).  On 30-JUN-2023, 6 hours after injection, the patient had not had a pleasant reaction (ill-defined disorder). First thing she felt was foggy feeling (feeling abnormal). Went to bed because she didn't feel comfortable moving about the house. Felt as if getting cold. Felt cold then hot then felt cold (feeling of body temperature change). Hot one second cold the next. Next thing was severe pain on her where the injection site was higher up on shoulder (vaccination site pain). Pain down top of rotator cuff and that pain was all on her upper arm and it was so painful she could not move her arm, she felt like neurological problem in a way. Pain was off the chart, and she could stand a lot of pain. Took 2 advil. Couldn't use or raise arm above straight out. This was caused by injection. Top of arm in front, not triceps, left of biceps it was hard and swollen, arm was swollen and hard to touch (Peripheral swelling) (Induration). Then more strangely she got like when you wear a t-shirt and get line from sunburn it's opposite that she had big red mark exact straight line right over biceps and back of triceps that encompassed half triceps and half bicep (Erythema). Could feel cold feeling in back of arm like stuck there (Peripheral coldness). Also felt weak and fatigued and like she had to go to bed and control (Asthenia) (Fatigue). The outcome of induration, ill-defined disorder, fatigue, asthenia, peripheral coldness, erythema, peripheral swelling, feeling of body temperature change, vaccination site pain and feeling abnormal was unknown. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events was not applicable.   The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Nervous system disorder, Peripheral coldness
Clinical narrative: wrong vaccine administered; Foggy feeling; Severe pain on her where the injection site was higher up on shoulder; Felt cold then felt hot then felt cold; arm was swollen and hard to touch; She had big red mark exact straight line right over bicep and back of triceps that encompassed half triceps and half bicep; Could feel cold feeling in back of arm like stuck there; felt weak and fatigued; felt weak and fatigued; had not a a pleasant reaction; arm was hard to touch; This spontaneous report was received from a consumer and refers to a 69-year-old female patient with osteoporosis, arthritis, bundle branch block left and asthma. The patient's medical history included pneumonia. Concomitant therapies included alprazolam (XANAX) and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]). Historical vaccines included PFIZER BIONTECH COVID-19 VACCINE.  On 30-JUN-2023 the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # W001100 and expiration date, 0.5 milliliter, intramuscularly in the left arm for prophylaxis instead of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (wrong product administered).  On 30-JUN-2023, 6 hours after injection, the patient had not had a pleasant reaction (ill-defined disorder). First thing she felt was foggy feeling (feeling abnormal). Went to bed because she didn't feel comfortable moving about the house. Felt as if getting cold. Felt cold then hot then felt cold (feeling of body temperature change). Hot one second cold the next. Next thing was severe pain on her where the injection site was higher up on shoulder (vaccination site pain). Pain down top of rotator cuff and that pain was all on her upper arm and it was so painful she could not move her arm, she felt like neurological problem in a way. Pain was off the chart, and she could stand a lot of pain. Took 2 advil. Couldn't use or raise arm above straight out. This was caused by injection. Top of arm in front, not triceps, left of biceps it was hard and swollen, arm was swollen and hard to touch (Peripheral swelling) (Induration). Then more strangely she got like when you wear a t-shirt and get line from sunburn it's opposite that she had big red mark exact straight line right over biceps and back of triceps that encompassed half triceps and half bicep (Erythema). Could feel cold feeling in back of arm like stuck there (Peripheral coldness). Also felt weak and fatigued and like she had to go to bed and control (Asthenia) (Fatigue). The outcome of induration, ill-defined disorder, fatigue, asthenia, peripheral coldness, erythema, peripheral swelling, feeling of body temperature change, vaccination site pain and feeling abnormal was unknown. Action taken with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) regarding the events was not applicable.   The causality between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not provided.