chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Cough, Fatigue, Feeling abnormal, Pain
Clinical narrative: Received booster shot on 9/20/2022,Felt ok 9/21/2022,started to feel bad on the 22nd, really felt bad on the 23rd, took a at home test, and tested positive for Covid. Have know idea how I got it or where it came from. On the 26th I started the 5 day treatment of paxovid. I don't seem to have any long term effects. I did have a dry cough,body aches,very tired.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Received booster shot on 9/20/2022,Felt ok 9/21/2022,started to feel bad on the 22nd, really felt bad on the 23rd, took a at home test, and tested positive for Covid. Have know idea how I got it or where it came from. On the 26th I started the 5 day treatment of paxovid. I don't seem to have any long term effects. I did have a dry cough,body aches,very tired.
Age: 35.0
Sex: M
Vaccine: COVID19-2, FLUC4, TDAP
Symptoms: Electrocardiogram, Eye movement disorder, Immediate post-injection reaction, Loss of consciousness, Mobility decreased
Clinical narrative: Immediately after the 3rd vaccine, patient lost consciousness, eyes rolled back in head, became pale, had full body twitching with hands, clinched in a claw, regained conscousness, then 5 minutes later experienced the same symptoms again. Medics arroved, assessed patient, ran an EKG. After 20 mins, medics released patient. Fiance drive pt home.
Age: 35.0
Sex: M
Vaccine: COVID19-2, FLUC4, TDAP
Symptoms: Muscle twitching, Pallor, Symptom recurrence
Clinical narrative: Immediately after the 3rd vaccine, patient lost consciousness, eyes rolled back in head, became pale, had full body twitching with hands, clinched in a claw, regained conscousness, then 5 minutes later experienced the same symptoms again. Medics arroved, assessed patient, ran an EKG. After 20 mins, medics released patient. Fiance drive pt home.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: MODERNA PRIME VACCINE WAS GIVEN INSTEAD OF MODERNA BIVALENT Patient received his first dose of covid vaccine Janssen 5/19/21 Lot # 1805031
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Electrocardiogram normal, Full blood count abnormal, Influenza virus test, SARS-CoV-2 test, Syncope
Clinical narrative: Pt w/ syncopal episode w/ no LOC post administration-w/24hr's of Menactra #2 Men B. Seen in ER IV admin diphenhydramine Elevated CBC - repeat labs, flu, covid test done. EKG normal and ER referred to cardio & neuro
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Gastrointestinal disorder, Headache, Pain
Clinical narrative: Cough; heavy phlegm; GI symptoms; Fatigue; Achiness; Headache; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (on February 2023, the patient had 1st dose and experienced fatigue, achiness, headache and fever, refer case US2023060942).   On 23-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) .5 ml. In APR-2023, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue), pain (Verbatim: Achiness), headache (Verbatim: Headache) and fever (Verbatim: Fever). On 24-APR-2023, the patient experienced cough (Verbatim: Cough), phlegm (Verbatim: heavy phlegm) and gastrointestinal disorder (Verbatim: GI symptoms). Rechallenge with Shingrix was positive. The outcome of the fatigue, pain, headache, fever, cough, phlegm and gastrointestinal disorder were not resolved.   It was unknown if the reporter considered the fatigue, pain, headache, fever, cough, phlegm and gastrointestinal disorder to be related to Shingrix.     It was unknown if the company considered the fatigue, pain, headache, fever, cough, phlegm and gastrointestinal disorder to be related to Shingrix.   Linked case(s) involving the same patient:  US2023060942   Additional Information: GSK Receipt Date: 25-APR-2023 The patient reported that when he received his second Shingrix vaccine he experienced many of the same symptoms as the first vaccine, but they did not start until 10 hours after receiving the Shingrix vaccine and included fatigue, achiness, headache, fever.  The reporter also reported beginning 24th April 2023 in the evening, the patient experinced a cough and heavy phlegm and GI symptoms.  The patient will go see HCP on the day of reporting. Symptoms had not resolved after the second Shingrix vaccine.  The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023060942:Same reporter
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Productive cough, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Cough; heavy phlegm; GI symptoms; Fatigue; Achiness; Headache; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (on February 2023, the patient had 1st dose and experienced fatigue, achiness, headache and fever, refer case US2023060942).   On 23-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) .5 ml. In APR-2023, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue), pain (Verbatim: Achiness), headache (Verbatim: Headache) and fever (Verbatim: Fever). On 24-APR-2023, the patient experienced cough (Verbatim: Cough), phlegm (Verbatim: heavy phlegm) and gastrointestinal disorder (Verbatim: GI symptoms). Rechallenge with Shingrix was positive. The outcome of the fatigue, pain, headache, fever, cough, phlegm and gastrointestinal disorder were not resolved.   It was unknown if the reporter considered the fatigue, pain, headache, fever, cough, phlegm and gastrointestinal disorder to be related to Shingrix.     It was unknown if the company considered the fatigue, pain, headache, fever, cough, phlegm and gastrointestinal disorder to be related to Shingrix.   Linked case(s) involving the same patient:  US2023060942   Additional Information: GSK Receipt Date: 25-APR-2023 The patient reported that when he received his second Shingrix vaccine he experienced many of the same symptoms as the first vaccine, but they did not start until 10 hours after receiving the Shingrix vaccine and included fatigue, achiness, headache, fever.  The reporter also reported beginning 24th April 2023 in the evening, the patient experinced a cough and heavy phlegm and GI symptoms.  The patient will go see HCP on the day of reporting. Symptoms had not resolved after the second Shingrix vaccine.  The reporter did not consent to follow-up.; Sender's Comments:  US-GSK-US2023060942:Same reporter
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Mammogram abnormal, Pruritus, Ultrasound breast abnormal
Clinical narrative: bilateral breast itching (no rash) - a deep itching that is constant and started very soon after her first vaccine.  Of note, the itching worsened when she contracted covid in December of 2021.  PO steroids, antihistamines, and topical steroids have not helped at all.
Age: 30.0
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19-2
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No adverse side effects or reaction. Bivalent booster dose was given 34 days after the second primary monovalent dose and it should have been no sooner than 2 months after the primary dose.
Age: 30.0
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse side effects or reaction. Bivalent booster dose was given 34 days after the second primary monovalent dose and it should have been no sooner than 2 months after the primary dose.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, HPV9, MEN
Symptoms: Unevaluable event
Clinical narrative: No adverse event; Patient GARDASIL 9 schedule history as follows, 1st dose on 7/18/2019, 2nd dose on 2/19/2021, and 3rd dose on 4/26/2023; Third dose of GARDASIL 9 given in error, was meant to administer MENQUADFI (other company vaccine).; Patient GARDASIL 9 schedule history as follows, 1st dose on 7/18/2019, 2nd dose on 2/19/2021, and 3rd dose on 4/26/2023; This spontaneous report was received from Other and refers to a 16-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 18-JUL-2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 19-FEB-2021, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 26-APR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml/dose 3 of 3, lot #W021345, expiration date: 01-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient started therapy with meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On unknown date, risk manager called to report that a 16 year old patient was given 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of vaccine administered). Third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) given in error, was meant to administer MENQUADFI (other company vaccine) (Wrong product administered). Concomitant administration of both vaccines reported.  No side effects or symptoms reported. Caller filed with VAERS 4/27/2023. No additional AE/PQC.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ, HPV9, HPV9, MEN
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient GARDASIL 9 schedule history as follows, 1st dose on 7/18/2019, 2nd dose on 2/19/2021, and 3rd dose on 4/26/2023; Third dose of GARDASIL 9 given in error, was meant to administer MENQUADFI (other company vaccine).; Patient GARDASIL 9 schedule history as follows, 1st dose on 7/18/2019, 2nd dose on 2/19/2021, and 3rd dose on 4/26/2023; This spontaneous report was received from Other and refers to a 16-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions included  prophylaxis. Concomitant therapies were not reported.  On 18-JUL-2019, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 19-FEB-2021, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 26-APR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml/dose 3 of 3, lot #W021345, expiration date: 01-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient started therapy with meningococcal vaccine a/c/y/w conj (tet tox) (MENQUADFI), unk, administered for prophylaxis (strength, formulation, lot #, expiry date, and route of administration were not provided).  On unknown date, risk manager called to report that a 16 year old patient was given 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of vaccine administered). Third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) given in error, was meant to administer MENQUADFI (other company vaccine) (Wrong product administered). Concomitant administration of both vaccines reported.  No side effects or symptoms reported. Caller filed with VAERS 4/27/2023. No additional AE/PQC.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria
Clinical narrative: swollen feet and legs
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling
Clinical narrative: swollen feet and legs
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Decrease vision with increase cataracts; Decrease vision with increase cataracts; GFR decrease during this period; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), on 23Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2593) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "OSA Mild with CPAP Occasional use", start date: 01Jan2012 (ongoing), notes: Pertinent details: Borderline; "Urethral fascia sling repair removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent details: Sling broken in muscle; "Asthma" (ongoing); "Vaginal atrophy" (ongoing); "Rheum arthritis" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Raynauds" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR taken for asthma, start date: 2019 (ongoing); ATROVENT HFA taken for asthma, start date: 2019 (ongoing); PROAIR HFA taken for asthma, start date: 2019 (ongoing); ESTRACE VAGINAL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Single, At 14:00, Anatomical site: Left Upper Arm, Route: Intramuscular, Batch/Lot number: EZ9266), administration date: 21Feb2021, for COVID-19 immunization, reaction(s): "Cataract spots", "I have also had kidney issues", "Lip and tongue swelling", "Lip and tongue swelling", "Vision became dim", "Dizzy", "HA/Headaches"; BNT162b2 (Dose 2, 30 ug Single, At 09:00 , Anatomical site: Left Upper Arm, Route: Intramuscular , Batch/Lot number: EN6207), administration date: 19Mar2021, for COVID-19 immunization, reaction(s): "SOB", "CBC HgB norm low", "RDC norm high", "CBC HCT norm low", "Had increased Dizziness". The following information was reported: CATARACT (medically significant), VISUAL IMPAIRMENT (medically significant), outcome "unknown" and all described as "Decrease vision with increase cataracts"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "unknown", described as "GFR decrease during this period". The event "gfr decrease during this period" required physician office visit. The patient underwent the following laboratory tests and procedures: Metabolic function test: (29Dec2021) Within normal limits; Visual acuity tests: (unspecified date) Decrease vision with increase cataracts; Glomerular filtration rate: (unspecified date) Decrease. Clinical course: Nephrologist seen Feb2023. On 27Mar2023, patient did not receive vaccine. Prior to vaccine patient had no cataracts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300078947 Same patient, same product, different events (Dose 2);
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cataract, Glomerular filtration rate, Glomerular filtration rate decreased, Metabolic function test, Visual acuity tests
Clinical narrative: Decrease vision with increase cataracts; Decrease vision with increase cataracts; GFR decrease during this period; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), on 23Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2593) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "OSA Mild with CPAP Occasional use", start date: 01Jan2012 (ongoing), notes: Pertinent details: Borderline; "Urethral fascia sling repair removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent details: Sling broken in muscle; "Asthma" (ongoing); "Vaginal atrophy" (ongoing); "Rheum arthritis" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Raynauds" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR taken for asthma, start date: 2019 (ongoing); ATROVENT HFA taken for asthma, start date: 2019 (ongoing); PROAIR HFA taken for asthma, start date: 2019 (ongoing); ESTRACE VAGINAL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Single, At 14:00, Anatomical site: Left Upper Arm, Route: Intramuscular, Batch/Lot number: EZ9266), administration date: 21Feb2021, for COVID-19 immunization, reaction(s): "Cataract spots", "I have also had kidney issues", "Lip and tongue swelling", "Lip and tongue swelling", "Vision became dim", "Dizzy", "HA/Headaches"; BNT162b2 (Dose 2, 30 ug Single, At 09:00 , Anatomical site: Left Upper Arm, Route: Intramuscular , Batch/Lot number: EN6207), administration date: 19Mar2021, for COVID-19 immunization, reaction(s): "SOB", "CBC HgB norm low", "RDC norm high", "CBC HCT norm low", "Had increased Dizziness". The following information was reported: CATARACT (medically significant), VISUAL IMPAIRMENT (medically significant), outcome "unknown" and all described as "Decrease vision with increase cataracts"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "unknown", described as "GFR decrease during this period". The event "gfr decrease during this period" required physician office visit. The patient underwent the following laboratory tests and procedures: Metabolic function test: (29Dec2021) Within normal limits; Visual acuity tests: (unspecified date) Decrease vision with increase cataracts; Glomerular filtration rate: (unspecified date) Decrease. Clinical course: Nephrologist seen Feb2023. On 27Mar2023, patient did not receive vaccine. Prior to vaccine patient had no cataracts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300078947 Same patient, same product, different events (Dose 2);
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Decrease vision with increase cataracts; Decrease vision with increase cataracts; GFR decrease during this period; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old patient received BNT162b2 (BNT162B2), on 23Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2593) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "OSA Mild with CPAP Occasional use", start date: 01Jan2012 (ongoing), notes: Pertinent details: Borderline; "Urethral fascia sling repair removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent details: Sling broken in muscle; "Asthma" (ongoing); "Vaginal atrophy" (ongoing); "Rheum arthritis" (unspecified if ongoing); "Sjogrens" (unspecified if ongoing); "Raynauds" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR taken for asthma, start date: 2019 (ongoing); ATROVENT HFA taken for asthma, start date: 2019 (ongoing); PROAIR HFA taken for asthma, start date: 2019 (ongoing); ESTRACE VAGINAL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing). Vaccination history included: BNT162b2 (Dose 1, Single, At 14:00, Anatomical site: Left Upper Arm, Route: Intramuscular, Batch/Lot number: EZ9266), administration date: 21Feb2021, for COVID-19 immunization, reaction(s): "Cataract spots", "I have also had kidney issues", "Lip and tongue swelling", "Lip and tongue swelling", "Vision became dim", "Dizzy", "HA/Headaches"; BNT162b2 (Dose 2, 30 ug Single, At 09:00 , Anatomical site: Left Upper Arm, Route: Intramuscular , Batch/Lot number: EN6207), administration date: 19Mar2021, for COVID-19 immunization, reaction(s): "SOB", "CBC HgB norm low", "RDC norm high", "CBC HCT norm low", "Had increased Dizziness". The following information was reported: CATARACT (medically significant), VISUAL IMPAIRMENT (medically significant), outcome "unknown" and all described as "Decrease vision with increase cataracts"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "unknown", described as "GFR decrease during this period". The event "gfr decrease during this period" required physician office visit. The patient underwent the following laboratory tests and procedures: Metabolic function test: (29Dec2021) Within normal limits; Visual acuity tests: (unspecified date) Decrease vision with increase cataracts; Glomerular filtration rate: (unspecified date) Decrease. Clinical course: Nephrologist seen Feb2023. On 27Mar2023, patient did not receive vaccine. Prior to vaccine patient had no cataracts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300078947 Same patient, same product, different events (Dose 2);
Age: 26.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Indicate at which point in the process the medication error ocurred: Storage in clinical practice; No adverse reaction; HCP reports that a patient was given an expired dose of VAQTA; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 03-APR-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, dosage, vaccination scheme, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (expired product administered ). No additional adverse events were reported.  This case was classified as non-valid due to the lack of patient's identifiers.  Follow-up information was received from a pharmacist on 17-APR-2023.  The report concerns to 26-year-old patient.  The vaccine was administered via intramuscularly, the expiration date was reported as 30-MAR-2023.  It was reported that no adverse reaction occured and that medication error happened in the storage clinical practice (product storage error).
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: HCP called to report that the patient missed his second dose of GARDASIL 9 and will be receiving the second dose late. Limited information available on this case. No additional AE/PQC.; No adverse event; This spontaneous report has been received from a consumer, regarding to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters (ml), administered for prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number and expiration date were not reported). Additionally, it was reported that on 15-OCT-2022, the patient missed his second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (Inappropriate schedule of product administration).  No additional adverse events were reported in the patient.
Sex: M
Vaccine: MMRV
Symptoms: Accidental exposure to product, No adverse event, Product preparation error
Clinical narrative: administered STERILE DILUENT Reconstituted PROQUAD to Patient with Corresponding Patient having moved (See AE Case# 02371099) and with some of the Corresponding PROQUAD having sprayed into Physician's eyes; dministered STERILE DILUENT Reconstituted PROQUAD to Patient with Corresponding Patient having moved (See AE Case# 02371099) and with some of the Corresponding PROQUAD having sprayed into Physician's eyes; No additional AE reported.; This spontaneous report was received from a healthcare business professional referring to a 32-year-old male patient . Information regarding his medical history, concurrent conditions, and concomitant therapies were not reported.  On 13-APR-2023, the patient administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (dose, strength, vaccination scheme, frequency, lot#, expiration date, route of administration and anatomical site of injection, were not reported), which had been diluted  with sterile diluent solution for injection/infusion (dose, lot#, expiration date, frequency, anatomical location, and route of administration were not provided), for prophylaxis; nonetheless, it was reported that while it was being administered, the patient who he was administering the product to, moved and therefore, some of the product sprayed into the his eyes (accidental exposure to product, occupational exposure to produce). Moreover, following this event, the patient had flushed his eyes with water as confirmed by the reporter . It was unknown if any laboratory or diagnostics were performed due to the event; furthermore, the patient did not sought medical attention for this event. No additional adverse events were reported (no adverse event).
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Abdominal distension, Autoimmune disorder, Bowel movement irregularity, Colonoscopy normal, Feeling abnormal
Clinical narrative: nausea, abdominal distention, irregular bowel movements, a feeling of fullness even after eating very little, severe weight loss; autoimmune attack which damages the vagus nerve,; damages the vagus nerve; felt at an all-time low in terms of mental and physical health. He was in the worst shape of his life both physically and mentally.; felt at an all-time low in terms of mental and physical health. He was in the worst shape of his life both physically and mentally.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. It was reported that prior to receiving the vaccine the pt. was in the best shape of his life in terms of physical health and ability.  On 04-JUN-2020, the pt. was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for preventing cancer (dose, route of administration, lot number and expiration date were not reported).   Following his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, on an unspecified date, the pt. began suffering from nausea, abdominal distention, irregular bowel movements, a feeling of fullness even after eating very little, severe weight loss, and an inability to engage in normal physical activities. He received a colonoscopy which was negative for colitis was diagnosed with gastroparesis (paralysis of the stomach) (Impaired gastric emptying), which is a neurological disorder affecting the vagus nerve (vagus nerve disorder) interfering with the digestive process.  As a result of his post- human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt. had been unable to pursue his dream   He was devastated. To this day, pt. felt at an all-time low in terms of mental (Feeling abnormal) and physical health (General physical health deterioration). He was in the worst shape of his life both physically and mentally.  As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, including but not limited to costs for hospitalization (unknown date), physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages.  The outcome of all events was not reported. The causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was related.  Upon internal review, impaired gastric emptying and autoimmune disorder were considered to be medically significant.  The events were considered to be disabling by the reporter.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: General physical health deterioration, Impaired gastric emptying, Loss of personal independence in daily activities, Nausea, Vagus nerve disorder
Clinical narrative: nausea, abdominal distention, irregular bowel movements, a feeling of fullness even after eating very little, severe weight loss; autoimmune attack which damages the vagus nerve,; damages the vagus nerve; felt at an all-time low in terms of mental and physical health. He was in the worst shape of his life both physically and mentally.; felt at an all-time low in terms of mental and physical health. He was in the worst shape of his life both physically and mentally.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. It was reported that prior to receiving the vaccine the pt. was in the best shape of his life in terms of physical health and ability.  On 04-JUN-2020, the pt. was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for preventing cancer (dose, route of administration, lot number and expiration date were not reported).   Following his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, on an unspecified date, the pt. began suffering from nausea, abdominal distention, irregular bowel movements, a feeling of fullness even after eating very little, severe weight loss, and an inability to engage in normal physical activities. He received a colonoscopy which was negative for colitis was diagnosed with gastroparesis (paralysis of the stomach) (Impaired gastric emptying), which is a neurological disorder affecting the vagus nerve (vagus nerve disorder) interfering with the digestive process.  As a result of his post- human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt. had been unable to pursue his dream   He was devastated. To this day, pt. felt at an all-time low in terms of mental (Feeling abnormal) and physical health (General physical health deterioration). He was in the worst shape of his life both physically and mentally.  As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, including but not limited to costs for hospitalization (unknown date), physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages.  The outcome of all events was not reported. The causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was related.  Upon internal review, impaired gastric emptying and autoimmune disorder were considered to be medically significant.  The events were considered to be disabling by the reporter.
Age: 22.0
Sex: M
Vaccine: HPV4
Symptoms: Weight decreased
Clinical narrative: nausea, abdominal distention, irregular bowel movements, a feeling of fullness even after eating very little, severe weight loss; autoimmune attack which damages the vagus nerve,; damages the vagus nerve; felt at an all-time low in terms of mental and physical health. He was in the worst shape of his life both physically and mentally.; felt at an all-time low in terms of mental and physical health. He was in the worst shape of his life both physically and mentally.; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt.) of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. It was reported that prior to receiving the vaccine the pt. was in the best shape of his life in terms of physical health and ability.  On 04-JUN-2020, the pt. was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for preventing cancer (dose, route of administration, lot number and expiration date were not reported).   Following his quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection, on an unspecified date, the pt. began suffering from nausea, abdominal distention, irregular bowel movements, a feeling of fullness even after eating very little, severe weight loss, and an inability to engage in normal physical activities. He received a colonoscopy which was negative for colitis was diagnosed with gastroparesis (paralysis of the stomach) (Impaired gastric emptying), which is a neurological disorder affecting the vagus nerve (vagus nerve disorder) interfering with the digestive process.  As a result of his post- human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) symptoms, pt. had been unable to pursue his dream   He was devastated. To this day, pt. felt at an all-time low in terms of mental (Feeling abnormal) and physical health (General physical health deterioration). He was in the worst shape of his life both physically and mentally.  As a further proximate result, the pt had suffered and would continue to suffer significant medical expenses, including but not limited to costs for hospitalization (unknown date), physician care, monitoring, treatment, medications and supplies and suffered ongoing injuries, pain and other damages.  The outcome of all events was not reported. The causality between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was related.  Upon internal review, impaired gastric emptying and autoimmune disorder were considered to be medically significant.  The events were considered to be disabling by the reporter.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st and 2nd doses in 2006, now wants 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 14th July 2006) and Twinrix (2nd dose received on 14th August 2006).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st and 2nd doses in 2006, now wants 3rd dose). The outcome of the incomplete course of vaccination 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: 01-MAY-2023 A pharmacist reported that a patient would like to get the 3rd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive 3nd dose of Twinrix, which led to incomplete course of vaccination. Details pertains to 1st dose of Twinrix in product tab
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine administered after temperature excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine administered after temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 02-MAY-2023 The reporter was a pharmacist. The reporter reported that a dose of Shingrix vaccine was exposed to colder than recommended storage temperature and it was administered to the patient. The reporter was unable to provide any additional vaccine details at the time of reporting, because event was happened in a different pharmacy. There was no information provided to which temperature the vaccine was exposed only it was reported the below recommended temperature.  The reporter did consent to follow-up via email. The Shingrix vaccine was exposed to colder than recommended storage temperature, which led to incorrect storage of drug
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Suspected COVID-19, Vaccination failure
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This solicited report received from a health care professional concerned an adult of unspecified sex. The patient was enrolled in a non-company sponsored study. This report was also received from literature. The objective of the study was to do a retrospective, single-centre study, involving 254 patients vaccinated against COVID-19 infection, out of which five patients (4 women and one man) aged 31-62 years were described, who developed COVID-19 infection due to reduced humoral immunity to SARSCoV-2 following interaction between tozinameran, Ad26.COV2-S or elasomeran for immunisation against COVID-19 infection and ocrelizumab, rituximab or teriflunomide for multiple sclerosis. The patient's height, and weight were not reported. The patient's concurrent conditions included: multiple sclerosis and started receiving disease modifying therapies (DMTs), including teriflunomide or ocrelizumab or rituximab. Out of five patients, one patient had received covid-19 vaccine ad26.cov2.s for immunisation against covid-19 infection. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose and start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date, after 3 to 7 months post-immunisation, all patients (including the patient) experienced covid-19 infection (suspected covid-19 infection) with World Health Organization (WHO) covid severity of grade 1-4 due to reduced humoral immunity to SARSCoV-2. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test SARSCoV-2 spike antibody level in all patients was less than 20 µg/dL after immunization, with 4 out of 5 patients had spike level below the threshold of detection which led to confirmed immunological vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and confirmed immunological vaccination failure was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and confirmed immunological vaccination failure, and suspected covid-19 infection was not related. The author concluded that reduced humoral immunity to SARS-CoV-2 after vaccination in patients with multiple sclerosis (MS) on some disease modifying therapies (DMTs) are at increased risk of severe Coronavirus Disease 19 (COVID-19) and death. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230462641-confirmed immunological vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company (Pfizer) concerned a 59 year old male of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin was not reported, batch number: 1805020 expiry: unknown) dose was not reported, 1 total administered at right arm on 07-MAR-2021 10:00 for covid-19 prophylaxis. Age at time of vaccination 57 years old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received second dose of Non-company suspect vaccine included: tozinameran (Pfizer BioNTech covid-19 vaccine) (dose number in series 2) (form of admin and route of admin were not reported, batch number: unknown, expiry: Unknown) dose was not reported, administered to left arm on 28-OCT-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second dose of tozinameran (Pfizer BioNTech covid-19 vaccine) (dose number in series 2).  The patient received third dose of Non-company suspect vaccine included: tozinameran (Pfizer BioNTech covid-19 vaccine) (dose number in series 3) (form of admin and route of admin were not reported, batch number: unknown, expiry: Unknown) dose was not reported, administered to left arm on 20-JUL-2022 at 18:30 for covid-19 prophylaxis which was associated with revaccination with different covid-19 vaccine (dose number in series 3). On an unspecified date in APR-2023, the patient experienced suspected covid-19 infection (dose number in series 3) for which the patient received treatment with Non-company suspect drugs included: nirmatrelvir/ritonavir (form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 07-APR-2023 to 12-APR-2023 for covid-19 treatment. On 22-APR-2023, patient's covid symptoms were returned. The action taken with covid-19 vaccine ad26.cov2.s, tozinameran (dose number in series 2), and tozinameran (dose number in series 3) was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company (Pfizer Inc.) concerned a 51 year old male. The patient's height, and weight were not reported. The patient's past medical history included: allergy (unspecified). The patient had previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802068 expiry: unknown) dose was not reported, 1 total administered on 23-MAR-2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (does number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855191 expiry: unknown) dose was not reported, 1 total administered on 28-NOV-2021 for covid-19 prophylaxis. Age at time of vaccination 50 years old. No concomitant medications were reported. On an unspecified date in 2023, the patient experienced covid-19 which was suspected covid-19 infection (dose number in series 2). The patient received non-company suspect drugs included: nirmatrelvir/ritonavir (form of admin and route of admin were not reported, batch number: GG0067 expiry: unknown) dose and frequency were not reported from 08-APR-2023 to 13-APR-2023 for treatment of covid-19. On 17-APR-2023, the patient experienced covid rebound (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from suspected covid-19 infection. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023; No adverse event; A dose of Moderna vaccine was given beyond use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine was given beyond use by date), PRODUCT STORAGE ERROR (The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     It was unknown patient had any allergies to medications, has ever been diagnosed/ tested positive for COVID-19. It was unknown if patient had acute or chronic illness during the time of vaccination.     On 20-Apr-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine was given beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine was given beyond use by date), PRODUCT STORAGE ERROR (The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (A dose of Moderna vaccine was given beyond use by date) and PRODUCT STORAGE ERROR (The BUD was 13-Apr-2023 and the vaccine was administred on 20-Apr-2023).    Concomitant products were not reported.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-721275 (E2B Linked Report). This case was linked to MOD-2023-722084 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721275:Master case (cluster case)