chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, Deafness unilateral
Clinical narrative: I lost the hearing in my left ear; A 6 weeks later I came down with Covid; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (I lost the hearing in my left ear) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not provide any medical history, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (I lost the hearing in my left ear) (seriousness criterion medically significant) and COVID-19 (A 6 weeks later I came down with Covid). At the time of the report, DEAFNESS UNILATERAL (I lost the hearing in my left ear) and COVID-19 (A 6 weeks later I came down with Covid) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Within 24 hours of having 5th shot, patient lost the hearing in left ear. A 6 weeks later patient had Covid. Treatment medication was not reported. Patient was eligible for 6th Covid booster shot. Patient was planning vacation June and wanted to know benefits of getting another booster shot as patient was concerned about the risks.  Company comment- This spontaneous case concerns an adult patient of unknown gender and age with no medical history reported who experienced the serious unexpected (medically significant) event deafness unilateral along with the non-serious unexpected event COVID-19 within 24 hours to 6 weeks after a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a fifth dose of COVID vaccine schedule, was administered. It was reported that within 24 hours of having the 5th shot patient lost the hearing in left ear. Six weeks later patient came down with COVID. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2023: Non-significant follow up.
Age: 75.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 06-Apr-2023 and was administered on 09-May-2023).    Dosage text for suspect product was reported as unknown. Concomitant drugs were not reported. Treatment medications were not provided.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal discomfort, Blood test normal, Disorientation, Eye pain, Feeding disorder
Clinical narrative: Received shot on 5/4/23, painful at injection site but didn't spread out. Started not feeling late Tues/early Wed and got worse on Thur 5/11. 103 Fever and very Disoriented after mid day Nap Thursday. Was able to get fever down which kept maintaining high 101/102 until Sat. on 5/13 took to ER being we could not get down her 105 Fever causing excruciating pain in head and body. With each day that passed more symptoms followed. Started with just Fever, Eyes hurting and Headaches, which turned into a lasting high fever for 7 days straight. Developed a sore throat which went away for a day and then came back but with nasal congestion, upset tummy, couldn't eat, throwing up, body aches. Was tested for Covid, Strep and Flu - all Negative. Chest Ultrasound, blood test and urine test normal. They couldn't pin point it. Was given Antibiotic and Benedryl and sent home.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Influenza virus test negative, Injection site pain, Nasal congestion, Oropharyngeal pain
Clinical narrative: Received shot on 5/4/23, painful at injection site but didn't spread out. Started not feeling late Tues/early Wed and got worse on Thur 5/11. 103 Fever and very Disoriented after mid day Nap Thursday. Was able to get fever down which kept maintaining high 101/102 until Sat. on 5/13 took to ER being we could not get down her 105 Fever causing excruciating pain in head and body. With each day that passed more symptoms followed. Started with just Fever, Eyes hurting and Headaches, which turned into a lasting high fever for 7 days straight. Developed a sore throat which went away for a day and then came back but with nasal congestion, upset tummy, couldn't eat, throwing up, body aches. Was tested for Covid, Strep and Flu - all Negative. Chest Ultrasound, blood test and urine test normal. They couldn't pin point it. Was given Antibiotic and Benedryl and sent home.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative, Streptococcus test negative, Ultrasound chest
Clinical narrative: Received shot on 5/4/23, painful at injection site but didn't spread out. Started not feeling late Tues/early Wed and got worse on Thur 5/11. 103 Fever and very Disoriented after mid day Nap Thursday. Was able to get fever down which kept maintaining high 101/102 until Sat. on 5/13 took to ER being we could not get down her 105 Fever causing excruciating pain in head and body. With each day that passed more symptoms followed. Started with just Fever, Eyes hurting and Headaches, which turned into a lasting high fever for 7 days straight. Developed a sore throat which went away for a day and then came back but with nasal congestion, upset tummy, couldn't eat, throwing up, body aches. Was tested for Covid, Strep and Flu - all Negative. Chest Ultrasound, blood test and urine test normal. They couldn't pin point it. Was given Antibiotic and Benedryl and sent home.
Age: 9.0
Sex: F
Vaccine: TDAP
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: Received shot on 5/4/23, painful at injection site but didn't spread out. Started not feeling late Tues/early Wed and got worse on Thur 5/11. 103 Fever and very Disoriented after mid day Nap Thursday. Was able to get fever down which kept maintaining high 101/102 until Sat. on 5/13 took to ER being we could not get down her 105 Fever causing excruciating pain in head and body. With each day that passed more symptoms followed. Started with just Fever, Eyes hurting and Headaches, which turned into a lasting high fever for 7 days straight. Developed a sore throat which went away for a day and then came back but with nasal congestion, upset tummy, couldn't eat, throwing up, body aches. Was tested for Covid, Strep and Flu - all Negative. Chest Ultrasound, blood test and urine test normal. They couldn't pin point it. Was given Antibiotic and Benedryl and sent home.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: PT WAS GIVEN PFIZER MONOVALENT VACCINE, SHOULD HAVE BEEN GIVEN PFIZER BIVALENT, NO ADVERSE EVENT, OUTCOME - IS PER CDC GUIDANCE PT CAN RECIEVE A BIVALENT BOOSTER IN 4 MONTHS AS PT IS NOT IMMUNOCOMPRISED
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site urticaria, Urticaria, Vaccination site reaction
Clinical narrative: Patient has hives on her right upper arm abd right kneee, and on the vaccine site.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient has two records with different last names. Mom has been told Numerous times to bring legal Documentation to combine records.
Age: 40.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Diarrhoea, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Pt receive vaccine 5/11/23 same day PM start itchy Left arm/swelling 5/12/23 Fever chills 5/13 diarrhea 5/14 ED eval.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Balance disorder, Drooling, Dysphagia, Gait disturbance
Clinical narrative: Ongoing pain for 9 weeks, then stiffness in lips, face, throat, the drooling, difficulty swallowing, lost voice, now speech stronger but slowed.  Losing balance, dragging his feet when walking, feet 'feel heavy and stuck to carpet', neuropathy in right forehead, cheek, arm and leg.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Motor neurone disease, Musculoskeletal stiffness, Neuropathy peripheral, Pain
Clinical narrative: Ongoing pain for 9 weeks, then stiffness in lips, face, throat, the drooling, difficulty swallowing, lost voice, now speech stronger but slowed.  Losing balance, dragging his feet when walking, feet 'feel heavy and stuck to carpet', neuropathy in right forehead, cheek, arm and leg.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Slow speech
Clinical narrative: Ongoing pain for 9 weeks, then stiffness in lips, face, throat, the drooling, difficulty swallowing, lost voice, now speech stronger but slowed.  Losing balance, dragging his feet when walking, feet 'feel heavy and stuck to carpet', neuropathy in right forehead, cheek, arm and leg.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Dizziness, Pallor
Clinical narrative: Pt reported she needed a meningitis vaccine but did not specify which type she needed. Mother was shopping in grocery store at time of vaccination administration. Given pt's age and pt said she was going abroad, Trumenba selected for administration.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Unevaluable event
Clinical narrative: Pt reported she needed a meningitis vaccine but did not specify which type she needed. Mother was shopping in grocery store at time of vaccination administration. Given pt's age and pt said she was going abroad, Trumenba selected for administration.
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Acoustic stimulation tests, Ear discomfort, Tinnitus
Clinical narrative: Patient was seen  and vaccinated with Pfizer bivalent booster on 10/07/22.  Patient states she immediately started having clogged ears and high-pitched ringing in her ears.  Assumed it was ear wax, made an appt with PRIVACY on 10/11/22 and they found fluid in the ears.  She reports continual problems with her ears since vaccination.
Age: 65.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Ear discomfort, Immediate post-injection reaction, Middle ear effusion, Tinnitus
Clinical narrative: Patient was seen  and vaccinated with Pfizer bivalent booster on 10/07/22.  Patient states she immediately started having clogged ears and high-pitched ringing in her ears.  Assumed it was ear wax, made an appt with PRIVACY on 10/11/22 and they found fluid in the ears.  She reports continual problems with her ears since vaccination.
Age: 59.0
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) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Negative; (15May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient treated with Paxlovid from 06May2023 to 11May2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of Vaccine products; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 Clinical course: Patient received Paxlovid (01May2023 to 13May2023) as Treatment of COVID-19. Other medication in 2weeks: Unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; 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, COVID19
Symptoms: Body height, COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products; positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) and in 2023 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: she has asthma, is overweight and is 66 years old.; "overweight" (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 13May2023, outcome "unknown" and all described as "positive for Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) between 5'0'' and 5'1''; SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative before the social events all week; (unspecified date) Unknown Results; (unspecified date) Unknown Results; (13May2023) Positive, notes: tested positive for covid on Saturday; Weight: (unspecified date) around 260. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 13May2023). Clinical course: She has had 4 of the Pfizer covid vaccines which the first dose was in the beginning of Mar2021 and then had two Moderna booster doses - the last one was 2 weeks ago and the other was 6 months prior to that. Tested positive for covid on Saturday. She had 6 covid vaccines total. She woke up Saturday morning with a "weird scratchy thing", which she has a lot because her apartment is old and dry. She had social events all week and tested negative before the social events all week. However, she was on the way to graduation and there were two lines and she has tested twice since then and she has Covid. She was prescribed Paxlovid from her doctor. She has a runny nose and constant sneezing, feels like a bad cold.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight
Clinical narrative: Interchange of vaccine products; positive for Covid; positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2022 as dose 5 (booster), single (Batch/Lot number: unknown) and in 2023 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: she has asthma, is overweight and is 66 years old.; "overweight" (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 13May2023, outcome "unknown" and all described as "positive for Covid"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "positive for covid" required physician office visit. The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) between 5'0'' and 5'1''; SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative before the social events all week; (unspecified date) Unknown Results; (unspecified date) Unknown Results; (13May2023) Positive, notes: tested positive for covid on Saturday; Weight: (unspecified date) around 260. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid from 13May2023). Clinical course: She has had 4 of the Pfizer covid vaccines which the first dose was in the beginning of Mar2021 and then had two Moderna booster doses - the last one was 2 weeks ago and the other was 6 months prior to that. Tested positive for covid on Saturday. She had 6 covid vaccines total. She woke up Saturday morning with a "weird scratchy thing", which she has a lot because her apartment is old and dry. She had social events all week and tested negative before the social events all week. However, she was on the way to graduation and there were two lines and she has tested twice since then and she has Covid. She was prescribed Paxlovid from her doctor. She has a runny nose and constant sneezing, feels like a bad cold.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15May2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown), for COVID-19 Immunization.  The following information was reported: CHILLS (non-serious) with onset 15May2023, outcome "unknown".  Additional information: Reporter's wife had the shot today and she had got chills and she was having a reaction.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact, Hypersensitivity, Illness
Clinical narrative: New allergies; Sick for 1 month; Contact dermatitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Dec2022 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chronic conditions" (unspecified if ongoing); "Food allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DERMATITIS CONTACT (non-serious) with onset 01Dec2022, outcome "recovered with sequelae", described as "Contact dermatitis"; ILLNESS (non-serious) with onset 01Dec2022, outcome "recovered with sequelae", described as "Sick for 1 month"; HYPERSENSITIVITY (non-serious), outcome "recovered with sequelae", described as "New allergies". The events "sick for 1 month", "contact dermatitis" and "new allergies" required physician office visit. It was unknown if therapeutic measures were taken as a result of illness, dermatitis contact, hypersensitivity.  Additional information: Unknown if patient received other vaccine in four weeks. The patient received other unspecified medications in two weeks. Unknown if patient had covid prior vaccination or If covid tested post vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with covid; diagnosed with covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; BNT162b2 (BNT162B2), 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: "high blood pressure" (unspecified if ongoing), notes: diagnosed about ten years ago. Concomitant medication(s) included: VARICELLA ZOSTER VACCINE taken for immunisation, in Apr2023 as 2nd dose; AMLODIPINE BESYLATE oral taken for blood pressure abnormal. Vaccination history included: Shingles vaccine (1st dose), for immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15May2023, outcome "unknown" and all described as "diagnosed with covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid). Clinical course: Male patient reporting that he got covid after getting the Pfizer covid 19 vaccine and booster. Advised by his son that is a pulmonologist to get the vaccine since he has high blood pressure. The most recent covid vaccine was the second booster dose that he got on 27Oct2022, which was his fourth Pfizer covid vaccine. He is now prescribed with Paxlovid and is taking atorvastatin. He asked how long he will be protected with booster and if he should take Paxlovid with atorvastatin. Confirms all 4 covid vaccine doses were by Pfizer. The last covid vaccine was a bivalent booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost of taste and smell; lost of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost of taste and smell". Additional information: Patient was asking about the Pfizer covid vaccine and he already got the 2nd dose in 5 doses and experienced lost of taste and smell. He asked if he should still continue taking. Patient asked if there have been previously reported before and if not would there be other problems that can correlate to his symptoms like pancreatic cancer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Malaise
Clinical narrative: her daughter has a heart condition; was not feeling well after her last vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 18-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HLHS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "her daughter has a heart condition"; MALAISE (non-serious), outcome "unknown", described as "was not feeling well after her last vaccine". The events "her daughter has a heart condition" and "was not feeling well after her last vaccine" required physician office visit and emergency room visit. It was unknown if therapeutic measures were taken as a result of cardiac disorder, malaise.  Additional information: she mentioned that her daughter, age 18, was not feeling well after her last vaccine. Her daughter has a heart condition.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Medication error, No adverse event, Wrong technique in product usage process
Clinical narrative: staff gave only the liquid portion of Pentacel with no reported adverse event; Initial information received on 15-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient to whom staff gave only the liquid portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(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 (batch number, expiry date, dose number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunisation), only the liquid portion with no reported adverse event (wrong technique in product usage process) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event staff gave only the liquid portion of pentacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: used sterile water to mix it with the powder when they administered pentacel with no adverse event; Initial information was received on 15-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 15 months old male patient who used sterile water to mix it with the powder when they administered pentacel with no adverse event while receiving vaccine 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) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ 15V (CRM197) (VAXNEUVANCE) for Prophylactic vaccination.  On 15-May-2023, the patient received 0.5 ml, once dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ807AA, expiry date: 01-Oct-2023), (strength: standard) via intramuscular route in unknown administration site for Immunization.  On 15-May-2023, the patient had used sterile water to mix it with the powder when they administered pentacel with no adverse event (product preparation error) same day following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 15.0
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: they used sterile water to mix it with the powder when they administered pentacel/reconstitution of vaccine using an improper diluent with no reported adverse event; Initial information was received on 15-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 15 months old female patient who reported they used sterile water to mix it with the powder when they administered pentacel/reconstitution of vaccine using an improper diluent 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) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Vaxelis) and pneumococcal vaccine CONJ 15V (CRM197) (Vaxneuvance) for Prophylactic vaccination.  On 15-May-2023, the patient received a 0.5 ml once (dose 1) of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot:UJ807AA, expiry date: 01-Oct-2023) (Strength: Standard) via intramuscular route in unknown administration site for Immunization.  On 15-May-2023 the patient had used sterile water to mix it with the powder when they administered pentacel/reconstitution of vaccine using an improper diluent with no reported adverse event (product preparation error) same day following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: U
Vaccine: UNK
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired PENTACEL injection administered to 4 month old baby with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old patient of an unknown gender who was administered expired DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] injection with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-May-2023 at 5:15 hours, the patient received an unknown dose once of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (Suspension for injection) (strength; lot number; expiry date not reported) via unknown route in unknown administration site for immunization. Information regarding batch number was requested.  On 15-May-2023, a 4 months old patient was administered expired pentacel injection with no reported adverse event (expired product administered) (latency: same day).  It was reported, "HCP wanted to know if that is considered viable or do they need to repeat the dose."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of daptacel was administered to a patient with no reported adverse event; Initial information was received on 16-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 1 years old female patient who reported expired dose was administered to a patient with no reported adverse event after receiving diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (PREVNAR).  On 16-May-2023, the patient received a 0.5 ml, total (once) dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection (lot:C5893AA, expiry date: 11-May-2023, strength: standard) via intramuscular route in left thigh for Immunization.  On 16-May-2023 the patient had expired dose of daptacel was administered to a patient with no reported adverse event (expired product administered) same day following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 4.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: an expired DAPTACEL was inadvertently given to a patient, with no adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old patient of an unknown gender and reporter reported that the expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] was inadvertently given to a patient, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-May-2023, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE for suspension for injection (strength: standard) (expiry date: 11-May-2023, lot C5883AA) via intramuscular route in the left deltoid for Immunization and on the same day expired daptacel was inadvertently given to a patient, with no adverse event (expired product administered).Information on the batch number was requested.  No lab data available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV, PNC15
Symptoms: Nasopharyngitis, Urticaria
Clinical narrative: Patient with urticaria which started on 5/16/23. No fever.  Also has cold symptoms as well.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Flushing, Hyperhidrosis, Loss of personal independence in daily activities
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 5 mins after receiving vaccine, patient complained of lightheadedness and became diaphoretic. Was assisted to supine position on the examining table with legs elevated. Vital signs continuously monitored and pulse was in the 40's and 50's. EMS activated after 20 mins of no resolution in symptoms. Patient discharged home after evaluation by EMS personnel. Called patient today 05/15/2023 and he sated he is felling better and is back at school
Age: 70.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site pain, Insomnia, Mobility decreased, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Unable to Sleep-Medium, Additional Details: Patient called the pharmacy on 05/15/2023 complaining that he cannot lift his arm- said he started to get pain in his shoulder/arm starting the evening of 05/06/2023 and it just continued to get worse to now he struggles to put a shirt on and cannot lift his arm to wash his hair. Also states trouble sleeping at night due to pain at night.
Age: 86.0
Sex: M
Vaccine: COVID19-2
Symptoms: Balance disorder, Fall, Head injury
Clinical narrative: Systemic: patient fell about 10 minutes after vaccine administration and hit head-Mild, Additional Details: patient already using walker and was not stable to be stand from a sitting positon without help. patient was sitting outside the immunization room waiting for his wife to be immunized. when wife opened the door after immunization, patient was already standing with the help of his walker. He may have lost his balance when he looked over at her. Patient fell backwards and hit his head. called EMS who recommended he go the hospital due to possible cuncussion and patient being on blood thinner.
Age: 18.0
Sex: F
Vaccine: HEPAB
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: patient fainted after receiving the vaccine. She recovered after around 10 minutes.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Pt called and said her arm was bruised (black and blue) at the injection site, also redness.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Tenderness
Clinical narrative: Received Shingrix vaccine on 4/24, developed small shingles or shingles-like rash on left side, itchy and tender, on 4/28. Reported to office on 4/30 and determined to be shingles on 5/1
Age: 28.0
Sex: F
Vaccine: FLUC4, TTOX
Symptoms: Asthenia, CSF culture, Fall, Immune system disorder, Immunoglobulin therapy
Clinical narrative: Guillain-Barre-like syndrome with progressive weakness/multiple falls for 3 weeks. Recent vaccine history shows that pt received their influenza and tetanus together. Suspicion that it might be one or both vaccines causing the reaction. Pt also stated that she is a recovering alcoholic and has PMH significant for childhood Hodgkin lymphoma. CSF culture was unsuccessful and pt was discharged with IVIG x5 days.
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Diarrhoea, Headache, Pyrexia, Weight decreased
Clinical narrative: Headache, fever, severe diarrhea for 5 days, 8 lbs weight loss
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Anal incontinence, Anxiety, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache, fever, severe diarrhea for 5 days, 8 lbs weight loss
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Headache, fever, severe diarrhea for 5 days, 8 lbs weight loss
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: On 5/11/23 mom states child started with fever and rash on 5/10/23. Fever 101.8, rash little red spots that look like a bug bite and 1 that looks almost like a pimple.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Pain, Pruritus
Clinical narrative: Mom reports that patient has developed a rash next to the injection sight. Red, bullseye appearance. Mom states patient is reporting pain and itch. No fever.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Conjunctivitis allergic, Eye pruritus, Eye swelling, Ocular hyperaemia, Periorbital swelling
Clinical narrative: 3/6/23  My left eye started getting puffy like a stye was forming. By the time I had an appointment, 4 days later, the area under my eye had became puffy and I looked like I had been punched in the eye. I was diagnosed with allergic conjunctivitis in both eyes. I did not have itching at the time. started Lastaeaft eye drops At my normal visit, a month later, I still had the conjunctivitis.   A cold compress makes the swelling go away.  On 5/14/23, my eyes were red, swollen and itchy, but not swollen as before.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, Cough, Fatigue, No adverse event, Rhinorrhoea
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 05/18/2023. I have a runny nose, cough and fatigue. I contacted my doctor and got a prescription for Paxlovid. I have taken two doses and so far, I am tolerating the medication.
Age: 57.0
Sex: M
Vaccine: COVID19-2
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 05/18/2023. I have a runny nose, cough and fatigue. I contacted my doctor and got a prescription for Paxlovid. I have taken two doses and so far, I am tolerating the medication.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fall
Clinical narrative: Fall, found to have COVID during hip fracture work up
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphonia, Goitre, Pharyngitis streptococcal, Streptococcus test positive
Clinical narrative: I developed a sore throat, but didn't have a fever. I waited to see if a fever to see if it was strep throat but one never came in. My voice gradually became hoarse, so I decided to visit my clinic. They told me my thyroid seemed to be enlarged during examination and conducted a throat swab on me to test for viral and bacterial infections. It came back positive for strep throat, and I was prescribed me Azithromycin 500mg for 5 days for recovery. This is the second time this has happened in between vaccinations of contracting a strep throat.
Age: 87.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient vaccinated against then tested positive for COVID-19
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: 1 YEAR LATER APRIL 23, 2023 HAD SERIOUS COVID AND TESTED POSITIVE DR PRESCRIBED PAXLOVID - LASTED 3 WEEKS BEFORE TESTED NEGATIVE
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions. Extra dose of hep B given before MICR will recognize but was given at least 8 weeks after the previous injection.