chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: an 84 year-old patient received two doses of Shingrix the same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number FF25X, expiry date 21-NOV-2025) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 05-MAR-2024, the patient received the 2nd dose of Shingrix. On 05-MAR-2024, an unknown time after receiving Shingrix, the patient experienced overdose (Verbatim: an 84 year-old patient received two doses of Shingrix the same day). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 05-Mar-2024 The reporter was a pharmacy technician. The reporter reported that an 84 year old patient received two doses of Shingrix vaccine on the same day, which led to overdose. The reporter asked for guidance on this situation and if the patient will need a third dose. The reporter mentioned that this was the first dose of the series. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Administration after exposure to freezing temperatures.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 25A2F) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number 3553D) for prophylaxis.   On 29-FEB-2024, the patient received Boostrix and Menveo. On an unknown date, an unknown time after receiving Boostrix and Menveo, the patient experienced incorrect storage of drug (Verbatim: Administration after exposure to freezing temperatures.). The outcome of the incorrect storage of drug 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: 05-MAR-2024 The nurse called to inform that, a dose of Boostrix and a dose of Menveo (one-vial presentation) were administered to a patient.  Such doses had been exposed to the temperature of 31.3°F, that was, temperatures below freezing, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: patient had reported shingles episode after vaccination/suspected vaccination failure; shingles; Shingrix - Postherpetic neuralgia; This serious case was reported by a physician via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: patient had reported shingles episode after vaccination/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: Shingrix - Postherpetic neuralgia). The outcome of the vaccination failure and shingles were unknown and the outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2024 The physician reported he had a patient who had completed the series of Shingrix vaccine a few years ago. The patient had an episode of shingles after vaccination and currently had postherpetic neuralgia. The patient wanted to receive the vaccine again and the doctor asked if administration of Shingrix could increase the pain (postherpetic neuralgia). This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 29-FEB-2024 was received on 29-FEB-2024 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: blood transfusion, appendectomy, and nonsmoker with history of smoking, and concurrent conditions included: postural orthostatic tachycardia syndrome, supraventricular tachycardia, chronic stress, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number: 842A21A) dose was not reported, administered on 01-APR-2021 to Left Arm for covid-19 prophylaxis.  Non-company suspect vaccine included: tozinameran (dose series 2) ( batch number: FF2593, form of admin, route of admin, and were not reported) dose was not reported, administered on 25-OCT-2021 to Left Arm for covid-19 prophylaxis (captured as Revaccination with different COVID-19 vaccine dose series 2).  No concomitant medications were reported.  On 13-FEB-2024, the patient experienced confirmed covid-19 infection, and confirmed clinical vaccine failure (dose series 2). Patient was sick for approximately 36 hours after testing positive on 13-FEB-2024 and starting Paxlovid. Primarily GI symptoms and severe exhaustion, no respiratory symptoms. Tested negative and felt fully recovered on third day after beginning Paxlovid (16-FEB-2024). Remained negative through 9 days after initial negative test and then developed tickle in nose and tested positive on 25-FEB-2024. Only symptom is slightly stuffy nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure and Revaccination with different COVID-19 vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Vaccination failure; The event is a special reporting situation and owing to its nature, it is not possible to attribute this occurrence to the suspect vaccine. Hence, the causality is considered as not related.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Myalgia, Pain in extremity, Sleep disorder
Clinical narrative: interfere with sleep; Muscle pain; fatigue; stiffness; leg pain interfere with sleep; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (leg pain interfere with sleep), SLEEP DISORDER (interfere with sleep), MYALGIA (Muscle pain) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 2clfle3a) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes, Obesity and Blood pressure high. Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    On 19-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 23-Sep-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (leg pain interfere with sleep), MYALGIA (Muscle pain) and FATIGUE (fatigue). On an unknown date, the patient experienced SLEEP DISORDER (interfere with sleep). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness), PAIN IN EXTREMITY (leg pain interfere with sleep), MYALGIA (Muscle pain) and FATIGUE (fatigue) was resolving and SLEEP DISORDER (interfere with sleep) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were not reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient had positive covid test the 27 FEB 2024; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Patient had positive covid test the 27 FEB 2024) in a 62-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1), Moderna COVID-19 Vaccine (Dose 4), Moderna COVID-19 Vaccine (Dose 3) and Moderna COVID-19 Vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Sinus disorder NOS.    On 30-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) .5 milliliter. On 27-Feb-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (Patient had positive covid test the 27 FEB 2024). At the time of the report, COVID-19 (Patient had positive covid test the 27 FEB 2024) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2024, SARS-CoV-2 test: Positive.         It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The concomitant medication was not reported by reporter. The patient's wife reported that he had sinus related symptoms and fever during covid. She reported that the patient has a history of sinus problem. She also reported that patient had 2 nights of fever. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-762962 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-762962:Same Reporter other patient
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Full body urticaria (Hives) excluding eyes and mucous membranes; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Full body urticaria (Hives) excluding eyes and mucous membranes) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8059071) for COVID-19 prophylaxis.     The patient's past medical history included Sleep apnea and UTI (Recovering from UTI.). Previously administered products included for Antibiotic therapy: Nitrofurantoin (Antibiotic therapy Nitrofurantoin 100mgs completed and one dose was left after receiving Vaccine.). Past adverse reactions to the above products included No adverse effect with Nitrofurantoin. Concurrent medical conditions included Hypothyroidism and Psoriatic arthritis.    On 08-Mar-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 08-Mar-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URTICARIA (Full body urticaria (Hives) excluding eyes and mucous membranes). The patient was treated with CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 0.25 milligram and PREDNISONE at a dose of 20 milligram. At the time of the report, URTICARIA (Full body urticaria (Hives) excluding eyes and mucous membranes) was resolving.            Concomitant medication was not provided. Patient took IV therapy and Claritin /Benedral O.25mgs at Hospital and then 1 daily at home. Anti itch spray, Prednisone 20mgs on returning home.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing); "focal nodular hyperplasia" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: mushrooms" (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". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 28Feb2024 to 03Mar2024).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular, Skin disorder, Vaccination site pain, Vaccination site pruritus
Clinical narrative: I had a Pfizer COVID shot (Pfizer COVID-19 Vaccine) on 01May2023, all of my other vaccines (Moderna COVID Vaccine) were Moderna; I tested positive; I tested positive; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 as dose number unknown (booster), single (Lot number: GL0446) at the age of 65 years, in arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single) and as dose 2, single) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing); "Diabetes type 2" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "bladder issue" (unspecified if ongoing); "heart issues" (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 15Jan2024, outcome "unknown" and all described as "I tested positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "I had a Pfizer COVID shot (Pfizer COVID-19 Vaccine) on 01May2023, all of my other vaccines (Moderna COVID Vaccine) were Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2024) Positive; Weight: (unspecified date) 228. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test, Weight
Clinical narrative: I had a Pfizer COVID shot (Pfizer COVID-19 Vaccine) on 01May2023, all of my other vaccines (Moderna COVID Vaccine) were Moderna; I tested positive; I tested positive; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 66-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01May2023 as dose number unknown (booster), single (Lot number: GL0446) at the age of 65 years, in arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single) and as dose 2, single) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing); "Diabetes type 2" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "bladder issue" (unspecified if ongoing); "heart issues" (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 15Jan2024, outcome "unknown" and all described as "I tested positive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "I had a Pfizer COVID shot (Pfizer COVID-19 Vaccine) on 01May2023, all of my other vaccines (Moderna COVID Vaccine) were Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2024) Positive; Weight: (unspecified date) 228. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Did you/the patient previously receive a COVID-19 Vaccine?: Yes/ Reported Event: COVID rebound; Did you/the patient previously receive a COVID-19 Vaccine?: Yes/ Reported Event: COVID rebound; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Did you/the patient previously receive a COVID-19 Vaccine?: Yes/ Reported Event: COVID rebound". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was unknown if the patient was patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient has previously received a COVID-19 Vaccine. Paxlovid was taken as treatment for COVID 19 from 01Mar2024 to 06Mar2024  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from an Other HCP.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MCAS" (unspecified if ongoing), notes: Other medical history: MCAS; "POTS" (unspecified if ongoing), notes: Other medical history: POTS. The patient's concomitant medications were not reported. Past drug history included: Corn, reaction(s): "Known allergies: Corn", notes: Known allergies: Corn. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that the patient received other vaccination and medication in 2 weeks. Paxlovid was taken as treatment for COVID-19 from 04Mar2024 to 08Mar2024  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event drug ineffective (CoVID-19) with the suspect product BNT162B2 cannot be fully excluded.
Sex: U
Vaccine: COVID19
Symptoms: Deafness neurosensory, Nerve injury
Clinical narrative: viral nerve damage; sensorineural hearing loss; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID:.  A patient (age and gender not provided) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "sensorineural hearing loss", start date: 2021 (unspecified if ongoing), notes: 3 years ago I was diagnosed with sensorineural hearing loss on my left ear. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS NEUROSENSORY (medically significant) with onset 12Mar2024, outcome "unknown", described as "sensorineural hearing loss"; NERVE INJURY (medically significant), outcome "unknown", described as "viral nerve damage". The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received. Clinical course: Three years ago the patient was diagnosed with sensorineural hearing loss on his/her left ear and just recently (12Mar2024) the same in his/her right ear. Patient has being told that this sudden hearing loss is viral nerve damage from a severe infection, severe virus or exposure to medication related to those.  Patient has not had an infection or a virus but received a Pfizer Covid-19 vaccine that aligned with this issue.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Bell's palsy, Facial paralysis, Hemiparesis, Injection site hypoaesthesia, Sensory disturbance
Clinical narrative: Mom contacted Clinic on 3/6/24 at approximately 4:31 pm. Mom states patient was having complaints of numbness at the injection site and her arm was feeling funny where she obtained her HPV vaccine on 3/4/24. Nurse spoke with provider and explained symptoms per mom. Nurse returned to the phone and gave directions per provider to use warm compresses on affected area and if not better to return to clinic in 1-2 days for evaluation. Mom then stated patient has been to the park and doing normal activities and is acting fine. Mom stated that patient is telling her as we speak that her face feels like it is swollen, but mom stated that patient's face does not look swollen at all. Nurse explained to mom, due to patient feeling that her face feels like it is swollen nurse recommended mom to take patient to Emergency Department ASAP. Mom voiced understanding and was in agreement with plan. Mom stated she would contact Clinic with an update after patient was evaluated at ED. Nurse called patients mom on 3/13/24. Mom spoke with nurse and provider and stated the weakness on the side where patient received the HPV immunzation went away the following day (3/5/24) after receiving the HPV vaccine. Mom stated patient went to school and was doing normal activities. Mom stated that she took patient to town on Saturday (3/9/24) to purchase a new phone and she noticied that when she smiled her mouth was drooping. Mom took patient to ED on Saturday, 3/9/24 and patient was diagnosed with Bell's Palsy.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling face
Clinical narrative: Mom contacted Clinic on 3/6/24 at approximately 4:31 pm. Mom states patient was having complaints of numbness at the injection site and her arm was feeling funny where she obtained her HPV vaccine on 3/4/24. Nurse spoke with provider and explained symptoms per mom. Nurse returned to the phone and gave directions per provider to use warm compresses on affected area and if not better to return to clinic in 1-2 days for evaluation. Mom then stated patient has been to the park and doing normal activities and is acting fine. Mom stated that patient is telling her as we speak that her face feels like it is swollen, but mom stated that patient's face does not look swollen at all. Nurse explained to mom, due to patient feeling that her face feels like it is swollen nurse recommended mom to take patient to Emergency Department ASAP. Mom voiced understanding and was in agreement with plan. Mom stated she would contact Clinic with an update after patient was evaluated at ED. Nurse called patients mom on 3/13/24. Mom spoke with nurse and provider and stated the weakness on the side where patient received the HPV immunzation went away the following day (3/5/24) after receiving the HPV vaccine. Mom stated patient went to school and was doing normal activities. Mom stated that she took patient to town on Saturday (3/9/24) to purchase a new phone and she noticied that when she smiled her mouth was drooping. Mom took patient to ED on Saturday, 3/9/24 and patient was diagnosed with Bell's Palsy.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria, Urticaria
Clinical narrative: Uticaria/Dermatographism/Hives for the past 9+ months after receiving the Moderna Covid Booster shot. Have been taking an antihistamine daily for relief for the past 9 months.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness, Eye movement disorder, Pallor
Clinical narrative: PATIENT RECEIVED VACCINE AND THEN GOT LIGHT HEADED AND DIZZY. SHE PASSED OUT, FACE TURNED PALE, AND HER EYES ROLLED BACK. SHE CAME TO WITHIN ABOUT A MINUTE AND REGAINED FACIAL COLOR--STILL REMAINED LIGHT HEADED.
Age: 59.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Erythema, Urticaria
Clinical narrative: Developed extremely large erythematous wheel day after vaccine.  Grew over two days then resolved
Age: 0.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient was given the wrong vaccinations, patient is only 6 months old
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Autopsy, Cardiac failure acute, Death, Dyspnoea, Fatigue
Clinical narrative: Ss cardiac failure  edema ,sob, increased fatigue , acute heart failure . Death at  age 55 on  7/15/22.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Left ventricular failure, Myocardial oedema
Clinical narrative: Ss cardiac failure  edema ,sob, increased fatigue , acute heart failure . Death at  age 55 on  7/15/22.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle atrophy, Pain in extremity
Clinical narrative: Severe arm pain. Loss of range of motion and muscle atrophy.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Pyrexia, Thinking abnormal
Clinical narrative: fever; shaking; chills; increased HR (about 120); muddled thinking; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; TREMOR (non-serious), outcome "unknown", described as "shaking"; CHILLS (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "increased HR (about 120)"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "muddled thinking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, tremor, chills, heart rate increased, thinking abnormal.  Additional information: At each of the vaccines (Pfizer's and Monerna's), the side effects began about 8-9 hours after receiving vaccine and lasted 36 hours. During this time, she experienced (every time, every vaccine) fever, shaking, chills, increased HR (about 120), and muddled thinking, A cool bath helped with the shaking every time. So maybe her body's response to COVID vaccine and COVID. Normally, she has no symptoms with vaccinations besides a tender spot at injection site.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: fever; shaking; chills; increased HR (about 120); muddled thinking; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; TREMOR (non-serious), outcome "unknown", described as "shaking"; CHILLS (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "increased HR (about 120)"; THINKING ABNORMAL (non-serious), outcome "unknown", described as "muddled thinking". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, tremor, chills, heart rate increased, thinking abnormal.  Additional information: At each of the vaccines (Pfizer's and Monerna's), the side effects began about 8-9 hours after receiving vaccine and lasted 36 hours. During this time, she experienced (every time, every vaccine) fever, shaking, chills, increased HR (about 120), and muddled thinking, A cool bath helped with the shaking every time. So maybe her body's response to COVID vaccine and COVID. Normally, she has no symptoms with vaccinations besides a tender spot at injection site.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Positive for COVID (13Oct2023); Positive for COVID (13Oct2023); 1st: Johnson& Johnson in 2021, 2nd: Moderna 02Dec2021 3rd: Moderna 29Apr2022; 4th: Pfizer 04Oct2022; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): C-INT-0011397 (Moderna).  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 4 (booster), single (Lot number: GJ5342) for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), in 2021 as dose 1, single) for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 02Dec2021 as dose 2 (booster), single) and on 29Apr2022 as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2022, outcome "recovered", described as "1st: Johnson& Johnson in 2021, 2nd: Moderna 02Dec2021 3rd: Moderna 29Apr2022; 4th: Pfizer 04Oct2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Oct2023, outcome "recovered" and all described as "Positive for COVID (13Oct2023)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Oct2023) Positive.  No follow-up attempts are possible.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Administered a patient both Pentacel and Pediarix at the same date with no reported adverse event; Initial information received on 06-Mar-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient where patient got administered both diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [Pentacel (VERO)] and Pediarix at the same date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Feb-2024, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection (lot- UJ868AA) (route, administration site , dose, strength and expiration date: not provided) for Immunisation and received a dose of suspect pediarix not produced by Sanofi Pasteur lot number not reported (route, administration site, dose, formulation, strength and expiration date: not provided) for Immunisation (Extra dose administered) (latency- same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 73.0
Sex: U
Vaccine: MEN
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the meningitis vaccine, menquadfi. she stated that the doses should be 8 weeks apart but patient received another dose after six weeks with no reported ae; Initial information received on 08-Mar-2024 regarding an unsolicited valid  non-serious case received from a pharmacist via call center.  This case involves a 73 years old and unknown gender patient who was Vaccinated with another dose of Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] after six weeks but the reporter stated that the doses should be 8 weeks apart, 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 had received 0.5 ml (dose: 2) of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot U7852AB, expiry date and strength not reported) via unknown route in unknown administration site for Immunization (inappropriate schedule of product administration) (Unknown).   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE REACTIONS NOTED. SPOKE WITH MOM AND PT IS DOING WELL.
Age: 53.0
Sex: F
Vaccine: PNC20
Symptoms: Pharyngeal paraesthesia, Rash
Clinical narrative: Patient developed tingling in throat and rash 5 minutes after vaccine was given.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Anti-thyroid antibody increased, Autoimmune thyroiditis, Menstruation irregular
Clinical narrative: Mother reports that 6 months after receiving HPV #2 patient started developing irregularities with her menses.  She was subequently dx with positive thyroid peroxidase antibody and later developed Hashimotos Thyroiditis.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, HIBV, MMR, PNC20, VARCEL
Symptoms: Rash, Rash maculo-papular, Rash pruritic
Clinical narrative: pruritic maculopapular rash began in face and descended across skin even palms and bottom of feet.   no fever, no respiratory compromise, and no vaginal or oral mucosal involvement.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I checked the System and it showed that patient was due for 4th dose of dtap. Patient was administered his 4th dose outside the of interval from his 3rd dose.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Blood follicle stimulating hormone, Blood luteinising hormone, Oestradiol, Premature menopause
Clinical narrative: Mother reports that after COVID vaccine.  Patient stopped menstruating.  Mom reports that she never had her period again and patient has subsequently been diagnosed with premature ovarian failure.
Age: 52.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: administer after the beyond use date of 2/18/24
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Contusion, Pain, Tenderness
Clinical narrative: Pt developed a bruise and a sharp pain. The pain and bruise have gotten a little better since 02/16 (per pt about 10 % better), but still hurts when she touches it.
Age: 60.0
Sex: F
Vaccine: PNC20
Symptoms: Electrocardiogram normal, Lethargy, Tachycardia, Vomiting
Clinical narrative: Lethargy, vomiting and tachycardia (111bpm).  Per patient, was instructed to monitor symptoms and drink electrolytes d/t vomiting.
Age: 56.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Pain upon touch in a 3" radius around injection site on upper left arm. Noticeable muscle weakness when raising left arm above head. Injection was 4 months ago.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Cardioversion, Death, Syncope, Ventricular fibrillation
Clinical narrative: Above patient received vaccine on the above day uncertain time. She was later out shopping and collapsed witnessed by family. She had cardiac arrest and EMS called. She was shocked 5-6 times due to v-fib. She was transported to local hospital ER and pronounced dead.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Itchy red rash oer lower half of upper left arm since last night (2/20/24). Immnizations were given in upper left arm on 2/19/24. No other symptoms.
Age: 31.0
Sex: F
Vaccine: YF
Symptoms: Chills, Lymphadenopathy, Oropharyngeal pain, Pruritus, Pyrexia
Clinical narrative: Approx. 24 hours after receiving a yellow fever vaccine, pt reports experiencing hives on trunk only. Patient also reports having put on a new sports bra at the same time that the hives appeared. This bra was not washed, since being purchased. The hives are a dime to a quarter in circumference. Raised and itchy. She also experienced a sore throat, fever, chills, swollen lymph nodes which have since gone away. Only hives persist. She called today to report. She has an appointment today w/PCP + Dermatologist
Age: 31.0
Sex: F
Vaccine: YF
Symptoms: Skin swelling, Urticaria
Clinical narrative: Approx. 24 hours after receiving a yellow fever vaccine, pt reports experiencing hives on trunk only. Patient also reports having put on a new sports bra at the same time that the hives appeared. This bra was not washed, since being purchased. The hives are a dime to a quarter in circumference. Raised and itchy. She also experienced a sore throat, fever, chills, swollen lymph nodes which have since gone away. Only hives persist. She called today to report. She has an appointment today w/PCP + Dermatologist
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Candida infection
Clinical narrative: thrush; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure", start date: Jul2019 (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in Sep2023; ATENOLOL taken for heart rate (ongoing); LOSARTAN HCT (ongoing); MONTELUKAST (ongoing). Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (dose number unknown), for Covid-19 immunization, reaction(s): "thrush"; Bnt162b2 (dose number unknown), for Covid-19 immunization, reaction(s): "thrush". The following information was reported: CANDIDA INFECTION (non-serious) with onset 2023, outcome "unknown", described as "thrush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of candida infection.  Additional information: The patient mentioned that has had all the Pfizer Covid-19 vaccines and every 3 months, after getting the vaccines, he gets thrush, 8 times already per patient. His doctor also prescribed him medication for the thrush, but it comes back after 8-9 weeks later. He mentioned he has only one vocal chord and that is why he sounds that way when talking.  200mg Fluconazole was what caller was prescribed for thrush every time. The last time he got thrush was in Jan2024 and the Fluconazole was issued 12Jan2024. Fluconazole is in tablet form. Ever since he got thrush the first time, he has had coating on tongue that won't go away. It is a milky white brownish coating, and it won't go away. Then caller states in Feb2024 he got Nystatin that was prescribed by his Ears, Nose, and Throat doctor.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400061745 same patient/drug, different dose/AE;US-PFIZER INC-202400061744 same patient/drug, different dose/AE;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Candida infection
Clinical narrative: thrush; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 70-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure", start date: Jul2019 (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in Sep2023; ATENOLOL taken for heart rate (ongoing); LOSARTAN HCT (ongoing); MONTELUKAST (ongoing). Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (dose number unknown), for Covid-19 immunization, reaction(s): "thrush"; Bnt162b2 (dose number unknown), for Covid-19 immunization, reaction(s): "thrush". The following information was reported: CANDIDA INFECTION (non-serious) with onset 2023, outcome "unknown", described as "thrush". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of candida infection.  Additional information: The patient mentioned that has had all the Pfizer Covid-19 vaccines and every 3 months, after getting the vaccines, he gets thrush, 8 times already per patient. His doctor also prescribed him medication for the thrush, but it comes back after 8-9 weeks later. He mentioned he has only one vocal chord and that is why he sounds that way when talking.  200mg Fluconazole was what caller was prescribed for thrush every time. The last time he got thrush was in Jan2024 and the Fluconazole was issued 12Jan2024. Fluconazole is in tablet form. Ever since he got thrush the first time, he has had coating on tongue that won't go away. It is a milky white brownish coating, and it won't go away. Then caller states in Feb2024 he got Nystatin that was prescribed by his Ears, Nose, and Throat doctor.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400061745 same patient/drug, different dose/AE;US-PFIZER INC-202400061744 same patient/drug, different dose/AE;
Age: 1.25
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No symptoms reported/No other AE; HCP states a second dose of both vaccines was inadvertently administered to a 15 month old patient and dose was administered too early; HCP states a second dose of both vaccines was inadvertently administered to a 15 month old patient and dose was administered too early; This spontaneous report was received from a physician and refers to a 15-month-old patient of unknown gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.    On an unknown date, the patient was vaccinated with the first doses of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) both administered as prophylaxis.  On 28-FEB-2024, the patient was vaccinated with the second doses of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) both administered as prophylaxis. Furthermore, it was reported that the doses of abovementioned vaccines were administered earlier than recommended age and second dose of both vaccines was inadvertently administered (inappropriate schedule of vaccine administered and inappropriate age at vaccine administration). No other adverse event (AE).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse calling to report that a dose of MMRII was accidentally given after its labeled expiration date.; This spontaneous report as received from a nurse concerning a patient of unknown age. There was no information about the patients' medical history, concurrent conditions or concomitant medications.    On 07-MAR-2024,  the patient accidentally was vaccinated  with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)rHA, Subcutaneous Injection, lot # w006738, expiration date:  25-FEB-2024  for prophylaxis (dose, route and anatomical location was not reported) after its labeled expiration date (expired product administered). She confirmed that the dose of the product had never undergone a temperature excursion. No additional adverse event reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE. No PQC.; HCP calling to report that patient received MMR II and VARIVAX during temp excursion.  Caller unable to provide time or highest temperatures reached as she states excursion occurred during power outage/transport and was not monitored.  Associated AE; This spontaneous report was received from a Medical Assistant and refers to a patient pf unknown age and gender. The patient's medical, concurrent conditions and concomitant therapies were not reported.  On 05-MAR-2024, the patient was vaccinated at a clinic with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X021281, (expiration date: 20-AUG-2025), administered for prophylaxis (strength and route of administration were not provided); and  with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, Lot # reported as W03848 which was determined to be an invalid lot number by the validation lot team (expiration date reported as: 27-SEP-2024), administered for prophylaxis (strength and route of administration were not provided), the above mentioned vaccines were administered to the patient during temperature excursion (Product storage error), the reporter was unable to provide time or highest temperatures reached as she states excursion occurred during power outage/transport and was not monitored. Moreover, it was unknown if there were previous temperature excursions. No additional adverse event (AE) (No adverse event). No product quality complaint (PQC).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2403USA003324: