chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Wrong product administered
Clinical narrative: on 1/19/24, MCV4 was given instead of Men B.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Brachial plexopathy, Computerised tomogram head, Detoxification, Echocardiogram
Clinical narrative: BELL'S PALSY LEFT FACE, LEFT BRACHIAL PLEXOPATHY LOWER MOTOR NEURON INJURY SYNDOME.  STROKE RULED OUT BY CT AND MRI AND EXAM.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electromyogram, Imaging procedure, Laboratory test, Lower motor neurone lesion
Clinical narrative: BELL'S PALSY LEFT FACE, LEFT BRACHIAL PLEXOPATHY LOWER MOTOR NEURON INJURY SYNDOME.  STROKE RULED OUT BY CT AND MRI AND EXAM.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head
Clinical narrative: BELL'S PALSY LEFT FACE, LEFT BRACHIAL PLEXOPATHY LOWER MOTOR NEURON INJURY SYNDOME.  STROKE RULED OUT BY CT AND MRI AND EXAM.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling, Urticaria
Clinical narrative: Woke up the morning after shots were administered with profuse hives on his back/front/and legs and his entire Left leg swollen.  Patient was seen at Doctors office today 2/26/24 and still had some hives on his body and the swelling had improved to a 9x9 inch area only.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Injection site pruritus, Peripheral swelling
Clinical narrative: Vaccines were administered at 12:55 pm. Patient complained of itching at injection site at 1:10 pm. Patient had localized redness and small elevated bump to right arm. Notified provider at 1:12 pm and sent photo of site. Provider advised for parents to give Benadryl at home and apply cold compress to injection site 3 times a day for 15 minutes. Advise to go to ER if any additional symptoms occur or any difficulty breathing. Called father to follow up at 4:39 pm and father verbalized that patient redness to arm went away and patient was feeling okay.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature abnormal, Breast pain, Chest discomfort, Chest pain
Clinical narrative: Lt arm pain, heart palpitations and breast pain immediately following vaccination. 12/2021, palpitations worsening, dizziness, still chest/breast pain, 05/2022 mammogram performed. 01/2023 dizziness escalated and unable to drive, 05/2023, heart palpitations worsening, POTS type symptoms, double vision, increased sweating, fatigue/heaviness, 06/2023 SOB, pressure in diaghram , GI issues, 09/2023 muscle twitching, increased fatigue and weakness, pins and needles in hands 12/2023 muscle wasting, numbness, twitching, tremors, fatigue, weakness, SOB, sweating, unable to control temperature. 02/2024 doctors still unsure of what is happening to me and no diagnosis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Diplopia, Discomfort, Dizziness, Electrocardiogram
Clinical narrative: Lt arm pain, heart palpitations and breast pain immediately following vaccination. 12/2021, palpitations worsening, dizziness, still chest/breast pain, 05/2022 mammogram performed. 01/2023 dizziness escalated and unable to drive, 05/2023, heart palpitations worsening, POTS type symptoms, double vision, increased sweating, fatigue/heaviness, 06/2023 SOB, pressure in diaghram , GI issues, 09/2023 muscle twitching, increased fatigue and weakness, pins and needles in hands 12/2023 muscle wasting, numbness, twitching, tremors, fatigue, weakness, SOB, sweating, unable to control temperature. 02/2024 doctors still unsure of what is happening to me and no diagnosis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Electromyogram, Fatigue, Hyperhidrosis, Hypoaesthesia, Immediate post-injection reaction
Clinical narrative: Lt arm pain, heart palpitations and breast pain immediately following vaccination. 12/2021, palpitations worsening, dizziness, still chest/breast pain, 05/2022 mammogram performed. 01/2023 dizziness escalated and unable to drive, 05/2023, heart palpitations worsening, POTS type symptoms, double vision, increased sweating, fatigue/heaviness, 06/2023 SOB, pressure in diaghram , GI issues, 09/2023 muscle twitching, increased fatigue and weakness, pins and needles in hands 12/2023 muscle wasting, numbness, twitching, tremors, fatigue, weakness, SOB, sweating, unable to control temperature. 02/2024 doctors still unsure of what is happening to me and no diagnosis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Impaired work ability, Laboratory test, Magnetic resonance imaging, Mammogram
Clinical narrative: Lt arm pain, heart palpitations and breast pain immediately following vaccination. 12/2021, palpitations worsening, dizziness, still chest/breast pain, 05/2022 mammogram performed. 01/2023 dizziness escalated and unable to drive, 05/2023, heart palpitations worsening, POTS type symptoms, double vision, increased sweating, fatigue/heaviness, 06/2023 SOB, pressure in diaghram , GI issues, 09/2023 muscle twitching, increased fatigue and weakness, pins and needles in hands 12/2023 muscle wasting, numbness, twitching, tremors, fatigue, weakness, SOB, sweating, unable to control temperature. 02/2024 doctors still unsure of what is happening to me and no diagnosis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness, Muscle atrophy, Muscle twitching, Neurological symptom, Pain in extremity
Clinical narrative: Lt arm pain, heart palpitations and breast pain immediately following vaccination. 12/2021, palpitations worsening, dizziness, still chest/breast pain, 05/2022 mammogram performed. 01/2023 dizziness escalated and unable to drive, 05/2023, heart palpitations worsening, POTS type symptoms, double vision, increased sweating, fatigue/heaviness, 06/2023 SOB, pressure in diaghram , GI issues, 09/2023 muscle twitching, increased fatigue and weakness, pins and needles in hands 12/2023 muscle wasting, numbness, twitching, tremors, fatigue, weakness, SOB, sweating, unable to control temperature. 02/2024 doctors still unsure of what is happening to me and no diagnosis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia, Seizure like phenomena, Tilt table test, Tremor
Clinical narrative: Lt arm pain, heart palpitations and breast pain immediately following vaccination. 12/2021, palpitations worsening, dizziness, still chest/breast pain, 05/2022 mammogram performed. 01/2023 dizziness escalated and unable to drive, 05/2023, heart palpitations worsening, POTS type symptoms, double vision, increased sweating, fatigue/heaviness, 06/2023 SOB, pressure in diaghram , GI issues, 09/2023 muscle twitching, increased fatigue and weakness, pins and needles in hands 12/2023 muscle wasting, numbness, twitching, tremors, fatigue, weakness, SOB, sweating, unable to control temperature. 02/2024 doctors still unsure of what is happening to me and no diagnosis
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Lt arm pain, heart palpitations and breast pain immediately following vaccination. 12/2021, palpitations worsening, dizziness, still chest/breast pain, 05/2022 mammogram performed. 01/2023 dizziness escalated and unable to drive, 05/2023, heart palpitations worsening, POTS type symptoms, double vision, increased sweating, fatigue/heaviness, 06/2023 SOB, pressure in diaghram , GI issues, 09/2023 muscle twitching, increased fatigue and weakness, pins and needles in hands 12/2023 muscle wasting, numbness, twitching, tremors, fatigue, weakness, SOB, sweating, unable to control temperature. 02/2024 doctors still unsure of what is happening to me and no diagnosis
Age: 0.5
Sex: F
Vaccine: HIBV, PNC
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No additional AE; this was the patients 3rd dose of PEDVAXHIB; Medical assistant called and reported that a 6 month old patient was inadvertently administered a PEDVAXHIB dose instead of PREVNAR on 2/5/2024. Caller stated this was the patients 3rd dose of PEDVAXHIB, dates of previous doses not available. Caller; This spontaneous report was received from a medical assistant, referring to a 6-month-old female patient.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-FEB-2024, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided); instead of pneumococcal vaccine conj 7v (crm197) (PREVNAR).  The medical assistant called and reported that a 6 month old patient was inadvertently administered a ("3rd dose of") haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) dose instead of pneumococcal vaccine conj 7v (crm197) (PREVNAR) (dates of previous doses not available, It was unknown if the patient received previous doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) or pneumococcal vaccine conj 7v (crm197) (PREVNAR)). No additional adverse events were reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No side effects reported; PROQUAD was administered after it experienced a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  On 07-FEB-2024, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, 0.5 milliliter, lot #  X019303, expiration date: 14-JAN-2025, administered for prophylaxis (strength, vaccination schedule, injection anatomical location, and route of administration were not provided); which was administered after it experienced a temperature excursion (Product storage error). No adverse events were reported.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP called to report TE where products have been administered to patients. 5.8F for 0 hours 15 minutes 0 seconds; This spontaneous report has been received from other, regarding to a 1-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 05-FEB-2024, the patient was vaccinated with an improperly stored dose of with improperly storage dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) at a dose of 0.5 milliliters (ml), as prophylaxis (lot number: X022923, which was determined to be valid, with an expiration date on 12-MAR-2025) (strength, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 5.8 degrees Fahrenheit (F), during a time frame of 15 minutes (product storage error). There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE/PQC reported; HCP reported that a male patient was inadverntly administered the PROQUAD vaccine, instead of the MMR II and VARIVAX vaccines; This spontaneous report was received from a medical assistant concerning a male patient of unknown age. Patient's concurrent conditions, pertinent medical history and concomitant medications were not provided.  On 19-FEB-2024, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot number reported as X018575 and expiration date: 05-JAN-2025, administered for prophylaxis (strength, lot #, and route of administration were not provided), instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  and  varicella virus vaccine live (oka/merck) (VARIVAX) (wrong vaccine administered).  No additional adverse events reported.
Age: 0.5
Sex: M
Vaccine: PNC15
Symptoms: No adverse event, Syringe issue, Underdose, Wrong technique in product usage process
Clinical narrative: No Adverse Event; After she heard the cracking sound product leaked from needle attachment; After she heard the cracking sound product leaked from needle attachment; She reports in order to not waste the product she then drew the product up from the broken PFS into a different syringe and; drew the product up from the broken PFS into a different syringe; incorrect dose administered; This spontaneous report as received from a medical assistant via field based employee (FBE) refers to a 6-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-FEB-2024, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL, lot # X022028 (pre-filled syringe formulation), expiration date: 22-OCT-2025 (route of administration and anatomical location were not reported) for prophylaxis. On that day, when preparing product for administration, medical assistant heard a cracking sound (Syringe issue). When she cleared the bubbles and started to push the medication, it was coming out of the syringe where the needle was attached (near luer lock needle attachement)(also reported that after she heard the cracking sound product leaked from needle attachment point) (Device leakage). In order to not waste the product, she then drew the product up from the broken pre-filled syringe into a different syringe(Wrong technique in device usage process), and administered pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) to a patient (Poor quality product administered; Incorrect dose administered). No injuries occurred as a result of the breakage. No additional adverse event was reported (No adverse event).
Age: 42.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Adult patient received PROQUAD; No additional AEs; This spontaneous report has been received from a nurse prescriber, concerning a 42-year-old patient of unknown gender, via a company representative.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On an unknown date, the adult patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, administered as prophylaxis by a Health Professional (exact dose, lot number, expiration date, route of administration, and anatomical location were not provided) (Product administered to patient of inappropriate age).  No additional adverse events (AEs) were reported. No other information provided.  Lot # is being requested and will be submitted if received.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Dizziness and lightheadedness; weird feeling in head been going on all day; This non-serious case was reported by a consumer and described the occurrence of dizziness in a 59-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included depression (On 24th October 2023 received Effexor for treatment of depression) and herpes simplex. Concomitant products included venlafaxine hydrochloride (Effexor) and aciclovir (Acyclovir).   On 16-FEB-2024, the patient received the 2nd dose of Shingles vaccine. In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced weird feeling (Verbatim: weird feeling in head been going on all day). On 16-FEB-2024, the patient experienced dizziness (Verbatim: Dizziness and lightheadedness). The outcome of the dizziness was not resolved and the outcome of the weird feeling was not reported.   It was unknown if the reporter considered the dizziness and weird feeling to be related to Shingles vaccine.     It was unknown if the company considered the dizziness and weird feeling to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-FEB-2024 The reporter was a patient. Patient reported that after receiving Shingles vaccine she had dizziness and light headedness and overall weird feeling in head been going on all day. The symptoms were not treated. Patient received Effexor for depression. Patient received acyclovir for herpes simplex. The reporter requested consent to follow-up.
Sex: U
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: sick for the 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced sickness (Verbatim: sick for the 3 days). The outcome of the sickness was resolved (duration 3 days).   It was unknown if the reporter considered the sickness to be related to Arexvy.     It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-FEB-2024 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The reporter stated that the vaccine was working and sick for following 3 days Arexvy vaccination but it happened. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: COVID19
Symptoms: Escherichia infection, Thrombosis
Clinical narrative: E. COLI; TWO BLOOD CLOTS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced two blood clots (Dose in series 1), and  E. coli (Dose in series 1), and was hospitalized (date unspecified). The patient reported that eight months of dealing with E. coli which the form it had was in the J&J vaccine (Dose in series 1), and was hospitalized. The patient had to have surgery to remove the inflammation.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two blood clots and E. coli was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: Thrombosis and Escherichia infection -The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hot flush, Hyperhidrosis, Insomnia, Myalgia
Clinical narrative: lack of sleep; muscle pain; hot flashes with a lot of sweating; hot flashes with a lot of sweating; restless bilateral legs and arms (which she cannot take medication for); restless bilateral legs and arms (which she cannot take medication for); weakness; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (hot flashes with a lot of sweating), HYPERHIDROSIS (hot flashes with a lot of sweating), RESTLESS LEGS SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), RESTLESS ARM SYNDROME (restless bilateral legs and arms (which she cannot take medication for)) and ASTHENIA (weakness) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 2000 and Fibromyalgia since 2000.    On 04-Jan-2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Jan-2024 at 5:00 PM, the patient experienced HOT FLUSH (hot flashes with a lot of sweating), HYPERHIDROSIS (hot flashes with a lot of sweating), RESTLESS LEGS SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), RESTLESS ARM SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), ASTHENIA (weakness) and MYALGIA (muscle pain). On an unknown date, the patient experienced INSOMNIA (lack of sleep). On 05-Jan-2024 at 5:00 AM, HOT FLUSH (hot flashes with a lot of sweating), HYPERHIDROSIS (hot flashes with a lot of sweating), RESTLESS LEGS SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), RESTLESS ARM SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), ASTHENIA (weakness) and MYALGIA (muscle pain) had resolved. At the time of the report, INSOMNIA (lack of sleep) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   The patient was not getting more than 20 minutes of sleep at a time, and maybe a collection of 2 to 3 hours of sleep a night. She was so tired and weak from the lack of sleep.  On 05 Feb 2024, she went to the emergency room because she was at her wits end however they couldn't do anything for her. She had been referred to neurology but there was a 6month wait.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-761251 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2024-761253 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761251:Daughter case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Restless arm syndrome, Restless legs syndrome
Clinical narrative: lack of sleep; muscle pain; hot flashes with a lot of sweating; hot flashes with a lot of sweating; restless bilateral legs and arms (which she cannot take medication for); restless bilateral legs and arms (which she cannot take medication for); weakness; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (hot flashes with a lot of sweating), HYPERHIDROSIS (hot flashes with a lot of sweating), RESTLESS LEGS SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), RESTLESS ARM SYNDROME (restless bilateral legs and arms (which she cannot take medication for)) and ASTHENIA (weakness) in a 59-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis since 2000 and Fibromyalgia since 2000.    On 04-Jan-2024, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Jan-2024 at 5:00 PM, the patient experienced HOT FLUSH (hot flashes with a lot of sweating), HYPERHIDROSIS (hot flashes with a lot of sweating), RESTLESS LEGS SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), RESTLESS ARM SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), ASTHENIA (weakness) and MYALGIA (muscle pain). On an unknown date, the patient experienced INSOMNIA (lack of sleep). On 05-Jan-2024 at 5:00 AM, HOT FLUSH (hot flashes with a lot of sweating), HYPERHIDROSIS (hot flashes with a lot of sweating), RESTLESS LEGS SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), RESTLESS ARM SYNDROME (restless bilateral legs and arms (which she cannot take medication for)), ASTHENIA (weakness) and MYALGIA (muscle pain) had resolved. At the time of the report, INSOMNIA (lack of sleep) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   The patient was not getting more than 20 minutes of sleep at a time, and maybe a collection of 2 to 3 hours of sleep a night. She was so tired and weak from the lack of sleep.  On 05 Feb 2024, she went to the emergency room because she was at her wits end however they couldn't do anything for her. She had been referred to neurology but there was a 6month wait.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-761251 (E2B Linked Report). This case was linked to US-MODERNATX, INC.-MOD-2024-761253 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-761251:Daughter case
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Swelling, Swelling face, Syncope
Clinical narrative: seen at urgent care for neck swelling and facial swelling, weakness, fainting, confusion
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough
Clinical narrative: Dry cough for approx 1 month now
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema
Clinical narrative: redness
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood sodium decreased, Cardiac failure, Decreased appetite, Dyspnoea, Ejection fraction decreased
Clinical narrative: Severe fatigue and difficulty walking the next day. Progressed to severe shortness of breath. Barely able to walk at 48 hours, lack of appetite, change in taste perception
Age: 83.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Gait disturbance, Hyponatraemia, Taste disorder, Ventricular hypokinesia
Clinical narrative: Severe fatigue and difficulty walking the next day. Progressed to severe shortness of breath. Barely able to walk at 48 hours, lack of appetite, change in taste perception
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Pfizer COVID 5-11 years was given past the BUD 2-13-24 on 2/15/24 , only side effect is sore arm.
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Eczema, General physical health deterioration, Hormone analysis, Impetigo
Clinical narrative: Prior to vaccination, my exzema had cleared and I had been clear of serious illnesses for many years. Since the vaccination my eczema has relapsed and is incredible painful and not responding to treatments. I got this vaccination for my new job. Since starting my new job I have gotten sick with flu/ sinus infections/ impetigo/ and other infections every months. my illnesses barely recover before I get sick again. I have not had this issue with my immune system or eczema in many years
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Infection, Influenza, Liver function test normal, Pain, Renal function test normal
Clinical narrative: Prior to vaccination, my exzema had cleared and I had been clear of serious illnesses for many years. Since the vaccination my eczema has relapsed and is incredible painful and not responding to treatments. I got this vaccination for my new job. Since starting my new job I have gotten sick with flu/ sinus infections/ impetigo/ and other infections every months. my illnesses barely recover before I get sick again. I have not had this issue with my immune system or eczema in many years
Age: 26.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sinusitis
Clinical narrative: Prior to vaccination, my exzema had cleared and I had been clear of serious illnesses for many years. Since the vaccination my eczema has relapsed and is incredible painful and not responding to treatments. I got this vaccination for my new job. Since starting my new job I have gotten sick with flu/ sinus infections/ impetigo/ and other infections every months. my illnesses barely recover before I get sick again. I have not had this issue with my immune system or eczema in many years
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Pfizer COVID 5-11 years vaccine was given on 2/22/24 after the BUD of 2-13-2024. parents only indicated sore arm.
Age: 34.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: PATIENT WAS GIVEN AREXVY INSTEAD OF ABRYSVO . PATIENT HAS GIVEN BIRTH TO  A HEATHY BABY (1 MONTH OLD NOW). NO ISSUES IDENTIFIED AFTER THE VACCINE WAS GIVEN, ACCORDING TO THE MOTHER.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort
Clinical narrative: After two days from  the shot, I felt like I was going into heart failure my chest on the left side felt heavy. After a week I felt better but then it was like my heart was skipping a beat. Like it would stop and then restart again. It does that atleast once a day. But today it was different it did it 4 times in a row. I have no prior heart probs. I had echo done in Nov of last year it was fine. I made a appt to see a cardiologist in April if this year to check it out
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer COVID 5-11 years was given on 2-16-24 and BUD was at 2-13-2024. no symptoms , provider infomed and parents
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer COVID 5-11 year was given on 2/21/24 and the BUD was 2/13/24, no other syemptms parents and provider informed.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Chills, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Symptoms escalated 2 mornings after receiving vaccine. 8 hour straight period of violent, uncontrollable vomiting and diarrhea, sometimes simultaneously with defecating on self while vomiting. Intense chills. Sweating. Excruciating pain. Before the intense symptoms kicked in there was fatigue, chills, nausea, dizzyness, light-headedness, but on a more functional degree. First intense symptom wave appears to be subsiding, but there is still a food sensitivity so unsure if patient is is through it yet.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Pain, Vomiting
Clinical narrative: Symptoms escalated 2 mornings after receiving vaccine. 8 hour straight period of violent, uncontrollable vomiting and diarrhea, sometimes simultaneously with defecating on self while vomiting. Intense chills. Sweating. Excruciating pain. Before the intense symptoms kicked in there was fatigue, chills, nausea, dizzyness, light-headedness, but on a more functional degree. First intense symptom wave appears to be subsiding, but there is still a food sensitivity so unsure if patient is is through it yet.
Age: 6.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: The patient was given COVID-19 dose for age >12 years; but the patient was 6 years of age at the time of dosing.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pain
Clinical narrative: Erythema and soreness around injection site, chills, body aches. Treatments tried is Advil with relief. Outcomes. 3 days after injection site, patient came to the urgent care as vaccination was given at another location with another unrelated provider. She is well appearing, no signs of a bacterial infection. No chest pain or shortness of breath. Vital signs are stable, No abdominal tenderness. Symptoms are mild.  No signs of anaphylaxis. Likely normal affects from vaccination. She did receive a polio vaccination booster as well on her right upper extremity the same day but not pain or redness to that site. It is unknown which specific vaccinations were given. She just informed me that they were the pneumococcal vaccination along with polio. She also had yellow fever and MMR 2 weeks ago. she was discharged home in stable condition with supportive care.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased, Pericarditis
Clinical narrative: Had to receive vaccination while at school and they provided the Janssen on 04/07/2021.  On 12/10/2021 he was required to get a second shot and Pfizer was given.  Part of the requirement to work at as an intern for school required yet another vaccination and we elected to go with Novavax on 03/21/2023 due to questions regarding sided effect of gynecomastia from the previous pfizer vaccine in which a report was filled out.  On 08/05/2023 while vacationing patient woke up early in the AM with difficulty breathing, increased heart rate and chest tightness.  He was taken to  a rural hospital for care and determined he had periocarditis after multiple tests.  He was followed up with a cardiologist and confirmed the periocarditis diagnosis.  Could not come to any known cause as patient has had no health issues prior to the vaccines.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: Chief Complaint Patient presents with   Allergic Reaction     Pt arrives to triage with complaint of allergic reaction, pt states she received the shingle shot and developed itchy throat and rash took 25 mg of benadryl pt speaking in sentences    Patient is a 58 y.o. female with a PMHx of CKD, DVT, CRPS, HLD, MDD, GERD, takotsubo cardiomyopathy who presents to the ED for evaluation of allergic reaction onset today.    Patient explains she received a Shingles vaccination shot earlier today and endorses the onset of a sore and itchy throat, a cough, and nausea. To treat her symptoms, patient endorses taking 25 mg of Benadryl, Montelukast, Pepcid, and her Epipen with no relief to her symptoms. Patient denies any chest pain, shortness of breath, abdominal pain, or vomiting.           Anaphylaxis secondary to shingles vaccine , resolved The patient had rash, shortness breath, wheezing off after receiving shingles vaccine Afebrile, hemodynamically stable  Currently saturating well on room air  Start prednisone Start scheduled Benadryl  Monitor in hospital for now New during this hospitalization patient has been monitored for her allergic reaction, patient has been asymptomatic except for some dry mouth, patient had very clear lung sounds to auscultation without any signs of inspiratory or expiratory wheezing, crackles or any other worsening signs, no rashes were noted on the patient patient's vitals has been all stable for the last 24 hours.   Patient initially  was discharged on 4 more days of prednisone, was started on Symbicort low dose, albuterol PRN, Benadryl and was advised to use EpiPen as directed.  Although after she expressed her desire to be dec 'ed later yesterday dn after palcing Dc orders pt stated that its too late for her and preferred to stay for tonight. Dc orders we held and to be revaluated in am.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Auscultation, Cough, Dry mouth, Dysphagia
Clinical narrative: Chief Complaint Patient presents with   Allergic Reaction     Pt arrives to triage with complaint of allergic reaction, pt states she received the shingle shot and developed itchy throat and rash took 25 mg of benadryl pt speaking in sentences    Patient is a 58 y.o. female with a PMHx of CKD, DVT, CRPS, HLD, MDD, GERD, takotsubo cardiomyopathy who presents to the ED for evaluation of allergic reaction onset today.    Patient explains she received a Shingles vaccination shot earlier today and endorses the onset of a sore and itchy throat, a cough, and nausea. To treat her symptoms, patient endorses taking 25 mg of Benadryl, Montelukast, Pepcid, and her Epipen with no relief to her symptoms. Patient denies any chest pain, shortness of breath, abdominal pain, or vomiting.           Anaphylaxis secondary to shingles vaccine , resolved The patient had rash, shortness breath, wheezing off after receiving shingles vaccine Afebrile, hemodynamically stable  Currently saturating well on room air  Start prednisone Start scheduled Benadryl  Monitor in hospital for now New during this hospitalization patient has been monitored for her allergic reaction, patient has been asymptomatic except for some dry mouth, patient had very clear lung sounds to auscultation without any signs of inspiratory or expiratory wheezing, crackles or any other worsening signs, no rashes were noted on the patient patient's vitals has been all stable for the last 24 hours.   Patient initially  was discharged on 4 more days of prednisone, was started on Symbicort low dose, albuterol PRN, Benadryl and was advised to use EpiPen as directed.  Although after she expressed her desire to be dec 'ed later yesterday dn after palcing Dc orders pt stated that its too late for her and preferred to stay for tonight. Dc orders we held and to be revaluated in am.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Hypersensitivity, Nausea, Odynophagia, Oropharyngeal pain
Clinical narrative: Chief Complaint Patient presents with   Allergic Reaction     Pt arrives to triage with complaint of allergic reaction, pt states she received the shingle shot and developed itchy throat and rash took 25 mg of benadryl pt speaking in sentences    Patient is a 58 y.o. female with a PMHx of CKD, DVT, CRPS, HLD, MDD, GERD, takotsubo cardiomyopathy who presents to the ED for evaluation of allergic reaction onset today.    Patient explains she received a Shingles vaccination shot earlier today and endorses the onset of a sore and itchy throat, a cough, and nausea. To treat her symptoms, patient endorses taking 25 mg of Benadryl, Montelukast, Pepcid, and her Epipen with no relief to her symptoms. Patient denies any chest pain, shortness of breath, abdominal pain, or vomiting.           Anaphylaxis secondary to shingles vaccine , resolved The patient had rash, shortness breath, wheezing off after receiving shingles vaccine Afebrile, hemodynamically stable  Currently saturating well on room air  Start prednisone Start scheduled Benadryl  Monitor in hospital for now New during this hospitalization patient has been monitored for her allergic reaction, patient has been asymptomatic except for some dry mouth, patient had very clear lung sounds to auscultation without any signs of inspiratory or expiratory wheezing, crackles or any other worsening signs, no rashes were noted on the patient patient's vitals has been all stable for the last 24 hours.   Patient initially  was discharged on 4 more days of prednisone, was started on Symbicort low dose, albuterol PRN, Benadryl and was advised to use EpiPen as directed.  Although after she expressed her desire to be dec 'ed later yesterday dn after palcing Dc orders pt stated that its too late for her and preferred to stay for tonight. Dc orders we held and to be revaluated in am.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Throat irritation, Wheezing
Clinical narrative: Chief Complaint Patient presents with   Allergic Reaction     Pt arrives to triage with complaint of allergic reaction, pt states she received the shingle shot and developed itchy throat and rash took 25 mg of benadryl pt speaking in sentences    Patient is a 58 y.o. female with a PMHx of CKD, DVT, CRPS, HLD, MDD, GERD, takotsubo cardiomyopathy who presents to the ED for evaluation of allergic reaction onset today.    Patient explains she received a Shingles vaccination shot earlier today and endorses the onset of a sore and itchy throat, a cough, and nausea. To treat her symptoms, patient endorses taking 25 mg of Benadryl, Montelukast, Pepcid, and her Epipen with no relief to her symptoms. Patient denies any chest pain, shortness of breath, abdominal pain, or vomiting.           Anaphylaxis secondary to shingles vaccine , resolved The patient had rash, shortness breath, wheezing off after receiving shingles vaccine Afebrile, hemodynamically stable  Currently saturating well on room air  Start prednisone Start scheduled Benadryl  Monitor in hospital for now New during this hospitalization patient has been monitored for her allergic reaction, patient has been asymptomatic except for some dry mouth, patient had very clear lung sounds to auscultation without any signs of inspiratory or expiratory wheezing, crackles or any other worsening signs, no rashes were noted on the patient patient's vitals has been all stable for the last 24 hours.   Patient initially  was discharged on 4 more days of prednisone, was started on Symbicort low dose, albuterol PRN, Benadryl and was advised to use EpiPen as directed.  Although after she expressed her desire to be dec 'ed later yesterday dn after palcing Dc orders pt stated that its too late for her and preferred to stay for tonight. Dc orders we held and to be revaluated in am.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Arthralgia, Guillain-Barre syndrome, Malaise, Paraesthesia
Clinical narrative: Guillain-Barre; tingling and numbness in his hand and his feet; numbness in his hand and his feet; Myalgia; This is a spontaneous report received from a Pharmacist.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; prednisone (PREDNISONE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset Jan2024, outcome "unknown", described as "Guillain-Barre"; MYALGIA (non-serious) with onset Jan2024, outcome "unknown"; HYPOAESTHESIA (non-serious) with onset Jan2024, outcome "unknown", described as "numbness in his hand and his feet"; PARAESTHESIA (non-serious) with onset Jan2024, outcome "unknown", described as "tingling and numbness in his hand and his feet". The events "tingling and numbness in his hand and his feet", "numbness in his hand and his feet" and "myalgia" required emergency room visit. The action taken for prednisone was unknown. Therapeutic measures were taken as a result of myalgia. Clinical courses is as follows: the reporter administered an Abrysvo RSV Vaccine to the patient on 18Jan, on the about 10 days after the vaccine was administered, he reported to the emergency room with tingling and numbness in his hand and his feet. He was discharge and sent home, the next day he went back to the emergency room and was diagnosed with general Myalgia after vaccination, and he was given Prednisone and again sent home. On 31Jan he was admitted to the hospital, where he is still in the hospital as of today. He does not have a diagnosis that the reporter knows of his Guillain-Barre, but the reporter was thinking that's what it might be, but it was so long after the vaccine was given. The patient was admitted to the hospital (reason of hospitalization and duration not available).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: The events Guillain-Barre syndrome, paraesthesia, hypoaesthesia, and myalgia are conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: RSV, RSV, RSV
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: Guillain-Barre; tingling and numbness in his hand and his feet; numbness in his hand and his feet; Myalgia; This is a spontaneous report received from a Pharmacist.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 18Jan2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; prednisone (PREDNISONE). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset Jan2024, outcome "unknown", described as "Guillain-Barre"; MYALGIA (non-serious) with onset Jan2024, outcome "unknown"; HYPOAESTHESIA (non-serious) with onset Jan2024, outcome "unknown", described as "numbness in his hand and his feet"; PARAESTHESIA (non-serious) with onset Jan2024, outcome "unknown", described as "tingling and numbness in his hand and his feet". The events "tingling and numbness in his hand and his feet", "numbness in his hand and his feet" and "myalgia" required emergency room visit. The action taken for prednisone was unknown. Therapeutic measures were taken as a result of myalgia. Clinical courses is as follows: the reporter administered an Abrysvo RSV Vaccine to the patient on 18Jan, on the about 10 days after the vaccine was administered, he reported to the emergency room with tingling and numbness in his hand and his feet. He was discharge and sent home, the next day he went back to the emergency room and was diagnosed with general Myalgia after vaccination, and he was given Prednisone and again sent home. On 31Jan he was admitted to the hospital, where he is still in the hospital as of today. He does not have a diagnosis that the reporter knows of his Guillain-Barre, but the reporter was thinking that's what it might be, but it was so long after the vaccine was given. The patient was admitted to the hospital (reason of hospitalization and duration not available).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.; Sender's Comments: The events Guillain-Barre syndrome, paraesthesia, hypoaesthesia, and myalgia are conservatively assessed as related to the suspect drug RSV VACCINE PROT.SUBUNIT PREF 2V based on close temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AEs or PQC reported; Caller reported 3 day old infant inadvertently received ROTATEQ, PREVNAR 13, PENTACEL and ENGERIX.; This spontaneous report was received from a physician and refers to a 3-day-old patient of unknown gender. Patient's concurrent conditions and pertinent medical history was not provided. Concomitant medications included pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and hepatitis b vaccine rhbsag (yeast) (ENGERIX).  On 21-FEB-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1932212, expiration date: 01-APR-2024, administered orally for prophylaxis (strength, dose and frequency were not provided) (Inappropriate age at vaccine administration).  No adverse events reported.