chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Chronic inflammatory demyelinating polyradiculoneuropathy, Neuropathy peripheral, Paraesthesia
Clinical narrative: Developed pins and needles, numbness, and then weakness approximately 3 weeks after the immunization, and subsequently has been diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) and is still symptomatic today and requiring multiple immunosuppressive medication.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Electromyogram, Hypoaesthesia
Clinical narrative: Developed pins and needles, numbness, and then weakness approximately 3 weeks after the immunization, and subsequently has been diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) and is still symptomatic today and requiring multiple immunosuppressive medication.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Paraesthesia
Clinical narrative: Developed pins and needles, numbness, and then weakness approximately 3 weeks after the immunization, and subsequently has been diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) and is still symptomatic today and requiring multiple immunosuppressive medication.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: Doses of PEDVAXHIB had been administered following a temperature excursion; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 11-AUG-2021, the patient was vaccinated with improperly stored Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliters (route of administration was not reported), lot # T026961 and expiration date 02-APR-2023 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion below 2 degree celsius (°C) (-40°C) and above of 8°C (9.6°C) for 15 minutes and 1 hour respectively on (date); no previous temperature excursions were reported.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2109USA006019: US-009507513-2109USA006020: US-009507513-2109USA006021: US-009507513-2109USA006022: US-009507513-2109USA006023:
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Chills, Dizziness, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; This spontaneous report has been received from a medical assistant, referring to a 45-year-old female patient.  No information was provided about the patients' concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions.    On 25-AUG-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccination scheme, anatomical location of administration were not reported. Lot number is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number U008600 does not match any company product as confirmed by lot verification team.) at a dose of 0.5 milliliter administered intramuscularly for immunization (prophylaxis).     On the same day, the patient reported that when she returned home, she started feeling bad (feeling abnormal) and having headache, chills, itching on the face (Pruritus), shortness of breath (Dyspnoea), and dizziness. On 26-AUG-2021, she went to the emergency room and was discharged home the same day. She was prescribed with 200mg of Excedrin. On 27-AUG-2021, she reported that the symptoms had resolved. No additional AE reported. No PQC reported. No additional information provided.  The causal relationship between therapy and the above-mentioned events was not provided.
Age: 45.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus
Clinical narrative: The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; The consumer reported that when she returned home she started feeling bad and having headache, chills, itching on the face, shortness of breath, and dizziness. On 8/26/2021 she went to the emergency room and was discharged home the same day; This spontaneous report has been received from a medical assistant, referring to a 45-year-old female patient.  No information was provided about the patients' concurrent conditions, pertinent medical history, concomitant therapies, drug and/or allergies reactions.    On 25-AUG-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (vaccination scheme, anatomical location of administration were not reported. Lot number is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Lot number U008600 does not match any company product as confirmed by lot verification team.) at a dose of 0.5 milliliter administered intramuscularly for immunization (prophylaxis).     On the same day, the patient reported that when she returned home, she started feeling bad (feeling abnormal) and having headache, chills, itching on the face (Pruritus), shortness of breath (Dyspnoea), and dizziness. On 26-AUG-2021, she went to the emergency room and was discharged home the same day. She was prescribed with 200mg of Excedrin. On 27-AUG-2021, she reported that the symptoms had resolved. No additional AE reported. No PQC reported. No additional information provided.  The causal relationship between therapy and the above-mentioned events was not provided.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: PNEUMOVAX on 20-FEB-2002 and on 15-FEB-2007; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2103USA004021), concerning a 60-year-old female patient. The patient's medical history, concurrent condition and concomitant medication was not provided.  On 20-FEB-2002, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # 640578/0996L has been verified to be valid, expiration date not reported, but upon internal validation established as 11-APR-2003; strength and route were unknown) for prophylaxis.  On 15-FEB-2007, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # 655289/0958F has been verified to be valid, expiration date not reported, but upon internal validation established as 21-OCT-2008; strength and route were unknown) for prophylaxis (inappropriate schedule of product administration).  On 05-FEB-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # J004332 has been verified to be valid, expiration date not reported, but upon internal validation established as 26-SEP-2014; strength and route were unknown) for prophylaxis.; Sender's Comments:  US-009507513-2103USA004021:
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; The pharmacist reported the patient did not come back until 05AUG2021 to receive her second dose; her first MMR II vaccine in September of 2019; This spontaneous report has been received from a pharmacist, referring to a 37 years old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  The patient received her first measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccine for prophylaxis in September of 2019 (Product administered to patient of inappropriate age). The pharmacist reported the patient did not come back until 05-AUG-2021 to receive her second dose measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (inappropriate schedule of product administration). No additional AE reported. The dose, strength, route, lot number and expiration date for suspect product was not reported.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Medical Assistant reporting a temperature excursion for GARDASIL 9 adminitestered to a patinet; This spontaneous report as received from a physician and a medical assistant, referring to a 12-year-old patient (gender not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 31-AUG-2021, the patient was vaccinated with an improperly storage first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # T026323 with expiration date on 22-FEB-2023, at 0.5 milliliter, intramuscularly for prophylaxis.   Administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) experienced the temperature excursion above 47 Fahrenheit degrees (47F) for 47 minutes (occurred on 06-AUG-2021). Digital data logger was not involved. There were no previous temperature excursions reported.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARIVAX vaccine was administered following a ssupported temperature excursion; This spontaneous report was received from a health care business professional, a chief executive officer, referring to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 13-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot# T038830, expiration date on 17-NOV-2022, for prophylaxis following a supported temperature excursion (on 28-JUN-2021). Temperature: 8.4 °F, time frame: 1 hour 30 minutes and 0 seconds, there was no previous temperature excursion.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administered after temperature excursion; 0.5 ml IM; This spontaneous report was received from a medical assistant, and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 13-SEP-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, intramuscularly for prophylaxis (lot number U015682, was verified to be valid, expiration date reported and established as 18-MAY-2021); (site of administration was not provided).   The administered dose of vaccine experienced a temperature excursion of 38 Fahrenheit degrees (F) for 4 hours. The patient did not experience any additional adverse event.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Per caller, she is not aware if either patient had any symptoms after administration. No additional AE's/PQC's reported.; Per caller, excursion occurred on 8/20/2021. Caller notes, the V ARlV AX has been administered to (2) patients.; This spontaneous report has been received from a nurse, concerning to a patient of unknown gender and age. No information was provided regarding the patients' pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 20-AUG-2021, the virus vaccine live (oka/merck) (VARIVAX) was improperly stored at -14.2 degrees Celsius (C) for a timeframe of 16 minutes (min); there were not previous temperature excursions reported (product storage error).   On 20-AUG-2021, the patient was vaccinated with one (1) varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T028306 has been verified to be a valid lot number, expiration date reported and established as 20-AUG-2022) as prophylaxis (exact dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported), which was possibly improperly stored as the nurse did not know if the temperature excursion occurred before the administration or as a result of it. The reporter was not aware if the patient had any symptoms after administration; no additional adverse events (AE) reported (no adverse event).  This is one of two reports received from the same reporter; Sender's Comments:  US-009507513-2109USA005042:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Per caller, she is not aware if either patient had any symptoms after administration. No additional AE's/PQC's reported.; Per caller, excursion occurred on 8/20/2021. Caller notes, the V ARlV AX has been administered to (2) patients.; This spontaneous report has been received from a nurse, concerning to a patient of unknown gender and age. No information was provided regarding the patients' pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 20-AUG-2021, the virus vaccine live (oka/merck) (VARIVAX) was improperly stored at -14.2 degrees Celsius (C) for a timeframe of 16 minutes (min); there were not previous temperature excursions reported (product storage error).   On 27-AUG-2021, the patient was vaccinated with one (1) improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T028306 has been verified to be a valid lot number, expiration date reported and established as 20-AUG-2022) as prophylaxis (exact dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported). No other adverse events reported (no adverse events).  This is one of two reports received from the same reporter; Sender's Comments:  US-009507513-2109USA005038:
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis, Fatigue, Magnetic resonance imaging head abnormal, Mental impairment, Seizure
Clinical narrative: Pt with seizures and encephalitis 10 days after 2nd COVID vaccine.  No source of encephalitis was found, although workup continues.  Pt is recovering but still has extreme fatigue and decreased functioning including decreased mental stamina.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: Standard achy, headache, chills.  Started 7 hours later, lasting 24 hours.  Difference, significant left armpit lymph node swelling, day 2, not present after first or second vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Heart rate increased, Rash
Clinical narrative: Rash on the arm the shot was administered and lasted a day. I also got rashes on my legs. A day after the shot, I got stomach aches and cramping. The cramping comes and goes occasionally. I also have had rapid heartbeats after the shot.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time, Adverse drug reaction, Arthropathy, Blood cholesterol normal, Blood glucose normal
Clinical narrative: left arm pain, fatigue, fever, but 4 days after vaccination felt a hot sensation left side of head/ as if heat coming out of ear.  developed elevated BP approx 1 week after vaccination, then ongoing HTN needing medication. ongoing left arm, left leg, left side of neck, left side of head pain. re-exam 9/22/2021: left UE weakness: 4/5 hand grip/shoulder abduction, hip flexion, knee extension, resisted lateral rotation of head to the left, decreased sensation left side of face, left arm, left leg- weakness and numbness all on left side diffusely.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium normal, Blood pressure increased, Blood thyroid stimulating hormone, Blood triglycerides normal, Fatigue
Clinical narrative: left arm pain, fatigue, fever, but 4 days after vaccination felt a hot sensation left side of head/ as if heat coming out of ear.  developed elevated BP approx 1 week after vaccination, then ongoing HTN needing medication. ongoing left arm, left leg, left side of neck, left side of head pain. re-exam 9/22/2021: left UE weakness: 4/5 hand grip/shoulder abduction, hip flexion, knee extension, resisted lateral rotation of head to the left, decreased sensation left side of face, left arm, left leg- weakness and numbness all on left side diffusely.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Fibrin D dimer, Full blood count, Glucose tolerance impaired, Glycosylated haemoglobin
Clinical narrative: left arm pain, fatigue, fever, but 4 days after vaccination felt a hot sensation left side of head/ as if heat coming out of ear.  developed elevated BP approx 1 week after vaccination, then ongoing HTN needing medication. ongoing left arm, left leg, left side of neck, left side of head pain. re-exam 9/22/2021: left UE weakness: 4/5 hand grip/shoulder abduction, hip flexion, knee extension, resisted lateral rotation of head to the left, decreased sensation left side of face, left arm, left leg- weakness and numbness all on left side diffusely.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, HIV test negative, Headache, Hemiparesis, Hepatitis C test negative
Clinical narrative: left arm pain, fatigue, fever, but 4 days after vaccination felt a hot sensation left side of head/ as if heat coming out of ear.  developed elevated BP approx 1 week after vaccination, then ongoing HTN needing medication. ongoing left arm, left leg, left side of neck, left side of head pain. re-exam 9/22/2021: left UE weakness: 4/5 hand grip/shoulder abduction, hip flexion, knee extension, resisted lateral rotation of head to the left, decreased sensation left side of face, left arm, left leg- weakness and numbness all on left side diffusely.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: High density lipoprotein normal, Hypertension, Hypoaesthesia, Joint hyperextension, Joint range of motion decreased
Clinical narrative: left arm pain, fatigue, fever, but 4 days after vaccination felt a hot sensation left side of head/ as if heat coming out of ear.  developed elevated BP approx 1 week after vaccination, then ongoing HTN needing medication. ongoing left arm, left leg, left side of neck, left side of head pain. re-exam 9/22/2021: left UE weakness: 4/5 hand grip/shoulder abduction, hip flexion, knee extension, resisted lateral rotation of head to the left, decreased sensation left side of face, left arm, left leg- weakness and numbness all on left side diffusely.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lipids increased, Low density lipoprotein normal, Metabolic function test normal, Movement disorder, Muscular weakness
Clinical narrative: left arm pain, fatigue, fever, but 4 days after vaccination felt a hot sensation left side of head/ as if heat coming out of ear.  developed elevated BP approx 1 week after vaccination, then ongoing HTN needing medication. ongoing left arm, left leg, left side of neck, left side of head pain. re-exam 9/22/2021: left UE weakness: 4/5 hand grip/shoulder abduction, hip flexion, knee extension, resisted lateral rotation of head to the left, decreased sensation left side of face, left arm, left leg- weakness and numbness all on left side diffusely.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Prothrombin time normal, Pyrexia, Red blood cell sedimentation rate normal
Clinical narrative: left arm pain, fatigue, fever, but 4 days after vaccination felt a hot sensation left side of head/ as if heat coming out of ear.  developed elevated BP approx 1 week after vaccination, then ongoing HTN needing medication. ongoing left arm, left leg, left side of neck, left side of head pain. re-exam 9/22/2021: left UE weakness: 4/5 hand grip/shoulder abduction, hip flexion, knee extension, resisted lateral rotation of head to the left, decreased sensation left side of face, left arm, left leg- weakness and numbness all on left side diffusely.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss, Vitamin D decreased, White blood cell count decreased
Clinical narrative: left arm pain, fatigue, fever, but 4 days after vaccination felt a hot sensation left side of head/ as if heat coming out of ear.  developed elevated BP approx 1 week after vaccination, then ongoing HTN needing medication. ongoing left arm, left leg, left side of neck, left side of head pain. re-exam 9/22/2021: left UE weakness: 4/5 hand grip/shoulder abduction, hip flexion, knee extension, resisted lateral rotation of head to the left, decreased sensation left side of face, left arm, left leg- weakness and numbness all on left side diffusely.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Redness, swelling, itching. Did not occur until 7 days post injection
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Peripheral swelling, Skin warm
Clinical narrative: Major anxiety attack (only 1 x in past history 2001 when given procardia after birth)   Anxiety attack lasted 4 hours.  Headache all day , sore arm (hot swollen ).
Age: 6.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: No additional AEs reported.; expired VAQTA was administered; This spontaneous report was received from a medical assistant, referring to a 6-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 24-AUG-2021, the patient was vaccinated with expired hepatitis a vaccine, inactivated (VAQTA) (lot # T008698, expiration date 04-JUN-2021, dose, strength and route were not provided) for prophylaxis (expired product administered).  No additional adverse event reported.  This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2109USA005216: US-009507513-2109USA005193:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Disturbance in attention, Fatigue, Feeling abnormal, Headache
Clinical narrative: Within 4 hours I developed severe fatigue and debilitating brain fog. I could not concentrate or even remember what I just thought. Also, body aches, chest pressure, headaches, and just an extreme unwell feeling. My arms also felt numb off and on.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Malaise, Pain
Clinical narrative: Within 4 hours I developed severe fatigue and debilitating brain fog. I could not concentrate or even remember what I just thought. Also, body aches, chest pressure, headaches, and just an extreme unwell feeling. My arms also felt numb off and on.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash, Tinnitus
Clinical narrative: Ringing in right ear occurring approximately 6-8 times per week. The ringing typically lasts 10-20 seconds. I have never had ear ringing or Tinnitus before.  I have developed a sudden allergy to deodorants and antiperspirants causing a rash in armpit.  I had been using same antiperspirant brand over a year with no issue. Upon getting rash in both underarms a few days after second Moderna  shot, I changed to a sensitive skin, aluminum free, antiperspirant which initially helped. After a couple months I switched to a deodorant only, with no aluminum or salts, and rash returned. Even switching back to the aluminum free antiperspirant gives rash. I have never had any allergic reaction to deodorants or antiperspirants prior.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site swelling
Clinical narrative: Tiredness, swelling at injection site.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory, Fatigue, Gastrointestinal disorder
Clinical narrative: Heart Racing, Fatigue, Insomnia, Nausea, Headaches, Severe GI issues, Shortness of breath
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Palpitations, SARS-CoV-2 test negative
Clinical narrative: Heart Racing, Fatigue, Insomnia, Nausea, Headaches, Severe GI issues, Shortness of breath
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: Severe, Chest pain/ shortness of breath/ rapid heart rate/
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate increased
Clinical narrative: Severe, Chest pain/ shortness of breath/ rapid heart rate/
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Tachycardia
Clinical narrative: Tachycardia  started approximately 30 minutes after  receiving dose.  Seizures began approximately 6 hours after receiving dose
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Myalgia
Clinical narrative: Tachycardia Fatigue Chills Muscle aches Joint pain  Site pain
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Tachycardia Fatigue Chills Muscle aches Joint pain  Site pain
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dyspnoea, Heart rate increased, Myocarditis
Clinical narrative: My symptoms occurred the following night of my first dose. Shortly after lying down I felt sharp chest pains as well as pains in my neck and shoulder area. Deep breaths were uncomfortable and my heart rate felt slightly elevated. I slowed down my physical activity a little as to not aggravate any symptoms. I assume it was a mild case of myocarditis that I slept off. I've felt fine since then but have not got the second dose yet.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: My symptoms occurred the following night of my first dose. Shortly after lying down I felt sharp chest pains as well as pains in my neck and shoulder area. Deep breaths were uncomfortable and my heart rate felt slightly elevated. I slowed down my physical activity a little as to not aggravate any symptoms. I assume it was a mild case of myocarditis that I slept off. I've felt fine since then but have not got the second dose yet.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: received improperly stored VARlVAX; Subcutaneous injection formulation administered by other route; This spontaneous report was received from a nurse referring to a 4 years old male patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 29-JUL-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T002847 that has been verified to be valid, expiration date 23-JAN-2022, intramuscular in the left thigh for prophylaxis (dose and strength were not reported) (product storage error and incorrect route of product administration). Temperature exposure detected. Data logger was involved. Vaccine was removed immediately. No further vaccine was administered. Parents were being noticed and this dose of vaccine will  be repeated with new vaccine stock.     This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA006311:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen and tender armpit (lymph nodes) Headaches tender arm
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue for entire day following 2nd shot.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood test, Chest X-ray, Chest pain, Computerised tomogram abdomen
Clinical narrative: Initial flu like symptoms first 2 days. Third day a chest pain came that progressively got worse and never went away. By the 6th day I went to the ER. Was diagnosed with Costochondritis that night.  Was sent to ER again by my doctor following an appointment a month later due to stomach issues. I was sent to the ER again via ambulance after getting blurry vision, slurred speech, loss of movement and nearly fainting August 19, 2021. I was then hospitalized august 20, 2021. I had extremely severe chest pain that night and I ended up experiencing whatever that was. The ER and hospital was unsure of what happened. Ambulance advised me that my pulse dropped and electrolytes were low. I have lost nearly 40 pounds since the shot due to loss of appetite. I have been given prednisone off and on, NSAIDs, oxycodone after my last ER visit and am currently taking gabapentin. I am now starting pain management and physical therapy.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Costochondritis, Decreased appetite, Dysarthria, Electroencephalogram
Clinical narrative: Initial flu like symptoms first 2 days. Third day a chest pain came that progressively got worse and never went away. By the 6th day I went to the ER. Was diagnosed with Costochondritis that night.  Was sent to ER again by my doctor following an appointment a month later due to stomach issues. I was sent to the ER again via ambulance after getting blurry vision, slurred speech, loss of movement and nearly fainting August 19, 2021. I was then hospitalized august 20, 2021. I had extremely severe chest pain that night and I ended up experiencing whatever that was. The ER and hospital was unsure of what happened. Ambulance advised me that my pulse dropped and electrolytes were low. I have lost nearly 40 pounds since the shot due to loss of appetite. I have been given prednisone off and on, NSAIDs, oxycodone after my last ER visit and am currently taking gabapentin. I am now starting pain management and physical therapy.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Electrolyte imbalance, Heart rate decreased, Influenza like illness, Mobility decreased, Presyncope
Clinical narrative: Initial flu like symptoms first 2 days. Third day a chest pain came that progressively got worse and never went away. By the 6th day I went to the ER. Was diagnosed with Costochondritis that night.  Was sent to ER again by my doctor following an appointment a month later due to stomach issues. I was sent to the ER again via ambulance after getting blurry vision, slurred speech, loss of movement and nearly fainting August 19, 2021. I was then hospitalized august 20, 2021. I had extremely severe chest pain that night and I ended up experiencing whatever that was. The ER and hospital was unsure of what happened. Ambulance advised me that my pulse dropped and electrolytes were low. I have lost nearly 40 pounds since the shot due to loss of appetite. I have been given prednisone off and on, NSAIDs, oxycodone after my last ER visit and am currently taking gabapentin. I am now starting pain management and physical therapy.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred, Weight decreased
Clinical narrative: Initial flu like symptoms first 2 days. Third day a chest pain came that progressively got worse and never went away. By the 6th day I went to the ER. Was diagnosed with Costochondritis that night.  Was sent to ER again by my doctor following an appointment a month later due to stomach issues. I was sent to the ER again via ambulance after getting blurry vision, slurred speech, loss of movement and nearly fainting August 19, 2021. I was then hospitalized august 20, 2021. I had extremely severe chest pain that night and I ended up experiencing whatever that was. The ER and hospital was unsure of what happened. Ambulance advised me that my pulse dropped and electrolytes were low. I have lost nearly 40 pounds since the shot due to loss of appetite. I have been given prednisone off and on, NSAIDs, oxycodone after my last ER visit and am currently taking gabapentin. I am now starting pain management and physical therapy.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Nausea, Panic attack, Tremor
Clinical narrative: Sudden rapid heartbeat and breathlessness, followed by shaking and nauseousness. Symptoms are similar to a panic attack.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: lmpropely stored vaccine administered; route: IM; This spontaneous report was received from a licensed practical nurse referring to a 15 months old (reported as 16 months old) male patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 11-AUG-2021 the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not reported, dose number: 1 (reported as previous doses number was 0), lot # T002847, expiration date: 23-JAN-2022) intramuscularly in the left thigh for prophylaxis (product storage error and incorrect route of product administration). The digital data logger was involved to capture the temperature excursion.       This is one of several report reported by the same reporter.; Sender's Comments:  US-009507513-2108USA006311:
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, Product storage error
Clinical narrative: lmpropely stored vaccine administered; route: IM; This spontaneous report was received from a licensed practical nurse referring to a 13 month old (reported as 14 months old) male patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.    On 03-AUG-2021, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose were not reported, dose number: 1 (reported as previous doses number was 0), lot # T002847, expiration date was reported as 23-JAN-2023, upon internal validation established as 23-JAN-2022) intramuscularly in the left thigh for prophylaxis (product storage error and incorrect route of product administration). The digital data logger was involved to capture the temperature excursion.       This is one of several report reported by the same reporter.; Sender's Comments:  US-009507513-2108USA006311:
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer referring to a currently 73 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 30-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) at an internal medicine medical office for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a nurse practitioner for the following injury resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster. The outcome of the event was unknown.
Age: 68.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to an elderly patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 28-JAN-2013 (at 68 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider at a healthcare facility for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event was unknown.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; A nurse called to report that VARlVAX had a prior temperature excursion/she was advised the product was supported but to use within 3 months/ new expiration date 17SEP2021/was administered to a patient on 20SEP2021/This was the patient's first dose; Varivax had a prior temperature excursion/she was advised the product was supported but to use within 3 months/short-date new expiration date 17-SEP-2021/administered to a patient on 20-SEP-2021.; This spontaneous report was received from a register nurse and refers to a 32-year-old female patient. Information about the patient's pertinent medical history, concomitant medications, past drug reactions or allergies was not reported.  On 17-JUN-2021, it was stated that the reporter called the Agency to report that the product varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature excursion of 14.6 degrees Celsius (C) during a time frame of 11 minutes. No previous temperature excursion was reported. It was advised that the product was supported to be used within 3 months and was provided with a new short expiration date of 17-SEP-2021 (unspecified if the advised and new expiration date came from manufacturer).  On 20-SEP-2021, the patient was vaccinated with her first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (mL) (vaccination scheme frequency, route and anatomical site of administration were not provided; lot number T031388, that was verified to be a valid lot number with an expiration date reported and established as 15-SEP-2022) for prophylaxis, after the temperature excursion and the short new expiration date for the vaccine (expired product administered) (product storage error). No additional adverse event (AE) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Post herpetic neuralgia, Trigeminal neuralgia
Clinical narrative: herpes zoster; postherpetic neuralgia; Ramsey Hunt Syndrome; trigeminal neuralgia; Information has been received from a lawyer regarding a case in litigation which referred to a patient (pt) of unknown gender and age. Information regarding concomitant medications, concurrent conditions or medical history was not provided. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster) (exact dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided). Afterwards, on an unknown date (reported as after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered herpes zoster, postherpetic neuralgia, Ramsey Hunt Syndrome (herpes zoster oticus) and trigeminal neuralgia. As a result of those symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt's condition. In addition, the pt sustained severe and permanent personal injuries. Further, the pt had suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Finally, as direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered as not recovered. The causal relationship between the events and zoster vaccine live (ZOSTAVAX) was assessed as related.  Herpes zoster, postherpetic neuralgia, trigeminal neuralgia, and herpes zoster oticus were considered as disabling events by the reporter.   Upon internal review, the event of herpes zoster oticus was determined to be medically significant.
Sex: F
Vaccine: MMR, TTOX
Symptoms: Illness, Neoplasm malignant
Clinical narrative: that vaccines cause cancer; sick; This spontaneous report has been received from a consumer via Pfizer referring to her mother of unknown age.  The patient's concurrent condition, medical history and concomitant medication were not provided.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot#, expiration date, dose and route were not reported) for prophylaxis.  Other suspect therapies included tetanus vaccine.      On unknown dates,  the patient experienced sick and cancer. The outcome of the events was unknown. The patient believed that the vaccines made her (captured in MARRS# 2109USA005483) and her mother sick and caused the cancer.; Sender's Comments:  US-009507513-2109USA005483:
Sex: F
Vaccine: MMR, TTOX, MMR, TTOX
Symptoms: Malaise, Neoplasm malignant, Suspected COVID-19
Clinical narrative: that vaccines cause cancer; sick; Covid virus symptoms; This spontaneous report has been received from a female patient of unknown age via Pfizer referring to herself.  The patient's concurrent condition, medical history and concomitant medication were not provided.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot#, expiration date, dose and route were not reported) for prophylaxis.  Other suspect therapies included tetanus vaccine.      On unknown dates,  the patient experienced sick and cancer. The patient also stated that she had 14 coronavirus disease (COVID) symptoms and didn't get tested and went to work. The outcome of the events was unknown. The patient believed that the vaccines made her and her mother (captured in MARRS# 2109USA005477) sick and caused the cancer. The causality of suspected covid-19 was not provided.; Sender's Comments:  US-009507513-2109USA005477:
Sex: F
Vaccine: MMR, TTOX, MMR, TTOX
Symptoms: Malaise
Clinical narrative: that vaccines cause cancer; sick; Covid virus symptoms; This spontaneous report has been received from a female patient of unknown age via Pfizer referring to herself.  The patient's concurrent condition, medical history and concomitant medication were not provided.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot#, expiration date, dose and route were not reported) for prophylaxis.  Other suspect therapies included tetanus vaccine.      On unknown dates,  the patient experienced sick and cancer. The patient also stated that she had 14 coronavirus disease (COVID) symptoms and didn't get tested and went to work. The outcome of the events was unknown. The patient believed that the vaccines made her and her mother (captured in MARRS# 2109USA005477) sick and caused the cancer. The causality of suspected covid-19 was not provided.; Sender's Comments:  US-009507513-2109USA005477:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: the physician has had no side affects; physician was accidently given VARlVAX vaccine instead of the Shingrix vaccine; This spontaneous report was received from a registered nurse refers to a 66-year-old patients of unknown gender, reported as physician. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 01-SEP-2021, the patient was accidently given 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) vaccine, 0.5 ml, subcutaneously (lot # T012551 and expiration date: 10-APR-2022) instead of varicella zoster vaccine rge (cho)(SHINGRIX) vaccine by a new nurse (wrong vaccine administered). The patient has had no side affects.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion for VARlVAX; This spontaneous report was received from a registered nurse (conflicting information as the reporter's title was reported as medical assitant) referring to a 5-year-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 10-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot number U015682, expiration date 18-MAY-2023 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.         The vaccine experienced a temeprature excursion on 07-SEP-2021 of 4 degrees Celsius (°C) for 20 minutes and on 09-SEP-2021 for the same temperature and duration. The vaccine experienced a previous temeprature excursion of 4°C for 7 hours and 30 minutes; Sender's Comments:  US-009507513-2109USA005628:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE; temperature excursion for VARlVAX; This spontaneous report was received from a registered nurse (conflicting information as the reporter's title was reported as medical assitant) referring to a 52-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 14-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot number U015682, expiration date 18-MAY-2023 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.         The vaccine experienced a temeprature excursion on 07-SEP-2021 of 4 degrees Celsius (°C) for 20 minutes and on 09-SEP-2021 for the same temperature and duration. The vaccine experienced a previous temeprature excursion of 4°C for 7 hours and 30 minutes; Sender's Comments:  US-009507513-2109USA005628: