chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria, Pruritus, Urticaria
Clinical narrative: Hive near injection site 1-3 cm occurred about 20-25 min post injection.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site mass, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Starting about four hours after receiving the injection I formed a large, hard, hot, painful and itchy lump under the skin.  By 8:00 PM that same night it measured 4.5 inches across and 3 inches tall.  As of two days later it is still just as large and is extremely hard and has formed a rash on the skin.  It's very painful, itchy, and is radiating heat.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Starting about four hours after receiving the injection I formed a large, hard, hot, painful and itchy lump under the skin.  By 8:00 PM that same night it measured 4.5 inches across and 3 inches tall.  As of two days later it is still just as large and is extremely hard and has formed a rash on the skin.  It's very painful, itchy, and is radiating heat.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Headache
Clinical narrative: Diarrhea,  stomach cramps, headache.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Near syncope. Monitored in clinic. Vitals stable. Self-resolved after 5 minutes. Monitored for 30 minutes
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is 17, receiving vaccine for 18 and older
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: I have a fever body aches headaches
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Skin burning sensation, Skin warm
Clinical narrative: patient reported first noticing redness on arm 8 days after moderna administration.  Arm is warm to touch, and at times burns and itches. Redness is approximately 5 inches in length and 1 to 3 inches wide on upper arm . Patient still has redness and itching. Patient has not self-treated any symptoms. counseled patient she may use a cold compress/ice pack on arm if needed or may also take acetaminophen or apply otc hydrocortisone cream for itch if needed. counseled patient that symptoms should resolve on their own. She should contact her prescriber if not getting better or if getting worse
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dyskinesia, Muscle rigidity, Posture abnormal
Clinical narrative: Patient felt lightheaded, Sat down to wait after vaccination in pharmacy. Patient went stiff, head fell back, hands and feet jerking.  I ran over to her and tried to get her to wake up.  She opened her eyes and was able to talk.  She was very groggy and was clammy to the touch.  We called 911 and paramedics came.  They took her to the ER to get checked out.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Patient felt lightheaded, Sat down to wait after vaccination in pharmacy. Patient went stiff, head fell back, hands and feet jerking.  I ran over to her and tried to get her to wake up.  She opened her eyes and was able to talk.  She was very groggy and was clammy to the touch.  We called 911 and paramedics came.  They took her to the ER to get checked out.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt received Moderna and was not eligible for vaccine
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Unresponsive to stimuli
Clinical narrative: Patient stated she faints when receiving vaccines or blood draws. Vaccinating nurse placed her on cot to give first dose of Moderna vaccine. Patient became lightheaded and dizzy after receiving vaccine. Became unresponsive for a few seconds, came to with the nurse calling her name. Responded to her name and complained of lightheadedness. Vitals were taken. Patient sat up after stating she felt better. Patient was able to sip water and stand without help. Advised patient to inform nurses for her second dose of vasovagal response, patient verbalized understanding. Vitals: 1703: BP 120/70 HR 82, O2: 99%.  1705 BP 107/54 HR 78, O2: 99%. 1711: 112/68, HR 74, O2 99%.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: PATIENT RECIEVED 2ND DOSE IN SERIES 10 DAYS TOO EARLY. PATIENT REPORTED HAVING A 100 DEGREE FEVER, HEADACHE AND CHILLS THAT LASTED FOR ABOUT 2 DAYS. NO CURRENT SYMPTOMS
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dissociation, Dizziness, Migraine, Pallor
Clinical narrative: client complained of dizziness after receiving 1st Moderna. EMT responded and PHN  joined shortly. First vitals at 1419: blood pressure 145/92, pulse 92, oxygen 97%. Client sitting in chair, alert and oriented, slightly pale. Client stated sitting down at 1415, and felt "disconnected" for a few seconds and dizzy. EMT gave client water. Per client no headache, blurry vision, nausea, chest pain, shortness of breath. Client stated current medical history: migraines, no medications and no allergies. Client asked to stay 30 mins total for observation, client stated sat down at 1415. Vitals at 1428: blood pressure 143/92, pulse 94, oxygen 97%. Per client still dizzy, but improving. Client stated feeling a migraine was coming on. Vitals at 1437: blood pressure 140/90, pulse 90, oxygen 97%. Client stated dizziness improving, skin color normal, headache same. Last vitals at 1447: blood pressure 138/88, pulse 89, oxygen 98%. Per client dizziness resolved, headache same, but normal for his migraine. Per client felt fine to drive home. ER precautions given, advised to follow up with provider. Client left facility with steady gait at 1450.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site erythema, Injection site mass, Injection site pain, Injection site warmth
Clinical narrative: Strong burning sensation upon the injection. Right arm is very painful. Injection site is hot and painful to touch. A lump can be felt at injection site. Area is also reddened. Pain upon any movement with RUE.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Strong burning sensation upon the injection. Right arm is very painful. Injection site is hot and painful to touch. A lump can be felt at injection site. Area is also reddened. Pain upon any movement with RUE.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Severe nose bleed approximately 90 minutes after vaccine. I just began a workout when the nosebleed began. It took approximately 15 minutes to resolve. I also experienced a nosebleed the following day and the day after.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy 5/12/2021.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Nausea, Pallor, Wheezing
Clinical narrative: Patient reported feeling nauseous nearly immediately after vaccination and retreated to the store bathroom. Upon arrival, I found him profusely diaphoretic and very pale. He reported some difficulty breathing and was wheezing when speaking. He did vomit briefly. An epinephrine 0.3 mg auto injector was administered to his right thigh pending the arrival of emergency services.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Pruritus, Urticaria
Clinical narrative: Pt and mother came back saying that pt felt itchy. (Mother said same thing happened to her and asked pharmacist if remembered. Pharmacist did) RPh inspected injection site and looked red with scratch marks. Pt mom also showed a couple of spots that daughter thought might have been mosquito bites but mom said could be hives because there were multiple spots on thigh above knee above ripped jeans on right side. Mom also said pt had a spot on her back. Rph offered patient liquid diphenhydramine orally (50mg) (20mL of 12.5 mg/5mL diphenhydramine). Pt took orally and was asked to wait an additional 15 minutes. Afterwards pt said she felt ok. Mom said she would give her more benadryl at home if she needed it and would watch closely and if anything happened would take her to ER.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Blister, Burning sensation, Paraesthesia, Skin warm
Clinical narrative: 4/22/2021 6;30/7 pm went to local pharmacy Got shot in left arm 2 hours later felt hot and burning tingling sensation down my back lower back and outer left thigh, woke up with blisters under breasts. i still feel burning pain like I'm getting shingles but there is no visible sign. I'm still burning after 3 weeks. Blisters went away after a few days.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: Patient presented to the pharmacy on 5/11/21.  She states that she has experience swelling and tenderness on her neck on the left side since her vaccination.  By observation, it looked more extensive than lymph node swelling as it extended from the base of her neck to her earlobe.  She wanted to know if she should postpone her second shot which was scheduled for 5/16.  I consulted my pharmacy and we instructed the patient to contact her medical provider before proceeding with the vaccination.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Eye pain, Fatigue, Headache
Clinical narrative: *2nd day of vaccine: Swollen neck and face, eyes are painful Since I received the vaccine until now, elevated blood pressure and heart rate.   I've been normal with these in my whole life, now I have 136/85 or more sometimes 140/90 BP and my heart rate is more than 105.  I am also delayed with my period, I am on contraceptive pills used to have period every 28 days but now I don't have my period I am delayed since then. Weakness, fatigue and headache until now.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Menstruation irregular, Swelling, Swelling face
Clinical narrative: *2nd day of vaccine: Swollen neck and face, eyes are painful Since I received the vaccine until now, elevated blood pressure and heart rate.   I've been normal with these in my whole life, now I have 136/85 or more sometimes 140/90 BP and my heart rate is more than 105.  I am also delayed with my period, I am on contraceptive pills used to have period every 28 days but now I don't have my period I am delayed since then. Weakness, fatigue and headache until now.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Immediate post-injection reaction
Clinical narrative: Immediately after the vaccination patient complained about extreme anxiety. We gave a dose of Benadryl. Patient said it might not be allergy but panic attack. EMT was called and the patient felt fine after the EMT attended.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is not 18 -
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06Feb2021 11:15 (Batch/Lot Number: EL9264) as single dose for COVID-19 immunisation. Medical history included Asthma, Hypertension, Thyroid, high cholesterol, Chronic obstructive pulmonary disease (COPD), patient had allergy to Penicillin. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); simvastatin (SIMVASTATIN); losartan (LOSARTAN); ibandronate sodium (BONIVA) and gabapentin (NEURONTIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number= EK4176) in the right arm on 16Jan2021. No covid prior vaccination. No covid tested post vaccination. On 07Feb2021, 06:00 AM, the patient had injection site swelling about 3" diameter, warm, hard and itchy. Hasn't gotten better in 4 days. No treatment received for AE. Outcome of the events was not recovered.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No further AEs reported,; expired dose of MMR II vaccine; This spontaneous report has been received from a medical assistant, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies was not provided.   On 13-APR-2021,  the patient was vaccinated with and expired dose (expired product administered)  of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), at a dose of 1 dosage form (1 injection), lot number S031702 (has been invalid upon internal validation) and expiration date on 06-APR-2021 for prophylaxis (frequency, route of administration and anatomical location were not provided). On the same date, the patient was vaccinated with a dose of measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) (therapy type: rHA), lot number S031702 (has been valid upon internal validation), with an expiration date on 06-APR-2021 (expired product administered)  for prophylaxis (dose, frequency, route of administration and anatomical location were not provided).  No further adverse events were provided.
Age: 0.5
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: No additional AEs.; inadvertent administration of GARDASIL 9 to a 6 month old male.; This spontaneous report was received from an office manager referring to a 6 months old male patient. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 20-APR-2021, the patient was inadvertent administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T026168, expiration date was reported as 04-DEC-2022, 0.5 milliliter, strength, route and indication were not reported) (inappropriate age at vaccine administration). No additional adverse event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.   devicelotnumber: T026168; expirationdate: 04-DEC-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; This spontaneous report has received from a physician referring to a male patient of unknown age. Concurrent condition, medical history, and concomitant therapy were not reported.  On an unknown date, the patient as child was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported).  On an unknown date, the patient as child was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) for prophylaxis (formulation, strength, dose, route, lot#, and expiration date were not reported).  On an unknown date, the patient developed a rash at posterior thigh, which was diagnosed as shingles (herpes zoster) by dermatology. The outcome of herpes zoster was unknown.  The causality between the event and the suspect vaccine was not reported.  This is one of 2 reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002054:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: GARDASIL 9 was improperly stored and administered to a patient.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.    On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1687290 and expiration date of 06-SEP-2022 verified as valid, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided). The vaccine was exposed to multiple temperature excursions that started on 09-MAR-2021 and  was improperly stored at 34.5 Fahrenheit degrees (product storage error) for 3.5 hours, which was detected by digital data logger. By reporting time, it was unknown the total time of temperature excursions.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002270: US-009507513-2105USA002246: US-009507513-2105USA002232:01924937
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; expired MMR vaccine was administered to a patient; This spontaneous report was received from a registered nurse, referring to a 40 year old patient. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.     On 10-MAY-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S013539, 0.5 milliliter for prophylaxis (route and site of administration were not reported) which had expired on 02--MAY-2021.  The vaccine had not had any temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
Age: 78.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation referring to currently 86-year-old patient (pt) of unknown gender. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 21-JAN-2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (route of administration was unknown and strength, dose, anatomical location, lot # and expiration date were not reported). On an unknown date, reported as subsequently, pt was treated by a physician and a physician assistant, at a local medical center, for shingles (herpes zoster) which resulted from zoster vaccine live (ZOSTAVAX) use. At reporting time, the outcome of herpes zoster was unknown
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination failure, Varicella
Clinical narrative: patient received Varicella vaccine as a child but developed primary chicken pox; after direct exposure; patient received Varicella vaccine as a child but developed primary chicken pox with first lesion appearing on 4/28/21 after direct exposure; This spontaneous report was received from a physician and refers to a 21-year-old female patient. There was no information about her concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, she was on therapy included infliximab (REMICADE) (formulation, strength, dose, frequency, route of administration, indication, lot # and expiration date were not reported). On 28-APR-2021, the patient developed primary chicken pox with first lesion appearing after direct exposure to her boyfriend's shingles lesions. On an unknown date, she sought medical attention. The outcome of the events was not reported. The causality between the vaccination failure and varicella virus vaccine live (oka/merck)(VARIVAX) was assessed to be related. The causality assessment between the event of Varicella and varicella virus vaccine live (oka/merck)(VARIVAX) was not provided. The causality assessment between the events and infliximab (REMICADE) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE's/PQC's reported; Temperature excursion for VARIVAX which was administered to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 04-MAY-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S015459 with an expiration date on 20-MAY-2021, and T012550 with an expiration date on 10-APR-2022) for prophylaxis  (strength, dose, anatomical location, and route of administration were not reported).         The dose of varicella virus vaccine live (oka/merck)(VARIVAX) was exposed to a temperature excursion of -6.8°Celsius degrees (°C) during a time frame of 3 hours and 54 minutes. The data logger was not involved.  There was no prior temperature excursion and no adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional adverse effect reported; M-M-R II that underwent a temperature excursion was administered; This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided.  On 11-MAY-2021, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) vaccine lot number S037497 and expiration date of 20-NOV-2021; underwent a temperature excursion and was administered to the patient for prophylaxis (route of administration, dose and anatomical location were unknown). Previous temperature excursions were reported as follows: 2°C to 8°C (1.7°C) for 37 minutes; 2°C to 8°C (1.8°C) for 25 minutes and 2°C to 8°C (1.5°C) for 32 minutes. No additional adverse effect reported.
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Pharmacist reports that 15 year old patient reports that he may have received one dose of VARIVAX at the age of 3.; This spontaneous report was received from a pharmacist referring to a 15 year old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On an unknown date (reported as at the age of 3), the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. The reported stated that there was a possible adverse event due to possible interruption of dosing schedule. No additional adverse events reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Malaise, Mobility decreased, Speech disorder
Clinical narrative: Patient's daughter reported that about 2 weeks after second vaccine her mother became very ill. She was having trouble talking, walking, and moving. She stated that she had been taken to the hospital and it was possibly a stroke. We have since spoken with the patient on multiple occasions on the phone and she has not mentioned problems concerning her vaccine.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Blood thyroid stimulating hormone, Differential white blood cell count, Ear pain, Fatigue
Clinical narrative: Intermittent lymphadenopathy of the upper body (pre- and post auricular, submental, cervical, axillary, occipital). Fatigue, ear pain, injection site pain still present at day of report. Treatment for intermittent pain has been NSAIDs PRN and Wellbutrin for the fatigue.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematology test, Injection site pain, Laboratory test, Lymphadenopathy, Thyroxine
Clinical narrative: Intermittent lymphadenopathy of the upper body (pre- and post auricular, submental, cervical, axillary, occipital). Fatigue, ear pain, injection site pain still present at day of report. Treatment for intermittent pain has been NSAIDs PRN and Wellbutrin for the fatigue.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Hypoaesthesia, Hypoaesthesia oral, Migraine
Clinical narrative: Migraines on 4/26/2021 followed by numbness/paresthesia on left cheek, eye, forehead and tongue. Some decreased hearing as well.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pain
Clinical narrative: APPROX 12 HOURS AFTER 2ND SHOT, AT 1 IN THE MORNING, WOKE UP GASPING, THEN WENT FOR APPROX 8 HOURS CONTINUOUSLY GASPING AT EVERY BREATH, SHORT AND QUICK BREATHS.  SEEMED LIKE I NEVER FEEL ASLEEP UNTIL GASPING SUBSIDED AT BOUT 7 THE NEXT MORNING.  TWO DAYS LATER STILL ACHY AND LIGHT HEADED.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Dyspnoea, Wheezing
Clinical narrative: Shortness of Breath, Tight Chest, Coughing & Wheezing Treatment: Prednisone Shot and 3 breathing treatments Elapsed Time: 3 hours
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis
Clinical narrative: During observation after vaccine, Mom informed Pharmacist that patient was very sweaty.  Pharmacist informed mom and patient. to elevate feet, stay seated while an ice pack and cold water were retrieved.  Blood pressure was taken (97/56 mmhg 88 bpm).  Patient kept feet elevated and ice pack and was coherent the entire time.  Denied feeling dizzy, light headed, or seeing "star lights/spots".  Patient started feeling better shortly after drinking water, Mom noted the sweating had decreased or subsided.  Both denied paramedics to be called.  They were advised to continue to sit with feet elevated.  after a few more minutes, patient asked if he could leave.  Confirmed he was feeling much better. Informed Mom to have him rest, drink water and if there are any further concerns to seek medical attention.  Patient walked out unassisted.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Developed covid approximately 1 month after vaccination and required hospitalization and oxygen for 7 days.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: l had Shingles twice. I had the Vaccination, the last ones after Vaccination / Suspect vaccination failure; l had Shingles twice; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had once before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient experienced shingles twice. The patient had the last shingles after vaccination and he/she stated that they were awful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was provided a Moderna vaccine, instead of providing a Pfizer vaccine.  NO reactions with mixing both vaccines.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain, Vertigo, Vomiting projectile
Clinical narrative: Projectile vomiting; vertigo; nausea; body aches; extreme fatigue.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Dyspnoea, Echocardiogram, Electrocardiogram
Clinical narrative: Chest pain, SOB Treated with nitroglycerin, heart catherization, echocardiogram, EKG, anti-inflammatories , Atorvastin and Metoprolol.   Spent night in hospital under observation.  High Troponin levels of 11.01 which decreased over 24 hours .  Patient d/c and will see cardiologist next week.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: Chest pain, SOB Treated with nitroglycerin, heart catherization, echocardiogram, EKG, anti-inflammatories , Atorvastin and Metoprolol.   Spent night in hospital under observation.  High Troponin levels of 11.01 which decreased over 24 hours .  Patient d/c and will see cardiologist next week.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Injection site pruritus, Injection site reaction
Clinical narrative: Patient reports after first dose on 4/8/21 they had red rash on left arm, itchiness at site of injection, then itchiness spread over face and body and lasted for one week. Then on 4/28/21 patient had swelling in their thighs and went to the ER and was diagnosed with Urinary Tract Infection.   Patient reports after second dose of pfizer on 5/8/21 getting headache, joint pain, fever, cough, itchiness all over body/face, under right armpit. Symptoms started between 4-7pm on Saturday 5/8/21. Patient reports having fatigue on Sunday 5/9/21 and Monday 5/10/21. Patient  self treated at home and took tylenol, ketorolac, and benadryl for symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Peripheral swelling, Pruritus, Rash erythematous, Urinary tract infection
Clinical narrative: Patient reports after first dose on 4/8/21 they had red rash on left arm, itchiness at site of injection, then itchiness spread over face and body and lasted for one week. Then on 4/28/21 patient had swelling in their thighs and went to the ER and was diagnosed with Urinary Tract Infection.   Patient reports after second dose of pfizer on 5/8/21 getting headache, joint pain, fever, cough, itchiness all over body/face, under right armpit. Symptoms started between 4-7pm on Saturday 5/8/21. Patient reports having fatigue on Sunday 5/9/21 and Monday 5/10/21. Patient  self treated at home and took tylenol, ketorolac, and benadryl for symptoms.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have had the shingles several times and the shot hasn't helped me / suspected vaccination failure; have had the shingles several times and the shot hasn't helped me; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient was 17 years age when he/she 1st experienced this). On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that there were side effects to shingles shots and they were not good. The patient had shingles several times and the shot did not help. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Mouth ulceration, Pain, Pain in extremity, Pyrexia
Clinical narrative: Day 1 - 5  Shot, soreness in arm. Day 2- present - Fever, treatment Tylenol or Advil. Day 2-5 sore arm and body soreness (getting better). Day 2- present: Headache (Tylenol and Advil not provide relief). Day 4-present: Behcet symptoms appear, ulcers in the mouth and vulvitis.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvitis
Clinical narrative: Day 1 - 5  Shot, soreness in arm. Day 2- present - Fever, treatment Tylenol or Advil. Day 2-5 sore arm and body soreness (getting better). Day 2- present: Headache (Tylenol and Advil not provide relief). Day 4-present: Behcet symptoms appear, ulcers in the mouth and vulvitis.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst
Clinical narrative: I got a cyst on my left index finger
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Joint swelling
Clinical narrative: This morning I woke up with a  tenderness,  swelling,  pain in the same arm of the vaccine, left shoulder. I also developed fatigue, headache, chills and fever of 104.00.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This morning I woke up with a  tenderness,  swelling,  pain in the same arm of the vaccine, left shoulder. I also developed fatigue, headache, chills and fever of 104.00.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Asthenia, Balance disorder, Cerebrovascular accident, Deafness
Clinical narrative: ears went dead with no sound to be heard,  went to walk felt like could not control body, was swaying all over the place, and really sick.  sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike  up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours.  Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital.  Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysarthria, Dysstasia, Gait disturbance, Hemiparesis
Clinical narrative: ears went dead with no sound to be heard,  went to walk felt like could not control body, was swaying all over the place, and really sick.  sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike  up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours.  Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital.  Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Magnetic resonance imaging head, Malaise, Mobility decreased, Urinary incontinence
Clinical narrative: ears went dead with no sound to be heard,  went to walk felt like could not control body, was swaying all over the place, and really sick.  sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike  up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours.  Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital.  Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: ears went dead with no sound to be heard,  went to walk felt like could not control body, was swaying all over the place, and really sick.  sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike  up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours.  Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital.  Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Pt received a third dose of Shingrix (first two doses were given in 2018)
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Gout
Clinical narrative: Gout flare-up; ~42h after second dose of Moderna COVID-19 vaccine
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Ear pain, Mastication disorder, Mobility decreased
Clinical narrative: Extreme pain in left jaw/ear area that continues to be present almost 2weeks post vaccine. Started approximately 48hrs post vaccination. Cannot open mouth fully or chew properly due to the pain.   As well as: Joint Pain, more specifically, increased pain in areas with pre-existing nerve issues/concerns (carpal tunnel, damaged ulnar nerve in right arm, sciatic nerve pain in left hip).   Radiating pain in left pain from hip to ankle
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in jaw, Ultrasound scan normal
Clinical narrative: Extreme pain in left jaw/ear area that continues to be present almost 2weeks post vaccine. Started approximately 48hrs post vaccination. Cannot open mouth fully or chew properly due to the pain.   As well as: Joint Pain, more specifically, increased pain in areas with pre-existing nerve issues/concerns (carpal tunnel, damaged ulnar nerve in right arm, sciatic nerve pain in left hip).   Radiating pain in left pain from hip to ankle
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Axillary pain, Balance disorder, Dizziness, Feeling abnormal, Headache
Clinical narrative: Felt dizzy and unbalanced the morning after. Then felt ?off? since. Sore armpit/lymph node in right arm where I got the shot. On 5th & 6th day got a headache.
Age: 47.0
Sex: F
Vaccine: UNK
Symptoms: Lymph node pain
Clinical narrative: Felt dizzy and unbalanced the morning after. Then felt ?off? since. Sore armpit/lymph node in right arm where I got the shot. On 5th & 6th day got a headache.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had new shingles shots had shingles last October/Suspected vaccination failure; Shingles / on d and left side of face; Pain; This case was reported by a consumer via media and described the occurrence of Suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingles vaccine. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 9 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles on head and left side of face after new shingles shots. At the time of reporting only pain was relief as acupuncture done by chiropractor to patient best thing ever. This case was considered as suspected vaccination failure as details regarding, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Appendicectomy, Vomiting
Clinical narrative: Constant stomach pain , and vomiting  - symptoms occurred 24 hours after injection of 1st vaccine shot.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: No issues at all immediately after shot and for about two weeks after. Starting about 2 weeks after shot arm near injection site sore/achey. Has continued to be sore for past week.
Age: 101.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Patient (101 yr old) informed the long term care facility and the pharmacy administering the vaccination that she had not been previously vaccinated.  The Moderna vaccine was administered on 5/13/2021 (lot#022C21A).  Upon reporting it was discovered that she had received Pfizer covid-19 vaccine (lot#EN5318) on 2/02/2021. informed immediately and enhanced monitoring was put into place within 4 hours of the vaccination. I am not aware of any adverse effect at this time, however I am reporting as recommended on the CDC website for mixed series administration.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Swollen lymph node under arm of injection Muscle aches Chills Headache
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient advised started to develop numbness in left hand that started to traverse up the arm. Advised patient not a common adverse event and may want to seek medical attention at an urgent care. Called patient 2 hours later for follow up, she advised has not gotten worse, but has not gotten better either.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: My side effects turned right into shingles/suspected vaccination failure; Shingles; aching at the spot my shingles were, then it turned into Pain.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The patient stated that side effects are tough. The patient's side effects turned right into shingles, had aching at the spot his/her shingles were and then it turned into pain. The patient stated that surely they would not have that problem and get to the physician if they notice a rash. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR102623:same reporter
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate decreased, Loss of consciousness, Somnolence
Clinical narrative: Patient with complaints of lightheadedness 30 minutes after receiving vaccination. Patient stated that she did not eat today, powerade and a lollipop provided. Shortly after, patient with complaints of dizziness and slow heart rate. Vitals at 1546: HR 65 BP 90/62 and RR 20. At 1605, patient with increased drowsiness, dizziness and a brief moment of lapse in consciousness. Evaluated by paramedics on scene and declined transport to ER.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Syringe issue, Underdose
Clinical narrative: when  withdrawing syringe from patient's  arm, a bit of vaccine trickled  down  arm....Perhaps 0.1 cc
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Chest pain, Intensive care, Myocarditis, Troponin increased
Clinical narrative: Myocarditis.  Patient initially presented with chest pain 12 hours after vaccination. No other risk factors. Patient required to be in Pediatric ICU for treatment and cardiac monitoring.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac imaging procedure abnormal, Chest pain, Magnetic resonance imaging heart, Myocardial necrosis marker increased, Myocarditis
Clinical narrative: Myocarditis.  Patient initially presented with chest pain 12 hours after vaccination. No other risk factors. Patient required to be in Pediatric ICU for treatment and cardiac monitoring.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: Myocarditis.  Patient initially presented with chest pain 12 hours after vaccination. No other risk factors. Patient required to be in Pediatric ICU for treatment and cardiac monitoring.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Gait disturbance, Hypersomnia, Myalgia, Neuralgia
Clinical narrative: No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and unable to stay awake. I slept 4 hours past my normal time for getting up. I had no balance and would stagger when standing. My entire body was in muscle and nerve pain. Even my skin hurt. I took 300 mg of Gabapentine which eased my pain. I continued to be off balance the remainder of the day, however, by the end of the day I was much better. I took several 1 hour naps throughout the day.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Somnolence
Clinical narrative: No problems the remainder of day of injection. Next morning upon awakening, I was very groggy and unable to stay awake. I slept 4 hours past my normal time for getting up. I had no balance and would stagger when standing. My entire body was in muscle and nerve pain. Even my skin hurt. I took 300 mg of Gabapentine which eased my pain. I continued to be off balance the remainder of the day, however, by the end of the day I was much better. I took several 1 hour naps throughout the day.