chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA: hospitalized with acute hypoxemic respiratory failure due to COVID-19 and parainfluenza. Patient received remdesivir, steroids, supplemental oxygen, and anticoagulation. Discharged to home medically stable.
Patient developed redness and slight swelling around injection site & redness spread down arm to near elbow. She said it was slightly itchy but event was located only on arm and no were else on body. I instructed patient to go and see her doctor to assess further if she needed anything like oral steroids to help skin reaction clear up.
RACING HEART AND WERE REQUIRED HEART MEDS; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced racing heart and were required heart meds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of racing heart and were required heart meds was not reported. This report was non-serious.
Pain woke me up on the 4th day after vaccine. Pain was on my liver area. The following day my gallbladder was also acting up. On march 14, sharp pain was coming from appendix area, this pain continued for 2 weeks. Til today I still feel that sharp pain, with also liver pain.
No further AE reported; administration of an improperly stored dose of V ARlV AX; This spontaneous report was received from an office manager and refers to a male patient of unknown age. Information on his concurrent conditions, medical history, drug reactions and allergies and concomitant medications was not provided.      On 20-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 mL, lot # T017688, expiry date 21-MAY-2022 (route of administration was not reported) for prophylaxis (product storage error). The vaccine experienced temperature excursion of -10 to 8 degrees Celsius (-0.1 C) for 2 hours 3 minutes. There were also previous temperature excursions reported: -10 to 8 degrees Celsius (4.1 C) for 11 hours 2 minutes, -10 to 8 degrees Celsius (-7.1 C) for 1 hour 26 minutes, -10 to 8 degrees Celsius (6.6 C) for 5 hours 23 minutes. No further adverse event was reported. There was no product quality complaint.
Immediately after vaccine administration, pt. broke out in hives on face, abdomen, back, legs. Stayed in office for 30 min. after the vaccines given, hives began to dissipate.
The patient is reporting pain in the area the immunization was given. She reports experiencing pain when raising her arm to brush her hair, for instance. Patient states she believes the shot was given to high up on the arm.
pt returned to office aafter receiving his 4 year vaccines. he was alert, slightly dyspneic and with redness of his entire face and body with a few hives on cheek and arm. no stridor. no wheezing. he was given Claritin 10 mg, Benadryl 18.75 mg, Epi 0.15 mg and prednisolone 30 mg. within a few minutes, his breathing normalized, the redness improved and he was more talkative. 911 called to transport pt to the ED, where he was monitored for a few hours and sent home. Will refer to allergist for allergy testing
Discovered a positive pregnancy test after she took smallpox vaccine. Took pregnancy 5-6 weeks after vaccine. Test taken before vaccine was negative. Now 3 months pregnant according to ultrasound.
09/13/2002 "spots" face, back onset 09/12/2002
Uncontrollable body shake; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TREMOR (non-serious), outcome "unknown", described as "Uncontrollable body shake".  Additional information: The nurse has sent 7 kids home with severe cardiac and neurological ae, some have gone to the hospital with cardiac with myocarditis diagnosis and PVC (premature ventricular contraction 6 years old) some of them are experiencing crushing chest pain, bilateral arm and finger numbness, bilateral leg numbness, one girl yesterday was suffering from all over body shakes, incontrollable that she cant control, what the nurse was seeing over the past week; first kid sent home, right sidedness weakness, numbing and tingling in her arms and legs and she couldn't feel the right side of her face or her tongue with crushing stomach pain, other kid that couldn't feel both of her arms and fingers and terrible stomach pain, kid that was sent to hospital on Saturday, crushing chest pain, diagnosed with myocarditis and PVC, kid yesterday, had uncontrollable body shake and couldn't stop them sent to the doctor, today was a crushing chest pain, bilateral weakness of the hands and arms weakness on the legs and extreme exhaustion, hemiparesis on the right side she couldn't feel the entire side of her body including tongue her face and her nose. The nurse said that this happened in just one tiny school, all female. Age from 6-10.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna vaccine received on 5/21/2021 before adverse event then received Moderna vaccines on 8/27/2021 and 2/16/2022 after the event Hospitalized with Non-STEMI and congestive heart failure at Hospital in July 2021 Hospitalized with weakness on 8/4/2021 at Hospital.
This spontaneous report received from a pharmacist refers to a 88 year old female patient. On 16-SEP-2014 the patient was vaccinated with ZOSTAVAX (vial, lot # K007548, expiry date: 23-AUG-2015, subcutaneous) for vaccination. Concomitant therapies included prednisone (manufacturer unknown). On 16-SEP-2014 after receiving ZOSTAVAX the patient experienced dizziness. The patient did not seek medical attention. It was reported that no treatment was given for adverse event and no lab diagnostic was performed. The outcome of dizziness was reported as not recovered. The relatedness between ZOSTAVAX and dizziness was not reported. Additional information is not expected because there is no consent to contact the physician.
7/13/21: sore throat, low energy, cough 7/14/21: low energy, cough, fever, muscle aches, chills, loss of taste & smell - PCR test administered 7/15/21: low energy, cough, fever, no taste or smell, sore from coughing fits 7/16/21: energy regained, fever gone, occasional cough, stuffy nose, no taste or smell 7/17/21-present: occasional cough, occasional stuffy nose, very little taste or smell
It was realized after RotaTeq (oral) administration that the vaccine had an expiration of 5 days prior. It was properly stored and still in the refrigerator. I immediately called Merck and spoke with staff who told me that the efficacy of the vaccine has not been compromised. As the storage temperature was maintained that there are no ill effects to this event.  Dr. was notified as was the mother of the infant. She was still in the office with us. States understanding and had no further concerns or questions.
Ringing in right ear followed by dizziness. No treatment. The ringing in the right ear stays while the dizziness comes and goes.
Rash, breaking out in rashes every now and then; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash, breaking out in rashes every now and then) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Reactions to poison ivy).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash, breaking out in rashes every now and then). At the time of the report, RASH (Rash, breaking out in rashes every now and then) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient had same feeling with  poison ivy.  Concomitant medications were not reported.  No treatment information was specified.
My period stopped in December 2019, I got covid19 vaccine on 2/19/2021 in the morning and I got my period at night. Not sure it is side effect of vaccine or not.
8 days after injection I developed an oval-shaped rash around injection site, about 4 inches long and 2 inches wide. No pain, burn, or itch. The rash has gotten lighter each day (now 11 days after injection, 4 days of rash). It is darker red around the precise site of injection (a nickel sized red circle), then paler surrounding it, then the outer ring of the oval gets darker red again. Had a teledoc appointment and was told not to worry unless I develop symptoms of cellulitis. The rash is still there, lighter, but just as large (some parts have even spread larger, but have gotten less red). Still no pain or irritation. Have been putting hydrocortisone cream on 2-3x/day.
patient was administered an expired dose of Ipol/No AE; Initial information received on 23-Nov-2019 and additional information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 14 months old female patient who received expired dose of vaccine IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HAEMOPHILUS INFLUENZAE (HAEMOPHILUS INFLUENZAE) for Immunisation.  On 21-Nov-2019, the patient received third dose of 0.5 mL suspect IPV (VERO) lot N1J451M, expiry date-05-10-2019 via intramuscular route in the right thigh.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
like  sizure and a heart attack with numbnes and tingling as the first symptom then sick for following  2 days. 3rd day barely walk short of breath dizziness pain in back of neck lathargic ,major sweats followed by cold.5th daythrough7th major back pain lathergic realy weak still short of breath not as bad. 8th day weak cold sweats still dripping
Patient wanted to speak with someone regarding complications from the Flu Shot on 9/29/11. Thought the pain would pass. Right arm has been in great pain to the touch, to lift and move. Since patient taken the shots in previous years, figured the discomfort would pass a few days afterwards. The pain has progressively gotten worse and even warranted going to an urgent care facility on 10/22/11. The doctor said back shoulder, forearm and front part of shoulder felt warmer than normal & gave patient the following medications to take: Mobic (15 MG/once a day), Tylenol 3 (every six hours) & Clindamycin (300 MG/three times a day). Since then patient went to Dr. who said has Rotator Cuff Sprain, gave pain meds and scheduled Physical Therapy to start on 11/29/11. Today is 11/14/11 & patient has run out of pain meds. The doctor won't refill the prescription until patient starts P.T. on 11/29/11.  Patient is COMPLETELY out of meds. Nurse said the nerve test and X-Ray came out normal and the doctor won't do anything else until patient completes P.T. Again, patient is in great pain and the doctor treated it like it was nothing. Missed work due to this pain and all the doctors have done (basically) was told patient "it's nothing".
NO ADVERSE EVENT/REACTION.  PATIENT WAS GIVEN A 3RD DOSE OF PFIZER MONOVALENT RATHER THAN THE PFIZER BIVALENT AS A BOOSTER.
Big pimples on right side cheeks/Pimples on end of tongue; Lump in right side of throat; Chills; Weak; Dizziness; This is a spontaneous report received from a contactable consumer (Patient). A 55-year-old female patient received second dose of BNT162B2(PFIZER BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 18May2021 (at the age of 55 years) (Batch/Lot Number: EW0176) as second dose, single dose for covid-19 immunisation. Medical history included ongoing asthma Diagnosed about 2 years ago. The patient's concomitant medications were not reported. Patient historic vaccine included first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Lot Number: EW0162) received on 23Apr2021 (at the age of 55 years). Patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient denied any family medical History Relevant to adverse event. On an unspecified date in May2021, the patient experienced big pimples on right side cheeks/pimples on end of tongue, lump in right side of throat, chills, weak and dizziness. She stated that she had the Covid Pfizer Vaccine, second dose, on 18May2021. She then travelled on 24May2021. She was having side effects and wanted to report them. She was currently out of the country. Stated that the symptoms started after the second dose of the vaccine; but before she travelled out of the country. She developed big pimples on the right side of her cheeks. then a lump in the right side of her throat. She thought these were going away, so she went ahead and travelled. She stated now they've gotten bigger. She also had pimples on the end of her tongue. States she also experienced chills, being weak, and dizziness but that was okay now. Now everyday she noticed something new. She would like to know if she should continue this way if symptoms persist. Should she go back and receive treatment, or she should wait. She called her healthcare provider, but she isn't working on Fridays. She denied any medications, labs, testing, or treatments relevant to events. She was not visited to either emergency room or physician's office. Relevant teste was reported as none. The outcome of event Big pimples on right side cheeks/Pimples on end of tongue was unknown, Lump in right side of throat was worsened and not recovered and chills, weakness and dizziness were recovered on an unspecified date in May2021.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 21-year-old female patient who received Flu unspecified (Influenza vaccine) for prophylaxis. Concurrent medical conditions included autism, tourette's syndrome, charcot-marie-tooth disease, attention deficit/hyperactivity disorder, obsessive-compulsive disorder, endocrine disorder (Endocrine problems) and allergy. On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extremely red swollen injection site. For tolerability of FLULAVAL QUADRIVALENT 2018-2019 season vaccine, refer case US2018218622.
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown age (child) and gender. The nurse received this information from other patient's parent who heard about reported event. On an unknown date, the patient was vaccinated with an unspecified dose of PROQUAD (Merck) (dose, frequency, route, lot number and exp. date were not reported). On an unknown date, the patient was severely injured and the nurse believed that the injuries were similar to an encephalitis or an encephalopathy that this child developed after receiving PROQUAD (Merck). The nurse reported that the child's parents "went to court and won" and that compensation had already been granted. The outcome of encephalitis, encephalopathy and severely injury was unknown. The relatedness between reported events and PROQUAD (Merck) was not reported. Upon internal review, encephalitis and encephalopathy were considered to be medically significant. Additional information is not expected.
08/08/2013 Received telephone call from mother reporting that son's left deltoid area was swollen, red and itching. Already 3 days past vaccines, so was told to address itching with calamine.
This spontaneous case was reported by an other health care professional and describes the occurrence of CONJUNCTIVITIS (conjunctivitis) and VACCINATION SITE WARMTH (Warm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ALPRAZOLAM (XANAX) for Anxiety, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, HYDROCHLOROTHIAZIDE for Fluid retention, METOPROLOL for Heart rate, ESTRADIOL for Hormonal imbalance, LOSARTAN for Hypertension, CENTRUM SILVER for immunity. On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CONJUNCTIVITIS (conjunctivitis) and VACCINATION SITE WARMTH (Warm). At the time of the report, CONJUNCTIVITIS (conjunctivitis) had not resolved and VACCINATION SITE WARMTH (Warm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, Magnetic resonance imaging: The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included Ibuprofen, Eye drop for conjunctivitis right eye.
Weakness, fatigue, rapid HR, abd pain, numb legs- sx's intermittent since then and continue.  7/2/09 Medical records received DOS 11/11/08 to 6/12/09. Assessment: PCOS (Polycystic Ovary Syndrome). Acute and chronic cervicitis, squamous metaplasia, inflammatory atypia with mild koilocytosis. UTI.  Patient presents with abdominal pain, leg numbness, and cramping. Pelvic pain. Weakness, fatigue, rapid heart rate, short of breath, body numb. UTI. Feeling sick.  8/12/09 Received PCP medical records, no vax records. FINAL DX: conversion disorder Records reveal patient sexually active as well as having been sexually assaulted.  Undergoing psych counseling & on depoprovera. Bouts of URI & tonsillitis as well as ongoing abdominal pain.
30 yo male with no significant PMH presented to Clinic on 4/19/2010 to receive administration of Tdap vaccine. Patient then contact clinic via telephone to report swelling and pain at injection site on 4/19/10. Pt was evaluated in clinic on 4/20/2010. Per MD assessment, urticaria, erythema, and swelling were present at injection site. Pt instructed to use OTC ibuprofen PRN pain and diphenhydramine PRN itching. On 4/21/2010, Injection site was re-evaluated by MD and improvement in urticaria, erythema, and swelling were noted.
Bell's Palsy on the right side of my face; muscle weakness around the right corner of my mouth, cheek, and eye.
nausea, occasional emesis, malaise, fatigue, generalized weakness, loose bowel movements, thrombocytopenia and leukopenia
Initial information received on 20-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (with unknown demographics) who was vaccinated with a dose of ACT-HIB lot UI904AAA (Expiry date 19-SEP-2019 ) via unknown route in unknown administration site, on 18-Mar-2019. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication case error due inappropriate reconstitution technique. It was reported that nursing staff mixed sterile water instead of diluent for ACTHIB vaccine and injected. It was not reported that if any adverse reaction was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
6:00 abd pain, sleepy, lt shin pain w/pressure sensation, vomiting 3AM 21APR98 cont through the noc;very sleepy all of 21APR & 22APR;nausea & vomiting back to nl;rt arm ache, dizzy feeling also;
Cellulitis RUE deltoid where received PNVX. Required change of antibiotic to KEFLEX from Amoxicillin for sinus infection treated prior.