chrisvoncsefalvay/vaers-outcomes huggingface dataset:
myocarditis; pericarditis; Chest pain; rapid heartbeat; A spontaneous report was received from a 20-year- old male patient who experienced chest pain, myocarditis, pericarditis, inflammation of pericardium.  The patient's medical history was not provided. Concomitant medications included phenylpropanolamine, diclofenac sodium, and colchicine.  The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 20 Jan 2021 intramuscularly for the prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced chest pain, rapid heartbeat and went to emergency room (ER). He was hospitalized and was diagnosed with myocarditis, pericarditis, inflammation of pericardium. The patient was discharged on 31 Jan 2021.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, chest pain, myocarditis, pericarditis, inflammation of pericardium, was considered not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested. The use of concomitant medication, Pnenylpropanolamine, which is a sympathomimetic agent, is a risk factor and confounding factor for causality.
Pt presented to ED the evening following her vaccinations at approximately 1830 in which mother stated that she witness patient having seizure like activity of "shaking all over" after patient woke up from nap.  Provider deemed it a febrile seizure secondary to vaccinations.  Pt had no further seizure activity in ED and was responding to stimulus appropriately as well as drinking bottle with no complications.  Tylenol administered and take home pack of Tylenol sent with mother.
4 hours post-vaccination: pain and soreness in the arm where the injection was given; soreness got progressively worse for 24 hours and then rapidly improved 12 hours post-vaccination: malaise, nausea, stomach pain, muscle aches, chills (no fever), fatigue, headache, and light-headedness onset; symptoms persisted for 24 hours following onset and improved overnight. 24 hours post-vaccination: axillary lymphadenopathy, currently persistent  Overall, adverse effects felt like flu-like symptoms or a severe hangover
This is a spontaneous report from a contactable consumer, the patient. A 62-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER COVID-19 mRNA VACCINE BIONTECH, Lot number: UNKNOWN) via an unknown route of administration in the left arm on 16Mar2021 at 12:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient was having allergy to iodine contrast dye used for MRI. The concomitant medication received by the patient within two weeks of vaccination included multivitamin (MANUFACTURER UNKNOWN) and Caltrate calcium supplement (MANUFACTURER UNKNOWN), both were taken daily for unspecified indications. The patient previously received codeine (MANUFACTURER UNKNOWN) for unspecified indication on unknown date and patient experienced allergy to it. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Mar2021, post 48 hours of vaccination, the patient experienced rapid heartbeat, dizziness, severe muscle and back pain, weakness, fatigue and nausea. The patient still had nausea and mild fatigue and headache 20 days after receiving vaccine (as reported). Post vaccination, the patient underwent COVID-19 nasal swab test (SARS-coV-2 test) on 25Mar2021, the result of the same was pending. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse events and was prescribed ZOFRAN for nausea. The clinical outcome of all the reported events was resolving.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
At 2pm, blisters formed on injection site.  By evening time, the blisters had burst where an infection began.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 21-JUL-2016 the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD (lot # L046510, expiration date 19-MAY-2017, dose and route were not reported). The vaccine had been stored under temperature of 52.3 degree Fahrenheit for 11 hours. No previous excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
1s vaccines 03/24/2005 at 3pm. 4 hours later fussy, irritable , Tylenol given at 2 and 6pm. Up all night, fever 101 under arm, Tylenol continued. Heat rash like spots 03/24/2005, rash resolved about a day later. MD seen, did not consider infant to have had allergic response, advised vaccines be given separately.
Describes heavy lifting on Thurs 11-1 Pain in chest and back on 11-2 attributed to lifting neck pain, sore throat, gen aching, fever. Vaccination reaction included in differential diagnosis
PATIENT felt numbness in her face and swelling of the side where she got her shot.patient stated even her ears feels numb
Stroke; at 1:30 pm Sept.26 left arm became non-responsive; called 911;  in ER left side of face began to feel numb and left leg was becoming weaker;  doctors administered stroke medicine at 5pm after which left arm started responding, but fingers were still numb;
BODY ACHE; CHILLS; HEADACHE; FATIGUE; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included severe anaphylaxis with tree nuts, anaphylaxis with nsaids (angioedema), and anaphylaxis with fish. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 14:15 for prophylactic vaccination. Concomitant medications included epinephrine.  On 11-MAR-2021 approximately 8:45 p.m-9:45 p.m., the subject experienced shortness of breath. On an unspecified date, the subject experienced body ache, chills, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath on 11-MAR-2021, and the outcome of chills, headache, fatigue and body ache was not reported. The reporter causality and Company causality between JNJ-78436735 and shortness of breath, chills, headache, fatigue and body ache was possible.  This report was non-serious.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. Date of placed in refrigerator was on 17-Nov-2021. Vaccine did not undergone any temperature excursion. No other events were reported for patient. No treatment information was reported.
Bivalent booster dose administered as primary dose.  Incident report filed, provider and supervisor notified.
High fever (103). Small erythematous papules without erythema or exudate.
This patient was informed she was Covid positive on 10/26.  She endorsed a sore throat and nonproductive cough.  During my interview she was provided rationale and the fact sheet related to the emergency authorization use for monoclonal antibody.  She fully endorses administration however requested I communicate with her daughters.     This morning she remains asymptomatic other than the persistent cough.  She remains on room air.  There is no evidence of any other symptoms of Covid.   I discussed the situation with her daughter by telephone this morning.  She provided the history of identifying a cough about Thursday of last week.  Her family as well as her sisters family did visit her at the hospital throughout her acute admission as well as in rehabilitation.  All family members are vaccinated and compliant with masking during these visits.  She is scheduled for potential discharge to her daughters home later this week.  She expressed concerns which I did try to address to the best of my abilities.  The patient ordinarily lives alone and is independent.  They are hoping the situation is temporary and that she can return to her baseline.  The monoclonal antibody recommendation was addressed with family and endorses administration.   Symptom onset: Approximately Thursday 10/21 Test date: 10/26/2021
out of the body experience as he has a sensation like he feels like a different person and sees everything different/feels weird; feels dizzy/has dizziness/when he sits, he feels like he was moving; vertigo; feels like he was drunk but was not drinking; overslept; This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249, expiry date 31May2021) via an unspecified route of administration (right arm), on 19Jan2021, at single dose, for covid-19 immunization. Medical history included Wolff-Parkinson-White syndrome from Nov2019 wherein the patient had surgery to correct. There were no concomitant medications. The patient just received the vaccine yesterday and wanted to report side effects. He stated he overslept this morning on 20Jan2021, and he was supposed to be at work at 7am. He rushed to get into his vehicle, and he was sitting at a stop light and started feeling this way at 8am. He stated that on 20Jan2021 08:00 he has an out of the body experience as he has a sensation like he feels like a different person and sees everything different. He feels dizzy/has dizziness kinda like vertigo on 20Jan2021 08:00. He added it feels like vertigo, but it was not vertigo, he was unsure if it was vertigo. Everything feels weird. He feels like he was drunk but was not drinking and, when he sits, he feels like he was moving on 20Jan2021 08:00. The outcome of the events was unknown.
Patient came in with his entire upper left arm red and warm to the touch, the redness was complete wrapped under his arm. Patient had no difficulty in breathing. I suggested BENADRYL and if no relief by Thursday to make appt with his physician and to call me on Thursday to let me know how is was doing.
GI upset with lower abdominal cramping and pain the two mornings after receiving the vaccine.  Worse on day 2. Improved with eating.
ALLERGIC REACTION, INIT 1/13/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE REACTION (experienced a side effect within the first 7 minutes, it did subside within the hour). On an unknown date, the patient experienced MALAISE (Fealt so exhausted), PALPITATIONS (Heart racing), DIZZINESS (Dizzy as if being put under) and NAUSEA (Nauseous). At the time of the report, MALAISE (Fealt so exhausted), PALPITATIONS (Heart racing), DIZZINESS (Dizzy as if being put under) and NAUSEA (Nauseous) outcome was unknown and VACCINATION SITE REACTION (experienced a side effect within the first 7 minutes, it did subside within the hour) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided by reporter. No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up received; Reporter email address, Patient demographics, Drug information and event outcome was updated.
Mother stated child broke out with red bumps on his cheeks on 6/17/06 and spread to legs, not his trunk denied any itching to legs, child does scratch his face. Ran fever prior to bumps breaking out but not after. By 6/19/06 mother reported that bumps were resolving. Denied that red bumps drained or crusted over. Mother called MD office and they told her it was not necessary to bring child in unless the bumps lasted longer than 7-10 days.
IPOL was mistaken as a PPD formula and was given to a patient as 0.1mL intradermally with no reported adverse event; IPOL was mistaken as a PPD formula and was given to a patient as 0.1mL intradermally with no reported adverse event; IPOL was mistaken as a PPD formula and was given to a patient as 0.1mL intradermally with no reported adverse event; Initial information received on 09-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old male patient who was administered IPV (VERO) [Ipol] which was mistaken as a ppd formula and was given to a patient as 0.1ml intradermally with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination (Immunisation).  On 09-Aug-2023, the patient received a dose of 0.1 ml suspect IPV (VERO) (Suspension for injection) (lot: W1A191M) via intradermal route in the right forearm for mistakenly given for TB test (Immunization).  On 09-Aug-2023 the patient was administered ipol which was mistaken as a ppd formula and was given to a patient as 0.1ml intradermally with no reported adverse event (incorrect route of product administration) (incorrect dose administered) (latency: same day).  It was reported, "nurse asks how to proceed and if we have safety data for IPOL doses that are given inadvertently."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for all the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
acute myeloid leukemia; her platelets were below 30,000; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Feb2021 at single dose for COVID-19 immunization. Medical history included ongoing immunodeficiency (reported as immunocompromised). Concomitant medications were not reported. The patient had an acute myeloid leukemia and her platelets were below 30,000 on an unspecified date. Clinical outcome of the events was unknown.  Information on about lot/batch number has been requested.
I experienced pain, redness/rash and swelling at injection site (2" in diameter); tired, joint pain, itching at injection site; enlarged and painful lymph nodes in right arm pit; felt unwell (flu like/hang over symptoms); insomnia, diarrhea, loss of appetite. These symptoms onset was at day 2 and lasted 7 days.
On the date of first occurance March 10,  felt fatigue  and muscle ache in groin and legs, on first night felt restless, and sleepless with pain occuring in more  joints.  Next morning  March 11, could not get up out of bed without assistance.  Excruitiating joint and muscle pain .  Sleeping 10-12 hours during day.  Could barely walk pain persisting.   Foggy brain,  unable to consentrate.  Feeling  depressed.  This last through weekend, subsiding some on Sunday March 14.  Visited family physician, Dr. on Monday.  Diagnosed with Serum Sickness.  It has been a gradual decrease in joint pain, but still persists in my hips and legs  as I write this on March 22.
Patient states He had redness and itching on is lower legs and forearms. He had his regular appointment with his doctor and told his doctor about his symptoms. The doctor gave him some hydrocortisone valerate 0.2% to apply to the affected areas.
patient received the covid pfizer monovalent vaccine in error and was supposed to receive the covid pfizer bivalent vacccine
unable to receive second dose due to COVID; This case was reported by a consumer via call center representative and described the occurrence of social problem in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in Left deltoid by intramuscular route, 2 years ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not applicable for this report. The patient was unable to receive the 2nd dose due to traveling, Shingrix also shortage at the pharmacy, as well as the COVID situation (patient did not have COVID) which led to social problem. The reporter did not consent to follow-up with health care professional.  The reporter did not consent to follow-up. The patient was misinformed by Pharmacy to restart Shingrix vaccine series. VAERS details were reported for the 1st dose of Shingrix.
patient received expired dose of TENIVAC/no AE; Initial information received on 21-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 7 year-old male patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE [TENIVAC] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD); INFLUENZA VACCINE INACT SPLIT 3V (FLULAVAL); HEPATITIS B VACCINE RHBSAG (YEAST) (ENGERIX-B) and HEPATITIS A VACCINE INACT (HAVRIX) for prophylactic vaccination.  On 20-Apr-2021, the patient received a first dose 0.5 mL of suspect DIPHTHERIA-2/TETANUS-5 TOXOIDS WITH PRESERVATIVE (strength: standard; lot U6265AA and expiry date 19-Apr-2021) via an intramuscular route in the right arm for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Result of assessment was not 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 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.
cannot walk right now; This is a spontaneous report from a contactable consumer (patient) from a Pfizer. A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date in 2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she had her first dose over 3 weeks ago on an unspecified date in 2021. She was supposed to get her second dose which was due last Friday. She had a surgery on her foot and could not walk right now (from an unspecified date in 2021). She wanted to know how long she must wait to get second dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
had to sleep because she couldn't move; she couldn't move; arm was aching; pain in her joints; erythema around her injection site; pain in her eye socket /  pain behind her eye ball; shaky; chills; intense muscle pain; This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax with an associated reaction of pain (In past, the patient experienced mild achy feeling in her arm after receiving the vaccine).   On 19th June 2020, the patient received the 1st dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced tremor, chills and myalgia. On 19th June 2020, the patient experienced pain in arm, joint pain, injection site erythema and eye pain. On 20th June 2020, the patient experienced bedridden and mobility decreased. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the joint pain, injection site erythema, bedridden, eye pain, tremor, chills, myalgia and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm, joint pain, injection site erythema, bedridden, eye pain, tremor, chills, myalgia and mobility decreased to be related to Shingrix.  Additional case details were reported as follows: By 9:00 am, the patient received Shingrix in left arm. The patient experienced arm was aching and within 2 hours she had pain in her joints. The patient received Tylenol 200 mg. for pain and it barely touched. The patient experienced pain in her eye socket and erythema around her injection site.  On 20th June 2020, 1 day after vaccination the patient had to sleep because she could not move. Her side effects have all resolved today. The patient mentioned that she had had the Zostavax previously and other flu shots and she experienced a mild achy feeling in her arm, however, it was nothing similar to what she experienced with the Shingrix vaccine. The patient described her Shingrix side effects as the most intense muscle pain with shaky chills and pain behind her eye ball.  The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020107111:same reporter US-GLAXOSMITHKLINE-US2020AMR107678:same reporter
Patient experienced swelling and pain at injection site as well as swelling down arm. Also had low grade fever (101 degrees F) and experienced lip swelling without resp. involvement.
Initial information has been received from a physician concerning a patient with an unspecified age, gender, pertinent medical history or drug reactions / allergies. On 06-OCT-2011, the patient was vaccinated with the first dose of PNEUMOVAX23 (dose, route and lot number were not reported) and on 18-FEB-2013, the patient was vaccinated with the second dose of PNEUMOVAX23 (dose, route and lot number were not reported). No co-suspect medications were reported. No concomitant medications were reported. No adverse symptoms reported. No treatment information or laboratory studies were reported. Additional information has been requested.