chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional to sales representative and described the occurrence of the redness and swelling at the injection site in a15-18-month-old subject (unknown gender) who received diphtheria and tetanus toxoids an acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline). On a specified date in either March 2006 or April 2006, the subject received the 4th dose of Infanrix in an unspecified thigh (lot AC14B018AA). At an unspecified time after vaccination with Infanrix, on an unspecified date on or before 11 April 2006, the subject experienced redness and swelling at the injection site of Infanrix. The outcome of the events was not reported. The nurse considered the events to probably be related to vaccination with Infanrix.
Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death
Localized reaction, right thigh 6 x 8cm were Prevnar and Varicella given.
I received the Moderna booster on 11/5. on 11/11, six days after receiving the Moderna booster shot, I developed an itchy bump at the injection site with red hives surrounding, it was feverish to the touch. Over the course next nearly two weeks, the hives have grown progressively worse, and are covering my entire body. I received a prednisone shot on 11/17, which only helped temporarily. Have since been taking oral prednisone and Benadryl daily, both of which barely alleviate the symptoms.   I saw my allergist today, 11/23, and was prescribed Zyrtec, Pepcid AC, more prednisone, and an epi pen.
Colleague arrived to report a small hard pea sized lump to area of MMR vaccination on back of right arm.
A couple of days later, I started to feel numbness/tingliness throughout my body but most in my hands.  I saw my dr in May.
At approximately 9:00 p.m. on Saturday 1/30/2021, approximately 12 hours after receiving the moderna COVID 19 vaccination I passed out.    I?ve ran at temperature between 99.0 - 101.8 until approximately 6 p.m. 1/31/2021 Muscle and body aches Nausea and upset stomach
no other AEs reported; Caller is a medical assistant reporting that a 35 year old patient received a dose ofPROQUAD today, 25Jun2021. Per caller, the patient was supposed to receive MMR II and V ARlV AX separately.; Caller is a medical assistant reporting that a 35 year old patient received a dose ofPROQUAD today, 25Jun2021. Per caller, the patient was supposed to receive MMR II and V ARlV AX separately.; This spontaneous report was received from a medical assistant and refers to a 35-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 25-JUN-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant Human albumin) (PROQUAD) lot # T027112 was confirmed to be valid, expiration date 07-FEB-2022, 1 injection for prophylaxis (exact dose, route and site of administration were not reported) (inappropriate age at vaccine administration ). The patient was supposed to receive Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and varicella virus vaccine live (Oka/Merck) (VARIVAX) separately (wrong vaccine administered). No additional adverse event was reported.
REACTIONS; This spontaneous report received from a consumer via a company representative from social media 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 reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20220230451.
No adverse effects reported.; the patient received an improperly stored dose of PROQUAD; the patient received an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a patient of an unknown gender and age.   No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 06-MAY-2020 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose, route of administration, vaccination scheme and  anatomical site of vaccination, were not reported, lot # S013712,  expiration date 01-NOV-2020) as prophylaxis (incorrect product storage).  As concomitant therapy a sterile diluent (MERCK STERILE DILUENT) was used to reconstitute the vaccine. The vaccine was stored at a temperature of -9 degrees Celcius to 8 degrees Celcius (6.9 degrees Celcius) for a timeframe of 1 hour and 34 minutes. There was no previous temperature excursion and the call was made due to a digital data logger. No additional adverse effects were reported.
Patient describes very swollen arm at site of Pneumovax injection.  Tight skin and visible swelling from shoulder to elbow.  She also describes itching, but no rash.  Patient also reports nausea.  Symptoms resolved after Benadryl.
Stiff neck and really bad migraine.  I took my Sumitriptan and it went away after two doses.
patient felt fine immediately after shot, she fainted about 8 or 9 pm that evening.  She then felt body aches especially in her arms and legs from then and for 24 hours after.  She felt crampy due to oncoming menses so she took 400 mg ibuprofen,.  She took 400 mg more 2 hours later.  This second dose made her feel better.  The next morning  she felt a bit groggy but when she got up she felt fine and has not taken medications since.
This spontaneous report as received from a mother refers to her daughter of unknown age. The patient was vaccinated with dose 1, 0.5 ml GARDASIL in October 2007, by intramuscular injection. No other co-suspects were reported. No concomitant medications were reported. The patient got her second 0.5ml dose intramuscularly in December 2007 and third 0.5 ml dose intramuscularly in December 2009. No adverse event was reported. Additional information is not expected.
Mother states pt "felt hot" at home. No temperature recorded here at 97.8F. Had 1cm firm, red and slightly swollen area on left anterior thigh. Advised to use warm packs at home. It is still red.
Beginning this morning, 2/4/21, 8 days post vaccination, I began having mild to moderate itching, swelling and redness at the injection site.
HYPOTENSION 4/11/2023 OSTEOARTHRITIS OF LEFT HIP
Back stiffness in the morning that grew more severe and became pain as the day went on. Sharp pain with movement primarily in the lower back near the pelvis and spinal region.
Pt had 7 to 8cm of redness and swelling at site of injection (deltoid).
Full body rash, that moved to face 3 days after vaccine. Elevated resting heart rate at night (10 beats higher than average), restless sleep for 4 days following vaccine
9-23-15 First day headache. 9-24-15 Second day heavy weight on chest. 9-28-15 Sixth day passed out. 19-4-15 Twelfth day pounding heart beat.
Fever (100.2-101.1 F) Severe chills Body aches Injection site swelling, soreness Swollen lymph node (right armpit) Treated with acetaminophen and ibuprofen
Extreme lower back/kidney pain.  Worsened over the next couple of days.  Then started to get better. Still have slight pain on 11/23/2014.
father reported pt stiffened in car seat, fists clenched, pale, vomited;stated this happened immed p/leaving the hlth dept;advised to take to MD;pt c/o being tired a/coming to clinic;
Had first shot and noticed that I am getting like bump on my arm, it's getting hard around inside of it; Had first shot and noticed that I am getting like bump on my arm, it's getting hard around inside of it; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown) via an unspecified route of administration on an unspecified date (70-year-old at vaccination) as a Dose 1, Single for COVID-19 immunization. The patient medical history was not reported.  The patient reported that he took different kinds of medications (unspecified). He had the first shot on he believe it was on Wednesday of this week and have he noticed now he was getting like a bump on his arm it's like getting hard around inside of it. He queried if that was normal. The reported provide limited information. No investigation assessment was provided. The outcome of the events was unknown.
Patient described arm as numb, heavy no feeling. No treatment. Mom states lasted 2 days with last dose of HPV.
By 9:00 pm the evening of my vaccine I was having chills and a fever of 100 degrees. Not that high I know but for me it is and gave me a very bad headache and body aches.  I did not feel good enough to try to sleep until about 1:00 am after using a heating pad and hot tea to try and chase the chills away and Ibuprofen for the aches.  My shoulder was so sore from the shot that I could not lay on my left side.  The following day I was about 50% better. No more chills but still slight fever and no appetite.  Didn't feel good enough to do anything except take a nap.  The following day I was pretty much back to normal.
Patient reported swelling in the face, lips and nose the day after vaccination that lasted for 3 days.
Headache, Fever, SORENESS, LIGHTHEADEDNESS, FATIGUE Narrative:  Other Relevant History:
Patient is a 42 y.o. female with a history of lymphoma, and tobacco abuse who presented to RMH 6/26/2023 with shortness of breath, fever, cough. Found to be COVID positive with pneumonitis on imaging. Treated with steroids/remdesivir with improvement in symptoms.    1. COVID-19 pneumonia: 2nd infection. Vaccinated and boosted. Immunocompromised. Onset of symptoms 6 days prior to admit. Started on Decadron IV and Remdesivir inpatient - discharged on Decadron to complete 10 day total course. As patient is immunocompromised likely will need to remain in isolation for total 20 days until 7/11/23. 2. Acute hypoxic respiratory failure: due to above. CTPA as above. Placed on NC O2. Weaned to room air as of 6/28/23.  3. Diarrhea: per patient started with above. Likely due to COVID. Monitored, improved inpatient.  4. Non-hodgkin's Lymphoma: h/o. Follows Dr. (oncology). Was on bendamustine. Currently on Rituxan.  5. Elevated LFTs: ALK 174. Likely due to above. CTPA on admit showed hepatic steatosis. Monitor for now.  6. Microcytic Anemia: Hb 10.9 on admit. Likely due to chemo. Iron studies suggestive of anemia of chronic disease. Monitor. 7. Hypokalemia: K 3.2. on admit. Replaced.  8. Tobacco abuse: current smoker. 0.5 PPD. Cessation encouraged.
A report was received from a health care professional on 13 November 2003, concerning three vaccinees of unknown demography who inadvertently received expired Fluvirin on an unspecified date. On an unspecified date the vaccinees inadvertently received expired Fluvirin. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
After 20 minutes I lost feeling in the left side of my face.  It also radiated down my left arm.  It subsided after 7 hours and was gone after 18 hours.  The following morning I woke to a sore back in an area I have had issues with.  The pain progressed and has gotten worse over the past two months.  I have gone from training for a triathlon to only being able to walk about one mile with pain.  I am in pain 24 hours a day now.
pain at the top of my spine, at the base of my neck; pain at the top of my spine, at the base of my neck; This is a spontaneous report from a non-contactable consumer (patient). A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received the flu shot for immunization and her arm was sore. The patient got first Pfizer vaccine this morning (reported on 22Jan2021). She had been feeling fine. She didn't even have pain at the injection site. The patient had a pain at the top of spine, at the base of neck. She didn't know if it's related to the vaccine. The patient also stated the site couldn't change her appointment which was exactly 3 weeks from today but unfortunately, she had surgery scheduled that day. Outcome of the event was unknown.   No follow-up attempts are possible. Information about lot/batch number could not be requested. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions were not reported. On 24-APR-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected due to lack of contact details.
In 2017, at 83, my dad was diagnosed with Guillain-Barre.  By the time he was diagnosed he had lost all use of his legs.  After 2.5 months of physical therapy he walked out of the skilled nursing facility.  He continued an active life involved with family, his church and the community.  He received his first Pfizer COVID shot 1/27/2021 and noticed a tingling in his fingers shortly after, but thought nothing of it.  He received his second Pfizer COVID shot 2/17/2021 and began to notice a marked weakness in his legs.  This was reported to Dr., who began diagnostics.  He was diagnosed with Chronic inflammatory demyelinating polyneuropathy (CIPD) and IVIG
5/4 - increased upper arm swelling at injection site. 5/5 - increased upper arm swelling/redness/warmth/tingling right hand. 5/6 - increased pain, tingling/numbness both hands right  greater than left. 5/8 - improving symptoms. Seen in office - normal exam, minimal swelling noted right deltoid. Normal cervical xray.
hot & cold flashes, perspiration, nausea, neck ache, h/a, fever (actual temp not recorded @ time of report);
Information has been received from a 75 year old male with an aspirin allergy and adverse drug reaction to blood thinners who on 26-NOV-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  Concomitant drug therapy included a small dose of losartan potassium (MSD), COUMADIN, FLOMAX, vitamin D (unspecified), calcium (unspecified) and supplements.  On 30-NOV-2007 the patient was diagnosed with shingles.  The patient sought unspecified medical attention.  Lab diagnostic studies included a skin test.  The patient was not recovered at the time of this report.  There was no product quality complaint.  Additional information has been requested.
Soreness at injection site the next day, mild chills,, very sore lymph node in underarm, same side as injection
My cycle, which is consistent between 26-28 days, is now running into day 36. I have had PMS symptoms which are usually highly specific to me starting my period the next day on three separate occasions, with no cycle start. Two pregnancy tests are negative. I have also had period-like cramping.  I wanted to pass along the information that I have not had any stress, change in diet, change in work schedule, sexual activities, or other change in routine or status.
shortness of breath and cough, unclear if related to lung cancer or vaccine related, sent to facility for evaluation, admitted
other zoster related injuries; shingles; Initial information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown gender whose age at the time of report was 82 years old. No information was provided about the pt's medical history, concurrent conditions or concomitant medications. On an unknown date (reported as "on or about 41358"), the pt was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, on unknown dates, the pt was treated by a healthcare provider at a clinic walk-in, and other healthcare providers, for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX): shingles and other zoster related injuries. The outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: flared up of asthma-Medium, Additional Details: Resulted in visit to MD for albuterol inhaler due to more flare ups of asthma symptoms. Also experiencing chest tightness and has received orders for labs for troponin levels to rule out possible myocarditis.
HIVES; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hives was not reported. This report was non-serious.
Noticed lack of speech on 02/14/1999. In March 1999, noticed total loss of speech and eye contact. He began to arm flap and walk with gait. Over next few months "autistic" behaviors increased.
Per emergency room note, mom reported that patient started jerking both arms around 20:50pm and did not seem like herself. She was brought in to the ER via EMS and found to be in status epillepticus. This occured about 10 hours after getting 4 months old vaccines.
developed lichen planus rash over various parts of my body. used topical steroids but still have itching and scarring. rash is itchy and is on back of my hands, ankles, hips, and around breasts
The child accidentally received the first COVID dose , somehow it was not know pan that he was below age 12
20 minutes after receiving the vaccine, my head became flushed, my face turned red and I had a slight headache.  These symptoms lasted about 10 minutes and then went away.  No further reaction at this time.
This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 04-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
Pt recvd 3 doses of Heptavax or Recombivax-HB on 23AUG89, 27SEP89, & 27MAR90; titers were checked OCT90 & MAR91 pt was found to be a non-responder; recvd 1 dose of Engerix-B in APR91; titers were checked 16SEP91 & pt was still neg;
Lots of nasal mucus, constant nose blowing, nose running (no headache, cough, fever or other aches)
Temp of 104 x 24 hrs developed 24 hrs after injection. Severe pain at injection site x 4 days.
SEIZURE (PASSED OUT); WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 21-May-2021, the patient got the vaccine and passed out, patient had 2 seizures. patient had not eaten much during day so patient might have been weak.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure (passed out) and weak was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: covid-19 vaccine ad26.cov2.s-seizure (passed out). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Altered mental status and psychosis lasting several days which responded to therapeutic intervention including close psychiatry evaluation, PCP follow-up, and neurology consultation with medications including anti-psychotics (olanzepine 10 mg twice daily) and ramelteon (8 mg once daily at bedtime).
Patient was mistakenly given a 0.25ml dose instead of the indicated 0.5ml dose. Patient returned to the pharmacy the next day and was administered the remaining  dose.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced COVID-19 (tested positive for COVID). At the time of the report, COVID-19 (tested positive for COVID) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by the reporter. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: FU received on 22-Jun-2021 , Contains No New Information
Developed localized reaction on L thigh that spread over the next 24 hours. no fevers. otherwise acting well.
Pt was given 3rd dose 1/7/22, second dose was administered 8/31/21.
Approximately 5 minutes after receiving the Moderna vaccine, dose 2, the patient appeared to lose consciousness. Patient was seated in  chair at the time and was with her sister. The sister held on  to her so that she would not fall over (patient dropped cell phone on floor). About a minute or so later, the patient appeared to be conscious again and was resting in the waiting area of the pharmacy. At first the patient appeared confused and unaware of what was going on. Patient was given a bottle of water and paramedics were called. Paramedics arrived about 10 minutes later, checked all vitals and talked to the patient. Vitals appeared fine and no abnormalities noted. Paramedics then left and the pharmacist interviewed the patient, who by this time was aware and responsive. She indicated that she fainted shortly after receiving the vaccine but felt better after the paramedics left.
Patient started having cellulitis at the site of injection on 05/09/12. It was red & hot and 6 x 3 as described by the patient. Pt was painful as well. Patient seen the doctor on 05/10/12 & was given Cephalexin 500 mg to take tid.  Patient is getting better on 05/11/12.