chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A health care professional reported that a 6 month old female infant received an injection of Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) vaccine and developed a rash. The pt received her third dose on 23Feb04. The pt also received a dose of Tripedia (diphtheria/tetanus toxoid/acellular pertussis) vaccine, IPOL (poliomyelitis inactivated) vaccine and Engerix B (hep B) vaccine on 23Feb04. The reporter indicated that the pt is a well baby, no birth defects. Indication for Prevnar was immunization. Product was administered on 23Feb04. Dose regimen was 1 dose. Concomitant medications were not reported. On 25Feb04, two days post immunization, a female pt developed a rash that started on her legs and progressed to her upper body. Treatment was not provided. No additional information was available at the time of this report. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines.
Reported angioedema 12 days s/p vaccination.  Symptoms have resolved at this time.
R upper arm 9x12 cm area of erythema and induration adjacent to vaccine administration site.
Dose administered past the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered past the 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
trouble sleeping; dizziness; big red ball that hurts on right arm; big red ball that hurts on right arm; big red ball that hurts on right arm; headache; wants to throw up; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm) and VACCINATION SITE PAIN (big red ball that hurts on right arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm), VACCINATION SITE PAIN (big red ball that hurts on right arm), HEADACHE (headache), NAUSEA (wants to throw up), PYREXIA (fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm), VACCINATION SITE PAIN (big red ball that hurts on right arm), HEADACHE (headache), NAUSEA (wants to throw up), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.            This case was linked to MOD-2021-163692 (Patient Link).
Right arm welt, red and itchy presented 8 days after injection with associated arm numbness and stiffness as well as radiating pain into neck
COVID diagnosed with positive test, symptoms (lost taste and smell); This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored pro-gram . A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that on 12Mar2021 the patient got his first Pfizer shot and on 25Mar2021 he was diagnosed with Covid. Stated he is now symptom free and scheduled to go back to work tomorrow. The patient stated that he was tested positive after he got the 1st dose last 12Mar2021 and on the 25th he was tested positive, he lost his taste and smell but now it returned as per caller. He will be having the 2nd dose appointment on 01Apr2021, and he want to know if he can continue to get that since he is totally fine right now. Caller was asking if he is okay to get his next shot on 01Apr2021. Caller stated he had been on hold for 45 minutes and the 1st person he talked to knew what he was calling about and he was doing the right thing and now he can't get an answer. Stated this was straight forward. Caller stated if he was transferred again he will probably be on hold for another hour and he can' do that. States if he doesn't get it, what trouble will he have rescheduling it in a few weeks and can the call handler help him with that. Caller asking if he doesn't get the 2nd shot in 21 days how long he can wait until. Caller states this is very frustrating why the first person transferred him here. Caller states he will call his doctor and abruptly disconnected. Referred caller to his healthcare provider for medical advice. Referred caller to contact his local health department, doctors office or place that he had his dose scheduled for scheduling and availability questions. Investigation Assessment was Not Provided. Outcome of the event was recovered in Mar2021.
When I get up to go to bathroom everything was like going round and round I was very dizzy; I got scared; I don't feel good; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 14Jul2021 11:20 (Batch/Lot number was not reported, at age of 57 years old) as single dose for COVID-19 immunisation. Medical history included high blood pressure and diabetes, patient was a little disabled, she had hard time walking. Concomitant medications included unspecified medications and patient took it every day. On 15Jul2021, when the patient got up to go to bathroom everything was like going round and round she was very dizzy the only time she had no weakness, the patient had no pain nothing else just that very dizzy. The patient just got disabled 4 O' clock in the morning on 15Jul2021. She was fine all day. She didn't get nothing. The patient's blood pressure because she got scared 121/60 on unknown date. The patient didn't feel good to talk. The patient underwent lab tests and procedures which included blood pressure: 121/60 on unknown date. The patient did not receive any treatment for events, she didn't get nothing. The outcome of events was unknown. The patient had not received second dose yet, second one in 04Aug2021.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Redness, swelling, inflammation and slight itchiness. Dr prescribed cephalexin 500 mg 28, one by mouth 4 times daily x 7 days.
Patient with L hip pain 1 day after receiving the vaccine that persisted on day 2 post vaccine. Not improved with rest and heat. Patient had not trialed any medications. Pain on exam with no signs of infection or focal neurologic deficits. Will treat with NSAIDs, muscle relaxer, heat, rest. Outcome not assessed at this time
On 3-10-08 the mother returned with the child for additional immunization. She stated the child had inconsolable crying, lasting 12 hours, following the 1-7-08 immunization. No medical attention sought for this reaction no residual effect
I started having some bleeding; cramping day 2 post injection; I am 5 months pregnant and received the Moderna booster; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HAEMORRHAGE (I started having some bleeding) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 02-Dec-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am 5 months pregnant and received the Moderna booster). On 04-Dec-2021, the patient experienced HAEMORRHAGE (I started having some bleeding) (seriousness criterion medically significant) and MUSCLE SPASMS (cramping day 2 post injection). On 02-Dec-2021, MATERNAL EXPOSURE DURING PREGNANCY (I am 5 months pregnant and received the Moderna booster) had resolved. At the time of the report, HAEMORRHAGE (I started having some bleeding) and MUSCLE SPASMS (cramping day 2 post injection) outcome was unknown. Not Provided          No Concomitant medication were reported.  No Treatment information was reported.; Sender's Comments: This case concerns a female patient with no relevant medical history, who experienced the unexpected event of Hemorrhage. The event occurred approximately 3 days after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient called and stated she had numbness from her right ear to her mouth along with numbness of her right tongue. She also stated she was starting to feel tingling in her right side extremities.
apr90 pt vax hepta B. 7 days aft vax pt devel alopecia.  may90 pt vax 2nd hepta B. alopecia worsened to near baldness.  concombinant med included provera and synthroid.
Extreme body aches causing difficulty arising from bed Thursday morning. Very bad headache, similar to migraine which Tylenol helped with later in the day. Very low energy all day Thursday, the day after the vaccination. By Friday morning I felt much better and the symptoms were mainly gone except for a few sharp pains (not constant) in the head during the day. No treatment except the Tylenol and rest.
Patient tolerated well no adverse reaction, dose was given after vial had been in fridge longer than 30 days.
Complained of shoulder pain and loss of range of motion upon vaccination.  The patient ultimately went to an urgent care center and received a steroid injection.  The pain temporarily subsided but returned after the steroid injection worn off.  The patient then went to her primary care provider who ultimately ordered an MRI.
Body aches, chills, nausea and cramping.  Injection site soreness. No fever
Peds Pfizer administered during off site clinic  instead of Pfizer due to age level.
A localized reaction with erythema and tenderness in the arm; A localized reaction with erythema and tenderness in the arm; This spontaneous case was received on 11-Dec-2020 via agency (reference number: SEQW20-05717), reported by a physician and concerned a 39-year-old, female patient.  The patient's relevant medical history and concomitant medications were not reported.  On 08-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847 and expiry date was 30-Jun-2021.  On an unreported date in 2020, after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. The patient did not receive any treatment.  On an unreported date in 2020, within 48h to 72h, the patient recovered from the events.  The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202007626, 202007628 and 202007631 due to the same reporter.  Company comment: A 39-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.; Sender's Comments: A 39-year-old patient was administered Flucelvax Quadrivalent. An unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed a localized reaction with erythema and tenderness in the arm. Causality is assessed as possibly related for both events.
Pt came to ER c/o nausea and vomitting onset prior to arrival.
After I received the booster shot I was okay for the first ten days , after those ten days I woke up on the 30th and I felt like I was spinning so I laid back down as I was unable to get up until about two that afternoon, I was unable to drive . I took off from work for the day and for about two weeks after I was feeling dizzy randomly to the point where walking was a little harder. After the two weeks I was able to drive again . At the begging of January i had an MRI done and a hearing test done. both came back clear get up but i still feel dizzy at times when i get up to fast. If I move my neck to fast I feel dizzy.
Swelling around injection site from shoulder to half was to elbow and half way around arm, erythemic and hot to touch.
Patient with sitting in chair stated she felt like she was gonna pass out and felt warm. Patient was transferred into wheelchair and into the ems Room and put on our stretcherat 0900. Bas lins vs obtain 110/71 hr73 100% rep 18. Skin color pale . After about 10 min. Skin color cane back to normal.  Pt states she felt beter. . Pt was released at09:29
This spontaneous report received from a patient concerned a white, not Hispanic or Latino female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic constipation, and other pre-existing medical conditions included: patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, dose number in series 1, 01 total, administered on 10-MAR-2021 on right arm for prophylactic vaccination. On 13-MAR-2021, initially three days later, the patient experienced strong left thumb pain (dose number in series 1). On an unspecified date, later patient started, right wrist pain could be osteoarthritis, pain continues, burning pain (right arm, wrist and shoulder) and arthritis (dose number in series 1). She went to see her doctor and seeing other doctors as well. The action taken with Covid-19   vaccine ad26.cov2.s was not applicable. The patient had not recovered from strong left thumb pain, right wrist pain could be osteoarthritis, and burning pain (right arm, wrist and shoulder), and the outcome of arthritis was not reported. The patient additionally received Moderna Covid-19 vaccine (form of administration, route of administration not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series 2, administered on 10-NOV-2021 for prophylactic vaccination. No adverse events were reported after vaccination with Moderna vaccine (dose number in series 2). Concomitant medications included MiraLAX (macrogol 3350) for chronic constipation. On 14-MAR-2022, Laboratory data included: Colonoscopy which resulted in chronic constipation. This report was non-serious. Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non-serious.
Sever hives all over stomach, back, legs and arms and face completely swollen. Symptoms still lasting 4 days after shots. BENADRYL works for a few hours then hives get worse.
Pt recvd vax on Wednesday & on Saturday devel fever, achiness, h/a (different than migraine h/a);
a little bit fatigue; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 24Sep2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jan2021, for Covid-19 immunization, reaction(s): "shingles"; Bnt162b2 (DOSE 2, SINGLE), administration date: Feb2021, for COVID-19 immunization, reaction(s): "sore arms". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "a little bit fatigue"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: Caller wanted to get the booster dose as she was 74 years old, but she was informed that only immunocompromised individuals and those who have had a solid organ transplantation are eligible to receive the booster dose. Caller wanted to confirm this and mentioned that her son informed her other people have gotten the booster dose so wanted to know why the guidelines have changed. Caller wanted to also know who else gives out vaccinations. Caller stated that had previously called Pfizer due to having shingles after getting the 1st dose of the Comirnaty vaccine. She wanted to know if there are reports of people who have had this same side effect and she also wanted to know if this was normal. Caller also mentioned that she experienced sore arms after the 2nd dose. She also stated that she got the booster shot, three days ago and was feeling good, a little bit fatigue and sore arm, but she was good now. She further stated that arm was a little sore, but that was it. A contactable female consumer communicated to a Pfizer colleague via phone call that: Phone-Out 12:24 PM: 1st attempt by phone to consumer to obtain follow-up information contained on consumer questionnaire. Consumer did not want to provide mailing address but agree to provide e-mail address instead. She also stated: She got the booster shot, three days ago, feeling good, a little bit fatigue and sore arm, but she was good now. Arm a little sore, but that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Started chilling about 24 hrs. after vaccination.........then low grade fever for about 6 hrs.  Felt very sluggish, no energy, went to bed about 830 pm and slept thru to morning and symptoms were gone.  I took Tylenol 2 times the the afternoon.
02/22/22 presents to ED for "palpitations and persistent nausea". PMHx of "diabetes, CKD, hypertension, obstructive sleep apnea and atrial fibrillation on warfarin"
We had a healthy and normal pregnancy up until this vaccine was administered at 34 weeks. We experienced fetal demise and endured the stillbirth of our son shortly after receiving it. 3lb 2.6oz and 18" long at birth.
Broke out into bumps that were itchy on both his legs; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Broke out into bumps that were itchy on both his legs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRURITUS (Broke out into bumps that were itchy on both his legs). At the time of the report, PRURITUS (Broke out into bumps that were itchy on both his legs) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines reported. Treatment information for events included anti-itch products.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow up received on 22-Jul-2021 and included No new information.
Patient is a 61-year-old female who is self-referred for evaluation of left arm injection site reaction. Patient states she had a hepatitis A vaccination injection in her proximal left upper extremity on 10/8/18. Patient states approximately one week after receiving the injection, she noticed a red spot like a pimple with a Whitehead appear on the proximal left upper extremity near injection site. Patient states the lesion on her proximal left upper extremity continued to grow and busted draining yellow drainage. Patient states it also later drained bloody fluid. States that the lesion on her left upper extremity scabbed over, but seems to have come back. Patient denies fever, chills, sweats. Patient states she has been prescribed ciprofloxacin and minocycline by Dr. Patient also reports getting an influenza vaccination injection in her proximal right upper extremity, but denies any reactions in this arm. Follow up as needed.
Just 1 hour after injection started having her typical reaction to egg products including shortness of breath severe cough - used her rescue inhalers and allergy meds with some relief than on Monday 6-25-07 patient states developed into an upper respiratory infection, did fully resolve.
Presented with SOB, chest pressure, sore throat; Covid+ PTA x4 day; Tx: steroids, lovenox, zinc; O2 2-4 LPM per visit; back to baseline by d/c; remained very weak, went to rehab to continue to recover at d/c