chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 25-MAR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001836: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001841: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
ache in my shoulder that goes down my arm; ache in my shoulder that goes down my arm; can't lift my arm past my shoulder; wiped out/very tired; like have no energy; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration on 27Feb2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced ache in my shoulder that goes down my arm, can't lift my arm past my shoulder, wiped out/very tired and like have no energy on 01Mar2021. It was asked long will these side effects last. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received covid-19 treatment with Anti-viral Product Paxlovid from 08Jan2023 till 22Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Skin rash, hives - note patient not allergic to eggs, Thimerosal, gelatin, Neomycin, or Gentamycin.
An 11 year old patient arrived with 3 other family members to receive vaccines at a flu/covid clinic. The 11y.o. patient was administered a Pfizer-BioNTech COVID-19 bivalent booster vaccine that has an EUA for use in individuals 12 years of age and older. Upon notification, the mother indicated they didn't believe it to be a significant issue and that the patient would be turning 12 in less than 5 months. During follow-up with the family, the patient's mother noted the patient had experienced a sore arm and mild chills which were consistent with the side effects she experienced after her primary covid vaccine series. Of note, the 11 y.o. patient also received fluarix in the same arm separated by at least 1 inch that day. Patient's reported weight on the consent form is 160lbs. Patient's physician office was notified during business hours the morning after administration of the vaccine after physician contact information was obtained. Physician and nurse were unavailable so a message was left with staff at the office.
Mom called 3/2/11, small streaks of blood in diaper 3 separate episodes during same day. No other apparent symptoms/distress, febrile. Mom monitoring 3/2-3/3/11. Spoke to mother, follow-up 3-3-11. She saw a miniscule amount of blood in stool otherwise fine mom will monitor/call if sees any symptoms.
Patient developed swelling in her left axilla on day5 after vaccination.  Likely lymphadenitis after vaccination.  Treatment included ice to affected area and meloxicam.
Large red, itchy welts body rash.  Started on right thigh traveling to right side of trunk, then left side of trunk, chest, left groin/thigh area.  Welts continued to grow in size and itch grew in intensity from day 20 post vaccine to current.  Rash and itching calmed down during the 6 days on steroids and itching returned on the first day off of steroids.
Pt was vaccinated 11/28/16/ Began having reaction 11/30/16. Site of injection became red/raised, warm to touch, itchy and painful. The site (left deltoid) was large and pain tenderness lingered.
it was rpt p/ pt recv vax pt broke out w/full-blown chickenpox
Received vaccine at 12 pm. Began getting chilled about 4 hrs later. Felt like my throat had a lump in it and started coughing. Became more chilled and very tired. Went into bed at 5 pm unable to get warm - temp. climbed to 101.2 degrees F. Slept until 8 am waking on and off. Temp. normal in morning, felt fine thereafter.
2? diameter redness/swelling, soreness, some itching, resolved after 2 days
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12Feb2022 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 40th of 43 adult patients described by the reporter.   This case was linked to MODERNATX, INC.-MOD-2022-689222 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-689222:Master Case
wheezing, rash, rhinorhea, cough rx albuterol, pred, DPH;
The shingles vaccine injection site was firm and felt like a penny-sized lump. The arm was red, swollen, itchy, and very warm to the touch. I called the doctor's office on 1/20/13 and the nurse said to take Benadryl and Tylenol; if not better, make appt. for 1/20/13. I saw physician on 1/20 and she prescribed cephalexin 500 mg. She advised I make additional appt. for 1/22 or 1/23. I saw Dr. U (same office) on 1/23. My arm was still red and itchy, but no longer warm or swollen. Dr. told me to discontinue cephalexin prescription. Dr. could not find any reason for my adverse reaction.
My son experienced swelling of the lymph nodes in the his clavicular region. As of today, we just made note of the swelling and are observing since this seems to be a known side effect. We have not made a doctor visit, but if problem persists we will.
Pfizer 3/22 and 4/12. Positive on 9/2 admitted on 9/4 to current
accidental overdose is reported in a pt receiving fluogen; pt has a hx of alzheimer's disease; This is 1 of 30 cases reported from this site; no adverse effects noted;
I had a fever that night. Then, I developed an elevated heart rate and shortness of breath. I went to the emergency room and had some test ran, but all test came back normal. They did not prescribe any medications.
This case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced syncope, pain and dizziness. On an unknown date, the outcome of the syncope, pain and dizziness were unknown. It was unknown if the reporter considered the syncope, pain and dizziness to be related to BEXSERO. Additional details were provided as follows: The sales representative heard from the physician that she had at least two patients with the same side effects with BEXSERO. Additional details were provided as follows: The sales representative heard from the physician that she had at least two patients with the same side effects with BEXSERO. The representative did not have further details. This case had been linked with UG2017023508, reported by the same reporter. The country of occurrence and country of reporter were mistakenly entered as one country, however upon clarification it was confirmed to be another country.
approx. 10 minutes after receiving the vaccine client c/o dizziness and light headedness. a few minutes later started c/o headache and neck stiffening, left side weakness. NP said her left pupil was not responding the same as the right one. Benadryl 50mg Im given, EMSA called and client was transported to hospital.
DTaP and IPV, Prevnar (3rd dose each) given 10/01/2001. Child had febrile seizure 10/02/2001, followed by 2nd nonfebrile seizure 10/03/2001. Both seizures were tonic () less than two minutes. Has also had two episodes of nonfebrile staring (1-2 minutes).
About one minute after the woman sat down from getting her COVID shot she told our cashier she was feeling ill and was going to the bathroom.  I went in the bathroom and found her sitting on the floor with her head between her legs.  She said she started feeling ill and hot and sweaty.  Her palms were sweaty as well.  She was dizzy and she was starting to black out and then got tunnel vision.  I tried twice to take her blood pressure and could not get a reading from the machine.  We got her a glass of water that she wanted.  She said she did not eat that morning.  During our conversation she started feeling worse and laid down.  She felt that 911 did not need to be called.  After a few minutes she started feeling better and was able to stand.  She said she has previously passed out after getting a shot.  She  answered no on the questionairre and to the direct question of have you ever fainted afer getting a vaccine before the shot.  She went back out to sit in the waiting room for 15 more minutes.  Before she left she came to me and said she felt better.  We went to the HIGI machine to get her BP.  It was 116/79
Swollen arm from elbow to shoulder, unable to lift arm. Informed to ice arm and use BENADRYL.
This spontaneous report as received from a healthcare worker, concerning a patient of unknown age and gender. On 28-JUL-2017, the patient was vaccinated with VARIVAX lot # M033214 for prophylaxis instead of the intended dose of ZOSTAVAX no adverse effects were reported.
My symptom have been started on May 23, 2021. May 23, I saw 5 blue and brown spots on my both. 3-4 more came within 2 days. Those were disappeared after weeks. Couple of days my legs were clear. Again those come. This happened to me for 2 months.   My chronic problem has been started on first week of June. On June 4th while I was sleeping. I feel really hot. could not use light blanket or anything. I decreased my room temperature and still felt hot. In the  morning , I found my whole body was puffy. Hands and feet, and face were puffy and shiny. I was hot. I took cold shower and my body got normal. But I started to cook or did any activities I got hot. After couple of days I found out I could not sweat when my body became hot. I did not sweat till August 15. At that time my town got rain. Temperature were 75 F and I went to park for walk, that day I sweated first time after the vaccine. Above 90 F, I could not sweat. My body swollen and I feel dizzy. Even inside home I feel hot , If I do lighter activities: like cooking or other activities.   I still have this problem. My an trying too see endocrinologist. I report this to my PCP on June 16th 2021. I really help. I am using cooling device to sleep.   In hot temperature, I do not sweat instead my body gets swollen.  Need Help
States adverse event started approximately equal to 24 hours after receiving vaccine. Localized reaction at site of injection. Presently has a reddened circular area approximately equal to 2" diameter - area warm to touch and she comp. of the site being itchy. States she took BENADRYL with little to no effect. Now on ABX. from PCP.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that, on an unknown dates, an unspecified number of patients were vaccinated with improperly stored doses of PEDVAXHIB (lot numbers, expiration dates doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Admin PREVNAR (9/21) on Wed (9/23) admitted to hospital with high fever, chills, weakness, decreased appetite, then after rash, soreness, redness followed.
After injection, He became pale, started to slump forward and was nonresponsive. While being assisted to geri chair became rigid from shoulders to feet. Episode lasted 5-10 seconds. 911 called at 2:40 PM. Feet elevated, cool compress applied to forehead, B/P 108/54 P-63. At 2:44 remains pale, but more alert. At 2:45 B/P 94/57 P71 Remains in chair. At 2:46 PM Paramedics arrived. Report given. Patient complaint of being cold and shivering. Not diaphoretic, remains pale and subdued in mannerisms. Paramedics had patient ambulate to stretcher. Patient gestered with finger making circles indicating he was dizzy. At 2:51 PM transported to Hospital by ambulance.
Patient's left arm became red and swollen approximately softball diameter size.  Also, patient had mood swing (became irritable and is still showing signs almost a week later).
I woke up with a violent headache, which over the day into the next day, spread that pain to my neck shoulders and arms. The headache continues with powerful pain which is unresponsive to treatment with a combination of arthritis strength Tylenol and 1 adult aspirin. I feel weak and not well. I was perfectly healthy and not a "headache person" prior to the immunization.
Pink, swollen approx 6cm diameter non tender 1-2 days after DTaP and IPV injection . Reactive lesion right deltoid area.
COVID-19 symptoms started 06/20/22; tested positive on 06/21/22. I contacted Doctor and she prescribed Paxlovid so I took a 5 day course of that. Symptoms were sore throat, cough, body aches, fatigue, and after starting Paxlovid symptoms got better and I was pretty much symptom free 5-6 days later but I still continued to test positive for 2 weeks and finally tested negative with antigen and pcr.
PATIENT WAS GIVEN PFIZER FOR AGES 5-11 YEARS.  PATIENT ARE 12 YEARS OLD, PATIENT DECLINE ANY SYMTOMS OR REACTION AT THE TIME.
lethargy; problems with vision; visual vertigo; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE: 1), for Covid-19 immunization; Bnt162b2 (DOSE: 2), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: LETHARGY (non-serious), outcome "unknown"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "problems with vision"; VERTIGO (non-serious), outcome "unknown", described as "visual vertigo"; DIZZINESS (non-serious), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ischemic colitis; sore throat; constant headaches; ears hurt; dizzy; generally not feeling well; This is a spontaneous report from a contactable healthcare professional (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 65-year-old, via an unspecified route of administration, administered in left arm on 04Feb2021 (Lot Number: EL3246) as single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included the patient having known allergies (unspecified). Concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EL0140) at the age of 65-year-old, via an unspecified route of administration at the left arm on 14Jan2021 at 04:00 PM for Covid-19 immunization. On 01Mar2021, the patient experienced ischemic colitis, constant headaches, ears hurt, dizzy, generally not feeling well, and sore throat. The patient was hospitalized on an unspecified date due to the events for 5 days. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of ischemic colitis, which may  likely represent intercurrent medical condition.   Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the other reported events  due to temporal relationship   There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
PC to Kathy Maloney to obtain box 7 info; Reporter states does not have any further into; only know rxn occurred & required hospitalization;
On 9/29 I started feeling really sick. On 9/30 I felt like there was fire in my chest. I went to test for COVID-19 at a mobile station which was positive. My husband had me call my doctor and she prescribed me PAXLOIVD. I was better within a few days. However, my asthma has been worse since then. I am going to a hospital to work with long haul COVID-10 care to see if any damage was done to my lungs. I now use a FLOVENT inhaler, ipratropium bromide, and AYR gel regularly.
Spoke with mother, said: "child's right leg looks black, swollen, and child is fussy". Child was seen 9/20/10, leg looked swollen and bruised, child was fussy. Mother stated child had not had BM for couple of days. Seen 9/21/10, mother stated child seemed better and leg was a little bruise, more concern about child not passing BM. Did not observe black color on leg.