chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, however it could be 73 or 74 years. The patient did not remember the date he received a dose of SHINGRIX. The patient had pain after a dose of SHINGRIX. The first dose felt like a bubble was being injected into his arm and it made his arm painful. The pain resolved after a few days and did not return prior to his 2nd dose. The patient stated that he wanted to personally receive a letter from GlaxoSmithKline (GSK) so he could document his experience after receiving the SHINGRIX vaccine. This case has been linked to the US2018165488, reported by the same reporter.
Reduced right ear hearing from approximately 25% to almost no ability to hear.  Extremely loud tinnitus in right ear starting Aug 17th at 4:30 AM when reduced hearing was observed as well.  Brain fog/forgetful/difficulty word-finding.
Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2012 the patient was inoculated with ZOSTAVAX vaccine at a VA health center for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015 the patient was treated at a hospital for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
COVID 19 (Drug ineffective); COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 66 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing). No known allergies reported. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown", described as "COVID 19 (Drug ineffective)". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient was treated with nirmatrelvir, ritonavir (PAXLOVID), from 04Oct2023 to 08Oct2023.
Shoulder and arm somewhat immobile after almost 3 weeks; left arm very sore; Dose number=3; Difficult doing anything requiring reaching; top of shoulder was felt like bursitis; This is a spontaneous report from a contactable consumer (patient). A 86-Year-old female patient received third dose (booster) of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: FF2589 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 27Sep2021 at 15:00 PM (age at vaccination: 86 years), as dose 3 (booster), single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included cholesterol and blood pressure. Concomitant medications were not reported. Past drug included Keflex and had Known allergies: Keflex. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9809 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 04Feb2021 at 15:00 PM (age at vaccination: 85 years), as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VAC-CINE, Solution for injection, lot number: EN6203 and expiry date was not re-ported), via an unspecified route of administration, in Arm Left, on 24Feb2021 at 14:00 PM (age at vaccination: 85 years), as dose 2, single dose for COVID-19 immunization and had no reaction on previous exposure to vaccine for both dose. Concomitant medications included ongoing atenolol for blood pressure, pravastatin sodium (PRAVACOL), ongoing losartan for blood pressure, and on-going atorvastatin for cholesterol. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 27Sep2021 at 15:00 PM, the patient received dose number=3 (booster). On 27-SEP-2021 18:00, the patient experienced shoulder and arm somewhat immobile after almost 3 weeks. took Ibupropen regularly. No fever. Just continued soreness and limited mobility. After Booster, left arm very sore in 3 hours. (No problems with first two) The injection spot itself was not sore - top of shoulder was felt like bursitis. Could reach around back. Difficult doing anything requiring reaching Comfort with ibuprofen on an unspecified date in 2021. Soreness and lack of mobiling lasted over 3 weeks. Her guess was that needle hit bursa sac. Device Date was 16Oct2021. Outcome of the events shoulder and arm somewhat immobile after almost 3 weeks and left arm very sore was recovered on an unspecified date in 2021 and for all other events, it was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
A healthcare professional reported that a 52 year old female received an injection of Flu Shield '00-'01 on 11/29/00 and subsequently, experienced tingling in her legs and nausea. This is 1 of 2 pts from this facility who experienced this event following receipt of Flu Shield lot 4008185.
pt recvd vax & shortly p/vax c/o chest pain,SOB,nose became congested & started w/cough;given DPH;blotchy rash started to appear;Adrenalin & DPH given;pt d/c home 1130AM-no further chest pain or SOB-occasional cough
received first dose of Pfizer BioNTech Covid 19 vaccine on 11Mar2021 and developed sciatic nerve pain; 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 (159558). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "sciatic nerve pain" (unspecified if ongoing), notes: She has had issues with this before. The patient's concomitant medications were not reported. The following information was reported: SCIATICA (non-serious), outcome "unknown", described as "received first dose of Pfizer BioNTech Covid 19 vaccine on 11Mar2021 and developed sciatic nerve pain". Therapeutic measures were taken as a result of sciatica.  Additional Information: Verbatim and event description: caller had first shot and is due for 2nd shot. After 1st shot had sciatic nerve problems and was prescribed 20mg prednisone. Is wondering if she can go ahead with 2 shot of vaccine. Relayed number and transferred to PMI, (private) took call. Advised will also Fax AE due to long hold times. CEP (withheld). Were any unaddressed medical questions referred or forwarded to Medical Information, No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received first dose of pfizer vaccine, after about 5 minutes she came to the consult window saying she felt dizzy and asked if she could sit down. We asked her to sit down and grabbed her a water and asked what she was feeling. She stated at that time she had a history of fainting with vaccines, but did not state that on her questionnaire or before getting the vaccine. I could tell patient was about to lose consciousness, and she fainted. She gained consciousness after a minute and we gave her a banana, chocolate and some water as she stated she had not had anything to eat today. I began to check her vitals, her BP was 108/76. EMS was called and patient was evaluated by them and never returned.
patient experiences labored breathing with 17 medications and also experienced labored breathing with first covid vaccine. patient and patients PCP agreed patient should get second dose as labored breathing occurs for a short period and patient recovers, her mortality risk is greater than the adverse event. patient was treated by paramedics immediately onsite and recovered well
pt brought to ED with increasing SOB, cough, fever, headache; EMS states pt's O2 saturation between 68-80% in route; positive COVID test; admitted with AHRD secondary to COVID; O2 supplementation; DNI; given dexamethasone; worsening hypoxia; family transitioned pt to comfort care; pt expired in the hospital
I experienced bleeding on arm where shot was given. After 30 minutes I was very thirsty, I was dizzy and lightheaded. I was very hot and weak, unable to stand. It was difficult to breathe. I was able to gain some strength after drink water in about 30 minutes. But I was till tired. 3 days later on Wednesday at 3am I experienced sharp pain in my wrist. My heart was beating fast, I had nausea and diarrhea. My throat was swollen and it was difficult to breathe. For more than 3 weeks I could not sleep because of pain in feet, legs, goin, back, and head. I could not sit or stand for long periods of time. I experienced aches in my joints, back, knees, fingers, and toes. I was unable to perform normal activities.
The site of the injection is swollen still after 23 days; This is a spontaneous report received from a contactable consumer (patient reported herself). A 50-year-old non-pregnant female patient received first dose of BNT162B2 (COVID-19, Pfizer, Formulation: Solution for injection, Batch/Lot number: EN6203) via an unspecified route of administration to her left arm on 02Mar2021 04:45 PM at single dose for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient's medical history and concomitant medications were not reported. The patient was allergic to sulfa drugs. On 02Mar2021 05:00 PM, the site of the injection was swollen still after 23 days. The patient did not receive any treatment in response to the event. Outcome of the event was recovering. Vaccine facility information, ethnicity information and race information were available.  Information on the lot/batch number has been requested.
Left arm started itch on Day 7 - 2/17 night,  Skin rash 3 x 2 inch with lump on Day 8 - 2/18,  Rash area bigger on Day 9 - 2/19: 3 x 3 inch, but no itch, discomfort decreased.
severe chills not able to feel legs not able to ambulate at baseline unable to see symptoms lasted 3 days
Diffuse pruritic, erythematous, papular rash involving face/trunk/extremities/palms/soles.  Rash began 25 Sep (9 days after vaccination).  Symptoms preceded 2 days earlier by "flu-like" symptoms with nasal congestion, cough, headache, myalgias.  Prescribed prednisone, loratadine, hydroxyzine, and ranitidine today.
Delayed onset of menstrual cycle - normally like clockwork, 4 days late this month (was due to occur 12/2/2021, did not occur until 12/6/2021)
Patient stated feeling dizzy after getting vaccination. than patient felt hot and ice pack and fan stated. Patient BP taken 104/68, 55 Pulse, 20 R at 10:08 am. Shortly afterwards patient black out and  Nurse to get safely guide patient to floor, raised feet on chair and secured head up and continue to supply ice pack and fanning. Patient  stated seizure activity and Nurse administered Epi injection to control seizure that last only 30-45 seconds and stop. BP taken after seizure and EPI  injection 171/93, 65 pulse, 20 R, 98% sat.  Patient stated talking and color stated coming back and 911 was called and patient remain on floor talking as we fan continue ice packs on him. Pulse ox 98%, R 18 and
Within 20 minutes face, neck and head became warm and began throbbing and continues at 60 min. Headache began within 10 minutes of other symptoms.  Eyes became dry and continue dry at 60 minutes, sclera red on examination by RN.  Otherwise patient feels normal.
The day after I received my shot I felt light headed and fatigued and didn't think anything of it until I took my heart rate and my heart rate was between 115-126 for an hour straight and then was up and down all day not dropping below 80 most of the day and the next. I have a normal resting heart rate of 60 and average daily heart rate in the 70's.
itchy rash from injection site to below the site; dark red itchy rash from injection site to below the site; dark red rash from injection site to below the site; arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore), VACCINATION SITE PRURITUS (itchy rash from injection site to below the site), VACCINATION SITE RASH (dark red itchy rash from injection site to below the site) and VACCINATION SITE ERYTHEMA (dark red rash from injection site to below the site) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 10-Apr-2021, the patient experienced VACCINATION SITE RASH (dark red itchy rash from injection site to below the site) and VACCINATION SITE ERYTHEMA (dark red rash from injection site to below the site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itchy rash from injection site to below the site). On 06-Apr-2021, PAIN IN EXTREMITY (arm was a little sore) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchy rash from injection site to below the site), VACCINATION SITE RASH (dark red itchy rash from injection site to below the site) and VACCINATION SITE ERYTHEMA (dark red rash from injection site to below the site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was unknown. Treatment Benadryl and BioCatalase liposomal gluten free cream.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Outcome information
This case was reported by a physician and described the occurrence of adverse reaction in a 12-week-old female subject who was vaccinated with ROTARIX (GlaxoSmithKline). Concurrent vaccinations included HIB (manufacturer unspecified, unknown route, injection site and batch number), DTaP+HIB+IPV (GlaxoSmithKline, unknown route, injection site and batch number) and PREVNAR 13 (Non-GSK manufacturer, unknown route, injection site and batch number), all given on 16 August 2014. On 16 August 2014, the subject received erroneously 1st dose of ROTARIX via intramuscularly that led to inappropriate route of vaccination. At the time of reporting, the outcome of the event was unspecified. Follow-up information received on 05 February 2015: No new information. Follow-up can  e done with the nurse if needed.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-MAY-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot #, route of administration and dose were not reported). No adverse effects were reported. This is one of 3 reports received from the same reporter. Additional information has been requested.
I was diagnosed with re-activated epstein barr virus on 06.15.21 I woke up with a swollen lymph node.  It is still current today, 07.08.21.
Hospitalization for COVID pneumonia; hypoxemia. Treated with dexamethasone 6 mg IV daily; Remdesivir for 5 days.
My mom received the Pfizer Covid 19 vaccine on 1/4/21.  On 1/12/21  I received a call from the nursing home that my mom had stopped eating and drinking and that she had nothing to eat or drink for 3 days. I asked them why they didn't call me sooner but they did not have an answer. I was told to come in because she was very lethargic and possible dehydrated.  They tested her for Covid the morning of 1/12/21 and she tested negative.  I went into see my mom and she was barely conscious.  They gave her fluids intravenously but it had no positive affect on her condition.  On 1/14/21 she tested positive for covid and was moved to their covid unit.  I called in Hospice comfort care on 1/15/21.  My. mom died on 1/17/21.
Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 05Mar2021 at 15:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included Bp (blood pressure abnormal). 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 vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and Vyvase (MANUFACTURER UNKNOWN) from an unknown date for unspecified indication and unknown if ongoing. On 12Mar2021 at 06:00 the patient experienced vertigo. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of vertigo and included treatment with meclizine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vertigo was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Doses administered too early, before 16th birthday Menactra  will have to be repeated near high school graduation to extend through college years.
Transferred on 11/29 from urgent care clinic with diagnosis of pneumonia where he was given nevulizer treatmenst and supplemental O2.  Tested for pneumonia, negative and COVID -19, positive. Worsening oxygen requirements. Transferred to ICU on 12/11 on 100% FiO2 on Vapotherm. Completed courses of remdesviri and dexamthesone. Continued requirement of high amounts of oxygen.  ICU team, family and pallative care agreed to transition to DNR/DNI on 12/28.
Fever 101.6, then 5/22/2014 rash all over tummy and back and face. Little red bumps everywhere. Probably over 100. Still has rash and now worse 5/23/2014.
Lower back pain; Rash on arm for 2-3 days and it went away; A spontaneous report was received from a consumer concerning a 29-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash on arm for 2-3 days and it went away, rash is back and getting bigger, and lower back pain.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 011L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced the events rash on arm for 2-3 days and it went away. rash is back and getting bigger, and lower back pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of event, rash on arm for 2-3 days and it went away was recovered. The outcome of the events rash is back and getting bigger and lower back pain were unknown.; Reporter's Comments: Based on the current available information which shows a  temporal association between the use of the product and the start date of the reported event, a causal relationship with the event cannot be excluded.
On 25JAN92 rash appeared "above breast bone approx 2in diameter; Is beginning to go up lt side of neck, today 31JAN92;
No adverse effects reported for the patient; one dose of an improperly stored vaccine was administered to one patient; Information has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's concurrent condition, historical condition and concomitant medication were not provided.  On 13-AUG-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (one dose; lot number R021075; expiration date 10-JUN-2021;  route unknown) for prophylaxis (Product storage error). No adverse effect was reported. Temperature was 54.8 Fahrenheit. Time frame was 3 hours and 30 minutes. Previous temperature excursion was 56 Fahrenheit for 45 minutes. The call was because of a data logger.
On 09/05/2013 patient called our Employee Health office and notified us of a potential adverse vaccine reaction. She previously received a Tdap injection on 07/31/2013 during her pre-employment health screening. Referred her to Work Comp MD for evaluation.
sore injection site arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Heart disorder (Heart problems), Type 2 diabetes mellitus (Type 2 Diabetes) and Kidney disorder (Kidney problems).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.            No concomitant medications were reported.  After receiving both the first and second doses of Moderna vaccine, the patient experienced sore injection site arm.  No treatment medications were reported.   This case was linked to MOD-2022-675037 (Patient Link).
Fever 105, Chills, Nausea, Vomiting, Headache, Bodyaches,