chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship.  There is very limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  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.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 02-NOV-2015 the patient was vaccinated with ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Bright red patch about 2x3 inches that lasted about 2 weeks. Skin then turned more pink and seems to be clearing jup about 3 weeks later.
I woke up that morning of 03/24/2021 I did not know where I was. My husband called the ambulance, when admitted I was diagnosed with septic shock, temp was 106, O2 was low, and bp was low. I was in the hospital for 6 days.
Patient was injected with 4th dose of Pfizer on 9/20/22, patient admitted 2 months later on 12/26/2022 with severe headache for days.  Head CT identified R PICA aneurysm rupture.  Patient intubated and EVD drain placed.
Patient felt feverish, chills, weakness, nausea/vomiting and aches and pains same day and night after receiving vaccine. Felt a little better 1 day following, but still very weak, chills, feverish, etc. On the second day after the vaccine she went to the ER and was found to be dehydrated and received fluids and was sent home. She followed up with her PCP the following day. On day 3 following the vaccine she is feeling better but still weak.
Fatigue, migraine headaches, dry cough, numbness and tingling in both arms, more severe in left arm
Breakthrough case admission after 3 vaccines Pfizer 4/1/21 Lot# EP7534;  Pfizer 4/22/211 Lot# Ew0153;  Pfixer 9/28/21 Lot# FC3183
Day after received vaccine right, red, hot to touch, swollen, painful. 08/18/2005 seen in office, treated with Augmentin.
11Sept95 Pt recv 1 dose vax. 2 wk prior to vax Pt exposed to wild type. 12Jan98 Pt exp breakthrough case of varicella "w/40 vesicular & scabbing lesions on trunk & legs". No fever.
Information has been received from a medical assistant concerning a 23 year old female who on 15-APR-2008 was vaccinated with a first dose of GARDASIL (lot # not reported). The medical assistant reported "that same evening the client called the doctor office mail stating she had a fever of 100F, nausea and vomiting." Additional information has been requested.
Possible pneumonia; Kidney stone; A spontaneous report was received from a consumer concerning a 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced kidney stone and possible pneumonia.  The patient's medical history included coronary artery disease, prostate cancer and skin disease - itching and eczema. No relevant concomitant medications were reported.  On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient developed kidney stone and was hospitalized on 19 Feb 2021. Patient's status of kidney stone was unknown. On an unspecified date, the patient experienced pneumonia. Second vaccine date was outside dosing interval.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events kidney stone and pneumonia was not reported.  The outcome of the events kidney stone and pneumonia was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Progress Notes   Family Medicine     COVID VACCINE CLINIC, 3/3/2021    Patient:     Patient a 66 y.o. female who was seen at a COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness.  She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality  and rapid progression of symptoms.    Past Medical History: Diagnosis Date ? Depression   ? GERD (gastroesophageal reflux disease)   ? Hyperlipidemia   ? Hypertension   ? Obstructive sleep apnea (adult) (pediatric)   ? Osteoarthritis     She does have a way to monitor her blood pressure. She last ate around 9:30 am    ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, malaise/fatigue, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, abdominal pain, dizziness and headaches       Previous Reactions: none    Objective    Vitals Vitals:   03/03/21 1315 03/03/21 1326 03/03/21 1340 BP: (!) 167/81 (!) 167/81 (!) 163/63 Pulse: (!) 103 (!) 103 80 Resp: 18 18 16 SpO2: 100% 100% 100%        Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is well-developed. She is not ill-appearing, toxic-appearing or diaphoretic.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait abnormal (has her own wheelchair that she uses for long distances. ).  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) HTN   Overall well appearing, not in distress. Pt observed in the bay for approx 25 minutes.  Bp slowly improving. She is here with husband who will take her home. She feels better after water and snacks. Pt encouraged to monitor her bp at home. Follow up with pcp if continues to be elevated.  Pt and husband voices understanding and denies any other questions or concerns.       Electronically Signed 3/3/2021 1:27 PM
Persistent muscle twitching mostly in legs (calf/thigh) and arms (bicep/tricep/shoulders), but can appear all over (abdomen, back to lesser extent) except for face/neck area; This is a spontaneous report received from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 40-year-old male patient received bnt162b2 (BNT162B2) on 18May2021 as dose 2, single (Lot number: EW0187), at the age of 39 years, in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EW0167; Anatomical site: Right arm), administration date: 17Apr2021, when the patient was 39 years old, for COVID-19 immunisation.  The following information was reported: MUSCLE TWITCHING (non-serious) with onset 06Dec2021, outcome "not recovered", described as "Persistent muscle twitching mostly in legs (calf/thigh) and arms (bicep/tricep/shoulders), but can appear all over (abdomen, back to lesser extent) except for face/neck area". The event " Persistent muscle twitching mostly in legs (calf/thigh) and arms (bicep/tricep/shoulders), but can appear all over (abdomen, back to lesser extent) except for face/neck area" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle twitching.  Additional Information: 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. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Hard knot and red streaks at injection site. 3 inches from injection site 2 puss filled bumps.
11/3/03 client and her mom presented to the health dept with concern. I noted small red whole type area right arm, measured 2 x 1/2, warm to touch but not inflamed. Client denied pain and discomfort, just itchy. Mom stated she did give Motrin for the first day after immunization was given, did give Benadryl last night.
nosebleed; This is a spontaneous report from a non-contactable consumer reporting for their husband via the medical information team. An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date (Tuesday afternoon) at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. A consumer reported that their husband received the first dose of vaccine on Tuesday afternoon of unspecified date.  He developed a nosebleed on 21Jan2021 at 0230. Outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Clients spouse, called to report adverse event.  She reported that Medical Center directed her to call and make a report.  Her spouse experienced a stoke 3 days following booster vaccination.  Is currently hospitalized at Medical Center.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-APR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T025507, expiration date: 23-JAN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
covid vaccine breakthrough case  dose 1 Moderna 3/4/21 030A21A
A report has been received from a Health Professional concerning several children. This case belongs to one of them. Patient is a 10 year old. Female subject, who had been receiving FLUMIST (Intranasal). FLUMIST started on an unknown date. The patient experienced sneezing and it was reported that patient had been having sneezing fits after receiving FLUMIST which started on 14-Sep-2013. The outcome of the event of sneezing and sneezing after receiving the FMQ dose is unknown. The report was considered to be non-serious event of sneezing by the reporter and sneezing after receiving the FMQ dose by the company physician.
mom reports felt bad, sore arm soon p/vax-did not have appetite rested most of day-woke at 2AM 3OCT97 w/wheals type rash face-torso exp w/itching;n/v soon p/then diarrhea;DPh w/relief but was pale;
Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with GARDASIL 9 (lot # L043213, expiry date 28-AUG-2017) that was improperly stored. No adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient is a 56-year-old male with history of partial colectomy with a colostomy bag, Hypertension and a recent right humeral fracture presented to the emergency department via EMS for feeling dizzy and having a syncopal episode at home.  Patient states over the past approximately 1 week he has not felt well, he feels like he is fighting a cold and yesterday he developed nausea and vomiting and states he had multiple bouts of vomiting yesterday.  He denies abdominal pain, denies diarrhea and he has been having normal bowel movements into his colostomy bag.  Today when he was in the kitchen he felt dizzy and then had a syncopal episode causing an abrasion to the top of his head.  He does not take blood thinners.  He states he felt he was out for maybe a minute or 2 and then he stood up and called for his friend who called 911.  He denies any associated chest pain, shortness of breath, palpitations or headache prior to the episode, however he does state he felt dizzy.  Upon arrival he denies a headache or neck pain or any other injuries aside from the abrasion.  He is in a sling for A known right humeral fracture. Associated Symptoms: dizziness, fall, fatigue, nausea, URI symptoms, vomiting
Approximately 1 month after my 4th dose vaccination I contracted COVID-19 and had the following symptoms: Cough, Muscle Aches, Headache, Light Fever. I took Tylenol for treatment and it did help with my symptoms but I also consulted with my Doctor due to my positive test and he prescribed me with Paxlovid for 5 days. I started taking it on 06/29/2022 and as of today 07/05/2022 I am feeling so much better with just a little bit of cough.
MEDICATION ERROR; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. 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: 206A21A expiry: UNKNOWN) .5 ml, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-APR-2021, the subject experienced medication error. On 27-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and medication error was not reported. This report was non-serious.
One week after the shot, My arm became red and swollen, near where the shot was, and them spread down my arm to my elbow over the course of week.  Dr. had given me Clindamycin HCL 300 mg capsule 3 times a day starting on 5/21/21, for what he thought may be an infection from the shot.  1 week later still not better went back to Dr. on 5-27-21 and got Prednisone 20 mg tablets to take  3,3,3,2,2,2,1,1,1, a day in this way for 9 days.  He think now it is an allergic reaction to the shot.  Hopefully this will take away the swollen, red, pain and at times itchyness that has slide down my left arm below the site of the injection and going to the elbow.
Pt recvd 3 doses of Hep B & 2 wks p/3rd dose of Hep B lab eval revealed anti-HBC pos; no further details were provided;
Patient reported pain immediately after receiving vaccination.  Tenderness of the glenohumeral joint region, tenderness of the deltoid upon examination on 10/12/2022 by physician. Provider recommend stretches to the area, can use ice pack as needed for symptom relief, can use topical Icy Hot, Polar frost as needed. Allergic to nsaids. Recommend monitor symptoms for a week or so and follow up with PCP if symptoms unimproved, or sooner if symptoms worsen.
On 12/23/2022, I had symptoms with sneezing and runny nose and within 12 hours, I started running a fever and headache. I took a test and was positive from 12/24/2022 until 1/2/2023. I had fever for 72 hours and was very fatigued and runny nose. I had a telehealth visit on 12/24/2022 and could not get PAXLOVID due to the holiday. I was improving by day 4 so they did not prescribe when I returned from holiday. I still have some sneezing and other mild symptoms but better.
-Weakness(barely able to walk) - pain in arm so severe it cause nausea - fever - bump, redness and itching at injection site - fever like symptoms x4days - cold sweats in sleep;(took 2 Aleve every 12 hours x 4days); -> when I stopped symptoms returned.
aseptic meningitis;h/a, n/v, fatigue, weight loss;
First dose on 30Dec2020, got tested positive on 02Jan; This is a spontaneous report from a Pfizer-sponsored program. An unspecified age of contactable female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on 30Dec2020 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that the caller got her first dose on 30Dec2020, got tested positive on 02Jan. The outcome of the event was "Unknown".  Information on the lot/batch number has been requested.
This report describes an 86 y.o. female subject who tested positive for Hep B surface antigen after receiving Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history and concurrent conditions were unknown. Concurrent medications included atorvastatin calcium (Lipitor), aspirin, lisinopril, digoxin, metoprolol succinate (Toprol XL), "Nephplex Rx", ciprofloxacin hydrochloride (Cipro), intravenous cefazolin, intravenous gentamicin, and intravenous ceftazidime. On 8/14/02, the subject received two 20 mcg intramuscular injections to provide the recommended 40 mcg dose of Engerix-B. On 8/19/02, she was found to be Hep B surface antigen positive. The subject was kept in isolation. Hep B surface antigen titers measured on 8/23/02 and 8/26/02 were both negative and in-center isolation was discontinued. The reporter stated that the event was possibly due to Engerix-B administration. It was reported that the subject was "off dialysis". On follow-up, the reporter stated that the event was not serious and that the subject was not hospitalized. She was kept isolated from other dialysis patients while at the outpatient dialysis center. Therefore, this report has been reclassified as non-serious.
Pain at site, severe fatigue, chills, sweats, nausea, fever, headache, confusion, extreme lethargy, extreme lack of coordination, heart racing, joint pain, muscle pain full body.
Moderna COVID-19 Vaccine EUA This morning at 11A patient was getting changed which requires her wheelchair to be leaned back so she can raise up  as nurse pulls up pants. After raising chair back to sitting position, patient did not raise her head back to resting but instead kept it thrown back which is highly unusual. Her eyes stayed rolled to top of head and body stiffened. She was unresponsive. Signs suggesting seizure which patient does not have. It lasted approx. five seconds. Patient blinked and began to laugh. She said she blacked out but knew where she was and who everyone around was. All vitals are in normal range and she has not shown any other symptoms since injection. She also has been all normal since episode.
PATIENT DEVELOPED ATRIAL FLUTTER/FIBRILLATION IN JUNE 2009, AND WAS CONCERNED THAT IT MAY HAVE BEEN CAUSED BY VACCINE. 7/15/09-records received for DOS 6/12-6/15/09-DC DX: ANew onset atrial flutter/fibrillation. Cardiomyopathy, possibly related to tachydysrhythmia. Presented with 2 day history of palpitations and shortness of breath on exertion. In ED atrial flutter.   7/16/09 ICD-9 Codes: 427.32, 425.4, 785.2
approx 45 mins p/being vaxed began crying uncontrollably for long periods of time; t103 24APR93 lt arm red & dec in appetite; no n&v;
"Pt has a hx of anxiety. Pt c/o dry throat and mouth @11:30AM, 15mins post vaccination.  BP 120/82, HR 81, RR 20.  Pt had not eaten yet. A&Ox3.  Pt stable and released from the vaccination site @11:40 w/ sister to go get lunch.."
fever; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; PAIN (non-serious), outcome "unknown", described as "body aches". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Redness, flushing on chest and neck after 15 minutes. Lasted a few hours. No other symptoms. Pre-treated with Benadryl the next dose and did fine.
This is a spontaneous report from a contactable pharmacist. A female patient of unspecified age received at the same time single dose of PREVNAR 13 and high dose of Influenza vaccine (unknown manufacturer), both on unspecified date about a month before the report. Medical history and concomitant medications were not provided. The patient was still having at time of report a lot of pain in her arm to the point that she could not use it. The events developed on unknown date in 2014. Follow-up (14Jan2015): Follow-up attempts completed. No further information expected.
Aside from all of the flu like symptoms, 30 hours after the second dose, I got extremely dizzy, nauseous, and fainted, hitting my head on the wood floor. Also damaged my fridge when I went down.
Shortness of breath started 1 day after vaccine, palpitations started on day 3 and have been recurrent since with episodes lasting about 25 minutes. Referred to Cardiology