chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received on 16 October 2007 from a nurse practitioner. A 20-year-old female patient, with no concurrent illnesses, a past medical history of seasonal allergies, and who takes Yasmin, had received an intramuscular dose of Adacel (lot number A2731AA) in the left deltoid the morning of 11 October 2007. That evening, the patient felt dizzy, nauseated, and had pain in the left deltoid at the injection site. It was not reported whether the patient sought medical treatment at that time. The patient continued to feel "worse" and approximately five days later, around 16 October 2007, the patient was seen in a college health clinic for evaluation. The patient complained that she had developed additional symptoms of headache, stiff neck, left arm soreness, and a "knot" at the injection site. The patient denied experiencing any fever or vomiting and was sent to the emergency room for evaluation. At the time of this report, the patient had not recovered. A corrective version was created on 23 October 2007 with the same latest received date as the previous version of 16 Oct 2007 for the sole purpose of entering the indication for the Adacel vaccine as prophylactic vaccinations, and to enter the country obtained, and to enter "A" in the A/C field on the product screen under the second therapy tab. No other relevant medically significant information was added to the case.
Right side of mouth dropped; Diagnosed with paresthesia; Numbness in her cheek, tongue, jaw and head on the right side; Slurring; Blood pressure shot up; Bad headache; A spontaneous case was reported by a consumer concerning a 66-year-old female patient who received Moderna's COVID-19 (mRNA-1273) vaccine and experienced the following: diagnosed with paresthesia (paraesthesia),  numbness in her cheek, tongue, jaw and head on the right side (hypaesthesia), right side of mouth dropped (facial paralysis), slurring (dysarthria), blood pressure shot up (hypertension) and bad headache (headache).    The patient's past medical history included stroke (she had stroke about 7 years ago). Concomitant products included blood pressure medication (not otherwise specified).  On 16-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Batch no. 031L20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.     On 16-Feb-2021, within one minute after receiving the vaccine, the  patient experienced numbness in her cheek and tongue on the right side. The numbness moved to her jaw and head and she also had slurring. The right side of her mouth dropped, her blood pressure shot up, and she had a bad headache. The patient was taken to the emergency room (ER) and diagnosed with paresthesia and also treated for stroke symptoms. The patient was in the hospital from about 10:30-5:00 pm.  Treatment included aspirin and IV. The recommendation was made for the patient to take atorvastatin, but the patient was not taking it. The patient went to see her physician on 22-Feb-2021.  At the time of this report, the patient's side effects had not completely resolved.      The action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, diagnosed with paresthesia, numbness in her cheek, tongue, jaw and head on the right side, right side of mouth dropped, slurring, blood pressure shot up, and bad headache, was considered not recovered/not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested. The patient's past medical history of stroke and ongoing history of hypertension remains a confounder.
Began with pain, burning sensation, numbness, weakness and tingling of left arm/leg. Symptoms continued and began in R arm and leg on 4/10/03 with generalized weakness over entire body. To ER on 4/10/03 continues with neuropathy.
Completed 2nd COVID-19 vaccine March 16, 2021 - On May 13, 2021, he had massive pulmonary embolism resulting in cardiac arrest.  Pulmonary embolism occluded pulmonary arteries to both lungs.
Patient received Moderna vaccine and approximately 30 minutes later she returned to clinic with complaint of left eye swelling that progressed to throat swelling and shortness of breath. She was transferred to emergency room via ambulance.
Low oxygen noticed at doctors office, was rushed to the ER.  Is now on oxygen 24/7.  Drops extremely low with any movement.
About 3 1/2 hrs after FLUMIST, pale ring lesion to end of nose, got progressively darker to dark burgundy color as days goes by. It gotten to black color by Friday (10/1/10). Taken to Hospital ER by ENT's ER doctor. Treated with BACTROBAN ointment and AUGMENTIN (Abx).
The person giving me the flu shot gave it to me in the wrong area; into tendon and the injection was extremely painful. I have had flu shot before; never, never was it so painful. I can barely raise my right arm. It is difficult to get dressed and extremely painful. My doctor has suggested I go to physical therapy. I am in pain all of the time.Information from Medical records states disc disease, arthritis, tendonitis. msv
This spontaneous report was received from a medical assistant regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition, medical history and concomitant medication. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, M005733, 01-OCT-2017, M006111 18-NOV-2017, M016238 07-DEC-2017. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16-Apr-2022) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2a) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a  expired vaccine 16-Apr-2022) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication was reported. No Treatment medication was reported.
Patient felt sick, turned white. I laid him back he passed out with eyes open. Eyes began to roll to the back, head turned to the left, arms went to the face with hands curled, moaning occurred, head turned to the right, hands curled and pressed against face. This lasted about two minutes. Patient regained consciousness with loss of memory as to what happened right before. Juice and crackers were administered by doctors. It took a good 10 or more minutes to regain facial color. A headache persisted after the event and into the night. Seemed to be syncope with tonic movements.
It started with a really bad slight headache work up with a severe migraine, fever, nausea. My chief concern was my headache, ringing of my ears (mainly in left ear). I decided to inform my husband went to Urgent care. The wait was so long we went to hospital had test ran for my migraine. I vomited from Friday, Saturday, Sunday and on Tuesday. I took Zofran which has not help with my vomiting, I have also exp sharp in my left eye cause it to twitch.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 5-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
I woke up several times throughout the night feeling dizzy and nauseous. I also feel pressure in my head, headache and pain down the right side of my neck. It is now 6 o?clock in the morning and I still feel this way.
died; devel thrombocytopenia 2 wks p/vax; No autopsy performed;
This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unspecified date, in 2015, the patient was vaccinated with the first dose in the series of GARDASIL (dose, route of administrations, Lot # and expiration date were not reported) for prophylaxis. The healthcare worker reported that the patient was in the office, on 16-JAN-2017, to receive the second dose in the series of GARDASIL, which was longer than recommended, but she did not receive the dose as the Center was closed and she was unable to call them to ask if GARDASIL 9 could be used as the second dose. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Day after receiving vaccines, skin red & blotchy & itchy. That evening vomitted & body aches. Saw MD Thurs 10/20 who put client on ZYRTEC & said to continue with BENADRYL.
Both my husband & myself became nauseated, felt like going to "black out", face & body "fever like", hands shaky", heart pounding hard & fast!"  Condition in both of us lasted approx an hour.  Felt milder symptoms approx 2 to 8 hours beyond.
began screaming, shrill cry 3 hrs p/vax given; screamed from 6PM 27JUN94 until 330A 28JUN94; did not stop crying when held upright; mom had never hear pt cry like this; mom described cry as shrill
EE felt itching at injection site right away.  provided Benadryl 25mg po at 12:17pm and cold pack to area
Pt. began to vomit @ 12:55 p.m.  approximately 1/2 an hour after the injection was given.
This spontaneous report has been received from a medical assistant (also reported as nurse), referring to patient of unknown age (reported as "pediatric aged") and gender. Information regarding medical history, drug reactions and concomitant therapies was not reported. On 15-DEC-2016, the patient was vaccinated with an expired PROQUAD, subcutaneously, (dose, and frequency were not provided), lot# K022285 and expiration date 12-NOV-2016 for prophylaxis. No adverse effect was reported. Product quality complaint was not involved. Additional information has been requested.
This spontaneous report as received from a Certificate medical assistant refers to a 9 week old patient. On 10-DEC-2013 the patient was vaccinated with the first dose of oral ROTATEQ (lot # J009050, expired date 09-SEP-2014) (dosage information and routed unspecified). On 10-DEC-2013, the patient experienced vomiting immediately after vaccination. The patient saw an unspecified physician on 11-DEC-2013 because the vomiting had continued for 24 hours. The outcome of vomiting was unknown. The relatedness between the therapy and the event was unspecified. This is one of several reports received from same source. Additional information has been requested.
The same day as the vax, the pt developed a maculo papular non pruritic rash on the abdominal with unconsolable crying lasting for 12-24 hours then he developed high pitched unconsolable crying lasting more than 3 hours. No treatment was given except acetaminophen.
Immediately, post vax, the student said "my head hurts", and started leaning to the left as if he was fainting but his arms and hands had muscle contractions. The episode lasted 10-20 seconds; then he asked "what happened?" and was coherent, pale and diaphoretic. His balance and mental status was fine afterwards. He saw an MD, but the MD thought he had an exaggerated syncope episode/a reaction to the needle rather than the vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. Concurrent conditions and medical history were not reported. The pharmacist reported that on 02-OCT-2015, the patient received their first dose of PNEUMOVAX 23 (route, lot number and expiration date were unspecified). Concomitant medications were not reported. The pharmacist also reported that an on 23-NOV-2015, the patient received the second dose of PNEUMOVAX 23 (route, lot number and expiration date were not reported). No adverse effect reported. Additional information has been requested.
Heart rate went from normal (53-60) to 100 bpm; Felt flushing feeling; blood pressure went up to 127/90 (usually 90/60); Had difficulty swallowing; Fingers started tingling; Chills (lasted 15-20 minutes); This is a spontaneous report from a contactable consumer.  A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 15Jan2021, after 2 minutes of the vaccine, patient heart rate went from normal (53-60) to 100 bpm; the patient felt flushing feeling and blood pressure went up to 127/90 (usually 90/60); patient had difficulty swallowing and fingers started tingling, followed by chills (lasted 15-20 minutes, as reported). The patient was ok 90 minutes after the shot. No treatment given. The final outcome of all the events was recovered in Jan2021.Information on the batch/lot number has been requested.
body pain/pain; headache; can't sleep, pain is keeping her awake; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 26Oct2021 09:55 (Lot number: EN6199) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Back surgeries" (unspecified if ongoing), notes: Has had back pain and has had 3 back surgeries; "Depression" (unspecified if ongoing); "Nerves" (unspecified if ongoing); "Has had back pain" (unspecified if ongoing), notes: Has had back pain and has had 3 back surgeries; "cigarettes smoker" (unspecified if ongoing), notes: she had 3 puffs left that she had one night. Concomitant medication(s) included: DULOXETINE [DULOXETINE HYDROCHLORIDE] taken for depression (ongoing); GABAPENTIN taken for nerve injury (ongoing). Vaccination history included: Bnt162b2 (First dose, Anatomical Location: left arm), administration date: 05Mar2021, when the patient was 69 years old, for Covid-19 Immunisation; Bnt162b2 (Second dose, Anatomical Location: left arm), administration date: 26Mar2021, when the patient was 69 years old, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 27Oct2021, outcome "not recovered", described as "body pain/pain"; HEADACHE (non-serious) with onset Oct2021, outcome "not recovered", described as "headache"; INSOMNIA (non-serious) with onset 2021, outcome "not recovered", described as "can't sleep, pain is keeping her awake". Therapeutic measures were taken as a result of pain, headache, insomnia.  Additional information: Caller recieved her Pfizer Covid 19 Vaccine Booster on the. She has experienced pain, headache, body pain.  She wants to know how long the side effects will last. She wants to know when these pains are going to go away because she can't sleep at night. The pain started the day after she got the shot. After 2 or 3 days, the headaches and small body aches came and then quit. The next day, they started hurting and then quit. She states that the only reason she is calling because it hurts. Can't sleep at night: It started about 4 days after the shot. Caller states she has had bad sleeping before but now the pain was keeping her awake and it was bad. She takes marijuana and it expired. She had cigarettes left over from the last one, she had 3 puffs left that she had one night. States that she has not had any other medication. Her doctor won't give her nothing and she has not had any pain medication in a while.   No follow-up attempts are possible. No further information is expected.
Day after severe body aches and fatigue - no fever. Day 2 ok. Day 3 started severe headache/migraine and severe fatigue which continued to 5/12/2021.  5/13/2021 diarrhea and fatigue that lasted until 5/15/2021. 5/16/2021 fatigue. 5/17/2021 severe body aches, fatigue and diarrhea - no fever
Treatment of COVID-19; Treatment of COVID-19; 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 male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Prostrate cancer" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: 31Dec2014; CENTRUM [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHLORINE;CHROMIUM;COPPER;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;MOLYBDENUM;NICKEL;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRI, start date: 31Dec2009; LUPRON, start date: 18Nov2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
a 64-years-old female patient was given Fluzone High Dose instead of the Fluzone quadrivalent, no AE; a 64-years-old patient was given Fluzone High Dose quadrivalent, no AE; a 64-years-old patient was given Fluzone High Dose quadrivalent, no AE; Initial information received on 15-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional.  This case is linked to cases 2020SA252226, 2020SA252621 and 2020SA253258.  This case involves a 64 years old female patient who received 0.7 mL dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE []FLUZONE HIGH-DOSE QUADRIVALENT (lot UJ453AB and expiry date: 30-Jun-2021) via an intramuscular route in the left deltoid for prophylactic vaccination, on 10-Sep-2020 instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered, product administered to patient of inappropriate age and overdose).  Medical history, past medical treatments, vaccination and family history were not provided. Patient did not have any other vaccines.  It is an actual medication error case due to wrong vaccine administered, inappropriate age at vaccine administration and it was a case of overdose (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a pharmacist concerning a female who on an unspecified date, was vaccinated with a dose of GARDASIL (unknown which dose). The pharmacist mentioned that a while ago the patient received GARDASIL and fainted. The patient sought unspecified medical attention. No further information is available.
Left eye lower lid was very swollen, it got worse; It is not like a small growing, it is really big and all the way to the cheek bone; high fever; This is a spontaneous report from a contactable consumer. This consumer(patient) reported that a 67 years old female patient received 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE BNT162B2 on 05Apr2021 at single dose on left arm for covid-19 immunization. Medical history and concomitant drug were not reported. Caller states the thing is, on Monday 05Apr2021 she had her second Pfizer Covid vaccine and Monday afternoon she was okay, states from Monday night up until yesterday she had a very high fever, states right now it is reduced, she knows that is sort of normal, but states on Tuesday afternoon on left side of her eyelid is swollen very badly, it got worse. She got this Less than 24 hours of having the vaccine it has to be related to the vaccine, she never had this before. It is not like a small growing, it is really big and all the way to the cheek bone. Outcome of the event fever was recovering, for other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.