chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pretty severe reaction to it today - had two incidents that lasted about 30 minutes each with gastrointestinal issues and major abdominal pain. Nausea, vomiting , diarrhea. The second attack happened when I was driving at approximately 2pm and I pulled over to a gas station and couldn?t stand or sit up. Pain was at a 10 in my abdomen and my wife almost brought me to the ER. Sweating profusely got dizzy and nearly passed out laying in the dirt at the gas station watching the clouds thinking I was dying. Eventually it passed but now I?m afraid to get the 2nd dose.
Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was given an expired vaccine. The vaccine was left out over night and drawn up by a technician that did not know it was not a new vial. The patient was immediately notified and consented to receive a non-expired vaccine which was immediately administered.
Pt. was given the Pfizer vaccine as a 3rd dose booster, and his 1st two vaccines were Moderna.
Fatigue; Dizziness; Tachycardia/heart rate is 115 laying down and her heart rate is 123 walking around; patient may be having an allergic reaction; This is a spontaneous report from a contactable other healthcare professional (hcp). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, lot number: EL0140, NDC number: 59267-1000-1, Expiry Date: 31Mar2021), via intramuscular on 21Dec2020 09:15 at 0.3 mL, single (0.3ml intramuscular injection in arm) for preventative (COVID-19 immunization). There were no medical history or concomitant medications. The patient did not receive any other vaccines prior vaccinations (within 4 weeks) or on the same date. The reporter worried the patient may be having an allergic reaction. The patient experienced dizziness, tachycardia, and fatigue, all on 21Dec2020, started about 45 minutes after receiving the injection around 10:00 am. The patient's heart rate is 115 laying down and her heart rate is 123 walking around on 21Dec2020. It is not life threatening and is kind of minor. The patient does get motion sickness easily. The reporter also received an injection from the same lot number. The patient she was reporting on is the only patient she has had that had an adverse reaction. There had not been any issues with any of her other patients. Treatment: The patient took Advil pm last night and it did not help, states Advil PM has benadryl in it. States it did not help. The outcome of events was not recovered.   The causality between events dizziness, fatigue, tachycardia and BNT162B2 is considered related by Primary Source Reporter per Global Introspection.
TIGHTNESS OF CHEST/RIBS; REDNESS/HEAT/BUMP AT INJECTION SITE; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced tightness of chest/ribs, redness/heat/bump at injection site, fever, headache, and fatigue. The outcome of the fever, headache, fatigue, redness/heat/bump at injection site and tightness of chest/ribs was not reported. This report was non-serious.
Onset 0925 dizzy, photophobia, decreased blood pressure, positive orthostatic blood pressure with uncompensated heart rate. No chest pain , SOB, hives, tongue swelling, positive nausea txd with PHENERGAN.  VS monitored until stable at 1130 and pt reported feeling better.
Left arm pain at injection site; he was bite by a dog about 10 years ago on the right calf and 1 week after the vaccine began to feel pain in that right calf area where the dog bite occured and felt as though the bite had just happened all over again. Still occurring about 3-4 times per week for about an hour then goes away
Fever of 101 at 1500 hour on 5 March; Chills need heater and blankets Heart rate of 111 bpm on 6 March at 0600 hr. normal heart rate is 68. Now at 0708 pm it's finally down to 84 bpm Sweating on 6 March
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 18Mar2021 at 13:00 as dose 2, single (Lot number: ER2613), in left arm and on 14Oct2021 at 13:00 as dose 3 (booster), single (Lot number: FF2589) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 12Apr2022 as dose 4 (booster), single (Lot number: 048L21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Bradycardia pacemaker" (unspecified if ongoing), notes: Bradycardia pacemaker. The patient's concomitant medications were not reported. Past drug history included: Cephalosporins, reaction(s): "Allergy_Cephalosporins". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unspecified age and gender. The patients' concurrent conditions and medical history were unspecified. On an unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ (strength and anatomical location unspecified) with lot # L027726 and expiration date 10-MAY-2017; with lot# L033694 and expiration date 16-JUN-2017; viral oral route. Number of doses administered was unspecified. The vaccine was exposed to temperature of 33.6F, for time frame of 2 hours 30 minutes. No previous temperature excursion was reported. The temperature excursion was detected by a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
Patient did not report any adverse outcomes at the time of this report. It was identified a few hours after the patient was given her vaccination that she was incorrectly administered a booster dose of the Pfizer vaccine for 12 years and older. She is outside of the eligible age range for booster doses.
Right deltoid pain.  Ice/ROM/ibuprofen/TYL-time.
6-year-old 26kg male with NKDA and PMH significant for allegic rhinitis and eczema localized to penis was vaccinated with Pfizer COVID-19 vaccine (batch/lot# unknown) on ~11/12/2021. Patient reportedly had COVID-19 seven weeks before this vaccination (dose#1 of 2) was given. 24 hours following vaccination, patient had fever (102) and intermittent headache, which was managed with acetaminophen alternating with ibuprofen. No other symptoms. Fever and headache continued as of 1/2/2022; therefore patient was seen by urgent care clinic. Patient otherwise seemed healthy.  Patient tested negative for influenza, COVID-19 and strep A. Unable to rule-out possible prolonged immune-mediated fever versus viral infection. Patient to be seen by PCP.
1 week after receiving the  first vaccine, the patient developed a quarter sized area of redness, just inferior to the vaccine site. Over the course of several more days, this redness increased and was approximately 3" wide by 7" long down the patient's arm at the time of visit. The site was indurated, hot to the touch and itchy/painful. She was treated for a cellulitis but the redness continued to increase even while on treatment and she was thus treated for allergic response.  She was advised to notify her employer as she received her vaccine through their facility
Telephone call on 6/22/10 at 1:00pm that right arm swollen from shoulder to fingertips that started 5:00pm on 6/21/10.  Also right leg swollen from knee to her right foot, but able to wear her normal shoes. Denied numbness or tingling in right extremities.  After discussion with Dr. an appointment was scheduled at a clinic for the client to be seen later on 6/22/10 with client in agreement.  Telephone call on 6/23/10 and left message to call nurse back. Telephone call on 6/24/10 to patient and she states did not go to clinic appointment/cancelled it.  Patient states all swelling gone by 10:00pm on 6/23/10 in both right arm and right lower leg.
25 minutes patient started to have redness around her right arm, a little redness on her left arm and her cheeks were red. She denied dizziness, lightheadedness, nausea, difficulties breathing or swallowing. Vitals in clinic were BP: 118/82, HR: 75, Oxygen stat: 97%. She was alert and oriented and was conversational during her stay. She denied Benadryl when offered.  She left feeling slightly better. Warning signs to call 911 were discussed with patient.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Initial case was received from a consumer and nurse on 06 December 2013. This female patient (date of birth and age not reported) whose medical history and concomitant medication was not reported had received FLUZONE (batch number, route, dose and anatomical site of administration not reported) on an unspecified date in 2012. The patient had received previous 2 doses of FLUZONE. It was reported that on an unspecified date, patient has had "systemic reaction to FLUZONE each of the past 3 years, getting a little worse each year". The patient declined to provide further information. Last vaccine given in 2012. No laboratory details and corrective treatment was reported. The outcome of the event was unknown. The list of documents held by sender: none.
high blood pressure; This is a spontaneous report from a Pfizer-sponsored program, Support. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer Covid 19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included diabetic. Concomitant medications were not reported. The patient lost her vaccination card however, after her first dose, she experienced high blood pressure on an unspecified date because she was diabetic as well. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
w/in 7 hrs of 1st pre-exposure dose devel vomiting & diarrhea; was observed in ER for 18hrs & had fluid replacement; No other etiology found; works w/rabies virus;
Patient has never had a flu vaccine in the past. Patient received flu vaccine after denying allergies to anything, but Iodine. Stated, she has worn contacts and had no irritation to solution. Denies allergy to eggs or latex. Nurse administered flu vaccine 2-3 min later patient state "I can't breath. My arms tingle." 1 pm B/P 168/110 P 170 R 30. Squad called. EPI administered per directions. 1:50 patient state "I feel better. B/P 160/50 P 100 R 20. Alert, oriented. Squad arrived 2:00 pm transported to ER. 11-22-05 5 pm discharged from hospital with 2 more epi pins. 11/23/05 reported she had fully recovered to and went out Christmas shopping 11/23/05.
without any problems, other than a sore arm; This spontaneous report was received from a 61 years old White female patient who referring to herself. Concurrent condition, historical condition and concomitant therapy were not reported.   On unknown dates, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23); zoster vaccine live(ZOSTAVAX); poliovirus vaccine inactivated (unspecified)); influenza virus vaccine (unspecified) and tetanus toxoid (dose, unit, route, lot# and expiration date were not reported).      The patient stated that without any problems, other than a sore arm. The outcome was not reported. Action taken was not applicable.   The causality between the event and suspect therapies was not reported.
chest in flames when I laid down; Couldn't lay down; Joint pain; Big headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest in flames when I laid down), DISCOMFORT (Couldn't lay down), ARTHRALGIA (Joint pain) and HEADACHE (Big headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced CHEST DISCOMFORT (chest in flames when I laid down), DISCOMFORT (Couldn't lay down), ARTHRALGIA (Joint pain) and HEADACHE (Big headache). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 23-Feb-2021, CHEST DISCOMFORT (chest in flames when I laid down), DISCOMFORT (Couldn't lay down), ARTHRALGIA (Joint pain) and HEADACHE (Big headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Headache-Mild, Error: Wrong Route (SC, IM, etc.), Additional Details: Patient had bruising that was painful to the touch 3 weeks after the first dose. Patient also developed a headache for 4-5 days after. The shot was given to the right of the center of the deltoid (slightly lower also). She said she saw a nurse and her primary care and they said that the needle was too large and caused the bruising.
Pain in left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. In June 2021, the patient experienced PAIN IN EXTREMITY (Pain in left arm). At the time of the report, PAIN IN EXTREMITY (Pain in left arm) outcome was unknown.            No concomitant medications or treatment details reported.
Migraine, nausea, muscle ache, arm swollen- red hot to the touch, high fever for 48 hours
Fever between 99.6 and 100.6 treated with ibuprofen Muscle aches of whole body Weakness Fatigue  Nausea  Heartburn
Nine month old infant seen for well child visit given RotaTeq which exceeded the maximum age of 8 months.
He had cold; He was shivering/cold shivers; He had low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (He had cold), CHILLS (He was shivering/cold shivers) and PYREXIA (He had low-grade fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 008B21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced NASOPHARYNGITIS (He had cold), CHILLS (He was shivering/cold shivers) and PYREXIA (He had low-grade fever). At the time of the report, NASOPHARYNGITIS (He had cold) and PYREXIA (He had low-grade fever) was resolving and CHILLS (He was shivering/cold shivers) had not resolved.            Concomitant drug included inhaler for asthma. Treatment medications were not provided.  It was reported that patient was not feeling as bad.   This case was linked to MOD-2021-341881 (Patient Link).
rt thigh anterior aspect has large area the size of an orange redness, swollen & hot to touch in a 24hr period staring @ the size of a quarter; tx APAP;
I received the vaccine at 9:00am. At 4:00pm I started to experience brain fog and cloudy judgement. Around 8pm I felt the beginning of a fever. By 10:00pm I started vomiting. Checked my fever at 104 degrees. Had severe Fatigue for the next 24 hours.
This spontaneous report as received from a pharmacist refers to a 93 year old female patient. On 23-OCT-2013 the patient was vaccinated with PNEUMOVAX23 lot # J007059, exp date 31-JUL-2014, intramuscular. The pharmacist reported that the patient's arm still hurts at the injection site of PNEUMOVAX23 vaccination. Onset date was unspecified. The pharmacist had no other information about the patient's arm that still hurts at the injection site of the PNEUMOVAX23 vaccination. Outcome of the event was reported as not recovered. The patient contacted pharmacist for medical attention. Additional information has been requested.
1st flu shot given 12/3/10 in afternoon lo grade temp 27 hrs later. High fever approximately 104 36 hrs after vaccines 3 minute febrile seizure see in ER 12/5. Seen by MD 12/6/10 in office - child fine then.
Information has been received from a registered nurse concerning a now 25 year old male medical student who on 10-Apr-2008 was vaccinated with a third dose of MMRII. The nurse reported the medical student had negative titers for MMR II despite having two doses of MMR II in the past. The medical student was given his first dose 14-Oct-1982 and his second 03-Aug-1995. The nurse indicated she gave him a booster dose on 10-Apr-2008. At the time of the report, the patient's outcome was unknown. Information has been received from a health professional concerning a patient who received MMRII on 06-Jan-1984 and 03-Aug-1995. The patient had to prove immunity by titers. The titers drawn on 25-Mar-2008 were negative for measles, mumps and rubella. A boosters dose of MMR II was given on 10-Apr-2008 Lot 06674; Exp 23-Apr-2010. It was reported that the patient's hepatitis B titer returned also as negative and the question arose regarding the timing of administration of TWINRIX. It was advised to give the TWINRIX at anytime post MMR II. The patient received on 21-Apr-2008 1 dose TWINRIX Lot AHABB100A, EXP 05-Dec-2009. The patient also had an immune work-up that was negative. A post dose measles, mumps and rubella titer was done on 16-May-2008; measles-equivocal, mumps-negative, rubella-positive. Subsequently the patient had a booster dose of  MMR II, R/SQ at 10:00am on 20-Jun-2008, Lot 06674; Exp 23-Apr-2010. Additional information has been requested.
Test COVID 19 test/Date 21Feb2021/Result Positive; Test COVID 19 test/Date 21Feb2021/Result Positive; Chills; achy; slight cough; This is a spontaneous report from a contactable consumer (patient's daughter). A 86-year-old female patient received second dose of BNT162B2 (Solution for injection, via intramuscular, administered in left arm on 13Feb2021 (Batch/Lot number: unknown) at single dose for covid-19 immunisation. Medical history included patient is diabetic, congestive heart failure, Oxygen 2 lpm. Concomitant medication was not reported. The patient had a past drug of BNT162B2 for COVID-19 immunisation on Jan2021 at the age of 86-year in left arm via intramuscular. The patient was laying in bed and had cough, achy, chills on 19Feb2021. Patient had both Pfizer COVID-19 vaccinations. The first date was unknown, but believed to be 3 weeks prior to last administration date of 13Feb2021. On 21Feb2021 patient tested positive for COVID-19. Outcome of the event cough, achy, chills was recovered on an unspecified date of 2021 and outcome of other events was unknown.  Information on the lot/batch number has been requested.
Back ache; Headache; Sore throat; Mouth blisters; Fatigue; Runny nose; Cough; Elevated pulse rate (+20bpm); Loss of appetite; The patient received the third/booster dose of BNT162b2; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3189) via an unspecified route of administration in the right arm on 30Sep2021 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included influenza vaccine (flu shot) (MANUFACTURER UNKNOWN) taken for immunization on 28Sep2021. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 05Mar2021 (at the age of 52-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 04Oct2021, the patient experienced back ache, head ache, sore throat, mouth blisters, fatigue, runny nose, cough, elevated pulse rate (+20bpm) and loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. On 04Oct2021, the patient underwent pulse rate test and the result was +20 beats per minute (bpm). Since the vaccination, the patient had been tested for COVID-19. On 01Oct2021, the patient underwent SARS-CoV-2 test (Polymerase Chain Reaction (PCR); other) and the result was negative. The clinical outcome of the events back ache, head ache, sore throat, mouth blisters, fatigue, runny nose, cough, elevated pulse rate (+20bpm) and loss of appetite was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.