chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial muscle soreness in the arm where I had the injection day following the injection, followed by aches and pains elsewhere in my body and slight fever and headache the following three days. Took ibuprofen and seemed to health. I had no energy during the four days and a desire to sleep.  Might be described as mild flu like symptoms.
Headache, Myalgia, CoughWheeze, sore throat Narrative:  Started having a sore throat and cough 3 days later, voice is hoarse sounding. Taking OTC medication for headache, nothing for  cough or sore throat today.
Began developing redness on face and neck associated with feeling feverish a few hours after receiving vaccine. Symptoms persist and worsen at 8 hours post injection.
RECEIVED HALF DOSE FOR BOOSTER; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 43 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine ad26. cov2.s (from unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported (dose number in series was 1), administered 1 in total for prophylactic vaccination. No adverse events reported. The patient received half dose of covid-19 vaccine ad26.cov2.s booster dose (suspension for injection, route of admin not reported, batch number: 1822809 or 211A21A expiry: UNKNOWN) dose was not reported (dose number in series was 2), administered 1 in total on 27-NOV-2021 for prophylactic vaccination (RRT: Received half dose for booster, LLT: vaccine under dose, and Off label use) (both events dose number in series was 2). No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received half dose for booster and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211202250, 20211202193, 20211201082, 20211201450, 20211202199, 20211202469, 20211201286, 20211204104, 20211202379, 20211201179, 20211201443, 20211220152, 20211220146, 20211220262, 20211220250, 20211220145, 20211220619, 20211219871 and 20211220155.
Fatigue started at 8pm and was sudden onset, but felt like I couldn't move. Extreme exhaustion remained through the night and an additional 2 days. Activities of daily living were very difficult. I developed numbness in my arms(from elbows to hands) that still persists today. I also suffered from cramping in my lower legs, preventing me from sleeping or getting comfortable. The cramping turned to muscle spasms
she is allergic to one of the ingredients of the vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "she is allergic to one of the ingredients of the vaccine".  Additional information: Caller wanted to know if she should take her 3rd shot because she stated that she was allergic to one of the ingredients of the vaccine. Created manual AE form because she already had previous vaccines prior to the 3rd one.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
EXTREME DIZZINESS; ELEVATED BLOOD PRESSURE; HEART RATE 80; FATIGUE; MUSCULAR PAIN IN ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced elevated blood pressure. On 23-MAR-2021, the subject experienced heart rate 80. On 23-MAR-2021, the subject experienced fatigue. On 23-MAR-2021, the subject experienced muscular pain in arm. Laboratory data included: Blood pressure (NR: not provided) 137/80 mmHg, and Heart rate (NR: not provided) 80 BPM (units unspecified). On 24-MAR-2021, the subject experienced extreme dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscular pain in arm, fatigue, extreme dizziness, elevated blood pressure, and heart rate 80. This report was non-serious.
Imovax rabies second dose got delayed to 13 days instead of seven days, No AE; Initial information received on 05-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional via call center.  This case involves a 21-years-old female patient who received second and third dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiry date were not reported) via an unknown route and administration site for prophylactic vaccination on 21-Jul-2020 and 03-Aug-2020 respectively.  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was a case of an actual medication error case due to drug dose administration interval too long.  It was reported that the a female patient was vaccinated with Imovax rabies for pre-exposure series. The interval between the first dose and second dose was 13 days. The second dose got delayed to 13 days instead of seven days and dose third is scheduled for 15 days after dose.  At the time of this report, 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 holder's 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.  There will be no information available on the batch number for this case.
This is a spontaneous report from a contactable consumer (patient). A 52-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 19Mar2021 09:45 (batch/lot number EN6204 and expiry date not reported) at 52 years of age as single dose for covid-19 immunization in a hospital facility. Medical history included rheumatoid arthritis, ovarian cancer and had 6 chemo treatments, Sjogren's disease, obesity. The patient had no Covid prior vaccination. Concomitant medications included meloxicam (MOBIC); venlafaxine hydrochloride (EFFEXOR); hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); pantoprazole; biotin; fish oil (OMEGA 3 [FISH OIL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Remicade, Mucinex DM and fast acting cortisol shot; all experienced allergies. The patient had no other vaccine in four weeks. The patient informed that on 19Mar2021 16:30, her rheumatoid arthritis started acting up; it started in her right shoulder and spread to almost all her joints, every joint hurt except her back, neck, and jaw; then her bones started hurting, the patient informed that she had 6 chemo treatments and it felt just like a chemo treatment, hurting deep inside the bone marrow; she also had swelling in some of the muscles that were affected with rheumatoid arthritis; she felt lethargic and tired; she also had a welt at the injection site, it was 2 inches wide and wrapped halfway around her arm. The patient took all weekend for it to go down. The patient informed that it lasted till Sunday night (unspecified date). The patient was not Covid tested post vaccination. The patient received no treatment for the events. The outcome of the events was recovered.
Very itchy rash on my right side back rib cage midway up; two circles 1/2 inch in diameter and rash right side lower rib cage 3 inch in diameter and puffy.
I just got done going to the bathroom (2-4-2021) and was zipping up my pants  when I fainted.  I fell backwards into the bathtub  knocking down both shower doors.  My legs were hanging over the edge of the tub.  One shower door fell on my upper right chest area.   This happened just over 24 hours from when I received the vaccine.  I had not felt bad at all from the vaccine.  Didn't sleep too well that night (2-4-2021) because I hurt due to the fall.  I called my doctor on 2-5-2021 to let her know I fainted 24 hours after receiving the vaccine and wondered if that was due to it.  I do feel weak today (2-5-2021).
Four days later, fatigue. Fatigue was extreme for one week, let up for one week, and then returned and has persisted. Brain fog, overwhelm, high sensitivity to sensory input, dizziness, hot flashes, nausea.  Previous COVID infection in early June.
PATIENT NOTIFIED US DAYS LATER THAT HER LEFT ARM WAS VERY HOT TO THE TOUCH AND SWOLLEN WITH A BUMP.
WITHIN A MINUTE OF VACCINATION, THERE WAS LOCALIZED SWELLING AT INJECTION SITE-APPLIED ICE FOR AROUND 15 MINUTES. NO OTHER ADVERSE REACTIONS OBSERVED-CALLED TO CHECK ON HER LATER AND WAS OK.
Large localized reaction of Left arm migrating down to Left elbow with swelling started 9/16/2018. Has been slowly improving until time of appointment.
Left arm swollen and red and warm.  Dx Cellulitis due to injection  Tx  Augmentin ES 600/5- 2tsp BID x 7 days
Headache, NauseaVomiting, chills, body aches (unspecified) Narrative:
hives all over her body; Itching; This is a spontaneous report from a contactable Pharmacist.  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot EH9899, Expiration Date Mar2021, via intramuscular route of administration in right arm, on 18Dec2020 15:55, at single dose for COVID-19 immunization.  The vaccine was administered at Hospital Facility. The patient medical history and concomitant medications were not reported. The patient experienced hives all over her body and itching on 18Dec2020 at 19:00. The events required visit to Emergency Room. The patient was treated with Benadryl PO and Prednisone 60mg PO. The patient did not have any respiratory distress or anything.  They said this was related to the vaccine. The events were non serious. The outcome of the events was unknown.
Pt said she had stomach upset, chills and drop in body temperature almost immediately after leaving from vaccination location.
6 days p inj noted upper rt arm redness itching that spreadto include most of lateral upper arm
Fever and rash trunk after  8 hrs. Temps are as high as 101. Maculopapular rash chest abdomen, legs face. Rash became cellulitis in 240 with continued fevers stating continually and then more peripheral. Measles type rash. No Koplik spots.
WITHIN 1 HR OF RECEIVING THE FLULAVAL INJECTION, THE PATIENT STATED THAT SHE HAD A "METALLIC TASTE" IN HER MOUTH AND BEGAN FEELING HER LEFT ARM BEGIN TO SWELL. WITHIN 24 HOURS AFTER THE INJECTION, THE EPITROCHLEAR LYMPH NODES IN THE LEFT ARM BEGAN TO ENLARGE, BECAME PAINFUL AND HAD SUBCUTEANEOUS TISSUE SWELLING FROM THE LOWER MID ARM TO UPPER MID ARM. THE LYMPH NODES AND SUBCUTANEOUS TISSUE CONTINUED TO SWELL AND INCREASE IN SIZE AND PEAKED IN SIZE AFTER 6-7 DAYS AFTER THE INJECTION. RANGE OF MOTION TO THE LEFT ARM WAS ALSO LIMITED AND THE LYMPH NODES TO THE LEFT UNDERARM AREA WERE ALSO ENLARGED ABD PAINFUL. ON DAY 10, THE EPITROCHLEAR LYMPH NODES AND SUBCUTANEOUS TISSUE HAVE REDUCED SIGNIFICANTLY IN SIZE; ALTHOUGH, THE EPITROCHLEAR LYMPH NODE MEASURED 2 3/4 INCHES BY 1 3/4 INCHES. THE PATIENT ALSO EXPERIENCE MILD MYALGIA THROUGHOUT THIS PERIOD OF TIME.
This spontaneous report as received from a medical assistant refers to a patient of unknown age, unknown gender. On 10-MAY-2013 the patient was vaccinated with first dose of GARDASIL (lot # 668261/1397AA) that expired on 09-APR-2013 (strength, dose, frequency, route and site unspecified). The patient was not experiencing any symptoms. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Headache, Myalgia, HYPERtension, metallic taste/loss of taste appx 30 min after vaccine; bodyaches, headache, bp elevated.  taken to ER for further observation; treated with toradol, pepcid, zofran, ivf. d/c same day. had an episdoe of emesis (per er note, might have beenn due to eating at outside restaurant the day before)
Headache for two days.  Rash and Itching close to 3 weeks and continuing
August 15 she stated having symptoms of anxiety, vomiting, not able to sleep and started losing weight. She had lost 20 pounds in 6 months. She had no appetite, she would feel like she was going to pass out, if she ate, she felt like she would vomit.
Parents misrepresented child's birthdate and the 4 year old received a COVID vaccination for 5-11 year olds
9 hours after the shot I began to experience extreme chills, extremeties (hands and toes where ice cold).  Approximately 12 hours after the shot, I woke up with a heart rate 130-140s, with a sensation that my heart was going to cut down into my chest.  I had a fever of 102.1.  After vagal maneuvers I was able to bring my heart rate down to 70-80s which still lasted for a couple hours.  The sad thing is that my resting heart rate walking around is 50-52 bpm, and I've never experience anything like this before in my life.  I'm sure I've now induced some myocarditis.  Upon waking this morning 16 hours after the shot, I have an extreme cluster headache with difficulty looking forward with my vision and severe muscle aches as if I've worked out for hours at a time.
High fever 104.8; Diarrhea; Dose received 1, Current age 5 years (off label use); Dose received 1, Current age 5 years; This is a spontaneous report from a contactable consumer (parent). A 5-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Ik5127) via an unspecified route of administration in left arm on 07Nov2021 at 10:00 (at the age of 5 years-old) as dose 1, single for covid-19 immunization. Medical history included recent infected stye (that child received antibiotic for and recovered from more than 1 week prior). Patient had no known allergies. No other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. Concomitant medication in two weeks included cefalexin (CEFALEXIN) taken for an unspecified indication, start and stop date were not reported. A 5-year-old patient received the vaccine (coded to off label use and product use in unapproved population). The patient experienced high fever 104.8 and diarrhoea on 08Nov2021 at 15:00. It was reported that seriousness criteria did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating or congenital anomaly/birth defect. The patient underwent lab test and procedures which include body temperature with results high fever of 104.8 on 08Nov2021. Treatment medication included tylenol, motrin and cool bath. Device timestamp was reported as 14Nov2021. The clinical outcome of the events fever and diarrhoea was recovered in Nov2021 and for all other event was unknown.  Follow-up attempts are completed. No further information is expected.
Began 8 days after first Pfizer dose, had facial tingling and some weakness feeling of the face, approx 7 days thereafter the facial tingling was still present, but  progresses to head and facial pressure with tightness, severe fatigue, rapid weight loss, inability to walk up steps without cramping up or walk half a block.  I was admitted to hospital  for a possible stroke which turned up unfounded after 2 MRI. I?m still presented with head  and facial pressure and facial tingling  now months later with no known diagnosis as to why. I?ve seen a dentist, a chiropractic, a neurologist an internist and a regular doctor at this point. Had 2 MRI 1, MRA of the neck, 1 MRA of the brain and echocardiogram, CT of my chest and sinus and no findings as of yet of what the cause of this is. I am still going for more testing to this day
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider, a pharmacist, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient. On an unknown date in 2015, the patient was treated by her healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
lethargy & cyanosis & dec resp, profound unresponsiveness & ?seizure lasted 2 hrs; shock like state, shallow breathing (w/perioids of apnea);
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 44-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Recovery from Mastectomy" (unspecified if ongoing), notes: Other medical history:Recovery from mastectomy; "Skin necrosis" (unspecified if ongoing), notes: Other medical history: skin necrosis.; "Pre diabetic" (unspecified if ongoing), notes: Other medical history:Pre , diabetic. The patient's concomitant medications were not reported. Past drug history included: Percocet, reaction(s): "Known Allergies: Percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient went to Med Ctr ER for generalized seizure lasting 10 min and 2 partial seizures lasting a few seconds on same day she received listed immunizations. Given 20 mg/kg PHENOBARBITONE at ER and placed on maintenance dose of 5 mg/kg/day for 30 days. F/U PCP 2d.
dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.