chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingle outbreak 5 days after first shot in area of left side of neck, ear and back of head; Blister and extreme pain; Blister and extreme pain; Nerve pain; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 52-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Right on 17Mar2021 18:00 as dose 1, single and a second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0161), via an unspecified route of administration, administered in Arm Right on 13Apr2021 18:00 (at the age of 52-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were nor reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient had no health issues prior to vaccine. Patient received vaccine Facility in Hospital. On 22Mar2021 03:00, shingle outbreak 5 days after first shot in area of left side of neck, ear and back of head. Blister and extreme pain that required doctor care. Completed 10 days of prescribed medicine and was getting better. 2nd outbreak occurred after getting 2nd Covid vaccine. Same area, but less blistering. Still extreme nerve pain. Treatment was received for the events as Valacyclovir for 10 days. Patient visited Doctor or other healthcare professional office/clinic visit. The outcome of the events was reported as recovering.   Follow-Up (15Sep2021): Follow-up attempts are completed. No further information is expected.
Patient woke with hives on 9/7/18 on bilateral arms. Hives spread to full body and lips swelled despite PO BENADRYL. Pt was taken to urgent care for treatment. Hives and swelling of both lips continued despite 50 mg PO BENADRYL q 6 hours through current. No report of SOB, difficulty swallowing, itchiness of throat or mouth. Denies new foods, soaps, lotions, detergents etc. Seen for follow-up at our office on 9/11/18 for continued symptoms. Previous HPV-9 valent given 3/3/18.
Swelling & redness at the injection site.  Possible infection.  Given prescription for antibiotics.
Nausea starting 3.5 hours after shot, progressing to include dehydration-like headache, joint pain, fever, severe chills, and fatigue. Most symptoms abated in 24-36 hours, with some joint pain/fatigue lingering.  Treated with 2 doses of 500mg Tylenol, first at 24 hours post-vaccine, and the second 6 hours later.
an allergic reaction to an MMR vaccine (8 weeks of petichial rash); an allergic reaction to an MMR vaccine (8 weeks of petichial rash); This spontaneous report was received from a consumer via other company letter, and refers to a 12-year-old female patient. The patient's pertinent medical history included anaphylaxis to cashews and dairy. Information regarding the patient's concomitant therapies was not reported.    On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), as prophylaxis (dose, dose number, route of administration, lot number, and expiration date were not reported). The reporter stated the patient was having an alergiec reaction to the MMR vaccine (drug hypersensitivity): 8 weeks of petechial rash (petechiae).      The outcome of drug hypersensitivity and petechiae was unknown. The causal relationship between the occurred events and the suspect vaccine was implied.
Covid19 breakthrough.  1st vaccine received on 01/11/2021.  91 y/o PMHx of HTN, HLD, GERD, PSVT presents to ED via EMS for c/o lightheadedness.  Pt states has been Covid+ since Tuesday but was asymptomatic until today when felt dizzy and unbalanced.  Room air sat 89%, pt was placed on O2 2L NC and sats 97%.  Afebrile and CXR -no acute findings.  Pt treated with steroids.
Patient received undiluted 0.2 ML dose. No adverse reactions or symptoms notated during phone conversation with legal guardian.
Developed Covid. Started with sore throat and headache, went on to cough and congestion, mild fever and fatigue
delayed reaction of heart palpitations/hear her heartbeat in her ear; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (delayed reaction of heart palpitations/hear her heartbeat in her ear) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PALPITATIONS (delayed reaction of heart palpitations/hear her heartbeat in her ear). At the time of the report, PALPITATIONS (delayed reaction of heart palpitations/hear her heartbeat in her ear) had resolved. Unknown          No relevant concomitant medications were reported No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up information received on 23 JUN 2021, changed outcome as per obtained information.
Tingling on right side of lip and right of face.  Felt like numbness from local anesthesia at dental office.  Felt like throat was a little numb.  Numbness has mostly resolved approximately 1.5 hrs after vaccination.  Some lingering tingling on lips at 1 hr 45 mins post-vaccination.
Left breast painful lump about the size of a golf ball behind areola with a vertical red line up and down and veiny breast. Incapable of wearing bra and sensitive to touch it lasted that size for 24-48 hours, treated with antibiotics at an Urgent Care. I followed up with OB 2 days later, swelling improved and slimmed lump flat like a quarter, however lump is still present and painful. The plan is to follow up with OB  in 2 weeks. Primary suggested 12 weeks for full recovery.
Administered 2nd Moderna too early,  TC to  client and report doing fine and no pain .
This spontaneous report was received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. On unknown dates in April 2017 (reported as from 20-APR-2017 to 25-APR-2017), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot number L045117 with expiration date of 06-OCT-2018 and lot number M036156 with expiration date of 23-FEB-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 1 hour 17 minutes at a temperature between 9 degrees Celsius and 25 degrees Celsius on unspecified dates. No previous temperature excursion was reported. A data logger issue was involved. Additional information has been requested.; Sender's Comments: US-009507513-1704USA014144: US-009507513-1705USA001801:
DIZZY; PAIN IN ARM; This spontaneous report received from a patient concerned a male of unspecified age. 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: 2018218 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain in arm. On an unspecified date, the subject experienced dizzy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm and dizzy was not reported. This report was non-serious.
aches; chills; sweats; exhaustion; booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: FJ1620) , administration date 28Nov2021 15:00 at the age of 58 years as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization, reaction(s): "These symptoms were unlike what was experienced for the first and second doses resulting in much discomfort"; BNT162B2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization, reaction(s): "These symptoms were unlike what was experienced for the first and second doses resulting in much discomfort". The following information was reported: IMMUNISATION (non-serious) with onset 28Nov2021 15:00, outcome "unknown", described as "booster dose"; PAIN (non-serious) with onset 29Nov2021, outcome "recovering", described as "aches"; CHILLS (non-serious) with onset 29Nov2021, outcome "recovering", described as "chills"; HYPERHIDROSIS (non-serious) with onset 29Nov2021, outcome "recovering", described as "sweats"; FATIGUE (non-serious) with onset 29Nov2021, outcome "recovering", described as "exhaustion". Therapeutic measures were not taken as a result of pain, chills, hyperhidrosis, fatigue.   Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
patient was given the fluzone high dose in error. due to her age should have received quadrivalent
dry throat; coughing; headache; chilly; sore throat; her body is itching; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date was not reported), via an unspecified route of administration on 25Mar2021, as dose 1, single for COVID-19 immunisation. Medical history included seasonal allergy. Patient was taking unspecified concomitant medication for seasonal allergies. The patient experienced dry throat, coughing, headache, chilly, sore throat, and her body is itching on an unspecified date in Mar2021. Patient stated she was coughing too much. Patient took paracetamol (TYLENOL), Dextromethorphan (DELSYM), Acetaminophen, Chlorpheniramine, Dextromethorphan, Phenylephrine (ALKA-SETZER COLD & FLU), and benzocaine, menthol (CEPACOL) for sore throat and as a result of events. Patient stated it was not working and wants to know what she can do to feel better. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a office manager concerning a 13 year old female patient with no known drug reactions or allergies and no pertinent medical history noted who on an unspecified date, was intramuscularly vaccinated with the third dose of GARDASIL. There were no known concomitant medications. The office manager reported that approximately one year after she completed the GARDASIL series the patient complained of generalized muscle weakness, muscle and leg pain and syncope. It was reported that various lab and diagnostic studies were performed. The patient was seen by a cardiologist but the office manager did not know the exact labs and studies performed. The patient sought medical attention by visiting the doctor's office. The office manager stated that the patient was still being followed up by different physicians. At the time of the report, the office manager did not know whether the patient's symptoms had resolved. Generalized muscle weakness, muscle and leg pain and syncope were considered to be other important medical events by the office manager. Additional information has been requested.
Patient appeared to have had a systemic inflammatory syndrome vs anaphylactic  type reaction to the vaccine. She presented with dyspnea 12 hours after receiving the vaccine and ultimately required brief intubation and vasopressor support. She was extubated and weaned off pressors within 2 days and discharged at her baseline functional status.
PINK RASH SURROUNDING INJECTION SITE, AND A LIGHTER PINK SKIN COLOR EXTENDING SEVERAL INCHES BEYOND THAT.
a little tale tale sign is the grey/ on the face left a grey shadowing; has reactions to bee stings; anxiety; insect bites are worse and last longer/  mosquito bites last longer; gout; shingles/chicken pox/ since she had the reaction to the singles vaccine; shingles/chicken pox/ since she had the reaction to the singles vaccine; she had a rash that was torpedo shaped on almost her entire upper arm; This spontaneous report was received from a 70 years old female patient referring to herself. Concomitant products: no medications were relevant. She didn't take many medications back then and still didn't.  In approximately 2011 (reported as about 10 years ago/ between 8 to 10 years ago), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) in the left arm for prophylaxis.         The patient had reactions to the vaccine. After she received the shingles vaccine she had a rash that was torpedo shaped on almost her entire upper arm that lasted for 10 days (also reported would last 7 to 10 days) and then broke out into shingles/chicken pox that had 5 or 6 with two on her abdomen and some on her face but they did not itch or get pustular. When it went away it left a gray shadowing area on her face but not on her abdomen (skin discolouration). She would have looked like a camouflaged person. The patient did not have an allergic reaction to an ingredient but where she received it, said it was possible to get a few chickenpox/shingles from the vaccine. After the incidence with the shingles vaccine she now carried epi pens because she had reactions to bee stings and it was Iike anxiety so the doctor gave her a epi pen to carry in case she went into anaphylactic shock. The patient said that also insect bites were worse and last longer and mosquito bites last longer and stated she didn't know if the vaccine attributed to a change in her system. She also read something about vaccines and gout and she recently had gout. The outcome of shingles/chickenpox was unknown. She had recovered rash completely. Outcome of other events was unknown.  The causality between zoster vaccine live (ZOSTAVAX) and shingles/chickenpox, rash, skin discolouration was considered as related. The causality between zoster vaccine live (ZOSTAVAX) and other events was unknown.
FATIGUE WITH PRONOUNCE FEET ACHINESS AND BODY ACHE Narrative:
Patient received Pfizer vaccine on 4/6 at the Clinic Site out of allocated doses from 1582. She received vaccination, waited 15 minutes in one of the waiting room chairs, and while departing the facility fainted and fell into her significant other's arms. They were on the sidewalk and he brought her so that she was laying down. I called 911 and rushed over to her. It took her about 30 seconds to come to and she became coherent while I was on the phone with 911. Police were dispatched first, followed by EMS about 10 minutes later. Patient stated she has a history of fainting spells. This occurred about 4:27 pm on 4/6 and patient stated she last ate about 12:30 pm on 4/6. Patient was seen by EMS and cleared.
Experienced mild fever and headache the next day.  Hand Numbness (left) began the day following the 2nd Dose of Moderna Covid 19 vaccine.
got covid-19 after the first dose; got covid-19 after the first dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist stated having a patient who got COVID-19 after the first dose of the PFIZER-BIONTECH COVID-19 VACCINE on 23Mar2021. The patient got COVID-19 disease after the first dose and went to Urgent Care due to COVID-19 symptoms. The patient has now fully recovered and is planning to get her second dose of the PFIZER-BIONTECH COVID-19 VACCINE at the time of reporting.  Information on the lot/batch number has been requested.
"swollen glands  under left arm where injection was given and also had ache behind neck,This lasted for 4 days."
This spontaneous report was received from a registered nurse refers to two patients of unknown age. On 08-OCT-2013, the patients were inadvertently vaccinated with a dose of M-M-R II, (lot number 009784, expiry date 15-MAY-2014) which was improperly stored. No adverse effects reported. Additional information is not expected.
Pt became listless, crying, hypotonic, poor appetite and nystagmus. These symptoms were noted after her 4 month immunizations. She was seen by her physician at 5 1/2 months and noted she had no visual tracking. Referred to other physician and dx'd as legally blind. Other symptoms not addressed. Physicians felt she would grow out of the hypotonia and listlessness. The pt has had extensive workup so far for developmental delay and without any definite etiology being identified. A review of her course in infancy indicates that she had a normal head circumference at birth but thereafter, there was progressive decline in the head circumference after 6 months. She cannot even use her hands to feed herself finger foods (apraxia); is unable to walk without support and there is a tendency for repeated teeth grinding. I feel that the history of autistic features developing in association with regression in head growth as well as the associated hand wringing gestures and poor weight gain are highly suggestive of the Rett Syndrome. She is receiving speech therapy and she now walks with a platform walker. She has significant developmental delay/mental retardation of undetermined etiology. The 60 day follow-up states low tone, listless, developmental delay.
Range of motion loss in left arm. Appeared towards latter part of July. Doctors diagnosis of deltoid bursitis (visual and touch exam only). Physical therapy referral for comprehensive exam and treatment.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L044475 and expiration date 12-MAY-2017, dose and route of administration were not reported). The temperature of excursion was minus 2 Celsius degrees and the time frame was 20 hours. The conditions were back in range at the time of the report. There was no previous temperature excursion. It was stated that it was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
arm swollen to 6 1/2- 9 1/2cm; 22NOV93 sz approx 36 hrs p/dose;
High temperature 100.1, aching, chills, soreness at injection site symptoms lasted over 24 hours ending before 36 hours from start of adverse event
Itch, warmth, swelling and redness developed initially around injection site, spread to left upper extremity, encompassing arm laterally-anteriorly from shoulder to elbow.
Information has been received from an RN concerning an 18 year old Caucasian female pt who on 7/6/00 was vaccinated in the left deltoid with a 1st dose of Hep-B vaccine. Subsequently, on 7/8/00, the pt developed facial nerve tic with numbness. "The tic lasted for 1.5 days, no other adverse experiences occurred". Unspecified medical attention was sought. After 2 days, the pt recovered without treatment. Follow-up information from the RN indicated that the pt reported the symptoms started on 7/7/00 and were no painful. On 7/8/00, during the AM shift between 06:00 and 14:00, the pt presented to the office with symptoms of facial twitching which were present on the right side of her face. No muscle movement, other visible signs of muscle involvement, no facial drooping and no problems with verbal communication were noted. The physician's assistant on call was notified and instructions were given to observe the pt. If symptoms worsened, the pt was instructed to go to the ER. On 7/10/00, the pt was seen by the infectious disease nurse who reported that all symptoms of twitching had stopped and there was no need for the pt to be seen in the ER. The pt denies any problem with any other vaccines. No further information is expected.
This spontaneous report as received from a other health professional refers to approximately 18 year old female patient of unknown age. The pertinent medical history included urinary tract infection. The patient's concurrent conditions included hearing loss and ADHD. The patient received dose one and two of GARDASIL in June and August of 2011. On 17-JUL-2014 the patient received GARDASIL. No other concomitant therapies reported. The reporter stated that the patient received a confirmation of pregnancy via a urine test on 21-JUL-2014 and patient indicated that she must have been about 4.5 weeks pregnant when she received the third dose of the GARDASIL. The LMP was calculated as June 2014. There was no intervention required to prevent serious criteria. There was no significant disability or incapacity. No hospitalization required. The event was not life-threatening. The outcome of the event was reported as not recovered/not resolved. No PQC involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 51 years 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: "Chronic Kidney Disease (CKD) Stage 1" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 included: PF-07321332, ritonavir (PAXLOVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fine day after the vaccine administered.  Woke the next morning with significant headache, light sensitivity, feeling of wanting to throw up, spinning, not being able to feel anything, not being able to balance.  Walked to the bathroom, blacked out. Woke to laying on the counter.  Talked to my mother.  Went back to bed.  Woke back up at 9:42 AM at which time I talked to my father, mother came home to check on me, I did not remember speaking with her at all in the morning and could finally articulate to her the blacking out event in the bathroom.  She reported finding my appearance of having no color, not being able to put sentences together.  We called the clinic to see if I should be looked at or if these symptoms were normal following the COVID 19 vaccine, we were advised to be seen.