chrisvoncsefalvay/vaers-outcomes huggingface dataset:
C/o Generalized itchiness. No rash visible. VSS 123/84 HR 74 100% on RA RR 16. No tongue, lip swelling, no hives. No chest pain, sob. No hx of prior vaccine reaction. Hx of allergies to strawberries with anaphalaxis. Vaccine received at 0925. Pt still c/o itchng at 10:05. Will send to ER for further monitoring as may need antihistamines, steroids, h2 blockers. No signs of anaphalaxis.  Will need further monitoring.   ED Note: This is a well-appearing and pleasant 30-year-old female who presented to the emergency department for generalized body itching following getting the first dose of Pfizer COVID-19 vaccine at approximately 930 this morning.  On presentation patient is well-appearing, respirations are even and nonlabored, she is speaking in complete sentences with normal work of breathing.  She denies any symptoms other than itching currently on her upper arms and upper back.  She notes that the itching is already starting to resolve and has lessened.  There is no rash present on exam, no hives.  Airway is clear, uvula midline, patient is tolerating secretions well with no drooling or voice changes and there is no mouth or tongue swelling present.  Neck is supple without lymphadenopathy.  Patient was observed close to an hour and a half and she remained stable with no changes.  At time of discharge patient with no skin reaction, facial, mouth, or tongue swelling.  She is speaking in complete sentences with normal work of breathing, respirations even and nonlabored.  She appears well and appropriate for discharge.  I had an in-depth discussion with her regarding monitoring her symptoms at home seeking emergent care if she has any compromise. We discussed all signs and symptoms that she should look for that would be concerning and need emergent intervention. She indicated that she understood all instructions. Patient was given the opportunity to ask questions.  All questions and concerns were thoroughly addressed.  Patient indicated she understood all instructions was comfortable with this plan of care. No evidence of Stevens-Johnson syndrome, anaphylaxis, cellulitis, or systemic compromise. Feel supportive care and symptomatic treatment reasonable. I reviewed recent and relevant Chart Entries, Previous Notes, Previous Labs, Previous Radiology studies. Patient ambulated out of the emergency department with a steady gait.  Received benadryl and famotidine in the ED and take home prescriptions for famotidine and hydroxyzine.
Severe epigastric pain, nausea, diarrhea, abdominal pain, body aches, muscle spasms, weakness,
TIA.  My eyes pointed in different directions along with some dizziness.  Lasted 5-minutes.  Happened on 2 0ccasions.
chills, felt warm but no fever Narrative: Pt called 3/18/2021 reporting chills, feeling warm, dull headache for last 6 days. On 3/22/21, patient reports feeling better.
This spontaneous initial report was received from a medical assistant, via a company representative, regarding a 17 year old male patient (also reported as female). Patient's medical history, current conditions and concomitant medications were not reported. The medical assistant reported that on 06-OCT-2017, the patient was vaccinated a dose of GARDASIL 9 intramuscular, in the patient's right arm, lot #N004798, expiration date 31-OCT-2019 (strength and dose not reported), for prophylaxis, before the medical assistant realizaed that the patient had already already completed a GARDASIL or GARDASIL 9 series a few years ago. It was also reported that none other vaccines were administered within 4 weeks prios the vaccination. No adverse effects were reported.
Acute onset exhaustion, Passing nausea.  Vital Signs: BP 118/70 HR 80 Resp 18 O2Sat 96%  Skin Signs: Diaphoretic  Circulation: Cap refill <2sec  Initial Treatment: Observation. Patient denies recent illness, exposure, or ill family members. Scanned in at 100.1 temp on arrival.  3:14 PM Vital Signs: BP 116/68 HR 78 Resp 16 O2Sat 98%  Skin Signs: Warm and dry  Circulation: Cap refill <2sec  Follow up Treatment: Drinking water. Reports feeling better  D/C home by self. Complete recovery.
Temperature of 101.7, stomach ache, headache, chills, tired in the evening following the injection. Took extra strength Tylenol and "felt a little better".
I have started to have phases of my tongue feeling almost like it is numb. I will lose my taste for  1-3 days then my tongue will be numb for over a week. This has happened about 6 time's now since February.
Was much sicker when he was little and received small pox vaccine than with the Covid vaccine; Severe fever; Throwing up; This is a spontaneous report from a contactable consumer or other non hcp (patient). Communication: Report 2 of 2.   A 61-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: SOLUTION FOR INJECTION, LOT NUMBER: ER2613) via an unspecified route of administration in right arm on 23Mar2021 as single dose (age at vaccination 60-year-old )and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, FORMULATION: SOLUTION FOR INJECTION, LOT NUMBER: RE8736) via an unspecified route of administration in right arm on 29Apr2021 as single dose (age at vaccination 61-year-old ) for covid-19 immunisation. The patient's medical history was none, and concomitant medications were not reported. At age of 8-year-old, patient took smallpox vaccine on an unspecified date in 1968 in left arm for immunization and experienced sickness. When reporting on wife to agent, caller mentioned that he was much sicker when he was little and received the smallpox vaccine than with the Covid vaccine. Patient was sick for only a few days after he had the smallpox vaccine. Patient had severe fever and was throwing up. The outcome of events was unknown.
This spontaneous report was received from a pharmacist via company representative referring to a patient of unknown age and gender who on an unknown date, was vaccinated with a dose of ZOSTAVAX (lot # not reported). On an unknown date, the patient experienced silver dollar size red area on the arm where ZOSTAVAX was received that was not around the injection site. The outcome of silver dollar size red area on the arm where ZOSTAVAX was received that was not around the injection site was unknown. The patient contacted the pharmacist. Additional information has been requested.
Patient received a PREVNAR vaccine from our pharmacy and due to the administration of the vaccine the patient may have experienced a hit blood vessel. Per the patient report he had a extremely sore arm since getting the vaccine and was bruised from his elbow to shoulder on his right arm.
vomiting started 930PM; 19AUG93 legs still stiff; fever 100.3 lt side was stiff;
p/inject pt became nauseated & felt sick, like was going to throw up; threw up, eyes rolled back & appeared to lose consciousness & became unresponsive; began to quiver, breathing was sl eratic & short rapid breath; h/a, rigid, muscles tigh
Feeling tingling in the right side of my face; This is a spontaneous report from a contactable consumer (patient). An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date it was reported as patient stated that "when patient got the vaccine patient started felling tingling in the right side of patient face." Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Brief bloating/gas/indigestion, followed by rapid-onset fever which lasted 16 hours, even when treated with fever-reducers. Following two weeks marked by intermittent spells of fatigue, cognitive fog, dizziness, low-grade fever, appetite loss and intense muscle soreness/joint pain.
Nausea, joint pain. Nausea treated with Dimenhydrinate two 50mg tablets. Joint pain treated with Ibuprophen 400mg. By morning these symptoms were gone.
I had body aches, fatigue, and heart palpitations.  I needed up at the emergency room because the heart palpitations were bad.  After extensive tests they found no heart issues.  ER doctor said it was reaction from the vaccine.
Information has been received from a consumer concerning her daughter who had received a dose of Prevnar and developed an injection site reaction described as a hard, red, lump. No further information was available at the date of this report. Follow up information received on 23 APR 2002 from the patient's mother via manufacturer indicated her daughter's experience was an allergic reation (hypersensitivity NOS). Treatment was not provided.
Hearing loss, vertigo, diplopia, dysphagia, facial numbness, gait ataxia. Receiving IVIG infusions, etc. 1. Autoimmune mediated sensorineural hearing loss that progressed to Guillain Barre Miller-Fisher variant. 2. Diplopia, dysphagia, vertigo, tinnitus, decreased facial sensation bilaterally involving V1, V2, and V3 regions, dysphagia, bilateral upper extremity numbness consistent with C2-T1, vestibular symptoms with vertigo, gait ataxia, and decreased coordination. 3. Influenza vaccination given on 11/5/2010, _____strain. Examination is notable for decreased hearing on the right to near absent and markedly diminished on the left. Immune mediated sensorineural hearing loss. For its neuroprotective effects, we will prescribe tiagabine 4 mg t.i.d. , minocycline 100 mg b.i.d. For potential fluid etiology, she will be given furosemide 40 mg q.a.m. and for potential spitochetal disease such as lyme disease, we will add Pen-Vee K 500 mg q.i.d. x 7 days. We will also add fluconazole for dexamethasone. I will continue to monitor her progress.
Pain right side of neck and shoulder; Pain right side of neck and shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 33-year-old male patient who received HAV (Havrix) for prophylaxis.   On 23rd July 2019, the patient received Havrix (intramuscular) 1 ml. On 24th July 2019, 1 days after receiving Havrix, the patient experienced shoulder pain and neck pain. The patient was treated with muscle relaxants and analgesic, nos (Pain Medication). On an unknown date, the outcome of the shoulder pain and neck pain were not recovered/not resolved.   The reporter considered the shoulder pain and neck pain to be related to Havrix.  Additional details were provided as follows: The patient received the Havrix in the right deltoid and was continuing to have side effects.  The patient had pain in his right shoulder and neck area which was getting worse. The patient was advised to follow up with his physician. He reported that the doctor gave him muscle relaxers and pain medication but it had not helped.  He stated at first he thought it was a pulled muscle but he now thinks it was related to the vaccine. The reporter consented to follow up.
Extreme pain in left jaw/ear area that continues to be present almost 2weeks post vaccine. Started approximately 48hrs post vaccination. Cannot open mouth fully or chew properly due to the pain.   As well as: Joint Pain, more specifically, increased pain in areas with pre-existing nerve issues/concerns (carpal tunnel, damaged ulnar nerve in right arm, sciatic nerve pain in left hip).   Radiating pain in left pain from hip to ankle
03/19/2021 -   4 PM I STARTED TO NOT FEEL WELL. LEFT WORK - WENT HOME , STARTED TO SHAKE REALLY HARD WITH COLD CHILLS. LAID DOWN WITH TWO BLANKETS AND WAITED FOR THE SHAKING TO STOP...THEN FELL ASLEEP.  I  AM GUESSING SHAKING WENT ON FOR A GOOD 1/2 HR TO HOUR.  i WAS VERY WEAK TO GET UP TO GO THE BATHROOM. MY HUSBAND HELPED ME.
HEART FLUTTERS; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on SEP-2021 (dose series 1) for prophylactic vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry date were unknown) dose, frequency, and therapy dates were not reported for psoriatic arthritis. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On SEP-2021, the patient experienced heart flutters. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with adalimumab (Humira) was unknown. The patient recovered from heart flutters on an unspecified date of 2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211215302-COVID-19 VACCINE Ad26.COV2.S- Heart flutters. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
After receiving the vaccines client had an episode of syncope lasting 1 minute. Client place flat on exam table. After 1 minute, client regained consciousness & place on left side in recovery position. Client vomited small amount of clear mucous. Mother states client did not eat prior to apointment. Client monitored for 10 minutes & offered soda. Client's color returned & able to ambulate without difficulty to parent's vehicle. Mother with client during the appointment.
This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and he did not get the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and he did not get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and he did not get the second dose) had resolved. Concomitant medication was not reported. Treatment information was not reported.
numb sensation of head & cont to shoulder & arms & hands p/2nd dose; no other sx; called clinic where vax given; nurse instructed to given DPH; 9JUL92 local redness & swelling;
Patient has been complaining of burning in the shoulder since receiving the shot on 5/11/16; however patient went to ER on 5/16/16 and was given pain meds, muscle relaxer and a shot which he states did not help. He followed up with primary care doctor and is being refereed to a specialist. He states he can not sleep because of it.
No adverse event reported by parent as of 5/5/2022. Spoke with father, notified by providers office of vaccine matter.
This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had shingles twice). Previously administered products included ZOSTAVAX (received 2 years ago). On 14th June 2018, the patient received the 1st dose of SHINGRIX. On 14th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 15th June 2018, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 14th June 2018, Thursday, the patient received SHINGRIX on unknown arm and the injection was painful and arm continued to be sore. Next day after receiving SHINGRIX, the patient noticed baseball size redness and swelling about 4 inches below injection site. The patient was asked to if she could get the 2nd dose in 2 to 6 months. The patient was also scheduled for a cervical epidural on Tuesday. The patient was asking if there were any contraindications due to injection from getting the epidural. Clarification has been raised for the confirmation of latency and anatomical location for the adverse events (if erythema and swelling was at injection site or away from injection site).
Heavy menstrual-like bleeding and cramping. I have an IUD and have not bled monthly for approx 4 years.
fever up to 102.4, chills, headache, nausea, extreme weakness. this lasted for 36 hours
Fainting and welts on arm post dose; Fainting and welts on arm post dose; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A 20-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced fainting and welts on arm post dose on an unspecified date. Event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Woke up at approximately 3am on 05/03/2021 with sore arm. Around 9am on 05/03/2021 noticed large and swollen red mark that was warm to touch.  Went to urgent care on 05/04/2021 and was advised it was an allergic reaction to vaccine. On 05/05/2021 woke up to rash that has spread to full body, still have large swollen red bump on arm. Advised by urgent care this is another sign of an allergic reaction to vaccine.
severe tinnitus symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "severe tinnitus symptoms". It's been over 10 days.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Information has been received from a registered nurse concerning "whole wards" of children who were vaccinated with Recombivax HB. These children developed hepatitis B after vaccination with Recombivax HB. Additional information has been requested. Follow-up information received from a nurse stated that another patient's mother told her that while her child was hospitalized at the hospital for a liver transplant (WAES # 0707USA00679), there were other patients who had received hepatitis B vaccine (manufacturer unknown) that failed to seroconvert and had a "similar situation" like her son. The nurse could not provide any additional information since she did not take care of these patients.
Pain; Cold sore; Swelling of lip; Tingling to bottom lip; This spontaneous case was reported by a health care professional and describes the occurrence of LIP SWELLING (Swelling of lip), PARAESTHESIA ORAL (Tingling to bottom lip), PAIN (Pain) and ORAL HERPES (Cold sore) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 22-Apr-2021, the patient experienced LIP SWELLING (Swelling of lip), PARAESTHESIA ORAL (Tingling to bottom lip) and ORAL HERPES (Cold sore). On an unknown date, the patient experienced PAIN (Pain). The patient was treated with VALACYCLOVIR [VALACICLOVIR] at a dose of 2000 milligram X 2 doses. At the time of the report, LIP SWELLING (Swelling of lip), PARAESTHESIA ORAL (Tingling to bottom lip), PAIN (Pain) and ORAL HERPES (Cold sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient had restylane kysse  (lip filler) injected to the lips on 26 march 2021.
red bumpy rash on chest; feels like a pin prick, then itching; it spread to back, stomach, arms, legs, waist; red bumpy rash on chest; feels like a pin prick, then itching; it spread to back, stomach, arms, legs, waist; red bumpy rash on chest; feels like a pin prick, then itching; it spread to back, stomach, arms, legs, waist; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).     A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 27Feb2021, at 09:15 as single dose for covid-19 immunization at the age of 61-years.  The patient was not pregnant at the time of vaccination. Medical history included rheumatoid arthritis and asthma from an unknown date. Concomitant medications included verapamil (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; etanercept (ENBREL) taken for an unspecified indication, start and stop date were not reported; atenolol (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; morphine (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The  patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously took  Cosine comparing sulfur and experienced drug allergy.  On 27Feb2021, at 10:30, the  patient experienced red bumpy rash on chest; feels like a pin prick, then itching; it spread to back, stomach, arms, legs, waist. Details were as follows: one hour after the vaccine, the patient started getting red bumpy rash on chest. It felt like a pin prick, then itching occurred. It spread to her back stomach, arms, legs  and waist. It was now going on three weeks. Therapeutic measures included  unspecified many antihistamines and hydrocortisone cream, however the patient noted that nothing helped. The outcome of events was not recovered.
Pt. describes extreme fatigue and generalized body aches ot point of being bed-ridden x 2 days. No fever, nausea, diarrhea. Forced self up on 3rd day but fatigued and unable to do any activity. States able to eat and drink some but not usual amount.
extensive rash/hives to chest, arms and face with elevate pulse 103 - 109; bp 168/94 resp 16 spo2 98% on room air
Puss in the yesm itchy throat, swollen eyes, cough, Shortness of Breath.
4 DAYS POST ANTHRAX TO LEFT UPPER ARM, NOTED WALNUT SIZE, PAINFUL TO DEEP PALPATION, SPHERICAL, SMOOTH, LUMP LATERALLY JUST ABOVE LEFT ELBOW, APPROXIMATELY 8 INCHES FROM ORIGINAL INJECTION SITE