chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had extreme swelling on my upper right arm. From the elbow to the shoulder. I could not move my arm without extreme pain from Wednesday to Friday nor could I stand, eat or take care of myself. I slept for 48 hrs straight. The pain was a 10 plus if I moved. Today is Sunday and my arm still has swelling but much better. However I still cannot sleep at night as the pain returns. On Friday, I went to the pharmacy and they gave me this website to report it. I also had fever and chills at night. I have never had a reaction to these shots before. I am allergic to penicillin and its relatives. I told the pharmacy so. So what happened to me?
Patient came in for Pfizer COVID19 vaccination on 08/17/2021; Mother filled out paperwork stating patient was age 12. Paperwork was filled out false and patient was only 10 years of age. This is below the approved age for the EUA.  Called mother to notify her we would not be able to complete the second dose due to the unapproved age; mother reported no adverse effects for her child as a result of the vaccination.
Severe headaches, constant heart racing & feeling out of breath almost panic feeling, vomiting night of vaccine, body aches, very tired still, blood work affected along with my crohns.
Moderate Fatigue, extreme muscle soreness and loss of range of motion, pain at injection sight, mild headache
Pt received MENVEO vaccine in left deltoid. Pt began to turn pale within minutes. Pt began to seize? (eyes open, humming noise, vibrating, slumped over in chair) for about 30 seconds. Once pt placed on floor, she felt much better.
3-4?raised red itchy hive on upper FORWARD side of arm close to shoulder. Subsided and then returned. Still there.
Case described "flu like reaction" occurring within several hours of receiving vaccine. "Arm sore - appetite ruined." Next day - "okay."
Very tired; decreased appetite; sleeping less; less energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Very tired"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; INSOMNIA (non-serious), outcome "unknown", described as "sleeping less"; ASTHENIA (non-serious), outcome "unknown", described as "less energy".  Additional Information: Patient received two doses of Pfizer vaccine. She was given appointments at 2 weeks (14 days) apart instead of three weeks apart. Patient reacted in a way that resembles Covid. She is very tired, have decreased appetite, sleeping less, and have less energy. She don't have a thermometer so don't know if she has a fever. She wants to know if she is protected if it was given too soon.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On unknown dates, the patient was vaccinated with doses of GARDASIL (dose, frequency, route, lot # and expiration date were not reported). It was reported that the patient completed the series of GARDASIL receiving the last dose when she was 41 years of age. No adverse experiences were reported. Additional information has been requested.
Freezing; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing), PYREXIA (Fever) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced FEELING COLD (Freezing), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, FEELING COLD (Freezing), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Body temperature: 102.5 (High) Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up received on 15th March 2021 contains no new information
Pt reported severe pain to L eye radiating to side of head and ear. Pain is intermittent. Pain 9/10 initially, but now is 4/10 and intermittently occurring every 3-4 days. Pt describes a "swollen" feeling to her eye. Pt denies any change to vision. Pt states this is different than her sinus issues and pain is on side of her head.
Severe disequilibrium and gait changes noted 6 days later, on 10/6/21.  Difficulty in walking long distances due to severe lack of balance. I am very able to do normal daily work, but feel lack of balance, like I will tip forward. I have reported this to my PCP, and am taking  "wait and watch" approach.  I am myself a pediatrician, so am considering the possibility of vaccine triggered vestibular disorder or ( heaven forbid) demyelinating conditions
Edema, erythema, pain at sight, along with lymphadenitis, streaking into left axilla.  Vaccination on 04 Feb with smallpox vax with normal course up to day 10.  Keflex 250mg every 6 hours x 7 days
pt called hospital call center on 11/10/21 reporting side effects after receiving covid vaccine dose 2 on 11/8/21. c/o dizziness, weakness, chest pain x1 day (resolved), blurred vision, BUE pain, mouth numbness, loss of taste and pain in her feet. Pt denies SOB, or difficulty breathing.  Tried tylenol PRN but no relief. Pt was advised to go to ED for evaluation.
Injection site pain; Headache; Body aches; Low grade fever; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6727), via an unspecified route of administration in the left arm on 21Mar2021 at 15:00 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and high cholesterol. The patient was allergic to codeine (MANUFACTURER UNKNOWN) and BACTRIM. Concomitant medication included pravastatin (MANUFACTURER UNKNOWN) and fexofenadine (ALLEGRA); both for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 28Feb2021 at 14:30 (at the age of 57-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 07:00, the patient experienced vaccination site pain, headache, body aches, low grade fever and nausea. The patient did not receive any treatment for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site pain, headache, body aches, low grade fever and nausea were resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
New onset of LUPUS; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 (Lot number: EL9269) at the age of 51 years as dose 1, single and administered in arm right, administration date 03Mar2021 (Lot number: EN9581) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing); "barbiturates" (unspecified if ongoing). Concomitant medication(s) included: ESTROGEN; PROGESTERONE. Past drug history included: Percocet, reaction(s): "allergies"; Clindamycin, reaction(s): "allergies". The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant) with onset 22Feb2021, outcome "not recovered", described as "New onset of LUPUS". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Therapeutic measures were taken as a result of systemic lupus erythematosus.  Clinical course: Patient did not received any other vaccine in four weeks. Plaquenil was considered as treatment drug for the event. Patient did not had covid prior and post vaccination; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug BNT162B2 cannot be excluded. 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 and Investigators, as appropriate
Vesicular dermatomal rash (R) thorax on erythematous base developed less than 24hr after Zostavax administration.
rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
urticaria x 72hr;sl swelling tongue & lips x 24hr;rx claritin;
Fever, headache, chills, body aches same night shot was given. Next morning experienced vertigo and have been experiencing only vertigo for the past 7 days and unable to work or function like normal.
Body Aches, aching joints everywhere, it hurt to walk, ongoing pain focused on hands and wrists joints. In addition to the symptoms experienced allergic reaction, the doctor said it was a sinus infection. Referred to a cardiologist for ongoing treatment. The doctor diagnosed me with tendonitis.
hair loss; The initial case was missing the following minimum criteria: Unspecified Product. Upon receipt of follow-up information on (13Jan2023), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), 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), for Covid-19 immunization; Covid-19 vaccine (Dose 2), for Covid-19 immunization; Covid-19 vaccine (Dose 3), for Covid-19 immunization. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Course of events: Patient was losing her hair by the fistfuls. It kept clogging the bathtub drain. She did see a dermatologist that told her that the 4 vaccines she received was a major problem. Her physician recommended a special shampoo and conditioner which she cannot purchase because it is $66.00. Patient asked for help through this. It was traumatizing. She was very scared and unhappy.  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.
Shingles; Weakness; Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance; Ringing in ears; inner ear infection; sleeping most of the day; blank look in his eyes; Headache; Seeing things; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Seeing things) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Patient mole removed from his back and when after having the stitches removed, the incision opened.).   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HALLUCINATION, VISUAL (Seeing things) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache). At the time of the report, HALLUCINATION, VISUAL (Seeing things) had resolved and HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache) outcome was unknown.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.    Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-Jun-2021 contains non significant information; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Symptoms onset 5/22/2021 with cough, sore throat and fatigue.  Tested positive for Covid-19 on 5/24/2021.  Vaccinated on 3/20/2021 with Janssen.
Waited 30 minutes after injection felt fine and left.  At 45 minutes while driving home, began having severe itching on inside of mouth and feeling as though something was caught in my throat.   Took Benadryl at 6:30 p.m.   By 7:30 p.m. the throat symptoms had dissipated and itching in mouth calmed down.  Took another Benadryl at 10:30 p.m. and all symptoms were gone by 11:30 p.m.
Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching
No adverse event; Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose; 5 months old patient administered Moderna Covid 19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 months old patient administered Moderna Covid 19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 5-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 months old patient administered Moderna Covid 19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 months old patient administered Moderna Covid 19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 months old patient administered Moderna Covid 19 vaccine).    No concomitant medication was reported.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654129, US-MODERNATX, INC.-MOD-2022-654135, US-MODERNATX, INC.-MOD-2022-654136 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654129:same reporter US-MODERNATX, INC.-MOD-2022-654135:same reporter US-MODERNATX, INC.-MOD-2022-654136:same reporter
Swelling of lymph nodes in neck by the throat and sinuses feel stuffy. Feel tired.
Initial unsolicited case received from consumer via social media on 10-Oct-2016. This case is liked to 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851. (same source/site, same vaccine). This case involves a patient (age and gender not reported) who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (batch number, expiry date, route and site of administration: not reported) on an unspecified date (reported as in last year). Patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient experienced worst pain in thighs, it felt like patient had clamps tightening on thighs which was not intermittent, was horrible and constant and patient could not sleep at night. The patient described the reaction as bad and painful. Patient's lab data and corrective treatment was not reported. The reactions lasted for months, and on an unspecified date patient recovered from the events. List of documents held by sender: none.
This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (lot #, expiration date and dose were not reported), subcutaneously for prophylaxis instead of VARIVAX (wrong drug administered). No adverse effects were reported in the patient. No other information was available. Additional information has been requested.
Fevers, black and blue mark went to ER told vaccines were administer into wrong muscle very painful.
Patient feels like she is coming down with a vaginal yeast infection; Burning sensation; 2 days of fatigue/Tired; 2 days of fever; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL DISCOMFORT (Patient feels like she is coming down with a vaginal yeast infection), VULVOVAGINAL BURNING SENSATION (Burning sensation), FATIGUE (2 days of fatigue/Tired) and PYREXIA (2 days of fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 010A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced FATIGUE (2 days of fatigue/Tired) and PYREXIA (2 days of fever). On an unknown date, the patient experienced VULVOVAGINAL DISCOMFORT (Patient feels like she is coming down with a vaginal yeast infection) and VULVOVAGINAL BURNING SENSATION (Burning sensation). The patient was treated with ESTROGEN NOS on 05-Nov-2021 for Vulvovaginal burning sensation, at a dose of UNK dosage form. At the time of the report, VULVOVAGINAL DISCOMFORT (Patient feels like she is coming down with a vaginal yeast infection) outcome was unknown, VULVOVAGINAL BURNING SENSATION (Burning sensation) and PYREXIA (2 days of fever) was resolving and FATIGUE (2 days of fatigue/Tired) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Follow-up was received and adverse events added, treatment updated
Fever for 4-6 hr > 24 hrs post vaccine red, warm, swollen 3 X 5 cm around shot site
Patient reports after getting home, noticed redness and swelling. States swelling occurred from injection site to elbow. Redness, swelling and warmth noted to elbow today. Patient states improving since 10/02/02.