chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female with a history of acne and no known drug reactions/allergies who on 10-JAN-2011 was vaccinated IM with a dose GARDASIL. Concomitant therapy included YASMIN. On 12-JAN-2011 the patient experienced tremors in both of her arms. She had no other adverse effects at that time. There was no lab diagnostics studies performed. The patient had not recovered from tremors in both of her arms. The patient sought an unspecified medical attention. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
I have developed ringing in the left ear and a rattling like crickets in my ear. Very loud and it won?t go away. I was sick the day after the 2nd dose with body aches and chills and now left with this noice in my ear.
SOB, nausea checked by EMS. 11:32am symptoms abating- breathing easier. Sent home
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), first regimen from 29Oct2021 (Batch/Lot number: unknown) to 29Oct2021 at single (dose 3 (booster), single), second regimen from 15Mar2021 (Batch/Lot number: unknown) to 15Mar2021 at single (dose 2, single) and third regimen from 15Feb2021 (Batch/Lot number: unknown) to 15Feb2021 at single (dose 1, single) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive; (2022) Negative; (2022) Positive; (2022) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received anti-viral product of Pfizer brand for covid -19 treatment start date 11May2022 and stop date 15May2022. After full course of Paxlovid, the patient tested negative 3 days in a row for covid. On the 4th day, she tested positive again. Other medication in 2 weeks included levothyroxine. No known allergies were reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 21 days after second vaccine, employee began to have neurological symptoms consisting of right side facial numbness, drooling, tongue numbness, right arm/foot numbness.  Employee was hospitalized for  nine days and diagnosed with Nervitis/Myelitis.  She has again been hospitalized (4/6/21) with worsening symptoms.
47 year old Female history of asthma (hx of intubation), LE DVT 2011 on xarelto and DM2 presenting with dyspnea. Admitted with asthma exacerbation triggerd by covid 19 booster 10/8/21. Responded to steroids and nebs. Pulm consulted. Patient weaned to room air and symptoms resolved. Plan to taper prednisone with pulm f/u as outpatient. Discussed with Dr and patient stable for discharge home.
Received a call from the mother that the child was taken to the ER by ambulance on 4/27/01 and diagnosed with febrile seizures. Mother recalls being instructed to give Tylenol every 4 hours for 24 hours but stated that she did not do so. The child was discharged on Motrin and Ceftroxil. Mother denies any allergies or medical complication.
I am normally like clockwork on a 4 week cycle, but got my period and then got another period following 2 weeks later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 (Lot number: EW 0169) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibrous dysplasia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot: EW 0169, Location: Arm left), administration date: 19Apr2021, for COVID-19 Immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 24May2021, outcome "not recovered", described as "I am normally like clockwork on a 4 week cycle, but got my period and then got another period following 2 weeks later". The event "i am normally like clockwork on a 4 week cycle, but got my period and then got another period following 2 weeks later" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: Her menstrual cycle became irregular immediately following the second shot. She was normally like clockwork on a 4 week cycle, but got her period and then got another period following 2 weeks later. It had been now been 4 months, and things had not evened out. This past month, she slipped her period entirely, with no chance that she was pregnant. She had reported this to her doctor but been waived off, being told that this was not a reported symptom of the vaccine, but several of her female friends had also noted the same they all see a direct link between when we got the vaccine and when things began to go wrong. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Covid tested post vaccination. No known allergies. Facility where the most recent COVID-19 vaccine was administered was Other.  Follow-up attempts are completed. No further information is expected.
no adverse event; Expired VAQTA was administered to a patient; Ths spontaneous report has been received from a medical assistant, concerning a 44 year old patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On 16-MAY-2022, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) for prophylaxis lot #T036739  and expirationd ate reported as 22-APR-2022 (Strength, dose, frequency and route of administration was not provided). No additional adverse event was reported.
22OCT98 very sore arm on lt side @ inj site, achy 23OCT98;welts around site approx 6, still very achy, now gen achy denies fever;
Patient states pain with administration particularly in left arm, general weakness/fatigue, constant ache/soreness in left arm. She treated with half a hydrocodone/APAP tablet, Naproxen, and Ice to area. Around 3:30 AM (10/5/18) patient reports going to restroom and fainting while on toilet and bumping her head on ground. She has a bruise on left arm and right temple. Later she starting to experience lower back pain as well.
Diagnosed with Covid_19 after fever, chills, myalgias, HA, Laryngitis, cervical lymphadenopathy
Client passed out and began vomiting immediately after receiving vaccine.  She was groggy and unresponsive for about 8 minutes, though she was breathing.  911 was called.  Client revived and was talking and alert, refused transport to hospital by ambulance.
This spontaneous report as received from a nurse refers to a 5 year old male patient. No medical history and concurrent conditions were reported. On 07-APR-2016 the 5 year old male patient was inadvertently vaccinated with GARDASIL 9 (inappropriate schedule of drug administration) (lot # L026602, expiry date 19-OCT-2017) (dosing regimen and frequency unknown). It was reported that the vaccine was administered due to human error. No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with GARDASIL 9 was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
1st vaccine received in April of 2021, just a sore arm.  2nd COVID vaccine received in May 2021,  continuous headaches that lasted weeks.  Booster COVID vaccine received in December of 2021, down in bed for days.  Horrible headaches and body aches.  As of today, January 2, 2022, still have headaches and soreness in the back of the head and neck.  My vaccines were all MODERNA
Symptom onset scratchy throat on Sunday, this is after known exposure from family. It progressed to low grade fever of 100.5 degrees. I also had chills, aches, stuffy nose, and mild cough as of today. I haven't had fever of temperature since Monday night. I started PAXLOVID standard dose pack on yesterday. I tested positive yesterday as well.
Temp excursion  occurred on 9/14 . Data logger report reviewed and temp was negative  -1.1 degree below recommended refrigerated temp of  2c to 8 c  from 8/3 through 9/14 .  Manufactured notified  that temperature range exceeded 72 hour parameter of acceptable excursion . Patient notified and recommended to repeat vaccination.
Body rash, fever, swollen lymph nodes, red/swollen throat, body aches
I noticed that within an hour of receiving my (007C21A) Dose 2 Moderna on 05/03/2021 that my menstrual cycle that I was in the middle of completely stopped for 24 hours. The next day when my menstrual cycle returned it was extremely heavier than my normal and I had server cramping. Subsequently, every period after was extreme heavy periods, extreme cramping, and extreme hormone imbalance, which included achy off with ache and more emotional before my menstrual cycle. I called my physician when I experience the initial stop of my period after Dose 2. Directives if menstrual cycle continued to stop, to give a call back, would wait and with the vaccination being new they did not have any recourse. Since the vaccination, I am currently pregnant, we waited the recommended three months; however, found it difficult to get pregnant. I do not know if this issue is resolved since I am currently pregnant. This pregnancy is more difficult or harder.
RED RASH AROUND INJECTION SITE AND COVERING GOOD SIZE OF UPPER ARM. PATIENT STATED RASH IS 'HOT TO TOUCH'. PATIENT IS GOING TO URGENT CARE AND MAY RECEIVE A PRESCRIPTION FOR ANTIBIOTICS.
Got home from a cruise and felt a little bad and had a cough. Someone we were on the cruise with did test positive so on 05/26/2022 I took a home test and it was positive. I contacted my doctor and he prescribed my PAXLOVID. I have completed the medications and have no symptoms. I barely felt bad at all and would not have even thought I was sick.
COVID; This spontaneous report received from a patient via a company representative concerned a female 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, and batch number were not reported) dose was not reported, administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On DEC-2021, the patient experienced covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid. This report was non-serious. This case, from the same reporter is linked to 20221225991. This report was associated with a product quality complaint: 90000262890.
Patient felt lightheaded after injection and was prompted to lay flat for a few minutes. No change in vital signs. Left facility with Mother. Per Mother after getting home still complained of leg weakness and lightheadedness.
Had 1st COVID-19 vaccine (pfizer) 1/5 1/13 noticed right lower eyelid started twitching (this is not a new issue for him and frequently happens when fatigued) 1/20 sharp intermittent pain in right inner hear pinna which stopped 1 week ago 1 week ago noted some slight right facial droop which has persisted 2nd vaccine given 1/26 (prior to him seeking care for symptoms) He was seen in my office on 1/29 where he was treated for Bells Palsy.
3  FULL DAYS OF VERY SORE ARM, SORE NECK, NAUSEA, ACHINESS, DIARRHEA, FLU LIKE SYMPTOMS.  NO FEVER BUT IN BED WHOLE TIME.
During my first two rounds, I noticed blurred vision. I thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.; During my first two rounds, I noticed blurred vision. I thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.; During my first two rounds, I noticed blurred vision. I thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 10:00 (Lot number: EL3247) at the age of 33 years as dose 1, single and administered in arm left, administration date 17Feb2021 10:30 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DIFFERIN; CLINDAMYCIN. The following information was reported: HEADACHE (non-serious), VISION BLURRED (non-serious), DRY EYE (non-serious) all with onset 22Feb2021, outcome "recovering" and all described as "During my first two rounds, I noticed blurred vision. I thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.". The event "during my first two rounds, i noticed blurred vision. i thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.", "during my first two rounds, i noticed blurred vision. i thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong." and "during my first two rounds, i noticed blurred vision. i thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, vision blurred, dry eye.  Additional information: Patient did not receive other vaccines in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient took Differin, Clindamycin medications in two weeks. During her first two rounds, she noticed blurred vision. She thought it was due to contacts, dry eyes, etc. and went to her eye doctor but he said nothing was wrong. It eventually went away but seemed to take several weeks of slightly blurred vision leading to headaches. A day or two after getting her booster, she had noticed the same slight blurred vision. Post vaccination, the patient had been tested for COVID-19 (COVID test post vaccination: Nasal Swab, covid test result: Negative). The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
CVA the following day Patient had vaccine on 1/14/21 and was admitted to the hospital 1/15/21.
Shingles vaccine. Pain radiating down left arm. Increasing pain over next 2 wk.  I saw neurologist who did tests diagnosed with brachial neuritis. I?m in hand therapy and have been on disability. Still don?t have much functioning in my fingers. It has been devastating.
1. Small rash (less than softball size) at injection site, beginning 1 week and 1 day after vaccine received.   2. Delayed onset of menstrual cycle. I am not pregnant.
PATIENT STARTED EXPERIENCING TONGUE AND FACE TINGLING. THIS PROGRESSED TO WHOLE BODY ITCHING.
Virtually no reaction until +/- 3 days after the injection. Then headaches and  pain in left shoulder and swelling in deltoid, which intensified over the course of the day, peaking that night. Left arm not functional during the latter hours due to pain on moving. It was subsiding by the next morning but followed by similar, though less intense Sx in every joint that has been injured at any time during the last 20 years, plus headaches. That continues now.
I felt fine throughout the day? just a little arm soreness until about 9pm, I felt extremely tired. I went to bed and woke up at 11:53pm with excruciating right arm / Axilla pain . Then the chills set in, I woke up at 5AM with profuse sweating., neck and back stiffness. That morning I noticed my axilla is largely swollen and very sore to touch. Today, continued axilla swelling and very sore arm.
ADMINISTRATION OF VACCINE STORED OUTSIDE RECOMMENDED CONDITIONS; This spontaneous report received from a pharmacist concerned a 54 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (series 1, initial dose from unspecified manufacturer). The patient received booster dose of covid-19 vaccine ad26.cov2.s (Janssen series 2) (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered into left arm on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-NOV-2021, the patient received vaccine after being punctured for 20 hours (stored under refrigeration) for booster dose (administration of vaccine stored outside recommended conditions). The patient was well otherwise. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine stored outside recommended conditions was not reported. This report was non-serious.
Patient was given Pentacel and IPV vaccine in same visit.  This is a double dose of IPV.
Pt developed 3 X 2 cm elliptical shaped reddened area on right deltoid at injection site.
Initial misuse report received from a healthcare professional (nurse) on 22 April 2014. A patient (no information regarding patient was reported) had received a dose of YF VAX (batch number, route, site and dose in series was not reported) on an unspecified date. It was reported that the YF VAX was reconstituted with sterile water and administered. No adverse event was reported. List of documents held by sender: none
Arm soreness at injection site, which was better he next day. And mild upper body aches that evening, which were gone in the morning. Tired for about 3 days.
Dose 1/7/21, second dose 4/21/21. They then noticed that he had received a first dose / on 10/15/18; Second dose 4/21/21 / Then noticed / a first dose / on 10/15/18; This case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too long in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th October 2018).   On 7th January 2021, the patient received the 2nd dose of Shingrix. In April 2021, the patient received the 3rd dose of Shingrix. On 7th January 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. In April 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient had received first dose of Shingrix at their clinic on 7th January 2021 and then noticed that he had received a first dose of Shingrix on 15th October 2018 at another location outside their network which led to lengthening of vaccination schedule. On 21st April 2021 patient reported that received second dose of Shingrix which led to extra dose administered. The reporter consented to follow up.
Cough, red eyes, sensation of something caught in throat. Vital signs stable Peak flow 350. Treated w/ 4 mg chlorpheniramine and albuterol inhalation tx.
4yo patient came in on 12/16/22 to receive 2nd dose of the Moderna primary series (0.25mL of the Moderna monovalent for 6mo-5yo). 1st dose given on 9/26/22 (lot # AS1412B). There was a miscommunication and he was instead given 0.25mL of the Moderna Bivalent for 6yo+ (lot # 024H22A). No adverse affect noted. This is reported as an administration error.
it feels like when she has an allergic reaction; nasal congestion; chest tightness; diaphoresis; This is a spontaneous report from a contactable pharmacist. A 35-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), intramuscular on the left arm on 26Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included allergy to seafood. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular on the left arm on 04Jan2021 08:00 for COVID-19 immunization. The most recent COVID-19 vaccine was administered at the hospital. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient complained of nasal congestion, chest tightness, and diaphoresis approximately 20 mins after the second COVID vaccine on 26Jan2021 10:30. She had an allergy to seafood and stated this was what it felt like when she had an allergic reaction. The patient received one dose of Benadryl 50 mg IV, famotidine 20 mg IV, Solumedrol 125 mg IV, Zofran 4 mg IV and normal saline 500ml bolus. Patient became nauseated after receiving Benadryl and improved after receiving medications. The events were reported non-serious and required emergency room/department or urgent care. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The reported allergic reaction with symptoms of nasal congestion, chest tightness, and diaphoresis occurred approximately 20 mins after the second COVID vaccine is considered related to the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and the known safety profile of the suspect.   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 RA, IEC, as appropriate.
Seven hours after vaccine given, Pt began experiencing itching. Had wide spread areas of bright pink, some what swollen and confident macules on both upper arms, thighs and down both sides of trunk. No respiratory symptoms of any kind. Benadryl 50 mg PO Q 4hours.