chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4 / moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Lot number: GJ3277) at the age of 55 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0158), in left arm, on 04May2021 as dose 2, single (Lot number: EW0173), in left arm and on 04Nov2021 as dose 3 (booster), single (Lot number: FD0809), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23May2022 as dose 4 (booster), single (Lot number: 037A22B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight (210 pounds, 5'10")" (unspecified if ongoing), notes: Other medical history: Overweight (210 pounds, 5'10"); "complex sleep apnea" (unspecified if ongoing), notes: Other medical history: complex sleep apnea. The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23May2022, outcome "unknown", described as "Dose Number: 4 / moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Body height: (unspecified date) 5'10", notes: Overweight (210 pounds, 5'10"); SARS-CoV-2 test: (06Apr2023) Negative, notes: Tested negative on 06Apr and 07Apr on home test; (07Apr2023) Negative, notes: Tested negative on 06Apr and 07Apr on home test; (10Apr2023) Positive, notes: Symptoms resumed on 10Apr and tested positive on home test; Weight: (unspecified date) Overweight, notes: Overweight (210 pounds, 5'10"). Therapeutic measures were taken as a result of vaccination failure, covid-19.
A patient was administered a dose of improperly stored ROTATEQ; No adverse effects; This spontaneous report was received from a medical assistant referring to a patient, age and gender were not reported. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unspecified date, the patients were vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally,  for prophylaxis (lot # S000961 has been verified to be a valid lot number stored rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 19-OCT-2020) (strength, dose and frequency were not provided).   The temperature of storage and time frame of the excursion were above 47° Fahrenheit and 37 minutes. A digital data logger was involved but there was no previous temperature excursion. No adverse effect was reported.
Developed significant deltoid swelling, severe pain, muscle spasm, and limited range of motion x4 weeks.  Required prolonged steroid taper.  Developed axillary neuropathy following initial period of inflammation.
I had more of a cough and a low grade temp and general malaise. I took ibuprofen and Tylenol alternately.
Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who received their first Primary Covid-19 vaccine quite a long time ago More than 35 days between doses of the Moderna COVID-19 vaccine).    No concomitant medications were reported.No treatment details were reported. Reporter was asking if patient had to get second dose of Moderna vaccine series.   Reporter did not allow further contact
Hives and itching around the neckline for >15 minutes after giving but only lasted about 2-3 hours. No trouble breathing and medical assistance was not deemed necessary.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 19-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802, oral for prophylaxis. Concomitant therapies included PREVNAR 13 and HIB CONJ VACCINE (UNSPECIFIED CARRIER). On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-1707USA006507.
Chills around 7:00PM, Rapid heartbeat at 7:30PM, Fever 2:00AM on 2/18/22, Missed menstrual cycle on 2/26/22.
9 days p/vax pt exp neurological ills, including vertigo, swollen glands, sore throat, earache, inability to concentrate, vision disturbances (inability to focus & blurring), stiffness in neck & joints; 3 wks later EPV; upper resp viruses;
GARDASIL 9 was inadvertently given to a patient who was pregnant; therapy start date: 13-MAR-2017/ was given GARDASIL 9 before the office gave her an urine pregnancy test/ AE Onset date: 31-JAN-2020; GARDASIL 9 was inadvertently given to a patient who was pregnant; patient came into office for irregular bleeding; This spontaneous prospective pregnancy report was received from a medical assistant (also reported as nurse) referring to a currently 14-year-old female patient. The patient's concurrent conditions included depression and suicidal ideation. The patient's concomitant medication included medroxyprogesterone acetate. The patient had no previous drug allergies or reactions.       On 13-MAR-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 intramuscular injection as prophylaxis (strength, anatomical location, lot number and expiration date were not reported).  On an unspecified date, the patient experienced irregular bleeding (menstruation irregular).  On an unknown date, the patient became pregnant. The last menstrual period (LMP), the estimated date of delivery (EDD), and the estimated date of conception were not reported.   On 31-JAN-2020, the patient went to the physician's office due to the irregular bleeding, and was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 intramuscular injection as prophylaxis (dose number, strength and anatomical location were not reported; lot number R029512 has been verified to be valid, expiration date reported and validated as 08-JUL-2021) (inappropriate schedule of product administration) before the office gave her an urine pregnancy test which came back positive (vaccination error and exposure during pregnancy).   It was reported that the patient did not sought medical attention (conflicting information), did not received any treatment for the events, and that the therapy would be continued.  The outcome of the menstruation irregular was reported as recovered.  The causal relationship between the suspect therapy and the menstruation irregular was not reported.
pt recv vax 8NOV96 & 26NOV96 pt was again found to have elevated liver enzymes;pt has no sx other than elevated lab values;no tx given;
No additional adverse events reported; the patient was administered an improperly stored dose of MMR II that was reconstituted with a properly stored dose of diluent.; This spontaneous report has been received from a pharmacist, referring to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent. The patient's pertinent medical history and drug reactions/allergies were not provided.    On 16-JAN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (1 dose, lot # R030813, expiration date 24-OCT-2020; strength and route were unknown) for prophylaxis that was reconstituted with a properly stored dose of diluent.   The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was stored above 47 degrees Fahrenheit (74 degrees Fahrenheit) for 13 hours (product storage error). There was no previous temperature excursion. There was data logger involved. There was no additional adverse events reported (no adverse event).
"I took vaccine of Pfizer, was it yesterday at 9:15 and I was okay but now after 2 or 3 hours I got a fever."; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that, patient took the Pfizer vaccine at 9:15, patient was fine but currently after 2 or 3 hours patient got a fever. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
No adverse reactions within a month of receiving the April 2022 booster. In addition, I did not have any adverse reaction to the original COVID-19 immunization, nor to any of the other booster vaccines.    On December 24, 2022, I began feeling bad with a low-grade fever (under 100 degrees F). I also had a sore throat. About 5:00PM, I used an at-home test I had available; that test showed positive for COVID.   On December 25, 2022, I went to an available outpatient clinic. I was seen by a Nurse-Practioner. She administered another COVID test, which also returned a positive result. She said I had very mild symptoms. Because of the mild symptoms plus the fact I was using Rosuvistatin, she said I was not a candidate for Paxlovid. I used over the counter medications and all of my symptoms were clear by 27DEC2022.
Several weeks after the Covid vaccination I noticed a humming in my ears, which was mild at first but has become louder over time. This is devastating since I have good hearing and there is NO family history of this illness.
Presented to the ED on 12/7/21 via EMS after suffering 4 falls earlier today admitted for PT/OT and possibility of placement to a SNF. Found to be COVID positive on 12/7/21. She has been previously vaccinated with Moderna. Second dose was given in April 2021. Patient is overdue for her booster. Patient denies any loss of taste, smell, cough, shortness of breath or generalized fatigue.  Upon admission she tested post to COVID-19 and was noted to be hypoxic and was requiring 7 L of oxygen initially though initial chest x-ray was negative for pneumonia.  Subsequent chest imaging with CT angiogram done 12/15/21 did show extensive COVID-19 pneumonia without pulmonary emboli.  She received  appropriate treatments including Decadron, remdesivir and  antibiotics. She was followed by the  Pulmonary Service. Unfortunately, on 12/18/2021, her condition deteriorated while on BiPAP with FiO2 of 100%. She had a DNR status. Family decided to  transition to comfort care on 12/20/21 which was done and she sadly expired on 12/21/21 at 0505 AM.
Rash all over my back. Almost looked like little bug bites or shingles, but they were neither.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient received BNT162b2 (BNT162B2), 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) at the age of 55 years for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Apr2022, outcome "not recovered" and all described as "test positive on 15Apr2022, I had 2 Pfizer COVID vaccination and 1 booster". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Apr2022) Positive; (24Apr2022) Negative; (26Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information: Patient received on 16Apr2022 Paxlovid for COVID Positive. tested positive on 15Apr2022, tested Negative on 24Apr2022, tested Positive on 26Apr2022. Fine now. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feels "cruppy", wobbly and weak and thinks he may have a fever, but has no thermometer. Lasted approx 12-14 hours.
1) Major reaction at site of vaccinia vaccination 2) papules over rt distal forearm and (L) hand; 7-2007 -> 7-23-07 (resolved)
Two days after getting the second dose, my heart rate felt high so I took an at home EKG with my Kardia and I was in tachycardia which had never happened before. Since then, I have felt my heart "skip" or palpitations frequently while performing mundane chores like cooking or vacuuming, unlike in the past.
Patient received vaccine, sat for 1 minute , was told to wait in waiting area for 15 minutes before leaving store. After sitting in waiting area for less than 1 minute, patient had what appeared to be a seizure. Arms and  legs stiffened up and patient was shaking. Event lasted less than 5 minutes and the patient slowly regained strength and consciousness. 911 was called and the paramedics evaluated patient. Mom said patient was evaluated in parking lot by paramedics and vitals had returned to normal. Since the event mom says patient has not had any other related issues.
Information has been received from a medical assistant, via a company representative, concerning a female patient (age not specified), who in late December 2007 or early January 2008 was vaccinated with the first dose of GARDASIL (lot # not reported).  Concomitant therapy included an unspecified vaccine.  Following the vaccination, she became dizzy and her heart rate dropped.  The patient stated that she had not eaten yet that day.  The outcome of the events was not specified.  This is one of several reports received from the same source.  Additional information is not expected.
inc temp 99.8, c/o h/a, arm red & swollen 18 hrs p/inject; Seen 5SEP dec temp 98.8 AX; Pt active but arm reddened slightly warm to touch delt to elbow; By 6SEP AM no temp, active no redness nor warmth;
I gave the patient a Moderna 0.5 ml dose instead of a 0.25 ml dose. Patient was monitored for 30 mins while she was at work at the Health Dept.. She had no adverse effects
This spontaneous report was received from a medical assistant, concerning unspecified patients of unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On unspecified dates between 03-APR-2017 and 17-APR-2017, the patients were vaccinated with improperly stored doses of VARIVAX injection (dose, frequency and route were not reported) lot # M040139 with expiration date of 28-SEP-2018, for prophylaxis. The sterile diluent (manufacturer unknown) used to reconstitute the VARIVAX was not improperly stored. The temperature of the VARIVAX was between 6 °F and 14 °F for a time frame of 4 hours and 30 minutes, and between 15 °F and 46 °F for a time frame of 6 hours and 25 minutes. Also, a previous temperature excursion occurred between 6 °F and 14 °F for a time frame of 11 hours and 35 minutes. No adverse effects were reported. Data logger was involved. Additional information has been requested.
didn´t received the second dose of Havrix/ first dose was given during 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 37-year-old male patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, a patient did not received the second dose of Havrix at time, which led to incomplete course of vaccination. The reporter consented to follow up.
no adverse effects - just under the age of 18 17 years and 8 months old
PATIENT RECIEVED SMALLPOX VACCINE ON 28 JAN 2019. PATIENT PRESENTED TO PRIMARY CARE MANAGERWITH CHEIF COMPLAINT OF CHEST PAINS, SUBJECTIVE FEVERS, HEADACHES, NAUSEA, PLEURITIC CHEST PAIN. WAS SEEN BY DR., (06 FEB 2019 08:22AM.) PATIENT WAS THEN TRANSPORTED VIA PRIVATE VEHICLE TO EMERGENCY DEPARTMENT FOR EVAC AND FURTHER TREATMENT.
pt exp erythema & swelling @ inject site w/in 20 minutes p/vax; rxn appeared similar to a cellulitis, however, no evidence of infect; tx w/Ecotrin, Ornade & seldane;
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 68-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUAD (TIV) vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 06-Sep-2018, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804078 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
I went to the UTC on 4/1/2021 for a bruise/ hematoma to my right knee that was approximately 7?x 5? and extended down my leg, slight swelling. No pain was associated and no injuries occurred to have unexplained bruising. The CNP was unsure of what it could be. I expressed my concerns about Thrombocytopenia and being post covid vaccinated.
receiving a false positive covid test; This is a spontaneous report from a contactable nurse (patient). A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 13Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced a false positive covid test in Jan2021. On20Jan2021, the patient received monoclonal antibody infusion. The outcome of the event was unknown. The patient wanted to know if it safe to start the process over again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
High fever, ache (body) difficult breathing, tightness in chest, headache, coughing, sharp chest pain, fatigue, burned vision.
Vaccines were given at around 1030. Mom brought child back at around 1330 because of itchy rash on trunk, arms, neck. On exam, child was coughing but no wheezing. Oropharynx normal. She had hives on trunk. Will have her take BENADRYL and f/up 4/3.
THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE SECOND DOSE WAS GIVEN ON OCTOBER 1, 2022 WHICH HAD AN MANUFACTURER'S EXPIRATION DATE OF 09/30/2022.  WE HAD A LABEL WITH EXPIRATION DATE OF 10/21/2022 WHICH WAS 10 WEEKS AFTER RECIEVING SO I GAVE A DOSE THAT I THOUGHT WAS STILL IN DATE BUT HAD EXPIRED BY ONE DAY.
Pt received Hep-B vax to right deltoid. Noticed itching, swelling, redness that evening. Over next few days swelling and redness increased. Patient seen in office and dx with cellulitis vs allergic reaction. Did have warmth of skin in affected area.
Hives (Urticaria); Whole body itch; Taking Hydroxyzine hcl 25 mg as needed
me too, but I still got shingles/Suspected vaccination failure; shingles/ Still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 1-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The reporter denied to follow-up. The patient stated he/she too, but still got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Suspect was coded as per narrative information.
Normal rxn at site of shot. About to pass out in ER.  Rash. Rash still occurs when bathing, 6 wks later. Didn't feel this way until after vax and meds. Dr testing to see if allergic to shot.