chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient had not received a tetanus shot, but instead had received 0.5ml of Tubersol/no AE; Initial information regarding an unsolicited valid non-serious case from Regulatory Authority (Reference number- 00438275) was received from a Pharmacist and transmitted to Sanofi on 20-Jan-2021.  This case involved a 22-year-old female patient who stepped on a needle over the weekend. She went to an urgent care and requested a tetanus shot. She received a call yesterday informing her that she had not received a TETANUS TOXOID shot (produced by unknown manufacturer), but instead had received a 0.5ml of TUBERCULIN TEST [TUBERSOL] via intramuscular route at an unknown administration site for Tuberculin test (Wrong product administered) (lot number and expiry date were unknown for both).  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency same day).   At the time of reporting, no adverse event was reported.  The patient then contacted her pharmacy to ask about adverse effects. No other information available from HCP (Health Care Professional), but she would provide telephone number to patient for direct follow-up.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There would be no information available on the batch number for this case.
Patient was found to have hyperkalemia of 6.1 as outpatient, and was referred to the hospital for further evaluation and presented on 04/09/21; the patient has been afebrile, no supplemental oxygen was required.
MEMORY PROBLEMS; CLOGGED EARS; SWOLLEN AND PAINFUL LYMPH GLANDS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, route of admin, and batch number were not reported) dose, start therapy date were not reported, and dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced memory problems, clogged ears, swollen and painful lymph glands, off label use, and inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from memory problems, clogged ears, and swollen and painful lymph glands, and the outcome of off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
On April 27th participant stated she woke up with a congested chest and shortness of breath. Called her doctor and she scheduled an appointment on the 5th of May and put her on antibiotics because her doctor said her heart didn't sound right did an x-ray on her chest and sent her to a heart doctor. Seen Dr. on May 17th and he did an ultrasound and an acro-cardiogram. Got her test results back on June 7th and everything tuned out fine.
receiving 2nd dose 13 days after the 1st one; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose 13 days after the 1st one) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027b21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose 13 days after the 1st one). On 02-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose 13 days after the 1st one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No Treatment medications were provided.
Pt did not have immediate adverse reaction, but learned she was pregnant after receiving the anthrax vaccination. She had neg urine HCG at the time of anthrax admin (Aug 13,2008), but had a pos HCG on Jul 15, 2008. Pt's EDC is July 15th, based on pt history. Pt was likely pregnant at time of anthrax admin.
Information has been received from a consumer and a school nurse concerning 41 child patients who in approximately 1995 were each vaccinated with a dose of varicella virus vaccine live. In approximately 2003, the patients developed mild cases of chicken pox. Most of the children were in the first grade and had been vaccinated at their private pediatrician's offices in the area. The reporter noted that her elementary school was the only one out of six in the area that has experienced a chicken pox outbreak. The reporter notified the elementary school parents of the outbreak. Follow up information from the nurse indicated that 13 of the reported 41 patients were not previously vaccinated with a dose of varicella virus vaccine live and all of the cases of chicken pox have recovered. One of the previously vaccinated patients was a 7 year old male patient in the first grade who on 8/1/97 was vaccinated with a dose of varicella virus vaccine live. The patient was vaccinated while his older brother (who is in middle school) was experiencing active chicken pox. In early March 2003, the patient developed a very mild case of chicken pox, which consisted of one on his chest and one on his neck... they were raised, pink in color and then faded. The previously vaccinated patients included two siblings in elementary school who were vaccinated by the same pediatrician and subsequently developed mild outbreaks of chicken pox. The other patients that developed chicken pox post vaccination with varicella virus vaccine live were also identified. Additional information is not expected.
Patient received vaccines on 9/30/2010. That evening began shaking, running 102 temp, heart rate was between 110-120.
Breakthrough Case of COVID and adverse reaction to the vaccine, So on Tuesday, 05/10/2022, took an at home test for COVID and it came out negative, because I had a tickle in my throat and cough and post nasal drip. then Wednesday on the 05/11/2022 I was feeling very tired, and by supper time I was feeling pressure in my upper back, chest, and left arm. So by that time, I went to urgent care in town and they did an EKG and they did not like what they saw and they sent me to the ER in town, at this point I was still testing negative for COVID, they also took an EKG and did not like the results so they sent me to another hospital for possible heart attack. So they determine that I did not have any blockages and they took another COVID test and this one came back positive. On the 13th they did an echo which showed decrease left ventricular ejection fraction. They diagnosed with Takotsubo Cardiomyopathy, and started me on remdesivir.
The next day at about 12pm patient complained of abdominal pain, at about 5pm he started vomiting and had a fever that persisted until the following day, up to 103. Could not keep anything down and had to be brought to urgent care, got zofran there.
Pt recvd 1st dose of Engerix-B & exp hives 20 hrs p/inject & joint swelling p/that time; tx Pred & Seldane; Event resolved; Pt will consult w/allergist for skin patch test & then determine whether 2nd & 3rd doses should be given;
Employee developed fatigue, muscle pain and lymphadenopathy 9 days after vaccination. 2 lesions - chin, (L) great toe pustular.
This spontaneous report as received from a company representative refers to an unknown number of patients. The patients were vaccinated (date and route of administration unknown) with VARIVAX (Merck) (lot number and expiry date not provided). No other co-suspects were reported. No concomitant medications were reported. The reporter heard from an unspecified employee that an unknown number of patients, who may have received VARIVAX (Merck) in the past, have been diagnosed with varicella. No treatment information was reported. The outcome of varicella is unknown. The relatedness for varicella is unknown for VARIVAX (Merck). The reporter stated that she is attempting to collect additional information. Additional information has been requested.
Scattered papular lesions on trunk/exts some with whitish/yellowish fluid, none with eschar yet, different sizes, blanch chickenpox.
pt exp exaggerated redness, irritation, induration & marked tenderness in lt deltoid muscle;cold compresses used to treat area;
10 days after receiving the last of two shots (Moderna) I was diagnosed with shingles, on my left side front and back.
Immediately after injection, sharp pain up the left arm and warmness and pain all over left side of body.  Fever, body aches and not being able to lay on left side due to pain for up to 32 hours after injection. 5 days after injection, period started 1 week early with heavy bleeding, cramping and lasted 3 full days longer. Period then started again after 3 weeks with heavy bleeding , cramping and lasting 3 days longer. After 5 months, period finally went back to normal time frame with normal bleeding. Bra size increased by 1.5 cups in a matter of 2 weeks after injection and weight gain of 20 lbs in 1 month. Bra size and weight stayed, were not related to regular menstruation cycle. There was not a change in diet or exercise between before and after injection that would've caused such a drastic increase in weigh gain or bra size. After weight gain, with an increase in physical activity and a better diet there is a struggle to lose any weight. Have never had issues with losing weight when changing eating habits and increasing exercise and have never gained such a large amount of weight in little time. Since the injection have experienced many episodes of irritability, depression, anger and irrationality.
Pt developed induration and erythema ( 3 X 3in ) at the site of injection accompanied by pain within 12 hrs of injection.
March 2, 2021 right arm was swollen I couldn't lift arm, bend, and I went to Chiropractor for treatment.
DIFFICULTY SLEEPING; SORE ARM; FATIGUE; This spontaneous report received from a patient 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 not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced difficulty sleeping. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced fatigue. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, fatigue and difficulty sleeping was not reported. This report was non-serious.
Systemic: Weakness-Medium, Additional Details: 1 day after 1st shot, patient extreme fatigue/weakness & felt like passing out while cutting grass. He had to take frequent breaks in order to complete that task which was abnormal for patient. 3 days later, he noticed a 150 lb difference in the weight that he could lift. He saw MD (okayed 2nd shot) who stated that there's nothing wrong & all labwork/bloodwork came back normal. MD & I aren't sure of cause but patient states nothing else in his life changed including medications & stress level.
Arm of injection site sore beyond expected timeframe. Painful to lift & move.  Shot was given too high.  Took 6-8 weeks to heal.
Raspy voice started 15 minutes after vaccine given.   Went to the ED.  Patient has history of throat swelling after flu vaccine.  Premedicated with Benadryl 50 mg PO.   VS 153/77, HR 86 O2 97% on room air,  Denied SOB or rash.   At ED stated sor throate and some difficulty breathing.  Feels like a tickle and need to cough to clear.  In ED given Solu-Medrol 125 mg IV once and Pecid 20 mg IV once.   Discharged from ED.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. Since 22-OCT-2016 to 31-JAN-2017, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M024261 with expiration date: 30-JUL-2018 (route and dosage schedule were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The administered vaccines experienced temperature of (48 grades Fahrenheit), more than 46 grades Fahrenheit but less than 77 grades Fahrenheit for 24 hours and on 02-DEC-2016 (33 grades Fahrenheit), between 32 grades Fahrenheit and 36 grades Fahrenheit for 60 hours. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004995: US-009507513-1702USA004996: US-009507513-1702USA004997:
I received the dose at 3:30pm and there were no problems with the administration of the vaccine. I went home and worked, I saw patients through telehealth for about 3 hours and when i was finished I watched TV and about 10:00pm I experienced severe chills. I couldn't control it I was so cold. I tried to go to bed with blankets all over me I was freezing. Then about 2am I woke up and my head was pounding. I went and took 2 Tylenols and tried to go back to bed it took me 2 hours to fall back to sleep. Then at 7am in the morning I was hot and burning up. I took my temperature and it was 102. I was also feeling nauseated, I felt sharp pains in my feet, dizziness, and my vision was blurry in both eyes. I called my eye doctor 3/22/2022 early afternoon and he advise me to up my eye drop medication for both eyes and to come back and see him today 3/23/2022. He looked and at my eyes and he couldn't find any evidence of structural rejection. He did confirm that my vision did get blurrier. He requested that I come back in two weeks. He recommended that I stay on the Procinolol for 4 times a day until the next visit.
Pt received the high Dose Influenza vaccine. Notified patient. pt has no reaction or no symptoms
Papular lesions noted on trunk, extremities, and face; started 4 days ago (6/19/06). PE sparse about 7 papulovesicular lesions noted all over possibly from varicella shot.
Soreness around injection site beginning within two hours; peak soreness within eight hours, lasting 24-36 hours; soreness decreasing rapidly 48 hours after onset. At worst: pain rating 10/10, significant impact on daily function. Onset of mild fatigue and body aches overnight ~12-18 hours after injection; symptoms subsided same day; minimal impact on function.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Carotid artery dissection in 2000. Concurrent medical conditions included Cholesterol (controlled high cholesterol), Blood pressure high and Supraventricular tachycardia. Concomitant products included CARVEDILOL, DILTIAZEM, SPIRONOLACTONE and FISH OIL for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment medication was reported   This case was linked to US-MODERNATX, INC.-MOD-2021-078336 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078336:cross linked to Dose 2
constant nausea; facial and sinus pain; facial and sinus pain; headache; Sore left arm; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Left arm on 20Feb2021 11:00 at the age of 40-years-old as unknown, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, on an unspecified date received in two weeks of vaccination. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. On 21Feb2021 at 16:00, the patient experienced constant nausea for 3 days, facial and sinus pain, headache, and sore left arm and did not receive treatment for adverse events. The outcome of events was not recovered.  No follow up attempts are needed. No further information is expected.
Local reaction in (L) upper arm of erythema & increased warmth with some edema, tennis ball sized in diameter. Tx: BENADRYL/CLARITIN with hydrocortisone cream topically.
Information has been received from a nurse concerning a 18 year old female who on 28-OCT-2008 was vaccinated with the first dose of GARDASIL (lot# 0947X). Concomitant therapy included multivitamins VI and calcium (unspecified). The patient had a seizure after vaccination and received medical attention while in the physician's office. Subsequently, the patient recovered from seizure. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
Patient was found in the parking lot, with blood on her face. She reported that she tripped over the turned tire of her car. She denies any issues related to the vaccine.  She refused treatment other than having a bandaid placed on her forehead. She had a cut on the right side of her forehead and abrasions to her right cheek.
Very Sick; Huge lump; Fever 102.8 Degree Fahrenheit; Chills; big red lump; received 0.5ml instead of 0.25ml dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), PYREXIA (Fever 102.8 Degree Fahrenheit), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (big red lump) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004FZIA, 00B21A and 006MZOA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Emphysema (taking Trelegy inhaler for emphysema.). Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for Emphysema.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Oct-2021, the patient experienced ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), PYREXIA (Fever 102.8 Degree Fahrenheit), CHILLS (Chills), VACCINATION SITE ERYTHEMA (big red lump) and ACCIDENTAL OVERDOSE (received 0.5ml instead of 0.25ml dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at an unspecified dose and frequency. On 12-Oct-2021, ACCIDENTAL OVERDOSE (received 0.5ml instead of 0.25ml dose) had resolved. On 14-Oct-2021, PYREXIA (Fever 102.8 Degree Fahrenheit) had resolved. On 16-Oct-2021, ILLNESS (Very Sick), VACCINATION SITE MASS (Huge lump), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (big red lump) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Oct-2021, Pyrexia: 102.8 degree fahrenheit (High) 102.8 Degree Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to HCP and was told to take Antihistamine for redness and ice pack on the injection site. Patient mentioned that she already reported to DOH and pharmacy about the dosage that was given to her last October.
chills; body ache; feverish; feeling unwell; nose running with lots of sneezing; nose running with lots of sneezing; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Feb2021 at 13:00 (Batch/Lot number was not reported) (at the age of 70-year-old) as single dose for COVID-19 immunisation.  Medical history included blood pressure (BP) abnormal from an unknown date and unknown if ongoing. The patient did not have allergies. The patient did not have COVID-19 prior or post vaccination. Concomitant medications included regular medications for BP (unspecified). On 10Feb2021, the patient experienced chills, body ache, feverish, feeling unwell, nose running with lots of sneezing. Therapeutic measures were taken as a result of the events and included treatment with TYLENOL 500 mg. The patient outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10mins post vaccination pt had a syncopal event with associated headache, L arm feels coldm and injection site soreness Pt was put in the the trendelenburg position @18:20 Vitals: 18:20 127/58, 72, 14, 100% -- > 18:35 (sitting) 119/59, 73, 16, 100% -- > 18:40 (sitting) 131/61, 61, 14, 100% Pt given water and advised to f/u w/ doctor. S/S improved.  Pt ambulatory and d/c w/ mother @18:45.  Instructed to increase PO intake x3days to 8-10 cupps each day.  Pt is 5'2" ~120-130lbs
1 hour after vaccine administration patient had generalized seizure tonic-clonic for 1 minute that self-resolved.  She has no history of seizures and a normal neurodevelopmental history.