chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever up to 104, chills, vomiting, painful joints and muscles.  Reaction on site of injection Red, swollen and hard.
pt (pregnant estimated about 6 weeks received vaccine around 4:30pm 4/6/21 first dose. pt stated no previous hx of adverse rxn to vaccines. was able to walk to the post vaccine area and sat down and stated they felt well and fine. around 4: 40pm, pt had fainted after getting up. states did not injure themself or hit their head. walked pt into counseling imz booth, had feet elevated, provider water and ice packs. we monitor the patient for about an hour evaluating  every 5-10 min.  Patient stated they were feeling better. informed store management. pt was walked out with associate and had family member drive home. will fill out vaers
Patient contacted provider 12/26 with following symptoms: Dry cough, diarrhea, fatigue for 7 days. Covid test ordered and positive.  presented to ED on 12/31 and admitted into hospital.  Still inpatient as of 1/7/2021.
This spontaneous report as received from a physician refers to a 18 years old male patient. The patient had no pertinent medical history and no drug reaction/allergies. The patient was subcutaneously vaccinated with the first dose of 0.5 ml VARIVAX (Lot#0572AE, Exp: 15-MAR-2014) on 06-AUG-2012. No other co-suspects were reported. No concomitant medication was used. It was reported that the patient experienced hives and facial swelling 1-2 hours after administration of his first dose of VARIVAX (merck) on 06-AUG-2012. The patient called the office and was directed to take BENADRYL at home and the reported to the local emergency room. By the time of reporting the patient had sought medical attention and arrived at the emergency room, the symptoms had resolved so no further treatment was required. No lab diagnostic studies performed. The outcome was reported as recovered/resolved on 06-AUG-2012. Additional information has been requested.
R thigh red swollen puffy (localized reaction) 3/10/10, 3/13/10 pt broke out in full body rash - leg still very swollen spreading.
Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.; Total duration of the excursion refrigerated temps for max of 4 hrs.; Accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temp, re-frozen at the time of arrival.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for max of 4 hrs.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 06-Oct-2021, vaccine was moved to fridge. It was reported that the vaccines were shipped in refrigerated temps and then re-frozen for storage once arriving the facility. The vaccine was partially thawed/liquid and underwent temperature excursion for maximum of 4 hours.   No treatment medications were reported.
The patient received the vaccination on 5/8/19 and reported to the pharmacy on 5/12/19 that they experienced a severe allergic reaction that was described as having extreme difficulty with breathing. The patient decided to go to the ER for treatment.
Day after receiving vaccine itching mid back to under breast area and eruption of blisters on body in same area as itching rash.
she developed a sinus infection and was started on short term antibiotics/; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (Pfizer BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she received her first dose of the Pfizer BioNTech COVID-19 vaccine on 11MAR2021 and that following that, she developed a sinus infection and was started on short term antibiotics. She t received her second dose of the Pfizer BioNTech COVID-19 vaccine on 01ARP2021 and now her doctor wanted to start her on additional antibiotics as well as Prednisone. The event outcome was unknown.   No follow-up attempts are needed. No further information is expected.
At approximately 7:30 AM the following day, the patient woke up with the left eye being swollen and puffy as well as tender and slightly painful. Felt weird to blink but only in left eye. Took Acetaminophen 500mg and swelling decreased significantly around 2 hours later from the time it was first noticed.
About 5 minutes after I gave the patient his MENACTRA vaccine, he started feeling nauseous. Shortly after, he fainted. He was sitting down and fell to the floor. He was unconscious for only a few moments. He woke up quickly and understood where he was, what year it was, and who the President is. He had rug burn on his face and knee. He remained laying down until EMS arrived.
Developed cough on 9/20/13 after receiving FLUMIST on 9/17/13. Dx with croup at clinic on 9/22/13. Seen in office 9/23/13 with persistent croup and stridor. Given prednisolone x3 days.
Dose 1 Moderna 2/17/2021 Lot # N/A  Patient died at a local hospital 11/25/2021 from heart failure, pallitive care initiated. Not a Covid 19 death
Pt received vaccines two days before symptoms began. Pt had a fever starting at 2:00 am with a temperature of 103.5 taken axillary. Father reports giving patient tylenol which helped resolve the fever in two hours (at 4:00 am). Pt's temperature rose back up to 104.0 around 11:00 am that day and attending confirmed pt can take OTC medications to help with the fever. Pt is also having a productive cough.
Presented for chest pain on 3/30/22 to emergency and toponin and EKG were normal - DDX Neuritis; Represented to emergency on 4/1/22 8pm with worsening chest pain and dyspnea. Admitted to ER and Troponin levels severely elevated, echocardiogram diagnosed pericarditis with pericardial effusion, pleural effusion and abdominal effusion.  4/1/22 12:00 pm Emergency sternotomy and partial pericardectomy was performed.  In surgery a thymoma was discovered and removed.  Pericardium measured 1cm thick and appeared to be chronic in origin with an acute suppurative effusion and subsequent cardiac tamponade.
Headache, chills, and high grade fever lasting 5 hours (relieved with acetaminophen). General malaise lasting 30 hours. Site of administration soreness lasting 50 hours.
The individual was premedicated with 25 mg of Benadryl IM in the L arm. She was given the COVID Pfizer vaccine approximately 10-15 minutes after receiving Benadryl. Reported feeling like her throat started closing about 10 minutes after receiving the vaccine. She was provided with 2 doses of PO Bendaryl that she would take home with her. Instructed to take Benadryl PO q 8 hours for the next 72 hours. Family came to pick her up to take her home. She reported feeling better prior to leaving.
Rapid heartbeat for six hours beyond injection base line is 59 bpm - averaged 78-83  accompanied with extreme diarrhea during this time frame.  Beyond that six hours - Entire arm sore in the injected arm (too uncomfortable to lie on that arm overnight), fatigue, chills, fever at 93 degrees, or below  for up to 48 hours with this first injection.
This case was reported by a consumer via call center representative and described the occurrence of limbs stiffness in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included breast cancer (didn't get any vaccine or bloodwork done in right arm). Previously administered products included herpes zoster live-attenuated vaccine (received ZVL vaccine 5 years before the reporting date) and Flu vaccine (received every year). On 17th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced limbs stiffness and pain in arm. In April 2018, the outcome of the limbs stiffness was recovered/resolved. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the limbs stiffness and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in left arm. The caller reported that, the day after vaccination with SHINGRIX experienced stiff arm, lasted 3 days. It was like a tenderness, which the patient experienced when vaccinated with flu vaccine. Every year, the patient received flu vaccine, but did not always experience tenderness. The health care professional (HCP) not asked. This case linked with US2018GSK162375 and US2018156131, reported by the same reporter.
Developed a rash on face and neck. Redness and inflammation of skin on the face.
Within approximately 5-10 minutes of vaccine administration, pt. c/o momentary changes in vision, was pale and diaphoretic and vomitted.  VS as follows:  BP 90/60, AP 88 & reg, RR 20 and reg. Lungs clear, no wheezing.  No hives or rash. Injection sites right and left deltoid regions unremarkable for signs of local reaction. Sent to ER for further evaluation. Left clinic ambulatory with father and brother only c/o alternating hot and cold "flashes" and continued pallor. 17 year old brother received same immunizations (Hep A #2 and menactra) without reaction, however his menactra was a different lot number.
Administration Error - Patient received 1mL of Janssen CoVid-19 dose instead of the intended 0.5mL G1P0,  16wk5d, EDD 10/28/21, 109lb
35yo Female, previously healthy (body builder, nursing student), hx long covid (Dx 8/2021, symptoms lightheaded/sob resolved 1/2022) presenting with daily symptoms of nausea, lightheadedness, headache, weakness, cold intolerance, numbness in arms, and severe episodes of sob. These symptoms began 2 days after receiving Moderna booster on 4/22/22 (HC says 4/21, but patient states 4/22). Neg COVID PCR in ER, pt also states neg COVID rapid tests at home when sx began. She has had multiple ER visits, followed up w PCP, labs overall reassuring, neg CXR, CT head normal.  Infectious Disease specialists feel not related to vaccine, but recommend VAERS. Patient recieved JJ vaccine as first covid vaccination 3/12/21.
Incontinence; Aches all over the body; Shortness of breath; Fever > 102°F; Headache; Pain in the arm of the injection; Tiredness; A Spondaneous report was received from a Healthcare professional concerning a 70 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pain in the arm of the injection, Tiredness, Incontinence, Fever > 102°F, Aches all over the body, Headache, Shortness of breath, sore arm  The patient's medical history was not given. No information about the concomitant medication was given. On 22-01-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 batch no: 011J20A  intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22-01-2021, The patient experienced Pain in the arm of the injection, Tiredness. On 23-01-2021, the patient experienced incontinence, Fever > 102°F, Aches all over the body, headache, Shortness of Breath, Sore arm.  The laboratory information is not given. The patient was given Tylenol as treatment medication.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events pain in the arm of the injection, Tiredness, Incontinence was resolved on 24-01-2021. The outcome of the events , Fever > 102°F, Aches all over the body, headache, Shortness of Breath, Sore arm are unknown.
pt. woke w/hives on lower extrem feet and hands, swollen mouth. Extreme facial swelling. Admitted to hosp for heart arrythmia. RX steroids, benedryl, digitalis, cardizem. Continues w/hives;60 day follow-up states the pt has recovered.
Patient reports pain in chest. Patient is evaluated by personnel at medical emergency. Vital signs are monitored. BP 140/90 P 90. Sat% 99 Dx. 140mg/dl. Doctor is notified by phone. Patient is observed for 30 minutes. Patient indicates not having taken her blood pressure medications and indicates a history of Costochrondritis. Symptoms are reevaluated and vital signs BP 130/80 P 86 Sat% 99. Patient reports feeling better.
Complained of welts on arms, face, eyes red and burning on and off. No other problems. Sent the child to ER for further evaluation. Left message with Mom to call back with progress. Never received call back.
Patient received a bivalent Pfizer booster on 10.12.22. COVID vaccination received on 8.18.22. This is 55 days from previous dose and does not meet current EUA guidelines of receiving the bivalent booster at least 2 months after a previous vaccination (4 day grace period allowed would be 56 days) so this is 1 day too soon.
Client received both one dose of Pediarix and one dose of IPV in the same visit.
Multiple clusters of up to 5mm vesicular lesions on left anterior, medial and lateral thigh with a few lesions on anterior knee. Itching. c/o leg hurting since shots given 3 weeks ago, but mom just looked at skin, noted rash today. No tx given yet, I am prescribing hydroxyzine for itching and topical 1% hydrocortisone today.
This spontaneous report was received from a medical assistant regarding unspecified number of patients of unknown age and gender. The medical history of patients and their concurrent conditions were not reported. On an unknown date in 2016 (also reported as starting on or after 25-MAY-2016) unspecified number of patients were administered with improperly stored doses of ROTATEQ (lot # L033543, expiry date 30-MAY-2017) (therapy type digital data logger) dosing details and route unknown. Concomitant medications were not reported. The administered vaccines were subjected to temperature excursion of 63.3 degree F for a time frame of 2 hours and 1 minute. It was reported that the vaccines administered were not subjected to previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not filed. This is one of the three reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "wet AMD" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received covid-19 treatment with Anti-viral Product, Brand Pfizer (Lot number GF1137) from 13Feb2023 till 17Feb2023. Vaccine lot unknown reason for suspect product (dose 5) was stated as Misplaced/discarded. Patient Known allergies stated as NKA.  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.
This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient, who had gotten the pneumonia shot 5 days earlier, experienced pneumonia. Due to the event he was hospitalized. Outcome of the event was unknown.
FEVER; BODY ACHE; SORED ARM; HURTING ARM; This spontaneous report received from a consumer 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: Unk) dose was not reported, in her right arm on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 17-MAR-2021, the subject experienced sored arm. On 17-MAR-2021, the subject experienced hurting arm. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced body ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sored arm, and the outcome of hurting arm, fever and body ache was not reported. This report was non-serious.
Intense arm pain w/in 3-4 hrs of shot. Temp (104) w/in 12 hrs of shot. No redness or warmth at site.
got numbness and tingling all around my mouth and lower parts of my face; got numbness and tingling all around my mouth and lower parts of my face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (got numbness and tingling all around my mouth and lower parts of my face) and PARAESTHESIA ORAL (got numbness and tingling all around my mouth and lower parts of my face) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement in 2019. Concomitant products included LISINOPRIL, ROSUVASTATIN, METOPROLOL and ALLOPURINOL for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced HYPOAESTHESIA (got numbness and tingling all around my mouth and lower parts of my face) and PARAESTHESIA ORAL (got numbness and tingling all around my mouth and lower parts of my face). At the time of the report, HYPOAESTHESIA (got numbness and tingling all around my mouth and lower parts of my face) and PARAESTHESIA ORAL (got numbness and tingling all around my mouth and lower parts of my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported
vax given 1030Am 17JUN93; 18JUN92 330AM pt taken to ER w/high fever & sz, given medicine to reduce fever & released;
Patient received Moderna COVID vaccine on 2/11/21 and 3/11/21. On 9/16/21, patient tested positive for COVID in the community. On 9/26/21, patient admitted to our facility for acute respiratory failure with hypoxia due to COVID-19 pneumonia. As of 9/29/21, patient is still admitted in our med/surg unit.
Dry mouth; chapped lips; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on the left arm on 11Mar2021 at 09:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included obese, high triglycerides, prostate cancer treatment 5 years ago. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included lisinopril (MANUFACTURER UNKNOWN), VASCEPA, rosuvastatin (MANUFACTURER UNKNOWN) and fenofibrate (MANUFACTURER UNKNOWN). Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 07:00, the patient experienced dry mouth and chapped lips after five days of first vaccination. No therapeutic measures were taken for the reported events. The clinical outcome of the events dry mouth and chapped lips was resolving.   Information about lot/batch number cannot be obtained. No further information is expected.
4 cm x 4 cm reddened induration at vaccine site (R deltoid)
Presented to ED w/cough, congestion, & SOB; admitted for COVID PNA & acute resp w/hypoxia; hi-flo O2 started; 10/22 -tx w/bronchodilators, steroids, Levaquin; 10/23 - added Ceftriaxone & Azithromycin and thiamine; pt weaned to RA prior to DC & discharged home.
Flublock was given inadvertently to a 10 year old child, no AE; Initial information received on 03-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 10 years old male patient who was vaccinated with a 0.5 mL dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1901, expiry date: 17-May-2020 via unknown route in unknown administration site on 21-Aug-2019.  It is an actual medication error case due to Inappropriate age at vaccine administration.  It was not known whether the patient had any adverse event or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.  List of documents held by sender: none.
Light headedness an  hor after receiving. Fatigue in same time line.  Premenopausal but had just completed typical light, short menses cycle 3 days prior to vaccine.  The next night memses retumed and was very heavy , clotty and accompanied by cramps. I usually dont havr cramps, and i havent had a heavy period like that for seveal years. Still occurring on day 5 after vaccination. Typical periods are 3 days of minimal show.
I had a sore arm for about a day after receiving the vaccine.  I felt fatigued and a runny nose a couple of days before testing positive for COVID-19 on 11/25/2022. I contacted my doctor, and she did not recommend Paxlovid. This COVID-19 infection made my long COVID-19 symptoms worse. I am taking physical therapy and try to rest as much as possible. My asthma is worse again since having long COVID-19. I have trouble with foggy brain symptoms.