chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adverse reaction; swelling at injection site; itching at injection site; redness at injection site; hot to touch; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot to touch), ADVERSE REACTION (adverse reaction), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asymptomatic COVID-19. Concurrent medical conditions included Sulfonamide allergy (Sulfa). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PARACETAMOL (TYLENOL), OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and GABAPENTIN for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FEELING HOT (hot to touch), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, FEELING HOT (hot to touch), ADVERSE REACTION (adverse reaction), INJECTION SITE SWELLING (swelling at injection site), INJECTION SITE PRURITUS (itching at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       BP medicines & antibiotic were used as concomitant medications. No treatment medications were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: New event Adverse reaction added.
Most people get anxious; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Most people get anxious) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Most people get anxious). At the time of the report, ANXIETY (Most people get anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.
Patient states that she started having tingling around the left side of her lips on the evening of 10/27/17. She is concerned that it might be an adverse effect from the vaccine. She has had no other new medications. I told her she should check with her Dr if it continues.
the patient received a booster dose of Adacel before the ten years of tenivac with no reported adverse event; Initial information received on 04-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 54 years old female patient who received a booster dose of diphtheria-2/tetanus/5 ac pertussis vaccine [adacel] before the ten years of tenivac with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, tetanus vaccine toxoid (tenivac) for Prophylactic vaccination.  On 29-Dec-2022, the patient received a 0.5 ml dose once total of suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot: U7561AA; expiry date: 09-Nov-2024; strength: standard) via intramuscular route in the right deltoid for Immunization.  On 29-Dec-2022 the patient received a booster dose of adacel before the ten years of tenivac with no reported adverse event (inappropriate schedule of product administration) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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 were no adverse, the vaccine was given too early. This was reported to supervisors and doctor. No further test nor orders requested.
COVID Breakthrough  Pfizer Dose 1 1/30/21 (EL3302) Pfizer Dose 2 2/27/21 (EL9263) COVID Positive 8/20/21 Urgent Care Visit 8/20/21  8/28/21: History is obtained from patient as well as by personal review of records.  Patient is 81-year-old with known history of multiple medical problems.  Has coronary artery disease, portal hypertension, portal hypertension insulin-dependent diabetes mellitus, sleep apnea, stage 5 chronic kidney disease requiring peritoneal dialysis and other medical problems.   She has started having subjective fevers, cough, myalgias, sore throat is on 8/17/2021.  Her daughter who lives with patient had COVID-19.  She was evaluated on 8/20/2021 and tested positive for  SARS-CoV-2.  She presents to emergency department with worsening shortness of breath.  Worsening myalgias and subjective fever.  Blood gases showed arterial PO2 of 57 on room air.  She feels better after oxygen supplementation.  She is not a ideal candidate for remdesivir therapy in view of stage 5 chronic kidney disease.  Denied hematemesis, melena or hematochezia.   Chest x-ray showed bilateral pneumonia.  Will hold off on radiocontrast administration for now in view of chronic kidney disease.  8/31/21: Patient was admitted on August 29, 2021 for evaluation of COVID.  Initially patient was thought to be hypoxic and was placed on 1 L nasal cannula however no hypoxic readings were shown.  When the patient reached the floor the patient was placed off of oxygen.  Nephrology was consulted and resumed peritoneal dialysis.  Patient passed a walk test and determination for home O2.  Patient will be discharged with antibiotics and p.o. steroids
Chills, low grade fever, legs felt like Jell-O, and ties were very cold.
Patient received MODERNA BOOSTER vaccine on 11/17/2021.  Symptoms of "heart racing", pain and tenderness under left axilla, and left scapula.
I felt like I had a cold; I had a scratchy throat and felt a little off like I was coming down with something. The next day, my husband came down sick, and we both went over to the urgent care near our home. We took an at-home COVID-19 test prior to going to urgent care on 02/04/2023 which both came back positive for both of us. While at urgent care, they examined our throats and lungs and prescribed Paxlovid for treatment. We took the prescription course and all was well after.
Initial unsolicited report received from a non-health care professional on 14 October 2015. This case involves a (age unknown) female patient who was vaccinated with a [route and dose series not reported] 0.5 ml syringe dose of FLUZONE QIV (batch number, expiry date and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient had increased blood pressure. Patient laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none. Follow-up information received from a non-healthcare professional  on 11 January 2016. On an unspecified date the patient got recovered. It was reported that reaction was not due to the vaccine, Patient had several other stressors at the time.
Intense fatigue; Sweats; Chills; Muscle aches; Joint aches; This is a spontaneous report from a contactable physician, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 12Apr2021 at 12:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 2613) via an unspecified route of administration in the left arm on 23Mar2021 at 18:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. On 13Apr2021 at 12:00, the patient experienced intense fatigue, sweats, chills, muscle aches, joint aches. He could not work for two days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event intense fatigue, sweats, chills, muscle aches and joint aches was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Metallic taste within 1 hour after injection with abnormal taste for 30 hours; Metallic taste within 1 hour after injection with abnormal taste for 30 hours; This is a spontaneous report from a non-contactable (Patient, self-reported).   A 47-years-old (non pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an intramuscular route, administered in right arm on 05Mar2021 13:45 (at the age of 47-years-old), as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included known allergies to Penicillin and previously took doxycycline hyclate and experienced allergy. Concomitant medications included paracetamol (TYLENOL). Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 05Mar2021, 14:15, 1 hour after vaccination, the patient experienced metallic taste and  abnormal taste for 30 hours. Patient did not received treatment for adverse events. Outcome of the events was recovering.  No follow up attempts are possible. Information about lot/batch number cannot been obtained.
some of the content of the vaccine leaked out of the syringe, so the patient probably did not get the full dose; some of the content of the vaccine leaked out of the syringe; A spontaneous report was received from a pharmacist concerning a 28-year-old, female patient with unknown race who received Moderna's COVID-19 mRNA-1273 and experienced "a patient was receiving the Moderna vaccine and some of the content of the vaccine leaked out of the syringe".  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Feb 2021, prior to the event onset, patient received a dose of the Moderna vaccine mRNA-1273 (Lot number: 025J20A) by injection for prophylaxis of COVID-19 infection.  On 02 Feb 2021, while receiving the mRNA-1273 vaccine, some of the content of the vaccine leaked out of the syringe indicating that the patient may not have received the full dose of the vaccine.   Action taken with mRNA-1273 in response to the events was not reported.   The event "a patient was receiving the Moderna vaccine and some of the content of the vaccine leaked out of the syringe" was considered as resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered and syringe issue for mRNA-1273, lot # 025J20A. There were no reported AEs associated with this case of Incorrect dose administered and syringe issue.
No additional AE details; Temperature excrusion/TE evaluation states vaccines have been administered to multiple patients; Device or device component malfunction; This spontaneous report was received from a medical assistant and an other non-health care professional referring to a 4year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. No illness at time of vaccination nor vaccine within 4 weeks prior to vaccination date was reported.  On 23-MAR-2022, the temperature excursion occurred of varicella virus vaccine live (oka/merck) (VARIVAX). The storage temperature was -14 degree Celsius up to -10 degree Celsius for 3 hours and -10 degree Celsius up to 8 degree Celsius for 1 hour 30 minutes. There was no previous temperature excursion. The temperature excursion occurred as a result of a reading from a digital data logger. On 28-MAR-2022, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection by a healthcare professional for prophylaxis (subcutaneous, lot #U025790, expiration date: 19-AUG-2023; strength and dose were not provided) (product storage error). No additional adverse event (no adverse event) was reported. After administration, the reporter contacted company and verified the viability of vaccine. The vaccine was not available for return or evaluation because it was given to the patient. Additionally, it was reported device or device component malfunction.   This is one of several reports from the same reporter.
The evening after the vaccine patient noted swelling in a red band around the upper rt arm, painful to the touch.  3 days later patient returned to clinic for blood work.  RN noted red rash on the upper right inside of the arm with 3 finger width projections down the arm.  Provider palpated the arm, patient noted tenderness in the area of the lymph at the rt axial.
Generalized seizure -  neurologist consulted - MRI WNL, EEG with generalized spike waves, and placed on Lamictal.
sx started 25OCT96 7 days p/vax rt side of face started not to work;droopy side of face;couldn't chew, dx bell's palsy;relapsed 31OCT96 put back on pred;weak & tired;facial paralysis improved but still present to a sl degree;
Information has been received from a consumer concerning her 11 year old daughter with no drug reations/allergies or pertinent medical history who was vaccinated with varicella virus vaccine live (Oka/Merck) at age 14 months. There was no concomitant medication reported. The patient experienced a mild case of chickenpox which the patient's mother felt might have been due to receiving an unspecified anti-viral. The patient's outcome was not reported. No additional information was available.
Patient fainted and had hives all over chest and both arms. Gave BENADRYL.
bad front of the head headache; injection site is slightly sore when touched; This is a spontaneous report from a contactable consumer (patient herself). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 28Jan2021 13:45 at single dose for COVID-19 immunization in workplace clinic. The patient's medical history included asthma, chronic sinusitis with nasal polyps. The patient have allergies to medications, food, or other products. Concomitant medications included other medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient received other medications within 2 weeks of vaccination. It was reported that, woke up the next morning on 29Jan2021 07:00 AM with a bad front of the head headache and injection site was slightly sore when touched. The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the events was not recovered.
mom reports pt c/o h/a, stomach ache, sore legs;denies fever, loss of appetite;pt attending school regularly;mom states pt has c/o sx off & on since vax;
Patient received the pneumonia vaccine on 12/5/11 and called 12/6/11 with redness, pain & swelling of vaccinated arm. Her husband received the same vaccine with no reaction. BENADRYL has helped; will follow up w/patient.
New wheezing beginning November 5 through November 7, observed on trip to Grandparents' house. Followed up with allergist November 15, 2021. Received a prescription for Albuterol HFA rescue medication and Dulera maintenance medication with spacer. Peak flow test in office was normal.  We were instructed to observe whether child had repeated wheezing at next visit to Grandparents' house. Visited again November 24-27, 2021. Wheezing was observed with whistling sounds on exhale. Wheezing resolved with use of albuterol HFI inhaler but recurred later that night, then we gave Dulera and did not observe further wheezing. Child has never had Covid to our knowledge. Usually does not wheeze. Has routinely visited and stayed at grandparents' house previously, and never previously observed wheezing there, but this was his first visit there since December 2019.
increased pain in RA flareups; Brainfog; anxiety; sleep deprivation; shortness of memory; stiff and burning sensation in joints; stiff and burning sensation in joints; mouth sores; moving slower much slower; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955), first dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 (reported as 10:30) (at the age of 59 years old, not pregnant), single dose for covid-19 immunization. Medical history included rheumatoid arthritis, fibromyalgia, known allergies: Sulfa and tetracycline, from an unknown date. Concomitant medications included hydroxychloroquine; indometacin sodium (INDOCIN); methotrexate. On 20Mar2021, patient experienced Brainfog, anxiety, sleep deprivation, shortness of memory, increased pain in RA flareups, stiff and burning sensation in joints, mouth sores,moving slower much slower. The outcome of the events was not recovered. No treatment for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Information related to batch/Lot no. was requested.
This spontaneous report as received from a nurse practitioner, concerning to 133 patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the an unknown number of patients (of the 133 patients) were vaccinated with a dose of VAQTA (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The nurse practitioner reported that on an unknown date, patients were inadvertently administered VAQTA that had been improperly stored. No adverse effects reported.  This is one (1) of four (4) reports from the same source. Additional information is not expected. The nurse practitioner did not give the consent to contact her.
rash; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of rash erythematous (1st dose received on 10th July 2019, refer case US2019AMR166975).   On 10th September 2019, the patient received the 2nd dose of Shingrix. On 10th September 2019, less than a day after receiving Shingrix, the patient experienced red rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. within 24 hours the patient had the same exact side effect.
Dizzy, headache, felt faint, high HR, felt off - few episodes for about 30 min after injection
on going Tinnitus  since March 2nd.  Does not go away. Makes it difficult to sleep, work,
Vomited at 6 am no more after 7 am.  Headache started at 10 am.  Diarrhea started at 7 am.
Pt was brought in by her father for her first dose of Pfizer vaccine. Prior to receiving the vaccine, her father asked her to let the writer know of her fear of needle and what occurs when she she has blood draws or vaccination. Patient states that she usually lays down because she feels faint and passes out at times. After she sat down, another chair was provided to rest her legs. Pfizer dose was administered and within a minute, she acknowledged that she about to passed out. She had a near syncopal episode with both arms contracting. She was carried from the chair to the floor. Her father, who was prepared for this, had ammonia with him and had the patient sniff it and she responded to it. She was observed for little over 30 minutes and walked out of the pharmacy stating that she felt well. Throughout the ordeal, she was responding appropriately.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's wife. The reporter stated that in the past the patient had received the flu vaccine from unknown manufacturer and then gotten the flu after receiving the vaccine. The reporter did not consent to follow-up. This case was considered as suspected vaccination failure cases as the vaccination schedule, time to event onset and laboratory results were unknown at the time of reporting.
Chills, body aches, fatigue, nausea, vomiting all night. Slept all next day. Then fine.