chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; arm pain; muscular tightness throughout my neck and back; mild nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea). At the time of the report, DIZZINESS (dizziness), PAIN IN EXTREMITY (arm pain), MUSCLE TIGHTNESS (muscular tightness throughout my neck and back) and NAUSEA (mild nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported. No Treatment medications were reported.
Patient was not able to answer the date of most recent vaccination. Patient was adminstered Pfizer vaccine as assumed booster shot. Shortly after, the patient found his vaccination record and it was noted that he received two full doses of Pfizer vaccine within 10 days. Patient has not shown any adverse symptoms, as reported by the nurse at the site on 11.4.22.
I got a rash on my legs; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 51-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Patient was 51-years-old at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient experienced a rash on her legs. The outcome of the event was unknown on an unspecified date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swelling, mild pain, redness, itching at injection site 2 weeks after injection. Applied hydrocortisone cream for itching. .
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant referring to a 13-month-old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.   On 09-DEC-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose (lot # U015677, expiration date 18-MAY-2023; strength, route and anatomical location were not provided) for prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion in 39.55 Fahrenheit degrees (F) for 10 hours. There was no previous temperature excursion. No additional adverse events (AEs) were reported.
Developed acute cerebellar ataxia 36 days after varivax and MMR were administered, with vomiting and wide-based unstable gait.  CT scan of the brain was normal, patient was observed with no medication or further intervention
Patient noticed when she woke up the day after she received the shot that her arm was sore and thought she slept on it wrong.  Later in the day she observed that her arm was swollen, red and warm in a large circular area just above her elbow.
Enlarged Lymph Node in left Neck by jaw, very increased anxiety/Panic Attacks, BP spikes, increased GERD, increased IBS symptoms
PATIENT SAID SHE EXPERIENCED SIDE  EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-MAR-2021, the subject experienced subject said she experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from patient said she experienced side effects. This report was non-serious.
Patient received expired Pentacel vaccine during 4 month well child check. No adverse events occurred. Mother of child was notified and offered revaccination.
Cellulitis left thigh. Admitted through the ER and IV antibiotics to admitted to hospital x 3 days. Resolved cellulitis. No sequelae. No complications.   Nurse follow up on 07/08/04 states: "candidal diaper rash, reactive airway disease."
This spontaneous case report was received from an office manager refers to an unspecified number of patients of unknown age and gender. No medical history, allergy and concurrent conditions were reported. On an unspecified date between 27-NOV-2015 and 15-DEC-2015, these patients were vaccinated with improperly stored VARIVAX (dose, number, dosing regimen route and anatomical location were unknown) with lot number #K001390 (expiry date: 29-JAN-2016) or K026387 (expiry date: 15-DEC-2016) or L023587 (expiry date: 26-JUN-2017) or L026410 (expiry date: 15-FEB-2017). Concomitant medications of the patients were unknown. No adverse event reported. The outcome of the event incorrect product storage was unknown. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
tiredness; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness). At the time of the report, FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-047907 (Patient Link).
First Dose: Eye blood shot, sore arm, severe migraine starting day of and lasting 7 days, extreme bone, muscle, and joint pain in hips, lower back radiating to knees. Fatigue and weakness. The bone and joint pain started two days after the shot and lasted 3-4 days. Second Dose: Sore arm by evening of the dose, hardness and hot to the touch, severe enough to not be able to lay on that side. Day 2 or 3, noticed itching around the vaccine site. Rash appeared and blossomed, very itchy, very red, irregular borders. By Day 6 the blotches appear to be growing together.
The patient recieved Fluzone Quadrivalent High Dose that was too-long in transit and was not suitable for use, no AE; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse Practitioner.  This case is linked to cases 2020SA268090, 2020SA268092, 2020SA268094, 2020SA268091 and 2020SA268093 (same reporter).  This case involves a 66 year old male patient who was vaccinated with 0.7 ml dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (form: prefilled syringe, lot number: UJ498AA and expiration date: 30-Jun-2021) once via unknown route in the left deltoid for prophylactic vaccination on 28-Sep-2020. The vaccine was too-long in transit and was not suitable for use (PT: product storage error).  Medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to incorrect product storage.  The NP stated that they gave Fluzone high dose to the patients before they got call that vaccines were too long in transit and were not suitable for use. It was reported that the boxes were cold, but the ice packs were not hard frozen. Reporter asked if the vaccines were still good to be used or if they need to revaccinate. This was the only vaccine received by the patients.  No adverse event was reported at the time of reporting.  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.
Rash on lower arm between wrist and elbow on side of injection 4 days post injection of dose 1
Patient states that her arm has been sore since receiving the injection on 10-06-2009. This was the third dose. She reports that the soreness has never gone away. States at times she has "pain shooting form the top of her arm to her hand". Reports her arm is painful when she lifts her arm up. The muscle feels sore" like after you work out". She went to see doctor on 11-06-2009. She was given a cortisone injection and pain medicine. (Diclofenac sodium) which has helped. Reports that she is able to use her arm more since receiving treatment. States that MD advised if pain was not better in two weeks to  return for a visit at which time he will check for nerve damage.
Four days after receiving the vaccine, I started experiencing severe heart palpitations. I was hospitalized for observation overnight. No med changes made. The palpitations lasted for 3 weeks then diminished. I have had a few "thumps" in the previous 10 years. Taking atenolol for that.
No adverse reactions noted.  Patient denies change in health status.  Pt had shingles vac 2 yrs ago at different physician & did not remember until she asked nurse to put it on her shot record & first one was there so pt. actually received a second shingles vac.
11/18 Went to dinner with neighbor who later tested positive for COVID-19. 11/20 With nasal drip, cough, fever, and sore throat. 11/21 tested positive for COVID-19. Fever was as high as 102.9 with TYLENOL on board fever lasted 11/20-11/25. Worst of symptoms were 11/20-11/25. Nasal drip and cough was 11/20-11/30. Loss of taste and smell was 11/20-12/25.
Multiple patients were administered double doses in their 1st dose; A spontaneous report was received from a HCP concerning a  patient, of unspecified age and gender, who received  Moderna's COVID-19 vaccine(mRNA-1273) and experienced accidental overdose.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273(Lot/batch:unknown) through unknown route of administration for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was administered with double doses of 1 milliliter of the Moderna vaccine (more than recommended amount) from one syringe.  No lab reports  were provided. Treatment information was unknown.  Action taken with mRNA-1273  in response to the event was not reported.  At the time of the report, outcome of the event accidental overdose was considered resolved.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting accidental overdose without any associated adverse events.
1 of 3 pts vaxed from the same vial who devel redness & bruising on lt arm, hot & swollen; sore lymph nodes w/in 24 hrs p/vax; sx lasted 5-6 days; pt recovered;
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On 26-Sep-2018, the patient received a 0.25ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI983AA, expiry date 30 Jun 2019 via unknown route in the left deltoid. It was an actual medication error due to vaccine underdose. It was reported that 3-year-old who received 0.25 mL dose of FLUZONE QUAD instead of 0.5 mL dose. It was unknown whether patient experienced any adverse reaction after the injection. 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. List of documents held by sender- none.
Swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 15Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose: 01), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Swollen lymph nodes". Additional information: Action taken with respect to the suspect medication (i.e., in direct response to the AE): No action taken.  The lot number for bnt162b2 was not provided and will be requested during follow up.
moderate memory loss after 2nd injection; This is a spontaneous report from a contactable consumer (patient). The 69-year-old non-pregnant female patient received second dose of PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided), via an unspecified route of administration, in the left arm, on 17Feb2021 (at the age of 69-year-old) as a single dose for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. Patient's medical history and concomitan medications were not reported. Patient previously received first dose of covid vaccine on 27/01/2021 and experienced mild, short-term memory loss. Patient did not have covid prior vaccination. Patient was not tested covid post vaccination. Patient did not receive any other vaccine in four weeks. Patient did not receive other medications in two weeks. On 27Jan2021 at 10:30, patient experienced moderate memory loss after 2nd injection. Patient visited emergency room due to event. As reported, treatment received was unknown. The outcome of event was not resolved.  Information of lot/batch number has been requested.
1345 - Vaccine Given 1400 - 15 minutes of observation time should of ended, but patient reported feeling "flushed", vasovagal-like symptoms, so increased observation time to monitor and given juice and crackers.  1406 - Patient now reports "tingling in throat". Reviewed body systems. No difficulty breathing. Offered and given 25 mL Benadryl, which is consistent with vaccine clinic practice for patient's driving home and patient agreed as she "routinely takes Benadryl for anxiety".  1409 - Patient declined staying any longer and says "feels better". Advised of concerns to stay, but 1 of patient's 2 kids has to go to the bathroom and none acceptable on-site to patient. Advised of s/s to warrant urgent or emergent medical care, including but not limited to s/s of anaphylaxis. Patient left site.
Headache, Fever, left upper arm pain and lump at injection site on day of vaccine 2/3/21 Narrative:
In approximately December of 2021, I was feeling fatigued and I had pain in my left under arm.  I was going to the doctor about that, and they said there was nothing wrong.  The doctor suggested I go to a specialized clinic and I could not get in for 6 months.  I got an appointment at the doctor's office.  At that time, the pain was spreading.  I was more fatigued.  I was having a form of a seizure, so I saw a Neurologist at the healthcare facility.  In September of 2022, I saw a Cerebral Spinal Fluid Team. They put me on Acetazolamide and Gabapentin for my nerve related pain. I have lost over 30 pounds. About two weeks ago, the Cerebral Spinal Fluid Team sent me to Pain Rehab.  I have never tested positive for COVID-19, but they asked me to quarantine.  Doctors thought perhaps I did have COVID-19 and this could be Long COVID.  I am scheduling a longer stay at the healthcare facility. I have had several MRIs and CT Scans, I do not know the dates.
Sore arm for 3 days. Nausea vomiting SOB body aches joint pain skin pain headache neck pain for approximately 24 hours chest pain currently ongoing.
given to a customer subcutaneously instead of intermuscular; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a adult female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX45D) for prophylaxis.   On an unknown date, the patient received Arexvy (subcutaneous, left deltoid). On an unknown date, an unknown time after receiving Arexvy, the patient experienced intramuscular formulation administered by other route (Verbatim: given to a customer subcutaneously instead of intermuscular).The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2023 The reporter reported that an Arexvy vaccine was given to a customer subcutaneously instead of intermuscular, which led to intramuscular formulation administered by other route. The reporter called for guidance from medical information. The reporter consented to follow up.
The following individuals have positive COVID results after completing their vaccine series.  COVID Vaccine Facility: PV Date/Lot of 1st  dose: 12/16/2020 Pfizer EH9899 Date/Lot of 2nd dose: 1/6/2021 Pfizer EL1284  Date of COVID test: 4/5/2021 Date of exposure if known: unknown Exposure (Workplace vs. community): Community Symptomatic: Yes
I have a Mirena IUD and do not have my period. Two weeks after receiving the vaccine my menstrual cycle returned. It was heavy and painful.  I had a similar period in May 2021 before my period disappeared again.
Soreness and fatigue in first 24 hours.  2 weeks later (early December), symptoms of nausea, tea colored/cloudy urine, lower back pain, stomach upset. Began taking oral cranberry supplements, probiotics, and using heat on the lower back. Urine returned to normal, lower back pain subsided in 24-48 hours. Continued cranberry/probiotic supplements for 5 more days. Nausea persisted for 2 weeks and then abated.  2 weeks later (early January), nausea, cloudy urine, stomach upset symptoms recurred, but milder and without lower back pain. Home urine test strip revealed no UTI. Treated similarly with cranberry/probiotic supplements and heat. Urine/back pain symptoms abated. Nausea again persisted for 2 weeks, and then abated. 3 weeks later (late January), nausea and stomach upset recurred. Cranberry and probiotic supplements helped relieve the stomach upset but not the nausea, which persisted for 3 weeks and then abated.  3 weeks later (mid March), nausea and stomach upset recurred and were treated with the same pattern as above.  In the following months, the nausea and stomach upset continued to return, but with a less regular pattern: sometimes for several days, sometimes for several weeks, with unpredictable gaps of time in between. The urine eventually became cloudy every day. August 2022: on an all day outing, became dehydrated and experienced severe pain in midriff. Took cranberry and drank water, which relieved symptoms. Sensitivity to dehydration persisted. Began to experience severe pain after eating. Added enzyme supplements and cranberry supplements with each meal. Pain after eating was reduced.  October 2022: added D-mannose supplementation with every meal. Pain after eating was further reduced.
Vaccine was administered post use date. Patient's provider Dr. contacted parents or guardian on 02/22/23 stating manufacturer's vaccine activity at the time of administration.  Manufacturer Statement: Moderna reviewed the stability of the vaccine you received and determined that it maintained the activity necessary to protect against COVID-19 at time of administration. Moderna cannot guarantee the protection you have received is equivalent to what was seen in studies and data is not available to support administering an additional dose of vaccine to you. However, if you wish to undergo revaccination, we will provide you access as outlined below
No additional AE; VARIVAX underwent a temperature excursion, and the VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not provided. Concomitant medication included sterile diluent.  On 01-MAR-2022 (also reported as 01-MAR-2023), the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot# U016063, expiration date 20-MAY-2023, at a dose 0.5 milliliter (route of administration and dose number were not provided) for prophylaxis (product storage error). The vaccine was diluted with sterile diluent (0.5ml, lot# reported as T029529, expiration date reported as 16-APR-2023). The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) underwent a temperature excursion of -14.3 Celsius degree for 40 minutes. No previous temperature excursion involved. No additional adverse event (AE) or product quality complaints (PQC) was reported.
Developed significant size rash on the arm in which the vaccine was given. Patient went to urgent care and received OTC cream.
R09.02 HYPOXIA 4/26/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION
Patient received first dose of Shingrix vaccine on 4/4/2019 and second dose on 6/26/2019.  In April after receiving first dose patient began experiencing hoarse voice.  In June patient followed up with otolaryngologist and diagnosed with vocal cord paralysis.  A potential diagnosis is neuritis that could be due to a viral infection or possibly the shingrix vaccination.
Left shoulder pain with abduction off and on for 3 weeks after injection. Pain with abduction greater 90 degrees. Treated rest, ice, oral steroids.
Rash on right arm. Swollen left arm around injection site of vaccination. Fever. Headache.
Tired fell alseep afternoon starting at 5 PM on 3/16/2021.  Woke up at 8 PM then went back to sleep around 11 woke up with a horrible migraine headache.  Had to take medicine (Tylenol only had) but still lasted hours.  On left side into eye and jaw felt like head was going to explode. Next day tired no migraine.  Head still sore.  Then morning of 3/19/2021 not sure time maybe 5/ 6 AM another migraine.  Both on left side of head into eye and jaw.  Took excedrin.  I have not had a migraine since 2016 and before that only had a few in 2010 when I was on new progesterone only birth control (got off of it).  Very nervous I had multiple migraines on shot 1.  Don?t know if they will come back or are now gone.  I have had many vaccines as I traveled and lived in many countries.  And other than occasionally feeling unwell some years with flu shots (but not every one) this is the worst side effects I have ever had for a vaccine.