chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting the day after my 2nd shot, I started to experience lower back pain.  Over the following week, the pain intensified until it was so excruciating that I was completely debilitated. I was prescribed a steroid anti inflammatory and muscle relaxants. The next day the pain included radiating leg pain and numbness down my calf and including several toes. The pain was unbearable and the doctor recommended I go to the emergency room, which I did. At the ER I was given 2 injections. One, a powerful pain killer, (dilaudid), and the other, an anti-inflammatory, (toradol). After the powerful pain killer from the ER, the back pain mostly subsided, but the radiating leg pain and numbness persisted very intensely for the first few weeks, and less now, but it's still not gone.  I had a previous experience about 15 years ago of excruciating back pain due to a herniated disc, but my back has been doing well for the last 10 years or so and there was nothing I?m aware of that might have set it off. While I can?t say for sure if it was caused by the 2nd vaccine shot, because of the time correlation and after reading that extreme back pain can be a symptom of covid, I thought it was worth reporting.
she had diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (she had diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (she had diarrhea). At the time of the report, DIARRHOEA (she had diarrhea) outcome was unknown.            Relevant Text: The reporter was a Spanish caller and reported that the patient received their 1st dose on 02 Feb 2021 and the 2nd dose on 02 Mar 2021. After receiving the vaccine that patient had diarrhea on an unspecified date and visited the doctor. The patient reported that they were tested and had no antibodies. No more information was provided by the reporter.  Lab information:   No Concomitant product use was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Vaccine stored longer than recommended period of time, potentially up to 28 days, no adverse reaction, no illness
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted ~ 1 minute after vaccine, episode lasted ~30 seconds. Pt laid on floor for ~10 minutes afterwards and then sat in chair for 20 minutes. Pts blood pressure taken and monitored.
This spontaneous report was received from a pharmacist concerning her mother (patient) of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (19400, units unspecified) (lot number, dose unspecified). No concomitant medications were reported. On an unknown date, after the vaccination, the patient experienced injection site redness and swelling about an inch in diameter. The patient did not seek medical attention. The events injection site redness and swelling were resolved in about a week (date unspecified). The relatedness for injection site redness and swelling was unknown for ZOSTAVAX. This case is related to 1209USA005140 (same reporter link and patient/partner link). Additional information is not expected.
ringworm infection; rash/ rash progressed around and down his arm; This case was reported by a consumer via call center representative and described the occurrence of tinea in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced tinea and blistery rash. The patient was treated with antifungals for topical use (Antifungal Cream). On an unknown date, the outcome of the tinea and blistery rash were recovered/resolved.   It was unknown if the reporter considered the tinea and blistery rash to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The patient received dose of Shingrix in anunknown arm at a Clinic. The patient experienced a rash with blisters just below the injection site on left arm that progressed around and down his arm. The patient was treated with an antifungal cream in case it was a ringworm infection. The patient stated, it was resolved but that the clinic declined to give him 2nd dose due to concerns about the reaction. The patient then changed clinics in 2019 and received 2nd dose of Shingrix. For tolerance of 2nd dose, refer case US2019AMR162633. The patient consented to follow up and provided contact details of clinic.
(L) arm. More than half the arm is erythematous, warm to touch. Received MMR & Dtap. Tenderness to injection site, not entire arm.
fever 101 degrees 3 hours after vaccine,  103 degrees following AM and Child vomited x 1
Seizure activity x 3 in less than 24 hrs (Generalized tonic clonic)
Patient received vaccine on 11/08/2017. She came to the pharmacy on 11/09/2017 because the injection site was hot and she was having chills. She was advised to take TYLENOL and put ice in around the injection site.
I got pregnant via IVF in September 2021 after multiple rounds of IVF. Throughout the 1st trimester I had pregnancy bleeding including right after my Moderna shot. On January 28th that bleeding returned and on January 30th I went into labour at exactly 23 weeks pregnant. My son was born but could not survive. Medical exam showed my son and placenta were healthy. Exact reason for early labour in unknown. I tested negative for Covid-19 on Jan 30th and positive on February 7th.
Pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Mental disorder (mental health) on 01-Jan-2015, Depression since an unknown date, Anxiety since an unknown date and Allergy since an unknown date. Concomitant products included CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY) from 01-Jul-2018 to an unknown date for Allergy, CLONIDINE from 01-Jul-2018 to an unknown date for Anxiety, BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 01-Jul-2018 to an unknown date and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) from 01-Jul-2018 to an unknown date for Depression, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jul-2020 to an unknown date for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 04-Jul-2020 and the estimated date of delivery was 10-Apr-2021. On 20-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 20-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2020, Pregnancy test: positive (Positive) Pregnancy test positive..     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.   on 20jan2021, post vaccination, the patient reported that she experienced symptoms of exposure during pregnancy.   No treatment information was provided Internal review on 22jul2021 resulted in updates to pregnancy information   Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Internal review on 22jul2021 resulted in updates to pregnancy information; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 28-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Tight feeling in chest "elephant sitting on chest". Not complaining of difficulty of breathing or signs of anaphylaxis, no rash. Pharmacist and ER Dr. did not feel epinephrine was indicated.
Administered SARS-COV-2 (COVID) 2023-24 (6MO-11YR)(MODERNA), MRNA, 0.25 ML DOSE. The patient may have received 0.5mL per vial instead of 0.25mL / dose. The manufacture provided 0.5mL per single vial.
achy; upset stomach; exhausted; in bed all day; "knocked me off of my feet"; headache; fever; couldn't even keep water down; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL ("knocked me off of my feet"), ASTHENIA (in bed all day), PAIN (achy), ABDOMINAL DISCOMFORT (upset stomach) and FATIGUE (exhausted) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced FEELING ABNORMAL ("knocked me off of my feet"), HEADACHE (headache), PYREXIA (fever) and VOMITING (couldn't even keep water down). On 06-Mar-2021, the patient experienced ASTHENIA (in bed all day). On 09-Mar-2021, the patient experienced PAIN (achy), ABDOMINAL DISCOMFORT (upset stomach) and FATIGUE (exhausted). On 12-Mar-2021, FEELING ABNORMAL ("knocked me off of my feet"), ASTHENIA (in bed all day), PAIN (achy), ABDOMINAL DISCOMFORT (upset stomach), FATIGUE (exhausted), HEADACHE (headache), PYREXIA (fever) and VOMITING (couldn't even keep water down) had resolved.            No concomitant medications were provided by the reporter.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: follow-up received and updated email of reporter
The patient received her first dose of Moderna vaccine on March 18, 2021 and then her 2nd dose on April 1, 2021.  It was 14 days apart and not the 24-28 days.   She reported that she had nausea and dizziness yesterday (April 1, 2021) and is recovered today (April 2, 2021).
Complained but didn't pay any attention until 3/18/02. On 3/18/02, school nurse called and said the pt was in her office. The site of the chicken pox vaccine was swollen and raised 1 1/2" and he had a fever. Took him to see his doctor and he did a strept culture (neg) and drew a circle at the area. He prescribed Duricef. The next day, the wound grew to 2 3/4" area across. This was 2 weeks after shots were given. It took a week after medication before it got better. Arm remained sore for a month. He was accidentally given this Hep-B shot (it was his 4th).
Injection site was hot to touch and it was 100.8°F; Slept a lot; Body aches; Chills; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site was hot to touch and it was 100.8°F), HYPERSOMNIA (Slept a lot), MYALGIA (Body aches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site was hot to touch and it was 100.8°F), HYPERSOMNIA (Slept a lot), MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, VACCINATION SITE WARMTH (Injection site was hot to touch and it was 100.8°F), HYPERSOMNIA (Slept a lot), MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable.
I basically have been stomach issues since June 1 . Basically heart burn, nausea, cramping, gurgling warmth and burning sensations. Some diarrhea and constipation , and I have ben very tired.
HEADACHE; FEVER; VACCINATION ADVERSE REACTION; This spontaneous report received from a consumer concerned a 45 year old female. The patient's weight was 163 pounds, and height was 63 inches. The patient's past medical history included sulfa allergy, and iodine allergy, and concurrent conditions included sterilization, anxiety, depression, and rheumatoid arthritis. The patient experienced drug allergy when treated with diphenhydramine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included clonazepam for anxiety, bupropion hydrochloride for depression, fluoxetine hydrochloride for depression, metoprolol succinate for high blood pressure, and adalimumab for rheumatoid arthritis. On APR-2021, the subject experienced vaccination adverse reaction. On 08-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination adverse reaction on APR-2021, and headache, and fever on 13-APR-2021. This report was non-serious.
Initial case was received from a health care professional on 11 October 2013. A 74 years old male patient had no medical history reported, received a dose FLUZONE HD vaccine intramuscularly in right deltoid on 10 October 2013 (batch number U4717AA). Patient had not reported concomitant medication. It was reported that on 11 October 2013 patients had blisters around injection site which extended to under his arm and down his arm on palm of hand. No corrective treatment was reported. At the time of report the outcome of event was unknown.
Patient's mouth started itching after her second COVID-19 vaccine (Pfizer), 30 minutes after her injection.  Her mouth had been itching the entire time.    Patient was given Zyrtec 10 mg PO x 1.     She felt better and was discharged to home.
This case involves a 10-year-old female patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age). The patient past medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included NA (SODIUM). On 08-Dec-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot UJ724AA and expiry date: 30-Jun-2022) (Oral solution) (0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test--0.5ml) (Frequency once) via intramuscular route in the right deltoid for prophylactic vaccination. It was an actual medication error case due to product administered to patient of inappropriate age (latency: same day). It was reported "FLUBLOK vaccine was given to a 10 year old and wants to know what would happen or do they need to give another age appropriate flu shot?". At the time of reporting, no adverse event was reported. 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.
I was given an expired booster shot ten days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I was given an expired booster shot ten days ago) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (I was given an expired booster shot ten days ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I was given an expired booster shot ten days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient received booster shot 10 days ago
Severe pulsatile tinnitus, tingling and electric feelings in feet, unusual headaches
Admit Date:  6/27/2022   Discharge Date:   7/1/2022   Discharge Diagnosis:  Principal Problem:   COVID-19 virus detected Active Problems:   Acute on chronic respiratory failure with hypoxia and hypercapnia   C. difficile colitis   Morbid obesity   Primary hypertension     Hospital Course:  79 year old female from NH was admitted initially for Covid-19 pneumonia and treatment was started. She started refusing medications soon after admission. She also was found to have C diff colitis. She only received 3 doses of oral vancomycin before she started refusing medications again. She was transferred back to the NH due to this.     Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 98.2 °F (36.8 °C) Heart Rate (Monitor): 60 Pulse: 69 BP: 149/57 Respirations: 17 SpO2: 93 % O2 Flow Rate (l/min): 3 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: no edema Neuro: alert   Consults:  IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:   CXR   Operations: none   Disposition:  SNF   Discharge Condition:  Fair
Chest pain on multiple occasions. High blood pressure on 9/1 (first ER visit) . Didn?t think much of it.  It was higher on 9/9. Pre-vax Blood pressure was about 140/70.  9/1:  160/high 70s. 9/8: 172/low 80s. Not exact #?s, since it seems they only recorded my blood pressure after giving me metropolol(blood pressure med).
Patient was not feeling good BP was 178/89 HR 56. Patient wife said he has a history of Hypertension and is on Metoprplol 50  mg BID, and that this happens sometimes. Nurse advised wife of patient to sit in the observation area for an additional 15 minutes. Patient stated that he feels no pain, dizziness, or general discomfort. Wife of patient said that she would  keep an eye on him at home and if anything changes that she will seek medical attention. Patient had no S/S of pain of distress.
Usually very regular normal menstrual cycle) this time Menstruation started at 21 days into cycle (3 days after vaccine) with severe bleeding greater than 4 days.
pink area that is slightly itchy; pink area that is slightly itchy; Soreness on her arm; fever; fatigue; body ache; stabbing pain in her elbow area after the injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (pink area that is slightly itchy), PRURITUS (pink area that is slightly itchy), PAIN IN EXTREMITY (Soreness on her arm), PYREXIA (fever) and FATIGUE (fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included CLONIDINE for Blood pressure high, ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and SIMVASTATIN for an unknown indication.   On 20-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jul-2021, the patient experienced PAIN IN EXTREMITY (Soreness on her arm), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (body ache) and ARTHRALGIA (stabbing pain in her elbow area after the injection). On 23-Jul-2021, the patient experienced ERYTHEMA (pink area that is slightly itchy) and PRURITUS (pink area that is slightly itchy). At the time of the report, ERYTHEMA (pink area that is slightly itchy) and PRURITUS (pink area that is slightly itchy) had not resolved and PAIN IN EXTREMITY (Soreness on her arm), PYREXIA (fever), FATIGUE (fatigue), MYALGIA (body ache) and ARTHRALGIA (stabbing pain in her elbow area after the injection) had resolved.            Patient was unsure about dose-1 date and bath number. Patient stated that date could be 18 or 22 Jun and the batch number could be 026D21A or 086D21A. She sprayed some alcohol on her arm.  Treatment information was not provided.   This case was linked to MOD-2021-265327 (Patient Link).
PALE, DIAPHORETIC, LIMB BUT RESPONSIVE, NEAR SYNCOPE, CODE GREEN CALLED, BP 85/55 HR 70,  IVF STARTED, TRANSPORTED TO HOSPITAL.
Pt recvd vax 16FEB93 & devel a fever of 105 according to mom p/receiving the vax; pt taken to ER; MD advised mom in switching to ped DT w/future doses; advised high fever caused from DTP vax;
Extreme sensitivity to sound. Almost every sound feels like nails on a chalkboard. This happened before, in 2007, when I got vestibular neuronitis from a mono infection.
Saddlebag Pulmonary Embolism; Interchange of vaccine products; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An adult male patient received bnt162b2 (BNT162B2), on 27Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "TBI" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: Feb2021, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant, life threatening) with onset 24Oct2021, outcome "unknown"; PULMONARY EMBOLISM (hospitalization, medically significant, life threatening), outcome "recovered", described as "Saddlebag Pulmonary Embolism". The patient was hospitalized for pulmonary embolism, interchange of vaccine products (hospitalization duration: 7 day(s)). The event "saddlebag pulmonary embolism" required emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism.AE treatment: Surgery. No covid prior vaccination. Not covid tested post vaccination.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.