chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap) and NO ADVERSE EVENT (No adverse event) in a 20-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (1 st dose, lot AR9236B) on 27-Oct-2022, Moderna COVID-19 vaccine (2nd dose,lot AR9236B) on 01-Dec-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 31-Aug-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 31-Aug-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Moderna COVID19 vaccine bivalent -dark blue cap instead of a dose of the Moderna COVID19 vaccine bivalent - dark pink cap).    No concomitant medication was reported. No treatment information was provided.
Arm soreness; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue). On 04-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-021800 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: events are add
My 15 yr old child received the bivalent Covid booster by Pfizer around 6:30 pm yesterday. Overnight developed chills, fever (101), headache, nausea.
Left deltoid tenderness and pain.  Small interstitial edema with muscle tightness with movement.  Onset-10/14/2015 to date. Treatment--OTC anti-inflammatory and heat.
Pt reports seizure 2 days after MMR vaccine administered. She did not seek medical treatment.
Rash in B/L UE and upper chest. No SOB/mucous memb inv. Never had issues with IZ in the past.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. Since 14-NOV-2014 (dates unspecified), the patients were vaccinated with doses of MMR II (injection, lot#, dose, route and frequency were not provided), which were exposed to unknown temperatures since 14-NOV-2014 (due to the MinMax feature of the thermometer not being cleared with each temperature reading). Because the temperatures to which the vaccines had been exposed were not known, it was not known whether or not the vaccines were supported. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Red, raised, painful area. diagnosed as cellulitis. treated with doxycycline.
Case number PHEH2016US028522, is an initial spontaneous report received from a healthcare professional on 26 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX (batch number: 185887, expiry date: Apr 2017) at a dose of 0.5 ml subcutaneously on 24 Oct 2016. The pharmacist stated that, a female patient received FLUCELVAX via subcutaneous route and experienced 7 inch patch of erythema around the injection site on 25 Oct 2016. The patient used cold compress and ice for the erythema. The outcome of the event incorrect route of drug administration was unknown and of the other event was not reported. The seriousness of the event incorrect route of drug administration was reported as non serious and of other event was not reported. The causality of the events was not reported.
SWELLING IN LEFT ARM A FEW DAYS LATER AFTER THE SHOT.   ARM GOT REALLY RED AND HOT.   I WENT TO THE URGENT CARE AND WAS DIAGNOSE WITH CELLUTIS.   I WAS GIVEN AN ANTIBIOTIC FOR 10 DAYS STARTING 1/15/21.   I AM STILL TAKING THE ANTIBIOTIC AND IT IS GETTING BETTER.
ill for a day; loss of appetite; he had to take off work because he did not feel good; chills; nauseous; overwhelming feeling like he would puke; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill for a day), DECREASED APPETITE (loss of appetite), IMPAIRED WORK ABILITY (he had to take off work because he did not feel good), CHILLS (chills) and NAUSEA (nauseous) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for an unknown indication.   On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Aug-2021, the patient experienced ILLNESS (ill for a day), DECREASED APPETITE (loss of appetite), IMPAIRED WORK ABILITY (he had to take off work because he did not feel good), CHILLS (chills), NAUSEA (nauseous), VOMITING (overwhelming feeling like he would puke) and PYREXIA (fever). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (ill for a day), DECREASED APPETITE (loss of appetite), IMPAIRED WORK ABILITY (he had to take off work because he did not feel good), CHILLS (chills), NAUSEA (nauseous), VOMITING (overwhelming feeling like he would puke) and PYREXIA (fever) outcome was unknown.            This case was linked to MOD-2021-289744 (Patient Link).
Vial was punctured 21 times; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vial was punctured 21 times) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Vial was punctured 21 times). At the time of the report, PRODUCT ADMINISTRATION ERROR (Vial was punctured 21 times) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication given. No treatment information were given.
lump at the injection site; Feels the area hot to touch; Redness at injection site; Pain at injection site/Feels the area is flamed; low grade fever; Rash on neck, chest and shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced injection site lump, injection site warmth, injection site erythema, injection site burning, low grade fever and rash. On an unknown date, the outcome of the injection site lump, injection site warmth, low grade fever and rash were unknown and the outcome of the injection site erythema and injection site burning were not recovered/not resolved.   It was unknown if the reporter considered the injection site lump, injection site warmth, injection site erythema, injection site burning, low grade fever and rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist explained that both 1st and 2nd dose were administered on the same arm (not sure which arm as patient receive the vaccinations on different facility) and felt the area was flamed, hot to touch, lump at the injection site, rash on neck, chest and shoulder and low grade fever. The pharmacist also reports that patient experienced redness and pain at injection site.  The patient was still experiencing these symptoms, coming and going. For tolerance of 2nd dose, refer case US2020AMR214623. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR214623:2nd dose, same patient
not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 05May2021, outcome "unknown", described as "not feeling well".  Additional information included patient received the first dose of the vaccine today. She was currently not feeling well. She wanted to know if she can take Tylenol or Advil.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient falsified DOB when registering for vaccination. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB which made the vaccine a contraindication.  No known adverse reactions noted.
Massive bruising from top of L shoulder to above elbow & 1/2 around L arm. Possible dx-torn ligament. Bloody nose, purple spots on body and blk spots on tongue. Dx ITP.Tx w/ IV gammaglobulin.
Patient arrived to a clinic designated for 5-11 year old pediatric population. Patient was 14 years old and did make it through to the nurse where he was administered a dose of the Pfizer vaccine pediatric formulation. Patient had already received 2 doses of the Pfizer vaccination for those aged 12 + on 5/20 and 6/10. Patient was due for booster however received a pediatric dose instead. No know adverse reactions to the vaccination were noted.
24-48 hours after vaccine, acute onset apthor ulcers 24-48 hours later it dry whole body up in rash.
No adverse event; BUD was reported as 17-May-2022 and vaccine was administered on 12-May-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was reported as 17-May-2022 and vaccine was administered on 12-May-2022) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was reported as 17-May-2022 and vaccine was administered on 12-May-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was reported as 17-May-2022 and vaccine was administered on 12-May-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (BUD was reported as 17-May-2022 and vaccine was administered on 12-May-2022).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received contains additional no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
accidental eye exposure with the adjuvant portion  / happened / to one of their employees/ Inadvertent exposure to vaccine; accidental eye exposure with the adjuvant portion; exposed person was female and 18 weeks pregnant; This prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of accidental occupational exposure to product in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th July 2021, the patient received Shingrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Shingrix at an unknown time during the pregnancy. On 14th July 2021, unknown after receiving Shingrix, the patient experienced accidental occupational exposure to product, exposure via eye contact and vaccine exposure during pregnancy. On an unknown date, the outcome of the accidental occupational exposure to product, exposure via eye contact and vaccine exposure during pregnancy were unknown. The pregnancy was ongoing.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter reported, the accidental eye exposure with the adjuvant portion of the Shingrix vaccine on the same day of reporting to one of the employees, which led to accidental occupational exposure to product and exposure via eye contact. The exposed person was female and 18 weeks pregnant, which led to vaccine exposure during pregnancy. No further events or details about the event were clarified. The reporter consented to follow up.
Joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-May-2021 and was forwarded to Moderna on 13-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) 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 Fracture since an unknown date.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.            Patient reported she is on a lot of medicine for fractures in her back and other conditions, therefore she was not sure if the vaccine caused the reactions. Patient did not see her provider about the symptoms, she just talked with the nurse. Patient said she only took her normal medication and nothing extra to manage the symptoms.   This case was linked to MOD-2021-064252 (Patient Link).
As I recall, I did not have symptoms when I tested positive. I was feeling fine. My wife had tested positive so I tested on Wednesday 12/23. She had plenty of symptoms when she tested positive, like a bad cold. When I tested positive I still felt fine but I moved to the other bedroom. It seemed like a bad cold, I had a high fever at one time, congestion, tiredness. The cough came later and I'm still dealing with that. on Friday we called the doctor and she prescribed Paxlovid. I took that for 5 days. Its hard to know whether that made any difference or not, I've never had COVID-19 before. After the Paxlovid ended this cough kicked in that would not go away. The doctor prescribed a cough medicine that has helped a lot, but I still have it, just not as severe.
No additional AE details available; Products were administered to multiple patients.; This spontaneous report was received from a reporter and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-SEP-2022, a temperature excursion to rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (valid lot #W011278, expiration date: 01-NOV-2023) occurred. On 06-SEP-2022, the patient was vaccinated with improperly storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (valid lot #W011278, expiration date: 01-NOV-2023) (strength, anatomical location and route of administration were not provided). Temperature excursion was at 46 Fahrenheit (F) (62.8 F) for 8 hours. No previous temperature excursion occurred. No additional information or adverse event was reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2209USA002722: US-009507513-2209USA003021: US-009507513-2209USA003055: US-009507513-2209USA002557: US-009507513-2209USA002540: US-009507513-2209USA002566: US-009507513-2209USA002746: US-009507513-2209USA002481: US-009507513-2209USA002745: US-009507513-2209USA002570: US-009507513-2209USA002574: US-009507513-2209USA002469: US-009507513-2209USA002559: US-009507513-2209USA002573: US-009507513-2209USA002606: US-009507513-2209USA002532:
Information has been received from a nurse practitioner concerning a female nurse (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil. On 29-MAR-2007, the patient was vaccinated with a second dose of Gardasil (lot # not reported) IM. On the morning of 11-APR-2007, the patient was non-symptomatic. Later that day, she woke up from a nap and she could hear nothing in her ear, except ringing. The patient sought the medical attention of primary care, ear, nose and throat (ENT) and surgical ENT services. It was determined that the patient had a "92% hearing loss". A magnetic resonance imaging was performed, result not reported. She was treated with antibiotics, steroids, and steroids injected into her ear without any improvement. The diagnosis was sudden, unilateral hearing loss due to a viral attack on the nerve. The surgical ENT had no idea of the etiology except that this was a rare experience. The patient had no idea of the etiology except that this was a rare experience. The patient had 8% word recognition in the left ear with the ability to hear one tonal frequency. It was reported that the permanent hearing loss was disabling. At the time of reporting, the unilateral hearing loss persisted. Additional information has been requested.  8/28/07 Received medical records from reporter which reveal patient received #1 HPV vax 2/1/07, lot # 1427F.  #2 HPV vax 3/28/07 lot# 0314U.  #3 HPV vax 7/19/07, lot# 0524U.  With 3rd HPV, patient reported complete hearing loss of left ear which ENT felt permanent.  10/2/07 Reviewed ENT medical records of 5/1-9/13/2007 which reveal patient experienced sudden hearing loss of left ear on 4/11/2007.  Upon awakening from nap, had tinnitus & hearing loss.  Seen by pcp on 4/13 & referred to another ENT.  Hearing test at that time revealed left hearing loss at all frequencies.  Intratympanic steroid injection series x 3 w/o significant improvement. FINAL DX: viral labyrinthitis left ear; sudden hearing loss, left ear; tinnitus, left ear; abnormal auditory perception.
3 days after vaccination, 03/13/2021, I had  rapid severe onset of pain on  both arms from shoulder to fingertip , where I could not use either arms, simultaneously shooting pain on both arms. 8 days later I developed severe, severe dizziness. I went to my primary doctor. She prescribed  prednisone. The dizziness was so severe they did a brain MRI and it was normal.   I was referred to an orthopedic doctor, who did cortisone injection to both of my shoulders were unhelpful.  xrays of shoulders Orthopedic referred me to neurologist.  The neurologist diagnosed me with Parsonage Turner Syndrome. The neurologist said the dizziness was from the vaccine, not only my nerves in shoulder my scabulas my entire arm were being attacked.  It is also attacking my vestibular nerves in my ears. For the past 3 months, 24/7 days it has not gone away.
Syncope next morning after vaccination. Syncope happened after taking morning medications. Syncope also occurred on 7/28/2020 after first dose of Shingrix on 7/27/2020. Also in AM after taking morning medications the day following vaccination.
about 5 dasy p/vax began having jaw pain, pain upper back shoulder, sharp pain when opening mouth wide, otherwise dull aching; mild chills;
severe arm pain; numbness; lack of movement; right eye muscle spasm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain), HYPOAESTHESIA (numbness), MOBILITY DECREASED (lack of movement) and MUSCLE SPASMS (right eye muscle spasm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included MESALAZINE (PENTASA) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (severe arm pain), HYPOAESTHESIA (numbness), MOBILITY DECREASED (lack of movement) and MUSCLE SPASMS (right eye muscle spasm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe arm pain), HYPOAESTHESIA (numbness), MOBILITY DECREASED (lack of movement) and MUSCLE SPASMS (right eye muscle spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.