chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breast feeding) in a male infant of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 032L20A) , while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): The mother's past medical history included Seasonal allergy (Hay fever). Concurrent medical conditions included Polycystic ovarian syndrome since May 2006 and Nickel sensitivity (Skin rash from nickel). MEDICAL HISTORY (Patient): No medical history was reported.  Concomitant product exposures included FOLIC ACID from 04-Aug-2020 to an unknown date and PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID; RETINOL; TOCOPHEROL; VITAMIN B NOS;VITAMIN D NOS] from 14-Sep-2020 to an unknown date for Prenatal care, ASCORBIC ACID (VIT C) and LINUM USITATISSIMUM SEED OIL (FLAX OIL) for Vitamin supplementation. On 15-Jan-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The mother's last menstrual period was on 07-Aug-2020 and the estimated date of delivery was 28-May-2021. On 15-Jan-2021, the infant was diagnosed with EXPOSURE VIA BREAST MILK (Breast feeding). The mother had a vaginal delivery which occurred on an unknown date, which was reported as Full-term. For neonate 1, the birth weight was 1338 grams (2lbs 15oz) with an APGAR score of 9 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. 102.4 fever during delivery. On 15-Jan-2021, EXPOSURE VIA BREAST MILK (Breast feeding) had resolved. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments. Treatment medications were unknown. Concomitant medication includes prenatal gummy. This case was linked to MOD-2021-009555 (Parent-Child Link). See case MOD-2021-009555 for details regarding the Parent case.
Received influenza vaccine into left shoulder joint. Developed left shoulder pain, weakness, and limited range of motion, which have worsened over the past 10 months. Currently undergoing physical therapy for treatment.
Vaccines given 9/26/06.  Mom called 9/27/06 upper left arm, red, hot, swollen, hard and itchy.
Soreness in arm where vaccine given. Severe up all night, then fever/chills for 24 hrs after injection. Joint pain shoulders, back, neck. Skin hurt below her waist. Severe pain in arm, up into neck and down her arm. Still sore 8 days later and itchy.
My arm was sore and tender for the first day after receiving my first dose of the vaccine, which was expected. There was no redness at the time and no other symptoms. About 7 or 8 days after receiving the first dose, the area around the injection site became red and warm and the redness continued to spread over the next day. I will be trying an antihistamine to see if this resolves the redness/warmness, and will see a doctor if it does not resolve over the next day or two. Otherwise, I have no other symptoms and feel fine.
approx 4 weeks after shot, pericarditis pain in the heart felt - took dose of aspirin 1000mg each day for 1 week to dissipate symptoms 6 years earlier had treatment of colchicine to eliminate pericarditis so the pain was familiar and exactly same as previous diagnosis (which was completely cured and monitored by cardiologists).
19AUG95 weakness, inc temp to ER; could not walk; transferred to another hosp 21AUG94 to ICU on ventilator-completely paralyzed
vaccimore than half of vaccine leaked out patient received second dose in opposite arm; The vaccine leaked out and the patient believed they did not receive at least half of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    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 EXTRA DOSE ADMINISTERED (vaccimore than half of vaccine leaked out patient received second dose in opposite arm) and UNDERDOSE (The vaccine leaked out and the patient believed they did not receive at least half of the vaccine) 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 16-Jun-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 16-Jun-2021, the patient experienced EXTRA DOSE ADMINISTERED (vaccimore than half of vaccine leaked out patient received second dose in opposite arm) and UNDERDOSE (The vaccine leaked out and the patient believed they did not receive at least half of the vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (vaccimore than half of vaccine leaked out patient received second dose in opposite arm) and UNDERDOSE (The vaccine leaked out and the patient believed they did not receive at least half of the vaccine) had resolved.            Concomitant product details was not reported.  Treatment details was not reported .
Excruciating headache, fever, chills, high blood pressure, chest pain, heart rate 100-124, general discomfort. General decay, joint pain, loss of appetite.  By the second week, swelling of the lymph nodes in the neck, swollen tongue and extreme dryness of the mouth and throat.  The arms don't respond to reflexes, severe burning on the mediastinum. Lasting to today, disoriented, dizziness, nausea and others.
Patients received an expired dose; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.
Aching in my left arm that lasted for weeks. Could not straighten arm and I had to do telehealth call first then went to urgent care a few days later and was misdiagnosed with carpal tunnel. A few days after that I went to an ortho and was told that shot was given too high or too deep and diagnosed with bursitis. I had to go to physical therapy 5 times after that. The doctor thinks injection was just given too high and not from actual medication.
Approximately 12 days post vax, the pt experienced injection site redness, soreness and puffiness. The pt sought unspecified medical attention. Additional information has been requested.
Had extreme sweating and drop in blood pressure to 52/40. Proceeded to lose vision and have chills. Faint when standing. Went to hospital.
pt received a second bivalent booster and the pt is not 65 or older and does not appear to be immunocompromised. no adverse effects happened due to this.
Had an ER ride and hospital visit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an ER ride and hospital visit) 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 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an ER ride and hospital visit). At the time of the report, VACCINATION COMPLICATION (Had an ER ride and hospital visit) outcome was unknown.            No other medications were provided. No treatment medications were reported.
Early in the morning on 04/25/21, I passed a number of blood clots into the toilet with my stool. I have a photograph. I felt like I might be having a medical emergency so I went to the ER. I had some blood work, an ECG, and an abdominal CT scan, I was told by the two doctors who examined me in the ER, and later by the gastroenterologist I was referred to, that I had ischemic colitis. Since the ischemic colitis, I have been getting a monthly period from 3-4 orifices, including my vagina, my urethra, my colon, and occasionally, my throat. I have eight specialists now, and have had 2 more CT scans, and no one can explain either of these events, besides a possible adverse vaccine reaction.
Pt recvd vax & 3 days p/dose exp urticarial rash axillas & chest; pt was seen by MD & treated w/Atarax; sx have not subsided;
her right shoulder hurts a lot and it's getting more pronounced/ she got the shot in her right arm in the deltoid muscle; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (her right shoulder hurts a lot and it's getting more pronounced/ she got the shot in her right arm in the deltoid muscle) in an 80-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer COVID vaccines. Past adverse reactions to the above products included No adverse event with Pfizer COVID vaccines. Concurrent medical conditions included Arthritis (The patient also adds that on her thumb, every once in a while she has arthritis on her thumb. She put the topical medicine that the doctor had given her and wears a thin rubber glove on it. The digit was hurting at the bottom of her thumb). Concomitant products included VITAMIN B12 [VITAMIN B12 NOS] for Intrinsic factor deficiency.    On 04-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced VACCINATION SITE PAIN (her right shoulder hurts a lot and it's getting more pronounced/ she got the shot in her right arm in the deltoid muscle). At the time of the report, VACCINATION SITE PAIN (her right shoulder hurts a lot and it's getting more pronounced/ she got the shot in her right arm in the deltoid muscle) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The patient states she doesn't have intrinsic factor, so she got the B12 injection.  This was the first Moderna COVID vaccine she's taken. The patient does not have her COVID19 vaccination history. She provided number RX6125143. Lot number is unknown. Now it doesn't hurt because she used the medicine, but her right shoulder hurts a lot and it's getting more pronounced.  She wants to take something for the pain where the injection was.
Vaccine was expired by 2 days, waiting on patient response, spoke with Pfizer and verified there was not imminent danger to their health. We will attempt to re-administer once we can speak with patient.
4 Days after the vaccine, I experience tiredness, nausea, and diarrhea. These symptoms lasted for 12 hours. I was not able to eat or drink without using the restroom minutes later. Within the 12 hours I only ate one orange, and went to the restroom 10 + times.  It is now a week since my vaccine and my body seems like it is back to normal.
Approximately 5-10 minutes after H1N1 vaccination administered, patient complains of tightening in throat and was short of breath. EPI PEN dose and Dyphenhydramine administered, patient much improved. 11/20/09 Medical records received for DOS 11/10/FInal DX: allergic reaction to influenza vaccine Immediately s/p vaccine developed tingling in arm, chest tight, throat swelling. Bronchospasm, angioedema. Resolved. ICD9 Code: 995.27
Headache, Myalgia, Fever, NauseaVomiting, chills, fatigue Narrative: Headache, nausea, fever 101, myalgia, chills, fatigue; tylenol, exedrin.
Headache, Myalgia,  fever 100.3, chills, swelling in L axilla, fatigue Narrative:
PT developed body aches at 36 hrs, gout? pain after 48 hrs, slightly febrile and diarrhea on 2/13 resolved on 2/15. Shaking eyes? and 2/15 at 3:00 for 30 mins. PT has new info that primary vax took 6 wks to lose acid?
Systemic: Fainting / Unresponsive-Mild, Additional Details: received both bivalent pfizer booster as well as flucelvax flu shot on same visit. fainted twice after second vaccine given, each episode lasting briefly about 5-10 seconds each
on 6/8/21 he had a stroke  drs have not been able to link the stroke to the covid vax
2 HOURS AFTER VACCINE PATIENT HAD A "RUSH" OF ELECTRICITY STARTING FROM UPPER STOMACH/CHEST TRAVELLING UP TO THE CHEEK.  PATIENT WAS STUNNED, DESCRIBED BEING "FROZEN" FOR A MINUTE OR TWO.  NO FURTHER ISSUES FOLLOWING THIS EPISODE.
Patient stated that approximately 72 hours after receiving her first COVID-19 Pfizer vaccine she started to feel nauseous. She reported the nausea lasted for approximately two weeks.
Pt came to clinic requesting 3rd dose of COVID vaccine be given as mandatory requirement to work in nursing home. As per patient, she was "emailed and called by her facility to have booster completed by the end of this week or she will not be able to start".  3rd dose of Pfizer COVID vaccine was administered to healthcare professional on 7/29. 2nd COVID dose 6/3/22. 3rd COVID dose given 2 MONTHS after 2nd dose. As per CDC guideline, administered too early. 3rd vaccine not considered booster for her series and consider this 3rd vaccine as additional 2nd dose.
IMMUNOCOMPROMISED; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis (since 2002). The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, frequency time 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Simponi (golimumab) for drug used for unknown indication. On an unspecified date, the patient was self isolated herself as she was immunocompromised and she did not get out of the house often. She didn't specify if she became immunocompromised after getting the vaccine or before.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of immunocompromised was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211122405-COVID-19 VACCINE AD26.COV2.S- immunocompromised. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS
Hot flashes and cold sweats, Muscle Cramps and spasms also loss of coordination
HISTORY OF PRESENT ILLNESS  Patient is a 68 y.o. male who was admitted for weakness and fatigue in the setting of missing dialysis. His comorbidities include the following:   1. End-stage renal disease on hemodialysis Tuesday/Thursday/Saturday 2. COVID-19 infection 3. Type 2 MI 4. Severe coronary artery disease with prior NSTEMI in July 2019 5. Recurrent venous thromboembolism on apixaban 6. Type 2 diabetes mellitus 7. Diabetic nephropathy 8. Hypertension 9. Hyperlipidemia   Summary of hospitalization: Patient was admitted after developing weakness and fatigue, and a new cough.  He is wheelchair-bound at baseline, and refused to get up out of bed yesterday at his group home.  Due to persistent fatigue, he did not go to his dialysis appointment yesterday.  Due to this, he was brought to the emergency room by his care providers. Evaluation revealed no acute changes on his ECG.  His troponins are mildly elevated but flat.  COVID test was positive.  Due to mild troponin elevation in the setting of him missing his dialysis session, he was admitted to the Cardiology Service.  Since arriving on the floor, he has been in stable condition with no active symptoms apart from a cough.     Overnight:  No acute issues. He underwent dialysis last night which was uneventful. No new complaints this morning.
Information has been received from a physician's assistant concerning a female with a history of shingles who on approximately 12-AUG-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). The patient developed shingles under her chin and abdomen with little or no pain after getting ZOSTAVAX (Oka/Merck). The patient was seen by doctor. No product quality complaint was involved. Additional information has been requested.
Miid arm pain, general achiness, feeling unwell, chills. Mild symptoms overnight pretty much resolved by 10:00 am the day following vaccination. No treatment received.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. Information regarding medical history and drug reactions or allergies was not reported. The nurse reported that on unspecified date in approximately 2014, unspecified patients were vaccinated with  (oka/merck) VARIVAX (subcutaneous injection, 0.5 ml once, subcutaneous, strength, lot #, expiration date and anatomical location not reported), that was improperly stored at a maximum of 7.5 degrees Fahrenheit for up to 11 hours in July 2014 and August 2014. Concomitant medications were not reported. No adverse effects reported. Follow up information has been received from medical assistant on 27-AUG-2014. The medical assistant was able to provide patient identifier, lot number and expiration dates of (oka/merck) VARIVAX that was administered to a 4 year old patient on 07-AUG-2014: lot# J013067 and expiration date: 16-OCT-2015. This is one several reports received from the same source. Additional information has been requested.
Swollen glands behind ear. Red spots 10-10 on chest and upper arm 10 days after the vaccines. Follow up on 11/20/2003: "Initial telephone attempt 11/04/2003, 17:30 no answer; left message on recorder.  11/05/2003: Telephoned, 08:05 spoke with patient who indicated that he is doing just fine and is not experiencing difficulty from his immunizations."
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 11-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011977: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Today is the first day that I have noticed a large, red, swollen rash on my arm where I got the injection. It is warm to the touch and itches a bit.
I started having nasal congestion, sore throat I started feeling like I cant breath when I went to the emergency room. I had a chest X-ray, blood test and an EKG. I also, was tested for COVID-19 and everything was negative. They gave me cough medication and I started feeling better, then it came back and I have been sick for 2 weeks but I don't have COVID. On the 24MAR2023 I started to have a head cold, I went to urgent care and found that I have a sinus infection.
Left arm, near injection site, was reddened, raised and warm to touch 9 days after the day of injection.  approximately 3x3 inches.  Was seen in the ER where I work and it was recommended that I start Cephalexin 500mg 1 capsule 4 times per day x 10 days.  Diagnosed as a Cellulitis.
Magnet sticking at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Magnet sticking at the injection site) 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 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 VACCINATION SITE REACTION (Magnet sticking at the injection site). At the time of the report, VACCINATION SITE REACTION (Magnet sticking at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up information received on 17-Jun-2021, contains no new information.
That evening it started with a slight headache and then my fever spiked to 100.5 and my normal is always 94-95 so this was extremely high for me, everything hurt, and the headache was very bad, and I was so weak and continue to take fluids. I was in bed for 3 days straight. The evening after 3 days I was fine but then the ringing on both ears were very loud and my eyesight was very weak, I mean, I see but they get tired very quickly. Still, I have the ringing on the left ear. One thing I have notice is that I feel very foggy on my head, and I feel very tired ever since. I got my booster on 10/29/2021 and I just had a slight headache.
Onset next day Chills. Fever,  body aches,  joint pain,  abdominal pain,  left breast swelled to double the size
This spontaneous report was received from a practice administrator refers to a patient of unknown age and gender. The administrator reported that on 10-NOV-2014, a nurse gave the patient an expired dose of ZOSTAVAX (expiry 30-SEP-3014). No adverse effect noted. Additional information has been requested.
positive Covid 19 test; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACINE; lot number EN5318) via an unspecified route of administration on 11Feb as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, he had the 1st Pfizer vaccine dose on 11Feb and on 12Feb he received antiviral treatment for a positive Covid 19 test. My 2nd Vaccine dose was due on 04Mar. When can he get 2nd vaccine dose. The patient underwent lab tests and procedures which included sars-cov-2 test positive on 12Feb2021. The outcome of COVID-19 was unknown.   Information about lot/batch number requested.
Shot was in left arm. About 5 days later my left armpit got super sore and sensitive. Didn't think much of it until someone else had the same symptom less than a week after their shot.
One dose of moderna given beyond the BUD. Manufacturer expiration date 7/13/22, stored in freezer until 5/10/22 when transferred to the refrigerator with new BUD of 6/9/2022. Vial punctured for the first time on 6/14/22 (after BUD of 6/9/22) then discarded. No other doses dispensed form this vial.