chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sweating; dizziness; weakness; passed out; arm soreness; headaches; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history). Concomitant products included LISINOPRIL for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm soreness) and HEADACHE (headaches). On 12-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), HYPERHIDROSIS (sweating), DIZZINESS (dizziness) and ASTHENIA (weakness). On 12-Mar-2021, LOSS OF CONSCIOUSNESS (passed out), HYPERHIDROSIS (sweating) and DIZZINESS (dizziness) had resolved. At the time of the report, PAIN IN EXTREMITY (arm soreness), ASTHENIA (weakness) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter believed that other patient's had received SHINGRIX subcutaneously Instead of intramuscularly, which led to inappropriate route of vaccine administration. This case has been linked with US2018144849 (reported by same reporter for herself).
Developed atypical measles 40d. after vaccine given. Mild course, required no specific treatment
fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and PYREXIA (fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (fatigue). On 29-Jan-2021, the patient experienced PYREXIA (fever). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 28-Jan-2021, FATIGUE (fatigue) had resolved. At the time of the report, PYREXIA (fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Mood stabilizers, Anti-anxiety.
One year old female was vaccinated with 0.5ml of Influenza D2 vaccine instead of receiving age appropriate dose of 0.25ml.
I have been post menopausal for ~10 years. On the 2nd morning after the second dose, I was bleeding. I am not sure if the blood came from my vagina or bladder/kidneys
Burning in breasts; Shooting pain in nipples; Keeping me up at night.; This is a spontaneous report from a contactable consumer, the patient. An unspecified aged non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 07Apr2021 at 13:15 as a single dose for COVID-19 immunisation. Medical history included hypertension and chronic migraines. The patient had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 13:45 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 15:30, the patient experienced burning in breasts and shooting pain in nipples which was keeping the patient up at night. After the first day only in the right breast and had continued through day 4. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of reported events. The clinical outcomes of burning in breasts and shooting pain in nipples were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Cheeks became red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Cheeks became red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neck pain. Concomitant products included PARACETAMOL (TYLENOL) for Neck pain.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced ERYTHEMA (Cheeks became red). On 24-Feb-2021, ERYTHEMA (Cheeks became red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was reported.
First it started feeling a little cloudy, everyday was feeling like it was full, like a lot of pressure around my face. My eyes started swelling up, then my face started swelling up. Then a week or two, some fluid started coming out of my nose like water. I started fainting through out my day, in my house. I was hospitalized for it. The longest I was in there was 2-3 weeks and they explained to me that it was SBC SYNDROM. After that I was off and on in the hospital. When I was in the hospital 3 doctors came in my room explaining to me what SBC syndrom is, and they explained that I needed more radiation. They then put me on blood thinners, they made me take 2 80mg of shots I had to give myself; enoxaparin injections. Then I ended up bleeding so much during my regular menstrual cycle, so I then had to get a blood transfusion.  Hospital dates: May 2021 - May 2022
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date in June 2016 (reported as on unspecified date since last week), the patient was vaccinated with one dose of improperly stored RECOMBIVAX HB lot # L027733, expiration date 13-SEP-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 33.5 degrees Fahrenheit for 28 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, muscle ache, headache starting about 6 hours after vaccination, worst symptoms at about 12th hours since vaccination, symptoms starting to clear at about 20th hour.
I experienced memory loss the day after the first dose...was brought to urgent care and then transported via ambulance to local hospital I was admitted and released the following day. Diagnosis was Transient Global Amnesia. I have no memory of most of the tests and procedures that were administered at urgent care or the hospital and I am still experiencing headaches and brain fog. I believe the TGA lasted approximately 4 hours.
Lower back and left leg spasms (LLE spasms q/min or <), patches of BLE dermatomes. Bilateral anterolateral thigh muscle burning sensation during prolonged exertion. Difficulty standing from a crouched position.  G.U. Urgency.  Symptoms similar to viral transverse myelitis diagnosed in 2013
Narrative: 78 year old male patient with a recent diagnosis of small cell cancer of unknown primary origin and liver mets died 2 days after receiving his second dose of Moderna vaccine. Patient received his first COVID-19 vaccine on 4/1/21 and his second dose on 4/30/21. On 5/2/21, patient passed away. Time of death was confirmed at the facility. Per 4/30/21 hospice/palliative care note, "He was found to have acute hepatitis and cirrhosis. A liver biopsy was done and showed metastatic small cell cancer from unknown primary. His prognosis is likely days to weeks given the rapid and progressive high symptom burden." . Addendum to note also stated, "Patient's overall clinical condition is declining. He likely has days for life expectancy". Unlikely that patient's death was directly related to the COVID-19 vaccine.
First had mild nausea and pain at injection site. Nausea continued to worsen, injection site was swollen @ 8:00 pm. Began wrenching at 8:30 pm. With chills and body aches. By 9:30 pm could barely sit up due to extreme nausea and dizziness. Started going from sweats to chills every 15-30 minutes. Lay on bathroom floor until 11:00 pm. Able to get into bed and wretch into plastic bag for rest of the night. Woke up nauseous with body aches and unsteadiness.
Patient c\o itching in the throat s\p vaccination. Patient given Benadryl 25mg po as ordered PRN and symptoms resolved.
On 02/21/2023, I started getting a cough, different from the cough I always have. When I returned from a trip, on 02/21/2023, I got into the doctor's office, a nurse practitioner prescribed a steroid. Allergy season hit and the cough is still persisting.
Pt felt heart racing, shaking hands, dizziness  Hx of POTS  at 15:04pm BP 118/74 HR 106 o2 97  at 15:09pm BP 116/64 HR 80 o2 97
Febrile seizure at 3:10 am lasting 2 minutes per dad report. Patient remained conscious, did not suffer from injury. Emergency medical services were called and patient's vitals were normal (values not known) per dad report.
Arm has hurt ever since. Pain constant but worse when raising arm or lifting. Pain around injection  site and up into shoulder. Primary care are writing this off as my body reacting oddly but 2 months of this is ridiculous. Pain is achy and becomes more noticeable on use.
Headache, Myalgia, Arthralgia, chills, fatigue Narrative:  Arthralgia, myalgia, headache, chills, fatigue; took in fluids; recovering but not complete
Yellow fever vaccine given 11/23/13. Pine mono papular non-pruritic rash noticed on 12/2/13. Perio-lesion pallor prominent. Very "viral" looking. Associated with mild sore throat and achiness, which both improved by 12/4. No fever. No other meals or vaccine prior to rash eruptions.
Run from right side to left side at my back pain and my left hand Numbs and  in pain. Back pain.
upon awakening had diff walking legs & hips stiff & sore; duration cont-now over entire body has seen pvt MD; no numbness, or tingling-feels weak;
Administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time). On 11-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Date refrigerated was on 13APR2021.  Temperature changes (in F): 41 was noted.  Concomitant product use was not provided by reporter.  No treatment information was provided by the reporter.
Temperature excursions duration 7 days/ the vial undergo temperature excursions; No adverse event; Dose administered after exposure to room temperature >24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions duration 7 days/ the vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 014B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions duration 7 days/ the vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions duration 7 days/ the vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after exposure to room temperature >24 hours) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions duration 7 days/ the vial undergo temperature excursions).    It was unknown that other vaccines were received by the patient within 1 month prior to Moderna COVID-19 vaccine.   It was unknown that patient received any concomitant and treatment medication.  It was unknown that patient received a full dose for primary series or a booster dose. Number of doses/vials were 1 dose from 1 vial.  It was unknown when the vial was initially stored in the refrigerator. It was reported that vial undergone temperature excursion for 7 days. Storage condition at the time of the excursion was room temperature.
This spontaneous report was received from a consumer a 75 year old female patient about herself. Concomitant medication and medical history was not reported. On 06-NOV-2008 the patient was vaccinated with both ZOSTAVAX and PNEUMOVAX 23 at the same time. Patient experienced shingles on 08-FEB-2016, and again on 18-AUG-2016. The patient stated that she was treated by her physician both times with unspecified medication. The patient stated that the second episode of shingles was much worse than the previous episode as it was more painful and described shingles rash was throughout her body. The outcome of second episode of shingles was reported as not recovered as it had not cleared up yet. The causality of shingles was unknown. Additional information has been requested.
p/vax pt devel inj site react; edema; redness & knot beneath the inj site;
Pt presented to the emergency room on 4/19/2021 c/o being extremely weak and tired and had a near syncopal episode and a fall. Pt reported developing sudden onset severe diarrhea on 2/27 which has persisted since. She had her 1st covid 19 vaccine on 2/1 and second on 3/1. She denies prior hx of diarrhea. She reports the diarrhea worsened after her second vaccine. She was seen in urgent care the beginning of april and had a negative stool culture and neg covid test. She has been taking imodium without relief and then was prescribed lomotil without relief. she denied any recent antibiotic use, diet or medication changes. she has tried changing her diet to a brat diet without improvement and eliminated milk without improvement. celiac test was neg. she is having 2-3 episodes a day of explosive diarrhea. she denied abdominal pain or fever, chills, nausea or vomiting,. she reported a 10 lb weight loss due to the diarrhea. she was referred by her pcp to a gi specialist and has an appt in may. c diff pcr was negative,. she was given ivf and potassium and discharged home to follow up with GI.
This spontaneous report as received from a pharmacist, via a field representative, refers to a early 70s years old female patient. Within the last three weeks (assumed in November 2013) the patient was vaccinated with ZOSTAVAX (dosing information and route were not provided). Immediately within minutes the injections site became swollen and itchy. The physician immediately gave the patient Benadryl and within 15 minutes the swelling dissipated and the patient was fully recovered. Reporter causality was not provided. Additional information has been requested.
Pt came back down to vaccine rooms to let me know she was feeling itchy on her arm and had some red blotches on her neck and shoulders she came down at 1:50pm.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4498686-00.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) till Jul2022 at unk, citrate free and second regimen since Aug2022 (ongoing) (Batch/Lot number: unknown) at unk, citrate free, all subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was dosage not changed. Clinical course: Solicited report by a consumer of a 64-year-old female with an event of non-serious COVID with Humira (Adalimumab). There was no reported medical history. In Jul2022, the patient experienced COVID Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded. Concomitant drugs and Other Relevant History were not reported. Events abate after stopping drug was NA.  Causality for Humira (Adalimumab): The reporter causality for the event(s) of COVID with Humira(Adalimumab) was no reasonable possibility. Causality: COVID-19: (COVID-19). Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Not related. Dechallenge: N/A Causality: COVID-19: (COVID-19), Action(s) taken with drug: Unknown. Causality as per reporter (Drug/Vaccine): Possible. Dechallenge: N/A.  The reporter considered "covid-19" related to BNT162b2.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the packaging was discarded.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events.
I have developed burning of the skin on my ears, nose, lips and chest.  My skin peels creating sores with the burning sensation.
This spontaneous report as received from a pharmacist refers to a 71 year old male patient, who on 25-AUG-2013, was vaccinated with a dose of ZOSTAVAX (lot # J002242, exp: 21-MAY-2014), 0.65 ml, subcutaneously for immunization. The patient received FLUZONE in the same vaccination session. On 25-AUG-2013, the patient experienced feeling clammy, sweaty and reported feeling anxiety. The patient reported that these symptoms began after receiving ZOSTAVAX and had not resolved as of 03-SEP-2013 (the day of reporting). The patient had not yet seen the physician, however he sought medical attention via calling pharmacy. No treatment was given for the events. No laboratory diagnostic studies were performed. The outcome of the events was reported as not recovered. The reporter did not rate the relatedness of the events to ZOSTAVAX. Additional information has been requested.
Approx 1 1/2 days p/vax constant crying w/loud screaming x 3 hrs somewhat high pitched; ex normal 2 days p/vax;
Patient reported having soreness, tingling, a lump to the left arm in at the injection site left deltoid about 2 weeks receiving Hep A vaccine (HAVRIX Hep A Adult dose Manufacturer: GlaxoSmithKline, lot# MB3Y2; expiration date 6/10/2018). Patient reported that the lump resolved. However, still reports having tinging and soreness to left arm after 2 months of receiving vaccine.
Patient was administered first Pfizer vaccine today.  After administration it was discovered that patient had already received a Johnson and Johnson vaccine on 3/28/2021.
Patient had rash about the size of a golfball, raised skin, tender to touch, felt fatigued, tired, diarrhea, loss of appetite. Patient called pharmacy and was told to seek urgent care if symptoms did not resolve or got worse. Patient called prescriber and was told to take Benadryl. Patient felt better after taking Bendaryl.
My wife  and I got the Moderna vaccine on March 24th. About 4 days after the shot, it hit us both very hard. We typically never get sick, but we were both down for about 4-5 days. As a precaution, She got tested for COVID and it came back positive. On April 21st, we got our second shot. Around May 1st,  started feeling tingling in her toes. It slowly moved into her feet. As it gradually moved up her legs, we took her for blood work.. While we were waiting for the bloodwork results, she got to where she couldn't walk, so we took her last weekend to the emergency room. They now believe she has Guillain-Barre syndrome. She is currently taking IV treatments to slow / stop the progression. We've been advised to expect a long recovery process. We don't know what caused it. COVID, the vaccine, neither, both. But I wanted to share this info with you in case you know anyone who is tracking or hoping to study rare reactions. We seem to be getting good care, but we're in a relatively small town, and I'm sure they don't have the benefits of the broader field of vision and cases that you no doubt have. So I'm passing this info along, in case you are trying to find rare cases that could ultimately help us and/or others.
Information has been received from a physician concerning a 65-year-old female who on an unspecified date was vaccinated with a dose of Zostavax. Subsequently, four days after the vaccination, the patient developed a soreness and had a red papule on the patient's upper shoulder opposite to where the vaccine was administered. Unspecified medical attention was sought. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.