chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) 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 13-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Action taken with the mRNA-1273 in response to the event is not applicable.
Received call from mother, saying child had raised area on left VL approx. 2cm-4cm, warm to the touch with redness. No increased temperature. (+) TTP.
Patient received  a 3 weeks expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received  a 3 weeks expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received  a 3 weeks expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received  a 3 weeks expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  It was reported that the vial was initially stored in refrigerator on 20-Oct-2021 and the vial did not undergone any temperature excursions.
Developed redness/swelling of right upper arm sometime late afternoon 1/6/05. No fever or respiratory problems associated. Area became slightly larger on 01/07/05 but according to father was not painful to child and was less warm than on 1/6/05. Child received Benadryl once on evening of 1/6/05. I felt it was a local reaction and not a cellulitis on my exam on 1/7/05.
Initial report received from consumer on 01 DEC 2014. A male patient (62 years at the time of report), whose medical history and concomitant medications were not reported, had received a dose of INFLUENZA (batch number, dose, dose number, route and site of vaccination not reported) on an unspecified date (reported as 20 years back). It was reported that the patient had been strenuously hiking two days before vaccination. It was reported that on an unspecified date following vaccination, the patient experienced pain in both knees. The patient experienced severe arthritis in knees for two months. The patient had not consulted a physician. Lab details and corrective treatments were not reported. The outcome of event was recovered. Document held by sender: none.
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and unknown gender. Patients concurrent conditions and relevant medical history was not reported. On an unknown dates (reported as since 01-DEC-2014), unspecified patients were vaccinated with VAQTA (lot number, dose, frequency and route unspecified) that was exposed to a supported temperature excursion on 01-DEC-2014. No adverse effect have been reported. The outcome of the events was unknown. The causality of the events with VAQTA was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
The patient stood up to signal something was wrong, and she immediately sat back down. As I went over to her, she was leaning over out of her chair at which time she fainted, and I had her lieing on the groung. she woke up 5-10 seconds later and didn't know what had happeneded and was upset. We moved to the immunization room and elevated her legs while applying ice packs to the back of her neck. She drank water and ate an apple. Within 45 minute she was feeling a lot better.
Extreme fatigue, nausea and vomiting, muscle aches and pains, extreme tremors from shivering, feeling very cold, headache, minor heart palpitations.  Out of work for two-and-a-half days.
pt recv vax 15JAN98 & w/in 90min devel an allergic rxn characterized by swelling of the throat, wheezing & croup like sx;hosp & treated w/med;dx angioneurotic edema;
ONE HOUR AFTER RECEIVING INFLUENZA VACCINATION PATIENT BEGAN TO FEEL DIZZY AND RIGHT SIDE OF BODY BECAME RED/HOT TO TOUCH
suspected vaccination failure; fairly severe case of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mesothelioma.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported the patient received the series of Shingrix in the proper timeframe and had developed a fairly severe case of shingles. As timeframe between the dose and the event was unknwon. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were not reported.
patient received 0.25ml dose; A spontaneous report was received from a consumer concerning a 29-Year-old female patient, of unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported vaccine underdose.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination.  On 25 Mar 2021, prior to the onset of the events, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: 017B21A) via intramuscular route into her left arm for prophylaxis of COVID-19 infection .  On 25 mar 2021, the 2 nurses administered 0.25 ml doses to 5 patients and all were employees of prison. Nurses would like to know if another dose should be administered immediately.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, underdose, was recovered.; Reporter's Comments: This report refers to a case of Underdose, for mRNA-1273, lot #: 017B21A, with no associated AEs.
Headache, fever, lethargy, entire body ached, very increased neuralgia which I haven't experienced for a very long time (stemming from Shingles years ago) took lots of Tylenol, slept for about 12+ hours straight, lots of water Outcome - still a bit feverish on 2nd day and tired but no headache
sick for 1-2 days; COVID disease; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 1-2 days) and COVID-19 (COVID disease) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 1-2 days) and COVID-19 (COVID disease). At the time of the report, ILLNESS (sick for 1-2 days) had resolved and COVID-19 (COVID disease) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medications was reported.
Two days post injection of vaccine, it was noted that an area below ideal injection site was warm, red and painful to the touch. On-call provider looked at and diagnosed with cellulites. She was started on IV antibiotic Vancomycin (three doses).  Incident report started as location of the injection was in question. Per nurse who administered it, she went four finger widths below shoulder joint, and injected with one inch needle.   Location most likely not into the Deltoid, but subcutaneously due to patient arm size and placement.
Very weak, unable to stand for more than about 30 minutes without feeling faint and dizzy. No appetite led to eating less than I should, which triggered possible anemia.
Patient is a 77 y.o. female presenting with cough and decreased mental status. Patient is mostly non-verbal, so all history obtained from chart and via phone from patient's daughter, who cares for her full-time. Per daughter, the patient has been coughing and seems to be choking while coughing for the past 1-2 days. She has been giving her cold medicine but it did not seem to be getting better, so she brought her to the ED. In the ED, she was found to be COVID (+). Her CXR was negative for acute processes, and O2 saturation has been in high 90s on room air.   Patient was found to be positive for Covid. She was also dehydrated so was given fluids. Her mental status improved to baseline of mostly non verbal and AAo*1. Patient was also able to tolerate TFs and free water without any vomiting. Her diarrhea resolved. She didn't have any other symptoms from Covid and din't require any Covid specific therapy. She had foley catheter inserted in ED< which was removed and she was able to void successfully. She was discharged home in stable condition under care of her daughter once ambulance was arranged with instructions for 10 day isolation given her mild symptoms and follow up with PCP once out of isolation.   Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Chills, body aches, tiredness and fever.  Rest, fluids and tylenol
On 10/19/01, the pt broke out with a rash. On 10/21/01, the pt developed a fever of 101F and itching. Rx'd with Tylenol and Amoxicillin (for Otitis).
Information has been received from a licensed visiting nurse concerning an 18 month old male with reactive airways disease and a history of febrile convulsion in 2008, who on 04-MAR-2009 was vaccinated SC with first 0.5mL dose of VARIVAX (Merck) (lot number 661989/1740X).  Concomitant therapy included Hep A (manufacturer unknown).  On 08-APR-2009 the patient was seen at physicians office and was described as having "mild case" of chickenpox.  No lab studies were performed.  At the time of reporting the patient was recovering from the event.  This is one of two reports from the same source.  Additional information has been requested.
Experienced a seizure (jerking) for about 30 seconds while in car. Took to emergency room immediately.
BAD HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 24-MAR-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache. This report was non-serious.
Extremely sore left arm for days 1-3,  On third day awoke with debilitating dizziness, nausea and headache. Dizziness was so extreme any movement sent my head spinning and I began sweating and experienced nausea. Had to go to the hospital for treatment.  Dizziness continued on the fourth morning but subsides after taking 25mg of Meclizine HCL. headache continues as well. Other side effects: Complete loss of appetite  Blurred vision in right eye
Diagnosed with C. difficile.; Nasty abdominal cramps; Passing out; Lack of appetite; Diarrhea; Falling; Arm pain; A spontaneous report was received from a consumer concerning a 68 year old, female patient who developed severe stomach cramps, passed out, lack of appetite, falling and diarrhea.   The patient's medical history was not provided. Concomitant product use included Tums (up to 2 tabs five times per day), Gas-X, Pepto, Probiotic (30 billion units) and clindamycin, all were used for an unknown indication.   The patient received the first of two planned doses of mRNA-1273 (Batch number: 010M20A) on 27 Jan 2021. On 24 Feb 2021, approximately 5 hours prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 013A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    After the first shot of vaccine the patient reported no reactions other than mild arm pain. After the second dose of vaccine the patient had gastrointestinal distress. The patient had severe stomach cramps, she passed out while on the toilet, she fell in toilet and her husband helped to stabilize, lack of appetite and diarrhea. Patient had been instructed to adhere to a bland diet consisting of toast, rice, bananas, broth, and Pedialyte by her physician. She reported that she was hospitalized on 09 Mar 2021 and was released on 11 Mar 2021. She stated that she ended up being diagnosed with C. difficile. She stated the gastroenterologist did not believe the C. difficile was caused directly from the second dose in the series from Moderna's COVID-19 vaccination. Consumer reported that she was originally was taking a three days course of clindamycin which is a suspect for C. difficile. She was prescribed a 10 days course of vancomycin. Treatment for the event included Bland diet, Tums, Gas- X, Pepto, Probiotic.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, severe stomach cramps, passed out, lack of appetite, diarrhea, was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
About 20 pink papules (about 5mm) scattered over face, ears, chest & arms.  No obvious vesicles however several of lesions on face have slightly raised unctate central areas.
Covid arm after the first two vaccine doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm after the first two vaccine doses) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Have a history of exercise-induced asthma from childhood which never needed to be treated), Hypersensitivity, Drug allergy (Sulfa allergy. Only experienced as a baby, probably swelling) in 1984, Allergy to metals (Metal sensitivity- Get a skin rash when wear cheap metal that's not sterling silver) and Migraine (Started in childhood (few times per year)). Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (AZURETTE) for Birth control.    On 27-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Covid arm after the first two vaccine doses). In 2021, VACCINATION SITE REACTION (Covid arm after the first two vaccine doses) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2022-473381, MOD-2022-439984 (Patient Link).
ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/2/2021 NONTRAUMATIC ACUTE KIDNEY INJURY
pins & needles in her muscles; sometimes her legs would give way; shortness of breath; blue lips; loss of balance; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (pins & needles in her muscles), LIMB DISCOMFORT (sometimes her legs would give way), DYSPNOEA (shortness of breath), CYANOSIS (blue lips) and BALANCE DISORDER (loss of balance) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (pins & needles in her muscles), LIMB DISCOMFORT (sometimes her legs would give way), DYSPNOEA (shortness of breath), CYANOSIS (blue lips) and BALANCE DISORDER (loss of balance). At the time of the report, PARAESTHESIA (pins & needles in her muscles), LIMB DISCOMFORT (sometimes her legs would give way), DYSPNOEA (shortness of breath), CYANOSIS (blue lips) and BALANCE DISORDER (loss of balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to her cardiologist & had a stress test & echocardiogram and they said her side effects could possibly be due to the vaccine. The patient is wondering whether or not to get her 2nd dose & wants to know if loss of balance is a normal, common side effect of the vaccine. Before providing more information on the shortness of breath (the myo/pericarditis questions)  Concomitant medications was not provided by the reporter. Treatment information was not provided.
FLU LIKE SYMPTOMS(LOW GRADE FEVER, BODY ACHE, HEADACHE, CHILLS); NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-APR-2021, the subject experienced flu like symptoms (low grade fever, body ache, headache, chills). On 11-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms(low grade fever, body ache, headache, chills) and nausea was not reported. This report was non-serious.
Pt received Pneumovax 3/31/05. The following day, pt developed soreness at injection site inflammation. Over a period of 4 days  symptoms continued along with temp up to 101.2, chills, general aches. Prescribed Zithromax.
mom states pt c/o leg pain @ bedtime on HS; on morning of 13SEP94 was limping & mom noticed legs was reddened was seen in office on 14SEP94 & dx w/cellulitis rt thigh & treated w/Keflex;
Following Symptoms began and ended around the same time  12:24pm 5 min long  Dizziness/feeling of fainting Lowered ability to hear Chills/sweating Nausea
I did not have an adverse reaction to the vaccine. I have a history of arthritis for years but since the vaccine I have pronounced connective tissue issues. I had surgery on 01/16/2023 for tendinitis in my arm.  I have another surgery scheduled for torn muscles in my right arm.
102.9 FEVER. Rash, Achy. Lasted 24 hours
very sensitive to the touch; Today I noticed that my armpit is swollen; a slight temperature 99.5F; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA (very sensitive to the touch), LYMPHADENOPATHY (Today I noticed that my armpit is swollen) and PYREXIA (a slight temperature 99.5F) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PYREXIA (a slight temperature 99.5F). On 01-Feb-2021, the patient experienced HYPERAESTHESIA (very sensitive to the touch) and LYMPHADENOPATHY (Today I noticed that my armpit is swollen). The patient was treated with PARACETAMOL (TYLENOL) on 29-Jan-2021 for Fever and Myalgia, at an unspecified dose and frequency. On 30-Jan-2021, PYREXIA (a slight temperature 99.5F) had resolved. At the time of the report, HYPERAESTHESIA (very sensitive to the touch) and LYMPHADENOPATHY (Today I noticed that my armpit is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 99.5f (Inconclusive) Slight temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.
I had a miscarriage at 5 weeks pregnancy. Conception on July 18-20, positive pregnancy test August 5, miscarriage August 12-13.
Tests positive for covid; Tests positive for COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a patient of unspecified age and gender received BNT162B2, dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The nurse stated that patient received first dose on 12Feb2021 and now, on an unspecified date, tests positive for COVID. The nurse wanted to know if it is okay to administer second dose. The outcome of the event was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective / COVID-19 cannot be ruled out.
Within weeks of vaccinations, she became rowsy/lethargic/"drugged" briefly- then lost facial expression, language/social skills previously acquired.
Vaccine is identified as Comirnaty by Pfizer. I had redness at the site, larger than normally seen with other shots.  At midnight bedtime, I was totally wiped out; lethargic, lightheaded, and felt like I would faint. This was felt from 12:00 a.m. on 10/24 through the entire day.  (I did have syncope with the 2nd dose of Moderna Covid vaccine ion 1/30/2021, and fell on my face, heavy bruising and black eye; had a brain scan but no enduring issues.) So I was cautious this time drinking during the night with bottled water by bedside, and woke my husband if I had to go to the bathroom so I would not faint again; otherwise, I believe I would have. I began feeling myself on day 10/25 a.m.
pt recv vax 24NOV97 & w/in 10min of vax pt exp numbness in hands, tingling in fingers & nausea;
a day after receiving COVID vaccine, small unraised blotches appeared on and around injection site. Left arm was itchy for about 2-3 days.
NAUSEA, VOMITING, FEVER, SWOLLEN ARM AND LUMP AT INJECTION SITE.