chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling Weak; Fast heartbeat; 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 ASTHENIA (Feeling Weak) and TACHYCARDIA (Fast heartbeat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feeling Weak) and TACHYCARDIA (Fast heartbeat). At the time of the report, ASTHENIA (Feeling Weak) and TACHYCARDIA (Fast heartbeat) outcome was unknown.            Reporter did not allow further contact
Information has been received from an immunization field consultant concerning an approximately 62 day old (also reported as 2 months old) patient who on an unspecified date was vaccinated with the first dose of ROTATEQ (lot # not reported). After receiving the vaccination the patient had developed diarrhea for 2 weeks. On an unspecified date the patient recovered on therapy. Additional information has been requested.
4x5.5 area on right thigh.  Induration around site, erythema, warm to touch, nontender, blanching, patient diagnosed with Cellulitis of right lower extremity/thigh.  Child complaint of itching.
Patient received MENACTRA IM injection to left deltoid and within a minute to two reported blurred vision, changes in hearing, nausea and appeared pale. Patient was sitting in exam table and was placed in supine position after reporting symptoms. Systolic blood pressure was reading 80 and patient started to have a seizure, pupils appeared dilated and patient was unresponsive. Medical assistant called EMS. Seizure lasted less than a minute and patient's BP was rechecked at 82/50 around 11:51 a.m. Patient was then awake and wanting to sit up because he was nauseated. Patient was still appearing pale. Paramedics arrived to clinic at 11:56 at which time patient was sitting up answering questions and found to be alert and oriented to person, place, time and recent events. Was able to identify his mother present in the room. Blood pressure was rechecked at that time at 92/60 and paramedics placed patient in stretcher. Patient was ambulatory and interacting with paramedics, his mother and myself.
EPILEPSY, UNSPECIFIED ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY HYPOXIA 2/24/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Rash showed up on left arm about two weeks later and turned out to be viral meningitis that needed a 4 day hospital stay and treatment. It is believed the virus that caused the meningitis was the varicella virus. Rash developed into serious illness over the span of one week.
Pt had cellulitis around site of inj. (R) delt KEFLEX was given at time of visit on 9/17/15.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. Pharmacist was informed by an unspecified nurse that the patient received the first two doses of GARDASIL "approximately six years ago.", approximately June 2007 (dose, route and lot # unknown). Pharmacist was unsure if the patient was in the physician's office "now" 13-JUN-2013 to receive the third dose. No adverse effect reported. Additional information has been requested.
w/in five minutes of receiving a dose of Influenza vax, pt devel an anaphylactic rxn; Became light-headed, pale, unresponsive, cyanotic & began to convulse; tx Epi & regained consciousness immediately; Sent to ER where observed;
Patient says her arm was hurting she could barely lift her arm up yesterday and her whole arm was hurting. She was having a hard time washing her hair and lifting her arm up to change clothes.
Patient had significant bruising down and around her arm- above her elbow area in particular was worse than at the actual injection site. She also said there was pain in her arm for a couple days but that had resolved.
Patient was given a Covid 19 Bivalent vaccine on 8/3/23 that had a use by date of 7/24/23. Patient had no adverse events or treatment needed.
pt recv vax 18NOV96 & 20NOV pt devel ipsilateral lymphangitis lasting 2 days;this was followed by an allergic rash which has been steroid resistant;
This spontaneous report as received from a other health professional (registered nurse) refer to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with ROTATEQ for an unknown indication (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date unspecified number of patients received ROTATEQ after being improperly stored. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Reactions due to polyethylene glycol; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Reactions due to polyethylene glycol) 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 ADVERSE DRUG REACTION (Reactions due to polyethylene glycol). At the time of the report, ADVERSE DRUG REACTION (Reactions due to polyethylene glycol) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
On 8/12/2021 a rash showed up on the right lower side of my body that was very itchy.  By 8/16/2021 when it had not cleared and was still extremely itchy I went to an urgent care to be seen. The diagnosis was shingles and I was put on valACYclovir to take 3 times a day for 7 days.  It took at least another week for the itchiness to subside and about the same time for the blisters to heal.
Recurrent Minimal Change Disease; Disease recurrence; This literature-non-study case was reported in a literature article and describes the occurrence of GLOMERULONEPHRITIS MINIMAL LESION (Recurrent Minimal Change Disease) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE     The patient's past medical history included Minimal change disease (MCD diagnosed in the past, and one episode of relapsed minimal change disease following COVID-19 infection) and COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2022, the patient experienced GLOMERULONEPHRITIS MINIMAL LESION (Recurrent Minimal Change Disease) (seriousness criterion medically significant) and DISEASE RECURRENCE (Disease recurrence). At the time of the report, GLOMERULONEPHRITIS MINIMAL LESION (Recurrent Minimal Change Disease) and DISEASE RECURRENCE (Disease recurrence) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2022, Biopsy kidney: consistent with recurrent MCD. On an unknown date, Blood creatinine: 1.03. On an unknown date, Urine protein/creatinine ratio: 9.04.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GLOMERULONEPHRITIS MINIMAL LESION (Recurrent Minimal Change Disease) and DISEASE RECURRENCE (Disease recurrence) to be related.    Concomitant and treatment medications were not reported.  This study identified eight patients with renal biopsy proven renal diseases due to COVID infection from the end of 2020 to the middle of 2022.   After Moderna COVID-19 vaccine, he developed nephrotic range proteinuria  Patient developed one episode of relapsed MCD after his COVID infection, followed by another episode of relapsed MCD, which was triggered by COVID-19 vaccination.  Biopsy type was reported as native.  Company Comment: This literature-non-study case concerns a 73-year-old male patient, with relevant medical history of minimal change disease (MCD) in the past and one episode of relapsed MCD following COVID-19 infection, who experienced the unexpected and serious (due to medically significant) event of Glomerulonephritis minimal lesion (reported as recurrent minimal change disease), which occurred within 2 weeks after mRNA-1273 vaccine, administered as third booster within COVID-19 vaccination schedule. After 2 weeks of vaccination, patient developed nephrotic range proteinuria. Diagnostic tests revealed blood creatinine of 1.03 and urine protein/creatinine ratio of 9.04. Renal biopsy confirmed diagnosis of relapsed MCD. No information disclosed about clinical course or treatments received. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Blood clots Leg dis function Headaches Burning pain Joint issues Pins and needles all over Eye pain Fatigue
Had vesicular lesions < 50 on abdomen, groin. Pt had no fever prior to breakout.
Per medical records. Per mother, child saw PCP and received FLUMIST on 10/17/14. By the time they arrived home the child developed watery diarrhea and vomiting. Next day child had droopy eyelids and rhinorrhea. Over the course of a few days this progressed to truncal ataxia, dysphagia, ptosis and slurred speech. The child progressed to respiratory failure and cardiac arrest. No treatment, aside from supportive fluids and tube feeding provided.
No adverse event; 15 years old received an adult dose of VAQTA.; received 1.0 ml instead of 0.5 ml; This spontaneous report was received from a medical assistant concerning a 15-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 25-JUN-2021, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA), 1 ml instead of 0.5 ml, intramuscular,  lot # T017179, expiration date: 26-OCT-2021, for prophylaxis. No adverse events reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T017179; expirationdate: 26-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
muscle contractions pulling both shoulders together as in fetal position, lost 17 pounds,Extremely painful could not use arms in helping to get out of bed. Autoimmune swelling in major areas ( shoulders, elbows, wrists, hands, fingers, hips, knees, ankles, neck, upper back) Doctors have been treating me for arthritis with testing and drugs. The reaction to the first injection was the slowest to come on but the most severe in pain and loss of movement.  The second injection increase in symptoms happened by the second day.  The third injection had the most immediate reaction of chills for 2 days.  Pain and stiffness followed.  It has been 51 days and pain and stiffness of my shoulders continues.  I have been having  heart irregularities and have started metoprolol. I have been prescribed prednisone and hydroxychloroquine to minimize the pain and swelling throughout my body.
pt recvd vax; exp high fever w/ screaming episodes;apap given immed p/ vax; fever of 103;
30 mins after vaccine felt numbness on tip of tongue and slight shortness of breath. Took inhaler and nasal spray, helped "a little bit". Also c/o general weakness. Also took BENADRYL.
Information was received from an attorney regarding a case in litigation concerning a female patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. In or about 16-NOV-2012, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster.  On or about 29-MAY-2016, the patient was treated for onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The patient has been prescribed valacyclovir, prednisone, and tramadol for management of her painful symptoms. As a direct an proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long term prevention of shingles. The patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
itchy and scratching; scratching; lichenoid dermatitis; This spontaneous case was reported by a non-health professional and describes the occurrence of PRURITUS (itchy and scratching), SCRATCH (scratching) and LICHENOID KERATOSIS (lichenoid dermatitis) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy and scratching), SCRATCH (scratching) and LICHENOID KERATOSIS (lichenoid dermatitis). At the time of the report, PRURITUS (itchy and scratching), SCRATCH (scratching) and LICHENOID KERATOSIS (lichenoid dermatitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Lt leg @ injection site showed redness, warmth, swelling.  Area was also tender to touch.  Also started w/temp 99.3 today
syringe was broken; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, 0.5 ml single (Lot number: GM9409, Expiration Date: Aug2024) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "syringe was broken".  Additional information: NDC number of Prevnar 20: 0005200010. Product damaged in transit: Had it in the fridge, went to administer it and when it was taken out of the box it was realized that the neck of the syringe was broken and there was no vaccine in it. Order was received on 08Feb2023. Neck of the syringe was broken and there was no vaccine in it. First time product was ever damaged during transit, only one effected. Sample of the product available to be returned, if requested.
little lightheaded; tired; This is a spontaneous report from a contactable consumer via medical information team. A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 04Mar2021 as dose 1, single for COVID-19 immunization. The medical history included chronic lymphocytic leukaemia (CLL), he was diagnosed 14-15 months ago with CLL and had been taking Imbruvica 420mg/day. His WBC count was 16K and was 50-60% lymphocytes but now his bloodwork was good and controlled by Imbruvica. He also had dental, orthopaedic and heart issues. He had a spleen that was measuring 22cm and was pushing his stomach out. He then moved from to a private doctor and had moved from Stage 2 to Stage 0. He had had no side effects from the Imbruvica. The patient's concomitant medications were not reported. On 04Mar2021 after the first shot the patient felt a little lightheaded and then tired the same day. He also received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported) on 24Mar2021. On an unspecified date the patient underwent lab tests and procedures which included immunity test to check if he gained immunity to the shots like Corona IGG /Sars Covid 2 IGG spikes both came out negative. The first was an ABIGG, SPIKE S done two weeks after the vaccine and the reading was a little arrow to the left less than 1. His doctor told him that this only shows recent infection. The second antibody test he had done four weeks after the vaccine was a CoV-2 IGG/IGM and the little arrow read to the left of 1.4. and then later were 0.04 and 0.02 readings. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No adverse event; HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     The patient had no known conditions.     On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4APR2023 after the expiration date of 01APR2023.).    No concomitant medications were reported.     The patient had not reported any adverse events (AEs).  No treatment medications were reported.
On the evening of March 1, I started to get a slight scratchy throat that was due to the winds and rain from Spring. By the next day I started feeling a little worse, I started having a fever around 7:30PM on March 2 of 101F and kept going up. By 2:18AM it went up to the mid 103F, I had the chills, sweats. When my temperature got up to 103.8F I called my doctor's office and got an on-call nurse who suggested I sleep with a sheet and call the doctor in the morning. I called the doctor in the morning. I let the doctor know I had tested myself on both 03/02/2023 it was negative and 03/03/2023 it was positive. I had a video visit with a doctor for PAXLOVID that I was not able to get filled the pharmacy lost the prescription. The first couple of days I sparingly used MUCINEX and rotated between TYLENOL and ibuprofen every six hours. The fever finally ended by 03/04/2023. I feel like the scratchy throat is gone, I have a slight cough, my nose is stuffy, I still have a slight cough.
I  was  involved  in  a  traffic  accident  around  12:00  noon  approximately  15  to  20  min   after     leaving  the  doctors  office  after  receiving  the  flu  vaccine  on  01/09/2019.  I  contacted  my  Doctors  office  and  reported  the  accident  approximately  3:00 pm  the  same  day.
Stress at work; Hidradenitis suppurativa flare ups; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Hidradenitis suppurativa flare ups) and STRESS AT WORK (Stress at work) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF, Solution for injection in pre-filled pen. In August 2021, the patient experienced CONDITION AGGRAVATED (Hidradenitis suppurativa flare ups). On an unknown date, the patient experienced STRESS AT WORK (Stress at work). At the time of the report, CONDITION AGGRAVATED (Hidradenitis suppurativa flare ups) and STRESS AT WORK (Stress at work) outcome was unknown.            The concomitant medication was not reported by reporter. On an unknown date, the patient experienced work-related stress. In Aug-2021, the patient experienced hidradenitis suppurativa flare ups after second dose of covid vaccine. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The treatment medication was not reported by reporter.
Began with papules on 5/4/10 and developed crops of vesicles, pustules, and papules head, trunk, legs, back, abdomen.
had more trouble with the second shot; This case was received via an unknown source (no reference has been entered for a health authority or partner) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-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 VACCINATION COMPLICATION (had more trouble with the second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had more trouble with the second shot). At the time of the report, VACCINATION COMPLICATION (had more trouble with the second shot) outcome was unknown.            No Concomitant drugs were reported.  No Treatment information  were reported.
began itching within 24 hours, within 5 days couldn't move on her own, by 6th day was having respiratory issues, by day 7 unresponsive, by day 8 dead
Bone pain, muscle pain, chronic diarrhea, joint pain. Per follow up report received on 06/09/2005:  Multiple arthralgia, neurological effects, fibromyalgia, skin rashes, hair loss, menstrual disorders, chronic fatigue.
Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.
Within 4 to 5 hours of inadvertently receiving an intradermal injection of Tetanus Toxoid Adsorbed, Purogenated pt developed an injection site reaction characterized by redness the size of nickels and experienced pain.  As of 01/05/2000 the redness persisted.