chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy rash on the arm where she was injected; Developed a small red, itchy rash on the arm where she was injected; A small red, itchy rash on the arm where she was injected; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy rash on the arm where she was injected), VACCINATION SITE RASH (Developed a small red, itchy rash on the arm where she was injected) and VACCINATION SITE ERYTHEMA (A small red, itchy rash on the arm where she was injected) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-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 04-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy rash on the arm where she was injected), VACCINATION SITE RASH (Developed a small red, itchy rash on the arm where she was injected) and VACCINATION SITE ERYTHEMA (A small red, itchy rash on the arm where she was injected). At the time of the report, VACCINATION SITE PRURITUS (Itchy rash on the arm where she was injected), VACCINATION SITE RASH (Developed a small red, itchy rash on the arm where she was injected) and VACCINATION SITE ERYTHEMA (A small red, itchy rash on the arm where she was injected) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
High temperature, Cough. c/o low grade fever and cough which appeared on 11/16/2002. 2 days after vaccination. Pt was seen on 11/18/2002. He was in satisfactory condition. No fever. Physical findings: nasal congestion and erythema of posterior wall of pharings. Dx URI, pharyngitis. Rx: Rediscare 3/4 t sp Q ID, Motrin QID PRN
swelling noted at 1 day, on exam 48 hours after administration, warm and tense with well demarcated erythema not responsive to Benadryl consistent with celullitis
Client lost consciousness and became unresponsive after vaccination in observation area of clinic.  Staff nurse in observation area responded, states client was diaphoretic and pale, had weak pulse, and did not observe chest rise.  RN administered epi-pen 0.15mg  in left thigh, 911 was called.  Lead nurse onsite and nurse manager responded after epi-pen administration, client was rousable and responding minimally to questions. BP 124/60, HR 50-60, o2sat 98-100%.  Client was intermittently drowsy, remained diaphoretic and pale, oriented x4.  911 arrived 7 minutes after call, assessed pt and transported to hospital.
Patient had shingles vaccination on 9/18/14. Pt became ill on 9/22/14, with fever, chills.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Sometime in July 2015 and August 2015 (specific dates unavailable) these patients received doses of improperly stored ROTATEQ (dose was not reported, lot # K004795, expiration date 11-FEB-2016) orally. No symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
Patient received 0.25ml of Moderna bivalent vaccine; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.   It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up received patient age group, narrative updated.
PATIENT FELT NAUSEOUS AND DIZZY 2-5 MINUTES AFTER GETTING THE VACCINE. THE NAUSEA AND DIZZINESS LASTED ~ 15 MINUTES.  HE ALSO SAID HE FELT VERY TIRED.  PATIENT FELT BETTER AND AFTER ~15 MIN AND WAS MONITORED FOR 30 MINUTES. HE WAS ADVISED TO SEEK MEDICAL ATTENTION IF THE DIZZINESS RETURNS, BUT WAS GOING HOME TO BE MONITORED BY HIS WIFE.
sudden sensorineural hearing loss in the right ear, audiology and ENT assessment, currently being treated with steroid medication
PATIENT WAS INFORMED OF THE ERROR MADE ON 12/27 ON 12/28. I ASKED THE PATIENT IF SHE WAS HAVING ANY SYMPTOMS, SHE STATED: TIRED, BODY ACHES, HEART BURN AND LATHARGIC. WHEN I ASKED IF SHE HAD ANY SYMPTOMS WITH THE FIRST COVID INJECTION SHE STATED THEY WERE PRETTY MUCH THE SAME JUST THE HEART BURN WAS DIFFERENT.
Redness and soreness (L) deltoid. Started suddenly having chills, vomiting, headache and sever "thirst". He could not get warm enough. Start on same day that he received vaccine 12/1/14 at 1000pm - 4 am. Fell asleep at 4 am.
Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Diarrhea-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Unable to Sleep-Severe, Additional Details: Severe Palpitation
Initial report from a health care provider in the United States on 15 August 2007. A 12-year-old male with a history of seasonal allergies, had received a dose of Adacel (lot number, route and site not reported) on 01 August 2007 and nine days later complained of malaise and presented with erythema multiforme on hands, feet, elbows, and inside of moth (two lesions). The patient had no illness at the time of vaccination. The reporter stated the patient had not experienced any adverse events with prior pediatric vaccinations. The patient was last immunized with DTaP on 30 June 1999. The patient had not yet been evaluated by their physician for this event and their recovery status has been reported as "not recovered". No additional information had been provided at the time of this report.
approx two weeks after my daughter got the 1st Gardisil vaccine shot she started having seizures, she has no family history of seizures and has always been a healthy  person. she is now on medication to help control the seizures (keppra)500 mg in the morning and 1000 mg at night.  4/8/09 neuro consults received dated 12/30/2008 and 1/20/2009. Pt in for evaluation of ? seizures following multiple episodes of shaking of left arm, staring and unresponsiveness.  Episodes first began in late summer 2008 which consited of just arm shaking lasting less than a minute.  In 11/2008 pt c/o H/A and parent noticed pt with L arm shaking, dropped the object pt was holding, staring and unresponsive.  Pt reports awareness of event but was unable to speak. Resolved after approx 1 minute.  In early 12/2008 pt found apparently sleeping on bathroom floor. Slept 2 hrs after event. Sent for EEG which was abnormal and c/w non-convulsive primary generalized epilepsy. F/U 1/20/09 with continued episodes. In addition, pt again found on BR floor apparently sleeping. Started on Keppra although unclear if episodes are seizures.
Wobbly legs; Weak legs; feeling a little under the weather in terms of the mood; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Wobbly legs), ASTHENIA (Weak legs), MALAISE (feeling a little under the weather in terms of the mood) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and INSULIN LISPRO (HUMALOG) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Wobbly legs), ASTHENIA (Weak legs), MALAISE (feeling a little under the weather in terms of the mood) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of prior to taking 2nd shot. At the time of the report, LIMB DISCOMFORT (Wobbly legs), ASTHENIA (Weak legs), MALAISE (feeling a little under the weather in terms of the mood) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-027030 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: The patient stated she did not receive the AE form.
Friday - Started with rapid heartbeat, sweating, feverish, woke next morning (Saturday) with extreme body pain and fatigue into Sunday. Started with nausea and diarrhea early Sunday morning.  Less body aches and not as tired.  Sunday evening began feeling sick again into Monday.  Stayed home Monday from continued diarrhea, headache and tired.  Fell asleep for 4 hours, woke feeling almost normal.  During this period of time I also experienced the feeling of being depressed and a lot of crying.  I treated myself by drinking lots of water and resting.  Ate small meals when I could.
SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; SKIN PEELING; ARTHRITIS AGGRAVATED; This spontaneous report received from a patient concerned a 65 year old female of an unspecified race and ethnic origin. Initial information was processed along with additional information received on 03-JUN-2022 and 06-JUN-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: psoriatic arthritis. Patient did not report any relevant past medical history. On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 40 mg, 1 in every 14 days from 02-AUG-2021 to MAR-2022 for psoriatic arthritis. No concomitant medications were reported. On MAR-2022, the patient experienced skin peeling, and arthritis aggravated (Dose number in series: 1). On an unspecified date, the patient had no antibodies against covid-19 despite receiving vaccine (suspected immunological vaccination failure) (Dose number in series: 1). Laboratory data (dates unspecified) included: Antibody test Negative. On an unspecified date, patient additionally received 2 doses of elasomeran (Moderna) (Dose number in series: 2) (form of admin not reported, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with elasomeran (Moderna) (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s, and adalimumab was not applicable; and action taken with elasomeran was not reported. The outcome of the suspected immunological vaccination failure, skin peeling and arthritis aggravated was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number. The suspected product quality complaint has been confirmed to be voided as the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the evaluation/investigation performed.; Sender's Comments: V0-20220607585-Covid-19 vaccine ad26.cov2.s-Suspected Immunological Vaccination Failure. 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: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Rash on trunk and buttocks, itchy after 2 doses of Varivax #1 2/24/06 and #2 6/10/08.
After first dose pt had headaches and joint aches in his hands. After 2nd dose he had rash on bilateral hands. Has been 2 weeks and still has dry/cracking skin, itching.
On 9/12/12 patient spoke with pharmacist. On 9/8/12 she noticed her arm became red and swollen. She contacted her PCP, who advised her to take BENADRYL. As of 9/14/12 - the patient says swelling is gone and arm feels better. Per patient arm was so swollen could not bend it.
I was standing in bathroom, got super-hot flush from head to toe within 5 minutes gone and no; This spontaneous case was reported by a nurse and describes the occurrence of HOT FLUSH (I was standing in bathroom, got super-hot flush from head to toe within 5 minutes gone and no) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SPIRONOLACTONE and MINOCYCLINE for Acne, BIMATOPROST (LUMIGAN) for Dry eyes, CICLOSPORIN (RESTASIS) for Preglaucoma, unspecified, THYROID (ARMOUR THYROID) for Thyroid disorder, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Weight loss, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FISH OIL, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced HOT FLUSH (I was standing in bathroom, got super-hot flush from head to toe within 5 minutes gone and no). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and CAFFEINE, PARACETAMOL (EXCEDRIN ASPIRIN FREE) ongoing since an unknown date at a dose of 1 dosage form. On 31-Dec-2020, HOT FLUSH (I was standing in bathroom, got super-hot flush from head to toe within 5 minutes gone and no) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Over the next several weeks, the patient had headaches that were all sharp and stabbing, but would migrate. Sometimes they were in the back of her head, sometimes behind one of her eyes, over her temporal lobe etc but they were all the exact same sharp, stabbing pains. All these weeks later, the patient still got the headaches, but they were less often and less intense.   This case was linked to MOD-2021-023660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Patient information updated On 07-Jul-2021: Event verbatim was updated
Fever, fatigue, headache, chills. My main concern is that about 15 hours after my shot I got very dizzy, nearly passed out, and threw up twice.
The pt rubbed her arm and then 10 minutes post vax, she said she felt sleepy. She talked and she felt better.
Post vax, the pt developed redness, swelling, and soreness on left arm from shoulder to elbow.
consumer reports  pt devel fever of 104 on 28APR93, 24 hrs p/immun had febrile sz; given APAP; fever 101 persisting; but devel a cold 3MAY93; had fever 102, staring episode, vomited x 1; dx probable febrile seizure;
SIDS per autopsy 1/3/06.  No added information from autopsy report rec'd 01/18/2006/sr
Information has been received from a nurse concerning a 49 year old male recent transplant patient with renal cell carcinoma stage unspecified, right ventricular hypertrophy "EF40%", hyperlipidaemia, anemia and history of pharyngitis streptococcal and pneumonia with high fevers that occur every February at the same time with similar symptoms and no known allergies or drug reactions who on 08-NOV-2007 was vaccinated via IV push with 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot# 657525/0554U). The patient had received pneumococcal 23v polysaccharide vaccine approximately 10 years ago. Concomitant therapy included cyclosporine 25mg twice daily, atorvastatin calcium (LIPITOR), sirolimus (RAPAMUNE), clonidine, nifedipine, furosemide sodium (LASIX, labetalol HCl, ascorbic acid/folic acid/vitamin B complex (NEPEROCAPS) and Mg oxide (MAG-OX 420 TABLETS). On 08-NOV-2007, 30 seconds post vaccination, the patient experienced itchy throat and throbbing in the genital area. The patient was given diphenhydramine hydrochloride (BENADRYL) 25mg and recovered. Additional information has been requested.
Site of PNEUMOVAX became red and swollen and painful, patient went to ER. Either cellulitis or allergic rxn - MD unsure (rxn was definitely around PNEUMOVAX site).
Patient presented to ED with generalized weakness, fever and cough. O2 saturation at 84 %.Pt admitted to hospital.
Patient experienced pain in the left shoulder that radiated up to her neck. She became lightheaded, started convulsing, and hit her head on the wall.
The day after I got the vaccine I could not lift my right arm even up to shoulder height. That took 5 days to finally feel normal. Recently (last month or 2) when I do overhead work or shovel light snow for 5 minutes, my arm is tired and is burning near the top of my arm where the injection was given.
I do not know the type of RSV Shot. I have a rash that started on the right arm and has reoccurred in both armpits and between both my thighs and legs.
We received via agency, and Novartis Pharmaceuticals, from a healthcare professional the following information on 01 DEC 2009: This case refers to a male infant, born by C-section on 30 NOV 2009. The baby was delivered in the 27th week of gestation after his mother died on the same day after an collapse (please refer to cases MA2009-5711 and -5712 for the mother) following vaccination with FLUVIRIN and pandemic FLUVIRIN (both batch numbers unknown) on 18 NOV 2009. The child was healthy. The outcome was unknown. Agency ref. no.: NA09-008971. Novartis Pharmaceuticals ref. no.: S2009US27919.
Whole body tremors/shaking x 30 minutes on 11/28/2017 and 4/9/2018. Not consistent with seizure, although we are trying to figure out if it is a seizure.
This spontaneous report was received from an administrator and refers to a 4 month old patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, (dose, frequency and route of administration were not reported) lot # M044397 with expiration date: 20-JUN-2018 or lot# N003984 with expiration date: 19-NOV-2018. The specific lot # of ROTATEQ administered to the patient was unknown by reporter. No adverse effects were reported. The ROTATEQ vaccine was stored in or above 32 degrees Fahrenheit (F) up to 35 F (35.4 F) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No causality assessment was provided by the reporter.
Low grade fever, joint aches, injection site swelling, redness, induration, nausea.
Information has been received from a health professional concerning a 4 yr old male with allergies to amoxicillin and azithromycin (Zithromax) and no medical history, who on 13Jun02 was vaccinated with a 0.5ml SC first dose in the left anterior lateral thigh of varicella virus vaccine live (lot640467/0971L). Concomitant vaccines administered on the same day included a first SC dose in the left deltoid of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot642439/0234M) and a fourth IM dose in the left anterior lateral thigh of Hib conj vaccine (Tet toxoid) (Acthib) (lotUA696AA). There was no other concomitant medication. It was reported that on 20Jul05 the pt experienced red areas and 12 blisters on his legs, arms and back with a fever of 101F. The pt was seen in the office on 22Jul05 and was diagnosed with varicella. He was treated with diphenhydramine hydrochloride (Benadryl) and acetaminophen (Tylenol). It was reported that the pt was recovering. No product quality complaint was involved. Follow up information from a health professional indicated that on 20Jul05 the pt began at the beach with a hoarse voice. The next day the pt developed red areas, possibly bug bites, as the day progressed more appeared and they started to look like blisters. There were about 12 total, on his arms, legs, cheek, and back. It was noted that the pt was scratching at the areas, and that his temp was 101. Additional information has been requested.
First 2 days left arm was sore next day chills rash on left side of face headache blisters in left side of mouth upper, achy, face and head extremely tender to touch. Called family dr advised me to go to emergency hospital or urgent care. Went to urgent care . Was diagnosed with shingles and given valtrex and lidocaine swish and spit, recommended to take Motrin or Tylenol.
ADMINISTERED THE JANSSEN  COVID-19 VACCINE TO A FEMALE  PATIENT AND GAVE HER THE ENTIRE  VIAL; OFF LABEL USE; This spontaneous report received from a health care professional concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced administered the janssen covid-19 vaccine to a female patient and gave her the entire vial. On 25-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered the janssen covid-19 vaccine to a female patient and gave her the entire vial and off label use was not reported. This report was non-serious.
first 2 days slight headache and body aches,   third day through 10th day, nausea, vomiting on the days 9 and 10,   stomach pain, hives.  I went to the ER on March 19  for nausea and vomitting, was dehydrated and received IV fluids. I also had hives which I was prescribed Steroids for.  The next day, March 20, I went to urgent care for severe hives and was given a steroid shot and epinephrine shot.  I don't know if these symptoms are a result of the vaccine, but I did not have them prior to the vaccine so I thought they should be reported.  Thanks
Besides the usual fever, aches, fatigue I have hives like rash on my right upper arm near first injection.  Very very itchy