chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Body ache), NAUSEA (Nausea) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included VITAMIN D NOS, VITAMIN C [ASCORBIC ACID], ATENOLOL, ZINC and THYROID for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), PAIN (Body ache), NAUSEA (Nausea) and PYREXIA (Fever). The patient was treated with CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), PAIN (Body ache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
on 12/16 i was given the vaccine at noon and finished my day as usual, I had a beer before bed and fell asleep at 9pm, at about 1am on 12/17/2020 I woke up with severe chest pain like something was crushing me, like a car being crush it felt like. I went to the ER at 3am and I was told I had a severe reaction to the vaccine. I had a weird taste in my mouth, cough, watery eyes, pain in all limbs, jaw pain and neck pain. I am going to get tested today 12/18/2020 for covid
This spontaneous report was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified doses of GARDASIL (route of administration, anatomical location, lot number and expiration date were not reported); the doses were exposed to temperatures outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
Left arm started swelling and getting redness at the area of injection.Its extremely itchy and warm to touch.
PATIENT SAID SHE HAD SORENESS AND REDNESS AT SITE OF INJECTION, ITCHING AND RASH  LASTS FOR MORE THAN 4 WEEKS
On 8/17/2021, Patient had a sudden onset of migraine, which led to hemiplegic migraine, with paralysis on her left side. This resulted in ambulance transport to local emergency department and admittance to ICU. A second emergency department visit was necessary on 9/7/2021, for similar symptoms as well as difficulty swallowing. Stroke was ruled out by CT, MRI, and various lab tests.
Immediate sweating and slight  SOB then localized site pain then within 24 hours severe muscle pain and weakness needing assistance with walking for 2 days after .  Symptoms got better on 9/8/2020
Severe headache, crying, chills 13:30 pain level from 1-10 being the worst 10. 15:31 much better pain 3.
High Fever from 101.5 the next morning after second vaccine to 103 degrees.  Body aches/chills...took Tylenols and advil every 5-6 hours.  arm pain...very sore...used ice pack in the evening and same tylenols/advil as for fever.
Left arm pain, a light throbbing chest pain near arm pit throughout the 2nd and 3rd day after shot.
Received injection on Saturday, November 13 at 12:25 p.m. Symptoms began with fever, body aches about 10 hours after injection. Fever subsided the next day but body aches remained, some chest pain. On Monday, body aches reduced but chest tightness remained, exacerbated with physical activity. Tuesday morning around 8:30 a.m. I was woken up by intense aching in shoulders, neck, and back, along with further chest pain and nausea. Could not get comfortable in any position, attempted to treat with ibuprofen which did not resolve symptoms. Went to urgent care and had an abnormal EKG, received 4 baby aspirin. Transferred to Hospital, given stronger ibuprofen and Colchicine. Symptoms improved, although heart rate remained irregular. The next morning experienced heart issues similar to the day before, accompanied by vomiting. Proceeded to take Colchicine but not ibuprofen out of concern for kidneys. Troponin and creatinine levels were elevated. Diagnosed as myopericarditis as a result of the COVID-19 vaccine booster shot.
I tested positive for COVID-19 on 06/02/2022. I had a runny nose and it was kind of dry and crusty. I felt like I had a fever, but when I took my temperature it was 97.3. My skin was kind of clammy feeling. I didn't have diarrhea until the end of taking my medicine yesterday 06/08/2022. I had puss pocket on the back of my throat; I gargled with warm salt water immediately and that went away. I didn't have a cough at all with this. I am a little hoarse today. I started Paxlovid on 06/03/2022 in the evening.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I was sicker than when I had COVID), PAIN IN EXTREMITY (sore arm), PALPITATIONS (heart rate spiked up in the morning/felt my heart beating faster), FEELING ABNORMAL (felt lousy all day) and TACHYCARDIA (heart beating faster) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020.Concurrent medical conditions included Left bundle branch block (diagnosed with approximately 10 years ago).Concomitant products included LOSARTAN, LEVOTHYROXINE, CETIRIZINE, FAMOTIDINE, SIMVASTATIN, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), BIOTIN, COLECALCIFEROL (VITAMIN D3), LORAZEPAM and BEVACIZUMAB (AVASTIN [BEVACIZUMAB]) for an unknown indication.On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION COMPLICATION (I was sicker than when I had COVID), PAIN IN EXTREMITY (sore arm), PALPITATIONS (heart rate spiked up in the morning/felt my heart beating faster), CHILLS (chills) and PYREXIA (fever). 06-Feb-2021, the patient experienced FEELING ABNORMAL (felt lousy all day). On 07-Feb-2021, the patient experienced TACHYCARDIA (heart beating faster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever, at a dose of 1 dosage form. On 06-Feb-2021, FEELING ABNORMAL (felt lousy all day) had resolved. On 07-Feb-2021, TACHYCARDIA (heart beating faster) had resolved. On 08-Feb-2021, VACCINATION COMPLICATION (I was sicker than when I had COVID), PAIN IN EXTREMITY (sore arm), PALPITATIONS (heart rate spiked up in the morning/felt my heart beating faster), CHILLS (chills) and PYREXIA (fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On 06-Feb-2021, Heart rate: 93-124 (High) 93-124 beats per minute. On 07-Feb-2021, Heart rate: 62-72 (normal) 62-72 beats per minute.On an unknown date, Cardiac function test: normal (normal) Normal.On an unknown date, Electrocardiogram: normal (normal) normal and only showed the previously known left bundle branch block.On an unknown date, Heart rate: normal (normal) In the mornings it would spike up into the 100s.On an unknown date, Myocardial necrosis marker: normal (normal) Normal.The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.Other Concomitant   medication included Probiotic.On 21-Dec-2020 patient was tested positive COVID-19.And patient lost sense of taste, smell and experienced an increase in heart rate .Patient noticed that her heart rate was dipped down into the 80s during the day after vaccination .Patient also informed that her heart rate used to 62-72 beats per minute during night after vaccination. However usually her rate used to low 50s-60s.This case was linked to MOD-2021-395745 (Patient Link).
Extreme dizziness, vertigo, falling toward the left when walking. Lasts all day until bed and asleep.
Soreness at injection site; Fever; Chills; Overall aches; Headache; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, chills, pain, headache and fatigue. On an unknown date, the outcome of the injection site pain, fever, chills, pain, headache and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, pain, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had first 24 hours soreness at injection sight. The 24 hours later fever, chills, overall aches, headache and fatigue. The patient continued with very sore at injection site. The reporter did not gave permission to follow up.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the health department and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare facility is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
PM of vax pt exp hive like rash on upper arms & face. c/o of itchiness. left upper arm became swollen & hard. advised to use benadryl
Per father, through interpreter: child developed wheezing about 6 hours after immunizations, was brought to ER with treatment of Nebs and Prednisone. Was discharged from ER to home.
Information has been received from a physician concerning a 22 year old female with history of fainting when receiving needles and no drug reaction/allergies who on an unspecified date was vaccinated with the first dose of GARDASIL and on 15-AUG-2008 was vaccinated with the second dose of GARDASIL (Lot no. 0250X). Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). On 15-AUG-2008m the patient passed out the needle was injected. When the patient became alert she complained of nausea and lightheadedness. The patient did receive GARDASIL. At the time of the reporting the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
Initial and follow up information has been received from a registered nurse concerning a 46 year old female with allergies to corticosteroids Unspecified (steroids) who on 11/7/05 was vaccinated IM in the right deltoid muscle with Pneumococcal 23v polysaccharide vaccine, (lot 650541/1004P). On 11/8/05, reportedly at 2:04pm, the pt reported that she developed a large knot on area where she received the injection and she couldn't move her arm. The pt reported that she had to leave work and take pain medication. Subsequently, the pt reported that she was feeling better and wanted to advise the doctors office of the reaction. On 11/9/05, the pt recovered. In follow up it was reported, by the registered nurse that the pt had no further problems. Additional information has been requested.
Next morning chills, fever, and achy all over. Started Tylenol every six hours. Saturday morning felt better, fever broke then rash showed up above and the right of the shot. Bruise where shot was given.
Pt developed swelling and redness in left thigh. Pt walked with a slight limp and had pain in area when touched. He had a slight fever. Treated with cold compresses to site.
Extreme irritability/ inconsolable for 5 hours. Tylenol: resolved later.
Patient presented to ED today with chief complaint of productive cough, worsening dyspnea, and increased oxygen requirements.The patient states that for the past several days, he has been experiencing worsening shortness of breath, cough productive of yellow sputum, and a "spasm" sensation in his chest that causes him to cough. Constitutional: Positive for activity change and fatigue. Negative for chills, fever and unexpected weight change.  HENT: Positive for congestion. Negative for ear pain, hearing loss, sinus pressure, sore throat and trouble swallowing.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough, shortness of breath and wheezing.   Cardiovascular: Negative for chest pain and palpitations.  Gastrointestinal: Negative for abdominal pain, blood in stool, constipation, diarrhea, nausea and vomiting.  Genitourinary: Negative for decreased urine volume, dysuria and hematuria.  Musculoskeletal: Negative for back pain, gait problem, joint swelling and myalgias.  Skin: Negative for rash and wound.  Neurological: Positive for headaches. Negative for dizziness, syncope, weakness, light-headedness and numbness.    Acute hypoxic respiratory failure on chronic nocturnal hypoxemia with OSA COPD bronchitis exacerbation and bronchospasms due to influenza A ?Patient with recent failed partial treatment outpatient with doxycycline and steroids -- > Initially placed on IV Rocephin, azithromycin, transitioned to ceftin which is now complete. Azithromycin to be completed soon. ?Solu-Medrol 60 mg every 12 hours ?Finished Tamiflu course ?DuoNebs scheduled and PRN, Pulmicort nebs BID, Brovana BID, Daliresp, Singulair ?Scheduled cough medication with expectorant --CXR 3/2 unremarkable However, patient had some violent coughing spells that made him decompensate rapidly and was diagnosed to have a pneumothorax. Shifted to ICU where chest tube was inserted with resolution of the same. Subsequently was transferred back to the floor where after clamping trial, the tube was taken out. Patient back at his baseline at discharge  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Pt described as "fuzzy" day of vaccination. Day following, fed and napped normally at 9am. Found at 11:15am and found to be diaphoretic, listless, & heavy breathing, possibly status post unwitnessed seizure. Then 2 witnessed seizures x3min with unilateral arm/leg movement in ER with fever >105 degrees F, given APAP rectally. Presented with diarrhea, lethargy, and cyanosis.
SkinRash, Rash, TINGLING LIPS AND ITCHY THROAT Narrative:  PT WAS GIVEN BENADRYL 25MG IM. WITH IN 30 SXS WERE MUCH BETTER.
Dizzy, shaky, trouble breathing, flushed. BP 120/86, heart pounding.  Treatment: Benadryl and inhaler.
Patient was administered an expired Tenivac with no reported adverse event; Initial information received on 09-Mar-2022 regarding an unsolicited valid non-serious case received from an other health professional via call center.  This case involves an unknown age and unknown gender patient who was administered an expired tenivac with no reported adverse event while receiving vaccine diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult suspension for injection (lot U6603AA; expiry date: 05-Mar-2022; strength, frequency: unknown) at an unknown dose via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was administered an expired tenivac with no reported adverse event (expired product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt received DPaT and varivax on 9/23/03.  Mother noticed swelling at site of DPaT next AM.  Swelling increased over the next 2 days.  Pt was seen on 9/26/03 for significant induration and inflammation at site (about 3").  Site was tender, red and warm.  Pt was otherwise well.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-MAR-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion for one time. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degrees) and the type of excursion (refrigerator/freezer) (R/F) were 216, 34 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Patient was vaccinated on 06/01/07 then on 6/5/07 he had a syncopal attack with a seizure which lasted very short. Patient had trauma to the face an avulsion of tooth due to fall. He recovered.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 26-FEB-2013, the patient received dose 1 MMR II (lot# and expiry not reported) 0.5 milliliter (ml), subcutaneously. On 05-MAR-2013, the patient was vaccinated subcutaneously with dose 2 of MMR II (lot# H012571, expiry: 29-JUN-2014). No adverse effects reported. Additional information has been requested.
Swelling, induration, slightly red- not painful to touch. Pt seen by doctor after clinic 3/26/04.
feeling very fatigued; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26May2021 (Batch/Lot number: unknown) as a single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset May2021, outcome "not recovered", described as "feeling very fatigued"; DIZZINESS (non-serious) with onset May2021, outcome "not recovered", described as "dizzy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelled; rash-full body; head, neck and arm swelling; welts and red streaks. BENADRYL 2 tabs twice a day x 4 days then symptoms resolved completely.
Hospitalization for Sepsis due to UTI and COVID on dates 2/12/2023- 2/14/2023. Treated with dexamethasone, Remdesivir, vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Prominent hot itchy rash at the site of the injection (aka "covid arm"). Immediately preceded by hives in the corresponding armpit area.
Urticaria daily ranging from mild to severe. Now on antihistamines daily which do not eliminate the hives but occasionally minimize the severity. The hives did not start until after the second Moderna vaccine. I have no previous history of urticaria.
Swelling at injection site measuring 4 inches x 4 inches in the right arm starting the following day after immunization; nothing on left arm. Painful and hot to touch. Mother has been giving allegra, zyrtec, ice and applying antihistamine cream to the area. The spread of reaction seems to be slowing as of today (07/27)
Achy; Slight fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PYREXIA (Slight fever) and HEADACHE (Headache) in a 20-year-old female patient 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 PAIN (Achy), PYREXIA (Slight fever) and HEADACHE (Headache). At the time of the report, PAIN (Achy), PYREXIA (Slight fever) and HEADACHE (Headache) outcome was unknown.            Reporter did not allow further contact
Pain in arm day of but no redness or swelling up to the night of. Pain continued through night (affecting sleep) and through day. Around 2:15 pm next day I noticed a red ring and swelling at injection site, almost 2 inches in diameter, warm to touch.
Tiredness, swelling, red rash expanding in size and hot to the touch, arm soreness.
VOMITING AND DIARRHEA APROXIMATELY 24 HOURS POST ADMINSTRATION. PATIENT'S GUARDIAN STATED SHE VOMITIED TWICE AND COULND'T HOLD FLUIDS. REFERRING TO THE ER
Pfizer vaccine was administered  - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  SLEEP APNEA 6/25/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA SLEEP APNEA 6/25/2021 HX OF LUNG CANCER ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 HX OF LUNG CANCER SLEEP APNEA 6/25/2021 CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 CHRONIC HYPOXEMIC RESPIRATORY FAILURE SLEEP APNEA 6/25/2021 COVID-19 DISEASE ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/6/2022 COVID-19 DISEASE
PATIENT GOT DIZZY AND PASSED OUT AFTER SITTING FOR 10 MINS.
Injection site slightly red and swollen, no fever, cool compressed applied, area much improved as of 07-24-2006.
Information has been received from a vaccine coordinator referring to unspecified patients. The patients' concurrent condition and medical history were not reported. Concomitant medication was not provided. On an unknown date, the patients were vaccinated with two improperly stored doses of PEDVAXHIB (dose, unit, route unknown, lot # M006710, expiration date 12-JUN-2018, another lot # M001813, expiration date 14-OCT-2018) once. No adverse event was reported. No product quality issue involved. Additional information has been requested. This is one of several reports received from the same reporter.