chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I contracted COVID-19 on 05/19/2022 with symptoms of sore throat, loss of taste, loss of smell, runny nose, congestion, and I had a sore in my mouth. I received Monoclonal Antibodies on 05/22/2022. I was ill for 5 days  before my symptoms resolved. My sense of taste and smell have not fully returned, but my other symptoms fully resolved.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Additional Details: Patient received vaccine and reported feeling dizzy upon standing after the 15 minute observation period. Pt complained of dizziness, headache, double vision, and feeling a cold sensation in her body. After the patient started feeling symptoms, the family reported that she is menstruating, fasting, and has not eaten since 2 am. EMS was called and patient was taken to the ER.
This spontaneous report as received from an healthcare worker refers to unspecified patients of unknown ages. Since an unknown dates in July 2014 the patients were vaccinated with improperly stored VAQTA (lot#, strength, dosage, frequency and route unknown). No adverse effects were reported on the reporting time. This is one of several reports received from the same reporter. Additional information has been requested.
Case number PHEH2012US009496 is an initial spontaneous report received from a medical assistant on 02 May 2012. This report refers to an unknown age and gender patient. The patient was vaccinated with MENVEO (batch number: unknown) on unspecified date. On unspecified date, the patient experienced swelling in the arm. The outcome and causality of the events was not reported.
patient was accidentally administered an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number J953N, expiry date 11-MAY-2023) for prophylaxis.   On 28-JUN-2023, the patient received the 3rd dose of Pediarix. On 28-JUN-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: patient was accidentally administered an expired dose). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Jun-2023 The registered medical assistant provided information about vaccines, dose, vaccination but declined to receive follow up information. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received an expired dose of Pediarix, which led to expired vaccine used.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Mar2021 as dose 2, single (Lot number: EN62002) at the age of 73 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "giant cell arteritis in remission" (unspecified if ongoing), notes: Other medical history: giant cell arteritis in remission; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medication(s) included: VALACYCLOVIR [VALACICLOVIR], start date: 31May2022, stop date: 06Jun2022 and Northstar. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Additional information: Patient received other medication in 2weeks. Anti-viral details Product: COVID 19 Treatment, Brand: Plaxovid, Treatment start date: 15Jun2022, Treatment stop date: 20Jun2022, Indication: Treatment of COVID-19. Return of symptoms (runny nose, dry coughing spasms) four days after completing Paxlovid regimen.
left arm sore. Left arm painful to lift up. Pain runs from left arm to neck left tendon. Entire body is cold even with two layers of clothing. Especially both feet.
This case was reported by a physician to a sales representative and described the occurrence of antigenemia in an adult subject of unspecified age and gender who was vaccinated with Twinrix for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. At the time of reporting, the subject was in an alcohol and drug treatment center. On an unspecified date prior to 21 July 2006, the subject received an unspecified dose of Twinrix (lot number unknown). Two days after the vaccination with Twinrix, the subject tested positive for hepatitis B. No additional information was reported.
Inconsolable crying last 2-3 hrs, 3-4 x day, decreased appetite, feeding. No fever, no local inflammation, no other apparent neurologic sequelae
Acute -onset red 1-2 mm papular rash diffusely spreading from upper thighs to GU to lower abdomen. Given 1 mg/kg benadryl.
Fever to 100.6 with weakness and fatigue on day #11 after 2nd vaccine given. Symptoms resolved within 24 hours.
Had redness on side of back, had red spots - on wrist still visible 10/11/17, she said nothing near injection site. She applied HC cream. She went to MD for son and MD asked if she got the ZOSTAVAX instead - I said no you got flu shot. Pt. is fine.
Vaccinated on 8/15/16 an d3 days later pt with maculopapular rash on torso that spread to ace/head. Present fussy, decrease PO intake. Temp afebrile but 99 degree F. Present greenish stool w/mucus appearance on 8/10/16 mom instructed to give TYLENON and pt slept better.
Headache; Nausea; A spontaneous report was received from a consumer concerning a 53 years old female patient who experienced headache and nausea.   The patient's medical history included fibromyalgia and IBS (Irritable bowel syndrome). Products known to have been used by the patient, within two weeks prior to the event, included Aluminium Hydroxide, Dicyclomine Hydrochloride, Amitriptyline, Pregabalin.    The patient received her unknown dose of two planned doses of mRNA-1273 (Batch number: 025J20-2A) on 12 Jan 2021 in the left arm at 10.30am for prophylaxis of COVID-19 infection.    On 12 Jan 2021 the patient experienced headache and nausea. Treatment information were not provided.    Action taken with mRNA-1273 in response to the events were not provided.  The outcome of the event(s) headache and nausea were not reported. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia and Irritable bowel syndrome. Concomitant products included PREGABALIN for Fibromyalgia, ALUMINIUM HYDROXIDE, DICYCLOVERINE HYDROCHLORIDE, MAGNESIUM OXIDUM LEVE (DICYCLOMINE CO) and AMITRIPTYLINE for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided.   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.; Sender'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.
Patient became nauseated 5 minutes after vaccine administration. She ended up vomiting in pharmacy lobby.  There was blood in vomit so emergency was called.  Patient was transported to hospital. At this time no information on outcome.
Apneic and bradycardia events with severe desaturation requiring vigorous stimulation. Appx 8 hrs after immunization ventilatory support added (to high flow O2/2L - 100%) Septic workup completed, antibiotics started. Viral URI PCR (-).
Pt vaccinated with DTP/OPV/HIB approx 4 hrs after vaccine child awoke from nap screaming, became pale, limp, eyes rolled backwards for 10 secs. Having labored breathing. No tonic clonic, temp102, HR 176, Taken to ER.
By evening, arm around the injection site grew increasingly painful, to the point where it hurt to move or touch (not unbearable but more soreness than any other injection I've ever received). Over night contracted a fever, by the time I was able to get up to measure it (around 3:45 AM) it was 99.5 degrees, and broke by 5 AM. Had fever dreams prior to waking around 3 AM, and had chills for the remainder of the night. Felt  achy and a little unsteady for the rest of the day but was fully recovered by 12/31
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck) (lot number unknown, expiry date 24-JUL-2015) (lot number and frequency unknown) (dosing regimen and frequency unknown) that were exposed to temperatures of 22 degrees F for 716 hours and was not supported the in house stability. There were multiple excursions over 72 hours going back into and out of range more than once. According to the Prescribing Information for these products, the products should be stored frozen between 58 degrees Fahrenheit and +5 degrees Fahrenheit (-50 degrees Celsius and -l5 degrees Celsius). Use of dry ice may subject these products to temperatures colder than -58 degrees Fahrenheit (-50 degrees Celsius). No concomitant medications were reported. No product quality issue was reported. No adverse events were reported. This case is related to case numbers 1404USA010834 and 1404USA010632 via same reporter link. Additional information has been requested.
Pt came down with a fever yesterday. It was 102 yesterday evening. He had ibuprofen this morning. He had been playing normally, slightly reduced but still pretty good appetite, normal bowel movement this morning, no reason for concern. Mom put him down for his nap and he slept for about 45 minutes and she heard a muffled cry. She came in to see him. He was very limp, eyes rolled back in the back of his head and he was not breathing properly or responding properly. He did not seem to have vomited and there was nothing in the playpen where he was sleeping that seemed to be amiss, that he might have choked on. He did have a pacifier in his mouth and he was lying stomach down with his head turned towards the plastic coated mattress. He has no previous history of seizures or other health problems.
Rash on injection site; A spontaneous report was received from a 43 year old female consumer who was participating in the mRNA-1273 Emergency Use Program and developed rash at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot# 027KWA) intramuscularly in the left for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient started having a rash at injection site. Patient treated the injection site rash with ibuprofen with no effect.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, rash at injection site, was not known.  The reporter did not provide an assessment for the events.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of rash, a causal relationship cannot be excluded.
Case number PHEH2014US025157, is an initial spontaneous report from a nurse received on 09 DEC 2014. This report refers to a 65 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 OCT 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 OCT 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
pt recv vax;inconsolable crying for 3-4 hr p/ having 2nd vax;
Aprox 8-10 hrs after vaccine chills/ rigors, extreme fatigue, body aches, abd pain at Crohns hotspots:  @ 12hrs temp 102.6 F: @ 15hrs Oxygen desaturation 89-90%, weakness, extreme fatigue Seen at ED aprox 6PM on 1/9/21: CBC, chem panel, CT abd, CXR Continued to have low sats and was admitted to hospital on 1/10/21 adverse reaction to vaccine, Reactive airway, asthma excerbation discharged on 1/12/21
The small spot of eczema got about six or seven times larger. It was swollen, itchy, red. A week later I developed little red dots that looked like a petechiae rash, that I was later informed was inflamed hair follicles from the swelling. I do not have a fever, no high blood pressure. I was prescribed steroid cream to put on the areas to help with the itching and inflammation.
For Vaccine Pfizer-BioNTech COVID-19 Vaccine: I'm experiencing  extreme tiredness, light headed and dizziness, body aches especially on my back, loss of appetite, chills and a mild fever. Have rested for 2 days in bed and no change in the tiredness.
No adverse effects; Calling to report a temperature excursion; This spontaneous report was received from a Medical Assistant, refers to a patient of unknown age and gender. Information regrading the patient's pertinent medical history, known allergies, concurrent conditions and concomitant therapies was not provided.      On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) lot # T008697 with expiration date on 04-JUN-2021 (strength, route and dose were not provided) for prophylaxis.         On 16-NOV-2020, it was found that hepatitis a vaccine, inactivated (VAQTA), experienced a temperature excursion of 3.0F, on a time frame of 3 hours and 30 minutes. Information regrading previous excursions was not provided. Call was made due to a data logger. The reported stated that the patient had no adverse reactions.   This is one of several reports received by the same source. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008697; expirationdate: 04-JUN-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 meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA010974: US-009507513-2012USA006027:
Headache, fever over 100, chills, weakness, nausea and vomiting  subsiding by the second day.
This literature marketed report was received from the authors of a published article and refers to 5 patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medication as reported. On unknown dates, the patients were vaccinated with one dose of MMR (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). On unknown dates between 28-DEC-2014 and 08-FEB-2015, the patients experienced measles with rash (vaccination failure). It was unspecified if the patients were exposed to measles in one or both of the two theme parks, if there was secondary exposure to measles or the source of measles exposure was unknown. The outcome of the event was not reported. The authors considered the event of measles outbreak despite of one dose of measles-containing vaccine to be related to MMR (manufacturer unknown). This is one of several cases received from the same literature (cross-referenced cases MARRS # 1606USA005685 and 1606USA005686). Additional information has been requested.
A non-serious spontaneous report of wheezing was received from a physician concerning an 11-year-old male subsequent to FLUMIST. The patient has no history of asthma, wheezing, or allergies. No concomitant medications were reported. The patient received FLUMIST on 24-Sep-2008. Fifteen minutes after receiving FLUMIST, the patient started wheezing. The symptoms required treatment with nebulized albuterol. The wheezing improved but still ongoing as of 24-Sep-2008.
Five hours after receiving the influenza vaccine, I felt very weak and tired, experienced a headache and body aches and chills. While in bed I experienced body sweats from my fever breaking. The entire next day, I continued to feel weak and tired and had a bad headache. I took ALEVE and decided to wait out the side effects hoping I would feel better soon. Today is day three following the injection and I am tired and a little weak. My headache is gone. Why would I experience such adverse effects?
Tightness in throat, Left arm itching. Administered 50 mg Benadryl. Vitals and assessment throughout remained WNL . Condition during observation unchanged, no additional airway change, swelling, or itching. Patient with extensive health hx including anaphylaxis to peanuts. After an extended observation period with MA and RN patient is stable to go home. Advised her to take at least 25 mg Benadryl prior to her next vaccine and give detailed history to staff.
fever over 102, swelling, aching soreness p/2 days; entire upper 1/2 arm & shoulder having joint pain, localized area-bright red report from client;
Acute Asthma attack, wheezing and difficulty breathing, significant cough. Red rash on face around eyes and forehead.
Soarness at injection sight, heavy bleeding than normal for menstrual cycle, headache, pain in back and around belly
Lightheadedness; immune system did not respond to her anxiety and depression medicine; This spontaneous case was reported by a consumer and describes the occurrence of INHIBITORY DRUG INTERACTION (immune system did not respond to her anxiety and depression medicine) and DIZZINESS (Lightheadedness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Depression. Concomitant products included SERTRALINE for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced INHIBITORY DRUG INTERACTION (immune system did not respond to her anxiety and depression medicine). On an unknown date, the patient experienced DIZZINESS (Lightheadedness). At the time of the report, INHIBITORY DRUG INTERACTION (immune system did not respond to her anxiety and depression medicine) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-045940, MOD-2021-045940 (Patient Link).
The day of the vaccine my arm became immobile due to pain.  I could not move my are for 3 days. My arm is still sore after more than a week.
Pt had headache 1 hour after injection that lasted 2 weeks, and rash on left arm where vaccine was administered.
Getting the vaccine threw off my very predictable menstrual cycle. My period is 5 days late and I am not pregnant. As someone who is trying to conceive, this is devastating.
02/02/2018- Was prescribed Amoxicillin for 10 days. 02/20/2018- Patient started with a 1 cm circular spot rash on her torso. 02/21/2018- Diffuse redness covering all surfaces including skin surrounding both eyes (swollen) as well as covering spares palms and soles. Tympanic membrane appeared dull, bilaterally indicative of healing otitis media. Diagnosis: Erythema Multiforme. Treatment: OTC Children's BENADRYL, 0.5 tsp q 6-8 hours and follow up today 02/23/2018.
At the site of injection, about 1 week after vaccination, at the injection site arm started to turn red. Arm began swelling, being red, and was painful especially with any movement.
Pt states had rash all over body was referred by MD to allergies because rash came back p/Pred therapy;
Patient developed a "rash" one week after flu vaccine - states rash on inner elbows and all of legs. Felt hot and tingling; also itched. Had same rash 3-4 years ago after the flu vaccine which lasted 3-4 months and was much worse. She has taken more antihistamines this time, which has helped.
received 2 shots but broken out with shingles/suspected vaccination failure; broken out with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, 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 Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comment:This case was reported by a consumer via interactive digital media. The patient had received 2 shot of shingles but had broken out with shingles again. The patient wanted to know if she/she could receive the vaccine again. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
patient received vaccine on the afternoon of 12/15/19. Starting the evening of 12/16, she noticed redness, raised bumps and the arm where she got shot. It was also itchy
Pt. reports having headache since the vaccine along w/ 2 bumps on the back of her neck that she believes to be swollen lymph nodes. She said ibuprofen nor Tylenol has helped her headache. PharmD advised her to call her MD.
Fifteen to twenty minutes post vax the pt experienced an approximately 2-3 cm raised wheal on the left chin. Then a rash appeared on the right cheek of the face approximately the size of a quarter. The infant was kept at the clinic until 7:30 PM. The rash would "came and went". The pt recovered from the rash by the time the mother arrived home at approximately 7:45 PM. No further information is available.
Throat felt funny for 30-45 minutes Benadryl 25mg  and prednisone 20mg were given PO HR-117
Patient was given influenza vaccine on 2 different occasions (7 days apart) unintentionally.