chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was initially stored in refrigerator on 04-Apr-2022, expired on 01-Apr-2022 and administered on 12-Apr-2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Apr-2022, expired on 01-Apr-2022 and administered on 12-Apr-2022) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Apr-2022, expired on 01-Apr-2022 and administered on 12-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 04-Apr-2022, expired on 01-Apr-2022 and administered on 12-Apr-2022) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Vial did not undergo any temperature excursions.  No treatment medications were provided.
Lump under left arm, left breast pain.; left breast pain.; neck also got swollen; This is a spontaneous report from a contactable consumer (patient).   A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EW0198) via an unspecified route of administration, administered in arm left on 30Jul2021 at 09: 15 (at the age of 39-years-old) as dose 1, single for covid-19 immunization. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had not received any other vaccine in four weeks. Concomitant medications included famotidine and ketoconazole (in two weeks). Patient's past drug included Percocet and she had Known allergy with Percocet. On 31Jul2021, the patient experienced lump under left arm and left breast pain and neck also got swollen. The patient visited doctor or other healthcare professional office/clinic visit and emergency room as result in the events. The patient reported that the day after 1st dose my armpit got swollen and painful. The patient reported that the day after 1st dose her armpit got swollen and painful. This lasted for weeks, her neck also got swollen, she also experienced breast pain, visited doctor the day before 2nd dose on 19Aug2021. The outcome of the events lump under left arm, left breast pain was not recovered. The outcome of the event neck also got swollen was unknown.
I had diarrhea, cough, fatigue, and loss of weight. I also lost my taste and smell. These lasted for about week. In Oct, I tested positive for COVID-19.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # L041629, expiry date: 22-ApR-2017). No adverse effects were reported. Excursion information: Time: 30 minutes, Temperature: -13C and Time: 30 minutes, Temperature: -11C. The call was because of a data logger. The improperly stored doses were administered. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
MMR given (R) VL. 6/27/08. 6/28/08- Mild redness. 6/29/08-Quarter sized area of redness. 6/30/08 approx 4 cm diameter area of redness. (+) itchy (+) blanches
10/5/2021: chills, soreness injection site, headache, fatigue (12am) 6am: severe fatigue chills stayed home from work. Could not get out of bed until noon. Took 1g Tylenol did not help at 6am. Entire day chills fatigue 10-5-2021 10-6-2021: night sweats and day sweats but able to go to work and do daily activities  10-7-2021: 2am night sweat drenched
Contracted COVID; Contracted COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 30Jun2021 13:00 (Batch/Lot number: unknown) at the age of 21 years as dose 2, single and intramuscular, administered in arm right, administration date 23Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: drug ineffective, COVID-19 (medically significant) all with onset 23Dec2021, outcome recovered (2021). Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: No other vaccine in four weeks. It was unknown if the patient had Covid prior vaccination. Patient had covid tested post vaccination. No Known allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Hand feels like its going numb; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hand feels like its going numb) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history per source document.).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HYPOAESTHESIA (Hand feels like its going numb) and CHILLS (Chills). At the time of the report, HYPOAESTHESIA (Hand feels like its going numb) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No conmeds were provided.  Treatment information was not provided.   Reporter did not allow further contact; 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.
Post COVID vaccination vasovagal  episode witnessed by mother and clinic staff. Client sitting in post vaccination area and lost consciousness after saying he felt nausea and dizziness. Immediate return to A&Ox4. walked with assist to wheelchair and rested in stretcher area. discharged home. bp 128/72, hr 64 POX 98%. -RN MD assessment: pt had 5-6 seconds of tonic/clonic activity with amnesia. Able to assist to the floor without trauma. Pt cleared quickly without restriction. advised to follow up with peds or family PCP-MD.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-JUL-2016 the patient received an improperly stored dose of VARIVAX (lot # L031066, expiry date: 13-JAN-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Dose # 1: no effect Dose # 2: headache, nausea, fatigue. chills, fever3/13/2021 All day in bed
Effect of April 3rd I became incapacitated I was not able to get up and stand by nyself  I was not able to move without excruciating pain in my lower back going all the way down my leg the pain into my feet ..the pain that I experience already intensified and magnified to about a 15-18... i  was not able to lay in my bed until April 11th due to the pain that was shooting up and down my right leg my right leg became very swollen I experienced chills  with fatigue.... but I still try my best not to sit around because I knew that the pain would increase so any chance that I was able to get up and move about I would do so and drink plenty of water take the came to the point that I didn't even want to eat
Migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2201715US (RA).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "Migraines". Therapeutic measures were taken as a result of migraine.  Additional information: Patient do not know where they got this information, it was incorrect. Patient had no adverse reaction to Ketorolac, Patient had a serious adverse reaction from the Pfizer vaccine lasting 4 months and it was still an ongoing issue. Patient was prescribed Ketorolac for the migraines being one of the adverse side effects from the vaccine. Please get there facts right.   The lot number for bnt162b2 was not provided and will be requested during follow up.
pt recv vax 25OCT96 & pt exp pain @ inj site, a few papules @ inj site;fatigue, & a tender, red, raised area;
Subject in pneumococcal vaccine trial, with severe COPD, was diagnosed with left upper lobe squamous cell lung cancer on 3/24/08. Vaccination took place on 1/7/08.. According to the physician, the relationship to treatment is 'None'. We would be happy to forward the Study's SAE Reporting Form upon request.
After the cocktail of shots Dizziness, muscle spasms, Foot locked for approximately 2 weeks hospitalized tons of tests ran because neurologists and orthopedic surgeon had never seen anything like this. Released from hospital and foot locked again back in for another 3 weeks. Diagnosed with focal dystonia.
TINGLING IN MOUTH; 2 BODY RASHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced tingling in mouth, and 2 body rashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the 2 body rashes and tingling in mouth was not reported. This report was non-serious.
Rash spread from my armpit to my elbow on arm. Rash area was swollen and itchy. Swelling lasted 3 days. Rash is still present as is itching. Tx'd with Zyrtec-resolved.
This report was received from the investigator in a trial on 07 June 2010. A 42 year-old male subject with a history of elevated cholesterol received ACAM2000 (lot number not reported) on 29 January 2010. The subject previously received the following vaccines on 06 January 2010: hepatitis B vaccine (other manufacturer and lot number not reported); and pandemic (H1N1) influenza vaccine (manufacturer unknown and lot number not reported). Ten days after receipt of ACAM2000, the subject was diagnosed with unspecified disease of the pericardium. On Day 10 (08 February 2010), the subject had a Troponin I of 0.52 (abnormal); an electrocardiogram which was normal; and an echocardiogram which was abnormal. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
INJECTION SITE BRUISING; INJECTION SITE KNOTTING; INJECTION SITE SORENESS/PAIN; FEVER; COUGH; INJECTION SITE HEAT; INJECTION SITE RASH; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042a21a, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced injection site heat. On APR-2021, the subject experienced injection site rash. On 02-APR-2021, the subject experienced cough. On 02-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced injection site bruising. On 03-APR-2021, the subject experienced injection site knotting. On 03-APR-2021, the subject experienced injection site soreness/pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 05-APR-2021, was recovering from injection site bruising, injection site soreness/pain, injection site knotting, and cough, and the outcome of injection site rash and injection site heat was not reported. This report was non-serious. This case, from the same reporter is linked to 20210544451.
PATIENT CAME IN ON 8/11/2022  TO GET THE BOOSTER DOSE OF COVID19 VACCINE . PATIENT  HAD COMPLETED THE PRIMARY SERIES WITH MODERNA BUT WANTED TO SWITCH TO PFIZER  THIS TIME.  SHE WAS VACINATED AT 10:38 AM ON THE RIGHT ARM INTRAMUSCULARLY WITH 0.3 ML OF PFIZER LOT #FP7137.  PATIENT REPORTED 24 HOURS LATER ON THE NEXT DAY IN THE MORNING,  HER UNDERARM WAS SWOLLEN BUT SAID THERE WAS NO FEVER OR PAIN OR WARM SENSATION. SHE  FEELS OKAY BUT JUST A BIT UNCOMFORTABLE ABOUT THE SWELLING  AS SHE COULD FEEL IT.  I TOLD HER TO TAKE SOME ANTI-INFLAMATORY DRUG AND USE ICE TO ALLEVIATE THE SWELLING AND LET US KNOW IF IT GETS BETTER.  PATIENT SAID OKAY AND LEFT.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were unknown. On 02-MAY-2016, the patient was vaccinated with an improperly stored dose (temperature 52F, for 1 hour 15 minutes, not because of data logger), of VAQTA, 25/0.5 ml, lot # L046953, expiry date 14-JAN-2017, (dose, frequency and route of administration not reported). There was no previous temperature excursion. No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information provided. Additional information has been requested.
A report has been received from a Health Professional concerning a female patient, who had been receiving Nasal FLUMIST Quadrivalent., 0.1 ml in each nostril. Once/Single administration. FLUMIST Quadrivalent started on an unknown date. The patient number two given FLUMIST vaccine that underwent a temperature excursion and it was unknown if the dose of 0.1 ml was given in each nostril. FLUMIST Quadrivalent was continued. The outcome of the event of patient number two given FLUMIST vaccine that underwent a temperature excursion and it is unknown if the dose of 0.1 ml was given in each nostril was unknown. The report was considered to be non-serious by company physician.
Received small pox vaccine on 11/17; Read major reaction 11/24/2004 on 11/25 started to breakout in small pustules all over body. Seen 11/29 diffuse areas of erythematous pustular lesions back, chest, neck, arms, legs. No LA, afebrile, off work until 12/3, re-eval; pictures taken 12/3/04 pustular rash healed sm papules
3 Seizures on 3/10 8 Seizures on 3/12 Placed on Ventilaor 3/12 Removed on 3/13 5 seizures on 3/13 Placed back on vent 3/13 Removed  from vent 3/15 Seizure on 3/15
patient given flu shot at pharmacy at 8:00 pm on 9-11-19. Woke up following morning (9-12-19) with left sided numbness, mild nausea, unsteady gait
RN reported they inadvertently administered Boostrix (Tdap) dose to a 2 hour old infant yesterday on 5/21/23 in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap; RN reported they inadvertently administered Boostrix (Tdap) dose to a 2 hour old infant yesterday on 5/21/23 in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a male patient who received DTPa (Reduced antigen) (Boostrix) (batch number C3SB5, expiry date 09-MAY-2025) for prophylaxis.   On 21-MAY-2023, the patient received Boostrix (left thigh). On 21-MAY-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: RN reported they inadvertently administered Boostrix (Tdap) dose to a 2 hour old infant yesterday on 5/21/23 in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap) and wrong vaccine administered (Verbatim: RN reported they inadvertently administered Boostrix (Tdap) dose to a 2 hour old infant yesterday on 5/21/23 in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-May-2023  Registered Nurse (RN) reported they inadvertently administered Boostrix (Tdap) dose to a 2-hour old infant the day before reporting in the left thigh. RN mentioned they were trying to administer a vitamin K dose but instead grabbed the Tdap. RN stated the patient did not have a first name yet but had a last name initial. The reporter consented to follow up. Registered Nurse called to inquire what to look for in the patient.
loss of appetite, weakness, tiredness, fever to 102.7;fever duration was 24hr;other sx lasted 36 to 48hr;
Fever (100.5?102 F), joint, muscle, back pain, flu-like symptoms for 3 days, swelling and pain at injection site, stiffness in arm (unable to move or bend for ~36 hours, then could lift not quite to shoulder height for the next 48 hours), redness and heat around injection site beginning ~3 days after vaccine administration and lasting for 4 days (day 7 post-vaccine), fatigue lasting for 10 days.
ANXIETY; FRUSTRATION DREAMS; INTENSE MINI-FLU; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number. No concomitant medications were reported.  On APR-2021, the subject experienced intense mini-flu. On 04-APR-2021, the subject experienced anxiety. On 04-APR-2021, the subject experienced frustration dreams. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anxiety, and frustration dreams, and the outcome of intense mini-flu was not reported. This report was non-serious.
PT. HAD NAUSEA, VOMITING AND FELT LIKE HAD HIGH BLOOD PRESSURE AND ALSO DIZZINESS
A pediatrician reported that a 4 month old male infant received Prevnar, Polio (IPOL), Daptacel (DTAP) and Hib-Titer vaccines on 7/12/02. Five hours, post vax, the infant developed hypovolemic shock. He was admitted to the PICU for 10 days. He has been discharged and fully recovered. No additional information was available as of the date of this report. *Follow-up report on 9/10/02: Follow-up info. received 9/3/02 from MD. Follow-up included medical history, lab tests performed and treatment medication for PT while hospitalized. A pediatrician reported that a 4-mt old male infant received Prevner (pneumococcal 7-valent conjugate vaccine), Polio vaccine (poliomyalitis vaccine inactivated), Daptamel (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed), and Hib-Titer vaccine (haemophilus B conjugate vaccine) on 7/12/02. Medical history includes a "small" ventricular septal defect. 5 hrs post-immunization, the infant developed hypovolemioc shock. He was admitted to the pediatric intensive care unit for 10 days. He was treated with intravenous dopamine for hypotension. Lab data included ABG, CBC, electrolytes, echocardiogram, urine analysis, CSF culture, results not specified. He was discharged and fully recovered. No add'l info. was available as of the date of this report.
Area of shot is puffy and red and itchy, hives have appeared on my left and right arm around my elbow and are spreading to hands and fingers
the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; the tingling/numbness came back in my face in waves, but moved to my lips and the tip of my tongue; I felt a "hot flash" over my face; anxiety; the left side of my face started to tingle and went numb; the left side of my face started to tingle and went numb; Lymph nodes in my neck were swollen and painful; Lymph nodes in my neck were swollen and painful; This is a spontaneous report from a contactable Other healthcare professional (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 12Jan2021 at single dose for COVID-19 immunization. Medical history included allergies: Penicillin, irritable bowel syndrome (IBS) and endometriosis. The patient's concomitant medications were not reported. The patient previously took dilaudid and experienced drug allergy. A minute after vaccination on 12Jan2021, the patient felt a "hot flash" over her face, thought it was anxiety and ignored it. 25-30min after vaccination the left side of her face started to tingle and went numb, lasted a few hours and went away. That night the patient's lymph nodes in her neck were swollen and painful. The following day after vaccination on 13Jan2021, the tingling/numbness came back in her face in waves, but moved to her lips and the tip of tongue. Day 3 after vaccination on 14Jan2021, the patient still feel some slight numbness in waves still only on one side of her face and the tip of tongue, but not as intense or frequent. Not sure if this could be an allergic reaction. Injection site was left arm and it was the left side of her face effected. The patient underwent lab tests and procedures which included COVID test Nasal Swab: negative on 14Jan2021. The outcome of events was recovering. Information on Lot/Batch number has been requested.