chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to an approximately 1 year old patient of unknown gender. On 04-NOV-2013 at 13:00 the patient was administered with M-M-R II (lot number J002867, expiry date 08-MAR-2015) (dosing regimen and frequency unknown) that was exposed to a cumulative time of 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade. The patient experienced no adverse event. On the following date the M-M-R II was exposed to approximately for 9.5 hours at temperatures of 8.0 degrees centigrade to 13.9 degrees centigrade, on 07-OCT-2013 from 17:14 to 18:08 the vaccine experienced a temperature of 9.4 degrees centigrade, on 10-OCT-2013 from 09.50 to 13:26 the vaccine experienced a temperature of 13.9 degrees centigrade, on 14-OCT-2013 from 13:56 to 16:08 the vaccine experienced a temperature of 12.8 degrees centigrade, on 17-OCT-2013 from 08:38 to 09:44 the vaccine experienced a temperature of 9.7degrees centigrade, on 18-OCT-2013 from 11:50 to 13:08 the vaccine experienced a temperature of 9.7 degrees centigrade. This is one of the 17 reports received from same reporter. Additional information has been requested.
4/21/2023 Felt Fatigue, body aches, and soreness at injection site lasting approximately 36 hours and I was recovered by 48 hours after the injection.   5/14/2023 returned from traveling.  Husband was symptomatic before returning from abroad. 5/15/2023 in the afternoon I noticed more sneezing, so I took an Allegra around 4 pm.  I felt fatigue about 5pm, and body aches manifested around 8 or 9 pm. Woke up feeling feverish over night.  5/16 woke up and tested with an At Home COVID-19 test, positive.  Televisit with doctor who proscribed Paxlovid and to treat symptomatically.  Began taking medication that evening. Congestion, headaches, body aches, sneezing.  Then 5/18 fever broke over night. Some dizziness when I attempted to do activity, but congestion abated.
Sub Q nodule felt at the injection site that increased in size over 4 days. No fever or discharge noted.
developed muscle aches in the neck and shoulder area within 12 hours of vaccine administration.  Took 96 hours for symptoms to resolve completely
Patient is fully vaccinated.  Hospitalized.  COVID + 1/6/2022. 73-year-old man with past medical history of asthma, COPD, dementia, depression, GERD, SSS who is a resident at nursing home presented to the hospital with fever. Mild SOB, 90% O2.  The patient reported weakness, fatigue.  In the emergency room , vitals were T-max 101.5, heart rate 76, respiratory rate 30, blood pressure 112/77.  EKG was reviewed, sinus rhythm.DX pneumonia due to COVID. Chest x-ray low lung volume and bibasilar airspace opacities reflect atelectasis, small pleural effusion.Blood work; sodium 136, potassium 4.4, creatinine 1.27.  Troponin 0.03.  CBC unremarkable.elevated D-dimer. CTA PE protocol no evidence of PE. Started on antibiotics.  The patient was not a candidate for remdesivir. Given decadron and antibiotics. Discharged.
No adr, patient recieved monovalent when she was supposed to get bivalent. Patietn was informed on 11/14/22 and asked to come back in 2 months for correct booster.
Symptoms:  101.5 Fever, Nausea, Chills, Body Aches, Neck ache, mild headache, exhaustion Treatment:  tylenol and rest.
CHILLS; FEVER; HEADACHE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. 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, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20211256220.
A delay reaction of week  Tele-visits treated as Cellutious with  antibiotic  Cephalexin 500 mg twice day 1 capsule daily  for a week.  It resolved itself within 3-4 days.
swallowing was difficult; Numbness in face; tingle in face; back of my throat & tongue swelled up.; back of my throat & tongue swelled up.; tingle in my lips; Numbness in my lips; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 26Feb2021 at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After vaccination patient had numbness/tingle in lips and face, back of throat, tongue swelled up. Patient could breath, but swallowing was difficult. Zyrtec helped a little. Patient started to feel better after a couple of days. Patient had 2 pieces of chocolate on 3rd day & facial numbing and tingling, tongue swelling returned. Claritin helped a little. The outcome of the events (swallowing was difficult, numbness/tingle in lips, throat swelled up) was recovering while rest of the events were not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
pt recv vax 28JUL97 & approx 7AUG97 pt exp measles-like rash;also exp an afebrile sz approx 9AUG97;
Information has been received from a certified medical assistant (C.M.A.) concerning a 6 month old infant who on 16-MAR-2011, was vaccinated with VAQTA (lot # 669749/1628Z) 0.5mL, intramuscularly instead of hepatitis B virus vaccine. No adverse effect was reported. Additional information has been requested.
In genital area is a vesicular rash thin roofed with some crusted (older) lesions and some erythematous mac/papules now consistent with mild varicella.
Patient received Tdap, MCV4, varicella, and HPV vaccine during routine well child visit on 9/24/07. It was later discovered that she was pregnant at the time, approximately 19 weeks. Patient delivered on 1/29/08, no adverse event known to this practice.
20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became itchy, sore and started to feel tight. I took 3 doses of benadryl to help calm the symptoms as I did not want to get stuck paying for an emergency room visit or use my EpiPen which would also result in an ER visit.  Soon after, I also  started feeling extremely  itchy all over but mainly at injection site.  My body became tingly and I had hot and cold flashes. About an hour after that, the headache, nausea and horrible body aches began. the itching at injection site stopped after 2 hours but the rest of the symptoms remained for 3 days with the exception of the headache, nausea and body aches which still remain and no amount of over the counter medication help.
This spontaneous report was received from a certified medical assistant and refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. Since 04-MAY-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # M025869, expiration date 24-MAY-2018 (dose and route were not reported) for prophylaxis, which were exposed to temperature excursion of -9°C to 8°C (-6°C) for 8 hours. There was a previous temperature excursion. Additionally, there was no data logger. The outcome of the vaccine was reported as supported. No adverse effected were reported. The information regarding the sterile diluent (manufacturer unknown) used to reconstitute the vaccine, was not reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1707USA012032.
Rash; lost her sense of taste; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9267, NDC number and Expiry date: unknown) via intramuscularly, administered in right arm on 17Feb2021 10:30 as dose 1, single for covid-19 immunization. Medical history included, ongoing angioplasty (heart stents), ongoing type 2 diabetes mellitus and medical diet. Concomitant medication(s) included dexlansoprazole (DEXILANT) for gastrooesophageal reflux disease, ranolazine (RANEXA) for cardiac disorder, olmesartan medoxomil (BENICAR) for cardiac disorder; levothyroxine sodium (SYNTHROID) for thyroid disorder, clopidogrel bisulfate (PLAVIX) for blood disorder, metoprolol succinate (TOPROL XL) for blood pressure measurement, acetylsalicylic acid (BAYER ASPIRIN) for cardiac disorder, ubidecarenone (COQ-10) for cardiac disorder and vitamin D3 (VITAMIN D3) as a supplementation therapy. The patient had not received any other vaccine within 4 weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261, expiration date: not reported), via an unspecified route of administration in left arm on 27Jan2021 11:00 (at age of 81 years) as dose 1, single for covid-19 immunization. On 18Feb2021, the patient experienced lost her sense of taste (ageusia) and on 20Feb2021 had rash. Additional information included that the caller is a consumer that was calling about the Covid-19 Vaccine and stated that she had the second one and said that she is having some minor reactions to it. Caller clarified that she had the first dose 27Jan2021 and was just a little tired from it. She said that she had the second one on 17Feb2021 and on the 18Feb2021 she lost her sense of taste and it lasted about 1 days. Stated that she tried something spicy and it just tasted like cardboard. On the 20Feb2021, she got a rash on her legs between her knees and her ankles on both legs. It was an itchy and bumpy rash and stated that it is subsiding but its still there. She takes thyroid medications, and blood thinners and blood pressure medications. She said that takes something to up her thyroid, but also takes something to down it. She does not know which one it is. The adverse events did not result in physician/ emergency room and there were no such events prior to vaccination. There was no family medical history relevant to adverse events but stated that she has sensitive skin, and it has been a dry winter. It has not been responsive to over-the-counter moisturizer creams. Outcome of the ageusia was recovered on 19Feb2021, whereas rash was recovering.  Follow-up attempts completed. No further information expected.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-NOV-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX 0.5 ml (unspecified dose) with lot number lot # L024256 (expiration ate 01-JUL-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Joint pain, headache, chills, fatigue, nausea, muscle cramps & pain
Incomplete course of vaccination; unintentionally given a SHINGRIX instead of a TWINRIX vaccine; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 46-year-old female patient who received Herpes zoster (Shingrix) (batch number Y7PP4, expiry date 07-MAY-2025) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (on an unknown date received 1st dose).   On 30-JUN-2023, the patient received Shingrix (injection, left deltoid). On an unknown date, the patient did not receive the 2nd dose of Twinrix. On 30-JUN-2023, an unknown time after receiving Shingrix and not applicable after receiving Twinrix, the patient experienced wrong vaccine administered (Verbatim: unintentionally given a SHINGRIX instead of a TWINRIX vaccine) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the wrong vaccine administered, inappropriate age at vaccine administration and incomplete course of vaccination were 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: 24-OCT-2023 Patient was given a Shingrix instead of Twinrix, it was supposed to be her 2nd dose of Twinrix.  The patient came back in for her third dose of Twinrix and the error was uncovered.  Patient was immunocompetent.  The reporter was a Licensed Practical Nurse who reported that a female patient under 50 years old received a Shingrix vaccine, which led to inappropriate age at vaccine administration. Patient was unintentionally given a Shingrix instead of a Twinrix vaccine, which led to wrong vaccine administration. The patient was late for 2nd dose for 2nd dose of Twinrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Pt received vaccine pulled into recovery had dazed blank stare , became pale and very diaphoretic. - LOC - SOB -N/V.  Left Deltoid site benign - redness - swelling. Trmt: VS 110/52, HR 58, resp 16 reg, non labored, SpO2 99% (pt stated he regularly has low HR and BP) Ice to back of neck,  gave water for hydration, reclined seat (refused to come to cot to lie down wanted to stay in vehicle). Changed monitor time to 30 min.  provided reassurance. After 15 min pallor and diaphoresis subsided. Pt stated he felt much better. Advised to let passenger drive home he agreed.  OK'd to exit after 30 min.
Pt received vaccine in right deltoid on 8/10/18. Pt returned to the pharmacy on 8/14/18 and reported that he still had significant pain in his arm near the site and up to shoulder that was impeding his arm/shoulder mobility. Pt has not taken any NSAIDS or pain relievers. Pt said symptoms have improved, but are still significant. We advised pt to call his physician if pain does not subside. At this point, the pt says he will monitor his pain and call his physician if it does not continue to improve.
Pt vaccinated /w DTP/OPV /w in 3 days /p immunization, child presented in ER w/fever, vomiting & Jaundice. Trans.to ICU at Med Ctr. Treatment-IV's, Steroids, Blood Tranfusions & O2. @ time of rpt, dx is pending. Pt off O2, remains in PICU.
Received vaccine on 6-23-14. C/O pain all week. Mom noticed on Friday that area where shot was given was full of fluid. Mom call pediatrician. Denied redness, warmth, or temperature. They were out of town and sent to ER. No treatment required at this time. 6-30-14 area of fluid is resolving and denies any pain.
Site: Bruising at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Abdominal Pain-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Lymph Node Swelling-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Severe, Additional Details: Stated received Moderna for 1st and 2nd dose and pfizer for the booster. pt reported having flutter, tachycardia,lymp node imflammation and pain, has large red and inflammed brused at the site of injection,feel warn to touch 24hours after vaccination.
Urticaria. Rash entire body appeared the next day of vaccination. Treatment: Cetirizine 5 mg/5 mL oral sol. 2.5 mL for 7 days.
This spontaneous report as received from a consumer refers to a 56 years old female patient. The patient's medical history included brain tumor (in 1984). The patient was vaccinated by her physician with ZOSTAVAX on 27-AUG-2012. Information regarding dose, frequency, or route was not provided. No other co-suspects were reported. Concomitant medications included PROVIGIL, VIIBRYD, NEXIUM, hydrocodone and PLAVIX. On 30-SEP-2012, 35 days after onset of therapy, the patient experienced sore throat, fever, and then broke out on her bottom with a rash, and was then diagnosed with shingles by her gynecologist. The patient received treatment with acyclovir. A blood test was performed (result not provided). The patient was not hospitalized. The event did not improve and the outcome for shingles was reported as not recovered/not resolved. A reporter causality for shingles was not provided for ZOSTAVAX. Additional information has been requested.
pt says she developed diarhea, nausea, fatigue, body chills, joint pain, dizziness, and itchy arm.   These symptoms lasted about 4 days then developed bumps on the back of the tongue.  She still has some diarhea and the bumps on the tongue.  Her anxiety and depression seem to be heightened.  Pt will contact her PCP.
Severe injection site pain, severe headache, dizziness and extended 104 degree fever.
Pfizer-BioNTechCOVID-19 Vaccine EUA - Patient complained of dizziness for 45 minutes after vaccination.
half of face is numb; tongue is numb; smile is off; flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 27-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot Number: EW0187) via an unspecified route of administration, administered in left arm on an unspecified date in Jun2021 on Friday at 09:15 as single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number: EW0173) via an unspecified route of administration, administered in left arm on 06May2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Jun2021, the patient experienced flu like symptoms on Saturday. On 27Jun2021, the patient experienced half of face is numb, tongue is numb and smile is off. Patient reported that she feels like she is going crazy and she received her second dose of the Pfizer-Biontech Covid19 vaccine this past Friday. On Saturday, she experienced flu-like symptoms, as she expected, which resolved by Sunday. On Sunday, she noticed that half of her face is numb, her tongue is numb, her smile is off. She wants to know if these symptoms have been reported before and she got answer as per fact sheet Bell's palsy (facial paralysis) was reported by four participants in the Pfizer-BioNTech COVID-19 Vaccine group. Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of Bell's palsy were reported in the placebo group. Currently available information is insufficient to determine a causal relationship with the vaccine. The outcome of the event flu like symptoms was recovered on Sunday 27Jun2021 and outcome of the remaining events was unknown.
Information has been received from a pharmacist concerning a 77 year old female who on 24-FEB-2007 was vaccinated with a dose of Zostavax. On 16-Mar-2007 the patient developed a rash on her face. The pharmacist referred the patient to a physician for an assessment. It was not reported if additional medical attention was sought. No further information available. Additional information has been requested.
Child Given vaccine that may have had temperature excursion (Data Logger Failure) with Stable Fridge temps Before & After. DOH determined the vaccine to Be AT Risk & Advised Reporting & Revaccination Child HAD No ill Effects thus FAR
About an hour after vaccination, my throat was tingling and my heart rate went up. It came down after a bit and my throat/tongue felt slightly numb until I took a Benadryl.
Patient waited 15 minutes at the pharmacy after the dose and left.  Mother states that after 10 minutes on the road in the car patient started to feel dizzy and had a visible rash on chest area.  They came back to pharmacy where patient seemed to want to faint, we called 911.  Ambulance came within 10 minutes and took her to ER.
Pt reported hives 2 hrs after receiving the vaccine.  He was treated with benadryl 50 mg IM and Solu-Medrol 125 mg IM. Pt was kept under close observation.
Started my menstrual cycle 2 weeks early. Have now been bleeding for 20 days. I usually do not bleed because of my nexplanon implant.