chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3/6/2023 I noticed a terrible sore throat. I thought I had strep throat.  I always have a runny nose, but it was running a lot more.   I took an at home COVID test and it was negative. The next morning, I felt terrible. I had a headache, sore throat, felt bad and achy all over.  I took an at home COVID test and it was positive.  I went to Urgent Care. They did a rapid and a rapid PCR COVID test, both were negative.  They sent me home.  That afternoon, they said the PCR test they sent off came back positive. My lungs were clear.  They could not prescribe Paxlovid because I did not have current bloodwork. I went to the hospital and had bloodwork, which came back with  normal renal function. I was prescribed Paxlovid and started taking it on 3/8/23.   I had a horrible migraine headache , shaking and chills. Once I started the Paxlovid, I felt better within a day. I still have a lingering cough.
Temperature of 102F since injection on 1/9/01 and leg pain. Small amount of induration on left upper thigh but no erythema. Walks with limp. Had hives in office on 1/11/01.
Had an acute gout attack and I have experienced this twice; First acute gout attack on my right great toe; Experienced my second one on my left great toe; This is a spontaneous report from a contactable physician (patient). A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 Immunization. Patient had an acute gout attack and patient has experienced this twice on an unspecified date in 2021. Patient have never had a history of gout, patient do not overconsume alcohol or any typical gout diet foods however the only change in my lifestyle is receiving both Pfizer vaccine injections, the last one was February 2nd (later clarified). Approximately, one month ago, patient experienced my first acute gout attack on my right great toe and yesterday, patient has now experienced my second one on my left great toe. So, patient wondering if there are any other reported cases of this happening. The outcome of the events was unknown.  Follow-up attempts are needed. Further information is expected.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The medical assistant reported that, on an unknown date, an unspecified number of patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot numbers, expiration dates, doses and routes of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
3 inches below injection site, swelling, pain, redness 4 inches long by 3 inches tall, skin hot to touch Symptoms faded without treatment
overall body muscle aches and headache started 12 hrs after shot, and lasted about 36 hrs. muscle ached settled in shoulders and neck after the 36 hours. irritated red raised rash approx 4" wide by 6"-8" long appeared on arm at vaccine site on 4th day after getting shot - and now has lasted 3 days and is not gone. arm pit at vaccinated arm is a bit swollen and a lump is felt in arm pit.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-MAY-2012, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 12-JAN-2014, the patient was treated for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed valacyclovir for the management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a physician concerning a 4 year old male who on 02-MAY-2002 was vaccinated with subcutaneous Varivax. On 10-JAN-2006, the patient experienced mild breakthrough varicella. Subsequently, the patient recovered from mild breakthrough varicella. Additional information has been requested.
Dark bruising at injection site.  Localized swelling of upper arm at and below injection site to 3" above elbow. Area pink, hard, swollen, edematous, tender, mottled, and very warm to touch. Pain - arm and headache.
Janssen Booster administered on October 29, 2021 November 4 went to medical facility for UTI symptoms - doctor prescribed Macrobid - after 4th day of dosing still had UTI symptoms (lower abdominal and back aches)  Doc. then prescribed Cipro - completed the Cipro of 24 pills over about 1.5 weeks and on or around November 15th, (4 days later) broke out into hives - On Dec 3 went to doctor - she prescribed an oral steroid - to relieve the itches at first thought the hives were from Cipro - but, found info. about 'Chronic Spontaneous Urticaria after Covid 19' -- Believe the hives were due to an Adverse reaction to Covid Booster -broke out in itchy hives n or about November 19th, 2021- as of Dec 26th, 2021 still having issues -- taking Zyrtek in day and benedryl at night and using topical Aveno anti itch lotion and benedryl anti itch lotion.
This spontaneous report as received from a pharmacist refers to a 77 year old female patient. She had no pertinent medical history. On 29-MAR-2013, the patient was vaccinated with 0.65ml ZOSTAVAX. The batch number was H019996. The patient did not take any concomitant medications. On 31-MAR-2013 the patient experienced lightheadedness and weakness. She sought medical attention for the adverse events: she visited the pharmacist. The outcome of lightheadedness and weakness was reported as not recovered/not resolved. She received no treatment for the adverse events. A causality between the adverse events and ZOSTAVAX was not provided by the reporter. Additional information has been requested.
Case previously recorded as MA2009-5498. Initial case report received via Med Com from a health care professional on 20 NOV 2009: A 30-month-old male patient was vaccinated with 0.5 ml of FLUVIRIN (batch no. 102044P1) i.m. on 19 NOV 2009. No adverse event was reported. MedCom ref. no: NA09-008669.
Shingrix incomplete dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 09-NOV-2023, the patient received Shingrix. On 09-NOV-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: Shingrix incomplete dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date:10-NOV-2023 Pharmacist reported while administering Shingrix the needle was not screwed correctly to the syringe and most of the vaccine was administered but saw one or two drops leaking, which led to incomplete dose administered. Information about patient and vaccine requested but call was decline because caller was not at facility at the moment of call. The reporter consented to follow up via email.
Rash from the area of the vaccination site extending most of the way down the arm.  Appeared the day following vaccination and remained for about 1 week.  Although rash did not itch patient took benadryl which helped.  No additional treatment was sought for the rash, but it was a factor in the patient delaying his 2nd dose of moderna until 44 days after the first.
pt began screaming immed p/vax; also devel large macula on lower extremities-rash resided until 15mins; screaming subsided w/in 15mins;
Upon administration of first covid vaccine, there was leakage of the vaccine.  It was not a large amount and the patient received some of the dose.  Upon asking our market manager, the recommendation was not to restart the series and complete the series as previously recommended.
2 hrs after immunizations, mom noticed redness in (L) deltoid after removing band aids, 6x3cm oval swollen, red, warmth. Possible fever 6 hrs later. Temp not taken, fever 101. 36hrs later but diagnosed with OM at subsequent visit 4/22/15.
No adverse reactions reported at this time. Expired vial used for vaccine injection- Aug 2021
Patient came to the ED with complaints of nause, vomiting, and low sPO2.  Pateint was admitted to the hospital with Covid pneumonia and treated with remdesivir.
No additional adverse events reported; The patient was administered with improperly stored vaccine; This spontaneous report was received from a licensed practical nurse referring to a 15-month-old patient of unknown gender. Information about the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies was not reported.   On 25-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot# T033815, expiration date 05-OCT-2022; strength, dose and route were not reported) for prophylaxis (product storage error).  The administered vaccine experienced a temperature excursion in 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions included 32.9 F for 53 hours 16 minutes, 49.1 F for 5 hours 9 minutes, and 56.3 F for 14 hours 7 minutes. No additional adverse events reported.   This is one of multiple cases received from the same reporter.; Sender's Comments:  US-009507513-2202USA003592: US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003333: US-009507513-2203USA003334: US-009507513-2203USA003335:
Patient with no known past medical history received his 2nd dose of Pfizer COVID-19 vaccine on 3/29/21 presented 5/19/21 with sudden chest pain presented to ED via EMS with acute inferior ST elevation MI.  Cardiac cath reveled 95% ostial stenosis not consistent with ECG changes.  Treated for myopericarditis with NSAIDs and steroids with resolution of chest pain.
it was on the shelf next to the appropriate vaccine and grabbed Flublok by mistake/no AE; a 13 year old was given Flublok inadvertently/no AE; Initial information regarding this unsolicited valid non-serious case from the The Agency (Reference number- 00342329) was received from a pharmacist and transmitted to Sanofi on 02-Nov-2020.  This case involved a 13 year old patient (unknown gender) who inadvertently received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number and expiry date not reported) (Product administered to patient of inappropriate age) via unknown route in unknown administration site for prophylactic vaccination and also reported that it was on the shelf next to the appropriate vaccine and grabbed Flublok by mistake (Wrong product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    It was an actual medication error case due to wrong vaccine administered and Inappropriate age at vaccine administration (latency same day).  Reporter asked for reports for giving Flublok out of recommended age and effects to watch for and told that she would call back with more adverse event details.  Potential PTC(product technical complaint)- no  At the time of reporting, no adverse event was reported.  There will be no information available on the batch number for this case.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.
nightmare; woke up sweating that night; Tinnitus temp disappeared.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021785350 (Pfizer).  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 10:00 (Lot number: EP69SS) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "bipolar" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing);" (unspecified if ongoing); "smoke cigarettes" (unspecified if ongoing). Concomitant medication(s) included: ABILIFY; HYDROXIZINE; QUININE; FLONASE ALLERGY RELIEF; VITAMINS A & D. The following information was reported: NIGHTMARE (non-serious) with onset 06May2021 12:00, outcome "unknown", described as "nightmare"; NIGHT SWEATS (non-serious) with onset 06May2021 12:00, outcome "unknown", described as "woke up sweating that night"; TINNITUS (non-serious) with onset 06May2021 12:00, outcome "unknown", described as "Tinnitus temp disappeared.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nightmare, night sweats, tinnitus.  Additional information: The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
2 weeks after Moderna vaccine for COVID.  Low fever 99.7,  Chills, headache, Joint/muscle body Aches, Fatigue, no appetite, and abdominal pain.  Duration was 24 hours.  Took Tylenol.
Almost certain it is Shingles on left side of torso.  Left shoulder blade area and under left arm pit.  Had chicken pox as a child.  Will visit doctor tomorrow. Note: The Lot Number on vaccination card is not clearly written.  It could be E128733 or something else....
Received call from mom on 10/5/16 that child received flu shot 10/4/16 at school now (L) arm quarter-size redness and swelling. Mom call back on 10/6/16 and state redness has spread to under arm and bruise to elbow and feels hot. Patient seen by provider on 10/6/16 by Dr and redness down arm-put on antihistamines with follow up on 10/7/16.
I had a bad reaction to the shingles vaccines 2nd step. I experienced shivering nausea, headache, staying in bed sleeping. People need to know it's like having the flu for a couple of days,
On one side of her chest and neck there is a very red rash with blisters; Blisters; Very painful; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vesicular rash, blister and pain. On an unknown date, the outcome of the vesicular rash, blister and pain were unknown.   It was unknown if the reporter considered the vesicular rash, blister and pain to be related to Shingrix.  Additional details were reported as follows: The reporter reported adverse events experienced by their mother in law. The age at vaccination was not reported but it could be 83 years or 84 years. The patient was vaccinated about a year before the reporting date. The reporter believed that, the patient had shingles and described symptoms of it. On one side of the patient's chest and neck there was a very red rash with blisters. It started small and spread over a couple of days. It was very painful and looked just like images of shingles that the reporter seen during research. The reporter also asked, could a person who was vaccinated with Shingrix develop shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
Hospitalized 01/09/2022; COVID-19 positive 01/09/2022; fully vaccinated  Discharge Provider:  Primary Care Provider: DO Admission Date: 1/9/2022 Discharge Date: Jan 13, 2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 52 y.o. male with past medical history significant for ETOH mediated cirrhosis, hx etoh use disorder in remission, chronic pancreatis with history necrotizing pancreatitis and pseudocyst briefly previously PGJ tube (removed 2017), portal vein thrombosis on warfarin, acquired type 1 diabetes mellitus secondary to pancreatitis, mild persistent asthma, active tobacco use disorder and chronic low back pain with chronic narcotic dependence who presents to the emergency room two days after testing positive for COVID 19 with worsening shortness of breath. He is fully vaccinated (3/2021) but not boosted. Patient was treated for COVID-19 pneumonia.  Patient required oxygen.  Completed a course of remdesivir while inpatient.  Was started on Decadron steroids, patient doing well and his O2 requirements stabilized for several days prior to discharge.  Pulmonary rehab was consulted and arranged home oxygen for home.  Management also arranged for patient to be enrolled in the COVID at home program for continued follow-up after discharge. Currently, patient was noted to have bilateral cavitary lung nodules and community-acquired pneumonia.  Pulmonology was consulted.  He was started on IV antibiotics.  Again, his respiratory status improved and patient was to complete a total 7 day course of IV antibiotics.  He he was also advised to follow up with a CT scan in the outpatient setting in 3 months.  This was noted in his discharge paperwork. Patient also developed bilateral thigh pain.  There was not a clear etiology of his symptoms but he was on atorvastatin which has a known side effect of myalgias.  This was discontinued on discharge. Patient also noted loose stools and reported history of greasy stools at home.  He was started on pancreatic enzyme replacement.  He was given prescriptions for this on discharge.
This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (rHA), lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning a 10 year old, male subject, who had been received FLUMIST QUDRIVALENT (intranasal). FLUMIST QUDRIVALENT (intranasal) started on 08-Sep-2014. Expired FLUMIST QUADRIVALENT was administered to the patient on 08-Sep-2014.The outcome of the event of administered expired FLUMIST QUADRAVALENT is unknown. The report was considered to be non-serious by the reporter.
MOTHER CALLED OFFICE ON 12/18/2007 AND STATES THAT CHILD IS NOW STUTTERING AND BLINKING EYES.
This study case was received from the investigator in a trial on 05 July 2013. A 45 year-old male subject had received an injection of ACAM2000 (lot number, route and site of administration not reported) on 02 April 2011. The subject had received the following other vaccines on 22 March 2011: TYPHIM VI (sanofi pasteur SA, lot number, route and site of administration not reported), Anthrax vaccine (other manufacturer; lot number, route and site of administration not reported), and Hepatitis B vaccine (other manufacturer; lot number, route and site of administration not reported). The subject experienced acute myocardial infarction (subendocardial infarction) and acute myocardial infarction (unspecified site) at 27 days post-vaccination of ACAM2000 on 29 April 2011. The Troponin I result, ECG and Echocardiogram were not available. Lumbar puncture and MRI of the brain, spinal cord and heart were also not available. The subject's past medical history records were not retrievable. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Lingering pain in arm that hurt to move, red area with the width of a dollar bill.  Redness decreased by Thursday, but switched to a persistent itch.  Redness was even toned and warm, skin felt slightly rough.
8-14-2021: admitted to the hospital for chest pain, stress test completed and negative. Negative troponins  9-24-2021: began having palpitations  10-2021: began having menorrhagia with irregular menstrual cycles requiring an ablation.  12-9-2021: cardiac arrest, MI with clot to LAD.  Inoxic brain injury due to multiple rounds of ACLS. Subsequently died on 12-21-2021
Pt recvd 1 dose of Engerix-B & 10AUG92 lt eye not blinking & lower corner of mouth drooping;
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored M-M-R II (dose, route of administration, lot # and expiration date were not reported), reconstituted with properly stored sterile diluent. Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA002966: US-009507513-1709USA007015: US-009507513-1709USA007016: US-009507513-1709USA007018: US-009507513-1709USA007019.
pt recv vax & exp a rash on the upper torso only 10-15min p/vax;
Pain in upper arm, originally originating from injection site, later to shoulder, armpit, and upper breast area. I have difficulty in dressing, holding items, (dog leash), even the motion of driving (steering)  an cause pain. Pain is worse when sleeping or first thing in the morning.
"Red, irritated, itchy skin all over". Clarified as "arms and legs". Took Benadryl OTC 1 tablet/allergy... No vaccine reactions prior to this.
Patient in office to have cast applied to wrist-Fx 2 days ago. Wt 72.2, Ht 57 inches, BP 100/60. Administered 2nd HPV following cast application. Five mins after shot patient hopped off table, fainted, hit back of head.