chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning a 63-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. ON 31-MAR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L035283, expiration date 15-DEC-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
On 12/14, I developed a sore throat, congested head which felt like a sinus infection, a dry cough, but it was only in my throat area.  Body aches, chills and loss of taste and on 12/16 I tested positive to Covid.
Several hours after receiving the vaccine I started to feel flu like, tired and achy.  In the middle of the night I developed a fever of 101.7, chills, body ache, headache and very fatigued.  All of the symptoms lasted for the next few days until Sunday morning (4/11/2021) when I then began to fell better and able to move around.   I receive the vaccine in my right arm but my left arm was the one that hurt and had trouble moving for a couple days.
pt recvd vax;3aug95 devel red area w/ 1 1/4 cm brown sore in the ctr & a rash on back & abd;devel raised red lesions over body; T 102;tx w/ dph;lesions healed by 8aug95;reporter felt chicken pox was related to vax;
CHIEF COMPLAINT/REASON FOR VISIT Chest Pain     HISTORY OF PRESENT ILLNESS  Pt is a COVID positive 83-year-old male with an extensive past medical history significant for CAD status post PCI of, heart failure with reduced ejection fraction most recent EF on 10/4 was 31%, atrial fibrillation status post pacemaker placement (not on anticoagulation due to recent history of GI bleed), mantle cell lymphoma on chemotherapy (recent history of tumor lysis syndrome during hospitalization from 09/21-9/30), who presents today with generalized weakness and mild central chest discomfort.  Of note, he was recently hospitalized from October 2nd through October 7th on the Cardiology Service for COVID-19 infection with acute o
Allergy to Flu vaccine; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age patient who experienced allergy to flu vaccine, while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and Expiry date unknown)via unknown route in unknown administration site.  The patient developed a non-serious allergy to flu vaccine (allergy to vaccine) (Unknown latency) following the administration of INFLUENZA VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was allergy to flu vaccine.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for allergy to flu vaccine.  There will be no information available on the batch number for this case.  List of documents held by sender: none.
fever next day 100; Friday 2APR devel fever again; 3APR diarrhea & vomitting started; to ER 103.4 gave Phenergan supp 2APR to 11 fever all wk-mom gave APAP & Bayer; rash devel 11APR; 12APR to MD caused by combination teething, shots, ?virus
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 62-year-old male patient received bnt162b2 (BNT162B2 NOS), on 01Nov2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "IBS" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient received Paxlovid from  01Oct2023 to 05Oct2023.. The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
The pt developed fat necrosis on right thigh (2x2cm) area reported on 03/26/2002 visit.
Several months after receiving one dose of varicella virus vaccine live the pt developed chickenpox. Two other family member reportedly had similar experiences.
Two weeks after the first Pfizer injection, a rash formed. It was very similar to shingles experienced in the past, intense itching, blistering, and weeping for weeks. At the same time a high increase in hair loss began and continues. Additional symptoms continued to appear. Eye styes became frequent for e few weeks. Chalazia formed on both eye lids, one still exists. Lower leg cramps occurred for weeks and have lessened, but leg swelling, cold extremities, and bright red toes can still occur. Brain fog, fatigue, and a general feeling of poor health have all been experienced since the first vaccination. With the hair loss and circulatory issues, a micro thrombosis is being researched.
Headache  Injection site pain left deltoid  Large amount of swelling in left armpit area very uncomfortable
Swelling of upper left arm through the should and neck. Headache, blurred vision and left eye visual disturbances for 48 hours. Nausea and vomiting as well. I am a nurse, so I treated as home. I nearly went to ED for management of the headache and N/V. Pain was 10/10 for two days.
Patient reported on 12/12/2019 that she has been having pain in the arm ever since she got the injection.  She went to her doctor and was told the injection was given in the wrong area and resulted in tendonitis.
07/15/2003: Photophobia; 07/16/2003: Macular pruritic rash; arthralgia right knee and right index finger; edema right index finger.
This spontaneous report was received from a consumer (brother of the patient) refers to a female patient of unknown age. Patient's medical history and drug reactions/allergies were not reported. In October 2013 the patient was vaccinated with ZOSTAVAX (dose, route and lot # were not reporter). No concomitant therapy was reported. On an unknown date, the patient experienced itching on her arms after receiving the ZOSTAVAX. On an unknown date, the patient received treatment with BENADRYL for the itching and also used topical treatments including essential therapeutic oils. No lab diagnostics were performed. The patient did not see any medical attention. The outcome of itching on her arms after receiving the ZOSTAVAX was reported as not recovered/not resolved. Additional information has been requested.
PATIENT EXPERIENCED WHAT APPEARED TO BE VASOVAGAL REACTION. SHE WAS FELT DIZZY WITH FEVER.
ACUTE NON ST ELEVATION MI 12/18/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 17-OCT-2017, the patient was inoculated with the ZOSTAVAX vaccine for routine health maintenance and for its intended purpose: the prevention of shingles (lot number, dosage and route of administration not provided). Less than one month after receiving the ZOSTAVAX, the patient suffered a shingles rash on her right forehead and down to her eye and nose. The patient was diagnosed with herpes zoster with ophthalmic complication, herpes zoster eye disease. As a direct and proximate result of zoster ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the ZOSTAVAX, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. Upon internal review, herpes zoster with ophthalmic complication/herpes zoster eye disease was determined to be medically significant. Herpes zoster with ophthalmic complication/herpes zoster eye disease was considered to be disabling. Additional information has been requested.
has had cough, chills, fever, fatigue, body aches since vaccination, 6/11/2021 woke with chest pain into L arm and back.  EKG changes were consistent with STEMI, this was ruled out by ECHO.
had extreme Covid like symptoms/ those side effects seem to be what it looks like, possible Covid; had extreme Covid like symptoms/ those side effects seem to be what it looks like, possible Covid; dry cough; fever; she has been laying in bed; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old adult female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced dry cough, fever, had extreme covid like symptoms/ those side effects seem to be what it looks like, possible covid and "she has been laying in bed." It was reported that patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine and afterwards, she had extreme Covid-like symptoms, which included dry cough, and fever. Reporter (patient's husband) informed that the patient's temperature yesterday was at 102.4 F and today the fever is low. Reporter said his wife does not feel like taking her regular vitamins and medications so he is worried. He said she has been laying in bed. Reporter wants to know if this is a common side effect reported with the vaccine, or if his wife actually has Covid. If so, reporter wants to know if his wife should get tested for Covid. The reporter was informed that there is no information about dry cough was associated with the vaccine and he was referred to his HCP for further guidance.The patient underwent lab tests and procedures which included body temperature: 100, 102.4 degree fahrenheit. She has had extreme Covid like symptoms, fever over 100 degrees, that spiked over 102 degrees. She didn't appear to have a fever this morning, but is laying in bed. He wonders if this is something that happens as a side effect or if she could actually have Covid since those side effects seem to be what it looks like, possible Covid. The outcome of the events was unknown.  Follow up attempts are needed; information about lot/batch number has been requested.
This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 59-year-old female patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot Number: unknown), via an unspecified route of administration on an unspecified date in Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history included Mercury poisoning, hot flashes (which she has had for a year or more), arthritis (she says she has arthritis in her neck and since receiving the vaccine feels like she is at the beginning of her physical therapy instead of towards the end) and physiotherapy. The patient concomitant medications were not reported. The patient reported that several adverse reactions after received the first dose of the vaccine 3.5 weeks ago. It was reported that on an unspecified date in 2021, the patient had an elevation in heart rate on and off for two weeks, an increase in blood pressure, aches, pain, brain fog, muscle weakness, and hot flashes, which she has had for a year or more. She also reported not feeling "as strong as I was before the first dose". The patient said she has arthritis in her neck and since receiving the vaccine feels like she is at the beginning of her physical therapy instead of towards the end. She reports not having a local HCP as she recently moved; her previous HCP recommended her not to get the vaccine as she has a history of mercury poisoning. The patient says she does want to be protected, wants to be a team player, and does want to get the second dose but says " I just know I would be in bad shape, I just need more time" (in getting the second dose now) wants more time than to recover from these symptoms so asked how long she can wait to get the second dose. The patient was referred to health care professional. The patient underwent lab tests and procedures which included blood pressure measurement: increase, heart rate: increased on an unspecified date in 2021. The outcome of the events was unknown. The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Patient states she had severe muscle cramps and muscles locked in her face and shoulder. she had seen the doctor 3 times since the vaccine.
Pain at the site on the next day, on Sunday.  Developed also muscle aches on that same day.  Took ibuprofen.   On Monday, developed a H/A.  Still has a H/A.  Has history of migraines.  Taking ibuprofen usually makes it worse.
Patient stated she was here for a vaccine and after getting the flu vaccine the patient asked for an immunization card.  After a discussion the vaccine was supposed to be the initial COVID vaccine
Pt brought to ED via EMS with weakness, chronic inability to walk, SOB, wheezing, decubitus ulcer, constipation; was sent to hospital by home health nurse to assess possible infection of decubitus; pt requesting SNF for rehab; pt has a feeding tube; recent hospitalization for pneumonia and sepsis; was on ABX through PICC line; has completed ABX and home health nurse removed PICC line; now CXR shows severe emphysematous changes bilaterally with right pleuroparenchymal disease; DNR/DNI; evaluation of decubitus, no surgical intervention needed; wound care ordered; pt found to be positive for COVID during hospitalization; started on ABX and Decadron; no acute respiratory issues;  dc'd for PT and continued care; pt passed away
FEELING AWFUL; EXTREME HEADACHE; NAUSEA; This spontaneous report received from a parent 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 not reported, batch number: Unk) dose was not reported, administered on 22-JUN-2021 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 JUN-2021, the subject experienced feeling awful. On JUN-2021, the subject experienced extreme headache. On JUN-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extreme headache, nausea and feeling awful was not reported. This report was non-serious.
Narrative: WAS VACCINATED IN TIMELY MANNER 2/9/21 AND 3/1/21 WITH PFIZER MRNA VACCINE. PRESENTED TO ED WITH WITH LE WEAKNESS. HE WAS TESTED FOR COVID UPON ADMIT AND HAD A POSITVE CEPHEID. RECEIVED MONOCLONAL ABS, BUT REMAINDER OF HOSPITAL STAY WAS RELATIVELY UNREMARKABLE FOR COVID.
Sick for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 2 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick for 2 days). At the time of the report, ILLNESS (Sick for 2 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications was reported. No treatment medications was reported.
Local reactions back to back; This spontaneous case was received on 17-Dec-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-05827) and concerned a patient of unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number reported was 279847, expiration date: 30-Jun-2021.  On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient developed local reactions back to back. It was not reported whether the patient received any corrective treatment.    The outcome of the event was unknown.  The reporter did not provide causality assessment.  The case is linked to the cases 202007728, 202007729 and 202007730 (the same reporter).  Company comment:The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.; Sender's Comments: The patient was vaccinated with the suspect product, Flucelvax Quadrivalent. On an unspecified date and unknown amount of time after receiving vaccine, the patient developed local reaction. Chronology is unclear. More information regarding temporal relationship, concomitant medications and underlying medical history is needed. Causality is assessed as unassessable due to lack of information.
The caller stated that her patient arrived with a frozen vaccine of Imovax, no AE; Initial information received on 26-Feb-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves patient (unknown demography) who arrived with a frozen IPV (VERO) [IMOVAX] vaccine (lot T1C66 and expiration date :17-Jun-2022) on an unknown date (product storage error).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of potential medication error due to product storage error temperature too low.  And the caller would like to know if the vaccine is still suitable for use.   At the time of reporting, the vaccine was not administered.  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.
4/9/21 got Pfizer covid vaccine 1st dose, Reaction with in 30 seconds, extreme rapid heart rate, weird taste, right side of face  felt numb.  Waited 30 mins on site, felt somewhat better and then went home. 90 minutes until resolved.
Pt has a golf ball size, red, raised, area on the outer Right thigh and injection site.  Parent denies fever, or rash since vaccine administration.
EXTRAORDINARY GOT SICK; TREMORS; CANNOT STAND UP; CANNOT FUNCTION; This spontaneous report received from a parent via a company representative concerned a female 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 extraordinary got sick, tremors, cannot stand up, and cannot function. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the extraordinary got sick, tremors, cannot stand up and cannot function was not reported. This report was non-serious. This case, from the same reporter is linked to 20220410434.
Quick onset of nausea, stood up and hearing was lost and felt ready to faint, drank a Gatorade and water and sat on the ground. Hearing came back after 5 minutes, but moderate body shakes began and lasted an hour. Got very cold feeling and began to feel fever like. Took acetaminophen and covered up with blankets and drank water. Took a couple hour nap and woke up sweating with terrible migraine and light body shakes. Fell asleep for a few more hours and woke up not feeling feverish, but migraine and body aches. 22 hours after onset I have a light headache and body aches and am mostly feeling recovered.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (exact dose and lot number were not provided) and had an unknown reaction to the vaccine. Unspecified treatment was provided to the patient. The outcome of the event was not reported. The event was considered to be related to PNEUMOVAX 23. Additional information is not expected as there is no consent to the contact the reporter.
Rash on (L) leg (quarter size erythemaous plaque, non tender, apparent local reaction) MMRV in that leg.
Pt recv vax on 5/18/98; on 5/19/98 pt exp vax site rx of tenderness, swelling & redness of LA
This spontaneous report as received from a medical assistant refers to a 4 years old patient. The patient was vaccinated subcutaneously with lot # (667002/0441Z; exp date 25-MAR-2012) of M-M-R II on 23-JUL-2012 around 11:30am. No other co-suspects and no concomitant medications were reported. No adverse effect were reported. No treatment information was reported. Additional information has been requested.
10 min after initial injection, I experienced a brief flush of heat that resolved after a few minutes. 6 hours later,  I had  a sudden onset of intense heat, diaphoresis, and a rash to my arms/legs, along with intense  muscle tremors, nausea, vomiting and stomach cramps.
next day woke up with severe body aches, chills, headache, low-grade fever
This spontaneous report as received from a physician via a company representative refers to a 31 year old female patient. On 16-JUN-2015, the patient was vaccinated a dose of PROQUAD (Merck) (dose: 0.5 ml, lot # and expiration date were not reported). The patient needed vaccination for both M-M-R II and VARIVAX (Merck) and was given PROQUAD (Merck). There was no adverse effect reported. The patient did not seek medical attention. Additional information has been requested.