chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme Arm soreness at site of injection, body aches and soreness, weak muscles, chills/shivers
1 day after shot I had flu symptoms and was basically out of the whole day.  2 days after  my fever cleared and I noticed a pain in my left leg calf.  I thought it was because of my shot but that it was just body aches.  The pain increased and eventually spread to my inside thigh. I went to the urgent care on 5/17/21 and an ultrasound discovered blood clots (Deep Vein Thrombosis)  Please note that I also had traveled 5 hours on a flight on 5/6/21 but I was stretching on the flight and have never had a DVT before.
p/vax pt devel resp arrest & died;it was reported that medical director felt there was no connection between vax & events;
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a 23-year-old female subject who was vaccinated with ENGERIX B (SmithKline Beecham). Concurrent vaccination included DTP-Hib (non-gsk); unknown given on an unspecified date; OPV (non-gsk); non-GSK manufacturer; oral given on an unspecified date. Concurrent medications included TB skin test. On 11 August 1993, 18 October 1993 and 24 July 1996 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown details). When the 3rd dose was administered on 24 July 1996, the subject experienced drug dose administration interval too long. The healthcare professional was unsure if the second dose was given on 18 October 1993 as it was administered at another facility. On 3 September 2013, 20 years after vaccination with 1st and 2nd dose of ENGERIX B, 17 years after vaccination with the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. Relevant diagnostic results included a "titer drawn and on 3 September 2013 was told that the levels in her body were inconsistent with immunity for hepatitis B." At the time of reporting the outcome of the events was unspecified. Follow up was received from the office manager on 29 October 2013. The office manager reported that the subject was a 20 year old female rather than a 23 year old as previously reported. On 3 September 2013, the subject received a hepatitis B surface antibody test with results of "non-reactive." The definition of non-reactive per the laboratory was 'inconsistent with immunity, less than 10 mIU per milliliter." The physical also documented that the 1st and 2nd doses of hepatitis B vaccine were by an unknown manufacturer as they were given by a previous doctor's office. Per the physician the immunization series was not discontinued or delayed and symptoms did not recur following subsequent administration. The subject had not experienced adverse events following previous vaccinations. Concurrent vaccinations included DTP-Hib (non-gsk); non-GSK manufacturer; unknown given on 11 August 1993 and 18 October 1993; OPV (non-gsk); non-GSK manufacturer; oral given on 11 August 1993 and 18 October 1993. Concurrent medications included TB skin test administered on 24 July 1996.
P7 and Varivax administered on 9/26/03 at LUE. Pt developed fastcitis LUE at site of injection. Hospitalized on 10/6/03-10/12/003. Discharge Summary received on 10/27/2003 states myositis and cellulitis.
6SEP97 pt devel high fever 103;adm to hosp d/t grand mal sz;adm dx febrile sz d/t high fever;final dx febrile sz;tonsillitis;fine red rash over neck & head & swollen lymph nodes in groin & neck;
Information has been received from a nurse concerning her daughter who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL.  The nurse reported that the patient had a fever after receiving the first dose.  The patient started to have fever just days prior to receiving her second dose of GARDASIL administered on 01-OCT-2008.  Additional information has been requested.
Spontaneous coronary dissection leading to VF arrest requiring cardiac cath lab and was still in ICU as of Friday AM (11.12.21)
Acute onset Encephalitis with fever & rash. Resulting in poorly controlled Seizures. Cognitive decline with Autoimmune systems. Autonomic nervous system instability. Body Rashes. Loss of oculomotor control.
Had the vaccine around 2 PM. Felt kind of tired later in the day and little appetite for dinner. Around 12 midnight (AM) that night, I felt a bit unwell - mild nausea/slight stomach ache. By 1 AM I began shivering, it became uncontrollable. I put on extra clothing but couldn't get warm. The shivering was pronounced, and lasted 3 plus hours almost continuously. My hands felt cold and a bit numb. After the 3 initial hours, there were a few brief mild bouts of shivering into the next midmorning. Aches - During the night, my shoulders began to feel a bit stiff and sore. By morning, my shoulders became sore, then my neck, especially to the base of the skull, and accompanied by a headache, feeling like pressure behind the eyes, and at the base of the skull. The next day, the mild nausea came back a few times, it was not intense but it was noticeable and I took some TUMS, and kept a mild diet that day and the following. During the second day, Wed, the achiness extended to the middle of my back, and I continued to feel weak and a bit woozy, activity was an effort, my head throbbed, and I ended up keeping to bed most of the day. I checked the paperwork, the pharmacist had told me some people experience this vaccine as worse than most vaccines, and feel it for 2-3 days anecdotally. The symptoms I felt seemed to be on the list of possible side effects, which I wish I'd known in advance - would have planned to take it when I had a few days to spare. I put in a call to my PCP to notify them, but didn't go in, as it was too much effort, and not sure what they could do to help anyway. ADVIL and Acetaminophen helped somewhat with the aches. After 36-48 hours, I felt normal temperature on the third day, and the headache abated, by midnight of the second day (Wed) 34 hrs, the feeling of weakness and exhaustion passed, and the following day, Thurs, by evening the aches had subsided, about 55 hrs after vaccination. Some injection site pain lasted longer, about 5 days, over an area the size of my palm.
expired dose being administered with no reported adverse event; Initial information received on 17-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 14 years old male patient to whom expired dose was being administered with no reported adverse event , it involved vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2022, the patient received a  0.5ml dose (once) of suspect IPV (VERO) , with an unknown formulation and strength, (lot: T1D482M ; expiry date: 25-Jul-2022 ) via subcutaneous route in the left arm. for immunization  On 15-Aug-2022 , an expired dose was administered to the patient with no reported adverse event (expired product administered) (latency: same day) following the administration of IPV (VERO). It was administered by licensed practitioner nurse (LPN)  Action taken : not applicable.  Outcome: unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
04/11/2021 - First hour of the shot - had hives and itching but it went away 04/14/2021 - Had flu like symptoms with headache it lasted 3 days
My daughter started vomiting around 12 pm on the 25th and started having very watery poop as well.  I took her to the er at 7:30 where the started an iv.  She is very fussy, tired, achy and has vomiting and runny poop.
The first 5 days of patient's fasting blood sugar rose from an average of 98 to an average of 113.6; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. Medical history included pre-diabetic and take blood sugar twice a day and record it in a spreadsheet. The patient concomitant medications were not reported. The patient stated that he/she received Covid-19 vaccine on 04Mar2021, and it appeared to have worked great. No issues of concern Just 1 piece of feedback. The patient stated that he/she was pre-diabetic and took blood sugar twice a day and record it in an spreadsheet. The first 5 days of patient's fasting blood sugar rose from an average of 98 to an average of 113.6. It was back to normal the morning (11Mar2021) when the patient reported was 97. No complaint just some feedback. The patient reported that he/she felt great. Outcome of the event was recovered on 11Mar2021.  Follow-up attempts completed. No further information expected.
Swollen lymph node in right armpit - same side as shot was given.  Lasted about a week.
COVID 19 Treatment; COVID 19 Treatment; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Had several negative rapid tests after the Paxlovid course was completed; Positive, notes: followed by a new positive test 7 days after completion of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Redness, swelling and pain at injection site. Patient instructed to use ibuprofen and alternate warm/cold compresses.  To ER if breathing difficulty.  See in office if symptoms worsen.
Urgent care walk in visit on 7/24. Case investigation interview completed and case manager stated, "started having symptoms on 7/21- congestion, headache, body aches, fatigue." SARS-CoV-2 RNA Resp Ql NAA+probe performed at urgent care on 7/24 and came back detected. Staying stable housing during isolation period and has family in home to support.
Spouse called pharmacy later that night to report patient was feeling confused and difficulty in seeing . wanted to know if injection could have been  side effect. I check drug reference and told her i did not believe it was the injection and strongly recommended he go to er. He was admitted with a stroke and has since experienced additional stroke in hospital is currently in induced coma in hospital.
A couple of months following my second dose of my Pfizer vaccine, I began experience joint pains. I did not have a history of any arthritis, but through June into July I began experiencing severe flares that resulted in a positive diagnosis for Rheumatoid Arthritis. I was unable to move limbs, was immobilized until my flares subsided and could not walk some days. I sought help from both a Rheumatologist and my Endocrinologist and at some point asked them about it being linked to my vaccinations, but they could not provide any credible links to the associated disease. Since that RA diagnosis, I've also been diagnosed with Type 1 Diabetes following my booster vaccine in late November 2021. These are severe autoimmune diseases that manifested within months of my vaccines, and will now last a lifetime. As time goes by, I'm starting to see credible research come out that can connect Autoimmune Responses to the Covid-19 vaccinations. I've also submitted an event regarding my Type 1 Diabetes diagnosis following my Moderna shot since these diagnoses took place within 7 months of each other (July 2021-February 2022). The timespan of my full vaccination record is as follows: 4/9- first Pfizer vaccine, 4/30, second Pfizer vaccine, 11/30, Moderna booster vaccine. My diagnoses were as such: July 1st experience pain in joints leading to urgent care and PCP visits. January 15 (or earlier)- February 16, experience multiple symptoms associated with Type 1 Diabetes, admitted to ER with confirmed Type 1 Diabetes diagnosis.
Patient received Tdap vaccine from The Clinic on 09/01/17 at 9:16 am. Started to have symptoms at 3pm that day. Patient started to feel weak, at 5:30pm patient had body aches, felt hot, and had chills. Patient had a headache and felt nauseous. She had difficulty sleeping that night. Patient felt better the next day, and notified our office 2 days after vaccine was given to update us on her symptoms. She is better now.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 16:30 as dose 1, single (Lot number: EL9266), in left arm, on 04Mar2021 at 16:30 as dose 2, single (Lot number: EN6205), in left arm and on 05Jan2022 at 12:00 as dose 3 (booster), single (Lot number: FL3198) at the age of 38 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Other medication in 2weeks was unknown. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Fatigue; Upset stomach; Diarrhea; Few blisters on stomach/side; 2 Shingrix vaccines only 3 weeks apart; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2021, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 1st August 2021, the patient experienced fatigue, upset stomach, diarrhea and blister. On an unknown date, the outcome of the fatigue, upset stomach, diarrhea and blister were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   The reporter considered the fatigue, upset stomach, diarrhea and blister to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. In June 2021, the patient received 1st dose of Shingrix intramuscularly in left arm. The patient received 2nd dose in the right arm. The patient received 1st dose of Shingrix in right arm and experienced fatigue, upset stomach, diarrhea, and a few blisters on her stomach or side, and symptoms were off and on as well as ongoing. The patient asked if the side effects experiencing could be from getting 2 doses of Shingrix too close together. The patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The patient also asked if she should get her COVID booster with her symptoms. The reporter consented to follow up.
On day #11, injection site became painful, red, indurated , warm to the touch.  It was not pruritic. Treated with cool compress. Resolved in one week. .
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2018, reported as between the 8-MAR-2018 until 14-MAR-2018, the patient was vaccinated with and improperly stored dose of GARDASIL 9 injection, lot # N010497, expiration date 15-JAN-2020, for prophylaxis (route and anatomical location were not provided). The administered dose of the vaccine experienced a temperature excursion in the range between 47°F to 77°F during 55 minutes as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. Sender's Comments: US-009507513-1803USA006513; US-009507513-1803USA009619; US-009507513-1803USA009620; US-009507513-1803USA009621; US-009507513-1803USA009622; US-009507513-1803USA009624.
small red area at the injection site.; temperature of 99°F; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (temperature of 99°F) and VACCINATION SITE ERYTHEMA (small red area at the injection site.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H217, 003A21A and 04262A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism in 1984, Hypertension in 1989, Colitis microscopic in 2014 and Osteoarthritis in 1995. Concurrent medical conditions included Drug allergy (Dulcolax - hives), Drug allergy (betadine - inflamation), Latex allergy (Rash after contact), Hives, Hay fever and Osteoporosis (Was on Fosomax, now on Prolia) since 1998. Concomitant products included DENOSUMAB (PROLIA) from 11-Jul-2021 to an unknown date for Osteoporosis, LISINOPRIL, AMLODIPINE, LEVOTHYROXINE, ALENDRONATE SODIUM (ALENDRONATE), BUSPIRONE and BACLOFEN for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Dec-2021, the patient experienced PYREXIA (temperature of 99°F). On 15-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (small red area at the injection site.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) from 07-Mar-2021 to 10-Mar-2021 for Adverse event, at a dose of 500 milligram,1-4 Daily. At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (temperature of 99°F) and VACCINATION SITE ERYTHEMA (small red area at the injection site.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, Body temperature: 100.6 (High) 100.6 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other treatment medication included Steroid cream and Benadryl was administered as anti histamine with 1 dose for 4 to 6 hrs from 07-Mar-2021 to 10- Mar-2021 was reported.   This case was linked to MOD-2021-404621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Follow up received contains significant information, reporter information added, patient height, weight, medical history and concomitant medication were reported were updated.
This spontaneous report as received from a medical assistant refers to two unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD lot # M003434, expiry date: 19-JUL-2017, (dose#, route and site of administration not reported). Concomitant medication was not mentioned. No adverse effects were reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the six reports received from the same reporter.
Light headed and dizzy for about 20 minutes, episode occurred 4 days after receiving vaccine. Fever peaking at 102 degrees in 48 hours after vaccine. Bivalent and Shingles vaccine received at the same time
Pet dander/grass/pollen allergies have gotten increasingly stronger, though the overall effect is mild. I take daily loratadine and hydroxyzine for these, and today I've had to apply my topical steroid to several areas from my hips to my face to combat the itchy rashes and areas of redness.
reached a low temperature of Negative 1.3 C and were out of range for 9 hours and 48 minutes with no adverse event; FLUZONE QIV NP PFS was administered to patient post temperature excursion with no reported adverse event; Initial information received on 16-Feb-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA057733 and 2023SA057309 (CLUSTER).  This case involves adult patient of an unknown gender and reporter reported Influenza Quadrival A-B Vaccine [Fluzone Qiv] reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event  It was unknown if the patient had any medical history, medical treatment (s), concomitant disease or risk factor.  On an unknown date, the reporter reported Influenza Quadrival A-B Vaccine Suspension for injection (lot number: UT7683NA, UT7682JA; Expiry date: 30-06-2023) reached a low temperature of negative 1.3 c and were out of range for 9 hours and 48 minutes and was administered to patient post temperature excursion with no reported adverse event (product storage error) (latency: unknown)  (poor quality product administered) (latency: same day) (with an unknown strength, dose) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  It was unknown if the patient experienced any additional symptoms/events   It was unknown if there were lab data/results available.   Action taken: not applicable.   Outcome:  Unknown for both the reported events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.