chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of low seroconversion to hepatitis b vaccine in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). There were no concurrent medications. On 1 August 1996, 29 August 1996 and 6 February 1997 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown, unknown deltoid). On 16 April 2012, 15 years after vaccination with ENGERIX B, 16 years after vaccination with ENGERIX B, the subject experienced not responding to therapy. Laboratory results on 16 April 2012 showed "no immunity to hep B. Result was less than 5mIU/mL". At the time of the report no additional information was available.
This spontaneous report was received from a Registered Nurse concerning an unknown number of patient of unknown age and gender. On unknown dates incorrectly stored doses of VAQTA (lot # M009786 and M003025; exp date: 26-MAY-2017), could have been administered. It was reported that, on an unknown date, the refrigerator was out of range for 22 hours, with a highest temperature of 48.6 degree F. Temperature was back in range at the time of call. The Registered Nurse reported that vaccines could have been administered before the excursion was identified. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
2 months after 2nd dose of vaccine. Had intense Headaches, could hear heart beating in ears, felt nauseas while showering at times. Diarrhea, Weight Loss, Rapid Heart rate, High BP.
COUMADIN LEVEL 8.0 PLUS. STOPPED TAKING COUMADIN FOR THREE DAYS. TOOK 1 VITAMIN K TAB 400MCG ON 4/9 AND 4/11. ATE LEAFY GREENS FOR 3 DAYS. INR VALUE 4/12 2.4. RED MARKS AND BRUISING AT INJECTION SITE AND ON BOTH FORE-ARMS. NICKED MYSELF SHAVING, TOOK 48 HOURS FOR BLEEDING TO STOP. NO BLOOD IN URINE OR STOOL.  JOINTS ACHE REALLY BAD, TAKING 1000MG TYLENOL EVERY 8 HRS, MUSCLES ACHE REALLY BAD, BESIDES TYLENOL, MASSAGING AFFECTED MUSCLES. LOTS AND LOTS OF PAIN
Mother reports she noted whelps on lower stomach and back which spread to legs and under arms. This occurred on 10/25/04 IMUN given on 10/22/04. By the end of the day whelps were on face and back of ears. Afebrile and not fussy. Mother states she remembers this happening once before but doesn't remember if it occurred in connection with IMUN. Reports once whelps occur the head turns white and in less than 1 hour and whelp turns red, in appearance and then goes to a bruised appearance. Seen Dr on 10/25/04 reports dx with hives not whelps. No improvement seen so on 10/27/04 seen Dr with Serum sickness most likely DTP immune reaction. Had lab work done at Hospital u/a and blood work up. By this time child's face and eyes were very swollen per mother report. Hives/whelps had covered entire body.
A few hours after receiving vaccine I developed a headache, body aches, 102F fever, chills, very sore arm with extreme pain/swelling/heat at injection site.  This lasted for about 36 hours, gradually lessening.  I took ibuprofen 600 mg PO and tylenol (alternating), which helped.  About 48 hours after receiving vaccine I became very light headed and dizzy.   Headache became a migraine about 72 hours after injection (felt like a hormonal migraine, which I get somewhat frequently, but this was 5 days earlier than expected).  Migraine lessened after about 72 hours.  Symptoms resolved 5 days after receiving vaccine.
Information was received 06-OCT-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX at a pharmacy on or about 04-MAR-2013, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 08-AUG-2016, the plaintiff was treated by a nurse practitioner at a health center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. The plaintiff had been prescribed gabapentin and VALTREX for management of her painful condition. It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Intense pain in site and left arm  After 1 month, pain move into left clavicle.  Severe itch and bright red rash on entire arm.
Chills; fever; headache; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 10:15 (at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patient was allergic to penicillin, sulfa drugs and dairy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date, as a single dose for COVID-19 immunisation. Concomitant medications within 2 weeks of vaccination included ethinylestradiol, etonogestrel (NUVARING ), loratadine (CLARITIN) and ibuprofen (MANUFACTURER UNKNOWN), all taken from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Apr2021 at 23:00, 13 hours after the vaccination, the patient experienced chills which continued for about 45 minutes, fever which lasted for 12 hours and headache during the last final hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event chills and headache was resolved on 02Apr2021, while that of fever was resolved on 03Apr2021 at 11:00.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was given Immunizations on Friday and did not come in to office untill Monday Morning with blister and redness to Varicella Immunization Area.
Client complained of "feeling funny" after the shots were given. BP 154/100. Client observed x 30 min. No difficulty breathing or swallowing. BP returned to normal. Client drank some Coke. C/O feeling dizzy. Father came to drive her home.
Initial case was retrieved from scientific literature on 16 May 2011 reported two cases however only one patient received pandemic inflenzavirus A (H1N1) vaccination (patient 1). Only patient 1 will be captured in this report and patient 2 with infection will not be captured in this report. A 52-year-old male patient, with a history of type I diabetes mellitus and pancreas transplant alone, received during the 2009-2010 flu season an injection (route and site not reported) of PANDEMIC INFLUENZA VACCINE (manufacturer and lot number not reported). The patient "received pancreas transplant alone (PTA) in 2001, using basiliximab induction and triple maintenance immunosuppression with tacrolimus, mycophenolate mofetil and short-course steroid." He "suddenly experienced pancreas rejection shortly after influenzavirus A (H1N1) vaccination." The patient "was a 52-year-old man (typed A*02, 08, B*18, DRB1*03; panel reactive antibody (PRA) 0%) who receive a PTA (portal-enteric drainage) in April 2001 from a 19-year-old cadaveric donor (typed A*02, 32, B*18, 35, DRB1*11, 14). Being a Jehovah witness, the recipient never received blood component transfusions. A follow-up study of serum in January 2009 by Screening Luminex assay showed no anti-HLA IgGs." "In December 2009, shortly after H1N1 vaccination (patient 1) reported hyperglycemia and hyperamylasemia, and lost insulin-independence. Blood levels of tacrolimus were within normal ranges, and pancreatic biopsies were finally performed: histologies showed septal inflammatory infiltrates and diffuse positive C4d stainings, so the recipients were finally diagnosed with acute rejection. At the time of rejection, Single-Antigen Luminex testing showed a broad sensitization against >18 different HLA class I and >13 HLA class II antigens in both patients (including donor-specific antibodies). Both patients also had a strikingly similar anti-HLA antibody pattern, suggesting a common antigen exposure, and steady autoantibody titers, excluding diabetes recurrence as the leading cause of rejection. Reactive epitopes for patient 1 were 82LR on A31 and 163LW on B35; 56PPA, 57PV and 74SV on DQB; 56RR5 and 47ERW on DQA." The outcome was not reported. Documents held by sender: None.
It was reported that a 47 year old female received a TD Adult  on 3/17/00. Reportedly, on 3/18/00, the pt complained of left deltoid soreness and left extremity swelling. The symptoms have reportedly subsided. From correspondence received on 4/10/00, additional pt and responsible physician information was provided.
Day 1- Arm pain started in the evening and was bad enough that I could not get comfortable enough to sleep through the night.  Day 2- Injection sight developed a round, warm, swollen,  red, itchy, firm lump about 3 inches in diameter by the morning. Slightly elevated fever 99.8. By the afternoon nausea, fatigue, total body and muscle aches- especially in arms and legs.  Day 3- Menstrual spotting, fatigue, and still have the same symptoms at injection sight.
His daughter had a rash after receiving the vaccine. Not a diffuse rash.; This is a spontaneous report received from contactable reporter(s) (Physician).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: RASH (non-serious), outcome "recovered", described as "His daughter had a rash after receiving the vaccine. Not a diffuse rash.". It was unknown if therapeutic measures were taken as a result of rash.  Additional information: It was unknown if patient received other vaccine in four weeks or other medications in two weeks. It was unknown if patient had any allergies. Other medical history was unknown.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Chest tightness, heaviness evening of 4/17/21, along with light headed. Tingling in left arm (injection arm).   EKG normal 4/19/21. Chest pain continues 4/20/21 , describes as a "zap" or static feeling upper left chest.   No SOB.
Mother mentions that the patient had rash in the whole body. You can see hives in the entire body.
Fever of 101.00, body aches, chills, headache; pain,  hardness, and swelling at injection site
Labial commissure deviation, unable to blink Rt eye, Rt eye mydriasis.
This spontaneous report was received from a physician via field employee regarding a male patient, above 70 years of age. Concurrent condition and medical history was not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dosing regimen unspecified) for prevention of shingles. The physician reported that "2-3 months" after receiving ZOSTAVAX the patient broke out in "full blown shingles" and "acute pain". He also reported that "the pain could also have been postherpetic neuralgia". The patient did not seek medical attention but did not know if the patient called the physician or was actually seen in the physician's office due to the reaction. VZV packet sent to the physician. The outcome of the events was unknown. The causality assessment was not provided. Additional information has been requested.
site of inject is red, swollen, warm to touch. Pt experienced HA & nausea after inject. Dr. prescribed Claratin.
Covid arm developed 2 days post vaccination. Two red splotches on left arm. Hot to touch. Grown larger by day 3. Muscle is swollen
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot # M043582, expiration date 28-OCT-2018; dose and route were unknown) reconstituted with properly stored sterile diluent (lot # was unknown) for prophylaxis. No adverse effects were reported. Data logger was involved. The vaccines stored under -9 Celsius degree to 8 Celsius degree for 4 hours 57 minutes. Previous temperature excursion was -9 Celsius degree to 8 Celsius degree for 2 hours 46 minutes.
0n 03/10/2021, that evening I was lethargic, fatigue, and was in bed for that day and the next day. My symptoms resolved in 48 hours.  Around the beginning of May, I was having shortness of breath. I could not breathe-in while I was mowing the lawn. On 06/01/2021- Dr. diagnosed me with pneumonia. And he found multiple nodules in my lungs, one was about 2cm,  in my lungs.   On 10/08/2021, I have a follow up appointment to have another CT scan to see if the nodules have become larger.   I am not saying the vaccine caused the pneumonia. I'm just saying this all happened after the vaccine.
Awoke next morning with redness and swelling (tennis ball size) on arm at site of injection of Prevnar 13 and flu shot.  No fever.  No antibiotics administered.  Nearly resolved by 10/7/10 in am.  Appeared to be arthus reaction to me. (I'm MD practicing clinical immunology)
Fatigue - persisting on day 3. Chills and fever (1 degree or so) - persisting on day 3. Nausea - first 24 hours - one episode at night. Pain, itching, swelling and hardness, and redness 2 inches out around the injection site - persisting on day 3.
11/5/09 Fever 104; to ER. Dx with swine Flu and Viral pneumonia.
LEFT FACIAL AND TONGUE NUMBNESS - WORK UP CVA NEG Narrative:  Developed left facial and tongue numbness 4 hours after vaccine - went to ER and admitted for 2 days, negative workup for CVA or other acute etiology. Symptoms resolved prior to discharge from hospital
Fever 105.9 S/P vaccines as per mother of child. Temp 103.8 at ER visit.
Woke up this morning feeling fine, showered, went downstairs to make tea, felt suddenly strange. Intense nausea and faintness. Lost consciousness for about 30 seconds (according to my husband).
immed swollen p/inj;increased heat & hard this AM;rt deltoid erythema & indurated, + tender, area noted 8cm;tx prescribed of keftab, hot packs & ROM;
Drowsiness; Fever; Chills; Bleeding at injection site; Sore arm /pain n arm; Pressure in arm; Inability to move arm; Feeling something in the chest; Feeling hot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bleeding at injection site), PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm) and CHEST DISCOMFORT (Feeling something in the chest) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension. Concomitant products included METFORMIN for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding at injection site), PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm), CHEST DISCOMFORT (Feeling something in the chest), FEELING HOT (Feeling hot), PYREXIA (Fever) and CHILLS (Chills). On 16-Mar-2021, the patient experienced SOMNOLENCE (Drowsiness). On 13-Mar-2021, VACCINATION SITE HAEMORRHAGE (Bleeding at injection site) had resolved. On 16-Mar-2021, CHEST DISCOMFORT (Feeling something in the chest), FEELING HOT (Feeling hot), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm /pain n arm), LIMB DISCOMFORT (Pressure in arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Inability to move arm) and SOMNOLENCE (Drowsiness) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, Blood pressure measurement: elevated (Inconclusive) Blood pressure increase was attributed to the pain in her arm following injection of Moderna on 13Mar2021.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included blood pressure medicine and pain medicine Treatment medication included Blood pressure medicine dose increase, Pain medicine, Antibiotic and Ice pack
Information has been received from a physician concerning a female who on 19-APR-2007 was vaccinated with Gardasil. On approximately 31-MAY-2007 the patient developed injection site redness and injection site swelling. The patient has not recovered. Additional information has been requested.
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 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "known allergies: yes" (unspecified if ongoing), notes: known allergies: yes. Concomitant medication(s) included: ATORVASTATIN; LOSARTAN; LORAZEPAM; TRULICITY; ASPIRIN [ACETYLSALICYLIC ACID]; JARDIANCE and also reported as, other medications/products within 2 weeks.The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 from 21May2022 to 23May2022.   Clinical course was reported as, The patient had to discontinue Paxlovid after dose five (day three, first dose) because severe severe nausea, vomiting on 23May2022. It worked very well up to then-COVID symptoms decreased greatly-but rebounded a bit after discontinuation, mainly as congestion at that point. Vaccine lot was not available/provided to reporter at the time of report completion. Patient was recovered from symptoms on 24May2022 and no treatment received for symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
patient said later that evening her left arm was red and hot. she experienced pain from site of injection to shoulder. she also had a rash on both arms. right arm however was not itchy, but left side itched. patient had seen dr who had given her an injection to help with the allergic reaction.
Extremely itchy red rash that covered entire upper torso and head; left arm at injection sight was itchy and sore; left arm at injection sight was itchy and sore; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El9261) via intramuscular route of administration, administered in arm left on an unspecified date at dose 2, single for covid-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. Patient had no Known allergies. Patient did not have Covid prior vaccination. Patient has not tested covid post vaccination. Patient did not have other vaccine in four weeks, other medications in two weeks. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: not reported) via intramuscular route of administration, administered in arm left on 02Feb2021 07:15 at dose 1, single for covid-19 immunisation and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: El1284) via unspecified route of administration, administered in arm left on 12Jan2021 at dose 1, single for covid-19 immunisation. On 05Feb2021 the patient experienced extremely itchy red rash that covered entire upper torso and head, left arm at injection site was itchy and sore. Adverse event: Extremely itchy red rash that covered entire upper torso and head. Started on third day after 2nd dose, my left arm at injection site was itchy and sore and after i scratched it the rash quickly covered my upper torso within an hour. I have been to the Emergency room twice and am on steroids for this now, but the rash does not seem to be getting any better. Adverse events resulted in Emergency room/department or urgent care. Patient received treatment with Antihistamines and steroids for the adverse events. Outcome of the events was not resolved.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
had her first dose / in 2018 / has not yet had second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in September 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient herself. The age at vaccination was not applicable for this report. The patient did not know a 2nd dose was required and till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient consented to follow up with her doctor. The reporter consented to follow-up.