chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may have been vaccinated with PNEUMOVAX 23 (dose, route, and lot number were not reported), that were improperly stored (49.3 degrees F. for 2 hours). Concomitant medications were not reported. No adverse effect reported. This case is linked to cases 1404USA005406, 1404USA007012, 1404USA007013 and 1404USA007015 via same reporter link. Additional information has been requested.
Next day post vax, the pt began to have raised areas on back, buttocks, and legs. Since that time they have steadily improved. On 8/11/00, 2 small raised areas on lower back and 1 raised area on buttock and 3-4 small areas on thighs appeared.
My UTI are out of control since I received the vaccination. It's not normal for me to have them. I started to notice my adverse event around Feb 2021.  Around January or February, I started to go to an urgent care, and I visited the doctor. If you contact my doctor, they will have the exact the dates and details.
After the second vaccine I noticed an marked increase in my blood pressure.  After talking with my kidney doctor we had to raise my BP meds.  I am still on the extra BP meds trying to keep from getting worse, which would be worse for my kidneys.  After the second shot, BP went up to 190+/110+.  (No office visit because of COVID restrictions.) Previous meds:  Losartan Potassium 25mg - 1/day; Triamterene - 1/2 on Monday and 1/2 on Friday Current meds:  Losartan Potassium 25mg - 2/day; Triamterene - 1 whole pill Monday, Wednesday, Friday Previous BP:  usually around 135/85 Current BP:  trying to keep below 150/90.
20 minutes after the shot my heart rate went up. 25 minutes after the shot there was chest tightness, similar to when having an angioadema/allergic reaction. 25mg of Benadryl was taken and things calmed down.  Since then there have been hives that have been slowly getting worse.  Prior to the shot, the chronic hives were under control.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2011, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome is unknown. Additional information has been requested.
Within 30 minutes- flushing, mild hives; Within 30 minutes- flushing, mild hives; Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Within 6 hours- headache mild visible facial swelling, Teeth pain (like after a root plaining); Next morning- eye irritation, elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days); Next morning- eye irritation, elevated blood pressure. (154/86 and staying between 140-152/70-88 over the next 5 days); Day 3 -left lower abdominal quadrant cramping and noted an increased amount of hair loss; Day 3 -left lower abdominal quadrant cramping and noted an increased amount of hair loss; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non pregnant female patient received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 27Aug2021 at 15:00 (at the age of 43-years-old) as single dose for covid-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome (PCOS), history of appendectomy, tonsillectomy and pelvic floor reconstruction. Patient had known allergies to penicillin, keflex, mild egg allergy food allergy from an unknown date and unknown if ongoing known allergy to penicillin, Keflex and mild egg allergy. Concomitant medications included levothyroxine, multivitamins, paracetamol (TYLENOL), loratadine (CLARITIN [LORATADINE]) and fish oil. The patient previously took keflex [cefalexin] and experienced drug allergy. Patient did not receive any other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. Patient was not tested for covid post vaccination. On 27Aug2021 at 15:15, patient experienced within 30 minutes- flushing, mild hives, within 6 hours- headache mild visible facial swelling, teeth pain (like after a root plaining), next morning- eye irritation, elevated blood pressure (154/86 and staying between 140-152/70-88 over the next 5 days). On day 3, patient experienced left lower abdominal quadrant cramping and noted an increased amount of hair loss. The patient underwent lab tests and procedures which included blood pressure measurement which was 154/86 and staying between 140-152/70-88 over the next 5 days). Therapeutic measures were taken due to the events and patient self-medicated with benadryl on the evening of 27Aug2021. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
R arm, deltoid, red, hot, swoolen-the size of baseball. Temperature 99F.
Patient was hospitalized for reaction on 10/25/2020-10/27/2020
A spontaneous report of asthma attack has been received from a health professional concerning a seven-year-old male, subsequent to FLUMIST.  Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 18-Sep-2009. The patient received a second dose of FLUMIST before the onset of the event on 29-Sep-2009. Eleven days after receiving the first dose of FLUMIST, on 29-Sep-2009, the patient developed an asthma attack after receiving a second dose. The outcome and causality were not reported for the event of asthma attack. The sponsor considers the events of inappropriate schedule of vaccine administered and asthma attack medically important events.
Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Fever-Severe
Minimally soreness at injection site, fatigue, and minimal chills (on and off) for 4 days Nauseated within 30 minutes after eating and lasting for a few hours.  This lasted about 4 days.
16 hrs after shot i had extreme fatigued i didn't even eat i was so tired. When i woke up the next day I was fine.
schizophrenic brain; nearly died/close to a code blue; allergic reaction; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001330.  A 72-year-old female patient received bnt162b2 (BNT162B2), on 05Feb2023 as dose 1, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to eggs" (unspecified if ongoing); "migraine" (unspecified if ongoing); "headaches" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obsessive-compulsive disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE), administration date: Mar2022, when the patient was 70 years old, for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 2023, outcome "recovered", described as "allergic reaction"; NEAR DEATH EXPERIENCE (medically significant) with onset 2023, outcome "recovered", described as "nearly died/close to a code blue"; SCHIZOPHRENIFORM DISORDER (non-serious), outcome "unknown", described as "schizophrenic brain". The events "nearly died/close to a code blue" and "allergic reaction" required emergency room visit. Therapeutic measures were taken as a result of near death experience, hypersensitivity. Clinical courses: On 19Oc2023 and 25Oct2023, it was reported that a  woman patient started treatment on 05Feb2023 with Pfizer BioNTech COVID-19 vaccine dose 1 for COVID-19 vaccination. It was reported the patient did not get the 2nd dose because she had an allergic reaction so bad she had to go to the ER, and was "close to a code blue" and "nearly died." It was reported an EpiPen was used to bring her back. It was reported the patient was allergic to eggs, and had migraine, headaches, asthma, and obsessive-compulsive disorder. The patient jokingly stated: "I think have a schizophrenic brain." She had the Janssen COVID-19 vaccine in Mar2022.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect vaccine bnt162b2 to the reported events Hypersensitivity and Near death experience cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history included asthma. On 12-MAR-2012 the patient was vaccinated with PNEUMOVAX23 (dose, route unknown) (lot# was reported as 1706AA, Exp date 03-OCT-2013). The physician reported that a patient developed an injection site reaction and developed flu-like symptoms following vaccination with PNEUMOVAX23. The injection site reaction following vaccination with PNEUMOVAX23 was described as redness and swelling at the injection site. The duration of the injection site swelling and flu-like symptoms was unspecified. The patient had contacted physician for medical attention. On an unknown date the patient had recovered from the events. Additional information is not expected.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen) was received from a healthcare professional regarding a 20-year-old female patient with systemic lupus erythematosus, who experienced nasal irritation and nasal dryness. The patient received a dose on 15-Dec-2003. Medical History: The patient's concurrent illness includes systemic lupus erythematosus (not currently receiving medication for Lupus). Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 15-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant Therapy: Concomitant therapy included tetanus and diptheria toxoids (manufacturer unknown) administered on 16-Dec-2003. Event Details: On 15-Dec-2003, subsequent to Flumist administration, the patient experienced nasal irritation (nasal passage irritation), including dryness (nasal dryness). The reported wanted to know if the patient was at risk for any specific complications due to the fact that she has a history of lupus. The patient's rhematologist is upset that FluMist was given to a patient with lupus (medication error). No additional information was available at the time of this report.
pt recv vax 2JUL96 & 3JUL96 exp muscle tightening;clavicle swollen;pt to hosp-MD in ER stated was rxn to vax;neck & rt shoulder swollen worse w/any movement of arm;pain swelling rt side of neck;joint pain;sl indurated;
Redness, swelling, and itching. On the morning of 8-14-14, the swelling increased. The child did not complain of pain. Treated with anti-itch cream. On the afternoon of 8-15-14, the swelling continued to increase and the area became "hot to the touch." Child was taken to a nurse practitioner who diagnosed cellulitis. Keflex 500mg, three times daily, 7 days prescribed.
Itchy, Red Rash forming in a circle shape the size of an egg just below the injection site on the left arm. The rash is a different temperature than the rest of the surrounding skin and breaks into hives only when I itch it. No treatments have been attempted, but pharmacy recommended Anti-histamine or cortisol cream.
Pt at PCP for WCC 5yr. Pt was given MMR in right upper thigh & VARIVAX in left upper thigh. Shortly after pt developed sneezing and blotchy red spots on face and vomiting with watery eyes. Rash then spread across whole body. Pt did have episode of unresponsiveness that lasted 5-10 seconds. Vitals once checked were stable, oxygen 98% nml temp and BP. Pt transported to hosp for tx of allergic reaction.
Information has been received from a licensed practical nurse, for the Pregnancy Registry for GARDASIL concerning a 25 year old female with a history of dysplasia and loop electrosurgical excision procedure (LEEP performed in 2003) and no drug reactions and allergies who on 01-MAR-2007 was vaccinated with GARDASIL (lot number 656049/0187U) 0.5 ml IM.  Concomitant therapy included NUVARING and LEXAPRO.  The nurse reported that on 13-JUN-2007 the patient was vaccinated with another dose of GARDASIL (Lot number 657737/0522U) 0.5 mL IM.  Medical attention was sought.  On 13-JUN-2007 a beta-human chorionic gonadotropin test (unspecified) was performed and the results were positive for pregnancy.  No symptoms have been reported.  No further information is available.  The date of the last menstrual period is 17-MAY-2007.  The estimated date of delivery is 21-Feb-2008.  Follow-up information was received via telephone from a licensed practical nurse.  The patient had an early spontaneous miscarriage at 6+ weeks EGA.  Additionally it was reported that the patient had been using the NUVARING when the patient conceived.  Upon internal review spontaneous abortion was considered to be an other medical event.  Additional information is not expected.
From initial information received on 07/20/2004 from a registered nurse regarding an adverse event occurring in the USA, it was reported that four patients, ages 15 months and two years (gender unknown) received a DAPTACEL vaccination, lot number C1697AA, administered intramuscularly in the deltoid on an unknown date. An unspecified time later patients developed a large, red, and swollen area on the deltoid and were diagnosed with cellulitis. It was reported that the patients recovered from this event. From additional information received on 08/27/2004 from the initial reporter, additional patient, vaccine, and adverse event information were provided. This patient was a a five year old male, who on 07/14/2004 was vaccinated with his fifth dose of DAPTACEL, given intramuscularly in the deltoid (side not reported and previously reported 4th dose), a fourth dose of IPOL, lot number X0553, administered sub sq in the left arm, a first dose of Hepatitis A  vaccine, lot number 0292P, manufactured by MERCK, administered intramuscularly in the right deltoid, and a second dose of MMR, lot number 0823N, manufactured by MERCK, and administered subq in the left arm. Two days later, on 07/16/2004,  the patinet developed cellulitis on his right upper arm extending from his shoulder to his elbow accompanied with warmth, tenderness, and erythema. The patient was treated with Keflex for 10 days and recovered from this event. No further information is anticipated, this case is considered closed.
This spontaneous report as received from a medical lab technician refers to a "31 or 32" year old female patient. In approximately 2011 (reported as 3 years ago), the patient was vaccinated with series doses of hepatitis b vaccine (manufacturer unspecified and RECOMBIVAX HB could not be ruled out) (lot #, dose and route not reported) and had negative hepatitis B titers. The patient went to school and was tested for hepatitis B titers that were found to be negative on an unspecified date. No treatment was given for adverse event. The patient sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Immed stinging down arm; in PM: muscular aches into neck & painful clavicle; in AM large red area over inject site & redness extending under arm; pain in elbow & down to wrist; 7OCT tenderness over site; pink site & pink areas to underarm;
Pt vaccinated w/OPV/MMR developed fever of 103, c/o of feeling achey in extremities. Given Tylenol 6AM.
pt brought to hospital; in hypoxic respiratory failure; found to be positive for COVID; admitted to ICU; high flow O2; ABX, dexamethasone and remdesivir given; pt's condition worsened; status changed to DNR/DNI; transitioned to comfort care and passed away in the hospital
Initial report was received 25 August and 26 August 2011 via a distributor (HSI item number 546-7789; Control # 41209), who received the report from a physician. The event for the other patient was capture in case number 2011-10008. A cluster of two unidentified patients had received an injection of ADACEL, lot number C3935AA (route, site and dates of administration not reported) and on 23 August 2011, both patients developed a 1/2 cm high raised red bump at the injection site. The events required a doctor's visit. Outcome was unknown. No additional information was provided at the time of the report. Follow-up information was received from a healthcare professional on 17 October 2-11. An 11-year-old male patient had received an injection of ADACEL in left deltoid on 22 August 2011. No further information was available at the time of the report. The patient outcome was reported as recovered/resolved. Documents held by sender: None.
Experiencing intermittent mild burning and tingling in hands, feet, and forearms which is consistent with small fiber neuropathy, a clinically documented pre existing condition that I suffer from.  However, the  new symptoms have excabertared directly following my dose.
Headache; body temperature at 99.9F; Whole body feels really hot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Whole body feels really hot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included METFORMIN for Diabetes, LOSARTAN for Hypertension.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 29-Dec-2020, the patient experienced FEELING HOT (Whole body feels really hot). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Whole body feels really hot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Body temperature: 99.9 °F 99.9.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-051429 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Mar-2021: The event outcomes, patient's medical history and treatment information were updated.
This spontaneous report was received from a healthcare worker 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 an improperly stored dose of VARIVAX lot # M042858, expiration date 21-OCT-2018 (dose and route of administration were not reported). Concomitant therapies included properly stored sterile diluent (manufacturer unknown), which was used to reconstitute the vaccine. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursions of: -14 to -10 degrees Celsius for 3 hours and 45 minutes; -9 to 8 degrees Celsius for 3 hours and 30 minutes. There were no previous temperature excursions reported. Data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008347:
arm hurts it's sore; Initial information received on 03-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves unknown age and gender patient who had non serious event "arm hurts it's sore" (pain in extremity), after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s), concomitant medication(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 not reported) via unknown route in an unknown administration site for prophylactic vaccination  On an unknown date the patient developed a non-serious arm hurts it's sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "My arm hurts it's sore."  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information on the batch number for this case.
Began 06/25/2021 that night of my vaccine, I began getting very tired, had a bad headache, chills, and pain all over, bones and skin. The next day my tonsils swollen. I went to my dr. 06/29/2021 and tested for strep, and it was negative. It was treated like a bacteria infection and prescribed a Z-Pac.
Client was vaccinated and notified staff that he felt lightheaded and had a metallic taste in his mouth. He reported only eating a piece of toast today. He was transported to sit on the floor and given juice for lightheadedness. Client reported that he has a history of DM and HTN and had not taken meds today. At 0955, BP was 200/140, O2 99%, & HR 85. 1000: BP 220/112, HR 80, O2 98%. 1010 BP 200/124, O2 99%, and reported an increased headache and still had a metallic taste in his mouth. He was breathing comfortably. 1015: EMS was called. 1025: EMS arrived, BG 333 and client was transported to sitting up and still lightheaded. Client agreed to be transported to Fairview Ridges, where he's been in the past.
Nausea, feeling cold, perspiring, hot, weak, didn't feel like to do anything.
DIME SIZE LUMP AT SITE OF INJECTION. REMAINS UNCHANGED, NON-TENDER TO TOUCH. NO SWELLINGS NOTED JUST THAT LUMP TO THE LEFT VASTUS LATERALIS
Intractable headache, 3 1/2 days (unsuccessfully treated with acetaminophen, ibuprofen; dark & quiet room, heating pad); hot & cold flashes, 2 days; nausea, 3 days ( successfully treated with zofran); body aches, 3 days; moderate - severe fatigue, 3 days
Increased shortness of breath, joint pain, increase in number of headaches, my right facial nerve is in pain constantly when it usually only when I have a migraine. When I blow my nose, there is blood clots. I have a rash to my back and abdomen.