chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning at injection site; Mild itch, rash/hives on fingers &palms.; Mild itch, rash/hives on fingers &palms.; Mild itch, rash/hives on fingers &palms/Continued sporadic rash/hives on hands, feet & ankles lasted thru 04/17/21. 04/24/21: Return of sporadic rash/hives on hands, feet &ankles lasted thru 04/28/21.; Later at home had mild widespread itching & slight left arm soreness.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 13Apr2021 09:00 (at the age of 66-year-old) as single dose for COVID-19 immunisation. Medical history included Ovarian cancer survivor, allergic asthma (not chronic). Concomitant medication(s) included losartan; rosuvastatin; timolol; latanoprost; chymotrypsin, trypsin (ALPH-INTERN), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 23Mar2021 09:30 (at the age of 66-year-old) as single dose for COVID-19 immunization and experienced mild widespread itching & slight left arm soreness and developed itchy rash behind right knee 42 hours later, which was confirmed as a delayed rash reaction. The patient previously took Shingrix vaccine for immunization, Sulfa drugs and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received second dose on 13Apr2021 09:00 and waited near EMTs for 30 min after 2nd dose. The patient had mild reactions began shortly after 2nd dose: Burning at injection site. Mild itch, rash/hives on fingers & palms. Later at home had mild widespread itching & slight left arm soreness. Continued sporadic rash/hives on hands, feet & ankles lasted thru 17Apr2021. From 24Apr2021: Return of sporadic rash/hives on hands, feet &ankles lasted thru 28Apr2021. The patient did not receive any treatment for the events. Outcome of events itch, rash, hives was recovered on 28Apr2021; Burning at injection site, slight left arm soreness was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
12/29/2020 Moderna Covid vaccine Lot # 025J20-2A 1/26/2021 Moderna Covid vaccine Lot #030L20-A 3/24/2021 Exposure to Covid from son 3/27/2021 became ill 4/5 tested positive for Covid with PCR test 4/14 Potential to return to work
10/10 left lateral hip cutaneous burning sensation that radiated to the inguinal region in a dermatomal distribution.
shingles; Information has been received from a lawyer concerning a case in litigation and refers to a patient of an unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. In 2015, the patient was inoculated with zoster vaccine live(ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) as prescribed and/or administered by a healthcare provider at the medical office for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient  was treated by a healthcare provider at the medical office for shingles. As a direct and proximate result of Plaintiffs use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient has and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was unknown. The causality was related.
Patient presented to the office for her Moderna booster vaccine (0.25 mL). It was brought to the attention of the vaccine manager, that the efficacy of the vaccines being administered that morning was diminished due to the length of time that the vaccine vial had been open for. The vial had been open for 24 hours at that point in time. The patient stayed under standard observation for 15 minutes and exhibited no ill effects.
This spontaneous report as received from a registered nurse refers to a 12 year old male patient. The concurrent condition, medical history and concomitant medication was unknown. On 16-MAR-2016, the patient was vaccinated with GARDASIL 9 (route, dose, frequency and lot details unavailable). On 17-MAY-2016, the patient received GARDASIL as the second dose (interchange of vaccine products and wrong drug administered). No adverse events was reported. Additional information has been requested.
Felt lightheaded upon standing and stated " my body felt whooshy "; HR-52-- baseline and remained alert and oriented x3; Benadryl 25 mg given --observed patient for 30 minutes; ambulated patient and she stated she felt fine--funny feeling gone
Patient reported a sore upper arm, with itchy warm rash. A fever of 103 degrees F, with confusion and falling. Stated these progressed over a couple days and went to E.R. where they admitted him to inpatient for two nights and treated him for cellulitis. A culture came back inconclusive but the patient's condition improved with care including antibiotics.
Severe Chills following day, 2/03/21.  On 2/07/21 started feeling fatigues and running a low grade temperature.  Treated with tylenol.  On February 12 city was shut down for a week due to winter storm and loss of power in the city.  Medical help was not available until 02/23 had telephone conference call.  Advised to wait and see if symptoms subsided.  On 2/28 face to face visit, testing was done and results received on 3/5.  Nothing significant noted so Primary Care Referred to Nephrologist who ordered Blood Culture  test.   Patient tested positive for Endocarditis and was immediately hospilized.
I had a mild fever, body aches, chills  and exhaustion for almost 4 days.  I was barely able to conduct my daily routines.
He is here with C/O night sweats. He thinks he is having an adverse reaction to the flu shot. He states after the injection, he felt like he had a LGT. This lasted for 2-3 days. He received the injection Dec 16th. Then he has started having night sweats. Sts his sheets were wet and pillow. This occurred Q HS. Then he started using a lighter blanket then immediately was better. He used the heavy blanket last night and had the night sweats again. He states he has had night sweats on and off his entire life. Denies cough and no weight loss. Appetite good, performing athletically at a high level. He one year ago had his colonoscopy. Allopurinol 300mg qd and no further gout episodes. Takes VIAGRA 25mg 1-2 po prn and it works well.
Fever; chills; headache; body aches; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 01Apr2021(at the age of 72-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma and hypertension. The patient did not have allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 11Mar2021 at 12:45 as a single dose for COVID-19 immunisation.  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 four weeks prior to the vaccination. On 02Apr2021 at 01:00  the patient experienced fever, chills, headache and  body aches. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever, chills, headache and body aches were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling and numbness to all four limbs began within 5 minutes of vaccination, after 30 minutes of being monitored of most of the tingling went away except for her feet which she felt warmer then usual.
Mother came to Health Department reporting temp of 104.  Mother talked with physician's office by phone while in Health Department.
BP prior to vaccination 140/80:                                 on 03/01/2021 - 180/90,                                 on 03/08/2021 - 230/130 - went to the ER for workup  ocular pressure prior to the vaccination 14-18:                                 on 03/05/2021 pressure was 24, ocular CT done and 1 month FU
after patient received shot she was sitting in waiting area and within 5 minutes started fanning herself. I went to check on her and she said she was hot and started to close her eyes. I helped her to lay down and had technician get her a wet rag. Once she said she was ok we moved her out of the main aisle and let her lay with cold compress until she was feeling ok and her mother came to make sure she was ok.
Information has been received from a physician concerning a female in her 40's who on 25-OCT-2007 was vaccinated with PNEUMOVAX 23 single dose. On an unspecified date "last week" the patient experienced fever, myalgia and redness at injection site. Medical attention was sought via telephone conversation. At the time of reporting it was unknown if the patient had recovered. Additional information has been requested. This is one of two reports from the same source.
Significant itching, minor pain, and slightly raised redness (approx. 2 inch square area) at injection site, minor body aches.
This spontaneous report was received from a nurse refers to a 16 year old patient of unknown gender. Information on the patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date approximately in 2013 (reported as 'at the age of 11'), the patient was vaccinated with 2 doses of GARDASIL injection (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis. On 16-AUG-2017, the patient was vaccinated with 1 dose of GARDASIL 9 injection (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis (interchange of vaccine products). On 28-FEB-2018, the patient was vaccinated with a second dose of GARDASIL 9 injection (strength, dose and route of administration were not reported) (lot# N021732 and expiration date: 01-FEB-2020) for prophylaxis. No adverse effects were reported. No further information was available. There was no product quality complaint (PQC) reported.
SWOLLEN LEFT LEG, NO PAIN, NOTHING ELSE JUST BIG, REAL TIGHT, FELLS HARD, NOT HOT TO TOUCH; This spontaneous report received from a patient concerned a 76 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204azia, and expiry: UNKNOWN) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swollen left leg, no pain, nothing else just big, real tight, fells hard, not hot to touch. The action taken with covid-19 vaccine  was not applicable. The outcome of swollen left leg, no pain, nothing else just big, real tight, fells hard, not hot to touch was not reported. This report was non-serious.
pt recvd vax for prophylaxis; 1 hr later, exp fever, mottled skin, & was lethargic; resolved
Patient experienced parasthesia to hands, face, and lower extremities (Left leg and foot). MD evaluation suggested that employee had a reaction to flu shot. Prescribed steroid (liquid) 2 tablespoons x 2 days
I had a small stroke. I began to have blurred vision, pain in back, numbness in fingers and very High Blood pressure. I called 911. Once, I got to ER and test were ran, I was told by doctor that I had a stroke due to AFIB but had never had heart issues before vaccine.
Subsequent to receiving the second dose of Engerix B the pt fainted. An ER or doctor visit was required and unspecified treatment was given. The most recent information received reports the outcome of the event as resolved.
02/26/08 Administered Hep. A and Hep. B Child then went to front lobby to wait for his brother to get his immunizations and office staff paged for nurses to come to the front lobby. Upon staff's arrival chlid laying on floor on his stomach. Another client setting in lobby stated this boy was setting in chair and slid out hitting his head on the floor. Rolled client over he was pale, alert and responding to questions by nodding his head. Gave client a sucker and a bottle of orange pop and cool cloth to head. He then began feeling much better talking, setting up and alert. Mother at childs side, assuring child that he was o.k. and that he must have gotten that fear of shots from her because she had done the same thing her self before. 2/27/08 Called child parent to check on child, mother stated child had a bruise a small scratch to underneath side of rt. eye and is feeling o.k. and denies any further problems.
I was 9 weeks pregnant at the time of the 1st dose Pfizer COVID-19 vaccine. My symptoms began approx 12 hours after the shot. I had fever of 101 and felt generalized weakness and debility throughout the following 12 hours. Symptoms also accompanied by headache and body aches and loss of appetite. Sequential headaches x1 week following the vaccine.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 18 months old. The patient demographics were updated. On 04-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Severe (L) arm pain, unable to raise arm, 2 full days, plus partially unable to raise 3 days.
"Felt tired and a cold developing. Went away around 7pm the same day, 1/27/2021"
pt recvd vax; 2 hrs later screaming began all day (>8 hrs); seen in ofc; nl exam;consolable by mom at times; fever devel overnoc 102; still somewhat whiney this am;
C/o pain that started in L wrist and did not radiate. Local L wrist pain.
Pt recvd 1st dose of vax 31JUL92 & 2 1/2 hrs p/felt nauseated & felt light-headed & terrible; lost consciousness for 5 mins; frightened, SOB, diaphoretic, dizzy, medicinal taste in mouth, low fever, & h/a;
TIRED; FEVER; 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tired, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20211004362.
Patient had injection site reaction: redness, swelling, and large ball on arm. Patient called Pharmacy for a different reason and mentioned adverse reaction. Pharmacy tried to contact patient for more information, but the patient was not reached.
Heat sensitivity; Nose bleeds in dry heat; Sore arm at injection site with Humira; This spontaneous case was reported by a consumer and describes the occurrence of TEMPERATURE INTOLERANCE (Heat sensitivity), EPISTAXIS (Nose bleeds in dry heat) and INJECTION SITE PAIN (Sore arm at injection site with Humira) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced TEMPERATURE INTOLERANCE (Heat sensitivity), EPISTAXIS (Nose bleeds in dry heat) and INJECTION SITE PAIN (Sore arm at injection site with Humira). At the time of the report, TEMPERATURE INTOLERANCE (Heat sensitivity) and INJECTION SITE PAIN (Sore arm at injection site with Humira) outcome was unknown and EPISTAXIS (Nose bleeds in dry heat) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event of nose bleeds in dry heat with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of sore arm at injection site and nose bleeds in dry heat was not provided. Treatment medications were not reported.
Swollen elbow; Numbness and Tingling to left side of the face; weakness in L) arm more than R) arm; Muscle pain in elbow; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22-Feb-2021 and second dose administered on 25-Apr-2021), MUSCULAR WEAKNESS (weakness in L) arm more than R) arm), MYALGIA (Muscle pain in elbow), JOINT SWELLING (Swollen elbow) and HYPOAESTHESIA (Numbness and Tingling to left side of the face) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Cholesterol, Thyroid hormone replacement therapy and Hypertension. Concomitant products included ROSUVASTATIN CALCIUM for Cholesterol, HYDROCHLOROTHIAZIDE and LOSARTAN POTASSIUM for Hypertension, LEVOTHYROXINE for Thyroid hormone replacement therapy.   On 22-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22-Feb-2021 and second dose administered on 25-Apr-2021), MUSCULAR WEAKNESS (weakness in L) arm more than R) arm) and MYALGIA (Muscle pain in elbow). 25-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness and Tingling to left side of the face). On an unknown date, the patient experienced JOINT SWELLING (Swollen elbow) and ARTHRALGIA (Pain in left elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22-Feb-2021 and second dose administered on 25-Apr-2021) had resolved. On 05-Apr-2021, HYPOAESTHESIA (Numbness and Tingling to left side of the face) had resolved. At the time of the report, MUSCULAR WEAKNESS (weakness in L) arm more than R) arm), MYALGIA (Muscle pain in elbow) and JOINT SWELLING (Swollen elbow) outcome was unknown and ARTHRALGIA (Pain in left elbow) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-Mar-2021, the patient had numbness and tingling in the left side of the face with jaw up to underside of eye. The laboratory tests were done after first COVID vaccine shot.   On an unknown date, after weeks of first vaccination, the patient had pain in left elbow.   On 22-JUn-2021, the patient had an appointment with the physician.   This case was linked to MOD-2021-025820 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information was received on 13-Jul-2021: additional suspect product details with facility details, concomitant medications were added and additional event details were added.