chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a golf-ball sized ball in arm; This spontaneous report has been received from a consumer in courtesy from Pfizer, referring to a 40 years old (estimated as DOB and AE onset date) female patient. The patient had familial Mediterranean fever (FMF/) but do not present active symptoms (Genetic asymptomatic carrier for Familial Mediterranean Fever) and also frequently suffered from migraines. Also reported that patient's immune system generally reacts strongly to all vaccines. Patient also had ongoing allergy to etodolac (LODINE). Past medical treatment(s) medical treatment(s), vaccination(s) and concomitant was not provided.  In 2019, the patient received a dose of suspect yellow fever vaccine produced by unknown manufacturer, a dose of suspect hepatitis a vaccine (manufacturer unknown), a dose of suspect hepatitis b vaccine (manufacturer unknown) and a dose of suspect measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), all for prophylactic vaccination. Strength, lot number and expiration date for all suspect vaccines were not reported. Route and administration site for all suspect product were unknown.   In 2019, the patient developed a non-serious strong reaction including a golf-ball sized ball in arm (limb mass), in the same year following the vaccinations and on the third Hepatitis A/ Hepatitis B dose. It was unknown if the patient experienced any additional symptoms/events. No laboratory data reported. Steroids as a corrective treatment was received by the patient to bring down the limb mass. At time of reporting, the outcome was unknown for the reported event. There would be no information on the batch number for this case. The causality assessment between all suspect vaccines and the event was not reported.  It was also reported that on 10- MAR-2021 07: 15 AM, the patient, who was 42 years old currently (pregnancy: no), received the most recent coronavirus disease 2019 (COVID-19) (coronavirus disease, two doses) vaccine in Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and also no any other medications was received within 2 weeks of vaccination. Reported event: for both doses: chills for about an hour (began exactly 3 hours after the shot was administered in both doses). First dose had a hangover-type headache the day after the shot. Second dose the hangover-type headache started the same day as the shot and with much greater intensity. It was day 2 and the headache was still present but with less intensity. Some chills in the morning sporadically. Patient thanked and said let's get rid of this COVID pandemic. She did not received treatment for the adverse event, Prior to vaccination, the patient was not diagnosed with COVID- 19 and since the vaccination, she had not been tested for COVID-19; Vaccine facility information available. Ethnicity information was available. Race information was available (race also reported as unknown).
This spontaneous report has been received from a Nurse Practitioner via Company Representative who was referring to her sister, a female patient of unknown age. Information on medical history, drug reactions or allergies not provided. On an unknown date the patient was vaccinated with ZOSTAVAX (lot number, expiry date, dose, route, dosage not reported). It was reported that Nurse Practitioner's sister received ZOSTAVAX and then developed a rash described as shingles (dates not provided). The outcome of rash described as shingles was unknown. It was unknown if the patient sought medical attention. The relatedness was not assessed by the reporter. Additional information has been requested.
blistering hives/rash; Left side severe back, flank and rib pain; blistering hives/rash; blistering hives/rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Dec2021 11:00 (Lot number: 331308A) at the age of 53 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "Drug allergy", notes: known allergies:  Keflex. The following information was reported: RASH (non-serious), BLISTER (non-serious), URTICARIA (non-serious) all with onset 18Dec2021, outcome "not recovered" and all described as "blistering hives/rash"; PAIN (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Left side severe back, flank and rib pain". Therapeutic measures were not taken as a result of rash, pain, blister, urticaria.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, no information on other medications that the patient received within 2 weeks of vaccination, Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19 Reported Events are Left side severe back, flank and rib pain followed by blistering hives/rash.
Rash on left arm surrounding injection site painful. 24 hours later. Probable Cellulitis, Keflex antibiotic.
Hot flashes (sweating); Cold chills; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on an unspecified date, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient had no known allergies. On 16Jan2021 after receiving the vaccine, the patient experienced hot flashes (sweating), cold chills, joint pain, and fatigue. The symptoms lasted roughly 7 days. No treatment was received for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the events on 23Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
On the day after receiving my 4th dose, I felt extreme fatigue, and had episodes of increased heart rate up to 80-90 BPM (normally in the 60's) with missed beats every 5-10 beats, while going on my usual 4 mile walk. I felt lightheaded, faint, diaphoretic, headachy, and had to sit down several times before I could complete my walk home. These episodes occurred up to 1-2 times a day for the first 2 weeks, and have decreased to 4-5 times a week since then, but I still do not have the same energy level, and often tire mid-day. I had the similar episodes occur sometime after receiving my first 2 doses in February 16, 2021 (Lot 041L20A) and March 16, 2021 (Lot 031A21A), and my 3rd booster dose on November 19, 2021 (Lot 033F21A). My physician ordered an Echocardiogram Stress Test and EKG in December, which were essentially normal, but the frequency of my episodes had decreased to 1-2 a month in December, and I did not experience these symptoms during the tests. It did not occur to me that the episodes might be related to the vaccine until they returned with surprising strength and frequency after my 4th dose of the vaccine on June 6. I will report this to my physician when I see him for my next appointment in September.
As you describe in your literature, my arm was quite sorea and red and could not raise over head for about 2  days. But the most troubling reaction was tat  I literally could not get out of bed for 24 hours, could not  eat, had upset stomach...almost like a severe case of mono. After 24 hours, I started to regain energy, but still fit wiped out and, appetite and ability to eat came back in a couple of days.
Rash, skin eruptions, itching.  Random locations - legs, buttocks, upper back and neck, upper neck into hairline, chest, belly, arms
Late 2nd dose, 1st on 10-SEP-2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th September 2020).   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: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix and was late, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
top of right knee cap stiffening when going from a sitting to a standing position; When stands up, it takes a while to walk off; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (top of right knee cap stiffening when going from a sitting to a standing position) and GAIT DISTURBANCE (When stands up, it takes a while to walk off) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no medical history.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced JOINT STIFFNESS (top of right knee cap stiffening when going from a sitting to a standing position) and GAIT DISTURBANCE (When stands up, it takes a while to walk off). At the time of the report, JOINT STIFFNESS (top of right knee cap stiffening when going from a sitting to a standing position) and GAIT DISTURBANCE (When stands up, it takes a while to walk off) outcome was unknown.            No concomitant medications were reported. No treatments were reported.
Bell's palsy; Information has been received regarding a case in litigation from an attorney reporting on a patient (pt) of unknown age and gender. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  In 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at the office of a physician for the long-term prevention of shingles and/or zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the pt vaccination with zoster vaccine live (ZOSTAVAX), on an unknown date, the pt was treated by the physician for Bell's palsy. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX)vaccine, pt had and would continue 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 would continue to suffer such losses, and damages in the future. The outcome of Bell's palsy was not provided.  Upon internal review, Bell's palsy was considered to be a medically significant event.
no adverse effect other than mildly sore p/the inj was given;on contact w/a rusty nail in sole of foot some 1 1/2mo later no lockjaw developed
Realized after the fact that vaccine had been given using 5/8 subcutaneous needle into deltoid.
Pain in arm where injection given - started about 2 hrs after shot. Fatigue/foginess - started when woke up next day 15 hours after shot. Headache, chills, body ache - started about 17 hours after shot. Feverish started about 24 hrs after.
Potential AE due to doses administered from vials that may have been compromised; Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by a pharmacist and describes the occurrence of IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). At the time of the report, IMMUNISATION REACTION (Potential AE due to doses administered from vials that may have been compromised), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Reporter stated that, they had a group of 13 pharmacies and had administered the Moderna vaccine. Their digital data loggers and freezers expired before they were re-calibrated. They were aware in some of the freezers there was a temperature excursion that their data logs showed. The vaccines never reached a temperature that was considered outside of frozen recommended range. The data loggers had laps where they were not considered calibrated, so they had a paper-logs to monitor those temperatures. This was in several different freezers and the vial temperatures never went out of range when they were using the paper log. The reporter was concerned that the vials have been compromised. Further reporter stated that, vaccines administered at their pharmacies that were stored in an unapproved freezer and thus, might had been compromised.  The beyond use date for vial was reported as 01-Dec-2021 to 15-Dec-2021.  No treatment information was provided.   This case was linked to MOD-2022-513803 (Patient Link).
HLH; joint pain; This spontaneous report was received from a physician via a company representative and refers to a 16-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-SEP-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter, via intramuscular route (injection site, lot # and expiration date were not reported) as cancer prevention. On the same day, she was vaccinated with influenza virus vaccine live (unspecified) (exact dose, injection site, route of administration, lot # and expiration date were not reported). On an unknown date in 2020 (reported as "sometime in the fall"), the patient was vaccinated with meningococcal b vaccine (unspecified) (exact dose, injection site, route of administration, lot # and expiration date were not reported).      On 03-SEP-2020, the patient experienced joint pain and has been diagnosed with haemophagocytic lymphohistiocytosis (HLH). The patient sought medical attention and was under the care of a hematologist. It was unknown if any treatment was given for the events or if any lab diagnostics were performed. The patient has not received any subsequent doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of the events was unknown.  There was no causality assessment provided by the reporter.  Upon internal review, the event of haemophagocytic lymphohistiocytosis was determined to be medically significant.
Case previously recorded as MA2009-6291. Initial case report received via MedCom from a physician on 25 NOV 2009: A 21-month-old male child was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 102129P1) i.m. on 25 NOV 2009. No adverse event was reported. Ref. no.: NA09-008870.
About 15 minutes after the injection. A few of my body parts started to itch  and little blistery pimples appeared. It is day three right now, and I still have this little blustery  itching pimples.
Under arm lymph nodes swollen, breasts swollen and painful, brain fog, headaches, all over body pain, jaw pain, eyesight worse, arthritis pain much worse.  Started about three weeks after second vaccine and continues today
Patient felt diaphoretic, shaky, pre-syncopal, placed in trendelburg position and hydrated.
Pain with foreign body sensation to arm. Fluctuance to injection site with numbness 14 days s/p vaccination. Will R/O abscess.
Patient received at a flu shot clinic at a casino a  flu shot high dose , in such conditions that patient is not 65 years old until December 24th, patient  did not have any side effect from vaccine , but he wrote on consent form 65 years old so pharmacist administered high dose instead of regular flu shot vaccine .
no adverse events. When I enter info in immunization Registry, I notice he got Moderna 1st dose on 1/1/21 and second dose on 1/30/2021 already. He lied that he never got covid vaccine before.
Severe swelling from shoulder down to elbow region. saw 3 days after administration. tender to touch. area of about 15 cm of erythema on left deltoid area
fever 100.6 chills diarrhea x3 days decreased appetite x 3 days brick on chest, resolved after first day weak sinus drainage nausea x 3 days
Migraine Headache, lasted 3 days, severe pain.  Tried Tylenol & Midrin, ice, heat, etc nothing worked.  I am pregnant so I had to wait it out.
"Past Medical History:  Diagnosis Date  ? ADHD, Predominantly Inattentive Type 6/12/2008  ? Asthma 6/12/2008  ? Sesamoiditis 12/27/2018  NKA  Current Medications: ? albuterol (PROAIR HFA) 90 mcg inhaler ProAir HFA 108 (90 Base) MCG/ACT Inhalation Aerosol Solution INHALE 2 PUFFS EVERY 4 HOURS AS NEEDED  7mins post vaccination, pt had a vasovagal/syncopal episode w/ clamy skin,respiratory distress and dizziness. Vitals: @17:17 BP 140/87, HR 80, RR 18, Temp 97.7, O2Sat 100% (supine)-- > @17:22 142/81, 80, 100%-- > @17:35 142/85, 77 Pt speaking in complete sentences.  pt initicaly c/i rapid HR and difficulty breathing but improved rapidly. Pt given juice and water.  Pt states he is symptom free @17:35. @17:49 pt standing symptom free. @17:52 pt stable and released from the vaccination site. NAD.  Recommended f/u w/ healthcare provider, instructions provided."
Info has been received from a physician and a 50 year old female immunization consultant with high cholesterol, arthritis and no allergies who in 1999 and 2000 was vaccinated with 2 doses, respectively, of VARIVAX, 5 to 6 months apart. Concomitant therapy included Celebrex, Synthroid and simvastatin. In 2001, the pt had her thyroid removed due to "cancerous spots". On 3/23/05, the pt developed a rash on her upper left cheek and neck area and behind her ear. She saw a physician on 3/28/05 and was diagnosed with shingles on left T1 dermatome. Valtrex and prednisone were prescribed as treatment. No laboratory or diagnostic studies were performed. It was also reported that the pt never experienced chickenpox as a child and she only experienced "very slight pain". At the time of this report, the physician reported that the pt had recovered. No product quality complaint was involved. The reporter considered her shingles to be an other important medical event: however, the physician did not assess the shingles as to be an other important medical event. Additional info has been requested.
Per TC from pt: sx's began 2-17-09 PM - pain L side only (arm, shoulder, breast). She went to work 2-18 and left early d/t sx's. Co-workers commented that her face was flushed. She has been taking Ibuprofen 2 tabs BID and "feels better" today, however, she continues to c/o L sided neck stiffness - "can't turn my head all the way."  Advised pt to see PCP d/t continued sx's and neck stiffness.  She will c/b 2-20 with f/u.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 29-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K006447, expiry date 16-JUN-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): one lasting for 24 hours, with the highest recorded temperature of 49 degrees Fahrenheit (9.44 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Chest and back burning with elevated blood pressure.  I never had high blood pressure, always low blood pressure.   Burning continued daily does almost 2 weeks and the worst in the evening.  On March 14th at about 8pm the burning was so bad, I was sweating all over and my clothes were soaked.  Blood pressure was high. I almost thought I will die and was needing to go to the hospital.
Right thigh red, warm to touch and swelling. Advised cool compress, Tylenol for pain and Benadryl for itching.
There is new onset, persistent swelling in both hands after vaccine.  This swelling has caused multiple trigger fingers to develop in both hands. There have been three episodes of swelling in both legs and feet that were never experienced prior to vaccine.
Itching injection site; Reddish pink injection site; Pain in her arm; A spontaneous report was received from a consumer concerning an 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events reddish pink injection site/ vaccination site erythema, itching injection site/ vaccination site pruritus, pain in her arm/ pain in extremity.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Feb 2021, approximately one day prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 028L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient experienced the event pain in her arm. On 22 Feb 2021, the patient experienced the events reddish pink injection site, itching injection site.   Treatment details included Ice, Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, the action taken with the drug in response to the events was not applicable. On 21 Feb 2021 the outcome of events pain in her arm was resolved. The outcome of events, reddish pink injection site, itching injection site was unknown.
Left arm has big knot, redness, warm. Took Tylenol Tues after shots and next morning. No fever. Mom reported this by phone.
Vaginal bleeding beginning May 18, 2021. Continued spotting for 2 months.  Dr. ordered transvaginal ultrasound, cervical cancer biopsies and CA125.  Ultrasound showed small fibroid, every other test negative.  No vaginal bleeding since menopause 15 years ago.  Began 6 weeks after second Moderna vaccination on April 2, 2021.  Lot number 012A21A.