chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tightness at the injection site; Red rash at the injection site is spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Tightness at the injection site) and VACCINATION SITE RASH (Red rash at the injection site is spreading) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Tightness at the injection site) and VACCINATION SITE RASH (Red rash at the injection site is spreading). At the time of the report, VACCINATION SITE INDURATION (Tightness at the injection site) and VACCINATION SITE RASH (Red rash at the injection site is spreading) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported Treatment medications were not provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: The additional information contains: New event updated On 22-Jun-2021: Follow up received on 22-JUN-21 contains TCR : AE outcome as recovered. The patient informed  he was fine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
bone pain; Joint pain; muscles pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), ARTHRALGIA (Joint pain), MYALGIA (muscles pain) and HEADACHE (headache  ) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-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 BONE PAIN (bone pain), ARTHRALGIA (Joint pain), MYALGIA (muscles pain) and HEADACHE (headache  ). At the time of the report, BONE PAIN (bone pain), ARTHRALGIA (Joint pain), MYALGIA (muscles pain) and HEADACHE (headache  ) outcome was unknown.
my menses are now 20 days apart. thanks a lot pfizer; my menses are now 20 days apart. thanks a lot pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Aug2021 (Lot number: FA6780) at the age of 30 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious), outcome "not recovered" and all described as "my menses are now 20 days apart. thanks a lot pfizer". Therapeutic measures were not taken as a result of menstruation irregular, menstrual disorder.  Additional information: Other medical history was reported as no. The patient had no known allergies. Patient did not receive any other vaccine in four weeks and not received any other medications in two weeks. COVID prior vaccination and COVID tested post vaccination was reported as no. Adverse event start date: 29Jul2021. Adverse event did not result in Emergency room or physician office visit.   No follow-up attempts are possible. No further information is expected.
Heart Palpitations. No treatment. Had a heart monitor for 14 days. Sleep apnea test scheduled for September 16th. Was told to reduce caffeine, which I've done and still have palpitations.
CLIENT HAD ITCHING, NO HIVES VISIBLE AND NO AIRWAY PROBLEMS. CLIENT GIVEN BENADRYL 50MG THAT RESOLVED ITCHING. SHE TOOK AT SECOND DOSE AT 2100 LATER THAT NIGHT FOR ITCHING AND HAD RESOLVED COMPLETELY THE DAY AFTER.
Breakthrough case admission after third dose. Pfizer 3/1/21 Lot# EN6207 Pfizer 4/1/21 Lot# ER8732 Pfizer 10/6/21 Lot# 301308A
Headache, Myalgia & Fever Narrative:  Fever, body ache, chills, fatigue, headache, sore throat
I did not feel well the day after the shot, on that Thursday I experienced fatigue, coughing, and shortness of breath. Come Friday, the 30th I became winded anytime I took more than a few steps. I started intensely coughing, muscle aches, fatigue, low fever, chest congestion, and shortness of breath to the point where going down a flight of stairs caused dizziness and took several minutes. I  wrote this off as vaccine side effects and was convinced to go to a friend's small wedding celebration that Saturday. Again, intense shortness of breath, coughing, and fatigue. A nurse friend was there and after an hour, where I couldn't stand up for more than 5 or so minutes at a time, suspected a covid infection. I was tested twice, may 4th and may 7th, negative both times. All 5 people I exposed all got tested the next day (may 2nd/3rd) and tested negative. By may 7th/8th my symptoms resolved generally, but the shortness of breath lingered for another week or two.
Patient received Moderna vaccine instead of Pfizer by nursing student at vaccine clinic. Once this was made aware to this nurse, this nurse notified coordinating nurse. This nurse called patient mother to advise, message left requesting callback. Nurse received call from patient, nurse requested patient parent phone number, patient provided. Nurse attempted phone call to patient parent x2. No answer. Message left requesting callback to nurse. Patient called this nurse back. Nurse requested to have mother call this nurse. Mother called patient back 03/10/2021. Nurse advised that Moderna was given, 2nd dose should be Pfizer.
Hypokalemia; Hypomagnesemia; Other ascites; Pneumonia due to COVID-19 virus
Approximately 2 months after first dose I began experiencing frequent migraines. I was having 15-18 migraines per month with a duration of  12-72 hours. Was prescribed sumatriptan for migraines which helped resolve migraines but did nothing to prevent. Was referred to neurologist. Neurologist had me try several herbal remedies and supplements with no help. Was placed on prescription med that didn't help. Was then started on Emgality  every 28 days. I still experience migraines but they are fewer, farther between and less intense.  Was having mild fibromyalgia symptoms prior to vaccine (undiagnosed at the time ). After receiving the vaccine I noticed symptoms of fibromyalgia worsening. Saw PCP for OMT appointments with little effect. Did Physical therapy with minimal improvement.  Was also diagnosed with Bladder Pain Syndrome after vaccine.
Local reaction @ injection site (LA). Obtained verbal consent via telephone for BENADRYL from child's father. BENADRYL 12.5 mg PO given x 1 dose @ 10:55. Child observed until 11:10 am. Redness decreased. No other signs or symptoms seen. Child allowed to return to classroom.
tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026A21A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, SIMVASTATIN and VENLAFAXINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Feb-2021, the patient experienced FATIGUE (tiredness). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, FATIGUE (tiredness) had not resolved. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-078051 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078051:
Dizziness, fatigue, difficulty breathing 24 hours after administration. Now having recurrent episodes of dizziness and shortness of breath daily in last 5 days since vaccines.
Information has been received from a health professional concerning an under 26 year old female patient who was vaccinated with the first dose of GARDASIL vaccine (yeast) initially at another facility, but when she went into the physician's office for the second dose of GARDASIL vaccine, the reporter detected an abnormal PAP at this annual visit. This is one of two cases reported from the same source. Additional information has been requested.
Approximately 5 minutes after receiving the vaccine the patient was calm, standing up, and suddenly lost consciousness and fell forward. Was unresponsive for up to 1 minute afterward with eyes open and staring, blue color around lips, arms bent and stiff, not crying. Recovered spontaneously and started crying. Event occurred before leaving the office.
Severe back pain and left sided sciatica. Symptoms start 24-ish hours after vaccine. No trauma or prior back conditions. Treated with two courses of steroids, gabapentin, and naproxen without relief. Pending neurosurgical evaluation. Patient had severe back pain for 2-3 days when he had COVID-19 back in December.
10/29/10 - Administered flu shot, & pt went to Hosp emerg room bec of red, swollen lt up arm (site of injection) on 10/31/10. Pt is pregnant, EDC -02/19/11. Pt was given KEFLEX & discharged.
Patient immediately turned blue and apneic; then very pale with poor capillary filling. Treated with oxygen as oxygen saturation 88-92%. Admitted to hospital. Discharge summary state hypotonic-hyporesponsive episode, stupor, cardiovascular disease. msv
Info has been received from a health professional concerning a 7 year old (previously reported as 4 year old) white male with no allergies or medical conditions who on 4/4/02, was vaccinated SC, in the left deltoid with a 0.5ml 1st dose of varicella virus vaccine live. There were no concomitant medications and no illness at the time of vaccination. On 4/7/05, the pt experienced breakthrough chickenpox. No labs or diagnostic tests were performed. Unspecified medical attention was sought. No product quality complaint was involved. No other info was available at this time. Follow-up info indicated that the pt recovered in April 2005, 2 weeks later. The pt's sibling (WAES0507USA02233) also developed breakthrough chickenpox after vaccination with varicella virus vaccine live. Additional info is not expected.
mouth cold sores; This is a spontaneous report from a contactable pharmacist reported different events under the same suspect product for 10 patients via Medical information team. This is 1st report. A female patient (reporter's sister) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as unknown single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had 2 outbreaks of mouth cold sores. The outcome for the events was unknown.  Information about batch/Lot number has been requested.
This spontaneous report as received from a registered pharmacist refers to an adult patient of unknown age. The patient was vaccinated with dose 1, dose 2 and dose 3 of RECOMBIVAX HB (lot #, dose and route not reported) on 23-SEP-2012, 23-OCT-2012 and 24-NOV-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
swallowing alot that evening; t100-102 for 1 1/2 days beginning the 9th day p/vax; isolated papules on both thighs & trunk appeared 10SEP93 lasting 3 days;
Pain in left arm that runs from forearm to fingers, loss of strength in left arm, inability to lift more than 3 lbs with left arm, sporadic pain and cramping in left hand and difficulty straightening hand and fingers, inability to sleep on my stomach without left arm going completely numb
A non-serious spontaneous report of hives, intermittent rash, and hips and shins hurting has been received from a physician in the USA concerning a three year old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  The patient had no known allergies and no relevant medical history.  There was no concomitant medication.  On 03-Sep-2008, The patient received FLUMIST, intranasal administration for flu immunization at approximately 11:00am.  The patient received no prior doses.   Approximately eight hours after FLUMIST administration on 03 Sep 2008,  the patient developed an intermittent rash and hives were on that "broke out" 5 times throughout that night and would come and go.  The rash and hives were on the patient's face, abdomen, and back, not on her arms or legs.  The hives were described as raised lesions the size of mosquito bites with pale centers and they itched.  The patient had no swelling, no trouble breathing, and no other symptoms.  She was treated with oral BENADRYL and seen in the office on 04-Sep-2008.  The rash and hives had improved.  The patient's mother called the physician's office on 10-Sep-2008 and reported she had stopped BENADRYL because the rash and hives went away but they subsequently came back.  She also reported the patient's hips and shins were hurting on 09-Sep-2008 but that stopped the following day.  The physician told the patient's mother  to continue oral BENADRYL because the hives could last up to 3 weeks and start TYLENOL for discomfort.  The patient recovered from the hips and shins hurting and as of the last phone call from the patient's mother to the physician on 10-Sep-2008.   The hives and intermittent rash were ongoing.  Additional information was received on 19-Sep-2008 and incorporated into the above narrative which included reporter information, vaccine information, additional events, and event outcomes.
I started to get bad chills about 7 hours post vaccination. My arm had been sore for several hours but I was shaking so much I couldn't move. I had a fever as well and was very cold despite being in a warm room. I couldn't sleep, and then the next morning I was extremely nauseous and almost threw up. I lost my appetite for the rest of the day and was so tired and weak I couldn't move from my bed. I continued to have a high temperature that morning and afternoon, and it started to go back down that night. Overall my temperature, nausea, inappetance, and sore arm lasted a little over a day.
I was 7 and half weeks pregnant when I received the second covid vaccine, then a week later, I began to have vaginal bleeding. 5 days after bleeding began, I miscarried while at home, passing a lot of tissue and lost a lot of blood, had to go the ER, had a syncopal episode due to blood loss and had to have an emergency D & C.
I was contacted to invite me to have a 3rd Pfizer COVID shot and the annual flu shot.  I am designated as immunocompromised due to MZL treatment and CLL diagnosis.  I received the vaccines in my right shoulder (different sites). Friday morning I developed a rash on my right bicep extending from the shoulder to my elbow.  The area became red, slightly swollen, itchy, and warm to the touch.  (No fever).  It was uncomfortable over the weekend but eased off by Monday evening.  Because the injections were in the same arm, I can?t discern if one or the other of the vaccines caused the effect or if it was a combination.  Perhaps I should have had the shots in opposite arms.  The flu shot was described to me as the ?strong? version.   I am reporting this because the directions are to notify the care provider of adverse reaction.
Pt reports that just over two hours after vaccination, he had about 4-5 hives show up on his right forearm. They were slightly itchy. After about 24 hours post vaccination, the hives he reports decreased to half their original size. He did take one dose of Benadryl, but did not require any further medical treatment.
abnormal uterine bleeding, severe mood swings, decreased appetite, nausea, food intolerance, polydipsia
was hot to the touch for five days; he got dizzy and weak after the shot; he got dizzy and weak after the shot; red rash on the side of arm; the second one was big red / second one was worst than the first and the second one was big red.; got covid arm; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and FEELING HOT (was hot to the touch for five days) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (was hot to the touch for five days). In March 2021, the patient experienced ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and DIZZINESS (he got dizzy and weak after the shot). On 18-Mar-2021, FEELING HOT (was hot to the touch for five days) had resolved. At the time of the report, ASTHENIA (he got dizzy and weak after the shot), RASH ERYTHEMATOUS (red rash on the side of arm), ERYTHEMA (the second one was big red / second one was worst than the first and the second one was big red.), VACCINATION SITE REACTION (got covid arm) and DIZZINESS (he got dizzy and weak after the shot) outcome was unknown.            No treatment medication was provided.   This case was linked to MOD-2021-410051 (Patient Link).
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 08-APR-2016, the patient was vaccinated with an expired dose of VARIVAX *which had the lot number of K002045, expiration date 10-FEB-2016) (strength, dose and route were not provided). Concomitant medication was not reported. It was also reported that no adverse effects were reported and there was not product quality complaint involved. Additional information has been requested.
Patient has adverse reaction" seizure "like response. She was awake but not reacting when question was asked. She vomited and she said she was filling better afterwards. 911 was called and she was taken to the hospital. This was her second shot and she had no reaction with first one.
Received the vaccine 2 weeks ago and came down with COVID; Received the vaccine 2 weeks ago and came down with COVID; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unknown date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine 2 weeks ago, unknown date in 2020 and came down with COVID on an unknown date. The outcome of the event was recovered on an unspecified date.    Information on Lot/Batch number has been requested; Sender's Comments: A causal association between reported event and suspect BNT162B2 cannot be excluded.
This is a Healthcare employee working at a facility, divested this center and it is under new management.   Previously on 12/1/2020 PT was diagnosed as COVID-19 positive, remained asymptomatic and returned to work on 12/11/2020.   On 12/28 administered the vaccine at a workplace clinic . 4 days post-immunization on 12/31/2020 PT reported feeling "unwell' to his direct supervisor and was sent home. On 1/4/2021 PT reported to his supervisor that he had gone to the hospital due to having a fever and shortness of breath, he was tested for COVID at that time and was negative. PT returned home.   On 1/13/2021 the center received a call from PT mother reporting that her son had returned to the hospital on the evening of 1/12/2021. Per his mother, PT was attempting to drink from a straw, but was unable to and had noted a facial droop. When he arrived at the hospital he was diagnosed with "suspected Bell's Palsy". Due to the immunization being administered on 12/28/2020 and suspected diagnosis of Bell's Palsy on 1/13/2021 it is unclear if the two events are related.
Injection site muscle soreness, fatigue, palpable tender lymph nodes left axillary region.
(R) thigh 2 cm x 3 cm redness at the site of PROQUAD S/C injection
negative for hepatitis B core antibody; second dose on 7/2/1996, and third dose on 1/6/1997.; her first dose on 4/3/1996, second dose on 7/2/1996; This spontaneous report has been received from a registered nurse concerning a 3-month-old female patient. The concomitant medications, medical history, drug reactions/allergies, and concurrent conditions were unknown.  On 03-APR-1996, the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose, strength, route of administration, anatomical location, lot # and expiration date were unknown) for prophylaxis. On 02-JUL-1996, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # 1404B was evaluated and changed to the valid lot # 614913/1404B, expiration date was unknown but upon internal validation established as 30-JAN-1998; dose, strength, route of administration and anatomical location was unknown) (Inappropriate schedule of product administration). On 06-JAN-1997, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # 1156D was evaluated and changed to the valid lot # 619298/1156D, expiration date was unknown but upon internal validation established as 04-FEB-1999; dose, strength, route of administration and anatomical location was unknown) (Inappropriate schedule of product administration).  The reporter said she thought the immunization documentation may be incorrect, because the patient's first dose appears to have been administered on the day she was born (03-APR-1996). On unknown date, the patient's new hire blood work was negative for hepatitis B core antibody. The patient had sought medical attentions. The treatments were not given to the patient. The outcome of negative for hepatitis B core antibody was not reported.   The causal relationship between negative for hepatitis B core antibody and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.