chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PAIN IN EXTREMITY (Soreness of the arm). At the time of the report, PAIN IN EXTREMITY (Soreness of the arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Patient received the Pfizer COVID 19 5-11 year old vaccine without dilution prior to administration yesterday 4/21/2022.  Per parent patient had a sore left leg this morning.  She had checked on her at daycare and was told by the daycare teacher she is doing well.
Eyes started itching. On December 20th eyes itched so bad that contacts were not able to be worn. Redness on hands and were itching which began 12/19 but on the 20th bumps and itchiness on elbows. I suffer from eczema and take self injection shots for it so the rash appeared as if my eczema was triggered.
3 DAYS FOLLOWING VACCINATION PATIENT STARTED TO DEVELOP A BLISTERY RASH ALONG HER TRUNK AND UPPER ABDOMEN
Left upper arm red, swollen, and warm to touch. Patient reports soreness into axilla. Advised by Dr. to use ice and Benadryl.
Patient said her breathing was more difficult than normal with suffering from COPD.  Advised patient that if it worsened to go to the emergency room and if the condition was manageable to call her PCP
pt recv vax 16JAN95 & c/o ear pressure; saw ENT 26JAN95 Cereminex given to get wax out but didn't work; AA-HC prescribed; pt began feeling ill & had low grade fever, noc sweats, tired, taking naps (not usual for pt); saw MD 10FEB95 had sz
Breakthrough case admission after 3 vaccines Moderna 01/18/2021 Lot# 012L20A;  Moderna 2/15/21 Lot# 004M20A;  Moderna 11/1/21 Lot# 004F21A
Injection site soreness continuous for the first 72 hours after first vaccination and second vaccination.  One month later,  I am experiencing intermittent soreness at the injection site (non dominant arm for both injections).  Does not inhibit function but sore feeling ebbs and flows and sometimes bicep feels sore.  Just wanted to report it.  No follow up needed
Stabbing acute headache - diagnosed three weeks later as Giant Cell Arteritis and Polymyalgia Rheumatica presently taking prednisone.
Redness and heat around injection site 3 inches in diameter;  Fever, chills about 16 hours after injection, lasted 12 hours
Almost one week post vaccination, I noticed unexplained bruising on the backs of my legs consistent with ITP. I was seen I two urgent cares and was sent for follow up bloodwork. By the time bloodwork came back, all levels were within normal range.
This veteran noticed his arm was reddish discolored at approx. noon today. He has experienced dull pain in area of injection. He had temperature of 100 degrees when seen in employee health at his job.
her arm was a little sore; Initial information received on 20-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to case 2022SA436139(CLUSTER).  This case involves a 67 years old female patient who experienced her arm was a little sore while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On an unknown date the patient developed a non-serious her arm was a little sore (pain in extremity) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event her arm was a little sore.; Sender's Comments:  SAD20221020002754:
pt recv vax & had fever & appeared gray, subdued w/cloudy eyes;this lasts 24-48hr p/vax pt returns to nl;appetite & activity are decreased but not excessively so;no h/a, n, fever abd pain or vomiting;
Taste Buds are off; loss of taste; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0165) via an unspecified route of administration, administered in Arm Right on 28Apr2021 (at the age of 60-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0162) on 06Apr2021 (at the age of 60-year-old) as dose 1, single for covid-19 immunisation. Patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient experienced taste buds are off, loss of taste on 29Apr2021. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
tired for a couple days; This is a spontaneous report from a contactable consumer reporting for the patient. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was tired for a couple days after the vaccine administration.  Information on the lot/batch number has been requested.
C/O body aches, fatigue afternoon after vaccine. Following night had Fever 100.5, body aches. Fever decreased with tylenol.
Flu like symptoms for 3 days, on December 14 at 1040 PM I went into Atrial Fibrillation, it last 1 hour 15 minutes, I had to go to the emergency Room. No treatment given other than monitoring and IV fluids. I saw a Cardiologist, no treatment needed since this was my first episode.
Child started running a fever up to 102.3 after vaccines were administered. The next day Mom noticed hives develop on child's face, back and extremities. The hives resolve within 15 minutes and have randomly reappeared since initial onset. TYLENOL has been used twice for treatment.
12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness; Heart arrhythmia issues slowly subsided; This is a spontaneous report from a contactable consumer (patient).    A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 30Jul2021 11:15 (Lot Number: EW0153) as dose number unknown, single (at 59 years old) for COVID-19 immunisation.  Medical history included hypertension. Concomitant medications included amlodipine; levothyroxine sodium (SYNTHROID); potassium, all taken for an unspecified indication, start and stop date were not reported.  The patient experienced 12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness on 30Jul2021 12:00 PM with outcome of unknown, heart arrhythmia issues slowly subsided on 30Jul2021 12:00 PM with outcome of recovering.   The clinical course was reported as follows: 12 hours later was walking from one room to another and completely collapsed with short period of unconsciousness. ECG indicated multiple events. Went to ER the next day. Admitted to hospital with multiple tests. Heart arrhythmia issues slowly subsided. No treatment required. The patient was hospitalized for the events for 1 days. Prior to vaccination, the patient was not diagnosed with COVID-19.   Follow-up attempts are completed. No further information is expected.
Initially sore arm, swelling of injection site.  Later in day headache, body-aches, joint pain, fever.
VACCINE WAS GIVEN FROM A PUNCTURED VIAL; KEPT AT FRIDGE TEMPERATURE, A FEW DAYS AFTER INITIAL PUNCTURE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine was given from a punctured vial, and kept at fridge temperature, a few days after initial puncture. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was given from a punctured vial and kept at fridge temperature, a few days after initial puncture was not reported. This report was non-serious.
(1) Soreness of (Rt) arm x 1 wk (2) Swelling & redness 2" x 4" x 4 days (3) Enlarged gland under (Rt) arm x 2 days (4) Body aches.
In 5/99 and on 6/28/99, the pt self-administered the first and second left thigh doses of Lymerix using pre-filled syringes.  Six weeks after receiving dose 2, on 8/9/99, the pt experienced a new onset of shooting pains through multiple joints. An MD's visit was required, and she was treated with an unspecified medication. The treating medication masks the pain but does not take it away. She has been to several MD's and no one can come up with any cause other than Lymerix. She went to an infectious disease physician and the Western blot was negative. X-rays taken "recently" showed nothing but "some degenerative changes" but physicians feel that the joint pain is not from this. "They have narrowed it down to Lymerix."  The most recent information received on 3/10/00 reports the condition of the pt as ongoing.
Patient called and complained 1 to 2 days after vaccine his lymph node swelled up to a size a little bigger than a pea on his right neck side - 2 fingers above the collar bone.
Redness, swelling and fever of 102.8F and enlarged at injection site 3" X 2" with extreme pain/sensitivity to arm.
A report has been received from a Health Professional concerning a 66 year old, male patient, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST Quadrivalent started on an unknown date. The reporter stated that patient was 66 y/o and was administered FLUMIST. The outcome of the event of administered FLUMIST by elder age was unknown. The report was considered to be non-serious.
Mother returned 2 days after vaccination was given. Child had severe swelling inflammation of R deltoid.
Arrhythmia, elevated blood pressure, tremors, anxiety, and poor digestion.
pt had a fever not measured & a sz @ home when mom was giving pt a bath w/episode of apnea;tx w/med @ hosp;
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's pertinent medical history and drug allergies were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, strength and route unknown). On an unknown date after receiving ZOSTAVAX the patient was diagnosed with an unspecified cancer diagnosis. Treatment was unspecified chemotherapy and radiation. On an unknown date of 2016 (reported as "recently"), the patient was diagnosed with a case of the shingles. Outcome of the events were unknown. Causality was not provided. Upon internal review, cancer was determined to be medically significant. Additional information has been requested.
I had the usual  arm soreness like any vaccine which completely dissipated after 48 hours.  On day 6 after injection, the injection site began swelling and getting hard. On day 7 the area had grown nearly twice in size, it was harder, red, hot, and I had a fever of 100.6  & headache but all clinics were closed when the fever developed. On day 8, the hardness had moved up to my shoulder, was harder, redder, hotter, headache but I had no fever. The urgent care clinic prescribed amoxicillin and clavulanate potassium tablets (500 mg, 2x/day for 10 days) and OTC antihistamines. On day 9 it was only slightly better. It is still hot, swollen, & hard. The headache is gone.
Quadracel was given to a male patient at the age of 9 years old/no AE; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 9 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapy reported.   On 07-Aug-2018, the patient received a single 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5248AA via intramuscular route in the left arm.  It was of actual medication error due to inappropriate age at vaccine administration.  No adverse event was experienced.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
I felt was a little numbness going down the vein that's my wrist and went away; This is a spontaneous report received from contactable consumer (patient). A female patient of an unknown age received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch number: HR2659903, lot number: EN6206), via an unspecified route of administration in left arm on 13Mar2021 as single for COVID-19 immunisation. The patient's medical history included dry palm. Concomitant medications were not reported. On an unknown date, the patient experienced "I felt was a little numbness going down the vein that's my wrist and went away". She was all concerned about her husband than for herself, so having those she meant she had dry palm that was how it was. She was due for second dose on that Saturday. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Headache & Fever Narrative:  chills, fever, soreness and headache  Other Relevant History:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 9:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Feb-2021 at 9:10 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.76 for dose administered on 12-Feb-2021.  No concomitant medications were reported.  Batch number 031L20A underwent temperature excursion on 12-Feb-2021 with temperature 29 degrees Fahrenheit at 09:00 AM and 35 degrees Fahrenheit at 10:00 AM to 11:00 AM. This vial was moved to fridge on 09-Feb-2021 and Product moved to clinic on 12-Feb-2021. Beyond use date for the vial was reported as 10-Mar-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
78-year-old man with past medical history of COPD, CKD, recurrent UTIs, HTN, and recurrent DVT who came to the emergency department with increased confusion and lethargy.  Work-up revealed acute uncomplicated diverticulitis, in addition to Klebsiella UTI, started on cefepime and metronidazole, received IV fluid hydration, he was found to be COVID-positive, evaluated by PRIVATE, started on Solu-Medrol, and received 3 doses of remdesivir.  Remains on room air, mental status improved and returned to baseline.  Evaluated by PRIVATE with recommendation for discharge on Augmentin to complete total of 10 days of antibiotics.
I had my first dose of the vaccine on Monday morning. I woke up Tuesday morning with a very sore arm, which I expected. I was also very tired with a bit of a headache. I teach school, and throughout the day I had very little energy and went to bed early that night. The next day (Wednesday) I felt the same, really wiped out, but also had some gastrointestinal issues and little appetite. Thursday I felt the same. Today is Friday, and I'm still dragging a bit but my appetite is returning. I feel like I'm getting back to normal.
5 minutes after vaccination, patient left leg feel little numb. Asked her to get up and moving around. She still feel little numb but still able to walk (watch her walk about 50 feet) she wants to go home and not seeking any treatment. Called patient about 30 minutes after she return home.
I was driving down the road and all of a sudden I got double vision & this happened twice before I went to dr. it lasted about 2-3 mins each time, the eye dr. said she could find nothing wrong with my eyes.
Narrative:  62 YO patient with PMH of HTN, HLD, CAD and DM reported mild shooting pain to R hand first and second digit following dose #1 of Covid-19 Pfizer vaccine, lasting two days. Pt reported this ADR when he returned for his second dose of COVID-19 VACCINE on 3/8/2021. Both doses were administered  without complications.
I had an episode of A fib accompanied by polyuria. I have had these episodes  for many years and I suspect it is just coincidence that it happened after the RSV shot.
3 days after vaccination; pt woke up having hard time getting out of bed, she had to hang on furniture to move around, sitting down caused extreme pain when pt had to get up.
Pt has a history of CVA and aspiration pneumonia in Feb 2021. Pt had been on olanzapine since 2/24 at Institute.  He was given his second Moderna Covid-19 vaccine on 03/10/21. Per note on 3/12, pt had seizure like symptoms at 0545 for approx. 45 seconds (eye rolling, lack of response, increased confusion)  Per staff, there was no flexing of limbs or loss of bowel or bladder control.  No noted stroke like symptoms but he appeared more confused at neuro check.  Pt was back to baseline at 15 min neuro check.  Pt reported to have had additional seizure, of approx. 4 minutes duration, during morning report that day-but when MD got to his room, he appeared ?post ictal with a mildly agitated restless delirium? rolling back and forth on the floor, moaning, and not making eye contact.  Pt did lose control of his bladder. Olanzapine was discontinued on 3/12, due to potential to lower the seizure threshold.  Divalproex was initiated for seizures.  Per note 3/22-no additional seizure type symptoms have occurred.
Severe headaches, fever, dizziness, joint aches,sleepy all the time, confusion, generally weak feeling, coughing. All continuous for 5 days after injection.
Patient did not do as advised and wait for 15 minutes.  They proceeded to walk around the store and the child passed out, and he hit his head, ambulance was called, but guardian declined the service.  The child was bleeding from a cut on his for head.  He was provided a cold bottle water and ice pack for the cut.  He remained sitting on the floor for 15 minutes and then left with his guardian feeling okay.
Waking up middle of night( around 0200, 16 hours after vaccine was given) with severe shivering and chills. Fell back sleep, woke up 0600 with fatigue and muscle aches. Took Ibuprofen 800mg at 0700. Improvement of muscle ache over several hours. Feeling fine this morning.
Vaccine administrator by accident dropped the vaccine on the floor.; Sore Arm; Headache; A spontaneous report  received from a consumer concerning, 20-year-old age female patient who experienced vaccine administrator by accident dropped the vaccine on the floor, sore arm and headache.   The patient's medical history was not included. Concomitant medications were not reported by reporter.  On unknown date in 2021, the patient received their second dose of the two planned doses of mRNA-1273 in the right arm shoulder deltoid muscle (Batch number unknown) intramuscularly for prophylaxis of COVID-19 infection.   Patient father stated that he took his daughter to the vaccination clinic to get her second dose of the Moderna COVID-19 vaccine. Patient father stated that when the provider brought the vaccine out to his daughter the vaccine administrator by accident dropped the vaccine on the floor. Patient had a sore arm and a headache.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event, vaccine administrator by accident dropped the vaccine on the floor, was considered resolved. The outcome of the events sore arm and headache were unknown.; Reporter'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.
7 days after receiving shot, my arm started to tighten, get sore, swell with slight itching.  The next morning, itching increased as well.
Within 48 hours of receiving my 1st dose of the Moderna Covid 19 Vaccine my mild Tenitus(sp?)-ringing in the ears-amplified to double my normal level. Within 48hrs of my 2nd dose of Moderna Covid 19 Vaccine my Tenitus amplified even higher and has remained at that highest level to this day. I saw an Ear, Nose, & Throat Specialist. He told me I was the 11th-12th patient reporting those symptoms after receiving any of the Covid 19 Vaccines. Just found out about your website & thought I'd report this side affect. Thanks.