chrisvoncsefalvay/vaers-outcomes huggingface dataset:
weakness; chills; high fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), CHILLS (chills), PYREXIA (high fever) and HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ASCORBIC ACID, BETA VULGARIS ROOT, IRON AMINO ACID CHELATE, ROSA CANINA FRUIT, RUBUS IDAEUS LEAF (IRON SUPPLEMENT WITH VIT C & HERBS) for an unknown indication.   On 02-May-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), CHILLS (chills), PYREXIA (high fever) and HEADACHE (headache). At the time of the report, ASTHENIA (weakness), CHILLS (chills), PYREXIA (high fever) and HEADACHE (headache) outcome was unknown.            This case was linked to MOD-2021-106689 (Patient Link).
"Covid arm" My left upper arm has a swollen, red, hot, tender patch and my left underarm is sensitive
Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in right deltoid.  Her deltoid hurt quite abit the night of shot and the day after but normal on the second day.
A 48 year old male patient, with history of enlarged prostate, depression, chronic obstructive pulmonary disease, and gastroesophageal reflux disease, reported that he experienced severe burning as flu vaccine was injected. He received FLUZONE, lot number U1839AA, intramuscularly on right deltoid on 03-Nov-2005. Patient's recovery status: not reported. Follow up information received on 06/Mar/2006 from a physician. Per the reporter, the patient only complained of injection site burning. The patient never had any other reaction or toxicity to the vaccine injection. The patient did not miss work or go to the emergency room as a result of this injection. No further information is expected. The coding of burning sensation was updated to injection site burning due to this new information. At the time of this report the patient had recovered from these events.
This case was reported by a consumer and described the occurrence of heartburn in a 47 year old female subject who was vaccinated with Fluarix for prophylaxis. The reporter is the subject. A physician or other health care professional has not verified this report. The subject's medical history included high cholesterol, osteoporosis, and "occasional heartburn after eating a large meal." Co suspect medication included Boniva (PO 02 Nov 2006) for osteoporosis. Concurrent medications included multivitamin, aspirin, Calcium and fish oil. On 02 November 2006, the subject received her first dose of oral Boniva. Approximately two days later, on 04 November 2006, the subject experienced chest pressure. On 06 November 2006, the subject received a dose of Fluarix. On 06 November 2006, less than one day after vaccination with Fluarix and four days after the receipt of Boniva, the subject experienced heartburn and "extreme" chest pain. The subject treated the events with antacid. The heartburn and chest pain improved "approximately three hours later." Therapy with Boniva was continued. At the time of initial reporting, 10 November 2006, the subject reported that she has not had another episode of heartburn with pain, but every time she eats, she feels like food just "sits on her chest" and she has a "dull ache between her breasts."
Muscle weakness and muscle loss in extremities, pain in legs, pain in hips and knees, loss of balance. Knowing what I want to say but it doesn't come out right (multiple times a day), confusion, unable to sleep all night, and my anxiety has increased (more than likely due to everything that has been going on with me since the vaccine).
Nausea, Slight Dizziness two hours from injection. 101 Degree fever at 8 pm. I took a shower and my GF put a cold compress on my head.  I feel loopy and feverish. She noticed and took my temperature when she came home. I was napping on the  couch and didn't know I had a fever until she checked.
Two hours after being administered both Td and Menactra, he developed a fine maculopapular rash.  This was pruritic, but not urticarial according to mother. He was given Benadryl, the rash resolved, and no further problems occurred.
Anaphylactic reaction.   Experienced throat closing, rash on upper body, couldn't swallow, shortness of breath.  Was in the emergency room 2 hours after getting vaccine.
Impingement syndrome. Pain in joint involving shoulder region. Initial report received on 25 March 2009 from a physician, who is also the patient. The initial report was received by Sanofi Aventis under the following reference numbers: Activity inquiry 1-201292577 and parent inquiry 1-201270726.  Follow up information was also received on 30 March 2009. A 36 year old male (who is a physician), with no history of impingement syndrome or left shoulder pain, received an injection of FLUZONE (lot number not reported) in October 2008. According to the patient, the nurse aimed too high and he believed that the injection went into the left subacromial bursa. Two or three days post vaccination, the patient experienced pain for the first time in the left subacromial area and shoulder. The symptoms were the same as impingement syndrome and continued. One of the patient's partner's an orthopedist, injected the shoulder with steroids three times since them, the most recent time a few weeks ago. At the time of the report, the patient was symptom free. If the symptoms return, he planned to undergo an MRI of the shoulder to look for the etiologies.
pt recvd vax & had occasional tenderness at inject site w/ pain & stiffness of left shoulder; pt dx w/ myositis secondary to the vax which was felt to be a delayed hypersensitivity;
Information has been received from a licensed practical nurse concerning a "50 year old" female who was vaccinated with 2 doses of MMR II as a child, but now had negative titers to mumps. No other adverse reaction reported. The outcome was not reported. Additional information has been requested.
8/22/17 Pt was admitted to hospital and diagnosed with intussusception which was surgically repaired.
HARD AND HOT, NOT RED, EXTREMELY PAINFUL. HURT EVEN WHEN NOT MOVING. WANTED TO PUT IN A SLING. COULD NOT SLEEP.
Patient reported that she experienced atrial fibrillations, headaches, vertigo and extreme tiredness beginning the day after date of vaccine administration. Area of injection appeared pink and patient reported that the area of injection was warm to the touch. Patient also reported that these effects were lessening at time of report.
hypertensive pt in a study for autonomic testing recvd flu vax & devel sx of atrial flutter;
By Tuesday, May 11, I was experiencing chest pain over the area of my heart. On Friday, May 14, I was still having pains, my heart seemed to be beating much more intensely than normal, and I was worri; By Tuesday, May 11, I was experiencing chest pain over the area of my heart. On Friday, May 14, I was still having pains, my heart seemed to be beating much more intensely than normal, and I was worri; By Tuesday, May 11, I was experiencing chest pain over the area of my heart. On Friday, May 14, I was still having pains, my heart seemed to be beating much more intensely than normal, and I was worri; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot number: EW0173) via an unspecified route of administration in Arm Right on 06May2021 14:15 as single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Concomitant medication(s) included famotidine (FAMOTIDINE); allopurinol (ALLOPURINOL) was taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient has been tested for COVID-19. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0150) via an unspecified route of administration in Arm left on 15Apr2021 10:15 AM as single dose for covid-19 immunisation. The patient experienced on 11May2021; he was experiencing chest pain over the area of my heart. On Friday, 14May2021, he was still having pains, my heart seemed to be beating much more in-tensely than normal, and he was worried about my health, so he visited an ER. The tests run at the ER showed no signs of heart damage. Since they could not detect any heart damage, he was not sure if he had a side effect from the vaccine, but since there are now articles about heart inflammation occurring 4 days after vaccination. The patient under-went lab tests and procedures which included electrocardiogram: no signs on 14May2021 no signs of heart damage. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts possible. No further information expected.
Nausea, fatigue, body aches-10 days  Chronic back and neck pain completely ceased for two weeks then returned but much worse with nerve pain that makes me nauseous. It doesn?t respond to otc meds, pt exercises, stretch or rest -ongoing.  Extreme brain fog with mental confusion. For two weeks. I?m still feeling out of it and slow.  Trouble staying awake while driving or sitting still-ongoing  Swelling of the jaw on right side-10 days  Loose molars and gum swelling.-ongoing
PERIPHERAL NEUROPATHY 3/9/2022 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Healthy, life time athlete: 10 days after Pfizer booster noticed heavier than normal breathing on intense workouts.  Also noticed slight out of breath when talking to people while standing up.  Check resting HR after 2 weeks of the above an notice my normal resting hr of 54 was now at 90 to 120. On this observation went into urgent care as I think I may have myocarditis from vaccine.  Urgent Care doctors did not observe any immediate issues but ran d-dimer test which came back at 2,030 ng/mL. Sent immediately to ER. CT reviled large blood clot in lungs. Admitted to hospital. Heparin drip 2 days. Changed to oral Xarelto  15mg 2 times a day for next 6 months. Released home
One day after injection I developed two nodules under the skin and some soreness. Both nodules and soreness gradually decreased and was virtually gone by Tuesday, 1/19/21. Evening of Wednesday, 1/20/21, the nodules had grown significantly in size and has become red and hot to the touch. Both nodules have grown to become one nodule. Pain has now started feeling similar to the soreness I experienced the day after initial injection.
COMPLETE PAIN IN LEFT ARM AND NUMBESS TOTAL DISCOMFORT.  CANT SLEEP AT NIGHT AFFECTING MY JOB .  MISSING TIME FROM WORK. NECK PAIN LEFT SIDE.  PAIN IN MY CHEST LEFT SIDE. PAIN IN LEFT SIDE ARMPIT.
Chills, rigors, body aches, headache, low body temp - started 24 hours after vaccine administration and lasted about 8 hours.
The vaccine this patient received was determined to have had a temperature excursion below the recommended storage temperature prior to administration. There was no guidance to repeat the dose from the vaccine manufacturer. At facility, I served as a Operator, who is responsible for transporting COVID-19 and flu vaccines to sites. Standards for transporting these vaccines include keeping said products between 2C-8C. In order to maintain such cold temperatures requires the use of: cooler bag, 3 fridge plates, 1 frozen plate, and 2 sheets of bubble wrap. The bubble wrap serves to protect the vaccines from having direct contact with any of the cold plates. Somewhere during the transportation process, one of the sides of the bubble wrap got pushed down, causing potential exposure of the vaccines to the cold plates, which are most likely below 2C. Due to insufficient data to support the idea that the vaccines were considered active, we must assume that the 4 Moderna vaccines provided during our shift on 3/7/2022 are possibly invalid.  We arrived to their sites around 9:00 AM on 3/7/2022. We provided our vaccination services to our patient, and followed standard procedure. After observing the patient for over 15 minutes, having the patient report no adverse symptoms, we allowed them to go back to their sites.
July 18th - 22nd my period was on off and was light. My periods are always regular and have a medium flow/bleeding. August i never got a period and it's now October and still haven't gotten a period but have been cramping in my lower abdomen. Doctors have checked me and can't find out what's wrong and they directed me to fill out this form.
As per patient she experienced all the side effects listed in the VIS and went to her md and the md said that she was ok if she didn't get the second shot. Patient is fine, no issues.
Switch from pfister to medor COVID vaccine. In my mid 60's have art. fib. Fever for 2 days. Developed blood clot and had a stroke
After 12?hours of receiving the vaccination I stated having child, muscle , joint & headache pains  Fever This morning I was nauseous & throw up
Mild pain started in left elbow; dizzy/feeling faint; rapid heartbeat; This is a spontaneous report from a contactable consumer (patient). A 75-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6200 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Feb2021 at 10:30 hours as dose 2, single (at the age of 75-years-old) for COVID-19 immunisation. The patient medical history was not reported. Patient had no other vaccine in four weeks. Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 27Jan2021 at 09:30 hours as dose 1, single (at the age of 75-years-old) for COVID-19 immunisation. Concomitant medication(s) included melatonin and famotidine taken for an unspecified indication, start and stop date were not reported. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for the COVID-19, post vaccination. On 17Feb2021, at 10:30 hours, patient experienced mild pain started in left elbow, then she became dizzy, feeling faint and had rapid heartbeat. Patient did not faint, and symptoms passed after about two to three minutes. Patient received no treatment for all the events. The outcome of all the events was recovered on 17Feb2021.  Follow-up attempts are completed. No further information is expected.
Symptoms resembling influenza: chills, fever, aches and pains in arms and body.  Arm unusually sore at the vaccination site on the day of injection and couple of days after injection on 10/21/08.  Flu-like symptoms again on 12/1/2008 that are still in progress with severe chills, fever, aches, pains, coughing, sneezing, running nose, etc.
Patient developed a swollen area on her posterior trunk that was tender to the touch the evening of her flu shot. She was later diagnosed with leiomyosarcoma 3/6/2023.
Patient believes she got Shingles from this vaccine.  Dr confirmed Shingles.  However, can not say it was caused by the vaccine.
Patient is new to country without any vaccine records. She was advised to receive vaccines based on age, school vaccines required and recommendations to which parent and child agreed to. Patient after receiving 4 of 10 vaccines said she felt dizzy and was noted to appear pale. Halted vaccination at this time and proceeded to perform recovery treatment. Patient's head brought down between her knees, applied compress to neck and continually monitoring patient. At patient request, patient laid down on chairs with feet higher than heart until fully recovered.
52 y/o M no PMH presents to ED w/ 24 hours progressive numbness/weakness 1 week after receiving flu shot. Unable to raise arms above head, difficulty walking, loss of fine motor skills. Also reports shortness of breath. Testing so far remains inconclusive, though evidence of acquired demyelinating process. IVIG x5 days. Remains in ICU.
Janssen's primary series patient received as a modern booster dose of 0.5mL instead of 0.25mL by the nurse. The case was consulted by Dr.
Arm became swollen and red. It traveled around the muscle of the arm like a band. Pain, unable to bend arm, hot like a sunburn, skin very sensitive. Went to urgent care and was prescribed KEFLEX 500 mgs. 1 every 6 hours.
On 11/5/2013, telephoned primary physician, and was diagnosed with tendinitis.  On 1/13/2014, office visit with Dr.  Diagnosed with shoulder impingement.  Left shoulder was x-rayed and Vicodin was prescribed.  On 1/17/2014, attended group physical therapy.
Left arm soreness up through left side of neck three weeks after injection,; headache from injection through this report (3 weeks post-injection); Left arm soreness up through left side of neck; This is a spontaneous report from a contactable patient. A 58-year-old adult non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH, Batch number was EL3247) via an unspecified route of administration on the left arm on 23Feb2021 at 11:00 AM (at the age of 58-years-old) for COVID-19 immunisation. Her medical history included allergic to penicillin, erythromycin, metronidazole (FLAGYL). Concomitant medications given within 2 weeks of vaccination included (levothyroxine) SYNTHROID, liothyronine (CYTOMEL), escitalopram (LEXAPRO), all administered for an unspecified indication however no any other vaccines were provided within 4 weeks prior to the COVID vaccine. Furthermore, prior to vaccination, she was diagnosed with COVID-19 and since the vaccination, she has not tested positive for COVID-19. On an unknown date in Mar2021 (3 weeks post vaccination), she experienced left arm soreness which then radiated to left side of neck three weeks after injection, headache from injection reported. Sumatriptan (IMITREX) was taken by the patient to treat these events and she visited doctor office due to these events as well. At the time of report, the clinical outcome of left arm soreness up through left side of neck and headache was not recovered. No follow-up attempts are possible. No further information is expected.
Fever, vomiting, narcolepsy.  Had a fever for several hours of 100.5.  It is currently 4/29/13 ay 10:09am and he has been sleeping almost non stop since 4/26/13.  He wakes up to eat, but sometimes throws up shortly after.  He always goes right back to sleep.  Nowhere near typical behavior for my one year old.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 04-SEP-2018, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Thimerosal free) (lot# R006746 and expiration date 19-NOV-2020) intramuscularly for prophylaxis (product storage error). The Merck Sterile Diluent (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001956; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959.
I had a three day period after the 1st vaccine on 9/18/2021 along with a 5 day period of spotting. After the 2nd vaccine on 10/09/2021 I had missed my period completely, i usually have a very regular period lasting 5 days.
The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 01Feb2016, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant via Pfizer Sales Representative. This medical assistant reported similar events on five patients. This is the third of five reports. A 65-year-old female patient received PREVNAR 13 (lot L99262, expiration date 28Feb2017, NDC number 0005-1971-02) on 25Sep2015 at 0.5ml single dose via unspecified route. On the same date the patient received FLUARIX. On 01Oct2015 the patient experienced cellulitis. No admission to hospital was involved. The patient received treatment for the event with AUGMENTIN. The patient recovered from the event.