chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PAIN (after the second one she has really bad pain all over her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (after the second one she has really bad pain all over her body). The patient was treated with METHYLPREDNISOLONE for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PAIN (after the second one she has really bad pain all over her body) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-176123 (Patient Link).
got black and blue in the shot area; This is a spontaneous report from a contactable consumer reported for his girlfriend. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the COVID vaccine and she got black and blue in the shot area on an unknown date. Th outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Itchiness, bump/swollen and redness on the 5th day, chills on the 3rd day but no fever
fever, headache, chills, body aches, burning eyes  followed by nausea and burning chest when taking deep breaths
Patient  did not have any reaction, however an expired vaccine was administered. Moderna Vial was punctured on 9/13/21 a little after 1:13 PM. Dose was given  a little after 12:30 PM on 9/14/21
Patient has temp of 100.6 , Cool to the touch and unresponsive , Pale color, and incontinent of bowel and bladder which is abnormal for this patient.
Terrible menstrual cramping and PMS symptoms.  Abdominal pain far exceeded 'normal' by my own experience (including some of the worst endometriosis flares). Lower back pain, breast soreness, headache, mood swings - all of these were significantly worse than usual.
Loss of appetite, dizziness, fatigue, joint pain, muscle aches, headaches, neuropathy- started winter of 2017 through currently (see question 5). Fall of 2018 anxiety increased, food smells caused nausea, previous symptoms are getting worse. Fall of 2019 (Oct 14) heart flutters occurred- heart monitor used for 24 hours. Winter of 2019 (Dec 4) diagnosed with P.O.T.S. has developed food sensitivities. Spring 2019 (03/26/2019) Dr diagnosed patient with fibromyalgia. Oct. 8, 2018 went to Dr because of shortness of breath
Bell's palsy developed within 21 days of vaccine administration 01/30/07-records received and reviewed from MD for DOS 11/3/06.  DX: Bell's Palsy. 9/3/06-complaint of ear ache and headache, 9/4/06 headache and weak face. Seen in ER treated with prednisone and Famvir for one week. Over time shown some recovery. Decreased tearing, has lost her taste on the left part of the tongue and that has returned. Has had some but not complete recovery of movement in her left face. Difficult for her to smile completely difficulty with blinking. Does not completely close her eyes at night uses artificial tears during day. No pain in face. Diffuse nondescript headaches occur more frequently.  Current medications: Zoloft, does get dizzy at times. Fainted a couple of weeks ago. EKG normal.
p/vax pt exp shaking uncontrollably; heavy breathing; sweating; aching joints; rt arm swelling; tx tylenol 2
pt recvd vax 11AUG92 & 2 days later devel hives & boils on head; 1MAR93 devel stiffness & pain in neck, swollen lymph glands, general malaise; lab eval on 1MAR93 revealed anti-HBs 1.6 & anti-HBc neg; seen by MD pt recovered;
Severe, itchy, red rash all over body for several days since the vaccine first dose.
his spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, AGEUSIA (loss of taste), DIARRHEA (diarrhea), COVID-19 (tested positive for COVID-19), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, SARS-CoV-2 test: positive (Positive) Positive on Rapid test and negative (Negative) Negative on Non-Rapid test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. This case concerns a 61-year-old female patient with no relevant medical history who experienced non serious unexpected events of special interest ageusia and COVID-19. The events occurred unspecified time after the first dose of Covid19 Moderna. Reportedly, after the first dose of Covid19 Moderna, the patient experienced diarhroea, headache, loss of taste and pyrexia and was tested positive for COVID-19 with rapid test. Afterwards, on a non-rapid test, the patient was negative for COVID-19. Rechallenge was not applicable due to nature of the event of COVID-19 and since the event outcome was unknown and there are no details regarding the second dose. Therefore, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report; Sender's Comments: This case concerns a 61-year-old female patient with no relevant medical history who experienced non serious unexpected events of special interest ageusia and COVID-19. The events occurred unspecified time after the first dose of Covid19 Moderna. Reportedly, after the first dose of Covid19 Moderna, the patient experienced diarhroea, headache, loss of taste and pyrexia and was tested positive for COVID-19 with rapid test. Afterwards, on a non-rapid test, the patient was negative for COVID-19. Rechallenge was not applicable due to nature of the event of COVID-19 and since the event outcome was unknown and there are no details regarding the second dose. Therefore, no rechallenge was done and recurrence was not applicable.  The benefit-risk relationship of drug is not affected by this report
Patient reported on 8/16/12 she had rash from shoulder to shoulder & on face accompanying itching.
Myalgia; no appetite; Vertigo; Dizziness; Bed bound; This case was reported by a pharmacist via sales rep and described the occurrence of myalgia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUAD) for prophylaxis.   In October 2020, the patient received Shingrix and FLUAD. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced myalgia, appetite lost, vertigo, dizziness and bedridden. On an unknown date, the outcome of the myalgia, appetite lost, vertigo, dizziness and bedridden were unknown.   It was unknown if the reporter considered the myalgia, appetite lost, vertigo, dizziness and bedridden to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and Fluad approximately in October 2020 and less than 2 years after vaccination, experienced myalgia, no appetite, vertigo, dizziness and was bed bound. It was unknown if the reporter considered the myalgia, appetite lost, vertigo, dizziness and bedridden to be related to Fluad.
Shakiness, nausea, dizziness, vomiting, extreme body aches, headache, cough, low grade fever first day, high fever 102.7 second day. Went to hospital second day approx. 4:00 PM, had IV drip, medication for fever. Fever finally down at approx. 8:30 PM, then discharged.
Symptoms lasting 48  hours- High fever (>102 despite taking ibuprofen and acetaminophen), nausea and vomiting, diarrhea, chills, body aches, tooth aches (throbbing in each tooth), blurred vision, extreme dizziness and vertigo, headache and injection site exceptionally swollen, red and hot to the touch.
Immediately that night I started having full nerve pain head to toe, not typical body aches. My lips went numb, I lost sensation in my hands and feet then it turned to pins and needles. Approx. 3 days after receiving the vaccination, it felt like I was walking on glass and my hands and feet would turn cyanotic off and on. Headaches and stiff neck. I ran fever for a week off and on, swelling, redness and heat to my Left upper extremity along with swelling of lymph nodes and breast to the left side. with extreme tenderness. My physician currently has me a Medrol dose pack to help with the pain to my arms, hands and feet. So far no changes.  The stiffness and headaches have slightly improved.
Information has been received from a certified medical assistant concerning a female (age unknown) with a history of negative Pap test, who was vaccinated with a first dose of Gardasil.  Subsequently, the patient's Pap test was positive for HPV.  Prior to the vaccination the patient's Pap test was negative for HPV.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Tiny red splotches on chest and back. Does not itch or hurt. Dr. says never seen anything like it and left untreated.
Patient blacked out for about 1 or 2 seconds. Pulse was fine, no anaphylaxis. Blood pressure was hard to obtain because of the patients small arm. Parents said she had a seizure, but this cannot be confirmed if it was a seizure or just that they fainted.
Narrative:  There is a written/verified report of a Positive COVID-19 PCR Lab test done at a location other than this facility. Date: August 30, 2021 Location: Outside Facility as per 8/31/21 Hospitalist note Assessment and Plan COVID 19 Infection. Patient is on 2L NC and febrile. On Decadron. Start remdesivir Patient is already on Eliquis Maintain droplet and contact precautions Tested positive on 8/30/21 Parkinsonism, tremor. He is on Sinemet as an outpatient. He follows with Neurology. Frequent falls at home. Physical and occupational therapy. Schizoaffective disorder, and major depressive disorder. Follows with a psychiatrist at the facility. Continue his home psychoactive medications. Obesity Reported orthostatic hypotension, none this admission Dyslipidemia. On rosuvastatin 10 mg. Primary hypertension COPD without exacerbation. Continue Stiolto. DVT prophylaxis: Eliquis 5 mg twice a day GI prophylaxis: Not applicable Diet: Moderate carb Glycemic control: Uncontrolled but better SARS-CoV-2 vaccine status: Fully vaccinated Blood pressure trend: Well controlled PT/OT: Following Disposition: Skilled nursing facility Discharge planning nursing home.
MOC states began c/o itching all over around 11PM 15JUL98;MOC states had welts all over chest, abd & back;temp not taken as child was not warm to touch;MOC called ARNP;mom stated to ARNP child had recv vax & also eaten ravioli from can;
Fever of 101.5 degrees - persisted 7 days.  This was followed by a measles looking rash on his entire body.  Today is 8/17/2011 and the rash is still spreading.
Breast Cancer; This case was reported by a nurse via call center representative and described the occurrence of breast cancer in a 67-year-old female patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   On 26th March 2022, the patient received the 1st dose of Havrix. In June 2022, less than 4 months after receiving Havrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was not recovered/not resolved.   It was unknown if the reporter considered the breast cancer to be related to Havrix.     Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: Nurse reported that the patient was diagnosed with breast cancer in early June 2022. The patient was scheduled to have a lumpectomy on 18 Aug 2022. The second dose of Havrix had not yet been administered. The Vaccine Administration Facility was the same as Primary Reporter. The consent to follow up was given.
This spontaneous report was received from a licensed vocational nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 24-AUG-2015 the patient was vaccinated with improperly stored dose of VARIVAX (Merck), lot #: K003420, expiration date: 06-MAR-2016 (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed left shoulder pain at the injection site several hours after the immunization was given on 2/14/23. The pain was as severe as 9/10. On 2/22/23, he was still having pain at the injection site but it is gradually improving (now 6/10). Normal exam with no palpable mass or erythema at the injection site.
Day 1-7 post vaccine- erythema, induration, itching and recurrent hives with skin hyperpigmentation.  Week 2 resolution of induration and itching but persisting skin discoloration/hyperpigmentation until today now week 3. No change is hyperpigmentation from week 2-3.
Within 15 minutes of receiving the vaccine, my left arm/hand was numb and tingling.  Within 1 hour of receiving the vaccine, both of my legs/feet and right arm/hand also became numb and tingling, and I felt muscle weakness.  On 06/17, I started taking Prednisone for 5 days, which helped reduce the numbness and tingling but did not eliminate it.  After ending the Prednisone treatment, the numbness and tingling increased again.  It has now been 17 days since the vaccine and I still feel numbness and tingling in both arms/hands and legs/feet.  It has reduced in intensity but has not gone away.
Patient came in today reported extreme pain in left shoulder spanning from shoulder to elbow. In addition she reported muscle spasms and nerve tingling. She saw her primary care doctor and then came in to pharmacy to report.
severe swollen lymph nodes to left arm pit ( injection arm); severe swollen lymph nodes to left arm pit ( injection arm); developed very mild headache; severe chills; muscle aches; This is a spontaneous report from a contactable nurse (patient). A 50-year-old female patient (pregnant: No) received second dose of bnt162b2 (lot number: EL1283), via an unspecified route of administration in left arm on 13Jan2021 07:45 at single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included loratadine, progesterone, docosahexaenoic acid, eicosapentaenoic acid (OMEGA 3 FISH OIL), colecalciferol (D3), cyanocobalamin (B12). The patient previous received the first dose of bnt162b2 (lot number: EK5730), via an unspecified route of administration in left arm on 23Dec2020 06:00 AM for COVID-19 immunization. The patient experienced developed very mild headache on 13Jan2021 11:00, severe chills on 13Jan2021, muscle aches on 13Jan2021, severe swollen lymph nodes to left arm pit on 14Jan2021. The treatment paracetamol (TYLENOL) and ibuprofen (ADVIL) was used. The event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Approximate 4 hours post second vaccine dose, developed very mild headache, followed by, approximate 15 hours post second dose, severe chills, muscle aches, lasting about 8 hours, followed by, approximate 24 hours post second dose, severe swollen lymph nodes to left arm pit (injection arm), lasting approximate 24 hours. The outcome of events was resolved in Jan2021. Facility type vaccine: Hospital. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. Not Known allergies.
1. Mild headache and soreness at injection site for 6 hours. 2. Then felt well for 4 hours. 3. Abrupt onset severe headache, chills, fever, myalgias (back, shoulder), hypersensitivity of skin. 4. Overall improved at time of recheck 3 days later but slight myalgias, fatigue remains. Still taking ASA every 6 hours.
Bright red ring around injection site about 4 or 5 inches around with hives and itching.  Itching also inside head and itching radiates then from the head on down to the arm to the injection site.
PATIENT COMPLAINED OF SEVERE BODY ACHE, SWELLING AND REDNESS AT TIME OF INJECTION.
102.4 temp, headache, body aches, chills, sweating, nausea. These symptoms began on 4/22/21 and continued for 2 days, ending on the evening of 4/23/21.
ringing in ear, like tinnitus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 09:15 (Lot number: ER8727) as dose 2, single and administration date 02Mar2021 09:15 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 22Mar2021, outcome "not recovered", described as "ringing in ear, like tinnitus".  Additional information: After the second dose vaccine on 23Mar2021, the ringing was very much louder in the ear. Prior vaccination within 4 weeks: No. AEs following prior vaccinations: not provided. Family medical history: no. Relevant tests: no. The ENT industry looking at the fact that they are having many patients coming in with this condition. They don't know if this was because of the vaccine or the fact that so many people are getting the vaccine. They are seeing an up rise in this condition and are dealing with it.  No follow-up attempts are possible. No further information is expected.
One day after receiving my second dose I noticed a nerve ending sensation to my torso at night that was much like a shingles type pain.  My torso felt inflamed and  burning with a prickly shooting pain to stomach area and back.   This was during sleep and I could tell that my  core temp was very hot.  Made it impossible to roll over or get comfortable.  Currently I have no rash, but my sister states that after her vaccine she had a rash on her torso with similar pain.
pt recv vax & 1NOV97 felt yucky & queasy took pepto bismol;also noticed itching & feelings as if skin was dry;itching inc;4NOV97 about 7-8PM cont itching, hives noticed on legs;5NOV97 cont itching;to see MD 6NOV97;
Patient received 3 total Moderna COVID-19 injections.  Patient received 2 injections from Pharmacy on 7/1/2021 and 8/3/2021. Patient indicated on the initial COVID-19 Vaccine Immunization Administration Record on 7/1/2021 that she had not received a COVID 19 vaccine, and returned for her second vaccine on 8/3/2021, stating she lost her vaccine record card and needed a new card as well. Patient did receive an initial injection on 5/27/2021. This was not determined that the patient received her third injection until insurance was processed on 8/3/2021 and the insurance rejected, stating 2 injections in a 300 day period, prompting a check of the website to determine an initial injection was given 5/27/2021. Upon discussion with the patient, she was aware she was getting 3 injections, as she stated the initial injection "did not feel right", due to an adverse reaction, and wanted to go to another facility. She also stated she heard about a third being necessary
Late on the day of the shot patient had redness and warmth at site of injection, the next day patient developed hive like redness on the face and slight discomfort to the throat.
Beginning 3/13/2021 I experienced weight gain with no change in diet or exercise.  The weight gain continued upward for months.  On July I was diagnosed with Hashimoto's Disease.  I had no weight gain or thyroid syptoms prior to receiving the second vaccine shot.
The 2 to 3 days after the vaccine was administered the left arm where the Hepatitis B vaccine was given began to feel very painful.  The patient exercised the arm and massaged the area of the injection. This has been going on for 2 months now.  Whenever she slept on this arm, the next day the arm was very painful.  She has had the arm swell off and on.  At times she wears a wrap on the arm and uses a heating pad at times.  She has not been seen by a physician.  A month after this injection, she refused to take the 2nd dose of Hepatitis B. The left arm initially was hot to the touch and never had any redness that she noticed.  She has been recommended to see a physician about the arm but has not seen a physician to date.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 26th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 7 days after receiving SHINGRIX, the patient experienced injection site pain. The patient was treated with Pain Reliever (Nos). On an unknown date, the outcome of the injection site pain was unchanged. The reporter considered the injection site pain to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient reported that the pain became progressively worse and had leveled off at the time of reporting. The patient said that all he had to do was press a little bit on the site and it was very painful and the painful area included the injection site, 2 to 3 inches in circumference around it. The patient went to the physician 2 to 3 weeks after receiving the injection and was told to take pain relievers twice daily for 7 days.
1 WEEK AFTER VACCINATION, PATIENT STARTED TO FEEL MUSCLE ACHNESS, MUSCLE WEAKNESS, AND DIZZINESS
Initial itching of L foot, followed by swelling, increased itching, local erythema, with small blisters. In erythema of both feet/buttocks/upper thigh area with 20 hrs.
Peak health at time of smallpox vaccination. Within two weeks, body fell apart. Constipation, depression, weight gain, fatigue, memory loss, heightened anxiety, SEVERE HAIR LOSS, etc. Diagnosis is chronic Hypothyroidism.
Starting just after 11:00pm on the 18th of August 2021 I started to slightly shake like the chills.  I was not cold or have a fever at this time.  While this continued for around an hour or so it gradually became worse until around 1:00am on the 19th of August I started having full body convulsions shaking violently.  The left side of my face and body felt like I had no control over it .  My face felt like it was drooping and my leg was dragging all on my left side.  Eventually around 3:00am the convulsions stopped. While the convulsions finally stopped my fever shot up to 101.9 at this time.  I took two Tylenol for the fever and around 4:00 am it finally broke but I was freezing after my temperature went back down to 98.0.  The next day I went to my doctor, Dr.  I have been extremely weak since these events which have made it difficult to perform my job.