chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weight gain; Dizziness; Headache; This spontaneous case was reported by a patient and describes the occurrence of WEIGHT INCREASED (Weight gain), DIZZINESS (Dizziness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOFACITINIB CITRATE (XELJANZ XR) tablet for an unknown indication.    Previously administered products included for Drug use for unknown indication: Methotrexate, Gabapentin, Singulair, Baclofen and Covaryx. Past adverse reactions to the above products included No adverse event with Baclofen, Covaryx, Gabapentin, Methotrexate and Singulair. Concurrent medical conditions included Allergy to antibiotic (Erythromycin), Drug allergy (Hydroxychloroquine sulfat), Drug allergy (Lisinopril) and Ankylosing spondylitis.   On 03-Aug-2021, the patient started TOFACITINIB CITRATE (XELJANZ XR) (Oral) at an unspecified dose once a day. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain), DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, WEIGHT INCREASED (Weight gain), DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient second dose of Moderna COVID-19 Vaccine was scheduled for 10-Sep-2021.  Patient believed headache, dizziness, and weight gain was from Moderna COVID-19 Vaccine and not Xeljanz.  No treatment medication was reported.   Reporter did not allow further contact
Information has been received from a physician referring to multiple unspecified patients of unknown age and gender. On unspecified dates in February 2016 (reported as between 15-FEB-2016 and 23-FEB-2016), the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose, route, lot# and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Arm painful,  worse than 1st dose  Horrible joint and body pains, couldn't get comfortable,  hurt to touch skin and dogs lick  Fever 101.3, chills dehydration  Fatigue,  feels like.hit by bus
DIZZY, OVERHEATED, AND THE POPLE AT THE POST OFFICE HELPED ME BECAUSE I ALMOST FAINTED.  THE POST OFFICE IS RIGHT DOWN THE STREET- CLOSE ENOUGH TO WALK, IF NEEDED.
Noted erythema and tenderness from injection site distally to elbow on back side of arm.  Felt warm to touch but denied systemic fever.  Erythema and tenderness lasted 5 days and resolved on own. Took Tylenol for the symptoms.
12 hours post vaccine, low grade fever, muscle aches, headache, joint aches, malaise for approx 48 hours. Within 5-6 days, moderate/severe flare of Rheumatoid Arthritis, with every joint affected in terms of pain, and several joints with swelling, tendon involvement of swollen Achilles in both feet, severe fatigue and malaise. Increasing dose of prednisone was ineffective in reducing flare, and flare continuously became worse over course of 2 months post vaccine. Patient started Xeljanz June 14 and this has been effective in reducing flare. Lab work showed abnormal levels of anti-ds DNA and low Complement C3c and C4c, indicative of lupus-like reaction. It is possible that adjuvant QS-21 that is used in SHINGRIX vaccine may be contraindicated for persons with autoimmune disease, as QS-21 is a powerful immunostimulant.
Possible Bell's Palsy  Facial Droop that became noticeable 2 days ago.  Continues with symptoms
Headache, chills, muscle aches, sour taste, night sweats, dehydration & fatigue
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with a dose of GARDASIL, strength reported as 120 Y, (dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient notified the pharmacy to tell us that her arm was swollen, burning, and itching. Pharmacist counseled pt to place cold compress on the arm and to take a pain/fever reliever such as ibuprofen. Told the patient seek medical attention if symptoms become worse or if she experiences oral swelling inside or outside the mouth, trouble swallowing, or rash beyond the the injection site.  The pharmacist would follow-up with pt in the morning.
We do not think this is related to the vaccine (just making that clear). Around 8pm on 11/12/2021, Patient had a fever of 101.6, and 320mg of acetaminophen was given. At 10:30pm he started vomiting, and continued to have bouts with about 20-30 minutes in between until 1am. From 1am on 11/13/2021 to about 8pm on 11/14/2021, he would throw up if given anything other than ice chips. He was producing enough urine to not need to go to urgent care/ER. His fever came and went (no meds administered), last occurrence evening of 11/14/2021. All day 11/15/2021, he was able to tolerate small amounts of liquid and applesauce. The morning of 11/16/2021 he threw up after drinking about 4oz of water. We took him to get a PCR COVID test, results should come back by 11/18/2021. Currently he is able to tolerate small amounts of liquid.
In the past had afib. After vaccine, started having shortness of breath upon exertion. Went to my annual Cardiology appointment and doctor wanted me to get a Stress Echocardiogram. My doctor is sending me to a Pulmonary Specialist, where another Echocardiogram Stress can be done.
tested positive for covid on     12-21-2020                            ,  forms report no symptoms at the time of testing,  patient deceased on   1-3-22                 .  I have no other information.
Circular swelling approx 15cm, red in color , occasional rash flare in area mainly at night . Nasal congestion, coughing, sore throat, hot flashes.
Got 1st vaccine 2 years ago / Will 2ndvaccine now make it effective or do we have to start over?; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago of reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The case was reported by the consumer itself. The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix two years back. Till the time of reporting, patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient wanted to know, would 2nd vaccine now make it effective or should they start over. The patient consented to follow up. No further information was provided. This case has been linked to US2021AMR113533, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR113533:same reporter
Mother states the day after receiving Influenza booster dose patient had hives on her back, chest, abdomen and a little on legs.  She also had a fever of 102 degrees Fahrenheit axillary.  Mom states she also vomited twice and had a cough and runny nose.  Mom states that fever lasted 5 days, she treated at home with OTC Tylenol and Benadryl.  Mom states that the Tylenol did bring the fever down.  Mom called Public Health office on 3/7/2016 after symptoms had resolved.  Mom states she called the doctor to and described symptoms because she wanted it noted in patients chart that she felt this was a reaction to the flu vaccine.  Mom states she did not take patient in to the MD to be evaluated.  Mom denies any previous vaccine reactions.
1st vaccine - 12 hours after receiving the vaccine I got a metal taste in my mouth and extreme thirst. Up all night. Body felt "electrified". 2nd vaccine - 4 hours after receiving the vaccine I got aches and pains. This progressed over the next several hours to: 1) my skin felt like it was on fire; 2) followed by chills and shaking; (all night); 3) hallucinations; 4) extreme fatigue to the point I felt like I was buried in cement and couldn't get out of bed to go to the bathroom.  At one point I thought about calling an ambulance but my mind was unable to figure out how to do that.  24 hours after injection: 1) headache, mild body aches and some feeling of skin burning.
I received the 2nd Moderna vaccination on 3/25/21.  I woke up at 4 am on 3/26/21 with extreme chills & weakness.  I couldn't get warm.  I finally managed to get out of bed.  I turned up the heat, put extra layers of clothes on & lay on the couch with 3 blankets & I still couldn't get warm.  Later when I sat up, I used a heating pad too.  I spent the day going from couch to bed, battling the chills.  At 4 PM that day, I checked my temperature & it was 99.8 F.  My normal temperature is around 97.  My arm was red & very warm.  The area of redness covered my bicep.  Tender to touch & sore.  The chills went away on the 3rd day, but the redness was there for a week, gradually fading to pink.  Today it is gone.
Stiff  and sore left arm at injection site, redness and swelling. Ice packs and betamethasone cream. Advil. Resolved within 2 days
Evening of receiving vaccine - slight pain at injection site; lower back pain; extreme chills; body aches  Day after: slight back and neck pain; pain at injection site and  shoulder
Chills, Subjective fever, Sneezing, Runny Nose.   Chills became severe towards evening.  Fever broke during night while asleep.  Resolved the following morning.
At 7am the  morning after I took the second vaccination, I woke up with major flue like symptoms. My whole body ached all over. My left arm was swollen where they injected me and it so painful where I could not even move my left arm. I hurt every where throughout my body. I literally felt like I had been poisoned. I was running a 100 degree fever, I was nauseated and very fatigued. I felt dizzy and had to lay down all day.  I was a bit congested. I could not really taste food and had no appetite. I had some shortness of breath. This lasted for a couple days. The fever finally went away after 24 hours. I was nauseous and still had trouble eating four days after the shot. I?ve been tired and fatigued still five days after the shot but I seem to be regaining my strength slowly.
DEVELOPED DECREASE IN PLATELET COUNTS, CONSISTENT WITH IMMUNE THROMBOCYTOPENIA,  TEN DAYS POST VACCINATION.  PLATELET COUNT 7000 ON MAY 21, 2021. HE WAS ADMITTED TO HOSPITAL AND RECEIVED TWO DOSES OF IMMUNE GLOBULIN AND DECADRON WITH IMPROVEMETN IN PLATELET LEVELS. HE REMAINED ASSYMPTOMATIC.
I received the third GARDASIL vaccination at approximately 9:30 am on Friday February 20th. Around 7:30 om I began to feel minor weakness and muscle aches. At 1:30 am on Saturday, February 21st I woke up with a low-grade fever (99 degrees) around 3:30/4 am I woke up with a fever of 102.3 as well as all over muscle aches. The fever and aches continued for approximately 24 hours, until early on Sunday, February 22nd. I had no symptoms other than a fever and aches, and no other flu or cold-like symptoms, such as cough, runny/stuffy nose, congestion, or sneezing. 1glass of wine was consumed approximately 8 hours after the shot was administered.
Fatigue, scratchy throat. After 2 days chills and by 3rd day rash  on my stomach and back. Day 4 more fatigue and a dry cough then chills and fever at night. Cough is still present, actually worse and comes with yellow mucus. Nose is runny at times, but clear. Fever spikes up and down throughout the day the highest being around 101.
vertigo; This is a spontaneous report from a contactable consumer (husband). This consumer reported similar events for two patients. This is 2nd of two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no. and expiry date were not reported), via an unspecified route of administration on 30Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer (husband) and his wife received the first dose of the pfizer covid 19 vaccine on Saturday 30Jan2021. The patient (wife) experienced vertigo type symptoms on unspecified date. The outcome of the event was unknown.        Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106174 Same drug and event with different patient
Initial and follow up information has been received from a health professional concerning a 20 year old female patient with a history of 2 therapeutic abortions (2000 and 2004) abdominal pain, mild rectal bleeding, papilloma viral infection and sexually transmitted disease who on 08-JAN-2007 was vaccinated IM into the left deltoid with a second 0.5 ml of Gardasil vaccine (yeast) (lot#655619/1427F). Concomitant therapy included Risperdal and Celexa. The patient was reportedly pregnant at this time and did not tell the office. An HCG pregnancy test was done. The patient is scheduled for a prenatal visit on 19-JAN-2007. Her LMP was approximately 11-OCT-2006 and EDD 19-JUL-2007. An ultrasound on 18-JAN-2007 for gestational dates revealed of 7 weeks of 7 weeks and 3 days. The patient had an elective termination on 23-JAN-2007. There was no further information available. The patient received a first 0.5 ml dose of Gardasil vaccine (yeast) (lot#654540/0800F) on 23-OCT-2006 IM into the left deltoid. Upon internal review, elective termination was considered to be an other important medical event. Additional information has been requested.
A report has been received from a Medical Rep concerning an about 11 or 12 years old Male patient, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Once/Single administration. FLUMIST (intranasal) started on 10-Oct-2015. The patient experienced SWOLLEN LYMPH GLANDS which started on 11-Oct-2015 and RUNNY NOSE which started during Oct-2015. At the time of reporting, the event of SWOLLEN LYMPH GLANDS was ongoing and the patient recovered from the event of RUNNY NOSE on an unspecified date. The report was considered to be non-serious by the company physician.
arm pain; body aches; chills; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. Medical history and patient's concomitant medications were not reported. Historical vaccine included BNT162B2 on 31Dec2021 for Covid-19 immunization and patient tested positive for COVID-19, nausea, diarrhea, fatigue, loss of taste and smell and stomach upset. The patient reported symptoms of arm pain, body ache and chills after receiving the second f=dose of vaccine that lasted 12 hours. The patient recovered from the events on 26Jan2021.  Information about Batch/Lot number has been requested.
No redness but severe, pustule like rashy bumps on both upper arms lasting approximately 4 days
2/9/16 PM: fever to max of 100.7. 2/11/16 AM: 2 min. unresponsive episode staring during therapy and "not herself" x 20 min. Seen in office: Temp 98.6 normal exam. 2/11/16 4 PM: 2nd episode of unresponsiveness - admitted thru ER - nl EEG.
This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 47-year-old female subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to case 1 in the literature article. Concurrent medical conditions included mild strabismic amblyopia in her right eye. In October 1994, the subject received an unspecified dose of Influenza vaccine (unknown) (administration site and route unspecified, batch number not provided). 1 week after vaccination with Influenza vaccine (unspecified), the subject experienced decreased vision with transient eye pain. 5 days later, she developed blurriness in her left eye and optic disc atrophy. This case was assessed as medically serious by GSK. On examination, her visual acuity was 20/20 in both eyes, but Goldman perimetry showed a superior arcuate defect in right eye and an inferior altitudinal defect in left eye. There was no relative afferent pupillary defect. Both optic discs were moderately edematous with splinter hemorrhages and cotton-wool spots. The serum protein electrophoresis with immunofixation showed a nonspecific polyclonal hypergammaglobulinemia. The subject was treated with methylprednisolone and prednisone. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for abnormal serum markers (elevated sedimentation rate and polyclonal hypergammaglobulinemia). The visual field defects in either eye didn't improve and eventually, segmental disc atrophy appeared. At the time of reporting, the events were unresolved. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subjects recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Patient was given first dose of Pfizer-BioNTech today 8/10/21 but had received another COVID19 vaccine product in previously. Patient tolerated vaccination well without side effects/symptoms in office
febrile 101.9 on 8MAR99-fussy;adm to hosp;blood cult negative;CSF-119 RBC, 30 WBC;urine cult negative;glucose 59, CSF viral cult done;rx w/ATB x48hr;discharged;has done well;
This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6206, expiry date: unknown) via unspecified route of administration, in right arm on 05Mar2021 12:00 (age at vaccination: 66-years-old) as dose number unknown, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history of patient included heart attacks, gall stones/gall bladder removal, low thyroid on an unspecified date (2 heart attacks, gall stones/gall bladder removal, low thyroid good health altogether). Patient had no known allergies. Concomitant medications included Synthroid and Prasugrel al, (in two weeks) taken for unspecified indication start and stop date not known. No other vaccine in four weeks was administered. On an unspecifed date in Mar2021, patient experienced intermittent diarrhea. It's gotten better, but still patient got it at least every other week. No treatment was given for the adverse event. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient underwent lab test for antigen test (nasal swab) with negative results on an unspecified date in Jul2021. The outcome of event was recovering.
This spontaneous case was received from a medical assistant referring to a 2 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date, the patient was administered an unspecified dose of ROTATEQ (lot: N021026, expiry date: 24-FEB-2019) that was improperly stored (product storage error). The vaccine was exposed to a temperature of 74F for 5 hours. The call was because of a digital data logger. There was no previous temperature excursion. No adverse effects reported. This is one of the two reports received from the same reporter.
feverish and chills; feverish and chills; arm was a little sore and a little black and blue; frequent urination / he started to pee every 20 minutes; arm was a little sore and a little black and blue; the site bled a little bit; little site soreness like a flu shot; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262 and Expiration date was not reported), via intramuscular route, administered in Arm Right on 29Jan2021 14:30, as single dose for COVID-19 immunization. Medical history included shellfish allergy (had a weird shellfish allergy, he said that he can eat cooked shrimp and lobsters. He said that he was peeling raw shrimp and his fingers started to itch, he started to swell, and his eyes started to swell. He said that this happened twice and once with lobster. He was treated with Benadryl IV), diminished kidney function which was diagnosed in 2015 and ongoing (kidney issues run in his family, had a uncle on dialysis), kidney stone had it for years and ongoing and stated that they monitor it every once in a while and enlarged prostate. Concomitant medications included FLOMAX [MORNIFLUMATE], 0.4 mg, one capsule orally in the evening taken for enlarged prostate from an unspecified start date and ongoing. His next vaccine is due on 18Jan2021 at 14:30 (as reported). The patient did not receive additional vaccine on the same date of Pfizer vaccine and also he did not receive any vaccine within 4 weeks. On 29Jan2021, about 8 hours after receiving the vaccine, the patient started to pee every 20 minutes and this went on for most of the night about 05:30 30Jan2021. He wanted to know if this was a reported side effect of vaccine. He stated that he was overdue for urology appointment. He also enquired if it is more common to experience, increased side effects after second dose. He said that normally he would get up about every 3 hours to go pee. He stated that the next day he was fine. On 29Jan2021, the patient arm was sore and a little black and blue. He stated that he had a little site soreness like a flu shot that lasted about 2 days and was still a little blue and black. On 30Jan2021, that he felt slightly feverish in the middle of the night and little bit of chills. He stated that the next day he drank a bunch of water and he was fine. He stated that the feverish and chills was at about 03:00 in the morning 30Jan2021. The patient reported that the lady administering the vaccine said that the site bled a little bit, but he said that it was nothing. The patient did not go to emergency room or physician office as a result of adverse events. The patient did not underwent any relevant tests. The outcome of the events recovered for feverish and chills, arm was a little sore and a little black and blue on 30Jan2021, frequent urination / he started to pee every 20 minutes on 30Jan2021 05:30, little site soreness like a flu shot on an unspecified date.  Follow-up (27May2021): Follow-up attempts completed. No further information expected.