chrisvoncsefalvay/vaers-outcomes huggingface dataset:
25AUG92 4PM h/a, fever 101 as evening progressed fever 105, mom giving APAP & cool water baths; phoned MD 26AUG92-MD prescribed APAP, Pediform; temp dropped 101 then to 98.6;
My joints started to swell (especially my knees and elbows), low grade fever, and body aches for a few days
On 1/11/17 patient had several seconds of tonic-clonic movements of all extremities which self resolved. It was followed by sleeping for 30 minutes and return to baseline.
Pt was given Varicella, HPV & Hep A vaccine on 9/12/11. Developed (L) arm swelling & redness upper bicep/deltoid to elbow. Worse yest. Seen today, got Ibup. swelling decreased, redness present. Sl tender lost full ROM.
Extreme heavy period, blood clots larger than golf balls for over 24 hours, extreme fatigue,
MAJOR FACIAL DROPPING; ANXIETY; DEPRESSION; FIBROMYALGIA; BODY WEAKNESS; This spontaneous report received from a patient via media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, after the vaccination, the patient had a bad reaction after which she was rushed to the hospital. When at the hospital, her medical records showed she was diagnosed with body weakness, anxiety, depression, major facial dropping and fibromyalgia. After being in intensive care, she was taken to patient care for the following two weeks where she received occupational, physical and speech therapy.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the events of body weakness, anxiety, depression, major facial dropping and fibromyalgia was unknown. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: This report was obtained  from media and concerned a female patient, unspecified age who, on an unspecified number of days, was rushed to the hospital, where she was noted with h body weakness, anxiety, depression, major facial dropping and fibromyalgia. She was initially brought to intensive care then taken to patient care for the following two weeks where she received occupational, physical and speech therapy. The patient's weight, height, and medical history were not reported. The information provided precludes and meaningful medical assessment. More information will be sought when contact information becomes available.
some pain and tenderness associated with it and fills as if it's full of liquid; he felt a large swelling in his left arm pit; feverish; chills; aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 30th January 2020, the patient received Shingrix (intramuscular) .5 ml and Tdap Vaccine (intramuscular). On 31st January 2020, 1 days after receiving Shingrix and Tdap Vaccine, the patient experienced fever, chills and pain. On 4th February 2020, the patient experienced axillary pain and localized edema. On 1st February 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills was not recovered/not resolved and the outcome of the pain was recovered/resolved and the outcome of the axillary pain and localized edema were recovering/resolving.   It was unknown if the reporter considered the fever, chills, pain, axillary pain and localized edema to be related to Shingrix and Tdap Vaccine.  Additional information was provided as follows: The patient received vaccine on his left arm. The patient felt feverish and had chills, he also had some general aches and pains. The symptoms were resolved. However, the patient still got chilly at night which was unusual for him. At the time of reporting, 5 days after vaccination, the patient took a shower and when he applied deodorant, he felt a large swelling in his left arm pit. It had some pain and tenderness associated with it and filled as if it's full of liquid. The reporter did not consent to follow up. The outcome of the events were reported in source document as recovered and resolved with sequel, however it was reported as recovered and resolved.
J96.00 ACUTE RESPIRATORY FAILURE 3/19/2021 PLEURAL EFFUSION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/4/2021 PLEURAL EFFUSION J96.00 ACUTE RESPIRATORY FAILURE 3/19/2021 PLEURAL EFFUSION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/4/2021 PLEURAL EFFUSION
coughing; loss of vision comes and goes; Chills; body and back pain; body and back pain; Fatigue: he has been in his bed and falling asleep in his chair for the past few days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8131), via an unspecified route of administration on 14Apr2021 at 09:20 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The first vaccine has been experiencing loss of vision, chills, body and back pain, and fatigue for the past 3 days, from 14Apr2021. He wanted to know if he should go to the ER. The patient was audibly coughing while on the call. He went to the appointment at 09:20 on 14Apr2021 and while driving back he noticed the loss of vision at about 10:15 on 14Apr2021. He said that the loss of vision comes and goes but is still persisting. On fatigue: Patient has been in his bed and falling asleep in his chair for the past few days. Chills, body and back pain and fatigue were reported as worsened. The outcome of the events loss of vision, chills, body and back pain, and fatigue was not recovered, while of coughing was unknown.
had oral lichen planus; This spontaneous case was reported by a patient and describes the occurrence of ORAL LICHEN PLANUS (had oral lichen planus) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 36C21A and 016C21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. No medical history related to mentioned AE and both acute and chronic illnesses at the time of vaccination. There were no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Allergic reaction to bee sting. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE BESILATE (NORVASC), PRAVASTATIN SODIUM (PRAVACHOL) and METOPROLOL SUCCINATE (TOPROL XL) for an unknown indication.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, the patient experienced ORAL LICHEN PLANUS (had oral lichen planus). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. At the time of the report, ORAL LICHEN PLANUS (had oral lichen planus) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had biopsy on 19-May-2022 and he did not know if it was related or not to the vaccine. The AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past. Reported that symptoms were improved.
Sore arms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arms) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arms). At the time of the report, PAIN IN EXTREMITY (Sore arms) 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.   Treatment information was not provided.
16 Year old boy accidentally got Moderna shot; A spontaneous report was received from consumer, concerning her son, a 16 years old male patient who accidentally received Moderna's covid-19 vaccine (mRNA-1273).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Feb 2021, the patient received first of two planned doses of mRNA-1273 (lot no:024M20A) intramuscularly for prophylaxis of covid-19 infection.  On 22 Feb 2021, a 16-year-old boy accidentally got Moderna vaccine shot.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event 16-Year-old boy accidentally got Moderna shot was considered recovered on 22 Feb 2021.; Reporter's Comments: This report refers to a case of a 16-year old male patient who accidentally received Moderna's covid-19 vaccine (mRNA-1273) lot # 024M20A with no associated AEs.
Covid 19 positive; Covid 19 positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Sep2022, outcome "unknown" and all described as "Covid 19 positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Sep2022) Positive, notes: Covid 19 positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Thank you for your email. Patient directly reported me the event, patient/reporter refused to be contacted for follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Starting in end of may of 2021 beginning with headaches along right side of face originating from my ear along the trigeminal nerve. Was treated for ear infections with success. Had MRI and was seen by my ENT without improvement. then week of thanksgiving my csection became abscessed and opened draining purulent drainage followed by a purple to right 4th toe with pain. Have seen PCP, foot specialist, and now a vascular surgeon. Had more labs, MRI with contrast, ABI, and CTA with contrast which shows large amount of plague buildup with lipid panel within normal. left lower leg has no circulation and right lower leg is limited.
This case was reported by a consumer via patient support programs and described the occurrence of chills in a 68-year-old female patient who received SHINGRIX (batch number ZN22Z, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (For tolerance after 1st dose of SHINGRIX, refer case US2018GSK121493). On 25th June 2018, the patient received the 2nd dose of SHINGRIX 50 µg. On 25th June 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and general body pain. On 25th June 2018, the outcome of the chills, fever and general body pain were recovered/resolved. The reporter considered the chills, fever and general body pain to be probably related to SHINGRIX. Additional details were reported as follows: The patient experienced body ache. The patient did not have any seriousness criteria (hospitalized, life threatening, disability, death, surgical or medical intervention or congenital anomaly). For tolerance after 1st dose of SHINGRIX, refer case US2018GSK12149.
Pt. states that after receiving the 3rd Booster of Moderna 10/25/2021, started experiencing symptoms 10/30/2021 of swollen bump in the left leg (thigh), electrical "shocks" throughout the left leg around the knee area. Orthotics Primary visit 11/20/2021 evaluated Knee was normal, Primary visit 11/09/2021 evaluated with no recommendations. Blood Work = Normal X-Rays = Normal
Patient developed symptoms of sinus congestion around 07/13/2021. She has pressure that is in her cheeks, forehead, and into her ears and gums. Also has had a headache, vomiting, mild cough, loose stools.
Patient was scared and crying during immunizations. After felt dizziness and laid down on exam table for 3-5 minutes. BP 111/69 laying down, sitting 117/61, standing 100/75. Patient stated felt better and had patient sit in waiting room for 10 minutes before leaving. Patient seemed might have been scared and not experiencing dizziness.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 025821A and 044A21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 27, 2021, patient experienced vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks). At the time of the report, vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks) outcome: unknown. No concomitant medications or treatment information reported. The patient stated the black and blue mark went away after 2 weeks and then came back in late September. This case linked to MOD-2021-066619 (patient link).
Started 4/10/21 at night, with muscle and joint pain. At 1am 4/11/21 got chills that lasted an hour, followed by a fever of 100F and a headache. It is currently 7:54pm CDT and I still have hot flashes and a headache. Slept most of the day.
I developed subacute thyroiditis 5 days after vaccination. I had pain and inflammation in my thyroid, neck and mouth. My THS , T3 and T4 indicated hyperthyroidism and subsequent hypothyroidism. I continue to take medication for hypothyroidism at 7 months and was feeling extreme fatigue, brain fog and lightheaded/ill until abt 8 weeks ago.
Redness, swelling and rash at injection site. Itchy as well. About 4 inches x 3 inches of redness. Have not sought medical attention as of  5/1 due to reading about ?COVID arm? related to COVID injection.
Raised, warm welt (approximately 2 inches diameter) at injection site, moderate itching at injection site
lump red; warm, hot; itchy; fever; big red mark at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (big red mark at the injection site), INJECTION SITE MASS (lump red), FEELING HOT (warm, hot), PRURITUS (itchy) and PYREXIA (fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, IBUPROFEN, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LURASIDONE HYDROCHLORIDE (LATUDA), OMEPRAZOLE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA 24 HOUR) and BUPROPION for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (big red mark at the injection site). On an unknown date, the patient experienced INJECTION SITE MASS (lump red), FEELING HOT (warm, hot), PRURITUS (itchy) and PYREXIA (fever). At the time of the report, INJECTION SITE ERYTHEMA (big red mark at the injection site) had not resolved and INJECTION SITE MASS (lump red), FEELING HOT (warm, hot), PRURITUS (itchy) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medication was Ibuprofen.
Itching  throat,mild swollen  tongue, breathing was ok, no  SOB, Oxy  sat 97% patient was given diphenylhydramine 25/10ml and the patient was observed for half hour
After receiving my second vaccination of Pfizer-BionTech Covid 19 injection, I have the following side effect. 1.Burning of the Tongue and mouth, Sluffing of the mouth skin, and Flim over Teeth, and Dry Mouth.
Narrative: 05/06 UA shows bacteruria and hematuria, prescribed nitrofurantoin 05/12 COVID vaccine dose #1 05/17 pt reports having "numbness in face, legs and feet; stopping antibiotic" 06/02 COVID vaccine dose #2 no further complaints or treatment for complaint
1:20PM 'PT FEELS SOB, LIGHT HEADED & EARS ARE RINGING'. DENIES ANY DYSPNEA.  W/D, RESP REG WITH EASE, NO LOC.  1:40PM JUICE GIVEN P.O. - 'FEELS BETTER'.  PLACED IN WHEELCHAIR/WAITING ON BOYFRIEND TO TAKE HER HOME. 2PM PT STATES 'SHE FEELS BETTER' . BOYFRIEND STATES HE WILL STAY WITH PT. RESP REG WITH EASE, NO ACUTE DISTRESS NOTED,  AMBULATORY - GAIT STEADY. 3-3-21 10:15AM PT STATES SHE' FEELS FINE' ALL S/S RESOLVED.
Pt. rec'd vaccination Friday afternoon 10/10/14. Rash, hives developed Saturday afternoon. Pt was given injection of KENALOG and DECADRON and advised to take CLARITIN for next several days. Rash and hives present on arms and upper torso.
Shortness of breath with minimal response to inhaler/nebulizer. Patient also had fever and chills but those resolved in about 1 day.
On 8/27/21 Provider recived request for medical exemption for 2nd COVID 19 vaccine. Pt stated had throat swelling with first dose a few hours after vaccine. Stated left side of throat swelled up and had shortness of breath. Did not take anything for it of seek medical attention. Lasted approx. 20 min.
Patient has recurring fever sometimes as high as 103 degrees. Fever reducer has alleviated  the symptoms but it is recurring.
pt recv vax 12JUN97 & 12JUN97 pt exp inj site pain w/no consequence;
PT WAS VACCIATED WITH MODERNA 3/11/21 (LOT 048A21A) + 4/15/20 (LOT 021A21A). S/O BEGAN 8/24/21, TESTED + 9/1/21
Within minutes of receiving the shot Patient  complained of feeling like she was going to pass out. At this point we had her lay down on the exam table where her eyes then rolled back and she passed out followed by convulsing/seizure.  Eventually we were able to get her to wake up. She was very disoriented and weak. She was then given some juice and continued to lay down.  As of 10:00 pm 8/10/2021 Patient is still complaining of not feeling well.
Sore breast on side of injection site, sore nipple and breast tissue directly behind nipple.   No treatment applied, went away 48 hours after starting
BP 120/70, HR 76, general rash-BENADRYL given at 12:00pm. Mom came to school to pick up. Received H1N1 this am at school. Approx 1200pm c/o rash to school nurse.
C/o raised, hot, swollen, sore left arm that began at the start of her 11PM-7AM shift and worsened during the night. The symptoms lasted for a few days, lessening over time with massage. She was encouraged to seek medical attention, but she did not go.
Initially no symptoms No pain One hour later pain and swelling at the injection site No systemic symptoms  Went out to dinner Went home as late and laid next to my wife at 11 PM Fell asleep Woke up at 4 AM shivering but it seemed cold out 50?s overnight temp) Left arm pain much better  No rash No more swelling Kept on waking up all night despite covers shivering  Got up at 7 and didn?t feel great Nonspecific myalgias Mainly neck shoulders and upper back Was visibly shaking  Could not get warm Turned up the heat Took a shower which helped all symptoms Sx better but persistent for 1 hour post shower Felt not right and checked my temp and it was 101.2  I take generic Oxy and NO Tylenol as have only one kidney after transplant donation to my wife 6 years ago Mild ?post op CKD? w Cr 1.5 and stable x 6 years)  With fevers knew this was side effect  I?ve had flu vaccines without problems First dose no similar systemic SE About 3-4 months ago No GU or other source of fevers I can tell Felt clearly vaccine related Maybe hyper amnestic response? Still w aches and fevers No rash Will try a Tylenol 500 mg and lots of fluids and watch Sx Felt I?d report it as advised and esp as a health professional (GASTRO x 20 years academic medicine)
Refrigerated vaccine was administered 2 days after the Beyond Used Date.  Beyond Use Date was 11/01/2023. Vaccine was administered on 11/03/2023.
Information has been received from a licensed practical nurse concerning a 6 year old patient of unknown gender. On 21-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
1. Sharp headache in middle of my head. 2. Ringing in my right ear
Information has been received from a physician concerning a pt who was vaccinated with a dose of varicella vaccine. Subsequently, the pt experienced severe chicken pox. The pt recovered from the severe chicken pox. Additional info has been requested.
Redness and swelling around site of vaccine. No treatment. Patient got better the next day.
Administration of incorrect vaccine, ZOSTAVAX instead of VARIVAX. No known ill effects.
Headache, Myalgia, Fever, CHILLS, PAIN AT INJECTION SITE Narrative:  Other Relevant History:
Pain, swelling, hardness in the injection site. Headache, chills, nausea. My temperatura regularly is 95F (35C), today reach 100F (37.9C). Slightly dizziness Weakness; Just want to sleep.
Day #2 patient laft leg edema, reddness and warmth noted.  area noted to be from groin to knee.  Site painful. Child to ER. Dr. ordered Benedryal and Keflex and child sent home. On 4-12 parents took child to Dr., CBC WNL DX: no infection, allergic reaction, keflex and benedryal continue. Site gradually improving.
Tiredness, pain in right side of the body stopped at knee, dizziness, unbalance, loss of appetite, symptoms continued about a week, pain in back, burning effect,  takes Tylenol every 8 hours
I was prescribed PAXLOVID. I was feeling really tired, achy and loss of taste and smell. I went to the doctor and was given a COVID test and it was positive.
Vaccine given on 7/27/05. On 7/29/05, patient developed hives all over face, low grade fever and nasal congestion. Patient seen 8/1/05. Patient was afebrile except for fading hives.