chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hip problems/Hip problem became critical/He was almost crippled; Unbearable pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Hip problems/Hip problem became critical/He was almost crippled) and ARTHRALGIA (Unbearable pain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced CONDITION AGGRAVATED (Hip problems/Hip problem became critical/He was almost crippled) and ARTHRALGIA (Unbearable pain). At the time of the report, CONDITION AGGRAVATED (Hip problems/Hip problem became critical/He was almost crippled) and ARTHRALGIA (Unbearable pain) was resolving.            No relevant concomitant medications were reported. No treatment information was provided It was reported that events lasted for 2 months, since then became a little bit better   This case was linked to MOD-2021-322467.
postherpetic polyneuropathy; herpes zoster; This initial spontaneous report was received from a lawyer on 06-MAR-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or around 02-MAR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (the dosage regimen information was not reported) for the prevention of shingles (herpes zoster). On an unknown date (also reported das "shortly after receiving the vaccine"), the patient suffered sudden pain in right flank and abrupt onset of a skin rash. The patient was diagnosed with herpes zoster with postherpetic polyneuropathy. As a direct and proximate result of vaccination, the patient's symptoms have resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the vaccination, the patient sustained severe and permanent personal injuries. Further, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages.
G40.901 STATUS EPILEPTICUS 11/30/2021 ANEMIA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 10/3/2021 ANEMIA J96.00 ACUTE RESPIRATORY FAILURE 11/30/2021 ANEMIA G40.901 STATUS EPILEPTICUS 11/30/2021 SEIZURE, UNSPECIFIED I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 10/3/2021 SEIZURE, UNSPECIFIED J96.00 ACUTE RESPIRATORY FAILURE 11/30/2021 SEIZURE, UNSPECIFIED
Fever (100.9-101.4) for 36 hours straight, body aches, headache, nausea, generalized fatigue.  Side effects were almost bad as to keeping me from doing basic daily tasks like feeding dogs
Patient in for her 2nd Pfizer covid vaccine dose, has history of dizziness with vaccinations, assisted to immunization room, given vaccine in supine position. 2 mins after vaccination, patient reported feeling dizzy. 3:50pm BP 105/69 HR 63 O2Sat 99%, remains alert and responsive. Advised to conitnue deep breathing and try to relax. 3:55 PM patient states she feels a little better BP 108/73 HR 65 Sat 100%. Advised patient to remain in supine position. 4PM, patient denies dizziness, BP 103/67 HR 59 Sat 98%. BP rechecked at 4:3pm 107/71, assisted in a sitting position (legs still up in the exma table/bed) 4:05pm BP 100/75 HR 71, Sat 100%. Denies diziness. 4:10PM sitting with leg dangling BP 104/72 HR 79 Sat 99%. Patient states she feels better, assisted into standing position 4:15PM BP 106/71 HR 66 Sat 99%, no dizziness, Patient to be discharged, assisted by NP to patient;s vehicle. Advised to contact primary MD if any other symptoms arise.
This spontaneous report as received from a nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with GARDASIL that was improperly stored. Dose, route, frequency, lot number and expiration date were not reported. No adverse effect reported. This is one of two reports from the same source (other case # 1407USA012568). Additional information has been requested.
Reported substantial swelling where she has filler in her lips, cheeks, under eye, chin.
9/24/2022-Presents to ED, c/o SOB. Recent d/c for PNA. Sat 93% on 3L. Bipap. ABG-7.37/57.3/49/ o2 sat 5L nc.  CXR-diffuse air space disease. WBC-11,EGFR- 39.Ordered Zosyn and vanco in ED.  Vanco, cefepime and flagyl, Admit hypoxemic resp failure s/t of multilobar pna. Covid - on admit.  9/25/2022-ID consult-stop Flagyl continue cefepime and add doxy.  9/26/2022- Remains on Bipap/HFC.  9/30/2022- Now on 4L, afebrile. Cefepime descalated to ceftriaxone 10/4/2022- Down to 2L nc.  10/5/2022- Last day of antibiotics, 2L nc bipap at HS, VSS. 10/6/2022-Covid +  10/8/2022- VSS, started on dexamethasone and remdesivir, on 2L nc.
She contracted what i thought was scarlet fever nearly two months after injections but all symptoms also line up with the adverse reactions to the GARDASIL 9 shot.
Along with slight chills and the temperature of 98F, I experienced unusual sensations (brain zaps) for a several minutes, on and off. It was not exactly an adverse event but I thought it was interesting.
There is persistent redness at center and scattered red dots in vicinity. The pharmacist advises me to use antibiotic ointment, but I'm worried about the redness. Not sore, not tender, but first time in decades of taking flu shot that I've had any reaction. I hope the ointment will help. My wife doesn't have this red infected look on her arm, but she does have itching periodically at the site. We wonder whether this batch of flu vaccine is different from past or has some defects.
Chest pain, numbness in my arm,  rapid heart beat, head aches. This happened a week after my first shot, subsided right before my second one and came back.
mom recv vax 30APR96 & denied pregnancy @ time of inj;later found was pregnant;baby born 3JAN97 wt @ birth 6#7oz;baby born w/imperforate anus-required colostomy-also born w/pyloric stenosis;
Patient received Moderna COVID vaccine and was only 17yrs of age.  This was the first vaccine in the series.  Patient will be 18yrs of age when she receives her 2nd dose of Moderna in the series.  No adverse events reported.
Nausea; Chills; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) in a 65-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea), CHILLS (Chills) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
HEP B vac was ordered and given.  Hep A Havrix was also given and not ordered. It is a vaccine approved for 12-18years.  No Adverse events took place.  No side effects or reactions noted. Patient left clinic without issue and in no acute distress.
Case number PHEH2013US024036 is an initial spontaneous report received from a pharmacist on 13 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to an adult female patient. She was vaccinated with FLUVIRIN (batch number: unknown) on 10 Nov 2013. It was reported that during withdrawal of the needle, some of the vaccine ran down the patient's arm, therefore she did not receive the full dose. No adverse event was reported following medication error. The pharmacist commented that it was because of misuse or malfunction of the device (which was supplied by Vanish Point). Follow-up received from the pharmacist on 16 Dec 2013: Updated comment from the reporter regarding syringe of the vaccine.
Two days after the shot, pain in thumb and index plus wrist in right hand, pain in thumb and index finger left hand.
I suffer chronically with Cyclic Vomiting Syndrome and this vaccine caused a so far 5 day long episode of vomiting. Symptoms are extreme nausea and vomiting, diarrhea and severe fatigue as well as muscle aches.
Received Flu vaccine on 12/21/2005.  Rash started 12/23/05.  Complained of itching and rash on upper torso.  States "looks like measles."  No fever or other symptoms.  Has Fractured arm (5 weeks ago) and is under care of a doctor.  States no pain meds
Seen in office after Td given on 1/3/04. Complained of itching, localized redness, swelling at site of the Td booster. 1/7/05 A lump has remained and is getting larger and sore. Referring to general surgeon. Exam 9 weeks post injection; 2 cm firm nodule at deltoid.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 21-FEB-2019 the patient was vaccinated with one dose of improperly stored VARIVAX injection (dose and frequency was not reported) (lot # R023502, expiry date: 16-AUG-2020) via subcutaneous route for prophylaxis. The sterile diluent (MRK) injection that was used to reconstitute the VARIVAX was stored properly. No adverse effect was reported. No product quality complaint was involved. The VARIVAX vaccine underwent a temperature excursion: 6 degree Fahrenheit (°F) to 14°F (7.2F) for a time frame of 4 hours. No previous temperature excursion was reported. Digital data logger was involved.
HEART RATE INCREASED; BODY FEELS HOT; CHILLS; HEADACHE; MUSCLE ACHE; This spontaneous report received from a parent concerned a 31 year old female. 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 admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 12:40 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced heart rate increased. On 05-APR-2021, the subject experienced body feels hot. On 05-APR-2021, the subject experienced chills. On 05-APR-2021, the subject experienced headache. On 05-APR-2021, the subject experienced muscle ache. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) Increased. Treatment medications (dates unspecified) included: naproxen sodium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, heart rate increased, headache, body feels hot, and muscle ache. This report was non-serious.
17 year old patient getting vaccine with her mom. She was scared to get the vaccine. Stood up too quick after getting it felt faint and dizzy couldn't see or hear. got her some water she was sweaty. medics were called they checked her out. she did not go with them or to hospital she went home with mom.
Patient received Tdap vaccine and later complained of severe redness and swelling at the injection site.
HEADACHE, CHILLS, SWEATS, FEVER OF 101.3, BODY ACHES, EXTREME FATIGUE. I BROKE THE FEVER BUT THE HEADACHE AND FATIGUE IS STILL HERE.
TENDERNESS AT INJECTION SITE; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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 admin not reported, batch number: Unknown) dose, start therapy date were not reported 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, the subject experienced tenderness at injection site, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness at injection site and slight headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210436174.
Headache and left arm swelling/pain. Induration and erythema measures 10 x 6 cm on 6-29-07 at site of injection recovering.
There was an excursion from their freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided. There was excursion from freezer on 01 oct 2021 , gave Excursion above 1 hour.
Fever 103-105 degrees for 4 days. Left arm red, swollen, bluish discoloration elbow to shoulder, pain with movement. Resolved 10/4.
Started flu sx evening 11/6 (presumed H1N1). Took Ibuprofen only. On 11/11 had staring spell, became nonverbal. Ambulance got normal glucose. Slowly improved over 2 hr in ER. Diagnosed "fatigue, 1st menses" I think this was a CNS symptom of influenza. Seen in office 11/12 normal neurological exam. Phone next day still sleeping a lot. Improving at date of report. Update: Pt hospitalized 11/15 - 17/09 for altered mental status. Extensive work up [EEG, LP, MRI, CT, Viral titers and PCR's] failed to identify a cause. As of today she is definitely improved.
Started with very itchy rash starting on 04/02/2002. appeared as clusters papules 2-3mm on area and much more on trunk, and extremities.
Coughing, Tightness in Throat, Airway Edema, Wheezing
cellulitis in elbow of injected arm; This is a spontaneous report from a contactable healthcare professional (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at right arm on 15Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included known allergies to penicillin and sulfa. Concomitant medication included acyclovir. The patient was not pregnant at the time of vaccination. The patient experienced cellulitis in elbow of injected arm on 03Feb2021 07:00 with outcome of recovering. Therapeutic measures were taken as a result of cellulitis in elbow of injected arm (cellulitis) with doxycycline as treatment. The event resulted in doctor or other healthcare professional office/clinic visit. The patient already took the second dose of BNT162B2 (lot number: EL9264) on 05Feb2021 08:00 at the right arm.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported cellulitis cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Vaccine 5 y/o - < 11 y/o given in error to patient who is 17 y/o.
I was mainly tired for the day after receiving the vaccine with a little soreness in the arm. On 07/19/2022 I tested positive with a home test for COVID-19. I went an urgent care facility for a prescription for PAXLOVID. Prior to going to urgent care, I drank lots of fluids and took TYLENOL. I had a cough, fever, cold and/or hot, achy and l lost taste/smell.
Day of dose #2 vaccination: nausea, extreme soreness of site of vaccination For the next two week: on-off nausea, left leg cramping pain while walking, "felt like she had the flu" Now, completely fine
Syncopal event: At 15 minutes post dose patient reported feeling faint in her chair in our waiting area. She was very pale and sweaty, c/o palpitations. Moved to a chair legs that elevate, given some water, refused food, (says she ate lunch prior to coming for vaccine) , We monitored her for about 1/2 hour and then she felt fine.
The patient is diagnosed with a right bundle branch block and an enlarged/dilated right ventricle. The Patient has had constant chest discomfort located over the heart after a month from receiving the vaccine. The patent has also experienced higher levels of exhaustion than normal. One event, while the patent was a rest, he experienced an increase in heart rate, blood pressure, nausea, and difficulty breathing. The patent nearly passed out. The following day the patient experience pain in the heart while running.
Information has been received from a physician concerning a 31 month old white female infant with no known allergies who on 13 DEC 1999 was vaccinated SQ in the left arm with a .5 mL first dose of varicella virus vaccine live (lot #631774/1034J). There were no concomitant medications or illnesses at the time of vaccination. It was noted that a rash did not occur at the site of injection or elsewhere within 42 days of vaccination. On 24 JUL 2001 the infant presented to the physician's office with herpes zoster (onset date of 17 JUL 2001) and was reported to have been fussy and uncomfortable. The lesions were distributed on the right dorsal forearm and 10-12 vesicles (in a 2.5 cm circle with one vesicle more dorsally near the wrist were present. It was noted that the infant was exposed to her mother who had a history of shingles in Nvember 2000. The infant's mother reported that the child has had the rash for approximately a 1-week duration. The infant was not treated with antivirals since the herpes zoster was of one week duration. There were nor prior adverse events following previous vaccinations. It was noted that the infant did not have a history of chickenpox and that the specimen was not obtained for PCR analysis. Follow up information has been received and indicated that infant has not been seen since the experience, and that it was unknown if she recovered. Additional information is not expected.
Patient passed through booster event of covid-19 Pfizer was told at check in she was not elidable for booster due to her first vaccine in series being Moderna. Since she was in same vehicle with her husband (who's first dose was Pfizer and there for booster dose) Misinformed vaccine staff she had moderna as primary dose and received Pfizer as second shot in her Covid series. Patient had no adverse reaction during her 30 minute observation period. Dr notified.
Neck stiffness. A nsg reported that an infant received his 1st Prevnar along with doses of Tripedia, Act-HIB, and IPOL vaccines on 5/2/01. 4 hrs post immunization the infant developed neck stiffness, described as the infant's head leaning to one side. The next day, he was seen in the ER. A lumbar puncture was performed, the result was clear. The reporter indicated that the infant refuses breast milk but will take a bottle. The physician suspects possible torticollis. Follow-up info received from the vaccine provider on 07/17/2001 indicated that the infant was evaluated by an MRI; no results werre found. The infant's symptoms improved over the next 4 to 6 weeks. On 07/09/2001, the physician stated that the infant received Prevnar, OPOL HIB and DTaP vaccines with no symptoms or adverse effects. The reporter also provided lot numbers for the concomitantly administered vaccines.
Mastitis in left breast, taquicardia, Arrithmia, swollen chest, short breath, chest pain.
DTP#4 26Apr91,feverish over wkend.Tenderness & lump @ inject site,rt deltoid,no impaired use of arm.Exam: 20X22mm induration in SQ fat(which is 3/16-1/4"thick) /w overlying violaceous skin.Advised:hot soaks 15 min qid &APAP.Call in 1 wk.
Pfizer Covid 19 vaccine for 12 year and up given instead of 5-11 year vaccine. Patient did not have any side effects after first dose was given.  Clinic became aware of this four days after it was given and family was notified and patient was doing well.
Numbness in fingertips and bottom of feet. Patient already taking Gabapentin and if symptoms do not resolve in the next  two weeks, to follow-up with her primary care physician.
Pt recvd vax & 13 hrs later exp numbness, tingling, weakness, swelling, erythema of rt arm;
Right arm has been painful and tender at the injection site ever since I got the shot on 12/2/21. I reported it to my doctor on 12/23/21.
On June 2nd and 3rd I felt like I just had seasonal allergies but then I had sweats and chills.  And then I began to have a cough and it was so strong that each time that I coughed I had bladder leakage.  I had body aches and my sense of taste and smell were  minimized.  Symptoms progressed and then subsided within about 4 days.  I had visited the doctor on June 4th and got the PCR that was positive and was prescribed an anti viral.  After about another few days I was feeling much better.  The symptom that lingered the longest was fatigue and lack of stamina.
SWELLING, RED, WARM TO TOUCH-BENADRYL 50MG
Arm was warm, swollen, red, itchy. Pt advised cold compress to area. Tylenol or Ibuprofen for discomfort, monitor for infection.
Approx 2 hours after vaccine, patient developed chest tightness, unrelenting cough. Returned to office, treated with albuterol nebulizer. Developed shaking chills approx 6 hours after vaccine. Treated with BENADRYL & Prednisone. Doing well the next day.
Arms hurt after receiving a dose; In bed sick like the flu; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arms hurt after receiving a dose) and INFLUENZA LIKE ILLNESS (In bed sick like the flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Arms hurt after receiving a dose) and INFLUENZA LIKE ILLNESS (In bed sick like the flu). At the time of the report, MYALGIA (Arms hurt after receiving a dose) and INFLUENZA LIKE ILLNESS (In bed sick like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.
Patient reported dizziness and headache 15 minutes after injection. At 30 minutes after shot patient complained of swelling feeling in neck. Denied shortness of breath but stated that she had an itchy feeling in throat. Patient was clearing throat and had a slight cough. EMS was contacted and upon examination stated there was some swelling in throat and they suggested transport to hospital. Patient agreed and was transported.
lot # FL2757 with manufacturer's expiration date of Sept 30, 22. Information has been received from the manufacturer indicating that stability and efficacy data supports the use of this product through Oct.19, 2022