chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received second dose of vaccine. Within 1 week, she developed significant lymph node swelling involving the neck, along with fatigue.  She went to her primary provider who obtained blood work, which demonstrated WBC count of 92.7 with 63% blasts.  She underwent bone marrow biopsy and was diagnosed with T-cell acute lymphoblastic leukemia (T-cell ALL). She is currently completing an intensive chemotherapy regimen.
Pt returned to clinic 2 days post vaccination, with left arm reddened and swollen and itchy.  Left upper arm at immunization administration site.  Benadryl and ice to site ordered.
Shivering, severe muscle pain, 100 degree temperature, pain at injection site, feeling extremely tired. Shivering gone and temperature normal after 24 hours. Still have muscle pain after 17 hours but less severe. Still tired after 17 hours but not as much as first 24 hours.
Bad headache; Joint ache; Left arm swelling; Red rash; first dose given on 17Feb2021, second dose on 03Mar2021; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 03Mar2021 at 10:30 (at the age of 67-years-old) as dose 2, single for COVID-19 immunisation. Medical history included multiple sclerosis and penicillin allergy both from an unknown date. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Concomitant medications included ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 17Feb2021 at 10:30 (at the age of 67-years-old) for COVID-19 immunisation. On 03Mar2021 at 21:00, the patient experienced bad headache, joint ache, left arm swelling, and red rash. The patient was administered with first dose of BNT162B2 on 17Feb2021 and second dose of BNT162B2 on 03Mar2021 which was an inappropriate schedule of vaccine administered. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received the Moderna Bivalent booster on 10/12/2022. On 1/2/2023, I had a sore throat and a headache during the evening. On 1/3/2023, I had chills, lethargy, headache, and runny nose. I took a home antigen test that day and got a positive result. At about 6 or 7 PM, I began to have nausea and diarrhea. I vomited once that evening. On 1/4/2023, I woke up with a severe headache. I then took some ADVIL, which got rid of the headache. Once the headache lifted, I felt fine again. I didn't feel sick anymore. I had a telehealth visit with my doctor that morning, also. He prescribed me PAXLOVID, ondansetron, and an ADVAIR inhaler. When I got the medication, I no longer felt sick, since the ADVIL had gotten rid of the headache, but I went ahead and took the PAXLOVID and ADVAIR my doctor had prescribed me. I didn't need the ondansetron anymore, since I was no longer nauseous. From this point on, I didn't really feel like I had COVID-19 symptoms, though I did have a very mild headache. One downside, though, was the metallic aftertaste that was caused by PAXLOVID. Also, after about 3 days of taking the PAXLOVID, I began to have loose stools. However, it was nothing serious. On 1/9/2023 and 1/10/2023, I took home antigen tests and got a negative result both times. I also did a PCR test at a doctor's office on 1/3/2023, and I got a positive result. At the time of this writing, I still feel normal and well.
Rheumatoid arthritis; agitated; patient is very sensitive to medication, oversensitive, also to other injections; severe diarrhea; extremely tired; severe headache; joint pain; vomiting; Tremors, all body shaking / hands shaking; This case was reported by a pharmacist via call center representative and described the occurrence of rheumatoid arthritis in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 3N7F2, expiry date 25th March 2022) for prophylaxis.   Concurrent medical conditions included drug hypersensitivity (very sensitive to medication, oversensitive, also to other injections).   On 17th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced agitation, vomiting and tremor. On 17th August 2020, the patient experienced joint pain. On 18th August 2020, the patient experienced diarrhea, tiredness and headache. On an unknown date, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant) and drug hypersensitivity. The patient was treated with paracetamol (Tylenol). In August 2020, the outcome of the agitation was recovered/resolved. On 21st August 2020, the outcome of the vomiting, diarrhea, tiredness, headache and joint pain were recovered/resolved and the outcome of the tremor was not recovered/not resolved. On an unknown date, the outcome of the rheumatoid arthritis and drug hypersensitivity were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, agitation, vomiting, tremor, diarrhea, tiredness, headache, joint pain and drug hypersensitivity to be related to Shingrix.  Additional information was provided as follows: The same evening of receiving vaccine, the patient had joint pain, and then took Tylenol. On Tuesday, 18th August 2020, the patient woke up with severe headache, extremely tired. During afternoon, she had severe diarrhea. Pharmacist also reported that the patient had tremors, all body shaking. She couldn't even use her phone because her hands were shaking, also she was vomiting.  On Thursday, 20th August 2020, patient was feeling better, only agitated. On Friday (on the day of reporting), 21st August 2020, patient was feeling better, all symptoms stopped, only her hands were still shaking. The reporter consented to follow up.
Pt (R) arm with urticaria from site of injection to midway to elbow. Pt does not complain of pain, just itching. Pt denies shortness of breath or difficulty breathing. Pt treated with BENADRYL and Hydrocortisone cream 0.5%.
Information has been received from a physician concerning a 35-month-old female with no pre-existing allergies, birth defects, or medical conditions who on 22-NOV-2004 was vaccinated subcutaneously with a first dose of Varivax (Lot # 649444/0649P). On 03-NOV-2006, the patient experienced a rash on her trunk, arms and legs. There were no relevant laboratory or diagnostic data. On 08-NOV-2006, the patient recovered. There were no adverse events following prior vaccinations of the patient or her siblings. There was no illness at the time of vaccination. No additional information to report. Additional information has been requested.
Initially she experienced fever, fatigue, aches, chills.  Then later, several days of tightening chest leading up to heart attack (20 days post vaccine).  Doctor expressed surprise by heart attack.  Not sure if there's a connection, but thought I'd submit.
09/04/10 - scratchy throat, nasal congestion, chills, very low fever. 09/06/10 - scratchy throat, fever and chills gone, but developed cough. 09/14/10 - still have nasal congestion and cough. A friend received a flu shot at her doctor's office on a different date she went out of town & developed the same symptoms that I had exactly 6 days following her flu shot.
patient complained of chest and throat tightness as well as lightheadedness following the injection, seen at urgent care 2 days later 7/29/2020
Sixteen patients were administered an expired doses of the Moderna COVID-19 vaccine/ The vaccine doses administered were past their 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Sixteen patients were administered an expired doses of the Moderna COVID-19 vaccine/ The vaccine doses administered were past their 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Sixteen patients were administered an expired doses of the Moderna COVID-19 vaccine/ The vaccine doses administered were past their 30 day use by date). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Sixteen patients were administered an expired doses of the Moderna COVID-19 vaccine/ The vaccine doses administered were past their 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.  The vial was initially stored in the refrigerator on 29OCT2021 and did not undergo any temperature excursions.
Metallic taste in mouth; Headache; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Mar2021 at 10:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and penicillin allergy and sulfa drugs . Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included verapamil hydrochloride (VERAPAMIL ER) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, at 12:00 (also reported as 00:00) the patient experienced metallic taste in mouth, headache and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events metallic taste in mouth, headache and diarrhea was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Nurse administering vaccinations was unaware that child had received 3 of the 5 vaccines to be administered on 11/3/2009, thus, child received dtap, hib, Prevnar twice in the same month.  Mother stated that child spiked a fever over 106 degrees Fahrenheit from vaccines administered 11/16/2009. Today, November 17, 2009 fever down to 104 degrees Fahrenheit.
In May of 2021, I experience sudden hearing loss in my one good ear (left), it continued for 3 days, and I contacted my ENT, presuming it was allergies, treated for that. When it didn't clear up on heavy antihistamines, he had me do a 5 day 50mg prednisone treatment. The hearing returned and was normal.  Since then I have now experienced the sudden hearing loss 3 more times in July, September, and I am experiencing one such episode currently (October).
Sick; Got the flu; This spontaneous case was reported by a physician and describes the occurrence of ILLNESS (Sick) and INFLUENZA (Got the flu) in a 27-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick) and INFLUENZA (Got the flu). At the time of the report, ILLNESS (Sick) had resolved and INFLUENZA (Got the flu) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The patient took a couple of weeks to recover from  sickness.  No treatment information was provided.     This case was linked to MOD-2021-337080 (Patient Link).
Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021and administered on 10-Nov-2021/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Discharge Provider: DO Primary Care Provider at Discharge: DO Admission Date: 4/8/2023 Discharge Date: 04/10/2023  Discharge Disposition: Home  PRESENTING PROBLEM: Diarrhea & weakness   HOSPITAL COURSE: Patient is a 86-year-old female who was admitted on 04/08/2023 for sepsis and questionable pneumonia, she was given Rocephin and azithromycin on 04/08, but no further doses as film array returned positive for COVID-19 infection.  Initially patient was also hypoxic down to 85% on room air and requiring 3 L, she has now been weaned to room air for 24 hours.  She was started on Decadron 6 mg daily for 2 doses, will not continue at discharge. Patient was thought to not be taking her Eliquis, as this had not been filled since September of 2022.  However patient states that Eliquis was not affordable and Cardiology was able to get her samples, she still has enough for 1.5 months.   Patient feels great and wants to go home.  Vitals are stable.  Medically clear for discharge.
RIGHT SIDE OF FACE BECAME PARALYZED ON WEDNESDAY EVENING.  WENT TO CLINIC AT 11:30 AM THURSDAY.  DIAGNOSED WITH BELL'S PALSY.  PUT ON PREDNISONE AND ANTICLOVER TO REDUCE SWELLING AND POSSIBLE VIRAL INFECTION. WAITING ON OUTCOME.  STILL HAVE PARALYSIS IN EYELID, EYEBROW AND MOUTH.
BUMPS NEAR INJECTION SITE. SPREAD TO COLLAR BONE DOWN TO BREAST AND OTHER AREAS FOR 3 DAYS.
Patient reports that 4 days after her first dose of the COVID-19 vaccine she started experiencing a continuous holocephalic headache and intermittent word-finding difficulty. She reports that she can usually find the word after a couple of minutes. She has never had any of these symptoms before. She went to her PCP and underwent CT of the head which showed wedge-shaped hypodensities in various vascular distributions and was sent for STAT brain MRI which demonstrated several T1 hypointense, T2 hyperintense lesions with small amounts of peripheral enhancement concerning for active demyelination. She was then sent to Medical Center for further  workup and treatment. While here, she underwent lumbar She underwent lumbar puncture which showed a pleiocytosis of 21, otherwise unremarkable. She was started on 1000 mg IV methyprednisone 5 day course. Other labs pending.
Patient hospitalized for spontaneous labor within 6 weeks of receiving covid vaccination. Patient had a 7 lb 14.3 oz baby boy, apgar scores 9 and 10. Postpartum course was uncomplicated.
Systemic: Chills-Severe, Systemic: Seizure-Severe, Systemic: Shakiness-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Patient shook for about and hour and her daughter said it looked she had a seizure. Patient did not seek medical help.
Syncopal episode over 24 hours after the vaccination. Still feeling tired after 5 days.
Patient experienced a vasovagal episode with extreme sweating. The ambulance was called and by the time they arrived patient was alert and talking. Patient was brought to the ED via ambulance out of caution.
Mere stiffness of muscle/ Felt like my muscle did not want to slide in movement; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL9261) via an unspecified route of administration on 05Feb2021 at 11:00 as a single dose in the right arm for COVID-19 immunization. The patient did not have any medical history ("0"). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included pantoprazole, sertraline hydrochloride (ZOLOFT), valacyclovir, and biotin from unknown dates for unknown indications. The patient did not have any known allergies. On 05Feb2021 at 22:00, the patient experienced mere stiffness of muscle that set in at 12 hours and was mostly gone at 24 hours. It felt like the muscle did not want to slide in movement. The patient reported it was not terribly severe and was really to be expected. The patient did not receive any treatment for the event. The outcome of mere stiffness of muscle was recovered. It was also reported that the patient was not tested for COVID-19 after vaccination.   No follow-up attempts are needed. No further information is expected.
covid arm after first dose; vertigo before the second dose, the same day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (covid arm after first dose) and VERTIGO (vertigo before the second dose, the same day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VERTIGO (vertigo before the second dose, the same day). On an unknown date, the patient experienced VACCINATION SITE REACTION (covid arm after first dose). At the time of the report, VACCINATION SITE REACTION (covid arm after first dose) outcome was unknown and VERTIGO (vertigo before the second dose, the same day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was reported. Caller said she has conditions that would make her fall into the immunocompromised category.   This case was linked to MOD-2021-331271 (Patient Link).   Reporter did not allow further contact
a 4 months old female patient was given an expired 0.5 ml dose of Act-HIB vaccine/No AE; Initial information received on 05-Dec-2019 regarding an unsolicited non-valid non-serious case received from an other health professional.  This case involves a four months old female patient who was vaccinated with an expired HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR).  On 04-Dec-2019, the patient received a 0.5 ml dose of expired suspect HIB (PRP/T) VACCINE (lot number: UI914AA and expiry date: 28-Nov-2019) via unknown route in the left thigh.  It was an actual medication error due to expired vaccine used.  No side effects were noted..  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hives within the first 15 minutes after dose during waiting period. Hot; red; itchy histamine response. Took Benadryl on location per pharmacist directions. Hives persisted until the following day.
Shot #1 was given left upper arm on Wednesday Feb 3 @ 1200.  Reaction on Thursday Feb 4 included rash around injection site, elevation of rash, arm hurt and nausea (picture was taken).  Didn't notice much on Friday Feb 5.  On Tuesday Feb 9th at approx 8:15am vial test right upper arm for allergy shots (new color started).  Normal reaction (for me)- failed vial test.  Wednesday, Feb 10 approx 6:30am left upper arm rash appeared same size and location as Shot #1 for Vax. (another picture was taken).
Rash left thigh; This is a spontaneous report from a contactable other health care professional (patient). A 37-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: Not reported) dose 2 via an unspecified route of administration, in left arm on 22Jan2021 16:30 (at the age of 37-year-old) as single dose for COVID-19 immunisation. Medical history included Pots (postural orthostatic tachycardia syndrome) from an unknown date and unknown if ongoing. No covid prior vaccination and not covid tested post vaccination. Concomitant medications were not reported. The patient historical vaccine included BNT162B2 (Lot Number: Not reported) dose 1 via an unspecified route of administration, in right arm on 23Dec2021 08:00 as single dose for COVID-19 immunisation. Other vaccine within four weeks included flu vaccine on 09Jan2021, dose 1 administered in left arm. The patient experienced rash left thigh on 01Feb2021 08:00. No treatment received for the event. The outcome of the event was reported as not recovered.  Follow-up attempts have been completed and no further information is expected.
Very sharp pain/cramp in thigh of left left. This type of pain increased for the next four days. On the fourth day from waist down, I experienced tingling and had limited ability to walk.
dizzy & groggy, fatigue, mild full body muscle soreness started feeling dizzy, groggy and fatigue about 12 pm same day, 2/4 My arm also started feeling sore around the same time - took 2 Aleve when arm starting hurting and 2 Aleve at night  - second day, 2/5 felt even more dizzy, groggy and fatigued, if I moved too much got a little disoriented. Full body muscle soreness started in the afternoon and also would get heat flashes but no temp. took 2 Aleve in the morning and 1 at night  2/6 - slept heavier than usual and longer than usual, felt a little better as day went on felt still a little groggy. Arm is still sore but didn't feel body aches any more