chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweats lasting approximately 8 hours; Unable to perform work related activities; Fatigue; Chills; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats lasting approximately 8 hours), IMPAIRED WORK ABILITY (Unable to perform work related activities), FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint Pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 01-Dec-2020. Concurrent medical conditions included Seasonal allergy and Grass allergy (trees allergy). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) from 01-Jan-2020 to an unknown date for Allergy, ZINC for Product used for unknown indication, VITAMIN B COMPLEX from 01-Jan-2020 to an unknown date and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced HYPERHIDROSIS (Sweats lasting approximately 8 hours), IMPAIRED WORK ABILITY (Unable to perform work related activities), FATIGUE (Fatigue) and CHILLS (Chills). 16-Mar-2021, the patient experienced ARTHRALGIA (Joint Pain). At the time of the report, HYPERHIDROSIS (Sweats lasting approximately 8 hours), IMPAIRED WORK ABILITY (Unable to perform work related activities), FATIGUE (Fatigue), CHILLS (Chills) and ARTHRALGIA (Joint Pain) outcome was unknown. Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included bed rest, increased fluids and ibuprofen.   This case was linked to MOD-2021-030216 (Patient Link).
Pain at injection site started about an hour or so after the shot. Felt ok until around 12:30 AM. Became cold and started shivering. Shortly after developed a headache (back of head and neck). Took two Tylenol around 2 AM. Had muscle pain and nausea all night. In bed for 12 hours but unable to sleep. Took two more Tylenol around 10 AM . Very lethargic and headache lingered into the next day.
Pt recvd vax 3DEC91 @ 130 then pt taken home; pt fussy during afternoon; temp continued to rise; t105 ax a/MN; pt taken to hosp to ER;
Pt recvd Engerix-B 7JUN91 & 8JUL91 & exp "negative seroconversion" 26AUG91 recvd a booster;
No Adverse Event; patient was given a 0.25mL dose as a booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient was given a 0.25mL dose as a booster dose) and NO ADVERSE EVENT (No Adverse Event) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 06-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ACCIDENTAL UNDERDOSE (patient was given a 0.25mL dose as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, ACCIDENTAL UNDERDOSE (patient was given a 0.25mL dose as a booster dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient was given a 0.25mL dose as a booster dose).    No concomitant medications were reported. No treatment information was provided.
Fever, chills, drowsiness, redness around injection site, significant bruising to the left of the injection site inner bicep. Patient is making doctor appointment to make sure no infection occurred and will follow up with us.
entire body rash; itching; Chills; Nausea; Severe Headache; Fever 99.7; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 301308A), via an unspecified route of administration in left arm on 28Sep2021 at 09:45 (at the age of 69-years-old) at dose 3 (booster), single for COVID-19 immunization. Medical history included penicillin allergy. He has no COVID prior to vaccination. Concomitant medications included vitamin B complex, ubidecarenone (COQ 10), omeprazole (PRILOSEC), fish oil, and ascorbic acid (VITAMIN C). The patient previously took aspirin and TYLENOL and experienced allergies. He also previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at dose 1, single and via an unspecified route of administration on an unspecified date at dose 2, single for COVID-19 immunization. Vaccination facility type was reported as pharmacy/ drug store. The patient was not tested for COVID post vaccination. On 28Sep2021 at 21:45, 12 hours after the booster dose, the patient experienced fever at 99.7 that lasted for 15 hours. He also experienced chills, nausea, and severe headache on 28Sep2021 at 22:00. On 29Sep2021 at 21:45, 36 hours after the shot, the patient experienced rash on his entire body and itching. He did not receive any treatment in response to the events. The outcome of the event "fever 99.7" was recovered on 29Sep2021 at 12:45 and recovering for all other events.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Since 22-AUG-2016, the patients were vaccinated with the doses of the improperly stored VAQTA (lot # L015460, expiration date 20-JUL-2017; dose and route were not reported. The vaccines were stored in 35.8 F for one hour and 15 minutes. All the vaccines were supported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Syncopal episode with loss of consciousness and fall with left head injury 2 minutes after vaccine administration. First Aid was administered immediately to stop the bleeding. Patient was awake and alert and declined further medical assistance. Pharmacist monitored for 30 more minutes before patient was able to walk away on their own.
Pt received dose 2 of Moderna COVID19 vaccine on 2/12.  Admitted to the hospital 2/24/21 with acute ITP.  Subsequently admitted 3/19 with extensive bilateral LE DVTs and pulmonary embolism.
Narrative: COVID infection following COVID vaccine series 02/10, Modern, dose #1 03/12, Moderna, dose #2 08/01 pt cc: fever, dyspnea, cough, bodyache, nausea exposure: several family members & wife COVID+ 08/02 COVID swab, result: not detected 08/06 COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE result: B.1.617.2 08/12 SARS-COV-2 CLADE results: 21A Delta
This spontaneous report as received from a pharmacist refers to a 60 year old female patient, whose current conditions included asthma, hypertension and type 2 diabetes. On an unknown date the patient was vaccinated with ZOSTAVAX (refrigerated vial, lot # K008881, expiry date 20-SEP-2015). Concomitant medications were not reported. On an unknown date the patient experienced a very bad rash on her forehead within two and a half hours of vaccine administration. Patient also reported shortness of breath but mentioned that the symptoms may have been anxiety related to the stress of developing the rash. Patient sought medical attentions and was treated with BENADRYL and hydrocortisone. Outcome of the events was reported as recovering/resolving (events improved in about a week). Shortness of breath was not related to ZOSTAVAX while causality of the other events was not provided. No product quality complaint was filed. Additional information has been requested.
Approximately 24 hours after administration site of injection inflamed to approximately 8 inches in diameter. Became hot to touch and mildly itchy. Patient counseled to take ibuprofen and/or BENADRYL. Also feels "bad" with flu-like symptoms.
pruritic erythematous rash on neck 30 minutes after injection, then blotchy erythematous pruritic rash and swelling of face and eyelids 5 days later
Patient experienced sores on head. Mildly painful, slightly itchy. Patient went in a few days after noticing this. Doctor diagnosed sores as a mild form of shingles.
High fever, 102.9 Axilary, Vomiting. He is still running a temp of 101.5 in the morning of 2-18-07. Contacted the Dr. @ 1AM. Administering Tylenol.
DEVELOPED REDNESS WARMTH AND SWELLING TO VACCINE. INJECTION SITE 7X10 INCHES IN DIAMETER WHICH RESPONDED TO ORAL ADMINITRATION OF BENADRYL AND RESOLVED WITHOUT ORAL ANTIBIOTICS AFTER 3-4 DAYS.
Patient became unconscious while waiting the 15-20 minute period after vaccination. His parents tried to wake him but no response. Was asked to call ambulance. While on phone with dispatcher, the parents threw water on him and he woke up. Parents said to cancel ambulance. Patient remained in pharmacy for another half hour while drinking water and eating candy. He felt back to normal and left with his parents.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Dec2022) negative, notes: I tested negative day 5 of paxlovid treatment and day  8; (02Jan2023) negative, notes: I tested negative day 5 of paxlovid treatment and day  8; (05Jan2023) Positive, notes: Then of day 11 tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recv vax 8APR97 & became pregnant (LMP 15MAR97);the expected date of delivery was 19DEC97;pt had a spontaneous abortion in the 7th week of pregnancy;
HEADACHE, CELLULITIS AT INJECTION SITE, BLOOD VALUES ELEVATUED FOR D DIMER
Before the administration of Pfizer COVID vaccine it was diluted by one of the pharmacists on duty, however she did not dilute it with the correct amount of diluent. The proper dilution amount is 1.8 ml of diluent added to the vial, but it was discovered that the vial was only diluted with 0.8 ml. The error was discovered, after 3 doses had been administered. While determining the number of doses remaining in the vial it was discovered that only 1 more dose remained instead of 3. This was caused by too little diluent being added resulting in each vaccine dose to be higher concentration than  recommended.
no previous history of covid and was fully vaccinated being very sick due to the delta variant; no previous history of covid and was fully vaccinated being very sick due to the delta variant; This is a spontaneous report from a contactable consumer from a Pfizer- Sponsored Program, reporting same event under the same suspect product for eight patients. This is one of eight reports. A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), dose 1 and dose 2, both via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient with no previous history of covid and was fully vaccinated being very sick due to the delta variant. The outcome of event was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101042702 same reporter/SD/AE, different patient
The evening of vaccination she seemed fine. During the night she was restless. The next morning Thursday, she stayed home, her arm was hurting and she was out of it. She had no appetite, she barely ate her breakfast and this is unlike her. She was fatigued and lethargic. She took her nap which was unlike her. She awoke from her nap and starting vomiting for about 30 mins. During vomiting and after she complained her stomach hurt. She had a telehealth appointment were the doctor said he was caused by the vaccine. She had a fever of 102.5. This ran all the way until her bed time she was very pale and tired. The doctor advised  for her to go to urgent care if the vomiting's did not stop.  She is now more talkative and stayed home, and  she seems more herself. She is a little tired.
Literally I thought I started coughing I thought I had the flu. Coughing a lot like nonstop it was in my chest and I had really bad shortness of breath. I thought I either have the flu or a reaction. I ran a low grade temperature. So sick I didn't want to move for a few weeks. I started using a inhaler and cough syrup (NyQuil at night and DayQuil in the day) I went on vacation in May and I was still on my inhaler for at least 2-3 times through the day. The second of April is when it actually started all the way into June. I still had to use my inhaler all through the summer. I went to see my Dr. and he asked about getting my booster vaccine but after a discussion we decided not to.
Beginning about 48 hours after I received my second Covid vaccination, I developed sudden hearing loss in my right ear associated with a feeling of ?having a sock over my ear? and buzzing around my ear. These symptoms occurred in conjunction with the expected side effects from the vaccine with mild chills, fatigue, and aching, which lasted for 1-2 days. I did not lose the hearing in my right ear completely, but had marked decrease in hearing only in the right ear. I received no treatment for that symptom, and only had slight improvement in the right ear hearing loss over the next 2 to 3 months. I saw Dr. (otolaryngologist) on  5/19/2021 to evaluate my hearing loss, and had an audiogram the same day, showing significant decrease in hearing in my right ear.
Vaccine given at 2:12 pm on R deltoid.  2:40 PM  patient c/o small bumps and redness on forearm. No reaction at injection site. 2:45 PM ice pack placed on R forearm 2:54 PM  HR 105, O2 95% rash size has not changed. 2:57 PM HR 98, O2 98% Pt calm, able to communicate, denies shortness of breath, Rash is the same size no noted changes 3:00 PM Pt sent home. Recommended to seek medical attention if here is difficulty breathing or any emergency.
On August 6, 2021, I started to experience rapid heart beat and shortness of breath. I thought I was having a heart attack and went to the ER. I was admitted to Hospital and was diagnosed the following day with POTS (Postural Orthostatic  Tachycardia Syndrome). Since then, I have been suffering daily with tachycardia, shortness of breath, lightheadedness/dizziness, heat intolerance, exercise intolerance, and light intolerance. I have not been able to return to work or resume any  normal activities.
This patient had post vaccine varicella, complicated by cellulitis and abscess. The patient required incision and drainage, hospitalization, and IV antibiotics.
headache, neck ache, general muscle aches, sensitivity to light and sound, chills, nausea. Self-treated with Alka Seltzer, acetaminophen, and rizatriptan. Lasted 3/16, 17, 18, 19.
pt received 1st vax which was moderna and was supposed  to be pfizer. on July 2, he recieved another shot of moderna instead of pfizer.  he has severe headaches,  nose bleeds, and weakness.
Information has been received from a health care professional for GARDASIL regarding a 15 year old female who on 29-FEB-2008 was vaccinated with an unknown dose of GARDASIL (lot number unspecified). On 29-FEB-2008 the patient received vaccine when she was pregnant. The patient's LMP=11/21/07. The patient is not experiencing any known symptoms. Unspecified labs were performed on 02-MAY-2008. The patient sought unspecified medical treatment in the office. Follow up information was received from a health care professional who reported on 24-AUG-2008 the patient delivered a normal, healthy female baby weighing 6 pounds, 11 ounces at her 39 weeks and 4 days from LMP. The baby's apgar score was 9/9. It was also reported other medications used during pregnancy included MACROBID due to urinary tract infection from 09-MAY-2008 to 15-MAY-2008, biotin (+) carbonyl iron (+) ducosate sodium (+) folic acid (+) minerals (unspecified) (+) vitamins (unspecified) PRENATE ELITE and EXPEXTA LIPIL for prenatal vitamins from 02-MAY-2008. Additional information is not expected.
Following administration of Influenza vax, pt devel pain & swelling @ inject site down to elbow; This rxn persistd for 2 days;
Discharge Provider: MD Primary Care Provider: MD Admission Date: 2/24/2023 Discharge Date: Mar 7, 2023  PRESENTING PROBLEM: Status epilepticus COVID-19  Seizure  Pneumonia due to Klebsiella pneumoniae    HOSPITAL COURSE: Patient is a 21 year old male with  a past medical history of CP, global DD, complex partial epilepsy on multiple AEDs who presented to emergency department on 2/24  with multiple witnessed seizures at home. Per mom, the patient last had seizures in September 2022. On day of arrival, she noted 2 seizures for which she gave him IM ativan x 2 doses. Patient has a brother at home who had been COVID positive for 3 days but they have done the best to keep the patient isolated.  In the ambulance a temperature of 101.3° was noted. In the ED, his Covid PCR test was positive. He continued to have seizure activity refractory to IV ativan and Keppra IV. After discussions with neurology, the patient was intubated for airway protection and to help facilitate management of his status epilepticus. He was admitted to the ICU for management, on continuous EEG with propofol and versed gtts. Propofol weaned off 2/25 and versed weaned off 2/26 with no further signs of epileptiform activity on EEG. Sputum cx grew MSSA and Klebsiella, noted multiple drug reactions to abx, now maintained on levofloxacin. Patient was extubated to RA on 3/2.  Neurology was consulted for adjustments of antiseizure medications.  The patient was transferred to the general medical floor.  NG tube was removed and he was able to take all his oral meds.  The patient was discharged home with the family in a stable condition.
I wake up in the middle of the night and sometimes during the day due to numbness in my feet.
After receiving the vaccine, I was tired and had a sore arm, I was also extremely hoarse and had a cough and it became difficult to speak but I remember very clearly that I wasn't able to speak at all by the weekend. I saw the ENT doctor on October 11th. It was six months before my voice began to come back. I believe that when I was given the vaccine, that I was injected with a full (double) dose rather than the normal recommended dose.
Pt said she had hives for days. She has had them before with her reaction to allergy with penicillin.
Patient called and wanted RPN name, who gave vaccinations.  She was very upset.  She stated that her left arm was swollen and is very painful to the point where she could not sleep for past 9 nights.  The pain also started to radiate from her arm to shoulder, neck and back.  She cannot move her hand, neck or turn due to pain.  Her husband is a physician, and he thinks that the RPN might have hit a blood vessel and patient is bleeding internally.  Patient states that the area is very red and there are spots around which are also red.
Scattered clusters pruritic papules groups 3 or 4. total skin lesions 5 or 6. No fever or other symptoms.
This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Second dose, unknown manufacturer), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "Pain in armpit after receiving booster shot".  Additional Information: It was reported that the patient had pain in armpit after receiving booster shot. No similar pain in previous shots. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe fatigue, 100 degree fever, intense chills and shivering. All began at approximately 5pm (6 hours after receiving vaccine) and continued until approximately 5pm the following day.
Headache; sore arm; off label use; booster; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 18:00 as dose 5 (booster), single (Lot number: gh9694) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE; unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Sep2022 at 18:00, outcome "unknown", described as "booster"; OFF LABEL USE (non-serious) with onset 22Sep2022 at 18:00, outcome "unknown"; HEADACHE (non-serious) with onset 23Sep2022, outcome "recovered" (Sep2022); PAIN IN EXTREMITY (non-serious) with onset 23Sep2022, outcome "recovered" (Sep2022), described as "sore arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  Additional information: Patient have not received other vaccine in four weeks. No Covid prior to vaccination and no covid tested post vaccination.