chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe body aches; joing pain; shivering, couldn't get warm; arm pain; severe headache; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE3590) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Coeliac disease" (unspecified if ongoing), notes: Other medical history: Celiac disease; "Known allergies: Gluten Free" (unspecified if ongoing), notes: Known allergies: Gluten Free. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 2, Single, lot number: EL1284), administration date: 13Jan2021, when the patient was 53-year-old, for Covid-19 Immunization, reaction(s): "Severe body aches", "joing pain", "shivering, couldn't get warm", "arm pain", "severe headache"; BNT162b2 (Dose 1, Single, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for COVID-19 immunization, reaction(s): "Severe body aches"; BNT162b2 (Dose 1, Single, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for Covid-19 Immunization, reaction(s): "joing pain"; BNT162b2 (Dose 1, Single, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for COVID-19 Immunization, reaction(s): "shivering, couldn't get warm"; BNT162b2 (Dose 1, Single, lot number: EJ1685), administration date: 23Dec2020, when the patient was 53-year-old, for covid-19 immunization, reaction(s): "arm pain", "severe headache". The following information was reported: PAIN (non-serious), outcome "recovering", described as "Severe body aches"; ARTHRALGIA (non-serious), outcome "recovering", described as "joing pain"; CHILLS (non-serious), outcome "recovering", described as "shivering, couldn't get warm"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "arm pain"; HEADACHE (non-serious), outcome "recovering", described as "severe headache".  Additional information: The patient did not receive other vaccine in four weeks and any other medications in two weeks. Patient reacted to both Covid 19 vaccine shots plus 2 boosters. Severe body aches and joint pain, shivering, couldn't get warm, arm pain, severe headache. Patient did not have covid prior to vaccination and not covid tested post vaccination.
Patient had initial redness/numbness after receiving and started subsiding, then 6 days later woke up with hives on back of arm travelling up neck.
Patient developed a blotchy, red rash from head to toe within moments of receiving the vaccines. Patient was given 2 ml of BENADRYL per doctor's orders. With 30 minutes of receiving BENADRYL rash began to disappear. Mom was informed to give another dose of BENADRYL before child was put to bed that evening. No additional follow ups were required.
1st Shot- Only pain in left arm  *2nd Shot- appox 12 hrs later woke up to pain and swelling in Left Hand, which traveled up my underside arm and into my Armpit, which started to swell. The pain continued into my left Breast and down my ribcage area. My breast gland felt swollen as well. During that afternoon my entire body where I have inflammation was ignited in pain. A few hrs later into the day I started having tingling in my upper lip and numbness in my Tongue. Called my Drs office and was told to go to Urgent Care, which I did. I was given a Shot of some kind of Anti inflammatory and given a 10 day prescription of Anti-inflam and told to see my Dr. on Monday.
atopic dermatitis involving eyelids , pataday drios and Benadryl, auquaphor
chills; With 2nd shot in series, I have large swollen, painful lymph nodes in my neck/collarbone and under arm.  Additionally, I had body aches and chills.; I had body aches; This is a spontaneous report from a contactable consumer (patient). A 39-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 25May2021 at 11:30 as dose 2, single (at the age of 39-years-old) for COVID-19 immunization at Pharmacy or Drug Store. Medical history included known allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19, and not received any other vaccines within 4 weeks. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included Escitalopram and Metoprolol within two weeks. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0170) via an unspecified route of administration, administered in left arm on 28Apr2021 at 02:30 as dose 1, single (at the age of 39-years-old) for COVID-19 immunization. On 26May2021 at 14:00, after 2nd vaccination, the patient experienced chills, large swollen, painful lymph nodes in my neck/collarbone and under arm and also had body aches. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 17May2021. No treatment received for adverse event. The outcome of the events was not recovered.
PER MOTHER T.CALL ON 11/04/09 AT 2PM, STATED, SON RECEIVED Tdap BOOSTER ON RIGHT ARM. FOR SCHOOL REQUEST. SON STARTED COMPLAINING WITH PAIN TO (R) ARM AND ARM SWOLLEN. MON GAVE MOTRIN FOR PAIN. Sr.PHN (R.N.) RECOMMENDED ICE COLD PACK TO ARM AS TOLERATED AND CONTINUE WITH MOTRIN PER PGK. RECOMMENDATIONS. MOM AGREED. Sr.PHN FOLLOWED-UP AND TALKED WITH MOM ON11/05/09. MOM STATED, SON STILL IN VERY MUCH PAIN THAT FEELS IT IS GOING ALL THE WAY DOWN TO HIS (R) HAND AND STILL SWOLLEN. NO FEVER. Sr.PHN STILL RECOMMENDED MORE ICE AS TOLERATED AND IF S/S DID NOT DECREASED, NEEDS TO SEE PRIVATE MD OR ER OF CHOICE AND WILL BE REPORTING THIS EVENT TO VAERS SYSTEM. MOM AGREED.
Difficulty swallowing Vitals stable PT discharged home at 1715  Seen by EMT on site
Day of Vaccination, fatigue 4 hours after.  12 - 13 hours after I woke up with unusual joint pain very intense in my ankles, feet and knees and a bad headache that was not like my usual headaches.  the next day, I felt pretty good, I told my husband I have a leg cramp tin my left leg that does not feel like a charley horse.  I ate a banana, drank lots of water and took a magnesium capsule to help with the leg cramp. and by 1pm I started to develop a headache.  I did not report because I have frequent headaches.  It intensified as the day progressed.  after Sunday, this became a daily occurrence. Early afternoon I would start to get intense headaches and i would go home take benadryl and sinus medicine to help  ease the pain.  Continued on daily until Saturday April 17th when my headache became so bad I could not stand it anymore.  I was nauseous and shaking.  No fever but profuse sweating and weakness.  Went to the ER around 930pm and was released around 12am after they gave me an IV with anti nausea meds and benadryl.  Sunday I was weak with headache all day.  Woke up today (Monday 4/19) with a headache and felt fatigued and severe headache.  It does not feel like a sinus headache nor tension, nor hormonal.  It is my entire head throbbing and left side of my head is sensitive to pressure.  I have not sustained any head injuries in the past year or longer.
mom called concerned because baby has had screaming episodes since getting shots this Am;lasted 4hr;
3/12/2021 Presented to the ED with left wrist pain and cat bite. Admitted for IV antibiotics for left wrist cellulitis.
nervousness inside; anxiety; headache; achy; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), DECREASED APPETITE (no appetite), NERVOUSNESS (nervousness inside), ANXIETY (anxiety) and HEADACHE (headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PAIN (achy), DECREASED APPETITE (no appetite) and HEADACHE (headache). On an unknown date, the patient experienced NERVOUSNESS (nervousness inside) and ANXIETY (anxiety). On 01-Mar-2021, PAIN (achy) had resolved. On 02-Mar-2021, DECREASED APPETITE (no appetite) and HEADACHE (headache) had resolved. At the time of the report, NERVOUSNESS (nervousness inside) and ANXIETY (anxiety) outcome was unknown. Unknown          Treatment information not reported. Concomitant medication information not reported.   This case was linked to MOD-2021-089245 (Patient Link).
Presents to ED on 11/25/09 @ 1727.  Mother stated that reaction began in the morning but did not know what time.  Initial vitals 38.8 °C (101.8°F)    Temp Source TYMPANIC -LM TYMPANIC -    Pulse 140  Resp 32 BP 99/57 mmHg    SpO2 98 % -LM   Patient presents with fever and rash on his upper proximal extremities. The rash is consistent with hives but is non-puritic, but painful. Patient observed in the ED until 19:18 11/25/09.  Patient given acetaminophen 15 mg/kg/dose and diphenhydramine 1 mg/kg/dose orally in the ED. Vitals at discharge are as follows:  BP 100/50 | Pulse 130 | Temp 97.7 | Resp 20 | Wt 15.6 kg | SaO2 99%.  Discharged home with Benadryl for use as needed and to follow up with PCP.
Information has been received from an X-ray technician referring to a 4.5 years old male patient. The patient's pertinent medical history, concomitant therapy and drug reactions/allergies was not reported. On 26-OCT-2018, the patient came into clinic to receive his second dose of VAQTA (50/1.0 U/ml, batch/lot # and expiration date were not reported ) intramuscularly for prophylaxis, but accidentally received the "adult VAQTA dose instead of the pediatric VAQTA dose (incorrect dose administered; adult product administered to child). On 27-OCT-2018, the patient was seen in the office and no adverse events were reported.
82 Y male with h/o prior covid infection (Dec 2020, no hospitalization) in setting of full vaccination, emphysema, CKD (baseline Cr 1.1), hx tobacco use (quit 1999), preDM (last A1C 5.9% 9/19), HTN, was admitted to the ICU from the ED for COVID PNA. Symptom onset sometime 1/2-1/6, presented to ED w/ progressive dyspnea, dehydration, weakness. Found to have new Afib w/ RVR. Developed AKI on admission in setting of severe sepsis, improved over admission. Admitted to ICU 1/12, initially required Bipap but now intubated. PNA suspected during admission given resp culture with chryseobacterium gleum. Continued to have intubation requirement without ability to be weaned off. Discussed GOC and prognosis with the family, who opted for compassionate extubation on 1/25.      Complications:  Delirium Acute respiratory failure AFib
This case was reported by a physician via sales rep and described the occurrence of periocular swelling in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced periocular swelling and periorbital pain. On an unknown date, the outcome of the periocular swelling was recovered/resolved and the outcome of the periorbital pain was unknown. It was unknown if the reporter considered the periocular swelling and periorbital pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swelling around both eyes and forehead between eyes for 2 to 3 days, with some pain. The physician asked the patient if she had eaten any new food or used any new products on skin and the answer was no. The physician thought that it might had been reaction to vaccine, but the physician was not sure. The reporter agreed to follow up from GlaxoSmithKline.
The patient began feeling light headed and dizzy, became unresponsive with tonic/clonic activities, unknowingly voided subsequently. EMS was contacted and patient was brought to Emergency Room, where he was later discharged home.
No adverse event; a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-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) 1 dosage form. On 07-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior) 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 EXPIRED PRODUCT ADMINISTERED (a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior).    No concomitant medications were reported. Health care professional stated that a patient was administered a Moderna COVID-19 bivalent booster dose from a vial that was punctured more than 12 hours prior.  The patient has not reported any adverse reactions to this dose at this time. No treatment medications were reported.
On 1/15/00, the pt developed a generalized, red, blistered, itchy rash with scabs all over the body. On approximately 1/28/00, the pt recovered from his experience.
Client already got vaccinated with Janssen (6/18/21) and Moderna booster (11/11/21) under his legal name and another series of Moderna 1st (12/29/21) and 2nd (2/25/22) under a different name. Only found out that he was fully vaccinated when client provided legal name after getting the second shot of Moderna on 2/25/22. Client got 4 COVID vaccines.
Information has been received from a registered nurse concerning an approximately 14 year old male patient who was vaccinated with a 1st and 2nd dose of Hepatitis B vaccine recombinant on 10/30/96 and 04/27/97, respectively. The patient's mother indicated that "he became very sensitive to the sun right after his 2nd dose. He developed a crusty ear lesion and a lesion on his finger in October of 1998. He got another sunburn of his face in May of 1999 that never went away. In August of 1999 by a dermatologist who made the diagnosis of discoid lupus. The nurse had no further information. Additional information has been requested.
Extreme menstrual disruption. Despite being on a continuous birth control pill, which means I normally never get my period, I menstruated for more than four weeks! That has literally never happened, not even close, not on or off the pill, ever in my life. I was so concerned I made a special appointment to see my gyno to get checked out. She thought it could be related to the generic version of the pill I was taking, but I think it was because of an inflammatory response to the vaccine. Eventually it did stop naturally.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received its 30-days Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had acute illnesses and chronic or long standing health conditions.     On 24-Jan-2022 at 2:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Jan-2022 at 2:36 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. The patient received vaccine past its 30 day expiry date on 24-Jan-2022 at 14:36:44. No treatment medication was reported by reporter.
On day 7 my arm swelled to the size of a golf ball, warm to touch, sometimes itches, and it?s tough when pressed on.  May be red but I?m unsure due to a tattoo on that location.
Exrtreme warm, soreness, redness, and swelling to injections site and area 2 inches below injection site (measuring 2 inches X 3 inches in width and height). Sudden onset of headache. Treated w/ ice compresses and NSAIDs.
Skin redness in multiple places on arms, face.  Itching back of neck, arms.  This has occurred after the second COVID shot, lot # 006m20a.  Delivered 02/24/2021
Swollen, warm arm; Unable to lift above head; Chills; tired; This is a spontaneous report from a contactable consumer (patient). A 68-Year-old female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Feb2021 at single dose in left arm for COVID-19 immunization at the age of 68-Year-old. Lot number was EL9269. Medical history included asthma, hypertension, diabetes. Concomitant medications included albuterol, mometasone furoate (ASMANEX), nebivolol hydrochloride (Bystolic), Montelukast sodium (SINGULAIR). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose in left arm for COVID-19 immunization at the age of 68-Year-old. On 17Feb2021, the patient experienced swollen, warm arm. Unable to lift above head. Chills, tired. The patient was not treated for the events. The patient recovered from the events. Follow-up attempts completed. No further information expected.
Injection site inflamed, red, hot.  Back of arm behind of injection site has red splotches.  Red, hot inflammation lasting for more than 1 week.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 24-SEP-2016, the patient was vaccinated with VAQTA (lot # L015460, expiry date: 20-JUL-2017) for prophylaxis (dose and route was not reported), which was stored improperly.
Redness, swelling at site, slight nausea. Mother states she had the same type reaction to the flu vaccine last year. Area red, raised 2 inch in diameter. Encouraged ice thru today. Instructed to call clinic if redness increases. Directed to ER if worsening symptoms.
pt went home p/vax & 9PM had t104.2 & redness, swelling & erythema-went to ER treated for cellulitis w/ATB;
Fever 102.3 F, nausea, chills, sweats, headache, fatigue, joint pain and body weakness
LITTLE RED BUMPS ON CHEST AND BACK, LOW GRADE TEMP FOR A DAY, UP TO 100. RASH IMPROVING 2 DAYS AFTER ONSET. FEVER RESOLVED AFTER ONE DAY.
58 yo M with ESRD on HD, HTN, and DM presents to ER from HD center via ambulance after receiving PNEUMOVAX and developing sudden SOB. Pt states he was feeling fine and he received the shot and about an hour after being vaccinated began feeling swelling in his throat and tightness in his chest. Pt received 0.5 of 1-1000 epi, 125mg SOLUMEDROL, 50 mg BENADRYL at HD center. Pt states he is now feeling better but still c/o SOB, throat fullness, and difficulty swallowing. Pt states he has never had symptoms like this before. Symptoms: Anaphylaxis. Treatment Drugs Used: 1 EPINEPHRINE, 2 METHYLPREDNISOLONE, 3 DIPHENHYDRAMINE.
Arm was going numb; Neck and head were hurting; Intense head pain; Really fatigued/ exhausted; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Arm was going numb), NECK PAIN (Neck and head were hurting), HEADACHE (Intense head pain) and FATIGUE (Really fatigued/ exhausted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID potentially in April and May).    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Arm was going numb), NECK PAIN (Neck and head were hurting), HEADACHE (Intense head pain) and FATIGUE (Really fatigued/ exhausted). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Arm was going numb), NECK PAIN (Neck and head were hurting), HEADACHE (Intense head pain) and FATIGUE (Really fatigued/ exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter.   Eight days the vaccination, the patient experienced intense head pain and her arm was going numb. She states that it was not a regular headache and occurred in one spot behind her head. She reported takin g Excedrin but that did not help. She was also prescribed with a steroid and antibiotics after the doctor thought she had an ear infection, but that did not help her symptoms. Her neck and head were hurting for the past 8 days.   Other treatment information included Steroid and Antibiotics.
About a week post-vaccination, patient noticed a red dot around injection site that has increased in size daily. It is stiff and itchy, per the patient. She also complains of stomach pain that comes and goes- some so severe that the patient finds herself unable to eat. Patient was advised to place warm compress on the area as well as take antihistamine for symptoms.