chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unusually swollen and painful arm.   In the evening became extremely cold, particularly hands and feet.  Resolved on its own within a few hours.
Golf-ball sized swelling the following day plus pain, warmth, redness. Two days later pain and swelling subsided but site started itching a lot. One week later injection site was still itchy and skin was peeling. No systemic effects noted.
Allergic reaction, macular/patchy erythematous rash whole body 2 days after 4 month imms (PEDIARIX, PREVNAR, Rota and Hib) in absence of other viral symptoms.
Child was noted to have breakout of hives about 1 1/2 hrs after vaccines were given. Rash began on lower back and spread over entire body. Child was given Benadryl every 4 hrs. x 3 days.
Expired vaccine used; 0.3ml administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 038B21A and 019B21A) for COVID-19 vaccination.     The patient's past medical history included Myalgia, Depression and Conjunctivitis. Concurrent medical conditions included Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 12-Mar-2021 to an unknown date and HYDROXYZINE (ATARAX [HYDROXYZINE]) from 12-Mar-2021 to an unknown date for Anxiety.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .3 milliliter. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and ACCIDENTAL OVERDOSE (0.3ml administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (0.3ml administered).    The patient received expired vaccine but not experienced any adverse reaction.  No treatment drug details was reported.   This case was linked to MOD-2022-486834 (Patient Link).
7 days after receiving the first vaccine shot a lump developed at the site of the injection. The lump is hard, hot to the touch, and itches. Online resources that describe this delayed reaction advise to treat with over the counter pain reliver, itch cream, and a cold compress. Lump has yet to subside; however it has only been 24 hours since the lump appeared.
Beginning near 8 pm (day of)?Fever of 101.6 (with Tylenol), dragging leg and falling over, hard lump with hives at injection site, labored breathing, severe pain in leg, moaning and restless sleep, extreme lethargy. 8 am following morning, hives still present, fever 100.3 (with Tylenol), limping, but no longer dragging foot/leg. Hives still present near injection.
migraine; body aches; fatigue; tachycardia; fever; swollen lymphnode; blood pressure started to elevate; nauseous; bad headache; dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 07Sep2021 14:30 (Lot number: FD0809) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose , Date: 16Aug2021, Time: 14:20 , Site and Route of injection:, Anatomical site of injection: Right Arm, Route of administration: Intramuscular, Batch number: EW0171 (Pfizer)), administration date: 16Aug2021, for COVID-19 Immunization, reaction(s): "Headaches", "Lightheadness", "Dizziness", "Nausea", "Tachycardia". The following information was reported: HYPERTENSION (non-serious) with onset 07Sep2021, outcome "unknown", described as "blood pressure started to elevate"; NAUSEA (non-serious) with onset 07Sep2021, outcome "unknown", described as "nauseous"; HEADACHE (non-serious) with onset 07Sep2021, outcome "unknown", described as "bad headache"; DIZZINESS (non-serious) with onset 07Sep2021, outcome "unknown", described as "dizzy"; MIGRAINE (non-serious) with onset 08Sep2021, outcome "unknown", described as "migraine"; PAIN (non-serious) with onset 08Sep2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 08Sep2021, outcome "unknown", described as "fatigue"; TACHYCARDIA (non-serious) with onset 08Sep2021, outcome "unknown", described as "tachycardia"; PYREXIA (non-serious) with onset 08Sep2021, outcome "unknown", described as "fever"; LYMPHADENOPATHY (non-serious) with onset 08Sep2021, outcome "unknown", described as "swollen lymphnode". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, headache.  Additional information: On 07Sep2021 at 02:30pm I received the second COVID-19 vaccine LOT# FD0809 at the same location after waiting 30 minutes with a nurse that was monitoring me my blood pressure started to elevated to high very high number and I started to feel super nauseous with a really bad headache. Once my time was up I left and started to drive home when I had to stop and pull over because I felt dizzy. On 08Sep2021 I began to have a migraine severe nausea, body aches, dizziness, fatigue tachycardia, fever, and swollen lymph node under my right arm that continued until 09Sep2021. I still have headaches, nausea and slight headaches as of 11Sep2021 that I have to take medication that was prescribed after the first vaccine on 16Aug2021. Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
L upper deltoid slightly swollen-area as big as adult palm, slightly red and warm to touch. Advised to apply cool compress to area per RN.
Soreness/fatigue on legs and toes. Painful cramping and unable to walk for long durations. Third day severe cramping on both sides of the neck (possible inflammation of lymph nodes) unable to turn neck left/right up and down. Slight soreness throughout the body.  Side effects came after drinking alcohol, symptoms stop after being sober. Symptoms of inflamed lymph nodes came after drinking (3rd day). Was notified by physical caretaker that alcohol intensifies the side effects, but was not told so by the vaccine distributor at the site. Tylenol and water have been helping reduce the pain.
received DTaP. developed swelling on injection site w/erythema extending to arm and face. Went to ER. Dx'ed w/immunization reaction no medication was needed. When he returned 5-27-20, He was well. (-) Swelling.
High fever (104) resistant to medications, erythema and swelling at injection site, chills, body aches, nausea and vomiting, tachycardia, left ear pain radiating to the back of head
Alternating chills, fever. Fever up to 101.8. Took Tylenol. By the morning of 4/8/2021 symptoms had subsided.
Patient stated that she was very tired that evening on 3/13/2021 and went to bed early at 9 pm. On 3/14/2021 patient woke up and stated was still very fatigued and barely could get out of bed. Patient also stated has a sinus like headache as well and did take Tylenol for this. Patient stated she went back to bed and slept around 30 hours and finally did get up and went to work on 3/15/2021 but was very tired/ fatigued throughout the day as well. On 3/16/2021 patient stated was finally feeling better.
Severe Lower Back Pain - Left side above hip - started day following the Covid Bivalent Booster Pfizer Vaccine. Started Saturday, 9/17/2022; has continued up to and including today, Monday, 9/19/2002, three days after vaccination.
Head aches, Arm became sore, at about 10:00pm, then noted that is was swollen, red painful to the touch. Area of redness was 70X120mm . Reported that his stomach felt " funny"
Provider discharge summary "patient is a 81 y/o male with a history of renal transplant who was admitted to the hospital on 1/14/22 due to shortness of breath and diarrhea. On arrival he was diagnosed with COVID and Ecoli diarrhea. He was started on supportive therapy and steroids. He was also treated with antibiotics for a possible superimposed bacterial pneumonia. Due to concern for baseline dementia he was seen by speech therapy and was determined to have a MOCA score of 14/30 consistent with mild dementia. His symptoms continued to improve over the course of his stay and the patient was on room air at time of discharge. His stay was slightly prolonged due to finding placement and waiting until the patient was cleared from COVID quarantine by infection prevention. Of note his home clonidine was held during this admission and BP remained moderately well controlled, this can be restarted outpatient if needed.    Patient/family verbalized understanding and agreement to the above discharge plan. All questions were answered at time of discharge. "
At approximatley 6:10, pt reported dizziness, mild tightness in chest, tachycardia (mild, pulse at 106) without nausea or syncopy.  BP:130/90.  Pt drank 500 ml, did not show signs of orthostatic hypotension and was escort to vehicle.
Patient had history of COPD, MS. Treated for pneumonia in February. Recently discharged from the hospital 2/24/2021 for pneumonia. Seen in the office on 3/1/2021 as a follow up. Given Covid vaccine on 3/15/2021. Patient was reportedly feeling well the day of vaccine. Patient collapsed on 3/19/2021 and died.
According to the observation nurse Patient lost consciousness for about 10 second after 10 minutes into observation. 90/50 for first BP, and 110 /80 taken 5 minutes after.  Other vitals stayed within normal range. Patient verbalized feeling fine after 10 minutes into the reaction.
Initial consumer report received on 11 Nov 2010: This patient received FLUVIRIN 2010-2011 (batch number not reported) intramuscularly on 09 Sep 2010. Three weeks later, the patient experienced easy bruising. The patient visited emergency room on 06 Oct 2010. On the same day, the patient was hospitalized and diagnosed with idiopathic thrombocytopenic purpura.
Left saphenous vein thrombosis diagnosed by doppler ultrasound on 5/25/22.  Pain in left foot started a few days prior.  She was seen in the ER for this condition which she attributes to a vaccine side effect which she received 2 weeks prior to symptoms starting.  She established care with me after her ER visit for hospital follow up of her chronic as well as acute condition.
Myalgia, Fever, CoughWheeze, SOB, metallic tast  Narrative: Using Albuterol inhaler for SOB from doctor's visit when had COVID prior to vaccine.
Sore Right  shoulder, weakness right arm and fingers of Rt.  Hand Sore lower Back  24 hours after vaccination
Child was given 2nd dose of MENQUADFI in error with no repoted adverse event; was inadvertently administered an extra dose of MENQUADFI with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 11 years old female patient who reported child was given 2nd dose of menquadfi in error with no repoted adverse event and was inadvertently administered an extra dose of menquadfi with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient received no concomitant vaccines on 18- Aug-2022.    On 18-Aug-2022, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE once (strength, formulation, lot number not reported) via intramuscular route  in arm NOS for immunization.  On 18-AUG-2022 (latency: same day), the patient reported a non-serious events child was given 2nd dose of menquadfi in error with no repoted adverse event (wrong product administered)and inadvertently administered an extra dose of menquadfi with no reported adverse event (extra dose administered)  following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.   Action taken: not applicable.   At time of reporting, the outcome was Unknown for the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Patient having progressive generalized weakness, diarrhea.  Bilateral lower lobe pneumonia:  Pneumonia protocol, Covid 19 positive placed on COVID-19 protocol
cough; feeling abnormal; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and FEELING ABNORMAL (feeling abnormal) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced COUGH (cough) and FEELING ABNORMAL (feeling abnormal). On 10-May-2021, FEELING ABNORMAL (feeling abnormal) outcome was unknown. At the time of the report, COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient computerized tomography (CT) scan on 05-may-2021. He had not taken any medication or been seen by a doctor since the vaccination. No concomitant medications were reported.
Son is reporting this information.  His mother got her vaccine and she went downhill, real quick.  She was having headaches, and she has had headaches prior to the vaccine, but she was having a hard time walking, hard time cooking.  She was a cook and loved to cook and after the vaccine she was not able to do this.  She was having hard time standing up after the vaccines.  He informed his mother that the doctors were not being straight with her and that all of the vaccines were the cause of them.  She told him that it has cost her much and that could be a possibility and she did not know.  She had no health issues prior to the vaccine that he is aware of.  He had issues with her shoulders, rotator cuff tear, etc. After a year of getting the vaccines she went to the doctor and he took away her license and she was unable to drive a car to visit him.  He states that his mother was diagnosed with ALS a couple of months ago, and died last week.    Her son states that her problems started with getting the vaccines.
This spontaneous report was received from a register nurse concerning a 26 year old female patient with seasonal allergies (unspecified) and seafood allergy and no pertinent medical history who on 25-JUL-2012 was vaccinated with dose 1 of GARDASIL, intramuscularly in the left arm (lot number 1696AA, expiration date 12-SEP-2014). No other co-suspects were reported. Concomitant therapy included fluconazole, one tablet administered later the dame day the vaccine was administered). The nurse reported that about two weeks after vaccination (approximately on 08-AUG-2012) with GARDASIL the patient experienced swollen glands in her armpits. The nurse reported that the patient's swollen glands first occurred about two weeks after vaccination. The nurse reported that the swollen glands went away but reoccurred about a week later and had continued to recur to the present time (exacts dates, number of occurrences and duration of the swollen glands was unspecified). The nurse reported that the swollen glands occurred under both armpits at the same time and at other times under one armpit (with can be either the left armpit or the right armpit). At the time of the report, the patient had not recovered from the event. Additional information has been requested.
My arm started getting really sore in the evening and then I went to bed really really and started having really vivid dreams. I jumped up at about 1 am by one of my dreams  and i started having an upset stomach, nausea, diarrhea, body chills, I got up at 7:30 am and everything hurt,  headache, I was able to take some Ibprhohen and that did help the aches and pains. After the 36 hours I was feeling fine except arm.
This is in follow-up to report (s) previously submitted on 4/13/2007. Information has been received from a registered nurse, via a company representative, concerning a female patient who was vaccinated, IM, with a dose of Gardasil vaccine (yeast) (date not specified). Subsequently the patient fainted after the vaccination was administered. The patient sought unspecified medical attention. No further information is expected.
Said she developed petechiae on both lower legs below knees, joint pain, and peripheral edema. She had a strong local reaction also with swelling, redness and knot. Said she couldn't raise her arm above chest level. Stated ANA test is elevated.
At time of injection, I felt an electric shock and deep pain shoot down my arm. Within a minute, my two last fingers had gone numb. I thought this was normal, but have since discovered that it's likely the doctor struck a nerve during injection. What I'm reporting today is a rash at the injection site that began on about day 7. About 2 inches in diameter, red, very itchy. The injection hole itself became quite red and irritated. The rash has not yet fully healed but is subsiding. The pain in my arm and hand is increasing in intensity and my hand looks like my sister's arthritic hand.
Eyes were twitching and kept switching from right to left; This is a spontaneous report from a contactable consumer, the patient. A 43-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 left arm on 30Mar2021 at 12:00 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced eyes were twitching and kept switching from right to left for 2 days after the first vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event eyes was twitching and kept switching from right to left was recovered on 02Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
After 2nd Dose: Extreme typical flu-like symptoms, swelling in leg, redness and heat, size of golf ball, around injection site. Began to develop cellulitis, went to get checked by doctor at urgent care 4 days later, was started on antibiotics (folsamist trimethoprim) and an extra Norco to deal with pain. Symptoms began to subside soon after treatment, still having lingering exhaustion. Site of shot still has a small lump there.
Began running a fever and experiencing cold chills after about 6 hours of receiving injection. Fever lasted about 12 hours. Once fever and chills subsided a migraine came on. Migraine lasted about 4 hours.
Patient was at work he was driving a skid that had trees on it and he slumped over. Squad was called he was sent to the ER.  He was flaccid on his right side and was non-verbal. Went unresponsive and was intubated.
Insomnia, Wide awake until 4:45 AM.  Usually sleeping by midnight.
She developed left arm soreness at injection site that started immediately after vaccination and has persisted since that time (she was seen today, 70 days out). Soreness extends beyond that which would be expected for typical vaccine reaction. She is tender over the injection site. Injection site appears to be in the deltoid, as patient recalls location, well below clavicle and subdeltoid bursa.
Pt reported temp 100.3, some L side anterior cervical LN redness, went home and slept unusual called in MN 0000 Sat and had fatigue, sore throat, nausea and vomiting,sweats, fever, chills. Placed on quarters Sat rx'd with motrin, tylenol helped with headache. Presented to ED on Sun. strep test positive. Begun on Amoxil 500mg TID on Sun. continue with Motrin and Tylenol. Placed on quarters on Sun. Today symptoms are improving, felt decreased energy persisting. Today feels ?, but not normal. Today temp is up and he was wondering if his cough may be something in his chest. Pt has dysphoresis.
Left side facial tingling and perception of face feeling cold. Occurred approximately 20-25 minutes after receiving vaccine and lasted 45-60  minutes.
This case was reported by a physician and described the occurrences of wrong vaccine administered in a 6-month-old patient who received KINRIX. On an unkown date, the patient received KINRIX at an unknown dose. On an unknown date, an unknown time after receiving KINRIX, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. Additional information: The doctor reported that a 6 month patient received a dose of KINRIX by mistake. Doctor does not have the lot number or expiratory date of the vaccine given. Doctor does not have the patient DOB or initials.
No additional adverse effect reported; unspecified patients were administered a dose of PNEUMOVAX23 that experienced a temperature excursion; This spontaneous report was received from a nurse prescriber referring to an unspecified patients of unknown age and gender. The patients pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On an unspecified date in 2019 (reported as after February 2019), the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number R009163 has been verified to be a valid lot number, expiration date was reported and validated as 06-JAN-2020). No adverse effects were reported for the patients.  According to the reporter, the temperature excursion was below36 degrees Fahrenheit  (34.6 degrees Fahrenheit) for a time frame of 45 minutes, on an unspecified dates after February 2019 (product storage error), with previous temperature excursion reported above 47 degrees Fahrenheit  (61.1 degrees Fahrenheit) for a time frame of 1 hour; which was detected by a digital data logger.  This is a non-valid case due to lack of patient identifiers.
This spontaneous report was received from a medical assitant, and refers to a 1 year old infant of unknown gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 13-AUG-2018, the patient was vaccinated with an expired VARIVAX lot # M035688 with expiration date on 10-AUG-2018, subcutaneous for prophylaxis  (dose was not reported) with MERCK STERILE DILUENT. However, the patient did not experienced any adverse event. This is one of two reports received from the same reporter. Sender's Comments:  US-009507512-1808USA006339.