chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site felt like a lump; Allergic reaction. It became pretty large.; Hardness at the injection site; Injection site is itchy; Redness; Irritated; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Irritated), PAIN IN EXTREMITY (sore arm), VACCINATION SITE MASS (Injection site felt like a lump), HYPERSENSITIVITY (Allergic reaction. It became pretty large.) and VACCINATION SITE INDURATION (Hardness at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced VACCINATION SITE IRRITATION (Irritated), VACCINATION SITE MASS (Injection site felt like a lump), HYPERSENSITIVITY (Allergic reaction. It became pretty large.), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE ERYTHEMA (Redness). On 16-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, VACCINATION SITE IRRITATION (Irritated), VACCINATION SITE MASS (Injection site felt like a lump), HYPERSENSITIVITY (Allergic reaction. It became pretty large.), VACCINATION SITE INDURATION (Hardness at the injection site), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Telephone Contact Report (TCR) was obtained on 14-APR-2021 contains no new information. On 08-Jun-2021: Follow up was received on 08-JUN-2021 found to be non-significant and Contact information was updated.
I had a medical reaction to the first shot of the covid  vaccine. I was seen in my pcp office short!y afterwards and my symptoms were pain in my arms, legs, hands and feet; nausea and vomiting; chest tightness, diarrhea, headache, muscle weakness, fatigue, and joint pain. I have a history of DVT so I chose the Moderna for that reason. I have been struggling with this ever since and now I have been diagnosed with CRPS. I can hardly walk and now I have been out of work for a few weeks.
A report has been received from regulatory authority via post-licensure surveillance of FLUMIST QUADRIVALENT concerning a 5 year old, female subject, enrolled in a non-interventional/post-marketing study. No information regarding the relevant history, concomitant disease and concomitant drug was provided. The patient received FLUMIST QUADRIVALENT (intranasal) on an unknown date. The patient experienced febrile seizures. Action taken with FLUMIST QUADRIVALENT was not applicable. The outcome of the event of febrile seizures was recovered. The report was considered to be non-serious by Company physician. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of febrile seizures to be not related to FLUMIST QUADRIVALENT.
Iron deficiency; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 12Aug2021 16:15 (Lot number: EW0179) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (ongoing), notes: OTC Iron Supplement, Route: PO, Date: Oct2021, ; "Hypercholesterolemia", start date: 26Apr2021 (ongoing), notes: No meds needed at this time. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose1, Time:16:45 PM, Anatomical site of injection: deltoid left, Route of administration: Intramuscular, Batch number: EW0179), administration date: 19Jul2021, for COVID-19 immunization. The following information was reported: IRON DEFICIENCY (non-serious) with onset 17Sep2021, outcome "not recovered", described as "Iron deficiency". Therapeutic measures were taken as a result of iron deficiency.  Additional information: It was reported that, patient had not received any other vaccine within 4 weeks Prior to vaccinations. patient was also receiving OTC Iron Supplement.   No follow-up attempts are possible. No further information is expected.
(1) Erythema multiforme x 3d. (2) Fever x 2d. (3) Diarrhea x 1 day.
No adverse events after 1st dose. I had very mild flu like symptoms 24 hours after 2nd dose.  Then a week later I began having ringing in my ears.  This has been continuous since that day.
significant upper arm edema, more notable than small swelling at the site of injection... soreness reported in one particular spot about 4" away from injection site
Patient was intended to have a booster dose (0.25 mL), but instead received a second dose volume (0.5 mL) from administering nurse.  No adverse effects noted, reported to VAERS for completeness.
catatonic seizure in upper left thigh and leg. extreme muscle cramps 1/2 hour Used to get these often but was cured years ago. Extremely painful. After released leg muscle very sore needing of rest so it did not repeat. Felt affects gone by 3/15.
Systemic: Weakness-Severe, Additional Details: AFTER 20 MINUTES WAITING TIME THE PATIENT WAS LEAVING THE STORE WHEN FELT AND BECOME UNRESPONSIVE, 911 WAS CALLED AND PATIENT TRANSPORTED TO MEDICAL CENTER. NO MORE INFORMATION KNOW
Initial symptoms were fever and chills immediately 24-48 hours from second vaccine. As of reporting date (today), I cannot see clearly and see spots in my vision. Bright colors and light is triggering it.
My arm at the injection site is still sore swollen warm to the touch and itchy  after a week and a half. Been putting cortisone 10 on the area for the itching .
Information has been received from a physician concerning a 42 month old male who on 20Nov02 was vaccinated SC with a 0.5mL dose of varicella virus vaccine live. On 09may05 the pt broke out with about 10 varicella lesions on the legs, back, buttocks, thighs, and face. His temp was 99.3F. The physician prescribed an antihistamine for itching. The physician indicated that the pt's brother who was not vaccinated, had a severe case of wild type chickenpox and believes he caused the breakthrough in his vaccinated brother. Unspecified medical attention was sought. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested.
Patient received the COVID-19 vaccine and fainted during the 15 min  wait in the observation room.
an expired dose of M-M-R II was administered to a patient; no additional AE reported; This spontaneous report was received from a registered nurse regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions were not reported and concomitant therapies included sterile diluent (STERILE DILUENT) (manufacturer unknown).  On 04-FEB-2022, an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # T001214 has been verified to be valid, expiration date: 12-JAN-2022), dose: 0.5 ml (strength, dose number, frequency) for prophylaxis was administered to the patient (expired product administered). There was no temperature excursion. No additional adverse events were reported (no adverse event). This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA003414: US-009507513-2202USA003751: US-009507513-2202USA003543: US-009507513-2202USA003627: US-009507513-2202USA003522: US-009507513-2202USA003651: US-009507513-2202USA003569: US-009507513-2202USA003660: US-009507513-2202USA003658: US-009507513-2202USA003778:
vaccine administered 4/27/22 expiration date was 5/31/2022 but beyond use date was 4/18/2022
Pain across the shoulders/ pain bilaterally on both shoulders; Pain in the neck; Pain at the injection site; A spontaneous report was received from consumer concerning, female, of unknown age, who was administered Moderna COVID-19 vaccine and experienced pain across the shoulders/ pain bilaterally on both shoulders, pain in the neck and pain at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection on 04-Jan-2021.   Patient reported that she was having pain across the shoulders. The symptoms started at night-10 hours after receiving the shot. She claimed that pain in the injection site was normal but it was happening bilaterally on both her shoulders and back in the neck. Patient wanted to know if she could take Tylenol and Multrim.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events pain across the shoulders/ pain bilaterally on both shoulders, pain in the neck and pain at the injection site was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
BRADYCARDIA  Typical flu like reaction to vaccine day after injection [Fri, 4/9 - Day 1 post vax (aka PV)] with modest HR increase (as expected) (Background: typical resting heart rate (rhr) taking into account variables (i.e. hormonal variations, hydration status, altitude changes etc) = 63 rhr - I am NOT an elite athlete, but am fit and active) Beginning Saturday, 4/10 - DAY 2 PV heart rate began steadily decreasing by two average heart beats / minute for three days, which has never happened before. Monday 4/12, DAY 4 PV, rhr dropped to 57, which is the lowest is has been ever.   Between 4/12 - 4/15, DAYS  4-7 rhr = 57/58 Friday, 4/16 DAY 8  rhr = 56 Saturday, 4/17 DAY 9 rhr = 56 Sunday, 4/18 DAY 10 rhr = 55  symptoms = increased fatigue, some weakness in hands, lightheadedness, decreased appetite
Low grade fever; Nausea; Soreness in arm; Severe headache; Fatigue; This is a spontaneous report received from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 02Mar2021 at 10:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in the left arm on 23Mar2021 at 10:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant past medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient experienced low grade fever, nausea, soreness in arm, severe headache and fatigue. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for the events. The clinical outcome of the events low grade fever, nausea, soreness in arm, severe headache and fatigue were resolving at the time of this report .   No follow-up attempts are needed. No further information is expected.
Resident was boosted on 11/17/21 and tested positive on 11/26/21
Generalized rash. Left arm red and swollen all the way to fingertips for 2-3 days. Soreness still present at 15 days.
Approx 30 min after injection pt experienced pain in rt upper arm.  Swollen from elbow to shoulder. Next day this area was very hard and painful. Swollen 2 weeks and pain. Even to today's visit pt still has lots of pain in injection site.
Patient began experiencing burning/itching sensation on R lateral and posterior sides of her neck 15 minutes after vaccine administration. Lacerations on her neck looked like scratch marks but patient states she did not scratch herself. No adverse reactions with first dose per patient. She has NKDA but does have a h/o hives. Benadryl 25 mg PO was administered and patient was observed for another 15 minutes. No other adverse events observed or reported.  Patient was ambulatory and able to drive herself home.
Vaccine stored under refrigeration beyond 30 days. Moderna: lot number 056m21a maintained the activity neccessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.
11/11/21 presents to EC ED for "significant fatigue, poor oral intake x 8 days". PMH "CVA, brain bleed, htn, afib, IDDM2".
1.5 CM AREA DIRECTLY OVER LEFT DELTOID MUSCLE WHERE VACCINE GIVEN WAS BLISTERED, OPEN AND OOZING.  LARGE SURROUNDING AREA OF REDNESS AND SWELLING APPROXIMATELY 10 CM IN DIAMETER.
vertigo/side effect got worse; Extreme brain fog / side effect got worse; Ruined day to day life with no signs of improvement; Extreme Tiredness / side effect got worse; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo/side effect got worse), FEELING ABNORMAL (Extreme brain fog / side effect got worse), IMPAIRED QUALITY OF LIFE (Ruined day to day life with no signs of improvement) and FATIGUE (Extreme Tiredness / side effect got worse) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo/side effect got worse), FEELING ABNORMAL (Extreme brain fog / side effect got worse), IMPAIRED QUALITY OF LIFE (Ruined day to day life with no signs of improvement) and FATIGUE (Extreme Tiredness / side effect got worse). At the time of the report, VERTIGO (vertigo/side effect got worse), FEELING ABNORMAL (Extreme brain fog / side effect got worse), IMPAIRED QUALITY OF LIFE (Ruined day to day life with no signs of improvement) and FATIGUE (Extreme Tiredness / side effect got worse) had not resolved. Not Provided          No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2021-404859 (Patient Link).
24 hours post-vaccination severe pain in the joints and thirsty 2 days later but the pain at the application site in the right arm deltoid region persists to the present day in the application area hurts very strongly in certain movements of the arm causing limitation in my functions daily because pain is awakened but only in certain movements, and lately slight numbness in my fingertips, more accentuated in the right upper extremity.
elevated PSA of about 2 points compared with a test he had 8 months ago; slight elevation in the monocyte level; This spontaneous case was reported by an other health care professional and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (elevated PSA of about 2 points compared with a test he had 8 months ago) and MONOCYTE COUNT INCREASED (slight elevation in the monocyte level) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 026L20A, 032L20A and 019F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient experienced PROSTATIC SPECIFIC ANTIGEN INCREASED (elevated PSA of about 2 points compared with a test he had 8 months ago) and MONOCYTE COUNT INCREASED (slight elevation in the monocyte level). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (elevated PSA of about 2 points compared with a test he had 8 months ago) and MONOCYTE COUNT INCREASED (slight elevation in the monocyte level) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, Blood test: elevated psa of about 2 points compared with a tes (abnormal) elevated PSA of about 2 points compared with a test he had 8 months ago & a slight elevation in the monocyte level..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The caller stated that in a news report a urologist saying it's possible for PSAs to be elevated short term after the Moderna Covid-19 Vaccine. No treatment information was provided.   This case was linked to MOD-2022-568625.
Chills; headache; Felt tired; vaccination site tenderness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (headache), FATIGUE (Felt tired) and VACCINATION SITE PAIN (vaccination site tenderness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     no specified medical history was reported.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (headache), FATIGUE (Felt tired) and VACCINATION SITE PAIN (vaccination site tenderness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Feb-2021, VACCINATION SITE PAIN (vaccination site tenderness) had resolved. On 09-Feb-2021, CHILLS (Chills), HEADACHE (headache) and FATIGUE (Felt tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient uses unspecified concomitant medications which includes heart , blood pressure and cholesterol medication,
This spontaneous case, initially received from the other health professional (pharmacist) on 10-Oct-2018, concerns a 3-year-old, child female patient. The patient had no relevant medical history. On 06-Oct-2018, the patient (under age of 4 years) was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm deltoid, batch number; 252225 and expiry date: 31-May-2019). At the time of this report, the patient did not report any complaints of side effects or adverse reactions. The reporter assessed the case as non-serious.
Patient received Janssen COVID-19 vaccine on 3/24/22 at 1315. A red blotchy rash appeared on bilateral lower extremities 72 hours later on 3/27/22, accompanied by sore throat, fatigue, and productive cough. Work up was done and infectious process such as COVID, influenza, RSV, Streptococcus pharyngitis were ruled out. Medication review was done and no other new medications started since admission. Possible that rash and presentation are due to delayed effects from COVID-19 vaccine.
began aching on 4SEP93 (generalized) devel rash on abdo on 9SEP93 & also aching in knees;
Fever, severe headaches, extremely light sensitive, tinnitus, diagnosed with glossitis, speech has diminished, dry eyes and mouth, burning of the skin, stiffness in joints.
Patient said she developed red bumps 9-10 days after receiving injection (thought she had poison ivy from gardening) went to md and they said they thought it was chicken pox and to use calamine lotion and make an appointment with a dermatologist.
This spontaneous report as received from a licenses practical nurse refers to a patient of unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/0294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 12-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Covid Arm - 2 1/2 inch round welt ( sore to the touch)  right under the injection site
got exposed to COVID; dizziness; big rash; nausea; This spontaneous case was reported by a patient and describes the occurrence of EXPOSURE TO SARS-COV-2 (got exposed to COVID), DIZZINESS (dizziness), RASH (big rash) and NAUSEA (nausea) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (got exposed to COVID), DIZZINESS (dizziness), RASH (big rash) and NAUSEA (nausea). At the time of the report, EXPOSURE TO SARS-COV-2 (got exposed to COVID), DIZZINESS (dizziness), RASH (big rash) and NAUSEA (nausea) outcome was unknown.            Patient got exposed to COVID before receiving second dose. No relevant concomitant medication was reported. Treatment information was not provided.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-JUN-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # K009809, expiration date 16-MAY-2015, intramuscularly (dose was not reported). No co-suspect and concomitant therapies were reported. No adverse effects reported. This was the first dose of PNEUMOVAX drawn from this PNEUMOVAX Multi-Dose Vial. Additional information has been requested.
ACUTE STROKE DUE TO OCCLUSION OF LEFT ANTERIOR CEREBRAL ARTERY
Left arm swelling; rash throughout body; left leg going numb; loss of balance; This is a spontaneous report from a contactable Other healthcare professional reported for herself. A 22-year-old non-pregnant female patient received first dose of bnt162b2 (pfizer-biontech covid 19 vaccine), intramuscularly on left arm on 17Dec2020 at 08:30 at single dose for immunization at workplace clinic. Medical history included known allergies to watermelon, cantaloupe, honey dew, kiwi.  There were no concomitant medications in two weeks nor other vaccine in four weeks. There is no prior covid vaccination nor covid tested post vaccination. The patient experienced left arm swelling, rash throughout body, left leg going numb, loss of balance on 17Dec2020 at 09:15 with outcome of unknown. No treatment was received for the events.   Information on the lot/batch number has been requested.
Fever or Chills, Fatigue, Muscle or body aches. Congestion or running nose
Pt developed urticaria and itching on bilateral arms, trunk and legs 2 days post vax. Pt also had a laceration on hand requiring sutures. Pt was treated with Benadryl and prednisone.
Potentially received an additional 3rd dose, nurse suspected he only received a booster for the 3rd dose and administered an additional.  County he received 3rd dose isnt able to confirm with any records so this is being submitted in precaution.