chrisvoncsefalvay/vaers-outcomes huggingface dataset:
48 hrs after Shingles vaccine, developed a rough, red skin rash at vaccine site and a small 1 inch red, rough skin area about 4 inches from injection site near armpit. The armpit site developed swelling and deep redness that spread about 6 inches across whole armpit and became very painful. On 5th day body aches, headache, chills and general weakness developed along with a violent itching and burning in armpit and surrounding areas. Dr. visit resulted in oral antibiotic script-CIPRO. After 4 days of no improvement and a second dr visit, was treated with 10 days IV vancomycin plus 4 wks doxycycline. Attempts at lancing area produced no result but at day 10 abscess opened and began to drain. Area drained for a week and then began to heal up. Am left with scarring and occasional tingling and itching in area.
Day 1 after vaccine - Fever 101.5, fatigue, nausea, vomiting, head congestion and headache; Day 2 - tired, headache, sensitive stomach; Day 3 - red warm itchy spot below vaccine site on arm. Injection site very sore for day of vaccine and first 2 days after.
mild fatigue and worsened arthritis pain & swelling.  24 to 48 hours after vaccine (I'm writing about 48 hrs after injection so I don't know how long it will last.)    The worsened arthritis  may or may not be a side effect of vaccine  because over the my degree of arthritis has varied in the past few years.  However,  it has worsened noticeably  since the shot - although  it within the range of previously experienced.
Petechial rash in arms and chest, no symptoms, no fever, no vesicles, no evident bleeding.
Patient states that he continues having pain in his left shoulder. There is no injection site reaction. The site is NOT red or swollen. He was advised to make an apt with MD
LOCALIZED INDURATION 3X6 CM, RED SKIN RASH, TENDERNESS-STARTED WITHIN 24 HOURS, NO SYSTEMIC REACTION.
Chest pains, pain down arm on left side. Blood pressure increased. Patient states was given 3 NTG and monitored.
something bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (something bad) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (something bad). At the time of the report, FEELING ABNORMAL (something bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information were provided. No treatment information were provided
pt recvd vax & had apnea w/o color change-responded to stimulation; pt on apnea monitor after 1st vax;
Acute respiratory distress, SOB, sats 70%; patient intubated approximately 12 hours after vaccine; extubated on 5/3.
About 1 week (on March 13) after first shot (inoculation occurred on March 5), a red circular rash about the size of a dime appeared around the injection site.  It was warm to the touch, sore, itchy, and swollen.  The inflammation increased slightly overnight.  The next day, the redness was about the size of a nickel with the same soreness, warmth, and itchiness, but the swelling was about two inches in diameter and flattened.  Over the next 24 hours, the symptoms and signs dissipated.  By Monday evening (third day), the signs and symptoms had declined and were gone by the evening.  Question: Since I had a delayed reaction (beyond the initial arm soreness and slight fatigue on the day of the injection) should I be concerned about having an allergic reaction with the second shot?
Nose blistered; Watering of eyes; Loss of appetite; Bleeding of left nose; Weak; Chills; Temperature 99.5; Pressure in chest; Pain in the left shoulder; Pain in left leg; Nose on the left side swell up to the size of golf ball; Stomach discomfort; Severe extreme painful headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Pressure in chest), EPISTAXIS (Bleeding of left nose), NASAL OEDEMA (Nose on the left side swell up to the size of golf ball), BLISTER (Nose blistered) and LACRIMATION INCREASED (Watering of eyes) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Severe extreme painful headache). On 01-Feb-2021, the patient experienced CHEST DISCOMFORT (Pressure in chest), PAIN IN EXTREMITY (Pain in left leg) and ARTHRALGIA (Pain in the left shoulder). 01-Feb-2021, the patient experienced NASAL OEDEMA (Nose on the left side swell up to the size of golf ball) and ABDOMINAL DISCOMFORT (Stomach discomfort). On an unknown date, the patient experienced EPISTAXIS (Bleeding of left nose), BLISTER (Nose blistered), LACRIMATION INCREASED (Watering of eyes), DECREASED APPETITE (Loss of appetite), ASTHENIA (Weak), CHILLS (Chills) and PYREXIA (Temperature 99.5). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHEST DISCOMFORT (Pressure in chest), NASAL OEDEMA (Nose on the left side swell up to the size of golf ball), BLISTER (Nose blistered), LACRIMATION INCREASED (Watering of eyes), ABDOMINAL DISCOMFORT (Stomach discomfort), ASTHENIA (Weak), PAIN IN EXTREMITY (Pain in left leg), ARTHRALGIA (Pain in the left shoulder), CHILLS (Chills) and PYREXIA (Temperature 99.5) outcome was unknown and EPISTAXIS (Bleeding of left nose), DECREASED APPETITE (Loss of appetite) and HEADACHE (Severe extreme painful headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (Inconclusive) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.
Dizziness, tired, headache within 3 hrs - then hallucinated that night - recovered within 3 days.
Swollen arm at injection site.  Warm to touch, itches within 24 hours.
INCORRECT STORAGE OF DRUG; VACCINE RECEIVED THAT HAD BEEN PUNCTURED 2 WEEKS PRIOR TO ADMINISTRATION; This spontaneous report received from a health care professional concerned an adult of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies and unknown drug abuse or illicit drug usage. It was unknown that the patient smoke and consume alcohol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A, and  expiry: 30-JUN-2021) .5 ml, administered on 15-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-APR-2021, the subject experienced vaccine received that had been punctured 2 weeks prior to administration. On an unspecified date, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine received that had been punctured 2 weeks prior to administration and incorrect storage of drug was not reported. This report was non-serious.
This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave out Covid vaccine to a 17 year old and gave Moderna) in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave out Covid vaccine to a 17 year old and gave Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Gave out Covid vaccine to a 17 year old and gave Moderna) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Reporter was director of nursing. No concomitant medications information was reported. No treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2022: Follow-up received contains no new information.
allergic reaction rash really bad on her back, arms and neck, legs little bit on her chest; This is a spontaneous report received from a contactable consumer, the patient. A 90-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 0878346) via an unspecified route of administration in left arm on 06Mar2021 at 12:15 (at the age of 90-year-old), as a single dose, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation and allergy to influenza vaccine. The patient previously received Influenza vaccine on an unknown date. The patient had received unspecified prescribed medications withing two weeks of vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine 4 weeks prior to COVID vaccine. On 09Mar2021 at 01:00, the patient experienced allergic rash on back, arm, neck and chest, which was really bad. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of allergic rash and included treatment with cream and pills (unspecified) from an unknown date. The clinical outcome of event allergic rash was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected
patient received his first dose on 3-OCT-2023 and the second dose today 6-OCT-2023; supposed to receive a COVID-19 vaccine today but was accidently given the AREXVY; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 93-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number nm5g5, expiry date 05-MAR-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 06-OCT-2023, the patient received the 2nd dose of Arexvy. On 06-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received his first dose on 3-OCT-2023 and the second dose today 6-OCT-2023) and wrong vaccine administered (Verbatim: supposed to receive a COVID-19 vaccine today but was accidently given the AREXVY). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 06-OCT-2023 The reporter stated that a patient accidently received 2 doses of Arexvy vaccine, which led to extra dose administered.  The patient received his first dose on 03-OCT-2023 and the second dose today (on the day of reporting). He was supposed to receive a COVID-19 vaccine today but was accidently given the Arexvy, which led to wrong vaccine administered. Both doses had the same lot number and expiration date. The consent to follow up granted.
Information has been received from a physician's assistant concerning a 13 year old female with seasonal allergy who in March 2007, was vaccinated IM with the first 0.5 mL dose of Gardasil. The physician's assistant reported that within 21 days of vaccination the patient developed bilateral axillary lymph node swelling. Multiple nodes were noted bilaterally. The patient was treated with Zithromax for three days. Unspecified laboratory tests were obtained; all reported as normal. The patient recovered within 1-2 weeks of Zithromax therapy. It was reported that the opposite side of vaccination resolved first, "in several days," then the side of vaccination resolved. Additional information has been requested.
This spontaneous report was received from a nurse referring to a 56 year old male patient.  No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-OCT-2011, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route of administration, lot number and expiration date were not reported). On an unspecified day in November 2016, the patient received a dose of PREVNAR 13. On 24-APR-2018, the patient was vaccinated with PNEUMOVAX 23, lot # R000692 expiring on 09-SEP-2019, 0.5 ml, intramuscularly for prophylaxis. On an unspecified day in April 2018 the patient experienced injection site cellulitis type reaction.  The patient was seen in the urgent care on 27-APR-2018 where he was given an antibiotic.    The outcome of injection site cellulitis was unknown. The event did not required hospitalization and was not considered a disabling or life threatening condition. This is one of two reports from the same source.; Sender's Comments: US-009507513-1805USA001324:
Information has been received from a physician and a certified medical assistant concerning a 4-year-old female with no pertinent medical history or allergies, who on 02-OCT-2006 was vaccinated subcutaneously on the right arm with a second 0.5 ml dose of varicella virus vaccine live (lot#652664/1033R).  There was no concomitant medication.  On 03-OCT-2006 the patient developed swelling of her arm (approximately 10 x 12 cm) and a rash.  It was reported that there were about 15-20 vesicular lesions.  Unspecified medical attention was sought and there were no laboratory or diagnostic tests performed.  The patient was treated with cool packs, ibuprofen and elevation of the arm. The outcome was recovered as of 05-OCT-2006.  No product quality complaint was involved. The reporter considered the patient's experiences to be other medical events.  Additional information has been requested. (OMIC)
Part of vaccine leaked out of a faulty syringe during administration of first shot; it leaked out of a faulty syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Part of vaccine leaked out of a faulty syringe during administration of first shot) and SYRINGE ISSUE (it leaked out of a faulty syringe) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced UNDERDOSE (Part of vaccine leaked out of a faulty syringe during administration of first shot) and SYRINGE ISSUE (it leaked out of a faulty syringe). At the time of the report, UNDERDOSE (Part of vaccine leaked out of a faulty syringe during administration of first shot) and SYRINGE ISSUE (it leaked out of a faulty syringe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
very fatigued after the first dose; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date was not reported), via an unspecified route of administration on 22Jan2021 (at the age of 48-years-old), as dose 1, single for COVID-19 immunization. Patient had no relevant medical history. The patient's concomitant medications were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very fatigued after the first dose on an unspecified date. The outcome of event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received Adult Pfizer Covid-19 vaccine on 1/18/2022 and this vial was unfrozen on 12/17/2021 at 12pm.  The vaccine was good for 31 days according to Pfizer help line but vaccine was given on day 32, it was given one day after it expired.
Patient was fully immunized and became ill w/ invasive Strept pneumoniae bacteremia.  Hospitalized 1/28/08-2/1/08 w/ severe tonsillitis and bacteremia.  Still recovering at home with PICC line and IV Rocephin x14 days. 2/12/08-records received for DOS 1/28-2/1/08-DC DX: Severe tonsillitis with strep pneumococcus on blood culture. Admitted with severe tonsillitis, high fever and dehydration. Ill for several days with high fever.
Patient received HPV dose #1 on 4/4/2023, administer by RN. Patient returned for HPV dose #2 on 5/9/2023, reporting "shoulder stiffness and reduced range of motion of left shoulder".  Patient denies nerve pain and denies tingling or shooting pain. Patient reports decreased range of motion and pain with lifting left arm upwards, however notes improvement over that last month with passive movement exercises. Pt educated to follow-up with PCP as the shoulder stiffness is not completely resolved after previous vacation of HPV #1 dose.
Beginning Wednesday 01/13/2021 first thing in the morning, around 6:00am, I noticed soreness in the lymph nodes under the arm where the injection was given.  The soreness extends down to the lower inner portion of my arm and persist today although it has lessened slightly.
On 11/1 patient received a booster shot from pharmacy. On approximately, 11/ 10 patient showing symptoms for cellulitis w/  left arm redness, itching, warmth, swelling after covid booster. On 11/11 patient received  treatment from primary care MD where she was diagnosed with cellulitis and prescribed doxycycline hyclate (VIBRAMYCIN) 100 MG capsule (Take 1 capsule by mouth 2 times daily). When antibiotics course was completed on 11/21, patient continued to experience jolts of pain in the area near the shot radiating down into her arm, the arm feels heavy,  weak and fatigued. Pt was prescribed meloxicam 15 MG tablet (1 tablet by mouth daily) for pain.
Seizures began 7-10 days after 2 Mon. Vaccines given on Aug. 21, 2006. Infantile spasms diagnosed on Oct. 18, 2006. After seizure free in Dec. 06, seizures returned 24 hrs after 4 mon. vaccines given on Dec. 19, 06. 12/22/08-records received-consultation report DOS 6/2/08-history of medical refractory infantile spasms since age 3 months. Clusters of infantile spasms on daily basis, 3-9 clusters per dasy lasting approximately one minute. Mostly the spasms involve truncal jerk but occasionally evolve to clonic seizures involving left leg. Making progress in milestones. Mild left arm weakness. 01/29/2010 Follow-up: Patient still suffers daily seizures that have caused global developmental delays. All testing has shown no other reason for his seizures.
Began with severe muscular pain in lower back, without any precipitating event.  After a week it also affected both knees, then a week later all joints and muscles are affected.  It has now been 8 weeks and I am still experiencing extreme pain and joint pain.  aching muscles after even short use.  jumps around during the day from muscle and joint to another one.  Back pain disappeared after 4 weeks just as suddenly as it had come.  I am now on a course of prednisone.
Very sore left arm; Nausea; Bad headache; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204) via unspecified route of administration in the left arm on 24Mar2021 at 14:30 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. The patient had allergy to sulfonamide. The patient did not medical history and did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and did not experience any side effects. Prior to vaccination, the patient did not test positive for COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced very sore left arm, nausea and dry heaves (on the next day), headache on 25Mar2021 at 16:00. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore arm, nausea, headache and dry heaves was recovering at the time of this report.                            No follow up attempts are possible. No further information is expected.
Tested positive for COVID; Lost sense of taste and smell; Lost sense of taste and smell; Congestion; Dry cough; This is a spontaneous report from a contactable consumer or other non hcp.  A 29-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), via intramuscular route, administered in Arm Left on 17Mar2021 (Batch/Lot Number: EN6206; Expiration Date: 30Jun2021) as DOSE UNKNOWN, 0.3ml SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Received call from consumer regarding the Pfizer COVID vaccine. He would like to speak with someone about the effects he had, and any suggestions Pfizer may have to help him. While reporting side effects for himself, he mentioned that his wife, son and daughter, all had side effects after receiving the vaccine. father of patient handed phone to his daughter after he reported for himself. His daughter came on the line and reported on behalf of herself that, she tested positive for COVID on 22 Monday, 22Mar2021, but did not get results until yesterday 25Mar2021. This occurred after she got the vaccine. On 20Mar2021, the patient had cough, on 21Mar2021, the patient had congestion and on 22Mar2021, the patient had Lost sense of taste and smell. The patient underwent lab tests and procedures which included sars-cov-2 antibody test positive: positive on 22Mar2021. Product quality complaint was recorded for compound BNT162 COVID-19 VACCINE SUSPENSION FOR INTRAMUSCULAR 2ML MULTIPLE DOSE VIAL X 1 (not clear after first shot or second Covid positive). The clinical outcome of the events (at the time of report was) Lost sense of taste and smell was not recovered, Congestion, dry cough was recovering, tested positive for COVID was unknown.  No follow-up attempts are possible; No further information is expected.
Headache, Myalgia, fatigue, "low-grade" fever, muscle pain around injection site Narrative:
Headache, fever (TMAX 100.8), fatigue and chills 5 days after vaccination administered