chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tendonitis; Bursitis; Severe R hip pain; Unable to stand upright; Borederline Acetabular Osteoarthritis; ACHES INTENSIFIED; INTOLERABLE BREATH TAKING PAIN; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (ACHES INTENSIFIED), CHEST DISCOMFORT (INTOLERABLE BREATH TAKING PAIN), DYSSTASIA (Unable to stand upright), ARTHRALGIA (Severe R hip pain) and OSTEOARTHRITIS (Borederline Acetabular Osteoarthritis) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tendonitis on 12-Mar-2021 and Bursitis on 12-Mar-2021. Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for Bone density abnormal, PITAVASTATIN CALCIUM (LIVALO) for Cholesterol, CURCUMA LONGA, LEVOMEFOLIC ACID, MECOBALAMIN (RHEUMATE) for Dietary control, IBUPROFEN (MOTRIN [IBUPROFEN]) from 17-Feb-2021 to an unknown date and METHYLPREDNISOLONE ACETATE (DEPO MEDROL) from 05-Mar-2021 to 07-Mar-2021 for Pain, KETOROLAC TROMETHAMINE (TORADOL) from 05-Mar-2021 to 07-Mar-2021 for Pain NOS.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (ACHES INTENSIFIED) and CHEST DISCOMFORT (INTOLERABLE BREATH TAKING PAIN). On 05-Mar-2021, the patient experienced DYSSTASIA (Unable to stand upright), ARTHRALGIA (Severe R hip pain) and OSTEOARTHRITIS (Borederline Acetabular Osteoarthritis). On 12-Mar-2021, the patient experienced TENDONITIS (Tendonitis) and BURSITIS (Bursitis). On 25-Feb-2021, PAIN (ACHES INTENSIFIED) and CHEST DISCOMFORT (INTOLERABLE BREATH TAKING PAIN) had not resolved. At the time of the report, DYSSTASIA (Unable to stand upright), ARTHRALGIA (Severe R hip pain), OSTEOARTHRITIS (Borederline Acetabular Osteoarthritis), TENDONITIS (Tendonitis) and BURSITIS (Bursitis) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, X-ray: (abnormal) Borderline acetabular osteoarthritis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    April 7th 2021, Patient  pain is easing, able to walk upright and is decreasing the treatment of Motrin.       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Non-significant follow-up
Pt vaccinated with OPV/DTP developed fever, cough (worse at night), loss of appetite, starting  day of immunization x 4 days duration.
This literature marketed report as received from a physician refers to a patient of unknown age and gender. Background: For mothers with chronic hepatitis B virus infection, the Centers for Disease Control and Prevention recommends immunoprophylaxis to decrease perinatal transmission. However, its effectiveness and risk factors for failure have not been well-studied in community practice. Objective: To investigate the effectiveness of a contemporary immunoprophylaxis protocol. Design: Observational study. Patients 4446 infants born to 3253 HBV-positive mothers between 1997 and 2010. Measurements: Adherence to immunoprophylaxis, follow-up testing rates, maternal risk factors to HBV transmission, and transmission rates. Tests for HBsAg (HBV DNA, e antigen, and liver function tests) were completed for 3353 (85%) of all infants, 2945 (85%) of the 3473 infants with maternal e antigen testing, and 837 (93%) of the 904 infants with both maternal viral load and e antigen testing (after 1 July 2007). Among all children, 0.75% (25 of 3353 tested) were HBsAg-positive as of January 2012 (Table 4). All these 25 patients had H-BIG and the first dose of RECOMBIVAX HB (lot#, dose, route not reported) within 12 hours of birth. 19 of the 25 patient had the second dose within 24 to 62 days of birth and the other 6 received it within 70 days of birth. Most of the 25 children (22 of 25) also received the third dose within the recommended 164 to 214 days and the remaining 3 received their third dose between 219 and 237 days (and received their second dose on time). Outcome of the event was unknown. The reporter considered the event to be related to RECOMBIVAX HB. A copy of the published article is attached as further documentation of the patient's experience. This is one of 25 reports from the same source. Additional information has been requested.
Patient given pfizer monovalent in error, bivalent ordered.  Patient notified, advised to get bivalent >= 2 months after erroneous monovalent administration
suspected vaccination failure/got the shot / got the shingles; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: Age at vaccination was not reported. The patient received Shingles vaccine and still experienced shingles and they were bad. Follow-up would not be possible as no contact details provided. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This 76  year old  black female received the Covid shot on 2/27/21    and went to the ED and was admitted on 3/17/21     and again to the ED and admitted on 4/7/21 with the diagnoses listed below. Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction Non-ST elevation (NSTEMI) myocardial infarction Epistaxis
Red itchy blob of injection site 4/23/2021 at 9:00 am and has continued to grow in size.
Swollen axillary lymph node on the right measuring about 1.5cm x 1cm. Not red, not painful, mobile.
Pt recvd HIB/MMR & devel eczematoid rash first @ lt thigh site, followed by similar rash on rt arm; Seen 28JAN92 & 29JAN92 & 30JAN92; local rashes followed by urticarial erythema multiforme type rash on legs & trunk resolved spontaneously;
No additional AE details available.; Nurse calling states an expired dose of GARDASIL 9 was inadvertently administered to a patient that was past expiry. The product expired 9/6/2022 and was administered 9/14/2022.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies were not reported.   On 14-SEP-2022, the patient was inadvertently vaccinated with a expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot number 1787290 is an invalid lot number, expiration date reported as 06-SEP-2022) (exact dose, strength, route of administration, anatomical injection site and vaccination scheme were not reported), administered for prophylaxis (expired product administered). It was reported that the product had not experienced any temperature excursions through the date of administration. No additional adverse events were reported.
Three years ago I had several shingles & I still have some pain.  So when I read about the vaccine, it sounded great!  I received the Shingles Vaccine - ZOSTAVAX - 10PK-S.C. InJ.MERC- in my upper left arm, at the Pharmacy.  In the next day or two a red bump appeared & it itched.  Over the next 4 months, it just got bigger, feverish itched & ached.  As I as being treated for something else, a few doctors looked at it & just recommended I apply NEOSPORIN.  Then in Jan. 2008, my primary Dr. suggested I see a Dermatologist.  He had no idea what it was, so took a deep biopsy & sent it in.  It came back no cancer, no infection, no fungus, no bacteria & not related to my Rheumatoid Arthritis condition.  By now it had a big hard, red ring around it, painful & weepy.  He gave me 6 small steroid shots around the wound & then removed the hard ring, the next month.  Now I had a hole about 1 1/2".  Always has a red aura around it, itches, weepy & rather feverish.  I've been to Do. once a month since & we're not making much headway.  I take 5 mgs of prednisone  a day & 10 Mgs of methotrexate once a week.  Is this the problem & is there anything we can do to get rid of this sore on my arm?  Any help you can give us will be much appreciated!  8/29/08 Reviewed dermatology medical records of 3/26-6/16/2008. FINAL DX: granulomatous dermatitis due to zostavax. Records reveal patient experienced left posterior arm 2 cm erythematous, indurated, itchy & painful plaque after vaccination & lasting approx 6 mos.  By last note of 6/2008 was beginning to slowly improve after trials on several different meds.  Had developed eschar & was started on oral antibiotics at that visit after debridement.
Allergic reaction at site of injection including pain, swelling, redness and itching. Area of reaction  spread to approximately 8" in length and 5" in height. Spreading continued for three days after injection.
after giving the shot pt fainted  and had a seizure  episode for 15- 20 seconds
chills; fever; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METOPROLOL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Immune disorder prophylaxis, AMITRIPTYLINE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site). On 17-Jan-2021, CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 101 degree Farenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took 2 acetaminophen to treat the symptoms.
Malaise, sweating, headache, sick stomach, no appetite, watery bowel movements.  sleep all day.  9/27/16 improved but left arm is still red and swollen and 2" greater in circumference than right arm that was not injected.
Caller stated that she received her second vaccine on 03/19/2021 and the following day her arm became itchy and red around the injection site. Redness is still there. She denies any other symptoms.
Pt. reported red swollen hive 2-4 hr. after shot, pt. called clinic 12/24 in pm. to report swelling size of golf ball and redness and warmth of upper arm. She was advised by provider on call to use ZANTAC and ZYRTEC and ibuprofen on 12/26 patient presented to ER with redness, swelling of arm. She was treated with BENADRYL - allergic reaction and KEFLEX for cellulitis. By 12/24 patient reported decreased swelling and redness and small lump at inject. site.
8/8/21: Patient presented to the emergency department with complaints of body aches, headaches, fevers, cough, sore throat, vomiting, diarrhea and shortness of breath x1 week. Wife is positive for COVID-19 at this time. He apparently had a negative rapid COVID test but due to hypoxia noted at home he decided to come to the ED for further evaluation. Patient tested positive for COVID-19 8/8/2021. Of note, patient received Pfizer COVID-19 vaccine, last dose administered April 2021. 8/16/2021: Patient still admitted as of report submission
9:35 c/o feeling really tired + continuously yawning, no resp. distress, skin W/D.  BP 110/60-82, 99%.  Advised to wait an additional 5 mins.  Left observation area.  Stated he still felt tired.  In no distress.  Mom driving.
Per patient starting having symptoms later that evening after receiving the vaccination.  She was light headed and felt nauseous which persisted for several days after getting the immunization.  She also had redness, pain and swelling at the injection site that extended the whole top of the arm and down to the elbow.
HCP reported that a 25 year old patient received PROQUAD dose 4 weeks ago (exact date was unknown) because her titers were low. No additional AE reported. No PQC reported. No further information was provided.; HCP reported that a 25 year old patient received PROQUAD dose 4 weeks ago (exact date was unknown) because her titers were low. No additional AE reported. No PQC reported. No further information was provided.; This spontaneous report was received from Other Health Professional and refers to a 25-year-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, 0.5 milliliter, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date (also reported as 4 weeks ago), HCP reported that a 25 year old patient received measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose, because her titers were low (Inappropriate age at vaccine administration). No additional AE reported. No PQC reported. No further information was provided. The action taken with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) regarding Antibody test negative was reported as Not Applicable.  The causal relationship between Antibody test negative and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was unknown.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. The reporter stated that between 28-APR-2015 and 30-JUN-2015 (exact dates of administration were not provided), the patients were vaccinated with improperly stored doses of PNEUMOVAX23, intramuscular (strength and dose were not provided), lot # K021577, expiration date 22-JUN-2016. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 9 yr old male who on 20Jun97 was vaccinated in the arm with a first dose of varicella virus vaccine live. (lot620619/1479D). The week of 19Dec05, the pt experienced mild breakthrough with less than 50 lesions. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information indicated that on 19Dec05 the pt experienced a rash and fever for 24 hrs. Small vesicles were noted on his head, neck, back and chest. Probable varicella was diagnosed by the doctor. Subsequently he recovered. No further information is available.
Patient experienced tingling down her right arm. She felt better within 1 hour and refused any further treatment
Bad headache, upset stomach,  very mild temp, extreme tiredness, started around 6 AM, got worse for about 5 hours. Headache first to go away. By 8 PM all but tiredness gone
Patient reportedly had a seizure within 12 hours of recieving Gardisil Vaccine.  This was her first dose.  It is undetermined how long the seizure lasted as the patient and her mother are poor historians.
Headaches, fatigue, nose bleeds, muscle and joint pain and weakness, dizziness, anxiety, sever nausea, all daily. Low blood platelets, bad blood work results, fibro adenomas in both breasts, hypothyroidism symptoms. Prescribed antibiotics and lots of rest to no avail. Multiple other symptoms and treatments.
4:30 am feeling very nauseas and tired  felt to tired to do even the smallest and lightest daily
Headache, Sedation, Myalgia, SkinRash, CoughWheeze, Syncope, fatigue, sweat, chills Narrative:  on 2nd day had soreness, fatigue - slept for 2 days. on 3rd day got sweat, chills, and rash on top side of abdomen. on 4th day sweat and chills continued with severe headache, sneezing, coughing, and fatigue. 1/22 was first day to feel normal
breast cancer; This is a spontaneous report from a contactable consumer reporting for self. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) via an unspecified route of administration on 13Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient said she was recently diagnosed with breast cancer and has been newly prescribed the hormone, Aromasin 25mg. She was scheduled to have her second COVID-19 Vaccine dose on 03Feb2021. She said she has not started the Aromasin 25mg. She said she wanted to check to see if she should hold off on starting the Aromasin 25mg until after she receives her second COVID-19 Vaccine dose, and when would be an appropriate time to start the Aromasin 25mg. Outcome of event was unknown.
Pt received vaccine 08 Dec 09. Pt noticed redness and swelling later that evening. Pt states she suspected the reaction was normal and decided to wait to be seen since she had to return to hospital 2 days later. Injection site is raised, red and warm to the touch with tenderness to palpation.
tingling, numbness from Right shoulder through right finger tips. Significant pain in upper right shoulder blade and neck. Day4 post vaccine and pain/symptoms are lingering
no other issues; incorrect storage PROQUAD was administered; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 23-NOV-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U019289 exp date 15-DEC-2022) (dose and route not reported) that was exposed to a temperature excursion of 29.9 F for a time frame of 3 hours and 2 minutes. The maximum temperature was -1.6 °C and had not back in range at the time of the report.
This spontaneous report was received from a certified medical assistant regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9, .5 ml, lot no. L0044475/expiration date- 12-MAY-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
56y.o. male with a hx of kidney transplant secondary to right kidney nephrectomy (2020) who presents to the ED for evaluation of shortness of breath with onset couple days
About a week following the second vaccination, I began to have intermittent left sided chest pain. This pain would be severe at time and would come and go. At time, the pain was stabbing. This lasted for about 4 weeks. My Doctor told me is was all muscle inflammation from receiving the vaccine. It was treated with over the counter meds.
Rec'd flu vaccine on 10.12.22 started with a rash on 10.15.22. Rash was on hands, inner arms, lower stomach and back, legs and feet.  Red, itching and stinging, at times looked liked whelps. Started taking Benadryl and on Monday went to doctor. Rec'd a Steroid injection by Wednesday 10.19.22 rash was starting to return. Doctor prescribed a methylprednisolone. Last pill was Monday morning 10.24.22. Rash started back on Tuesday morning 10.25.22 on hands and inner arms. Stinging and itching.
got real sick; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (demographics unknown) who got real sick (illness), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got real sick (illness) (unknown latency, non-serious) following the administration of INFLUENZA VACCINE.  The patient never had flu before that nor since 15 years. The reporter will never get another one.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown.  There will be no information available on the batch number for this case. .
Incapacitation for demyelinating disease onset. Loss of mobility, coordination, balance. Pain. Hospitalization for IV steroid treatment.
CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 15:53 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021 01:30, Laboratory data included: Body temperature (NR: not provided) 101.3. On 19-MAR-2021 02:02, Laboratory data included: Body temperature (NR: not provided) 101.7. On 19-MAR-2021 02:09, Laboratory data included: Body temperature (NR: not provided) 101.4. On an unspecified date, the subject experienced chills, fever, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea and chills was not reported. This report was non-serious.
Patient is 16 years of age and was given the Moderna vaccine in error.  No adverse reaction.