chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of mass is a 68-year-old female patient who received BOOSTRIX (batch number TX34X, expiry date 14 May 2017). On 21st September 2016, the patient received BOOSTRIX .5 ml. On 28th September 2016, 7 days after receiving BOOSTRIX, the patient experienced mass and nodule. On an unknown date, the outcome of the mass and nodule were not recovered/not resolved. The reporter considered the mass and nodule to be almost certainly related to BOOSTRIX. Additional details were provided as follows: The patient noticed lump or nodule 7 days after receiving BOOSTRIX vaccine.
On 01/01/2023 I started feeling extremely exhausted. Went to the doctor and was prescribed iron pills after being diagnosed as anemic.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Additional Details: this adverse event is for shingrx, not covid
After dose 2, I had the commonly reported reactions - fever, chills, headache, and vomiting.  I was in bed for 36 hours, and then the symptoms resolved.  After dose 1 in January, I and my stylist noted that my hair had a significant lack of growth.  About three weeks after dose 2, my hair began to fall out at a rapid rate.  This occurred especially on the top of my head.  Again, growth of hair has been minimal as well.
A lump about a quarter inch by quarter inch in size developed under the skin at injection site; Patient received the second dose of Gardasil 9 late, with "about 6 months gap" between the first and second dose; This spontaneous report as received from a consumer referring to her daughter a 17 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. Drug reactions or allergies included amoxicillin and singulair (captured in case # 2003USA005460).  On an unknown date in 2019 (reported as "about 6 months gap"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) dose 2 (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for prophylaxis.   On 03-FEB-2020, the patient was vaccinated with the 2 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (indication, strength, frequency, dose, route, anatomical location, lot # and expiration date were not provided) for cancer prevention.   On 08-FEB-2020, the patient developed a lump about a quarter inch by quarter inch in size developed under the skin at injection site; the lump can not be seen but can be palpated (Injection site mass). There was no pain, no swelling, no redness at injection site. It was also mentioned that the patient received her second dose late with "about 6 months gap" between the first and second dose. The outcome of injection site mass was reported as not resolved. The causality assessment was not provided.  This is one of two cases for the same patient.; Sender's Comments:  US-009507513-2003USA005460:
Could not walk; Eyes inflammed; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Could not walk) and EYE INFLAMMATION (Eyes inflammed) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On an unknown date, the patient experienced GAIT INABILITY (Could not walk) and EYE INFLAMMATION (Eyes inflamed). At the time of the report, GAIT INABILITY (Could not walk) and EYE INFLAMMATION (Eyes inflamed) outcome was unknown.     No concomitant medications were reported.  No treatment medications were reported.  It was unknown if patient was enrolled in COVID-19-vaccine trial.  The reporter's causality for the events of Could not walk and Eyes inflamed with adalimumab solution for injection was not provided. The reporter's causality for the events of Could not walk and Eyes inflamed with Moderna COVID-19 vaccine was assessed as reasonable possibility.
Bell's Palsy after second vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy after second vaccine) in a 60-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FACIAL PARALYSIS (Bell's Palsy after second vaccine) (seriousness criteria hospitalization and medically significant). At the time of the report, FACIAL PARALYSIS (Bell's Palsy after second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
pt recvd vax; exp fever of 104.8 that eve;over the next 4 days,t ranged from 101-105;seen in ofc 28jan; no signs of infect;tx w/ apap/advil; recovered w/ no sequelae;
Mild symptoms in the 3 days after the injection (mild soreness). Yesterday, 9 days after vaccine, I started noticing a red, swollen spot on my arm about 1 inch below the injection spot. Within 24 hours, the small rash has grown to a 4inch x 2 inch rash. It is very red, hot to the touch, swollen and itchy.  I reported my initial symptoms through the CDC v-safe reporting process, but that ended after 6 days.
never received his second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 31st December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not applicable for this report. The patient never received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter wanted to know if he should restart vaccine sequence or when to get second dose.  The reporter did not provide additional information.  The reporter did not provide consent to contact health care professional.
Soreness at injection site; Fever (low grade 100.6); Chills; Nausea; Diarrhea; Feeling unwell; This is a spontaneous report received from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; lot number Unknown) via an unspecified route of administration in the left arm on 16Mar2021 at 10:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea, high blood pressure, obese and acid reflux from an unknown date. The patient was allergic to penicillin. Concomitant medications included irbesartan (MANUFACTURER UNKNOWN) for an unknown indication, Esomeprazole (NEXIUM) for an unknown indication, famotidine (MANUFACTURER UNKNOWN) for an unknown indication and doxycycline(MANUFACTURER UNKNOWN) for an unknown indication. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On an unknown date, the patient experienced soreness at injection site, fever (low grade 100.6), chills, nausea, diarrhea and feeling unwell. The patient did not receive any treatment for the events The clinical outcome of the events soreness at injection site, fever (low grade 100.6), chills, nausea, diarrhea and feeling unwell were resolving at the time of report.   Information about lot number cannot be obtained. No further information is expected
Arm pain, Knot at injection site; pt states it hurts to raise her arm. Has been going on since injection given on 10-3-2020.
body aches; 101.9 fever; significant swollen glands on R side of neck; significant swollen glands on R side of neck with pain; sleep was interrupted; low grade fever; fatigue; 4 lb weight loss; elevated TSH; lymph/thyroid swelling; 2 nodules on the thyroid; This is a spontaneous report from a contactable other hcp. A elderly Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6200, Expiration date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 09:30 as dose 2, single for covid-19 immunisation. Medical history included Thyroiditis 25 years ago, inc BP, inc cholesterol, hypothyroid. Concomitant medication(s) included atorvastatin (ATORVASTATIN); levothyroxine (LEVOTHYROXINE); lisinopril (LISINOPRIL). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as dose 1, single for covid-19 immunisation and experienced 16 days after first Pfizer vaccine on 06Feb2021 developed swelling on L side of neck, Tenderness over thyroid mid and L side. Prior to 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 vaccines within four weeks prior to the vaccination. Patient visited doctor or other healthcare professional office/clinic visit. On 13Mar2021 the patient experienced in L arm with body aches, 101.9 fever, significant swollen glands on r side of neck with pain to palpation particularly over R thyroid, sleep was interrupted, low grade fever, fatigue, 4 lb weight loss, elevated tsh, lymph/thyroid swelling, 2 nodules on the thyroid. she was following up with an endocrinologist. her symptoms cleared up in approximately 8 days start to finish. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone was elevated, ultrasound thyroid was lymph/thyroid swelling, Fever 101.9, Fever was low grade fever, weight was 4 lb weight loss, Blood work result unknown. Patient received treatment of OTC meds, blood work and ultrasound. The outcome of event was lymph/thyroid swelling was unknown, rest of all events was recovered.  No follow-up attempts are possible. No further information is expected.
Report 2001016628-1 (subsequently assigned GSK reference number A0349688A) describes Lyme disease in a 56-year-old male who reportedly received the complete immunization series of LYMERIX.  This report was received from the vaccinee and has not been verified by a physician or other healthcare professional.  Medical history, concurrent conditions, and concurrent medications were not provided.  The vaccinee works outdoors.  The vaccinee stated that he received three injections of LYMERIX, with the last dose administered in May 2000.  Exact dates of immunization were not provided.  In early July 2001, approximately 14 months after completing the LYMERIX immunization series, the patient underwent a complete physical.  At that time, he reported to his physician that he had been experiencing fatigue, headaches, and "severe" joint pain, especially in his feet and hands.  The vaccinee requested to be tested for Lyme disease.  He was notified by his physician that an unspecified test for Lyme disease was positive.  Follow up information was received on 03 December 2008 via an interview between the subject and attorney(s).  The subject, who was in his thirties, was vaccinated with LYMERIX on 22 May 1999, 04 December 1999, and 10 July 2000.  In 1999 or 2000, he experienced headaches, neck pain, back pain, knee pain, wrist pain, foot pain, floaters (vision problems), heart palpitations, and ringing in ears.  On unspecified dates, he experienced numbness of the limbs, and shoulder and elbow pain.  Treatment included Tylenol and Ibuprofen.  In 2004 or 2005, he experienced fertility "issues" described as difficulty conceiving.  The subject reported that fertility testing revealed that sperm "morphology was zero", that he was prescribed amino acids, and that his wife conceived twins born in August 2008.  The fertility issues were assessed by GSK to be medically significant.  The events, with the exception of fertility problems, were unresolved at the time of this report.
It was discovered that approximately 6 of the Johnson and Johnson vaccines kept at room temperature were given more than 2 hours after puncture of the vial.  There was confusion about between Moderna and Johnson and Johnson.  Moderna is good 6 hours after puncture when left out of the fridge.  2 doses were given on 4/26/2021 (approximately 3.5 and 4.5 hours after puncture), 4/29/2021 (approximately 2 hours 45 minutes after puncture), 5/1/2021 (approximately 2 hours 15 minutes after puncture), and 5/5/2021 (approximately 2 hours 15 minutes and 3 hours after puncture.)  The manufacturer was contacted and advised that the only advise to revaccinate is if there is significant leakage, equipment malfunction, or if the patient moves when being given the dose.   The pharmacy was advised to watch for adverse reactions in the patients involved.
At site of injection (right upper thigh) - 6.5cm x 5.5cm red, warm indurated lesion - tender to touch.
Information received from a 40-year-old female dentist who was vaccinated with hepatitis b vaccine recombinant. In approximately 1996, the pt experienced arthritic joint pain that appears to be "fully disseminated." The pt also experienced neck pain and stiffness and noted "could not lift her head up." The pt also noted having a fever. The pt's symptoms continued at the time of reporting. Additional information has been requested.
Moderna Covid-19 vaccine EUA Joint pain, headaches, fatigue, vision worsening
Daptacel was inadvertently administered to an adolescent patient instead of Adacel, no adverse event; Daptacel was inadvertently administered to an 11 years old patient, no adverse event; Initial information received on 30-May-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 11 years old female patient who was vaccinated with a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of booster dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5254AA and Exp. Date not reported) via intramuscular route in the left deltoid on 23-May-2019.  The patient's medical history not reported and concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No adverse event experienced by patient post vaccination.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  List of documents held by sender: none.
24hr post vax area of red erythema, edema, warmth lt shoulder area;
Localized Redness, warmth to the touch. Appeared 3-4 hours after vaccine was given. When patient arrived at the office reaction had improved. Given TYLENOL for pain and advised to monitor.
pt recv vax 6OCT95 & MAR96 was notified that HTLV-1 test was inconclusive;blood bank informed the pt it may be r/t vax;caller also stated pt reported a brief episode of loss of consciousness of time, w/sweating;to ER CAT scan & neuro exam
The patient experienced swelling, redness and induration at the injection site 3 days post vax.
fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (fast heartbeat) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TACHYCARDIA (fast heartbeat). At the time of the report, TACHYCARDIA (fast heartbeat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were not provided.   Reporter did not allow further contact
day p/vax raised rash (hives) body & face swollen went to MD;
PAIN ALL OVER THE BODY AS IF A NEEDLE STICK OVER NIGHT, EXPERIENCED BLACK OUT AND FALL NEXT MORNING . REGAIN THE CONCIOUSNESS  LATER SAME DAY.  NO MEDICAL SERVICE REQUIRED.  BUT SEEN BY PCP 2 DAYS LATER.  NO  MEDICATION PRESCRIBED PER PATIENT.
No side effects reported / No additional information provided; HCP calling to report GARDASIL 9 was administered after it experienced a temperature excursion. No side effects reported. Excursion was supported. No additional information provided.         ?    Names of vaccines involved (including lot/exp): GARD; This spontaneous report was received from an medical assistantand refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W028573, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). On 27-JUL-2023, this vaccine udnerwent temperature excursion before administration to a patient in 50 Farenheit (F) for 1 hour 40 minutes (Product storage error). No additional adverse event was reported.
No reaction until today when arm was sore and has welts at injection site & down ward about 4?
13JUL92 pt recvd 1st dose of Engerix-B & 1 wk later devel h/a & was not feeling well; ER visit was required;
12 mo old boy with rash starting on back and spreading to rest of body one day - clearing 1 week after vaccines. No fever or other systemic sx. Possible rhinorrhea, wheezing. Rash was red-blanching, papular-plaque like lesions, welt like over back. Not pruritic.
Patient had finger stick to check lipids then received GARDASIL injection in (L) arm. Physician walked back in room to find patient vomiting in garbage can. He said he was fine within 10 min back to normal. Vitals at beginning visit 125/72 Pulse 61. Vitals post event 118/71 P 60 O2 97%.
Information has been received from a physician, via a company representative, concerning a 19 year old female patient, who on 01-OCT-2007 was vaccinated with the second dose of Gardasil vaccine (Lot # not provided). Concomitant therapy included Yasmin. On 01-OCT-2007, the patient experienced heavy pressure in her chest and nights sweats. Treatment was not specified. Subsequently, the patient recovered from the events, and had not sought medical attention. Additional information has been requested. Follow up information from a licensed practical nurse described the pain-like heavy pressure in the patient's chest as "heavy chest discomfort," and added that the patient had also experienced shortness of breath and headache. She indicated that though the patient sought medical attention, no treatment was required. The nurse stated these were the events that had been previously reported: the physician previously indicated that the patient had recovered from all events. The nurse added that the symptoms had resolved within 24 hours. Additional information is not expected.
General malaise , Body aches, dizziness , tiredness , extremely sore arm , rash at injection site after first shot that lasted 9 days
Rash on right leg and arm and trunk of body treated with Benadryl per Dr.
Later in the day I began to feel aches and pains all across my body. I woke up in the middle of the night with chills, aches, and an intense tenderness of the injection area.
Information has been received from a health professional concerning a 8 year old male pt who was vaccinated on 01Nov1996 with a dose of varicella virus vaccine live. Subsequently, on approx 29Mar04, the pt developed breakthrough chickenpox with greater than 500 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00592, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
10 days after MMR and Varivax got fever to 103, congestion/cough and erythema multiforme rash
Vaccine had expiration date of 4/3/22 but was kept frozen until date of administration. Moderna contacted and deemed the vaccine viable and repeat dose  not needed.  No adverse event to report.
Localized muscle pain at injection site began to be joined by intense bone pain from mid-collar bone all the way down to mid palm.  Especially noticeable in shoulder joint, elbow joint, wrist joint.  Nausea with pain, but never threw up.  Tried massage by myself, then had my husband try all along the humerus avoiding injection site.  Zero relief. Even though I knew tylenol would suppress the immune response, I finally gave in at 10:15 pm that night and took two tylenol and two ibuprofen.  Relief came at about 11 pm that night.  Injection site still ached however.  Next day arm was painful to use while raising  it above elbow level, injection site still ached and continues still.