chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started a period, it was heavy and lasted 6 days/period had been heavier and lasted longer than periods have in the last 7 years; spotting blood; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Nov2021 (Lot number: FG3527) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "perimenopause" (ongoing), notes: periods every 3 weeks and very light, last period in Mar2021. No COVID prior vaccination, no COVID tested post vaccination. No known allergy. Concomitant medication included: SYNTHROID. Vaccination history included: BNT162B2 (dose 1, lot number: 30145BA, left arm), administration date: 29Oct2021, when the patient was 52 years old, for COVID-19 immunization, reaction: "spotting blood". No other vaccine in four weeks. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset 30Nov2021, outcome "recovered" (03Dec2021), described as "spotting blood"; HEAVY MENSTRUAL BLEEDING (non-serious) with onset 06Dec2021, outcome "not recovered", described as "started a period, it was heavy and lasted 6 days/period had been heavier and lasted longer than periods have in the last 7 years". The patient reported that she had been in perimenopause for the past 5 years. Periods every 3 weeks and very light. Mar2021 was her last period. She went to the Gynecologist in Sep2021 for a check up and all was well. She said she was postmenopausal. She had her first shot on 29Oct2021. On 14Nov2021 started spotting blood. It lasted 3 days and then the spotting happened again on 30Nov2021 for 3 days (had the second shot on 26Nov2021). On 06Dec2021, after 9 months with no menstrual cycle, she started a period. It was heavy and lasted 6 days. She had not had a period like that for over 7 years. 27 days later on 04Jan2022, she had another one and 27 days later on 02Feb2022, she got another period. On all occasions, the period has been heavier and lasted longer than her periods have in the last 7 years. It is 04Feb2022 now and her bleeding continues to be heavy. She is 53 years old and this should not be happening. The events "spotting blood" and "started a period, it was heavy and lasted 6 days/period had been heavier and lasted longer than periods have in the last 7 years" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of postmenopausal haemorrhage, heavy menstrual bleeding.  Follow-up attempts are completed. No further information is expected.
Sore arm, body aches, headache. Delayed menstruated cycle, mood swings (feel related to hormonal changes)
pt recvd vax 11JAN93 & 12MAR93; blood culture & cerebrospinal fluid cultures on 11SEP93 revealed haemophilus influenzae type A & MD reported that pt had devel invasive haemophilus flu type A disease;
10/21 Itching on sides, red, took BENADRYL 8 AM. 1:00 Hives on torso. Spread to back by 2 PM. Called Dr. told to take 2 BENADRYL every 4 hrs. 10/22 Spread to arms and face in AM. By 10 PM voice raspy, hands/feet itchy. 10/23 Took BENADRYL 7 AM and noon. By 3 PM cleared up 99%.
Chills, fatigue, nausea, body aches, sore arm, night sweats
Patient experienced a rash on lower back 1 week after shingles shot. It looks like shingles however the patient has not seen a physician. Advised patient to call md.
On 11/16/2015, pt was seen in clinic for follow up visit. During visit, pt was ordered to receive Pneumococcal polysaccharide vaccine 23-valent greater than or equal to 2yo SQ/IM (PNEUMOVAX-23) Immunization/Injection. Per documentation, pt received an injection of 0.5 mL in left deltoid after "area was prepared aseptically free from redness, swelling, or any abnormalities" (Lot #L024129; exp: 1/21/2017). It was noted that pt "tolerated well without incident. Pt received written literature and verbalized understanding". On 11/18, pt sent an e-mail to provider stating "I am having a reaction to the pneumovax that I received on Monday. I noticed yesterday that my arm was sore, which I expected, but got a little worse throughout the day. Last night while getting ready for bed I noticed in the mirror that the area above my armpit and to the side (on my arm) were both splotchy red and very tender/sore and feel warm...." MD replied with instructions to "Take tylenol 650 mg and benadryl 25 mg right away" and return to clinic. On11/18, pt returned to clinic for evaluation. On exam, pt was found to have no fever, no swelling, no induration, no fluctuance, no drainage and no axillary adenopathy. Area was slightly tender to touch and slightly warm to touch. MD diagnosed cellulitis and pt was prescribed cephalexin 500 mg PO BID x 10 days. Pt treatment ongoing.
Pt had a large, red region at left deltoid region; no fever; had slight tenderness on compression.
Headache, joint pain, light fever, light-headedness. I almost passed out trying to walk to the dining hall for dinner.
Pain right arm- site of injection- not able to move for almost 3 days, followed by chills, body ache, and headache. Symptoms lasted for 3 days.
Call from ER hospital on 12-11-09 ER stated child coded and was careflighted to Hospital.  Hospital did not administer this H1N1 Vaccine. We only saw child in Emergegency Dept. Our local Health Dept.-submitted a VAERS form which gave you lot #, etc. please refer to that.
pt recvd vax & devel pruritus, rash, clay colored stools & jaundice; tests revealed GGT, SGOT, SGPT, total & direct bilirubin & alkaline phosphatase; pt devel obstructive jaundice due to thickened bile & stones;
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the Federal Government to DHS staff and then to the staff administering vaccine. Because of this delay, some monovalent vaccine throughout clinic was inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Vaccine given 10/11/11, s/sx pain sweating, no fever, swelling in legs, wrists, knees not related to previous hip injury decreased mobility ER visit 12/26/11, x-rays taken, 1/3/12 F/U visit to dr.
Vaccine documented as given on 1/1/2021 and 1/22/2021. On 8/13/21 this person presented to the emergency room and was admitted for COVID-19, this event requires VAERS reporting.
Swollen face; severe itchiness; tiredness; dull headache; This is a spontaneous report received from a non-contactable consumer(patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot number: EN6207, expiry date: not reported) via an unspecified route of administration at UNKNOWN SINGLE DOSE on 11Mar2021 for COVID-19 immunisation. Medical history included breast cancer. The patient was allergic to poultry. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication was not reported. The patient previously took tamoxifen and had allergic reaction to drug. On 11Mar2021, the patient experienced swollen face, severe itchiness, tiredness and dull headache which were still lasting even after 6 days (as reported). On an unspecified date, post the vaccination, the patient underwent a nasal swab test and the result was unknown. The patient did not receive any treatment for the events. The clinical outcome for the events swollen face, severe itchiness, tiredness and dull headache was reported as not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's first name added in patient tab, Patient's age/unit added in patient tab, duplicate reported indication of BNT162B2 removed, treatment received ticked as No, Concomitant therapy left blank since no information provided about the concomitant drug.
Started on thurs, it was a rash, started on both arms, then spread to legs and hands. now spreading to neck today.
DIZZINESS; pain all over; she feels like she is being hit by a baseball bat all over.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (DIZZINESS), PAIN (pain all over) and MYALGIA (she feels like she is being hit by a baseball bat all over.) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Sciatica. Concomitant products included GABAPENTIN, ATORVASTATIN, LANSOPRAZOLE, SERTRALINE, HYDROCHLOROTHIAZIDE, AMLODIPINE and CELECOXIB for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DIZZINESS (DIZZINESS), PAIN (pain all over) and MYALGIA (she feels like she is being hit by a baseball bat all over.). At the time of the report, DIZZINESS (DIZZINESS), PAIN (pain all over) and MYALGIA (she feels like she is being hit by a baseball bat all over.) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication information was provided.
This spontaneous report as received from a nurse refers to a patient of unknown age. The nurse reported that a patient was vaccinated with a dose of expired ZOSTAVAX (lot# H012521, expired date 09-OCT-2013) on 02-DEC-2013, subcutaneously, 0.65 ml. No adverse event was reported. No product quality Complaint. Additional information has been requested.
Product storage error; Expired vaccine administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided.   This case was linked to MOD-2021-285598 (Patient Link).
This report was received from a manufacturer for HIB-titer vaccine and was assigned manufacturer report number HQ8542119MAR2001. A physician reported that a female patient on 05 JUN 1996 was vaccinated with a dose of MMR. Concomitant therapy the same day included vaccination with varicella virus vaccine live and hib conjugate vaccine (HIBTITER). Two days later, on 07 JUN 1996, the patient developed a fever of 104 degrees F. The patient's outcome was unknown at the time of this report. Additional information has been requested. The physician also reported that the patient's sister experienced an injection site reaction after receiving therapy with MMR. Follow up information from a registered nurse indicated that she is unable to provide additional information because of a lack of patient's identity. No further informaton is available.
H/A, fatigue, nausea, T 100.8 <24 after adm
This spontaneous report was received from a physician regarding a 12.5 month old female patient with no pertinent medical history or drug reactions or allergies. On 20-JUN-2013 the patient was vaccinated with (merck) PROQUAD. The physician was unsure if the doses were administered as a dose of (merck) PROQUAD or as individual concomitant doses both MMR and (Merck) VARIVAX. On 21-JUN-2013 reported as "a day later" the patient developed a fever and broke out in a vesicular rash on the face and upper chest. The physician reported that "no culture was performed of the vesicular rash" however "titer studies were performed" when the patient visited the physician's office approximately on 27-JUN-2013 (reported as "a week later"). The physician reported that "chicken pox/varicella titers were low" and there was "a positive IgG and IgM to Herpes I". The physician reported that the patient could possibly be exposed to herpes I before receiving the vaccination. The physician reported that the patient is completely recovered at this time (date of recovery not reported). The physician did not assess the relatedness between fever, vesicular rash and positive to Herpes I and PROQUAD. VZVIP packet was sent. Additional information has been requested.
Administration error; patient is 16 and received Moderna for dose 1.  It was discovered when he came back for his second dose.  Moderna was administered for dose 2.
unspecified side effects; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (unspecified side effects) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (unspecified side effects). At the time of the report, IMMUNISATION REACTION (unspecified side effects) outcome was unknown.            No Concomitant medications were provided.  It was reported that patient received the updated Moderna booster on 25 Sep 2022 and had some questions regarding side effects, but call got disconnected before agent could ask for further details.  No treatment medications were provided.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a 13 week old male with no known allergies and reported to be otherwise healthy who on 5/9/05 was vaccinated with MMR (lot # 648461/1306N). There were no reported concomitant medications. On approximately 5/9/05 the patient developed a fever as high as 104 F, was lethargic, and cranky. It was reported that the patient sought unspecified medical attention and his fever was treated with ibuprofen. It was reported that the patient's fever had waxed and waned since the immunization and seemed to rise without regard to dosing of ibuprofen. The nurse reported that the patient's injection site was unremarkable. At the time of this report, the patient had not recovered from the events. The registered nurse considered the events to be other important medical events (OMIC). Additional information has been requested.
Patient hospitalized for vaginal delivery within 6 weeks of receiving COVID vaccination.  Per doctor's notes: "Her pregnancy was complicated by Rh neg status and measles nonimmune status. {During her labor, she received and epidural for pain management.  On 6/3/21 at 40w4d, she delivered a viable female infant via spontaneous vaginal delivery."
Moderna vaccine was used for in the morning for a covid clinic and it only yielded 9 doses instead of 10. We contacted Moderna and was told the effect was the same for 0.5ml and 1ml in the phase 2 trials of the covid vaccine. The patients still need a 2nd dose and that no unusual symptons were reported in phase 2 when given 0.5ml or 1ml doses.   Moderna also verified of at least one other account of using the medical 3ml syringe and needle,  and only being able to get 9 doses out of a 10 dose vial because the void space was rather large.
Patient presented to the ER ON 2/25/21 with symptoms of elevated blood pressure, severe lymph node swelling in her left axillary region and on her left shoulder. It was determined she also had cellulitis of the left shoulder. She was started on antibiotics.
Hives, bumps, redness and allergic reaction with itching, massive headache and lethargic for days after
Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic nodes, difficulty to breath and to swallow, weakness, disoriented, pain in body, difficulty to urinate, dizziness, blurry vision, nausea, tachardia, pulse rate increase, blood pressure increase, fatigue, body and muscle pain.
HCP called with a question regarding GARDASIL 9.  HCP asked if a patient currently in her 30's that received 2 prior doses of GARDASIL 9 in her 20s, needs to restart the series, or just be administered the 3rd dose in the regimen? Request case 02483; No additional AE/No PQC.; This spontaneous report was received from Other Health Professional and refers to an adult patient of unknown age and gender.  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 hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date, HCP called with a question regarding GARDASIL 9.  HCP asked if a patient currently in her 30's that received 2 prior doses of GARDASIL 9 in her 20s, needs to restart the series, or just be administered the 3rd dose in the regimen? Request case 02483557.  No adverse effects were reported. Consent to contact is no.  HCP refused providing patient information, and did not know exact dates of administration for the first 2 doses of GARDASIL 9.  No additional AE/No PQC.
69-year-old female brought to the emergency room by EMS.  It is my understanding that the patient was found by family to be shaking and have altered mental status.  According to nursing and the attending emergency room physician Dr. the patient was totally disoriented upon arrival and was having general body tremors.  According to nursing the patient was brought in on a non-rebreather mask.  I do not see any documented hypoxia.  At the time of my interview the patient is complaining of headache.  She thinks that it started a few days ago.  The patient is very vague on history.  She denies shortness of breath she denies cough she denies fever.  Patient has a history of chronic pain syndrome and is on morphine routinely and hydrocodone for breakthrough pain.  She is on muscle relaxants as well.  History is that at times the patient will forget that she has taken her medication and take more than she should.  It is unknown if she has done that at this time.  At the time of my interview the patient does not have any tremors.  She is currently oriented.  She does answer questions extremely vague however.  She denies tobacco use.  She denies alcohol use.  She denies illicit substance use.  I have been told that the patient has been on room air her entire up emergency room visit by the above emergency room physician however in the room the patient has oxygen by nasal cannula at 2 liters/minute.  She has had a CT head which shows no acute findings.  She has had a CTA of her chest abdomen pelvis which shows a triangular lesion in the right lung base.  There are no infiltrates consistent with COVID.  CT of the abdomen is unremarkable except for evidence of instrumentation in the urinary bladder.  The patient has had a Foley catheter placed for reasons I am unsure of.  Her COVID swab in the emergency room tonight is positive.  I have actually been asked to admit the patient because of her encephalopathy and the feeling that it is unsafe for her to return to home.  It is my understanding the patient is not on oxygen at home.  PT IS INPATIENT AT THIS TIME.
mom states pt had a t103 approx 7 hrs p/vax & took pt to ER; MD stated it was a react to DTP & advil mom not go have pertussis again;
Tingling of fingers and numbness of left cheek.  Did not get any worse after 30 minutes. Extremely tired and sore arm that day.  Day 2 - tired easily, no stamina.  Dizzy and nauseous after showering at3:30 pm.  By 10:30, both hands were red and itched.  Sometime in the night woke with a very sharp, painful headache.  Did not last.  No real problem again until Saturday.  Nausea at 11:20 am.  Sunday I sat all day doing taxes - no symptoms noted.  Monday after walking - rapid heart rate and very tired after what is normal activity.  By 4:30 I was tingling all over my body.  Tuesday night my ankles are swollen for the first time in years.  Only happened that nigh.  Wednesday morning, the tingling is very strong in my calves. and I had a sharp pain in the area of my Achilles tendon.  I believe that the vaccine has exacerbated the neuropathy (undiagnosed) of the bottom of my feet.  Today I am reporting because I fell for no reason getting out of a chair, and the tingling is in my legs, arms, shoulders.  I had not heard until today that the vaccine could affect the nervous system.  The effects are the worst they have been and it has been one week since I had the vaccine.  Should I get the second shot?  Due March 11,2021.
Information has been received from a nurse practitioner concerning an approximately 4 month old male who was vaccinated with Rotateq. Subsequently the patient experienced diarrhea and vomiting. The diarrhea lasted two weeks. As of 18-JUN-2007 the patient recovered from diarrhea and vomiting. The mother refused the third dose of Rotateq. Additional information is not expected.