chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heavy menstruation like never before. Very very heavy bleeding.  Started earlier than typical. Lasted 4 days, then stopped for 1 week and then started very heavy again. I?ve never had this much bleeding or this frequent of periods together. This is a first and there is no other change to my days, routines, stress etc than the covid shot. I?m a huge vaccine advocate but this very heavy bleeding is not normal for me.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1, (dose, lot # and expiry date unknown). On 12-MAY-2008, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 658023/0824U with expiry date of 25-MAY-2009. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a MA and described the occurrence of latex allergy in a child of unspecified age and gender who was vaccinated with Infanrix for prophylaxis. On an unspecified date on or before 8/2/05, the subject received a dose of Infanrix (dose number not provided), (lot AC14A011AA). At an unspecified time after vaccination with Infanrix, on or before 8/2/05, the subject experienced a "possible" latex allergy. The subject was seen by an "allergist physician" and was tested for latex allergy. The MA reported that, "the child tested positive for latex allergy, but it was unclear that the child had an allergic reaction". The MA reported that the Infanrix that the subject received "came from a single dose vial" and that she, "does not believe the Infanrix is the cause" of the latex allergy. The outcome of the event was not reported.
The pt was fussy, crying on and off all day. Mother said she didn't cry straight through, would stop when held, however, ti was continuous fussiness.
Pt reported that she fainted after getting her COVID 19 vaccine (she did not know the manufacturer, nor has a lot #). She also stated that when she went to the hospital she was told that she had "multiple mini-strokes"  She also tested positive to COVID 19 and required treatment.
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a 10-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 20-Nov-2011. On 28-Dec-2011, the patient inadvertently received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 19-Mar-2012: reporter's information and it was reported that the patient did not have any adverse events.
Client received Tdap vaccine at 2:49 PM Rt. deltoid IM and Depo Provera injection IM Lt. deltoid. Client fainted post administration. V/S: B/P 118/69, HR 67, RR 16, alert and oriented x3 at discharge. Client is diabetic, taking pills to   control. States last meal at 10:00 AM.
Headache, Fever, body aches (unspecified), lungs hurt Narrative:
pfizer vaccine was in fridge beyond 30 days at time of administration. pharmacist did not know of this until after administration. discussed with pt. pt stated experienced sore arm, headache, exhaustion. advised to repeat dose.
Menstrual cycle abnormalities, followed by menopausel symptoms. Resulting in Premature Ovarian Failure and infertility.
5 days after injection continued with red, indurated, painful area around injection site measuring 10cm. No discharge of fluctuance. Did treat with Keflex in case there was infection but no symptom or symptom of such.
Had a high fever and severe headache about 18 hours later; Had a high fever and severe headache about 18 hours later; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient (reported as Age: 44 male) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 18Mar2021 (at the age of 43-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that patient received second dose of the COVID vaccine on March 18. Had a high fever and severe headache about 18 hours later. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
on 09/12/22 durin Kindergarten physical at my clinic, her mother described a reaction further than expected local redness and swelling to the student's left arm where she received vaccines. It started approximately 12 hours after receiving the vaccines at the back of the arm where she received her MMR/Varicella (Proquad), and swelled up almost the entire back of the arm, she became congested, had rosy cheeks and a low grade fever, and  within 24 hours she developed a hive-like rash to her bilateral legs. Mother gave Tylenol and Benadryl. She did not receive any emergency services, nor did she call to notify me of the reaction. She got better in 5 days.
Body aches; Fever; Chills; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 17:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. The patient had unspecified allergies. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and omeprazole (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. Prior to the vaccination, the patient was 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. On 12May2021 at 11:30, the patient experienced body aches, fever, chills and pain at injection site. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care.  Therapeutic measures were not taken as a result of the events. The clinical outcome of the events body aches, fever, chills and pain at injection site were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
13OCT97 815PM pt recv vax & 2hr later exp tingling & edema @ site w/o wheal;10PM edema gradually spread to fingers;17OCT flu-likes sx w/o fever;no sx @ site or arm;20OCT dx URI per PMD placed on keflex & claritin-D arm & hand WNL;
Pt received the second dose of Moderna and after the vaccine was given, pt went to sit in the waiting area...pt alerted one of the technicians and alerted that she wasn't feeling well.  RPH gave the pt a bottle of water and a cold pack and measured her BP which was low (69/88) at the moment.  RPH rechecked the BP 5 minutes later and came to be normal again.  Pt wanted to lie down so a mat, pillow, and blanket was provided for the pt to lie down in the IMZ room. After 15 minutes of laying down, patient felt alot better and was ok to leave.  Pt was thankful for the care she received and we will follow up in around 4pm to see how pt is doing.
urticaria p/flu shot in OCT94;cont to persist;had rxn w/flu shot yr a/
Low grade fever on 11/6 (~101 degrees) and in am 11/7. Rapid fever spike to 103+ on 11/7 at 3 pm precipitating febrile seizure. 11/12/2009 Ed records for 11/7/2009, patient with c/o's fever, febrile seizure activity and cough. Tx: Tylenol. DC DX febrile seizures
Started having worsening, or new symptoms all include:  severe headaches, chest pains, shortness of breath, dizziness, speach difficulties, weakness in legs, feelings of going to pass out worse with standing, elevated heart rate, numbness and tingling in arms and legs, change in appetite, worsening constipation, abdominal pain, severly worsening tics, Nasal Cong. severe nausea, neck pain, severe anxiety, All of these symptoms caused visits to the doctor, changes in medications which did not help. I am not able to drive, work, go to school, persue life dreams, go out with family and or friends most of time. I am unable to make new friends because I cannot be sociable enough. Caused more anxiety for me and depression.
I had very severe heartburn. I rarely get heartburn. I am taking OTC medication for it. I also noticed on my 2nd dose which was Pfizer that I had got heartburn as well. I went to my doctor and suggested taking an OTC heartburn medication. It is still continuing to this day.
2 hours post injection, pain at site. Progressively worsened with small area of redness and more pain next morning. 24 hours after injection, I could not move arm; swollen, red, and hot. Called MD and told to go to ER. Admitted 12/12/04 with cellultiis. Need IV antibiotics and pain medicines in hospital.
hurts to lift her arm; hot to the touch/warm; possibly was an allergic reaction to the vaccine; itchy; arm was swollen; rashy / really big rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (hurts to lift her arm), VACCINATION SITE WARMTH (hot to the touch/warm), ALLERGY TO VACCINE (possibly was an allergic reaction to the vaccine), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE SWELLING (arm was swollen) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (hurts to lift her arm), VACCINATION SITE WARMTH (hot to the touch/warm), ALLERGY TO VACCINE (possibly was an allergic reaction to the vaccine), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE RASH (rashy / really big rash). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (hurts to lift her arm), VACCINATION SITE WARMTH (hot to the touch/warm), ALLERGY TO VACCINE (possibly was an allergic reaction to the vaccine), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (arm was swollen) and VACCINATION SITE RASH (rashy / really big rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant product usage were not reported by the reporter. No treatment details were added.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up Information includes Patient Demographics, 2 nd dose Information and Events Outcome
This is a spontaneous report from a contactable other health professional (medical assistant) who reported on behalf of a physician for a patient. A 58-year-old female patient received PREVNAR 13 single dose administered into her left deltoid via an unspecified route of administration on 20Mar2014 at 12:04 hours for immunization. The patient had no relevant medical history and was taking no concomitant medications. On 25Mar2014, the patient experienced redness and swelling in left shoulder which she mentioned was progressively worsened and redness and swelling spread to elbow, was warm to touch, redness on thumb, and burning sensations. No relevant laboratory data was reported. Therapeutic measures received, if any, were not reported. Clinical outcome of the events redness and swelling in left shoulder, redness and swelling spread to elbow, was warm to touch, redness on thumb, and burning sensations was unknown. Follow-up (28May2014): Follow-up attempts completed. No further information expected.
back pain radiating to chest.  Elevated BP.  Started on aspirin, colchicine and amlodipine.
Patient due to receive the Moderna Booster (0.25 mL). Received full dose (0.5 mL).
Very sore arm for 4 days,  extreme fatigue for 5 days. Diagnosed with Shingles on July 10., 2022Pain began on July 7, 2022
Information has been received from a physician assistant concerning a 6 month old male patient who on 25-FEB-2009 was vaccinated with a first dose of ROTATEQ (lot# 662800/1307X). On 24-APR-2009 he received second dose of ROTATEQ (lot # 662800/1307X). On 02-JUL-2009 he developed rotavirus. The same day on 02-JUL-2009 the patient was taken to the Emergency Room and was admitted to the hospital for 2 days. On unspecified date the patient recovered. Additional information has been requested.
This spontaneous report as received from a physician refers to a 15 years old female patient with no pertinent medical history and no drug allergy/reaction. The patient was vaccinated with the first dose of GARDASIL intramuscularly on 10-APR-2010. Lot# was unspecified. There was no concomitant medications. On 10-APR-2010, "on that same day" of vaccination, the patient experienced some pain at the injection site which lasted a couple of days. The present patient status was recovered. The reporter noted that the patient would be administered her second dose of GARDASIL today (09-OCT-2012). No treatment was given for the event. No lab diagnostic study performed. The patient saw the reporting physician in the office to seek medical attention. Additional information has been requested.
flu-like symptoms; nausea; feeling flushed; eye soreness; sore muscles; tiredness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose a couple of months back from reporting day).   On 2nd December 2020, the patient received the 2nd dose of Shingrix. On 3rd December 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, flushing, soreness in eyes, muscle soreness and tiredness. On an unknown date, the outcome of the influenza-like symptoms, nausea, flushing, soreness in eyes, muscle soreness and tiredness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, nausea, flushing, soreness in eyes, muscle soreness and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated with Shingrix. On next day after vaccination the patient woke up from his sleep with tiredness, sore muscles, eye soreness, feeling flushed, nausea and flu-like symptoms.  The patient did not had a temperature. The reporter consent to follow up.
11 weeks pregnant and vaccinated with H1N1 on Thursday, 1/27/11.  Showed signs of miscarriage on Sunday, 1/30/11.  Miscarriage confirmed 2/1/11.
This spontaneous report was received from a nurse and refers to a female patient of unknown age. There was no information regarding the patient's pertinent medical history and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, expiration date and dose were not reported), intramuscularly in the dorsogluteal region. The nurse explained that the patient received 3 other unspecified vaccines at the same time and there was nowhere to put them all. No adverse symptoms were reported. Additional information is not expected as there was no consent for follow-up.
dizziness; weakness; loss of balance; brain fog; lethargy; Dizziness and loss of balance led to a fall where an injury was sustained (leg weakness, loss of balance led to a fall down a flight of stairs with injury to right shoulder); Dizziness and loss of balance led to a fall where an injury was sustained (leg weakness, loss of balance led to a fall down a flight of stairs with injury to right shoulder); Dizziness and loss of balance led to a fall where an injury was sustained (leg weakness, loss of balance led to a fall down a flight of stairs with injury to right shoulder); This is a spontaneous report from a contactable nurse. This 41-year-old female nurse (patient) reported for herself that she received the first dose of BNT162B2 (Lot# EH9889) intramuscularly at left arm at single dose for COVID-19 ((PFIZER-BIONTECH COVID-19 VACCINE) immunisation on 17Dec2020. Relevant history was unknown. Relevant concomitant drug included multivitamin and ergocalciferol (VIT D).  No known allergies. No allergies to medications, food, or other products. Relevant medical history was none. After receiving first dose, the patient experienced dizziness, weakness, loss of balance, brain fog, lethargy on 18Dec2020, 07:00 AM. The dizziness and loss of balance led to a fall where an injury was sustained (leg weakness, loss of balance led to a fall down a flight of stairs with injury to right shoulder). No treatment was received. The patient resolved with sequel from the events. No covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events were considered as non-serious.
Doses administered beyond expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered beyond expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. The vaccine was removed from the freezer and placed in the refrigerator on 11/17/21.
Pt's parent reports fever and hives all over body following vaccination. Uticarial rash lasting 2-3 days On 12/21  Phone consult with Our clinic provider. Assessed for uticarial rash x 2 day. given Benadryl to reduce itchiness/Hives. Pt went to ER for fever and was found to have bulging and erythema on L tympanic membrane on 12/22. - Given APAP and Amoxicillin.
pediatric patient received an adult dose; pediatric patient received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old male patient who received HBV (Engerix B adult) (batch number J2J9R, expiry date 14th September 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th August 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. The action taken with Engerix B Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pediatric patient received an adult dose of Engerix-b instead of a pediatric dose, which led to adult product administered to child and overdose. The reporter consented to follow up.
Pt recv vax on 10/6/97; on 10/7/97 pt exp swelling & itching of hands; tx=Benadryl
Menstrual cycle adversely affected -- period no longer comes on time; spotting between cycles; very heavy bleeding and clotting; severe abdominal cramping (this started after the 2nd shot and worsened significantly after the booster)
My mouth became tingly approximately 15min after injection. My throat felt weird and mucus was forming in there. Had to clear it a lot . Felt itchy and flushed on my aroma and neck.  Took two Benadryl but it didn?t really do much.
Arm numbness (right after injection) Fever (around 5:30pm) Muscle soreness Joint pain Burning sensation/pressure in spine Those effects improved by the morning of April 19 **April 20 burning sensation/sensitivity throughout spine at around 2pm  Top of left side of head sensitivity
COVID arm at site of injection approximately one week after admin. Slight redness and bumpy and very itchy on ans off for about a week Sore arm right after injection for approx 24-48 hours
Information has been received from a physician concerning an "approximately 70 year old" male who in "July" 2007, was vaccinated with a 0.65 mL dose of Zostavax (Oka/Merck) (lot # not reported).  In "July" 2007, the patient developed ophthalmic zoster within two weeks of receiving a dose of Zostavax (Oka/Merck).  The patient sought unspecified medical attention.  The patient's ophthalmic zoster persisted.  There was no product quality complaint.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/24/2007.  On an unspecified date "patient has had a complete recovery from herpes zoster".  There was no product quality complaint.  Additional information has been requested.
Detached Retina  ( vision impairment)  seen Ophthalmologist   Dr / Dr  retina vitreous  surgery  1/13/2021 approx 3/2021 rem surgery laser surgery 07/2021 2/2022 cataract removal with  lens implant
pain, swelling, and itchy rash/redness in the arm where I got the shot, plus chills, tiredness, and headache throughout the rest of the body - also sharp pain in elbow when moving or picking up objects etc  - also I?ve been incredibly itchy generally, everything seems to irritate my skin
I was released a bit early from the drive through, driving on the way home my soft palate/back of mouth started swelling making it hard to swallow?soon my lymph glands on my neck swelled. Thinking it was an allergic reaction, I took my Allegra and nose spray flonase. As the day went on, both decreased but didn?t leave until 24 hours but neck lymphs still slightly swollen today. Very scary, and there was no one to contact after from the site.
Tested COVID-19 + on 4/27/21 during hospital admission screen for femoral neck fracture. Had previously tested positive for COVID-19 1/7/21 and had Moderna COVID-19 vaccines on 2/25/21 and 3/24/21. No overt COVID-19 symptoms, did begin needing 2L of oxygenon 4/28/21.