chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Postmenopausal heavy bleeding. I entered menopause 15 years ago and did not experienced ANY menstrual-type of bleeding sine 2009. Last week I started to experience pre-menstrual cramps that lasted about 6 days, on the day 2 I started spotting and that developed into what looks very much like heavy menstrual bleeding that is now lasting for 6 days with cramping coming and going. My OBGYN retired and I could not get appointment with the new Dr until June21st 2021. If the bleeding does not slow down I plan to go  the ER. .
Information has been received on 03-OCT-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. The patient was inoculated with ZOSTAVAX (lot number and expiration not reported), subcutaneous on or about 03-FEB-2015 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 30-SEP-2016, the patient was treated by a physician in a physician's office for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recvd 1 dose of vax AUG92 reported feeling poorly, head pounding, profuse sweating, temp, stomach sickness, joint aching, felt drained; sx resolved w/in 6 hrs;
On 9/29 she noticed the injection site was swollen and sore. On 9/30-10/2 she noticed Flu like symptoms and the swelling and pain spreading up to her shoulder and down to her elbow. She went to urgent care on 10/3 and was diagnosed with Cellulitis and given Dicloxacillin injections and a oral Dicloxacillin prescription for 10 days.
After Shot I got Arthritis of Bilat Knees. Bilat Patellofemoral Syndrome. Tendinitis of bilat quadriceps Tendon. Dorsalgia
Feeling Horrible; Sweating; Severe Migraine; Chills; Nausea; Muscle pain all over; A spontaneous report was received from a consumer concerning a 35 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced feeling horrible, sweating, chills, severe migraine, and muscle pain.   The patient's medical history was not provided. No relevant concomitant medications were reported   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient reports waking up feeling horrible, sweating, chills, severe migraine, and muscle pain all over. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was unknown.; Reporter's Comments: This case concerns a 35-year-old female who had NS unexpected events of migraine, feeling abnormal, hyperhidrosis, and NS expected events of nausea, chills, myalgia.  Event onset occurred Day 2 after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Patient called the clinic to report that she had red hives on the right side of her face 3 hours after the shot.  As time went on into the next day, the hives spread down to right arm to the elbow, on day 3 the rash went around the perimeter of her neck and on stomach and right leg.  She now states the rash/hives is improving.  She denies any shortness of breath, weezing, tightening of throat or any other symptoms. Patient has been taking hydrocortisone cream.  Advised to consult her provider at this time and inform them of having a rash from last year's Fluzone and a worsening rash after this year's Fluzone.
Sore and stiff; A spontaneous report, was received from a consumer (patient), concerning herself, a 69 years-old female patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore and stiff (vaccination site induration and vaccination site pain).  The patient's medical history was not provided. Concomitant medications reported included ibuprofen and cefixime.  On 13 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch N0: 011M201A), intramuscularly in the right arm for the prophylaxis of COVID-19 infection.  On 14 Feb 2021, next day following the vaccine, the patient's arm was sore and stiff. Treatment information was not provided.  Action taken with second dose of mRNA-1273 in response to the events was not provided.   The outcome of events, sore and stiff were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
ARM HURTS LIKE HELL; JOINTS ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced arm hurts like heck, and joints ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm hurts like hell, and the outcome of joints ache was not reported. This report was non-serious.
Employee received flu vaccine on 11/27/00 and on 11/28/00 employee stated that she broke out with welts, which started later in the evening on 11/27/00 and continued on to 11/28/00. Pt also complained of itching, scratches were on her back from itching. She took Benadryl 25mg.
Information has been received form a physician concerning a 70 year old female with no medical hx or allergies wh on 04NOV2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant medicaiton. On 06NOV2003 the pt complained that the injection site and the area two inches below the injection site was red, swollen, and warm. The physician advised the pt to treat the condition with an ice pack. There were no lab diagnostic studies performed and a product quality complaint was not involved. Additional information has been requested.
All joints in my body have swollen and causing pain, kept me up all night, sore left arm at injection site, headache
CHILD HAD RECIVED DTaP, PCV, AND VAR IMMEDIATELY STARTED HAVING SEIZURE LIKE ACTIVITY LASTING 10-15 SECONDS (JERKING OF HEAD AND LEGS EYES ROLLED BACK IN HEAD, PT SAW SPOTS AND SLUMPED TO THE RIGHT) COMPLETELY PALE, AFTERWARDS EXPERIECED NAUSEA, CHILD HAD NOTHING TO EAT THAT MORNING, NO SHORTNESS OF BREATH, NO RASH NOTED, BP WAS 80/58 AND PULSE WAS 60 LAYED HER DOWN AND ELEVATED FEET AND ICE PACK TO NECK EMS CALLED AND EVALUATED AND MOM DECLINED TO GO TO ER.  SPOKE WITH MOM PM ON 8-11-11 PT WAS SLEEPING BUT OK SPOKE WITH PT ON 8-12-11 MOM STATED PT WAS ALSO SPOKE WITH MOM ON 8-16-11 MOM STATED OK
COVID breakthrough case. I received my 2nd booster shot on 04/20/2022 and my COVID symptoms started on 05/30/2022 I felt a little achy at first in the morning but as the day began I was feeling more achy in my whole body. I  had runny nose and I thought it was from allergies or from a cold. I started feeling worse as the day went by and I said to myself something was not right so I decided to do a COVID home test at about 6pm which was positive. I have slight fever. I also had very mild headache. I did a telehealth with my doctor and she prescribed me with medication I haven't received it yet but will be taking med soon.
A non-serious spontaneous report of administration of expired FLUMIST was received from a registered nurse concerning a 12-year old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. On 05-Jan-2010, the patient received FLUMIST (expiration date 31-Dec-2009). There was no adverse event associated with this medication error; treatment and reporter/sponsor causality assessments are not applicable, and the events are considered resolved.
Elevated blood pressure 15 minutes after vacine administered. 168/113 HR 75. Checked into Emergency Room for observation. Blood work results for target vitals normal EKG normal. Blood pressure normalized after 4 hours.
Dizziness - was dizzy earlier, didn't sleep well last night.  B/P checked, on discharge b/p was 116/57.  Encouraged to hydrate and given some water.  Denies dizziness  on discharge
Feel rundown; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feel rundown) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feel rundown) and PYREXIA (Fever). At the time of the report, MALAISE (Feel rundown) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided No treatment medication information was provided
Deep depression lasting 3 months Blood sugar spiked and remained high over six months Diarrhea ongoing over six months beyond metformin related. Headache lasting over six months Prolonged fatigue lasting over six months On 3rd dose, neck swollen with itchy rash for several days.
06/21/2022 I started with pain in m abdomen and it didn't go away. I started vomiting and I vomited for an hour and the pain wouldn't go away so my son came over and called an ambulance. I was pretty sick and went in for emergency surgery because gallbladder was infected. It doesn't come on automatically and it builds up and you don't know it's happening until it does. Prior to that in the beginning of June my blood pressure was going up and down and my heart rate was up to 163 on two occasions and the doctor's didn't know why. It was fluctuating like crazy. The took out my gallbladder and it took two operations because biliary duct had to be cleaned.
Loss of taste; Loss of smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell). At the time of the report, AGEUSIA (Loss of taste) and ANOSMIA (Loss of smell) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) COVID-19 test was negative.         No concomitant medications were provided. No treatment details pertained to the events were provided.
Lipschutz Ulcer or Vulvar Aphthous Ulcer VIRUS.
Increase in migraines: 8/28/2021, 9/16/2021, 9/20/2021 More frequent intense headaches
ADMINISTERED VACCINE FROM A BATCH TO BE DISCARDED; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 47 year old male. 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, batch number: 1822809 expiry: 04-AUG-2022) dose was not reported, administered on 03-MAY-2022 for covid-19 prophylaxis. The drug was associated with Medication error. Age at time of vaccination 47 years old. No concomitant medications were reported. On 2022, the patient experienced incorrect product storage. On 03-MAY-2022, the patient experienced administered vaccine from a batch to be discarded. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and administered vaccine from a batch to be discarded was not reported. This report was non-serious. This case, from the same reporter is linked to 20220759289, 20220759052, 20220759113, 20220759160, 20220759219, 20220759222 and 20220761815.
No adverse effects reported; received improperly stored doses of PROQUAD; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (DTAP-IPV).  On 27-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012351: US-009507513-1910USA012240: US-009507513-1910USA012349: US-009507513-1910USA012981: US-009507513-1910USA012350: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360:
1 day after receiving the flu vaccine and the COVID booster shot, Pt developed acute hypoxic respiratory failure as well as myalgias and arthralgias.  This required hospitalization for COPD exacerbation.
Nausea, leg weakness, paleness, dizziness, headache, dry heaving, low grade temp.
Information has been received from a health professional concerning a 6 yr old female who on 18Jan00 was vaccinated with a dose of varicella virus vaccine live. On 26May05 the pt experienced breakthrough chickenpox. At that time, the pt was in the midst of an episode of eczema. This resulted in a severe rash on the pt's face, trunk and neck. The pt was hospitalized and treated with antibiotics. Subsequently, the pt recovered. There was no product quality complaint involved. Follow up information from the physician indicated that he did not give the original vaccine and he has no additional information to provide. Additional information is not expected.
Convulsions for about one hour followed by vomiting and high fever; ER administered Motrin and observed; discharged at 1:00 AM; was perfectly fine when he woke up next morning.
Developed chills and fever approximately 12 hours after shot. As I had the Covid 19 in May, (tested negative on the 18th May, positive on 21st May) the symptoms are very similar. Except for no loss of smell or taste. Moderate to extreme fatigue at this point 72 hours later seem to be the only lingering effects with some light headedness.
Initial case received from a consumer on 16 October 2012. A 74 year old female patient received an intramuscular injection in the right deltoid of ADACEL, Sanofi Pasteur Ltd., lot number C4210, (corresponding Sanofi Pasteur Inc. lot number U4395AA) on 01 October 2012. The patient also received an intramuscular injection in the left deltoid of an influenza vaccine on an unspecified date, Lot # 12U4001, manufacturer not specified. At the time of vaccination, it was reported that the patient had no illness. The patient had an extensive past medical history, reported as PMH and an allergy to FOSAMAX and BONIVA. Previous history of vaccinations with tetanus diphtheria vaccines were unknown. On 08 October 2012, the patient developed redness, swelling, and itching from the right shoulder to the elbow. The patient was treated with Loratadine, details of treatment not provided. On 08 October 2012, the patient was evaluated and was diagnosed with cellulitis. Laboratory tests were not reported and a culture was not obtained to determine organism of cause. On an unspecified date, the patient was prescribed KEFLEX 500 mg BID. The symptoms were reported as resolving as of 15 October 2012. At the time of this reported, the patient outcome was reported as resolved. Documents held by sender: None.
Patient developed questionable phlebitis on left upper arm from the site for Pneumococcal vaccine. The entire left arm edematous 2-3+ and reddened area all the way to left hand. Ice pack applied.
Yesterday her doctor, she was getting some joint pain/having joint pain; This is a spontaneous report from a Regulatory Authority via a contactable consumer reported for a patient (reporter's mother). A 91-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 08Feb2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose of COVID vaccine 08Feb2021. After 1st dose, on 25Feb2021, she was getting some joint pain and went to HCP and the doctor told her to hold of getting cortisone shot and the nurse gave cortisone shot to her. When probed for indication of cortisone, reporter stated that she guessed she got confused. The doctor said to hold off after the second shot but they were busy and the nurse came in and gave it to her. The reporter stated that her mother was scheduled to get her second Pfizer vaccine this Tuesday the 2nd. The reporter now wondered if her mom should get 2nd dose this coming Tuesday.She wanted to find out what was their recommendation as far as her getting her the vaccine 6 days after getting the cortisone shot. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Began with spasming of throat, difficulty breathing, violent body shakes, hot followed by cold temperature, headache, light headedness, aches, and chest pain. Lasted about 3 hours while in ER until some relief. ER stated some feelings could come back later in the evening. Headache, aches, and chest pain came back later in the evening with an overall sick feeling.
a lot of side effects; PAIN; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (a lot of side effects), PAIN (PAIN) and CHILLS (chills) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced ADVERSE EVENT (a lot of side effects), PAIN (PAIN) and CHILLS (chills).   At the time of the report, ADVERSE EVENT (a lot of side effects), PAIN (PAIN) and CHILLS (chills) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
red swollen lump on her arm; insomnia; anxiety; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "red swollen lump on her arm"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia"; ANXIETY (non-serious), outcome "unknown", described as "anxiety".  Additional information: Caller stated that she got the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 18Aug2021 and immediately after that she started experiencing insomnia and anxiety. Aside from that, she also has a red swollen lump on her arm. She was told to wait 3-6 months to get the second dose, but the symptoms have not receded.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding their medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (lot # L046506, expiry date: 17-MAY-2017). Nurse reported a temperature excursion for the following products: (Oka-Merck) PROQUAD (lot # L046506, expiry date: 17-MAY-2017) and (Oka/Merck) VARIVAX (Lot # L041207, expiration date: 20-OCT-2017), however only (Oka-Merck) PROQUAD was administered. The vaccine underwent a temperature excursion of -13 degree Celsius for 6 hours. No adverse effect was reported. This is one of the two reports received from the same reporter. Additional information has been requested.
4pm shivering and fever till 9pm took Tylenol. Fever 101.8. Massive headache and vomiting for 12hrs straight. Aches stopped around 11 pm on Wednesday. Exhausted and weak.
I had only a sore arm immediately after the vaccination.  I contracted covid approx 25 days after the second booster.  The second booster was on 4/22/22.  My covid symptoms included high fever for two nights, deep cough, and fatigue.  My autoimmune hepatitis had been controlled and stable for over a year taking only one RX, azathioprine, 25 mg.  I had an appointment with my GI doctor on Jume 8.  He ran blood tests for a variety of things including liver enzymes.  The bloodwork showed liver enzymes significantly elevated and out of reference range.  Dr. immediately started me on 20 mg/day prednisone and raised my dose of azathioprine to 50 mg/day. I believe my autoimmune situation was triggered by contracting covid (not the booster.) I am still recovering from the AI hepatitis.  Frequent labs are showing better liver function and I am tapering down on the prednisone.  I still have a cough from contracting covid--now two months ago.