chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose made her start her period. She didn't had a period in 7 or 8 years; she was having heavy periods that were causing her to have cysts; she was having heavy periods/ heavy period every other week for 6 week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 2, single (Lot number: EWO185) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "endometriosis" (unspecified if ongoing), notes: she had endometriosis. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EWO185; Expiration date: unknown), administration date: 06Aug2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant), outcome "unknown", described as "2nd dose made her start her period. She didn't had a period in 7 or 8 years"; OVARIAN CYST (non-serious), outcome "unknown", described as "she was having heavy periods that were causing her to have cysts"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "she was having heavy periods/ heavy period every other week for 6 week". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of postmenopausal haemorrhage, ovarian cyst, heavy menstrual bleeding.  Additional information: It was reported that, the 2nd dose made her start her period. She didn't had a period in 7 or 8 years, it was a full period for 6 weeks. When she took the Pfizer shot she started her period. She got heavy bleeding, she had endometriosis and she bleed out and up inside of her and her doctor didn't want her to do that. She got excessive bleeding. Reporter stated that, she started her period and could have had cysts on her ovaries. She did not know why this happened with a vaccination, it did not cause her to do that with the flu shot. Reporter stated that, she talked to another girl every time she took a shot she did the same thing, she started hers too and she was the same age. She had talked to several other people and they have the same thing. She hasn't bleed until the Pfizer shots. Attempted clarification again and reporter stated that, she was having heavy periods that were causing her to have cysts so she was then put on premarin to stop her menstrual cycle.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201140024 same patient/product/event, different dose;US-PFIZER INC-202201139438 same reporter/product/event, different patient;US-PFIZER INC-202201140024 same patient, different dose and different event.;
Knot at the site. Red rash with itching, Sore throat.  97.9 temp.
Significant increase to pre-existing neuropathy symptoms in hands and feet. Symptoms (numbness, tingling) extended to upper arms and thighs. The Shingrix injection site was very sore and sensitive with bright redness extending to a three-inch diameter lasting four days. Aimovig injection is given monthly in left thigh, last on Sep. 24. The site of that injection developed neuropathy-like symptoms that were intensified from the second to fifth day after Shingrix injection. This symptom has receded,  it is still noticeable as of this writing.
Patient fainted - was advised to stay in she still went outside - fell - got him to stay with knees between his arms - happened few minutes after shot was administered - only lasted few minutes.
From 2 hours post injection through mid Sunday (1/24) I experienced significant arm muscle pain in my left arm. Pain level of 9-10 when moving it from the shoulder in every direction. The pain was gone by Monday 1/24. On Thursday night of 1/28, the arm pain returned. On the following Friday-Saturday it was at a pain level of 6-8. By Sunday it had diminished again, but remains at a low level (2-4), with active muscle movement/use, especially a front raise.
arm started burning,  hives on roof of mouth,  developed ringing in the ears that wont go away.  Provider only said to take Benydral.
I know it was the quad, but not sure which one.  I had an extreme fever, 103-104, headache, aches, rapid heart beat.  this lasted for 48 hours, i did have times with no fever, was using tylenol and advil along with cold compresses to reduce the fever.  I woke up this am feeling much better.  Hopefully it is over.  I wanted to report this because of the covid and pneumonia tie in.  If i can be of any help to you please don't hesitate to call or email.
Pt recv vax on 11/4/98; 3 1/2 hr post vax pt exp fever, chills, neck ache, chest & arm pain
Information has been received from a licensed practical nurse concerning a 16 year old female with allergy to codeine and no pertinent medical history who on 17-SEP-2007 was vaccinated with GARDASIL (lot#: 658558/1061U) 0.5ml IM.  Concomitant therapy included ALDOMET.  Subsequently, she became pregnant.  Her LMP was 10-SEP-2007.  The estimated due date was 16-JUN-2008.  The patient delivered a baby on 20-JUN-2008.  She had a cesarean section because of "failure to descend".  The delivery was successful.  A cervical smear (PAP smear) was performed (results not reported).  The patient was seen by a physician.  Upon internal review, failure to descend, the indication for cesarean section, was considered to be an other important medical event.  Additional information has been requested.
7/22/02 had above immunization. 7/23/02 evening had fever of 103.8, irritable, crying unconsolable, Seen by MD's 7/23/02 and 7/24/02. CBC, blood cx, urine cx, due to no noted infection. All found WNL.
received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 31st March 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-March-2022 Reporter's Comments: The reporter consented to follow-up. Additional Supportive Information: On 31st March 2022, the patient received dose of Twinrix that was already got expired on 08th February 2022, which led to expired vaccine used.
A physician reported that a young child received the 1st dose of Prevnar and subsequently developed an injection site reaction characterized by erythema, induration, swelling, and tenderness. No fever was noted. The induration was described as "persistent", lasting more than 7 days. The child recovered. The reporter felt this reaction was medically important. MANUFACTURER'S COMMENT: The reporter indicated that 2 children experienced this event; however, they are not presently identifiable. An additional report will be generated when identifying information is provided.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (Lot#: K015970, expiry date: 23-SEP-2016, exposure on 22 F for 183 hours from 15-MAR-2015 to 16-JUN-2015; K021487, expiry date: 03-NOV-2016, exposure of 22 F for 183 hours from 15-MAR-2015 to 16-JUN-2015; L002871, expiry date: 27-JAN-2017, exposure on 22 F for 136 hours from 08-MAY-2015 to 13-JUL-2015; L005301, expiry date: 17-FEB-2017, exposure on 21 F for 109 hours from 14-JUN-2015 to 17-AUG-2015; L016127, expiry date: 06-MAY-2017, exposure on 21 F for 70 hours from 16-AUG-2015 to 27-SEP-2015; L019124, expiry date: 27-MAY-2017, exposure on 22 F for 134 hours from 23-SEP-2015 to 15-NOV-2015; L023588, expiry date: 26-JUN-2017, exposure on 22 F for 117 hours from 07-OCT-2015 to 15-NOV-2015). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
My Chronic Fatigue syndrome flared up, and is still active. I have had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in my legs since receiving the vaccine.; My Chronic Fatigue syndrome flared up, and is still active. I have had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in my legs since receiving the vaccine.; My Chronic Fatigue syndrome flared up, and is still active. I have had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in my legs since receiving the vaccine.; My Chronic Fatigue syndrome flared up, and is still active. I have had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in my legs since receiving the vaccine.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: GW0161), via an unspecified route of administration, administered in Arm Left on 16Apr2021 04:45 (at the age of 25-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic fatigue syndrome from an unknown date and unknown if ongoing, drug hypersensitivity (Nitrofurantoin) from an unknown date and unknown if ongoing, immunodeficiency from an unknown date and unknown if ongoing , hypersensitivity (silicone) from an unknown date and unknown if ongoing. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:45 PM (at the age of 25-year-old) as dose 1, single for COVID-19 immunization. On 17Apr2021, the patient experienced my chronic fatigue syndrome flared up, and is still active. Patient had consistent debilitating fatigue that does not improve without rest, brain fog, and aching in legs since vaccination. Before the vaccine, she had not experienced these symptoms in months. No treatment was taken as a result of events. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Admission Date: 3/6/2023 Discharge Date: 3/10/2023  PRESENTING PROBLEM: Generalized weakness Acute lower urinary tract infection  Fall from standing, initial encounter  Altered mental status, unspecified altered mental status type  COVID-19 virus infection  Pneumonia due to COVID-19 virus    HOSPITAL COURSE:  81-year-old who presented with weakness and shortness of breath.  Has a medical history significant for moderate persistent asthma, hypertension, stage IIIA CKD and paroxysmal atrial fibrillation.  She was hypoxic on admission and was found to be COVID-19 positive.  Chest x-ray with no significant infiltrate.  She was initially felt to have a concomitant bacterial pneumonia and was empirically started on ceftriaxone/azithromycin.  Procalcitonin was negative.  She was started on remdesivir/dexamethasone due to transient hypoxemia in the emergency department however was rapidly titrated to ambient air.  Her condition improved throughout hospitalization she did develop some diarrhea C difficile was negative.  Diarrhea was thought to be secondary to COVID-19 (consistent with previous gastrointestinal symptoms with COVID). .  She was afebrile and hemodynamically stable.  She was discharged home on 03/10/2023.
Abnormal vaginal bleeding - Menstruation x 7 days starting on Jan 15 exactly like a typical period  despite being 2+ years post-menopausal
10 min after vaccination developed mild arm soreness, slight diaphoresis and 5/10 headache. Normal BP and pulse. Looked fine. No arm erythema/swelling. No hives. No respiratory symptoms. Treated with water/hydration and noted improvement.
Progressive, dull anterior/posterior chest pain onset 1/26/2021.  Pain worse with deep inspiration. Symptoms similar to that experienced with prior pleuro-pericarditis.  Few episodes of palpitations which abated with cough or Valsalva.  Initiated high dose ASA and colchicine on 1/28/2021.  Symptoms abated by 2/03/2021.
This non-serious spontaneous case, was initially received from other health professional on 28-Sep-2017, concerning a 47-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported) as expired vaccine used. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
Swelling, erythema, tenderness distal to injection site; mother reporter "blister" on arm the night before I checked pt. Pt currently doing well.
Pt received HPV vaccine #3. Pt appeared to have a reaction. Doctor notified. Pt developed a vasovagal, fainting. Confan applied to pt. Pt was put in lying position and v/s monitored. Pt left clinic ambulating.
On 3/26/21, patient and guardian came in and received the Pfizer COVID-19 vaccine.  Patient/guardian stated on consent form that patient is 16 years old, but he doesn't turn 16 until 4/2/2021
COVID-19 symptoms started 07/15/22; tested positive 07/17/22. By the 15th I had a sore throat that was significant and later that night I developed a headache and my ears were clogged up. By the 16th I continued to have he sore throat and headache but I did not develop a cough. By the 17th I was sneezing a lot and still had sore throat and headache and also developed a low grade fever that didn't go above 99.1. By the 19th my headache was gone and I experienced fatigue all weekend. so from the 15th-20th. I didn't lose taste or smell and on the evening of the 20th I started PAXLOVID. I am still currently taking medication and final dose is on the 25th. I still have ear stuffiness, fatigue, but no headache or throat pain. I am pretty good and have been cleared to go back to work.
I have Eczema and on occasion will get a flare up lasting a few days / I have NEVER had a flare up as bad as this; break out with a rash, and pustules on my hands. This then spread to my legs, back, and swelling to my right eye; break out with a rash, and pustules on my hands. This then spread to my legs, back, and swelling to my right eye; swelling to my right eye; Both hands are loaded with bumps as well as both arms; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 03Mar2021 10:30 (at the age of 66 years) as DOSE 1, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other. Medical history included eczema from an unknown date. The patient was not allergies to medications, food, or other products. Concomitant medications were not reported. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient having eczema and on occasion will get a flare up lasting a few days. However, the day after the patient received vaccine, on 04Mar2021, patient started to break out with a rash, and pustules on patient hands. This then spread to legs, back, and swelling to right eye. The patient has never had a flare up as bad as this and used usual routine to control the flare up and it was calming down some until patient received second vaccine on 24Mar2021 at the same location. The patient arms now look like the patient was an IV drug user and the rash on patient back was getting larger. On an unknown date in 2021, both hands are loaded with bumps as well as both arms. The patient has an appointment with a dermatologist on 07Apr2021. The patient was not received treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events rash and rash pustular was not recovered and other events were unknown.   Additional information has been requested and will be provided as it becomes available.
This spontaneous report was received from a registered nurse via medical assistant and refers to a 12-month-old female patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 05-OCT-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
patient had lightheadedness and vomiting, diarrhea, low BP, and was unresponsive/staring at the wall immediately after the vaccine. 911 was called and she was taken to the hospital, patient was feeling a little better and was responsive when taken
Patient got dizzy immediately after getting vaccine  at the pharmacy. After sitting down for few minutes and drinking water , patient was perfectly fine and went  home with parent.
Patient woke up on 11/9/2021 with dysarthric speech and R sided Weakness, Patient went to the ER and is currently hospitalized for Acute Stroke.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 06/01/2021. PATIENT FULLY VACCINATED ON 02/18/2021.
Stiff neck, headache, sore throat, fever, eyes hurt. Woke feeling ill. Stayed in bed all day, into the next day taking OTC medications for fever and pain. Symptoms increased resulting in doctor visit confirming case of measles. Subsequently mumps developed followed by rubella, which resulted in hospitalization. Vision loss and hearing loss, both permanent developed. Treatment in hospital was IV steroids, 1000 mg daily for eight days to stop or attempt to stop autoimmune reaction. Demyelination of nerves occurred in brain along with optic neuritis in right eye and vestibular neuritis in right ear. Rash, joint swelling, fever, head pain, fatigue, sensitivity to light, nausea, dizziness, light-headed, poor balance, poor appetite. Doctor prescribed medications for nerve pain, nausea, inner ear motion illness, depression, steroids. Acupuncture for symptoms. Physical therapy for weakness. Pain management for nerve pain. Follow-up doctor appointments with infectious disease, neuro-opthalmologist, optometrist, ENT, Occupational Medicine, Workmens Comp QME with neurologist, neurologist(s). Adverse symptoms remain constant with increasing weakness and body inflammation and overall pain. Symptoms mimic those of MS. Hearing aids have been prescribed. I remain off of work.
fatigue; body and joint aches and pains; scratchy throat; cold sores; malaise; body and joint aches and pains; Severe Brain fog; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) second dose via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. Medical history included lupus from an unknown date and unknown if ongoing. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for lupus cystitis from an unspecified start date and ongoing; influenza vaccine (FLU) taken for immunisation, start and stop date were not reported. The patient experienced fatigue, malaise, scratchy throat, cold sores beginning 3 days after shot and body joint aches and pains, cold sores, and severe brain fog on an unspecified date. The reporter stated that long-standing history of lupus. Developed severe fatigue, body and joint aches and pains about 6 hours post 2nd vaccination with COVID vaccine. Resolved in about 36 hours after Tylenol Motrin combo. Severe brain fog for about 8 hours. Has similar but not as severe symptoms post flu shot. Was advised by rheumatologist to take the vaccine as the benefits outweighs the risks. Would take it again but would make sure to have a day off to recuperate. Therapeutic measures were taken as a result of fatigue, body and joint aches and pains, scratchy throat, cold sores, malaise, body and joint aches and pains and treatment included tylenol motrin combo. The outcome of the events was reported as resolved on an unspecified date.   No follow up attempts are possible; information about lot/batch number cannot be obtained.