chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I started a very heavy period that lasted 25 days. I usually have a light 2 day period like clockwork. No birth control.. very normal my whole life until my shot.  I had heavy bleeding along with clots of blood.
Headache SORE ARM Narrative: headache the evening and next day that went away (12/29). I had arm soreness a day following the vaccination (12/29) that also went away. Sunday 1/3 flu symptoms (Diarrhea, fatigue, coughing and chest congestion). Today 1/5 USING inhaler due to cough, and SOB. 1/6 very fatigues and dizzy at times. Not feeling very well at all and uncertain if this is related to the vaccine.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4445222-00.  A 55-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; risankizumab (SKYRIZI), (ongoing) (Lot number: 1160234), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "not recovered" and all described as "COVID-19". The action taken for risankizumab was unknown. Clinical course: During early week of 15Jun2022, the patient got COVID-19. She had cough due to COVID-19 symptoms. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "covid-19" related to BNT162b2.   The reporter's causality for Skyrizi (Risankizumab) for event COVID-19 was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective  (LOE) cannot be ruled out
Patient experiencing rashes on her lower and upper extremities, torso and face. She noticed pruritis on 5/20/18 then rashes on 5/22/18. Primary care provider referred patient to urgent care on 5/24/18.
PATIENT CALLED ON FRIDAY 5/20/2022 THAT SHE HAD A SERIOUS REACTION TO SHINGRIX.  SHE SAID SHE HAD EXTREME BODY ACHES, CHILLS, NAUSEA, AND HEADACHES.  SHE SAID SYMPTOMS WENT AWAY BUT SHE IS STILL HAVING SWELLING THAT IS GETTING BIGGER.  IT WAS SUGGESTED THAT SHE TRY HYDROCORTISONE CREAM.  BUT IF SWELLING KEEPS GETTING BIGGER, THEN TO GO TO URGENT CARE TO GET PRESCRIBED ORAL STEROIDS.
Patient experienced syncope shortly after receiving second shot (Fluarix). He hit is head, urinated, and felt slightly light headed after becoming aware within 15 seconds.
Information has been received from a physician and from a licensed practical nurse concerning a 17 year old female patient with no pertinent medical history and no drug reactions or allergies who on 08-NOV-2010, was vaccinated IM with the first 0.5 ml dose of GARDASIL (Lot# 666597/0768Z, expire date 17-OCT-2012). Concomitant medication included NECON. The patient did not receive any concomitant vaccination at that time. The nurse stated that on 08-NOV-2010, sometime after the patient had received the GARDASIL, the patient complained of difficulty breathing and was unable to swallow. The patient was seen in the emergency room. It was reported that the patient was positive for a strep infection (not specified). The patient's white blood cell (WBC) count was elevated. The patient was treated with a penicillin shot and was sent home and was not admitted to the hospital. Approximately twelve hours later on 09-NOV-2010, the patient experienced left leg pain (also reported as bilateral lower extremity pain) and weakness on. The patient was seen in the hospital and was admitted. The patient was hospitalized on 09-NOV-2010. The patient had a magnetic resonance imaging (MRI), computed axial tomography (CT) scan and a bone scan. The tests revealed fluid on the patient's hip. The patient was diagnosed with chronic regional pain syndrome. The patient was treated with extensive physical therapy. The patient was discharged on 14-NOV-2010 on NEURONTIN, amitriptyline hydrochloride and hydrocodone. The patient was now recovering but still had persistent pain and required a walker for ambulate due to muscular atrophy. The GARDASIL series had been discontinued. Chronic regional pain syndrome and the patient require a walker to ambulate due to muscular was considered by a physician to be disabling. Additional information has been requested.
Have headaches daily which increase in intensity where I become nauseous and sensitive to light and sound.. I call theses Migraines..  I have had these every day ever since 2nd vaccine... I have never been prone to headaches or migraines prior to this.. It has been years since I had a migraine.  I have been hoping this would stop since I was warned about headaches being a side effect and I did get one with the first dose.. But its been a full week without any relief...
The needle hit the bone during injection of the vaccine in my right arm. The site turned red, tender to touch and started to swell. I thought this would go away in a few days. I took nsaids but the pain started to travel down my arm and by Oct 25 my arm and down to my thumb was swollen and very painful. I was feeling a sharp pinpoint pain at the injection site which radiated down to my thumb upon touching it. I was unable to grasp or move my thumb.  I went to the ER and was tx for cellulitis and given a shot of toradol, a wrist splint and told to use heat pads. Xray revealed no foreign body at injection site. On Sunday I was still the same. I spoke with my sister whom told me she had and allergic reaction to the swine flu vaccine last year an had the same symptoms and was tx with Benadryl. I took 50mg and the pain swelling decreased.  As of today I still have pain at the injecton site and my thumb is still painful to move.
Sciatica with pain going down the back of her leg; This is a spontaneous report from a contactable Nurse (patient).   A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8731), an unspecified route of administration, in right arm on 09Apr2021 (at 67 years) at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis (diagnosed about a year ago; an overlap with rheumatoid arthritis a year ago; she has been in remission from her rheumatoid arthritis and off medication since Aug2020), ongoing hypothyroidism (diagnosed 2 years before in 2019), ongoing osteoarthritis (for years) and ongoing Sjogren's disease (for years). Previously patient took methylprednisolone (MEDROL) that worked before. The patient's concomitant medications were not reported.  The patient developed sciatica with pain going down the back of her leg in Apr2021, serious as medically significant and described as follows: patient had the first dose of the vaccine on 09Apr2021 and her symptoms started two weeks later in Apr2021; she went to her internist on 22Apr2021 because she was in such pain. Internist doctor said she had developed sciatica. Patient reported the pain was going down the back of her leg and knee was hurting, it was very painful, her foot was tingling, like when the foot was waking up from being asleep, has had this feeling before when she first got rheumatoid arthritis, stated behind her knee hurt so bad. Patient had a doppler done on an unknown date in 2021, that was negative for blood clots. Patient was put on a methylprednisolone (MEDROL) dose pack but it did not help at all, did nothing and made no difference whatsoever. Final outcome of the event was not recovered.Patient asked if there was any report of the first dose of the covid 19 vaccine that caused a flare or bring a person out of remission for persons with autoimmune disorders. Patient stated she was not sure if this sciatica was due to the vaccine revving up her autoimmune issues or if it was unrelated. Patient delayed the second dose by one week per the doctor's recommendation and second dose was administered on  07May2021 (at 68 years, lot ER8736) in right arm.; Sender's Comments: Based on available information, the contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8731), to the reported event sciatica cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN6201) at the age of 65 years, in left arm, on 04Mar2021 at 12:00 as dose 2, single (Lot number: EN6205) at the age of 65 years, in left arm and on 27Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 66 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Gluten/celiac disease" (unspecified if ongoing); "Gluten/celiac disease" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Patient antiviral details included product -COVID 19 Treatment, treatment stop date=04Jul2022.
We were at church and she had severe abdominal pains that sent us to the ER. She had a cyst that burst and had to have emergency surgery.
2 days p/flu vax pt had vessicular eruption @ immun site, w/12cm x 111cm swelling, erythema, warmth, no tenderness;
woke up with huge itchy all down from his rear end to his ankle and the back side of his leg; This is a spontaneous report from a contactable consumer reported for husband. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 16:30 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No issues for a couple of days, but then in the middle of the night at 3 a.m. husband woke up with huge itchy all down from his rear end to his ankle and the back side of his leg, itch came to the front a little bit, took some Benadryl 50 mg and itch cream, it pretty much subsided. The event outcome was recovering.  Information about lot/batch number has been requested.
Fine when she went to sleep at 9:00 PM. Gave Tylenol before sleep just to help with fever and aching from shot. No fever upon going to bed. Starting whining in her sleep around 1:10 or so. Never woke. After 20 minutes or so went upstairs to check on her. She sat up, threw up, and had a temp of 105.4 rectally. Stripped her of clothing. Tried to give Tylenol, but couldn't keep down. Took to ER. Told them I thought was flu shot reaction but they wanted to run tests just to make sure wasn't coincidence that something else wasn't going on. Did bloodwork, chest xray, and urine. All came back negative. Fever came down with rectal tylenol. Pediatrician says its a reaction to flu shot.
Pt recvd vax & 45mins to 1 hr later exp temp almost to 104, diarrhea, loss of appetite, hacking cough, lethargic, gray, restless, limp, irritable;
Pt noted redness & swelling in lt upper arm evening of 8JUN90; Had fever & chills X 2d. Swelling began to subside p/4-5 days. Seen by MD exam -lt UE w/a well demarcated area erythema on anterior arm; No warmth to touch,no ax adeno or edema.
2 days after 2nd Pfizer dose sudden severe chest pain with SOB, nausea, palpations. Unrelieved by OTC IB or rest.
Patient came in for Booster of Pfizer. Her first 2 vaccines were Moderna. Last one given in April. Patient sts has anaphylaxis reactions to both Moderna. Patient was treated with Epi 0.3 IM sent to the ED from clinic. Patient came in today and sts her physican requested her to get the Pfizer as a booster due to her immunocompromise conditions. 10 min after booster injection patient started to c/o SOB and voiced changed to raspy. Epi 0.3mg auto inject given in R thigh. Team alert called and member taken to ED. Patient recieved relief from Epinephrine inject. No SOB Vitals stable.
Severe fatigue/naps increased from 30 minutes a day to 5 hours a day. Ataxia - unable to keep balance walking or standing.
Felt Really Fatigued; Left Arm Hurt after First Dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 18Mar2021 17:10 (Lot number: EN6208) at the age of 60 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "hospitalization", start date: 15Oct2020, stop date: 27Oct2020, notes: gave him some tests, like COVID experimental drugs. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18Mar2021, outcome "recovered" (25Mar2021), described as "Left Arm Hurt after First Dose"; FATIGUE (non-serious) with onset 19Mar2021, outcome "recovered" (20Mar2021), described as "Felt Really Fatigued".  No follow-up attempts are possible. No further information is expected.
Joint dislocation/hip popped out of socket and it popped back in when stood up; Felt faint; Shoulder pain/left shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT DISLOCATION (Joint dislocation/hip popped out of socket and it popped back in when stood up), DIZZINESS (Felt faint) and ARTHRALGIA (Shoulder pain/left shoulder pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) citrate free. On an unknown date, the patient experienced JOINT DISLOCATION (Joint dislocation/hip popped out of socket and it popped back in when stood up), DIZZINESS (Felt faint) and ARTHRALGIA (Shoulder pain/left shoulder pain). At the time of the report, JOINT DISLOCATION (Joint dislocation/hip popped out of socket and it popped back in when stood up) had resolved and DIZZINESS (Felt faint) and ARTHRALGIA (Shoulder pain/left shoulder pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   On unknown dates, the patient experienced hip popped out of socket, almost passed out and it popped back in when stood up and left shoulder pain. Covid-19 vaccine  Moderna vaccine was also considered suspect.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Never had a reaction like this from any Vaccine, this vaccine made me sick for about 6 hours overnight, high fever 102, chills, body aches, headache, and nausea. I have had Covid19 before and Covid never made me this sick. I think there is a problem with this vaccine. I took Tylenol and a headache medication I have which helped a little bit. I am hoping that nothing more happens to me today, I received this Vaccine yesterday at Pharmacy 10/03/2023 another thing I noticed which I never experienced before my Arm was sore instantly after receiving this FluBlok vaccine. Not feeling the best today with some body aches.
body aches similar like the flu; sore throat; lungs hurt when she takes a deep breath; body aches similar like the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu). At the time of the report, INFLUENZA LIKE ILLNESS (body aches similar like the flu), OROPHARYNGEAL PAIN (sore throat), PULMONARY PAIN (lungs hurt when she takes a deep breath) and MYALGIA (body aches similar like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.   This case was linked to MOD-2021-106524 (E2B Linked Report).; Sender's Comments:  MOD-2021-106524:second dose
0.3 ml instead of 0.5ml; patient received an Expired dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (0.3 ml instead of 0.5ml), EXPIRED PRODUCT ADMINISTERED (patient received an Expired dose) and NO ADVERSE EVENT (No adverse event) in an 81-year-old male patient 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 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. On 15-Dec-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.3 ml instead of 0.5ml), EXPIRED PRODUCT ADMINISTERED (patient received an Expired dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (0.3 ml instead of 0.5ml), EXPIRED PRODUCT ADMINISTERED (patient received an Expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for ACCIDENTAL UNDERDOSE (0.3 ml instead of 0.5ml) and EXPIRED PRODUCT ADMINISTERED (patient received an Expired dose).    Relevant concomitant medications were not reported.  Treatment information was not provided. The vial was stored post puncture in room temperature. The vial was not undergo any temperature excursions.
First dose on 16-Jun-21 and second dose on 4-Aug-21; This spontaneous case was reported by a medical assistant and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Jun-21 and second dose on 4-Aug-21) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 047A21A) for COVID-19 vaccination.     No acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included Penicillin allergy, Drug allergy (Vancomycin), Type 2 diabetes mellitus, Hypertension, Gastrooesophageal reflux disease and Asthma. Concomitant products included ECONAZOLE from 17-Jan-2022 to an unknown date for Fungal infection, LIDOCAINE from 29-Mar-2022 to an unknown date for Pain, SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA) from 19-Oct-2020 to an unknown date, ISOPROPANOL (ALCOHOL PREP PADS) from 25-Feb-2022 to an unknown date, AMLODIPINE from 19-Jan-2022 to an unknown date, ATORVASTATIN from 01-Mar-2022 to an unknown date, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM CARBONATE AND VITAMIN D3) from 28-Feb-2022 to an unknown date, FAMOTIDINE from 01-Mar-2022 to an unknown date, FERROUS SULFATE from 28-Feb-2022 to an unknown date, FLUTICASONE PROPIONATE from 24-Feb-2022 to an unknown date, GABAPENTINE from 14-Mar-2022 to an unknown date, GLIMEPIRIDE from 24-Feb-2022 to an unknown date, HYDROCHLOROTHIAZIDE from 01-Mar-2022 to an unknown date, ACETAMINOPHEN;HYDROCODONE from 12-Apr-2022 to an unknown date, HYDROXYZINE PAMOATE from 11-Dec-2001 to an unknown date, INSULIN GLARGINE (LANTUS) from 01-Apr-2022 to an unknown date, LISINOPRIL from 19-Jan-2022 to an unknown date, MELOXICAM from 16-Jun-2020 to an unknown date, METFORMIN from 22-Mar-2022 to an unknown date, OMEPRAZOLE from 01-Mar-2022 to an unknown date and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) from 14-Mar-2022 to an unknown date for an unknown indication.   On 16-Jun-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-Aug-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Aug-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Jun-21 and second dose on 4-Aug-21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 16-Jun-21 and second dose on 4-Aug-21) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Accu-chek guide L1-L2 control solution, Accu-chek guide test strip, clevar choice comfort ex pen needle 31gx5mm misc and pharmacist choice ultra thine lancets 31g misc.  No treatment medication was reported   This case was linked to MOD-2022-544225 (Patient Link).
Patient has redness around the injection site. It is warm and slightly raised. He was seen by a doctor and prescribed cephalexin.
15 minutes after administration patient described her lips as feeling "sunburned" and that the tip of her tongue felt "tingly".  She denied any rash, feeling of swelling in her throat or tongue and had no trouble breathing. Patient declined to have EMTs called because she did not feel it was anaphylaxis.  A dose of 50mg of Benadryl was via orally and she was closely monitored.  Her blood preassure was 128/84 and heart rate was 80.  She had offers to drive her to either the ER or urgent care but declined saying it was isolated to her lips and the tip of her tongue.  Patient is a nurse and was aware of what to watch for.  Pharmacy staff continued to observe her for an additional 45 minutes.  At that time she said the issues were resolving and she would like to go home.  She was counseled on what to look for with worsening reaction but said she felt more frustrated that anything.  Pharmacist encouraged her to reach out to her PCP and also explained we would be unable to give her the next shot at a clinic.  She was advised to speak more with her doctor regarding if she should get a second dose.  Patient was followed up with 2 hours after vaccination by phone and reported symptoms resolved and she was just tired from the Benadryl.  Patient was also called the day after and said she had a bad headache but otherwise no other signs of adverse reaction.
Shortness of Breath, Pepper taste in mouth. Patient remained with nurse for the next 10 minutes and patient stated that her heart was not racing any more. Patients friend took her home.
(L) lower extremity pain, patient seen in office 2/19/2021, pt started on Eliquis
Severe nausea and vomiting. Went to ER, where I received 2.5 bags of fluids as well as IV Zofran and IV reglan.