chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 60 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jun2022 as dose 3 (booster), single (Lot number: GH9693), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PSEUDOEPHEDRINE, start date: 21Oct2022, stop date: 27Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
Constant, nonstop crying from time vaccine was given until the next day as per mom. Child was seen at hospital emergency room. No rx given.
In order- severe diarrhea, weakness, needed help of another to walk, tremor due to body temperature decrease to 97.0 degrees, BP increase to 168/80, HR increase to 90. Events from 3PM to 7PM
pt recv vax 31MAY96 & 1JUN96 pt exp uncontrollable itching, primarily @ noc, in the upper lt deltoid;sx cont as of 18JUL96;
Hand swelling/Feet swelling; Numbness and tingling in fingers/numbness and tingling in toes; Numbness and tingling in fingers/numbness and tingling in toes; Ankle swelling; Cold chills without a fever; Fatigue; Cold chills without a fever; 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 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6200) at the age of 53 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) with onset 15Mar2021, outcome "not recovered", described as "Hand swelling/Feet swelling"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "Numbness and tingling in fingers/numbness and tingling in toes"; JOINT SWELLING (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Ankle swelling"; NASOPHARYNGITIS (non-serious), CHILLS (non-serious) all with onset 15Mar2021, outcome "not recovered" and all described as "Cold chills without a fever"; FATIGUE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Fatigue". The events "hand swelling/feet swelling", "numbness and tingling in fingers/numbness and tingling in toes", "numbness and tingling in fingers/numbness and tingling in toes", "ankle swelling", "cold chills without a fever", "fatigue" and "cold chills without a fever" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of peripheral swelling, hypoaesthesia, paraesthesia, joint swelling, nasopharyngitis, fatigue, chills.  Additional information: Caller stated he has a primary care doctor and declined to provide HCP information. Patient stated cold chills without a fever is intermittent where it comes for day or two and then goes away for a day or two. Caller stated it is so bad and he has had fatigue where he is in his bed for 3 or 4 hours when it hits him during the day. Caller stated he has taken over the counter medications like Ibuprofen and Tylenol but he has been trying to stay clean with his eating habits and not drink anything. Patient did not administered any other additional vaccine.  No follow-up attempts are possible. No further information is expected.
Dear Sirs,  My family doctor suggested I contact you regarding my unusual side effect from the second Covid-19 injection I received recently.  History:  I am a 72 year old male.  I have high blood pressure treated with 25 mg Atenolol.  I have had repeated operations for skin cancer on my face and head.  I have had pre-cancerous polyps removed through my anus.  My doctor can provide a much more detailed history if required.  First Covid injection of Moderna:  This went well and the only side effect was a sore arm.  I only noticed it if I touched it, otherwise there was no pain.  It went away in a few days.  Second injection:  I was anticipating additional side effects after reading up on the subject.  I was not surprised when my arm hurt.  It was constant and worse than the first time, but not alarming.  I also had a headache which did not surprise me from the research I had done.  The headache felt like my brain had ballooned inside my head and was in compression.  It was uncomfortable, but not painful.     Now to the matter that concerned me:  I was unable to sleep.  This was not something I had read about anywhere in my research.  Being very tired and knowing how important sleep is I decided I should go to the Emergency Room of the local hospital to be looked at.  They told me that none of the doctors, nurses and technicians had ever heard of this effect.  A technician said he would do a world-wide research on the subject and get back to me.  3 hours later he said that he could find no reports on the subject.  They conducted blood and urine tests that they said returned results showing everything normal.  They told me that they did not want to prescribe sleeping drugs because they can be dangerous and were also concerned about any side effects that may result from interactions with the Covid injection that were unknown.   They suggested I talk to my family doctor and then released me.  After 40 hours (yes forty) of being awake I broke out in a profuse sweat.  I reduced the heat, removed clothing and put a fan on.  The next thing I was aware of was 4 hours later when I awoke from sleep.  The sweating had stopped and the headache had stopped.  Purpose:  I have two purposes for writing to you.  First, because my doctor had recommended it.  Second to offer myself as a research subject in the matter.  I recognize that the world is suffering terribly and is trying to understand everything about the pandemic in order to better deal with it on a continual basis.  To that end I recognize the value of research and want to help in some small way.  Thank you.
Dizziness, Headache, Myalgia, Arthralgia, Fever, Diarrhea,   right ear pain/right ear mass/abcess, muffled hearing on the  right side. right jaw pain. "fogginess" difficulty concentrating.
No adverse effects; One patient received one dose of improperly stored ROTATEQ; This spontaneous report was received from an office manager and refers to one patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 01-JUL-2019, the patient was vaccinated with one improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025713, expiration date: 20-JUN-2020 (dose, route of administration and anatomical location were not reported) as prophylaxis. The temperature excursion total time and lowest temperature below 36 °F, was 33.9 Fahrenheit (F) during a time frame of 40 minutes as recorded by data logger. A previous temperature excursion of 30.3 F was reported for 93 hours and 50 minutes. Also, it was reported previous temperature excursion as total time and lowest temperature below 36 °F (30.3 F) for 90 hours and 7 minutes; total time and lowest temperature below 36 °F (30.5 F) for 1 hour and 45 minutes; and total time and lowest temperature below 36 °F (35.2 F) for 2 hours and 5 minutes. No adverse effects were reported.
Daily chest pain starting 2 days after second dose to present (12/13/21) at random times throughout the day.
Uterine bleeding with severe pelvic pain started 2 days after receiving the Booster dose of Moderna?s COVID-19 vaccine
This vaccine vial was punctured at 8:15 am and beyond use date as 6 hours after this time.  the time then would be 2:15 pm.   This vaccine was stored in out refrigerator at  40 degrees Fahrenheit.  this vaccine then was administered at 3:30 pm making it out of the 6 hours use timeframe.  this vaccine was labeled with the Beyond use label and the time of the 2:15pm.   Assessed patient and there was no immediate reaction.   contacted Janssen and spoke with the pharmacist. She emailed me an appendix with guidelines and did not have any other guidance.
pt recvd vax; pt devel joint pain & swelling of hands & knees;
Allergic reaction - hives over entire body - started on arms spread to legs, stomach, and  neck Took Benadryl for 3 days after and symptoms cleared  after 3rd day..
Started with little pain in shoulder and became extreme pain after that, it is still very painful after 10 days also intermittent headache on the same side as injection. Ibuprofen 800 did not get rid of the pain, but took a little of the edge off it after about the 5th day. Took a muscle relaxer which made me dizzy and very sleepy. Only time I have no pain, is if I lay on the side of the injection so I have spend most of the days in bed.
This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates since 07-MAY-2015, the patients were vaccinated with doses of VARIVAX, lot number K016129, expiration date 23-SEP-2016 and lot number L002870, expiration date 27-JAN-2017, (dose, route of administration and injection site were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
1hr after vaccine: lightheaded + had presyncope when moving around, stretching, or moving from sitting to standing. Injection site sore from arm to shoulder and into neck, unable to lift arm for 3 days. 3hrs after vaccine: developed shortness of breath that is only getting better after day 6, Needed to use asthma inhaler several times. Prior to vaccine, had not needed inhaler for many months. Day after vaccine: developed severe migraine, vomited. Had persistent brain fog and made mistakes at work, didn?t start to get better until day 6 post-vaccine. Brain fog and shortness or breath have not fully resolved but do seem better today and more transient rather than constant (day 6 post vaccine). Side effects persisted far longer than expected, and were more severe than my peers, so I feel like it is notable.
Patient is a 64 y.o.  female admitted for acute DKA, glucose is 771 Severe ketoacidosis, bicarb is only 7 AKI, pseudohyponatremia  K 5.3 LFT's ok Got the covid 19 vaccine 2 days ago She has sore throat and chills She did vomit up coffee ground material
Fever up to 102.3 degrees taken with temporal thermometer. Left leg hot & red in area vaccine given.
Shingles Outbreak. Original visit 8/14/08- physician did not diagnose Shingles. Progress of lesions lead patient to revisit 8/18. Shingles verified. Valtrex prescribed. Patient will report on recovery process periodically.
transverse myelitis;onset of weakness in rt lower extremity on 20NOV98, peaking by 21NOV-22NOV, then improving;milder sx in lt lower extremity clonus at both ankles;
I was initially fine having the vaccine. I got covid in August 28, 2021.  I only had mild symptoms.  Around February 28, 2022, I had some type of cold symptoms.  It was not covid.  A week later, I had swollen lymphnodes on the left side of my body.  Later, I got diagnosed with bilateral ear infections.  I have had chronic ear infections since March.  It feels like my body went into over reaction mode after having some type of cold symptoms that was not covid.  Later along with the ear infections, I had two incidences of aural migraine.
Information has been received from a physician concerning a 19 year old female with vertigo, headache and on 20-APR-2008, the patient swallowed ring in tongue who on 21-APR-2008, was vaccinated with GARDASIL (LOT # 659964/1978U), 0.5ml, IM.  Concomitant therapy included ORTHO TRI-CYCLEN LO) and Tdap.  On 05-MAY-2008, the patient experienced vomiting, abdominal pain and back pain.  The mother of the patient called office for medical attention.  Emergency room did blood work and Computerized Axial Tomography scans (CAT), results not reported.  On an unspecified date, the patient experienced a possible urine infection.  On 22-MAY-2008, the patient recovered from vomiting, abdominal pain and back pain.  The outcome of the possible urine infection was not reported.  The physician felt that the vomiting, abdominal pain, back pain, and urine infection were disabling and other important medical events.  The physician felt that the possible urine infection was serious (other important medical event) because the patient needed unspecified antibiotics for the possible urine infection.  Additional information has been requested.
No energy since the 2nd dose/weak; Tired since the 2nd dose; Bigger knot on side of neck after 2nd dose; ache and pain; headache; a pain in the left side of the neck; temperature is 99.3 degrees; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (No energy since the 2nd dose/weak), FATIGUE (Tired since the 2nd dose), NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain), HEADACHE (headache), NECK PAIN (a pain in the left side of the neck) and PYREXIA (temperature is 99.3 degrees). On an unknown date, the patient experienced ASTHENIA (No energy since the 2nd dose/weak) and FATIGUE (Tired since the 2nd dose). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, ASTHENIA (No energy since the 2nd dose/weak), FATIGUE (Tired since the 2nd dose), NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain), HEADACHE (headache), NECK PAIN (a pain in the left side of the neck) and PYREXIA (temperature is 99.3 degrees) outcome was unknown.            Concomitant medications were not reported.   This case was linked to MOD-2021-049400 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Due to system limitation IRD captured as latest present in system 02-JUN-21 instead of backdated IRD of 17-APR-21.
covid-19; covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Arthritic Spine" (unspecified if ongoing), notes: Arthritic Spine; "Minor Bone Spurs In Upper Middle Spine" (unspecified if ongoing), notes: Minor Bone Spurs In Upper Middle Spine; "Gender Dysphoria" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient previously receive a COVID-19 Vaccine. Reported event was breaking out in an allergic reaction to paxlovid. Similar to chickenpox. It's painful to scratch. My tongue is also red, swollen and has sores. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
There is blood underneath area above on the shoulder from the injection site; It is itchy in area above on the shoulder from the injection site; One week after receiving 1st dose, patient noticed swelling above on the shoulder from the injection site; Redness above on the shoulder from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (One week after receiving 1st dose, patient noticed swelling above on the shoulder from the injection site), ERYTHEMA (Redness above on the shoulder from the injection site), VACCINATION SITE HAEMORRHAGE (There is blood underneath area above on the shoulder from the injection site) and VACCINATION SITE PRURITUS (It is itchy in area above on the shoulder from the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, CALCIUM, CYANOCOBALAMIN (VITAMIN B-12), POTASSIUM, BISOPROLOL, Thyroid medication and SIMVASTATIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced SWELLING (One week after receiving 1st dose, patient noticed swelling above on the shoulder from the injection site), ERYTHEMA (Redness above on the shoulder from the injection site) and VACCINATION SITE PRURITUS (It is itchy in area above on the shoulder from the injection site). On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (There is blood underneath area above on the shoulder from the injection site). At the time of the report, SWELLING (One week after receiving 1st dose, patient noticed swelling above on the shoulder from the injection site), ERYTHEMA (Redness above on the shoulder from the injection site), VACCINATION SITE HAEMORRHAGE (There is blood underneath area above on the shoulder from the injection site) and VACCINATION SITE PRURITUS (It is itchy in area above on the shoulder from the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Given shot @ night (L) felt achy (L) swelling put ice then get stiff took tylenol let it go then called on 10th. had 100.5 - 100.7 the night of shot. trouble sleeping on 5-19 the whole weekend achy painful not able to raise above breast tried to exercise daughter OT advised  looked up if given to high called again on Wed. she is ortho she is gong thurs. wrist hurting some.
Severe shoulder pain, pain with abduction and extension and weakness in rotator cuff muscles. stable and persistent over the next 6 weeks. (SIRVA).
Could barely walk; had zero energy; Had hard time breathing; Sweating profusely; Had chest pain; This spontaneous case was reported by an other caregiver and describes the occurrence of GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mast cell activation syndrome.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain). At the time of the report, GAIT INABILITY (Could barely walk), ASTHENIA (had zero energy), DYSPNOEA (Had hard time breathing), HYPERHIDROSIS (Sweating profusely) and CHEST PAIN (Had chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The symptoms were still going on, and the doctors has instructed her not to take the second vaccine. patient  has mast cell activation disease and takes 19 medication, but does know the names of the medication.  Treatment: Patient was given Aspirin but did not help.
Hib portion of vaccine was not added to DTAP + IPV portion of vaccine. No adverse reactions. Patient to return to clinic for HIB vaccine. Web-IZ updated to reflect only DTaP and IPV administered.
For a few days after my first dose, I felt dizzy and nauseous. I had a headache and I was fatigued. On August 8, 2021, I was at work and I walked into the bathroom. My head hurt really badly. I fainted on the floor. I went to the ER and had some tests done. I am still experiencing headaches.
This spontaneous report as received from a patient's sister refers to a 79 year old female patient with no drug reactions/allergies and a pertinent medical history of "rheumatic fever". Sometime in February 2012 the patient was vaccinated with a dose of ZOSTAVAX (lot # was not reported), subcutaneous. Concomitant therapies included LIPITOR and lisinopril (manufacturer unknown). The reporter stated the patient developed the following adverse reactions "four to six months" after ZOSTAVAX was administered: a lump on her collarbone that created pain, and rheumatoid arthritis. The patient sought medical attention by an office visit on an unspecified date. The patient was prescribed prednisone (unspecified dose, frequency and manufacturer) and methotrexate (unspecified dose, frequency and manufacturer). The patient also underwent "blood work". At the time of reporting, the patient was not recovered. Additional information is not expected.
A large, red rash with swelling at the injection site. The swelling has grown larger over night, and is currently about 2.5-3 inches in diameter. There is also a painful swelling in the armpit of the same arm.