chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID vaccine dose booster (third vaccine) Mom present no questions at present. Epi pen on hand. Multiple allergies. No reported concerns with previous 2 doses. Pfizer 12 yo and older. 30 min. Watch  15 minute of watch;mom came out of room, patient anxious c/o SOB asking for her inhaler. She had spacer with her but no albuterol. Mom had epi pen with her.  This writer (registered nurse) used auto inject through her pants to right thigh. 12:03pm 0.3mg Epi  Initial Pulse ox 100% Ap120  100 % non breathing No audible wheezing +diaphoresis, hunched over,  AP initially 120s at 100% Benadryl1 25 mg PO at 12:21pm Patient calming down, ice to nape of neck 130/76 AP 87  Refocused breathing with 100% non rebreather that was placed early on.   Transporting no more concerns. Lungs with excellent air movement in all fields  To ED for rebound monitoring.  Doctors assisted in evaluation and response. Registered nurse assisted in transport, oral medication Pulse oc, registered nurse. Supervisor registered nurse, certified, on hand. To ED with registered nurse and medical doctor, with O2.
Patient received Pfizer COVID vaccine on 9/29/21 and 10/20/21. On 1/18/22, patient tested positive for COVID. On 1/20/22, patient admitted to our inpatient facility (CCU) with acute respiratory failure with hypoxia and pneumonia due to COVID19, and acute kidney surgery with history of renal transplant. As of today (1/22/22), patient is still in CCU with HFNC.
approx 24hr p/vax mom noticed 3x3 area lt deltoid inflamed, indurated, painful;seems to be larger area affected today & pt notes itching @ the site;
Felt sluggish; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt sluggish) and HEADACHE (Headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Previously administered products included for Weight loss: Phentermine (30 milligram per day) from June 2020 to May 2021. Concurrent medical conditions included Vegetable allergy (Patient has Asparagus allergy, which results in Swelling, Hives and loss of breath) since 01-Jan-1971, Asthma since 1992, Chronic bronchitis (Patient reports Constant wheezing and trouble sleeping) since 09-Jun-2021, Palpitations (Patient reports that can feel her heart fluttering or skipping beats) since 29-Apr-2021, Joint pain (Severe joint pain throughout her whole body) since 29-Apr-2021, Migraine headache (Has been constant since the 2nd vaccine) since 29-Apr-2021, Nausea (Has been constant since the 2nd vaccine) since 29-Apr-2021, Diarrhea (Has been constant since the 2nd vaccine) since 29-Apr-2021, Rash (Has been constant since the 2nd vaccine) since 29-Apr-2021, Memory loss (Has been constant since the 2nd vaccine) since 29-Apr-2021, Vertigo (Has been constant since the 2nd vaccine) since 29-Apr-2021 and Pain. Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) from 19-Apr-2015 to an unknown date for Acid reflux (oesophageal), SUMATRIPTAN for Migraine, IBUPROFEN and OXYCODONE for Pain, MULTIVITAMIN [VITAMINS NOS], CHLORPHENIRAMINE [CHLORPHENAMINE], NORTRIPTYLINE and ATORVASTATIN for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced SLUGGISHNESS (Felt sluggish) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Headache and Sluggishness, at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (Felt sluggish) and HEADACHE (Headache) had resolved.        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.   This case was linked to MOD-2021-212202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: AE Outcome, Patient demographics provided, Other relevant history added, Concomitant medications added
Chills; coldness; Heart was beating fast; Palpitations; Headache; Dizzy; Tired/exhausted/feeling of exhaustion; Breathing was not coming on easily; Slight muscle ache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that after she got her vaccine, she was feeling fine. She did have chills and coldness. That was pretty much it. The nurse had asked if her heart was beating fast. She replied that it was, but she thought it was out of excitement or adrenaline. They said to let her doctor know if anything happens. She went home and Friday afternoon the chills were noticed more and her heart felt like it was beating faster. It was 100 beats per minute. She felt palpitations, chills, and headache coming on. The next morning, she felt much better than the night before. A little later that day she was getting tired, exhausted, and had a headache. The night before she felt a little dizzy too. Then the next day her breathing was not coming on easily. She also had a little muscle ache. Each day she is feeling better which is good. But the feeling of exhaustion is still there. The outcome of the event fatigue was not recovered while recovering for the other events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Individual went to immunization clinic and requested the Moderna vaccine booster. At the time EUA had not been approved for the third dose (booster) and the amount 0.5ML.  Employee
This spontaneous report as received from a Nurse refers to a currently 13 year old male patient with no pertinent Medical history or Drug reactions/allergies. On 06-AUG-2012 and on 19-OCT-2012, the patient was vaccinated, respectively, with the first and second dose of GARDASIL. On 18-FEB-2013, the patient was vaccinated intramuscularly (IM) with a 0.5 ml dose of GARDASIL lot # H016238, Expire date; 11-APR-2015. No concomitant Medications reported. On 19-FEB-2013, 24 hours after receiving the third dose of GARDASIL, the patient developed pain, warmth, pinkness at injection site. Nurse stated the patient's mother that the patient's pain was slightly more on 20-FEB-2013 so mother placed an ice pack on it. Patient's outcome was reported as not recovered. No lab tests were performed. The patient sought Medical Attention, his mother contacted office. The causal assessment was not provided by the reporter. Additional information has been requested.
pt recv vax;localized urticaria,swelling & warmth at inject site;DPH given;
over 7 days:  chills, teeth chattering, constantly clear running nose, exhaustion, lost voice, difficulty sleeping
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 02-FEB-2009, the patient was vaccinated by a  physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-MAR-2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. On or about 01-APR-2016, she sought subsequent treatment by a physician for the onset of severe zoster conjunctivitis also known as shingles in the eye. The patient has been prescribed gabapentin and valacyclovir (VALTREX) for management of her painful condition. 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. Upon internal review,severe zoster conjunctivitis also known as shingles in the eye was determined medically significant. Additional information has been requested.
The vaccinee received an injection of Engerix-B in 1998 (exact date not specified). At some later, (unspecified time), she experienced "urtica (stinging)"; the site of the stinging was not specified. Outcome of the event was not provided. Additional information has been requested.
Symptoms: pain in the right and left hip-bursitis Inflammation in both thighs-difficulty walking- heaviness and severe pain in the legs-tendinosis-cramp in the legs- pain in the lower back and buttocks. Change of color in the legs.
Reported pain, redness, swelling at injection site the day of injection. The day after injection began itching and developed "hives" around injection site. Employee Health Nurse was not available and employee advised that if worsening condition would need to report to the ED for further evaluation.
vaccine was administered on 11/7/22 after the beyond use date of 11/2/22. no adverse event.
Pt had arm issues that lasted beyond 2 weeks. She described typical arm soreness lasting 2-3 days Subsided a bit then got "Moderna arm" symptoms around day 9. Pain, redness, swelling. Pt presented to pharmacy 5/21/2021 asking about rxn and whether to get 2nd shot. Still had pain at certain extensions of arm due to unknown factor.
Painful increase in intestinal gas, abdominal pain/cramping. Consistent with past symptoms diagnosed as irritable bowel syndrome. I am treating it as if it were an IBS flare-up, by temporary dietary changes and use of herbal tincture. Symptoms started late Monday, continued Tuesday and into Wednesday (today), though today's are less severe.
AFTER THE VACCINATION, THE PATIENT CLAIMED HAVING TINGLY ON BOTH ARMS MORE ON THE SIDE OF THE SHOT ON THE LEFT ARM. PT SAID HE HAS A LUMP IN THE THROAT; DIZZINESS; AND ANXIETY.  PHARMACIST SUGGESTIONS: WE GAVE HIM A  BOTTLE OF WATER AND HAVE HIM SEAT FOR AT LEAST 40 MINS.  ICE PAKS WERE APPLIED ON THE SITE OF THE INJECTION WHILE PT WAS IN PHARMACY. AFTER THE REST PATIENT SAID HE WAS A LOT BETTER BUT STILL DIZZY. PHARMACIST OFFERED TO CALL AMBULANCE/ 911 PATIENT REFUSED.  SUGGESTIONS; ICE PAKS WERE APPLIED TO TE INECTION SITE WHILE PT WAS STILL IN PHARMACY TO TAKE TYLENOL AT HOME FOR ANY FEVER  AND BENADRYL AND TO LOGON TO THE V-SAFE WEDSITE TO REPORT SITE EFFECTS AND ADVRSE EVENT. GO TO THE HOSPITAL
I have flu shots every year without any adverse reaction.  This is the first time I had the senior FLUAD  vaccine.  The second evening after the shot I could not sleep and I felt dizzy.  The next morning I started severely vomiting along with nonstop diarrhea.  I live alone and I was so dizzy and weak I could hardly make it  from the couch to the bathroom.  I was vomiting so hard, I though I might need to go to the emergency room.  I was also sweating profusely and extremely weak.  I was not running a fever.  It felt like a severe bout of food poisoning.  I had not eaten anything suspicious whatsoever.  The reason I am reporting this is that if I had been in more fragile condition, I think this event could have been extremely dangerous.  In 2013 I was treated for triple negative breast cancer and given Cytoxan and Taxotere.  If I had this reaction during that treatment, I think I would have been in the hospital.  The symptoms abruptly stopped in about 8 hours.  I was very weak for a day or two but there were no more symptoms.
Patient came back to clinic day after receiving vaccine, Complaints of Fever, Chills, headache date after receiving Vaccine.
Information has been received from a nurse practitioner (N.P.) concerning a 5 year old female who on 08-MAY-2008 was vaccinated with a dose of VARIVAX (Oka/Merck). It was unclear if this was the first dose of VARIVAX (Oka/Merck). On the same day the patient was also vaccinated with a dose of MMR II and DTaP (+) tetanus toxoid and poliovirus vaccine. The patient was vaccinated in her legs, however it was not certain which vaccine was administered in which leg. At an unspecified time post vaccination, the patient developed bilateral leg and joint pain, muscle weakness and a "few lesions". She was seen at a hospital for the leg pain and had unspecified testing done (no results reported). On 22-MAY-2008 the patient was in the office by the N.P., and was not able to stand by herself. The child reportedly sat on the floor and the mother had to pick her up. She was also "shaky" when walking. Blood work was done (no results reported) and the child was referred to a specialist at the hospital for further testing to occur on 23-MAY-2008. At the time of the report no diagnosis had been made. The patient had not recovered from the events. The reporter felt that it was unknown if the events were related to vaccination or to some other condition. But she believed it was something beyond pain from the multiple injections the child received in the leg. Additional information has been requested.
Chronic uriticaria with characteristics of dermatographia beginning approximately 9 days post booster
This case was reported by a healthcare professional (nurse) and described the occurrence of swelling of arm at vaccination site in a 49-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). On 25 September 2013 the subject received a dose of FLUARIX (.5 ml, injection, unknown details). On the morning of 27 September 2013, 2 days after vaccination with FLUARIX, the subject experienced swelling of arm at vaccination site, injection site pain and injection site warmth. In 2013, within a week of vaccination with FLUARIX, the subject experienced ill defined disorder. The nurse reported that the subject woke up 2 days after the vaccination and found her hand and part of her arm swollen (swelling of arm at vaccination site). The nurse reported that the subject's "wrist hurt" (injection site pain) and "she could feel a knot there" (swelling of arm at vaccination site). There was some warmness at the injection site but "most of the symptoms were in lower arm." The subject sought medical attention from her chiropractor because "she felt something might be out of alignment but she felt it was caused by the vaccination" (ill defined disorder). At the time of reporting the events were improved. Per the nurse, the subject's symptoms were improving but her hand was still swollen and she could still feel the lump in her wrist. The healthcare professional considered the events were probably related to vaccination with FLUARIX.
Approx 9pm onset shakes, sweating , increase in temp99-100 F , chest pain ,  muscular pain and tightness throughout body.  In middle of night started vomiting . Approx 6am called primary MD. Was instructed to go to nearest hospital.
This literature market report has been received from authors of a published article. This report referred to a male patient of unknown age. The patient was born to healthy parents who was diagnosed at age 5 years with autoimmune lymphoproliferative syndrome (ALPS) with refractory immune thrombocytopenic purpura (ITP), anemia, neutropenia, and splenomegaly. The patient was splenectomized at age 7 years and subsequently received corticosteroids, mycophenolate-late mofetil (MMF), intravenous immunoglobulin, eltrombopag, and rituximab for refractory ITP. The platelet counts normalized after MMF and immunoglobulin treatment, suggesting an autoimmune etiology, though the patient did not have elevated autoantibodies (extractable nuclear antigens, deoxyribonucleic acids (DNA), ribonucleoprotein, antinuclear antibodies, anticardiolipin, and antithyroid). The patient had episodic aseptic meningitis, with lumbar punctures revealing reactive lymphocytosis in the cerebrospinal fluid consisting of 85% T cells in a 6:1 CD4+ to CD8+ ratio. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) (strength, dose detail, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date the patient had a systemic reaction to pneumococcal vaccine, polyvalent (23-valent) (manufacture unknown) with leukocytosis and hypertension. The outcome of leukocytosis and hypertension was unknown. The reporter considered leukocytosis and hypertension to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacture unknown).
Pt recvd 2nd dose of vax 7MAY92 & 8MAY92 devel pruritic macular papular rash on both arms & chest; poss allergic reaction to the vax & the vax series was discontinued;
Case number PHEH2014US019167 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 63 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014, he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml instead of the recommended 0.5 ml dose. Currently no complaint was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Received Moderna Covid 19 stored at minus 82 degrees Farenheight; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Received Moderna Covid 19 stored at minus 82 degrees Farenheight) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received Moderna Covid 19 stored at minus 82 degrees Farenheight). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Received Moderna Covid 19 stored at minus 82 degrees Farenheight) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient allergies was reported as unknown. It was also unknown if the patient was diagnosed with or tested positive for COVID-19. The patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees farenheight. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Treatment information was not reported.   This case was linked to MOD-2021-402935 (Patient Link).
Back ache, fever 104.2, numbness & tingling both arms/hands, n/v, mid upper epigast. pain, HA, muscle & joint pain, dyspnea, rapid pulse.
Received PREVNAR 13 on 5/20/15 and developed red, hot swollen lump on left arm. Came into office on 5/26/15 to have area evaluated. Dx with cellulitis and given doxycycline. for tx.
Felt terrible almost two weeks later; Moderna arm; Rash blistered; Nauseous; Tired; Feverish; Woke up with cold symptoms; Coughing; Sick; Swelling on my arm/Arm swelled to the size of a golf ball; Rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), FEELING ABNORMAL (Felt terrible almost two weeks later), NASOPHARYNGITIS (Woke up with cold symptoms), ILLNESS (Sick) and VACCINATION SITE REACTION (Moderna arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PERIPHERAL SWELLING (Swelling on my arm/Arm swelled to the size of a golf ball) and RASH (Rash on my arm). On 30-Oct-2021, the patient experienced ILLNESS (Sick). On 02-Nov-2021, the patient experienced COUGH (Coughing), NASOPHARYNGITIS (Woke up with cold symptoms) and PYREXIA (Feverish). On an unknown date, the patient experienced FEELING ABNORMAL (Felt terrible almost two weeks later), VACCINATION SITE REACTION (Moderna arm), RASH VESICULAR (Rash blistered), NAUSEA (Nauseous) and FATIGUE (Tired). The patient was treated with Manual therapy (Ice on her arm after blister popped) for Vaccination site reaction; Manual therapy (Ice on her arm after blister popped) for Rash vesicular; Manual therapy (Ice on her arm after blister popped) for Peripheral swelling and Manual therapy (Ice on her arm after blister popped) for Rash. At the time of the report, COUGH (Coughing) and FEELING ABNORMAL (Felt terrible almost two weeks later) had not resolved, NASOPHARYNGITIS (Woke up with cold symptoms), ILLNESS (Sick), NAUSEA (Nauseous), PYREXIA (Feverish) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE REACTION (Moderna arm), RASH VESICULAR (Rash blistered), PERIPHERAL SWELLING (Swelling on my arm/Arm swelled to the size of a golf ball) and RASH (Rash on my arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter.  On 03-NOV-2021 patient stated sickness got worse.
Pain in ear, progressed to severe Bell's Palsy on 09/01/2015.
Have had hives since Nov2021, after 1st booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Nov2021, outcome "unknown", described as "Have had hives since Nov2021, after 1st booster".  Additional information: Many people are suffering long term hives after booster, myself included. Have had hives since Nov2021, after 1st booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hard lump and red spot at injection site with 1/2" X 1" induration. Slight irritability.
2/25--4 days after second COVID vaccine patient visited ED for c/o SOA and dyspnea.  Chest CT shows "small sized pulmonary emboli in the right middle lobe branches", Venous doppler shows "venous thrombosis involving the right posterior tibial venous segment".  Hospitalized for 2 days--discharged home.
Experienced generalized itching (no rash) and swelling of the eyes 5 days after vaccines listed below.  Itching lasted several days.  Ocular swelling resolved in 4-6 hours.