chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 11 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 19-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # M024261, expiration date, dose and route unknown) for prophylaxis. The vaccines were stored at 11.6 degree Centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree Centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008047: US-009507513-1612USA007442: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1702USA010448.
Jaw pain; This is a spontaneous report received from non-contactable reporter (Consumer or other non HCP) from a Pfizer sales representative. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as unknown dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN JAW (non-serious), outcome "unknown", described as "Jaw pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a medical assistant and unspecified reporter refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 07-AUG-2018, the patient was vaccinated with improperly stored dose of Oka-Merck PROQUAD, lot # N034561, expiration date: 03-JUN-2019, (dose and route of administration were not provided) for prophylaxis (incorrect product storage). The vaccine was reconstituted with sterile diluent which was properly stored. The vaccine underwent a temperature excursion -14 to -10 degrees Celsius for 3 hours and 30 minutes. Digital data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006154: US-009507513-1809USA004441: US-009507513-1809USA004442: US-009507513-1809USA004443: US-009507513-1809USA004444: US-009507513-1809USA004445: US-009507513-1809USA004446: US-009507513-1809USA004447: US-009507513-1809USA004448: US-009507513-1809USA004449: US-009507513-1809USA004439.
Rash on both upper extremities and abdomen 3 hours after dose. 10/4/2017 ER visit given IV solumedrol, Benadryl, and pepsid. Symptoms relieved, discharged home. 10/5/2017 rash returned while at work, admitted to ER. Given IM Epi in the R deliod, IV Benadryl, solumedrol, pepsid. Rx for tapering does of prednisone given by ER doctor. 10/6/2017 started prednisone 40mg at 6AM, rash became red and inflamed at work, arrived at occupational health appointment at 09:00
about 10mins p/vax pt c/o dizziness;Epi & DPH given;pt transferred t hosp ER;
pt recv vax 27MAR96 & on 27FEB97 pt devel more mild case of varicella consisting of lesions all over body;rash was described as diffuse, erythematous, papules on all body surfaces, some w/vesicles, some excoriated;vesicles crusted & itchy
Right leg: Lightening strikes down back side of the leg. Mid-thigh to mid-calf. Electrical shock beginning at thigh and ending at calf. Jolting, shocking, irritating jolts. 6 or 8 of them. Occurred over 5-10 minutes while seated at a computer. Never felt before or since. Edema in both feet/ankles for 2 years. Numb big toes.  Separately at a later time sitting on toilet: deep breath, lung expands and touches a needle poking in my left breast near the nipple. (there is no needle). Surprised recoil. Cautious deep breath: again, needle sharp pain like a needle piecing a balloon. Scared to walk, maybe a heart attach? But no pain in arms, no shortness of breath, no other symptoms. Walked to other room to get cell phone to be ready to call 911. Then it's gone and never returned. No pain. Hugh breaths and no problem. Another time: heart feels like it's going to begin atrial fibrillation / tachycardia, but it doesn't happen. Heart feels very labored and tired. I've had tachycardia for 50 years, so I know what it feels like. This one was tachycardia without the fast heartbeat (135). Although heartbeat did go to 122 at one point. Went away after a half hour or so. Temp to 100.6. No cough's, no runny nose, no other symptoms. All symptoms occurred during the 3 days. Heartbeat went to 122, down to 57 and then back up to 100 again. Recovered without aid or medication.
Blister appeared in mouth on the skin on the roof of mouth towards the back; Slight tightness in chest.; Fever (101); Muscle aches; Extreme fatigue; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 16:00 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included anxiety. Concomitant medications included fluoxetine hydrochloride (PROZAC) 10mg and bupropion hydrochloride (WELLBUTRIN) 150mg SR. The patient experienced allergies to nickel, thimerosal, and other preservative found in soaps. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205,), via an unspecified route of administration in the left arm on 02Mar2021 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 25Mar2021 at 05:00, the patient experienced fever (101) (unspecified units) with muscle aches and extreme fatigue. The patient also reported that these events lasted roughly 24 hours. On 27Mar2021, then each day after the patient experienced slight fatigue that worsened towards the end of the day. A week later, on an unspecified date in Apr2021, the patient also experienced a blister that appeared in mouth on the skin on the roof of mouth towards the back. The patient had never experienced this before. On an unspecified date in Apr2021, the patient experienced slight tightness in the chest and some fatigue still. Therapeutic measures included intake of TYLENOL on 25Mar2021. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events fever and muscle aches were resolved on 26Mar2021. The clinical outcomes of the events fatigue, blister appeared in mouth and slight tightness in chest were resolving.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a licensed vocational nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection, lot # M004116, expiration date 12-OCT-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 30 degrees Fahrenheit for 334 hours. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of two reports received from the same reporter. Additional information has been requested.
In August 2005, the patient had a titer drawn that came back as inconclusive.  No further information is available regarding the event or patient's outcome.  There was no product quality complaint reported.  Follow up information received on 09/01/2005 reported that the health facility is changing their policy to include information on equivocal lab results after three doses of vaccine to determine antibody status.  It was reported that no adverse reaction occurred.  The patient sought unspecified medical attention.  No additional information is expected.
With a month of being vaccinated I have full neoropathy systems. Numbness, tingling, kiss of balance. Loss of coordination, pins and needles. It has been going on for 2 years.
Since 23 January she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. Symptoms led her to present to the ER on 25 January where she was treated with oral antihistamines. On 26 January she developed swelling affecting the skin around her eyes and her throat which caused difficulty swallowing and breathing; she was treated with oral antihistamine, oral corticosteroid, and IM epinephrine. She denies laryngeal symptoms since this episode. She was again treated with a course of oral corticosteroids in February due to persistent cutaneous symptoms. She denies laryngeal (except as noted above), pulmonary (except as noted above), GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 13 January, 10 days prior to onset of symptoms. She has used oral antihistamines and oral corticosteroids with benefit. She denies constitutional symptoms. UCT score today is 24 (3, 3, 3, 2, 2, 4, 4, 3). No history of adverse reactions to prior vaccines.
Patient is a 20-year-old female with history of kidney stones who presented to ER due to right lower quadrant pain.  Patient said that she started having right lower quadrant pain last night.  No nausea /vomiting, fever/chills, diarrhea or constipation.  No urinary complaints.  She reports history of kidney stones.  She thought that she was having kidney stone again so she came to ER.  Upon evaluation in ER, vital signs were stable and she was afebrile.  WBC 15.9.  CT scan of the abdomen and pelvis showed acute appendicitis without abscess or perforation.
Patient states she developed general body aches approximately 1 hour after H1N1 and seasonal influenza vaccinations were administered.  About 7 hours later, she had chills with extreme shaking, body pain, and nausea.  She was seen in the ED, presenting with same symptoms as well as rash on chest and temp of 100.8 degrees.  Per IV, she was given Benadryl, Zofran, Toradol, and NS. She was given Tylenol PO and diagnosed with "adverse reaction to influenza vaccine."  Patient was then sent home and stated that during the night, she had another episode of shaking and nausea/vomiting which was resolved with PO Benadryl.  The following day, she complained of slight nausea and a slight headache.  On 10/23/09, her headache remained but by 10/24/09, all symptoms had resolved.
Patient expressed to MS a higher intensity of adverse events during her second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient expressed to MS a higher intensity of adverse events during her second dose) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient expressed to MS a higher intensity of adverse events during her second dose). At the time of the report, VACCINATION COMPLICATION (Patient expressed to MS a higher intensity of adverse events during her second dose) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2021: Followup received on 22-APR-2021 and contains NNI.
Pt presented to office on 03/24/2003 with 5 scabbed over lesions. Mom reports that lesions had been fluid filled on previous day. No treatment was warranted and non was prescribed.
Arm very sore, red and swollen extensively over upper arm where injection occurred. Earlier in the day, around 4 pm, I was feeling very tired and my nose was running. The following morning I had a fever over 100 degrees, my arm continued to be very sore, puffed up and red. I was completely exhausted and found difficult to do the simplest of tasks.
Narrative: COVID infection following COVID vaccine series 02/11, Pfizer, dose# 1 03/04, Pfizer, dose #2 07/15 COVID swab, result: NOT detected 11/01 COVID swab, result: detected 11/01 pt cc: exposure: unknown 11/05 COVID swab, result: NOT detected
Severe headache, body ache, severe nausea, fatigue for first 72 hours. Then severe headache, severe neck ache, diarhea, fatigue, no appetite, dizziness  Continuing thru 01/29/21.
local reaction 2 days following.  wide spread grouped pruritic papules on trunk, limbs
This spontaneous report was received from a registered nurse referring to a currently 4 month year-old patient of unknown gender. The patient's medical history, current conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ (Lot#N005626, expiry date: 26-NOV-2018) orally, for prophylaxis. The vaccine underwent a temperature of 31.9 Fahrenheit degrees (°F) for a time frame of 10 minutes. There was no previous temperature excursions and digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA006754: US-009507513-1801USA007189: US-009507513-1801USA007191.
Fever and weakness; Fever and weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Fever and weakness) and PYREXIA (Fever and weakness) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE, LOSARTAN and METFORMIN for an unknown indication.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Oct-2022, the patient experienced ASTHENIA (Fever and weakness) and PYREXIA (Fever and weakness). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-May-2023 to 05-May-2023 for COVID-19 treatment, at an unspecified dose and frequency. On 29-Oct-2022, ASTHENIA (Fever and weakness) and PYREXIA (Fever and weakness) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient race was reported. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The Device date was reported as 13-May-2023.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Fever-Mild, Additional Details: Patient presented to pharmacy with injection site reaction, left arm was red, warm and tender, patient stated felt slight itch. Provided antihistamine and steroid cream to alleviate symptoms, pt stated slight fever that resolved quickly and arm was improving. Advised to notify if condition worsens and to contact provider if necessary. Patient to be counseled during second dose of Shingrix.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, route, lot# and expiration date were not reported; therapy type: digital data logger). Temperature excursion information was reported as: below 36 Fahrenheit, more than 25 times (unknown by the reporter). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sick; Shingles; Patient said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GH9702) 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 completed, Manufacturer Unknown), for Covid-19 immunization; Bnt162b2 (1st BOOSTER), for Covid-19 immunization; Bnt162b2 (Patient said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose.), for Covid-19 immunization. The following information was reported: ILLNESS (hospitalization), outcome "unknown", described as "Sick"; HERPES ZOSTER (hospitalization), outcome "unknown", described as "Shingles"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Patient said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose.".  Clinical course: Patient said he got the 2nd dose of Pfizer COVID vaccine Bivalent dose. What happened is he was in good shape but reduced blood level to the point where he caught COVID 19 and upon catching COVID, he wound up with Shingles. He does not want anyone else getting this and getting COVID and you wind up in the hospital and wound with Shingles. Was in good health before.
Severe pain in right arm and shoulder.  Pain radiates through neck and to other shoulder and her shoulder blade. Radiates down arm to wrist.
I gave Infanrix to a child over age 7yrs instead of Adacel. No symptoms while in clinic.
Left arm at injection site was red, swollen and hard. Site was 2 1/2 in by 2 1/2 in and roughly 1/2 inch deep. Also same side eye was red and puffy.
This spontaneous case was reported by a consumer and describes the occurrence of IRON DEFICIENCY ANAEMIA (iron deficiency anemia) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.  No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRON DEFICIENCY ANAEMIA (iron deficiency anemia). At the time of the report, IRON DEFICIENCY ANAEMIA (iron deficiency anemia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication history not provided. Treatment information was unknown. Reporter did not allow further contact
Starting soon after my COVID vaccine i began experiencing trouble breathing during normal activity. I'm an avid runner and swimmer and had been doing this throughout COVID with no issue. I've always been an asthmatic (not exercise induced), but have always been fine just taking albuterol 15 minutes before activity. and never had any issues. After the vaccine I began finding myself short of breath after relatively easy activity. For example, I typically swam 100 yards at a relaxed rate with no heavy breathing on 1 minute 30 seconds. this would have been a warm-up pace for me. Suddenly I was struggling to even complete 100 yards in that time and when i got to the wall I would be gasping for air. While swimming my arms and legs would feel sort of numb like they werent getting oxygen. This is not how I feel when I have an asthma attack. For an asthma attack it's always the same, I am wheezing, then my lips start to tingle and go numb, followed by my nose and then my hands start to cramp. What I was experiencing was not an asthma attack, there was no tingling/numbness in my face and I was never wheezing. Plus, my inhaler did nothing to help. I was just easily out of breath which is very odd for me, a lifetime athlete and former swimmer. Looking back I finally pinpointed when the issues began and it was right after the vaccine. I literally went from swimming fast with almost no effort to barely being able to swim  without feeling the need to stop at a wall. The issues seemed to subside over time, and then I got a booster shot and they started up again. I have not gotten another booster since and I believe the symptoms are slowly getting better, but I am nowhere near being able to do what I did prior to the vaccine.
Patient started to experience dizziness, nausea and frontal headaches about 45 minutes after vaccine was administered.
no adverse event; incorrect product storage; This spontaneous report was received from an officer manager concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not provided.  On 22-JUL-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379, expiration date 31-MAY-2022) at a dose of 0.5 milliliter for prophylaxis (strength, route, anatomical site and vaccination schedule were not provided), which ha a temperature excursion of 46.8°F for 9 hours which was detected by a data logger. The vaccine had no previous temperature excursion and no adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Mild headache in the back of the head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache in the back of the head) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, SERTRALINE, CLONAZEPAM, COLECALCIFEROL (VITAMIN D3) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (Mild headache in the back of the head). The patient was treated with XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, HEADACHE (Mild headache in the back of the head) outcome was unknown.            This case was linked to MOD-2021-367396, MOD-2021-367550 (Patient Link).