chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 008C21A and 030B21A) for COVID-19 vaccination. The patient had no allergies and the patient had not tested or diagnosed to Covid-19 ever. No acute and chronic illness at the time of vaccination and no the other vaccine was given within the month prior to Moderna Covid-19 vaccine. Concomitant products included LISINOPRIL, METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (SYNTHROID), METHOTREXATE, PROPRANOLOL HYDROCHLORIDE (INDERAL) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Apr-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 doses of an expired vial of the Moderna Covid-19 Vaccine were administered) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 05Apr2022, expired on 25Mar2022 and administered on 15Apr2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient was not experiencing any symptoms after receiving the vaccine. The vial did not undergo any temperature excursions. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow up received contains no new information.
Aching left heel: April 26,  progress into calf with swelling of foot, ankle & calf: evening April 27,  dvt found in left leg, pulmonary emboli in both lungs, right worse than left lung, shortness of breathe, tachycardia
Rash on face started in morning of 2/2/2011, rash spread to more of face by evening of 2/2/2011, rash had spread to more of face and difficulty breathing had begun by afternoon of 2/3/2011
For the first 24 hours I had no symptoms and no in in the injection site. But a little over 24 hours after dose, I have now developed chills and a fever.
vesicular rash, which was diagnosed as severe herpes zoster or shingles; The vaccine did not prevent shingles as intended; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age or gender. The patient's medical history, concurrent conditions and concomitant medication use were not provided.   On or about 25-JAN-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, strength, administration route, anatomical location, lot number and expiration date were not reported) for routine adult health maintenance and for the long-term prevention of shingles at a hospital.The reporter stated that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later on 20-MAY-2012, the patient was treated in a hospital, for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles. The patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages.
Felt like I was having a heart attack and have had a tight chest ever since.  My bowel movements have completely changed.  I then suffered a miscarriage.
Headache, fever (100 degrees plus), chills, tiredness, joint aches, flashes of pain in very specific parts of my body (not near the injection site), sore arm to the point it hurt to raise above shoulder level.
Pt seen at ER on 4/24/16 for seizure at home. Father noted shaking of arms and legs, eyes rolled back in head, when he woke child in AM. Arms folded tightly into chest. No fever. Episode lasted approx. 5 min.
Patient has a history of anaphylaxsis. Vaccine was administered at 9:46am to right deltoid.  At 10:15, patient described feeling a little bit funny.  The patient complained of tongue swelling at 10:20am.  Vitals signs Heart Rate 61 BP 152/62 spo2 was 97%.  At 10:25, the patient was assessed by an on site APN and was administered Benedryl 50mg IM.  She was placed in a supine position. At 10;52am, the patient reported feeling better and was discharge to home setting.
13 year old male received formulation Pfizer.  Mother notified.  No ADR reported.  Pt. to be given adult formulation when returns for second dose.
Vomiting, diarrhea, fever, dehydration 1 week, hospitalized for IV fluids.  08/25/2008 MR received for DOS 7/20-23/2008 with D/C DX: Acute Gastroenteritis.  Urinary Tract Infection.  Dehydration. Infant presented with 5 day hx of diarrhea and fever with 1 episode of emesis.  Pt noted to be dehydrated on admission with acidosis and transferred to higher level of care. Tx with abx and IVF.
A report has been received from a physician concerning her son, who is a 12 year old male patient (height: 161.0 centimeters; weight 54.0 kg). No medical history, concurrent disease or concomitant medication was provided. On 01-Feb-2013, the patient was vaccinated with nasal FLUENZ. On 03-Feb-2013, the boy suffered from flu-like symptoms like rhinitis, bone pain, headache, sore throat, weariness and fever. On an unknown date, the patient recovered from these symptoms but he experienced rotatory vertigo from 04-Feb-2013 onwards. The reporter described it as rotatory vertigo with a tendency to fall and certainly not orthostatic. At the time of the follow-up information, on 07-Feb-2013, the vertigo was still ongoing. The reporting physician assessed the events as certainly related to FLUENZ. The reporter considered rotatory vertigo to be serious with life-threatening criteria of seriousness, and the event of flu-like symptoms to be non-serious.
Patient report around 8:45 pm she stated having a cold sensation all over body... she took a hot shower to warm up... stated around 9 pm she couldn't move body until 12 am... she started having shakes and chills that night and felt nauseous... Next day felt headaches and joint pain with 103.7 fever...
70 doses of Pfizer-BioTech Covid Vaccine for patients Lot FK5618 were delivered assigned a beyond use date (BUD, do not use after date) by the manufacturer due to previous storage and handling issues at another facility.  The doses were mistakenly administered to 70 patients on 11/26/21
Thursday 1/6/21 body aches, fever, chills Fri, Sat, Sun- Vomiting and diarrhea. Low blood pressure (average 70/40 Went to  ER Sunday for hydration and low BP Wednesday 1/20/21 diarrhea x 25 episodes while at work, Sent home at 3:30pm. Body aches, chills, sever abdominal pain.
I miserable; hurt all over/Pain won't subside; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I miserable) and PAIN (hurt all over/Pain won't subside) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I miserable) and PAIN (hurt all over/Pain won't subside). At the time of the report, FEELING ABNORMAL (I miserable) and PAIN (hurt all over/Pain won't subside) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jun-2021, Body temperature: 102-103 (High) Fever is between 102 and 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter
Spontaneous Urticaria After COVID-19 Booster Vaccine (moderna):  3/28/2021 - 1st moderna, headache side effect 4/25/2021 - 2nd moderna, caused a extremely migraine, had to eventually go to urgent care to get relief, got IV fluids and sumaptrix to feel okay 11/21/2021 - got my moderna booster 11/29/2021 - started feeling the intense itchiness around 3p, started on my head / neck / ears then progressed throughout my whole body 12/14/2021 update- still having this reaction and itchiness!
Information has been received from a health professional concerning a patient (2 out of 40) who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot number 651406/0620F). It was unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day. Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. The patient went to the Emergency Department and was treated with IV antibiotics to "prevent further serious criteria" and was then discharged. Subsequently the patient had a "reaction to the antibiotics". The health professional stated the patient was disabled from the events, but it was "unclear if the disability was from the vaccination or the reaction to the antibiotics". Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm. Fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm were considered other medical events (OMIC). Additional information has been requested.
Swelling, itching, hot to touch, no pain, tenderness or edema. Photo taken of left arm to indicate area of redness/swelling.
7 cm x 8 cm edema and erythema, swollen, mild warm left upper lateral arm.
1. A large red patch appeared on my left arm, near the injection site on the second day after the shot. It caused no problem but minor itching and warmth at the site, lasting about ten days. 2. During the time after the shot as we sat waiting for a potential allergic reaction, I felt a cool sensation similar to a small drop of cool water travel slowly down my arm from the injection site and into my hand, spreading out and almost feeling for every arthritic spot. The same type of feeling occurred going into my head where my head seemed to swell like a balloon and into my abdomen and gut area. Both of these feelings caused nausea and intense discomfort for a short number of seconds, then receded. The one in my head went entirely away. The one in my gut stayed and I had discomfort in my gut for about three weeks afterward. The discomfort never developed into more than that and then it went away. 3. I felt unusually tired for two to three days after the shot.  4. About two weeks after the injection, I seemed to break out in some odd type of allergic reaction. I noticed tiny pink pinprick marks at random and varied places all over my legs and arms - not in rash-like clusters, but individually one here and another one there., spread at a distance from each other but all alike. I got a few on my face and torso but the torso is harder to see so there could have been more. The pin-prick-like dots had no texture to them at first but within days they developed a tiny coating over them - not like a scab but solid and skin-like. I tried to pick one off and got a gush of blood for my trouble. They neither itched or bothered me in any way except for being out of my experience. Over about two weeks they eventually faded entirely and went away.
PATIENT WAS GIVEN A VACCINE (DTAP-IPV) THAT IS NOT ADVISED FOR CHILDREN UNDER 4 YEARS OF AGE. NO COMPLICATIONS WITH INJECTION WERE REPORTED.
Had a bad reaction; Felt something happening in her body; Indigestion; Hard to breathe; Dizziness; Freezing cold in evening; Weakness; Headache; Chills; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe) and DIZZINESS (Dizziness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe), DIZZINESS (Dizziness), FEELING COLD (Freezing cold in evening), ASTHENIA (Weakness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, VACCINATION COMPLICATION (Had a bad reaction), FEELING ABNORMAL (Felt something happening in her body), DYSPEPSIA (Indigestion), DYSPNOEA (Hard to breathe), DIZZINESS (Dizziness), ASTHENIA (Weakness), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and FEELING COLD (Freezing cold in evening) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified blood thinner and blood pressure medication.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received, Email updated.
Neck to waist, front and back bright red sunburn like color with no rash. Itch that was relieved a little bit by benadryl. Lasted 3 days.
Vaccinated pt admitted to inpatient facility with covid infection. No information available on vaccine itself.
On 8/27/21 pt had 3rd covid booster. On 9/2/21 pt began having SOB. Pt went to an urgent care on multiple occasions and tested negative for covid. Pt was experiencing sob with oxygen into the 80s and some tachycardia. On 10/5/21 he was found to have a RLE DVT and pulonary emboli. Resulting in hospitalization. Pt also severaly anemic.
12/22/21 presents to Neurology as transfer from Hospital "for escalation of care" "recent embolic stroke, severe carotid A disease". PMHx of "HTN, HLD, CAD (MI in 2004) s/p stent, CKD, PAfib, Carotid A disease"
Diagnosed with COVID-19 disease; Diagnosed with COVID-19 disease; Sore throat; This is a spontaneous report based on information received by Pfizer [Reference: MOD21-158122] from a contactable consumer (patient's parent). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on May2021 (Lot number and expiration date was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Sep2021, the patient got a sore throat and was diagnosed with COVID-19 disease with Positive PCR test post Pfizer vaccine. The outcome of the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : MOD21-158122 Moderna
sore arm; general malaise; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MALAISE (general malaise) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and MALAISE (general malaise). At the time of the report, PAIN IN EXTREMITY (sore arm) and MALAISE (general malaise) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-385149 (Patient Link).
The evening of injection pt noted a small hard red area in the area of the shot. This continued to expand for 3 days. At time of MD notification it was quite large red indurated and tender to palpation. The area was about the size, in diameter, of an orange. Erythema multiform and edema at injection site. Diphenhydramine 25 mg hs, Loratadine 10 mg every day, cephalexin 500 mg QID.
p/vax draining clear & redness in both eyes;chills, cough, congestion w/yellow;heat @ inj site;redness, swelling @ inj site;
mom noticed swollen, red arm about 9PM 19SEP98;took child to ER;had swelling back to shoulder & to elbow;red, hot looked bruised;lt arm affected;given ATB & to use warm packs;went to MD;
patient was vaccinated on 2003, then on 2011; This spontaneous report has been received from a health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS# 2207USA008600) concerning female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in 2003 (at approximately 1 year old) and on an unknown date in 2011 (at approximately 9 years old), the patient was vaccinated with first and second dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration).  This is one from 2 cases from the same patient.; Sender's Comments:  US-009507513-2207USA008600:
The day after receiving the vaccine, the patient experienced redness and soreness around the injection site (left arm). She also had an approx. 6 inch in diameter area on the opposite side of the injection site (right side of body) that was bright red and very itchy. It was in her neck, chest and shoulder area. She is also experiencing severe insomnia and headaches that are lasting for 5 days.
Neurological sx-leg giving out-speech problems, nausea, weakness, fatigue.
48 hrs post injection pt came in, observation injection site warm to touch, pt states itchy off and on, pt followed up with observation was improved pt called 3wks later, complaint of stiffness.
soft tissue; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (soft tissue) and PAIN IN EXTREMITY (sore arm) 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 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (soft tissue) and PAIN IN EXTREMITY (sore arm). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (soft tissue) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-MAY-2021 Contains no new information.
One day after receiving Covid vaccine, the patient developed new onset oral herpes.  Treated with Valtrex.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age.  Information regarding medical history, concurrent conditions and concomitant medications was not provided.  On or about 28-FEB-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-MAR-2013, the patient was treated at an Eye Center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster and herpes zoster ophthalmicus, a damaging eye condition of zoster infections of the eye. The patient was prescribed prednisone, famciclovir, and cyclosporine ophthalmic emulsion (RESTASIS EYEDROPPERETTE) for management of her painful condition. On or about 13-MAY-2013, she sought subsequent treatment at an Eye Center for ongoing and worsening symptoms, which was then diagnosed as keratoconjunctivitis sicca, a chronic condition that damages the eye and can also lead to blindness. 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, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
pt recv vax  15OCT97 8AM & 12:45 turned blue 911 called- pulse oximetry 78-88%;
Left lower back oval, violaceous mark in the exact same location as previous reaction to 1st COVID vaccine. No other systemic signs and symptoms. Began to diminish today 7/12/21.
Patient called at 9pm  saying she was having a red rash all over her face. The pharmacist,  told her to take benadryl and the patient said it resolved.
fever, chills, lethargy, joint pain, muscle pain, loss of appetite, nausea
Patient Stated she had a rapid onset of feeling dizzy and Nausious. The patient was laid supine on the floor and assisted py paramedics. Responded, Patients father signed AMA via hospital. Patient released to father.
fever; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (Reporter's daughter) that: A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on Feb2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever on 15Feb2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Pfizer vaccine was administered to the patient that had an expiration date of 5/10/22. Since this vaccine was within the 72 day time frame the vaccine did not have to be repeated.
1-11-04 shot given @ 0830. Initial "bee sting" 1-12-04 3"x2" hot,red itchy site 1-13-04 4"x3" raised hot, red, itchy site with joint aches in rt shoulder and wrist. pain rt 4th & 5th digits to rt elbow. 1-14-04 5"x2" slightly hot, red and slightly indurated site. Less itchy.