chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was reported that a traveling health nurse who was providing TB screening to employees at a daycare center, stated that after several complaints of severe burning upon administration, she discovered that she was in fact, injecting influenza (Fluzone SV '99-'00). A 22 year old female pt stated that her arm is very red and swollen. The area is approx. 2" long and feels squishy also her forearm has "patchy numbness". The pt complains of a severe headache, "like a sinus infection". The pt is hesitant to be evaluated by a physician. Follow up #1 06/19/02:  During an internal auditing of all files, it is deemed necessary to amend the report by updating the Adverse Event coding (Added  Medication Error and re-ranked events)
The vaccination area was very sore and I had a welt the diameter of an orange and about 0.5" high. It was hard, red and painful. It didn't go away for about 6 weeks. I do still have a small hard spot where the welt was. I did have a doctor's visit for a physical last month and I did mention the pain and he prescribed celecoxib. These definitely seem to be helping.
EMERGENCY DEPARTMENT IMPRESSION: Closed fracture of left hip, Metabolic acidosis, Hypoglycemia, Alcoholic ketoacidosis, hypothermia, severe sepsis is differential diagnosis.
no adverse effects reported; A patient received improperly stored PROQUAD; Information has been received from a medical assistant and refers to a 4 year old patient of unknown gender. There was no information about patient's concurrent conditions, medical history or concomitant medications.  On 04-SEP-2019, the patient was vaccinated with a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rha)(PROQUAD) lot # S002494 with expiration date of 23-JUL-2020 (dose, frequency, route of administration and anatomical location were not reported), for prophylaxis which were stored in the range of 6 Fahrenheit degrees to 14 Fahrenheit degrees (10.2 Fahrenheit degrees) for 50 minutes. The vaccine was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT). No previous temperature excursion was reported.  No adverse effects were reported.   Digital data logger was involved.
Numbness arm, mouth, tongue, neck right away. (Nobody checked me-husband was EMT so took care of me). Clammy. About to faint but didn?t. Was able to walk out. Mouth/tongue stayed numb two days. Then rash, nausea, fatigue.  Then day 2 rash on face turned into needles burning sensation and numbness on upper right quadrant on head. Still happening. Called oral surgeon and he advised not to take second dose.
Lymph node swelling at the left armpit.; Soreness at the right neck; Soreness at the left jew.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 27Apr2021 at 14:15 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 10:00 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Apr2021 at 14:15, 24hrs after the vaccination, the patient experienced lymph node swelling in the left armpit, soreness in the right neck and left jaw. On 29Apr2021, 48 hours after the vaccination, the symptoms were ongoing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lymph node swelling in the left armpit, soreness in the right neck and left jaw was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 10-OCT-2016, a dose of ZOSTAVAX was reconstituted with 0.9% sodium chloride instead of provided diluent and the patient was vaccinated with this dose of ZOSTAVAX (lot # M015925, expiration date 15-JUN-2017, dose and route not reported). No adverse effects were reported. Additional information has been requested.
pt recv vax & 8 days p/vax pt exp rt flank discomfort, nausea, exhaustion, fever, chills, cough & a lightly elevated WBC count;sx resolved w/o tx;
Right Foot started hurting the night after the vaccine. The next day, it hurt to  walk on it. Mainly around the base of my 2nd and 3rd toes. The next day it hurt so bad I couldn't walk on it and saw the doctor. A red area had developed on top of my foot at the base on my toes. Doctor though could be Gout but didn't really look like it and usually that is in the big toes. Plus the timing of this issue and my vaccine were suspect. Had X-ray on that Friday, two days after vaccine and everything looked fine they said. I was prescribed Celebrex  and over the weekend took two per day due to the pain. I stayed in bed all weekend and pain got worse before taking another dose of medicine which helped for a while.  Swelling continued to be about the same or a bit more and the redness moved over to my big toe and then up my foot around towards the right side. Today my right side of foot is really soar now as well and still can't walk on it and still swollen. Doctor at a urgent care sports medicine location prescribed me Prednisone steroid to see if that helps. But so far 5 days after vaccine and my foot is still swollen, red across the top and so painful it keeps me up at night and I can't walk on it. I'm hoping the steroids work.
Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 08-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided by reporter.
Was very tired from February going further into the year, when standing blood pressure would drop. Was admitted to ER June 13th 2021 and was kept until June 15th 2021. Went to cardiologist that ruled out myocarditis.  Heart palpitations and major fatigue still current.
pt recvd vax 11OCT93 4PM rt deltoid; 12OCT93 devel t101 & chills @ 430PM; given rx of Amoxicillin by MD on 13OCT93 awakened discovered rt deltoid area edematous & hot to touch red areas present;
The night of the immunization patient got a bad headache and pain/stiffness in back of neck. This lasted till morning and slowly ended that morning.
BEGAN ITCHING IMMEDIATELY AFTER VACCINATION THEN LIGHT HEADED AND FELT LIKE THROAT WAS SWELLING
Patient received Anthrax vaccination on 10/04/2008 in the right deltoid area and within hours developed redness and swelling at the injection site which got worse, he did not experience any temperature elevations or drainage. He was admitted to into the hospital and was given Cipro and vancomycin.  It was not determined by the physician if this was an allergic process or an actual infection.
Achy, lethargic, all day stayed in bed, felt better next day, felt bad the week end, so he went to see the physican on Monday 3/14/11. Ordered liver function test, results showed that levels were abnormal, had an MRI on Friday which was basically negative, is now doing another liver function test, feels better now.
pt recv vax & devel muscle tremors & was adm to hosp w/t105;no further details were provided;
FEVER 103.1; LOSS OF BLADDER CONTROL; SEVERE JOINT PAIN; AFFECTED MUSCLE CONTROL; HEADACHE; TREMBLES; SEVERE MUSCLE CRAMPS; SEVERE INTESTINAL CRAMPS;
pt recv vax 15JAN97 & 28MAR97 pt devel herpes zoster consisting of a vesico bullous rash down one side of rt leg;
patient received his 2nd dose of vaccine at 3 weeks instead of 4 weeks; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his 2nd dose of vaccine at 3 weeks instead of 4 weeks) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his 2nd dose of vaccine at 3 weeks instead of 4 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received his 2nd dose of vaccine at 3 weeks instead of 4 weeks) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported.  It was reported that patient received second dose of vaccine at 3 weeks instead of 4 weeks. Dose given too early.  Treatment details were not reported.
Felt tingling all over.  Swelling in face, neck and throat.  Felt like a lump in throat.  50mg of diphenhydramine injected, 40mg of pepcid and 40mg of prednisone.
This spontaneous report was received from a Medical Assistant referring to a 2 month old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 06-FEB-2018, the patient was vaccinated with an expired dose RECOMBIVAX HB (route, dose, frequency, and anatomical location were unknown) with lot # L048849 and expiration date 04-FEB-2018 for prophylaxis. No adverse effects were reported.
Severe neurological and autoimmune symptoms. Initially, swelling, burning and pain in feet and ankles. Severe, debilitating headaches, strong bounding pulse on left side of head, sensation of something dripping left side of head, unable to tolerate light, joint pain, abdominal pain, nausea, chest pain, left hip and arm/neck/shoulder pain. Increased sensation to touch & heat of fingers. Muscle twitching, spasms and jerking (especially lower extremities but also all over).
Developed rash that got so bad (07Mar) that it covered my whole body running up my face; throat was feeling tight; Shortness of breath of the chest & abdomen; Body aches; fever of 100.4; chills; runny nose; sneezing; This is a spontaneous report from a contactable consumer(patient). A 64-year-old non pregnant female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, solution for injection, lot/batch number: not provided), via an unspecified route of administration on 04Mar2021 at 15:45 into left arm as a single dose for COVID-19 immunization. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, blood cholesterol abnormal from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Patient concomitant medications were Atorvastatin, Metoprolol, Triamterene, Levothyroxine. The patient had allergies to Penicillin, Codeine. Prior to the vaccination, the patient was diagnosed with COVID-19. Patient did not receive any other vaccine within 4 weeks. On 05Mar2021, patient experienced Body aches, fever of 100.4, chills, runny nose sneezing. On 07Mar2021 at 9:00, patient experienced developed rash that got so bad that it covered my whole body running up my face and my throat was feeling tight. Shortness of breath of the chest & abdomen. Then patient seeked medical help on. The patient was visited Emergency room/department or urgent care for the events. Patient was received Steroid shot, Steroid medication, Pepsid, Benadryl for the events. On 07-Mar2021, patient had COVID test (Nasal Swab) with negative result. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Amoxcillin), Blood cholesterol increased and Paroxysmal atrial tachycardia. Concomitant products included LOVASTATIN and DILTIAZEM for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 04-May-2021, HEADACHE (headache) had resolved. At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Magnetic resonance imaging: normal (normal) normal.         Treatment mediations included Tylenol, Advil, and Aleve.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Patient demographics updated, medical history, lab data and outcome of the event updated.
Patient was given a Hep A (adult) instead of a Hep A (pediatric).   Reported incident to supervisor  Consulted with Medical Provider of any issues that might arise from this.  Called the Mom to notify of incident. Mom reported no adverse symptoms
feet burned; neuropathy; arms and legs ached/sore arm; very tired; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, 10 days after receiving Shingrix, the patient experienced neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant) and pain in extremity (Verbatim: arms and legs ached/sore arm). On an unknown date, the patient experienced burn of unspecified degree of foot (Verbatim: feet burned) and tiredness (Verbatim: very tired). The outcome of the neuropathy and burn of unspecified degree of foot were unknown and the outcome of the pain in extremity and tiredness were resolved (duration 2 days).   It was unknown if the reporter considered the neuropathy, burn of unspecified degree of foot, pain in extremity and tiredness to be related to Shingrix.     It was unknown if the company considered the neuropathy, burn of unspecified degree of foot, pain in extremity and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2023 After the administration of first dose of Shingrix patient was very tired and her arm wee sore for 2 days. After 10 days, she got bad neuropathy. No further information was known. The call was disconnected before the consent for follow up was asked.
Within minutes of finishing up giving the patient her three vaccinations, she lost consciousness. We moved her to the floor from the chair and laid her on her side. She was still breathing and had a pulse. She woke up after approximately 30 seconds. We kept her in the recovery position and I monitored her heart rate and breathing. After she felt better we moved her to a sitting position and gave her some apple juice. After about 15 minutes she felt "normal" again and we allowed her to walk with her mother in front of the pharmacy to make sure she felt ok to go home. The patient was sent home with instructions on when to pursue medical attention, to call if she had any non-emergent questions and that we would follow up the next day. I did not feel an ambulance was necessary.
Mother returned with client 8/16/10 and reported that patient is 6 weeks pregnant.  They are worried about any adverse reactions that may occur with the unborn child.
1/6/10 H1N1 given on eve 1/8/10 c/o (L) arm soreness, body aches, stayed bed for eve -> Mon eve; cough still present. A number of staff have cough @ present.
severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Dizziness after first dose; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient want to know that at what point should seek medical attention when had dizziness after first dose. The follow-up would not possible, as no contact details were available.
Very itchy, sore,  raised welt about an inch and half in diameter at injection site and  rash about 3 inches or so in diameter. Today is the second day of symptoms. Worse at night.
Loss of smell; Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste). At the time of the report, ANOSMIA (Loss of smell) and AGEUSIA (Loss of taste) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.