chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 23 hours post Johnson and Johnson vaccination, I began to have a 10/10 headache (which was the worst headache of my life), nausea and severe aura. I then became extremely confused and was taken to the emergency department by my husband. The following was reported to me the next day when I awoke in the ICU at Hospital: within an hour of arriving at the ED, I exhibited a progressive hyperactive delirium, agitation, slurred speech (word salad), combativeness, confabulation, word finding difficulties and an inability to follow commands. The neurologist in the ED said that she was seeing this adverse vaccination side effect in other patients at the 24-hour period. I received Haldol, Zyprexa, and Ativan to control the delirium and received a head CT angiogram in the ED, which was normal. I was transferred by ambulance to the main hospital due to acute metabolic encephalopathy/altered mental status. I was admitted to the neurological unit whereby I became critically hypotensive (60s over 30s) and was transferred to the ICU due to persistent hypotension unresponsive to IV normal saline. I was then transferred and admitted to the ICU and was given continued IV fluid resuscitation and Levophed vasopressor. I was eventually weaned from vasopressors and was discharged back home in three days exhausted, bruised, fatigued and with continuous clouded mentation. I have been told by all of the doctors that this was a vaccination side-effect, which caused cerebritis. I was subsequently treated as an outpatient at Hospital for intractable aura with IV Valporic Acid, Magnesium, and Lasix infusion on April 1, 2021.
severe arm soreness; had a difficult time showering for a few days without assistance.; This is a spontaneous report from contactable Pharmacist via Pfizer Sales Representative.   A male patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation .  The patient medical history  and concomitant medications were not reported.  The patient experienced severe arm soreness  on an unspecified date with outcome of unknown , had a difficult time showering for a few days without assistance on an unspecified date with outcome of unknown.    The information on the batch number has been requested.
Three hours after ROTATEQ the patient started with diarrhea and it continued for 3 weeks with 4 to 6 watery stools per day.
Day 3 -experienced depth perception issues Day 4- double vision Day 4 - possible stroke, double vision, admitted into hospital and treated stroke protocol Day 6 - released from hospital w double vision and depth perception issues added blood thinners and 3 meds to help prevent future strokes. Met w optimalmologist starting vision therapy. Still waiting to meet w neutrogist
Mother stated pt was fine after injections. Went home and pt fell asleep and woke up crying in pain and mother noticed a small red bump to injection site. Bump continued to grow. When they came to clinic the color and pigmentation were abnormal to left thigh with erythema plaque, circular, 6x6cm, and was slightly warm to touch. Mother to use cool compresses and give patient Tylenol or Ibuprofen prn for pain. Patient will return to clinic on Monday.
SWELLING AND REDNESS CONTINUE TO INCREASE IN SIZE PER PATIENT. PATIENT STATES AREA IS ITCHY. REDNESS AND SWELLING NOTED AT SITE OF INJECTION, NO FEVERS. SKIN WARM AND DRY AS TO ADJUNCT SKIN.
pt received vaccine and was waiting the 15 minutes i noticed he was slumping in the chair, i caught him prior to hitting the ground. took his bp and was 80/45. raised his legs and he was feeling better, provided a cool compress a few minutes later bp was 128/88. I slowly sat him up and 20 minutes later was fine to leave
vesicles devel an 30APR98;chest & abd;no sore throat or fever;approx 40 spots itching;vesicles & individuals pox on legs, face & arms 4MAY98;some scabbing;no new one past 24hr;
Case number PHEH2013US024394, is an initial spontaneous report received from a medical assistant on19 Nov 2013 and a combined follow up report from the medical assistant received on 10 Dec 2013 and 16 Dec 2013. This report refers to a 20 months old male patient. His medical history included frequent infections and allergy (unspecified). He erroneously received only MENVEO, (batch number: M13014/X13014), without being reconstituted with Men A lyophilized conjugate vaccine component on 19 Nov 2013, intramuscularly in the left arm. No adverse event was reported following this administration error. Combined follow up report from the medical assistant received on 10 Dec 2013 and 16 Dec 2013: Medical history and site of vaccination were updated.
Hives for 3 days; arm also sore for 3 days. Had shortness of breath and sinus problems (bloody).
102.8 degree fever, sweating, chills, vertigo, severe arm/muscle pain, migraine
After injection patient felt dizzy and fainted. Vasovagal episode. Patient has a history of vasovagal. Patient awaken after ammonia. Vital signs taken by EMS. Patient is hypotensive. Patient was placed on stretcher in trendelenburg . Patient recovered
Patient received a Moderna booster shot on 7/15/22. After injection was given, administering nurse noted on her card that she had already had her 2nd booster shot on 5/4/22. Therefore, this was the third booster shot she had received. No adverse reaction to extra booster dose was noted and doctor was made aware.
Acute MI, new heart attack a week after 2nd dose of pfizer vaccination, stented 1 vessel, which failed and clotted 4 days after, needing a balloon and another stent.
STRONG/SEVERE ALLERGIC REACTION INCLUDING RASHES/ITCHING/DERMATOGRAPHIA COVERING VARIOUS BODY PARTS. ITHCING INDUCED EYE SWELLING.  SEVERITY CREATED INABILITY TO MAINTAIN NORMAL FUNCTIONALILITY.  AS OF TODAY, 01/04/22, ALLERGIC REACTION/SYMPTONS ARE ONGOING WITH ZERTEC TAKEN DAILY TO REDUCE SEVERITY.
The patient was given the vaccine from a vial that should have been disposed of. The vial expired the night at midnight 6/29  and the patient received the vaccine 6/29 at 11:02 am. I spoke with the patient on 6/30/22 at 2;30pm and she denied any adverse affects. she stated she was doing fine.
Pt has cross-inoculation around the injection site on left deltoid. Pt was seen at off base physicians office for nausea and severe lymph nodes swelling.
Fainted twice (once a few min after and the second about 12 hours later); dizziness for a few weeks; headaches; had been drinking a lot of water; patient received both the first dose and the second dose of BNT162B2 on 29Apr2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 29Apr2021 (batch/lot number was not reported) at 44 years old as 1ST DOSE, SINGLE and via an unspecified route of administration, administered in the left arm on 29Apr2021 (batch/lot number was not reported) at 44 years old as 2ND DOSE, SINGLE for COVID-19 immunization. The patient received the vaccination in Other Facility. The patient had no medical history. The patient was not pregnant. Concomitant medication received within 2 weeks of vaccination included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient received both the first dose and the second dose of BNT162B2 on 29Apr2021 (pending confirmation). On 29Apr2021, the patient fainted twice (once a few min after and the second about 12 hours later). The patient also experienced dizziness for a few weeks and headaches since 29Apr2021. After the second injection on 29Apr2021, patient had been drinking a lot of water but eight (8) days after the injection, patient still experienced significant dizziness. No treatment was received in response to the events faint, dizziness, headache, and increased thirst. The outcome of the events faint, dizziness, headache, and increased thirst at the time of last observation was not recovered/not resolved.   Information about the batch/lot numbers has been requested.
Body aches on day 2 after vaccine administered. Rash appeared on day 8 after vaccine was administered. Rash lasted 3 days.
Fever over 100 F, chills, muscle aches, sore throat, runny nose, headache. Started around 1 am following injection and lasted 2 days. Pain at injection site immediately after vaccine followed by swelling and soreness at injection site the next day as well as pain. Swelling lasted 1 week. Rash at injection site appeared 5 days after injection. Rash was 6 inches long and 3 inches wide and itchy. Lasted 1 week.
Information has been received from a pharmacist, via a company representative, concerning an about 80 years old male patient. The patient's pertinent medical history and concurrent conditions were not informed. In 2012, reported as "four years ago", the patient was vaccinated with the first dose of ZOSTAVAX (lot # and expiration date were not provided) administered per subcutaneous route. Concomitant therapies were not informed. The pharmacist reported that on an unknown date, the patient was inadvertently administered a second dose of ZOSTAVAX. No adverse experience was reported. Additional information has been requested.
2 huge red welted marks; Arm swollen; Left eye looks puffy; didn't get my 2nd dose.; Arm was sore; Face is puffy; Arm felt itchy; Arm still has a knot in it; Arms felt hot; Felt a little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), PERIORBITAL SWELLING (Left eye looks puffy), SWELLING FACE (Face is puffy), URTICARIA (2 huge red welted marks) and PERIPHERAL SWELLING (Arm swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore), SWELLING FACE (Face is puffy), PRURITUS (Arm felt itchy), INDURATION (Arm still has a knot in it), FEELING HOT (Arms felt hot) and FATIGUE (Felt a little tired). On an unknown date, the patient experienced PERIORBITAL SWELLING (Left eye looks puffy), URTICARIA (2 huge red welted marks), PERIPHERAL SWELLING (Arm swollen) and PRODUCT DOSE OMISSION ISSUE (didn't get my 2nd dose.). The patient was treated with LORATADINE (CLARITINE) at a dose of 1 dosage form and PREDNISONE at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Arm was sore), PERIORBITAL SWELLING (Left eye looks puffy), SWELLING FACE (Face is puffy), URTICARIA (2 huge red welted marks), PERIPHERAL SWELLING (Arm swollen), PRURITUS (Arm felt itchy), INDURATION (Arm still has a knot in it), FEELING HOT (Arms felt hot) and FATIGUE (Felt a little tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't get my 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information includes hot and cold compresses.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21-Jul-2021 and included New event missed dose was added and reporter details were updated. On 04-Aug-2021: Follow up received included no new information
After taking normal  medications prior to bed became acutely short of breath, mother states patients face turned blue then respiratory arrested followed by cardiac arrest. CPR was performed for approximately 10 minutes before pulse returned.
light rash on upper chest within an hour of inoculation-went away next day .  THIRTEEN  days later rash on left arm 3 inches by  1 inch.
A physician reported that an infant rec'd Prevnar, DTaP (manufacturer unknown), IPV , and Comvax vaccines. Approximately 2 to 3 hrs post vaccination, the infant developed a fever of 106F, which persisted for 18 hrs and then a fever of 102F which also persisted for 18 hrs. No further information was available at the date of this report. Additional information rec'd on 10/19/01 indicated that the pt was a 4 month old female who rec'd her second dose of Prevnar along with DTaP (manufacturer unknown), IPV and Comvax vaccines on 10/15/01. That same day, the infant developed a fever of 102F. Follow-up info received on 12/17/2001 indicated that the infant was a 2 month old female who received these vaccines on 08/21/2001. That same day, she developed a fever.
The injection site was swollen to the size of 1/2 dollar. Took BENADRYL and used cold compress. Was gone by Sat 12/17/11.
10/31 Chills. (R) arm - hot red rash, below injection site. 11/1/12 Fever. Antibiotics (prior) Nov. 1 last day. No fever 24 hours prior to vaccines.
tingling/pins and needles in both hands and fingers and scalp; cold sweat; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration on an unknown date in Apr2021 at 16:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, hashimoto's disease, pre-diabetic, and drug allergy (Liver inflammation with certain meds). Concomitant medications included fluoxetine hydrochloride (PROZAC) 10 mg. 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 an unknown date in Apr2021 at 16:30 the patient experienced tingling/pins and needles in both hands and fingers and scalp, cold sweat. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tingling/pins and needles in both hands and fingers and scalp, cold sweat was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been reported in a published literature article, tile as stated above, concerning an 11 month old patient (gender not reported). The patient was diagnosed at the age of eleven months with factor IX deficiency after prolonged bleeding following placement of tympanostomy tubes. Prior to evaluation for immunodeficiency, the patient had a history of persistent otitis requiring 5 sets of tympanostomy tubes and recurrent episodes of sinusitis. Additionally, the patient had also been hospitalized for three weeks for a pneumonia with a course significant for streptococcal bacteremia. Following administration of three rounds of pneumococcal 23v polysaccharide vaccine - conjugated and unconjugated, the patient failed to maintain protective antibody titers against pneumococcal serotypes and was about to start antibody replacement therapy. The authors reported that "to the best of their knowledge, this represents the first reported case of specific antibody of specific antibody deficiency in a patient with Factor IX deficiency." Additional information is not expected. A copy of the published literature article is attached as further documentation of the patient's experience.
Left arm felt swollen, warm to touch, developed body aches - flu like symptoms per patient.
Client denies any adverse effects from the vaccine.   A/O X3 TO name,place and time. Denies any shortness of breathe and no labored breathing noted. No redness,swelling or tenderteness noted at the injection site. Full ROM on all upper and lower extremities noted.
On Oct. 9 (the next day after receiving vaccine) I experienced loss of taste. I still have no sense of taste.
Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 23rd of 43 adult patients described by the reporter.
mom reports pt felt a little warm on 26APR96 (temp not taken);27APR96 pt felt warmer (temp not taken);pt had sz-not sure of time;called amb;pt taken to ER:MD stated pt had pink ear;vomited x 2 & had a loose stool;
22AUG97 10AM crying, inconsolable, fever (not measured);taken to PMD 101 w/APAP;no illness;fever cont;fever 104 was periodically fussy;27AUg is still very irritable; referred to PMD;
Rash all over back and front body. Also in arms.  Is given Prednisone 20 mg tab for 9 days.
Subsequent to receiving one dose of varicella vaccine live the pt experienced chickenpox with greater than 20 lesions. The pt was treated with Benadryl and Aveeno.
Facial and eyelid swelling with redness, burning, and skin peeled. Took Benadryl 50mg po bid for 1 day.
The patients father gave us the wrong birthday and mislead the pharmacy into thinking the patient was 12 years old.
not additional AE; improperly stored PEDVAX HIB 0.5ml IM was administered on 5/9/2022; This spontaneous report was received from licensed practical nurse, referring to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions.   On 09-MAY-2022, the patient was vaccinated licensed practical nurse haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 mL, administered intramuscularly, lot #U02621, expiration date: 02-NOV-2023,given as prophylaxis.The improperly stored dose underwent a temperature excursion at a temperature of at 42.5 degree Celsius (C) for 13 hours and 42 minutes (Product storage error). There were no previous temperature excursions. No additional adverse event was reported.
no adverse event; Report of concomitant administration of PROQUAD and MMRII; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 18-JAN-2023, the patient was inadvertently administered concomitantly with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) lot #W028564, expiration date: 06-MAR-2024 (formulation, exact dose, administration site and route of administration were not provided); and a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot #W009107, expiration date: 04-DEC-2023 (formulation, exact dose, administration site and route of administration were not provided) both administered for prophylaxis (accidental overdose). No additional adverse events (AE) were reported (no adverse event).
pt recv vax JUL69 & devel toxic epidermal necrolysis synd;this exp was considered life threatening;
2 weeks ago I received my 1st my vaccine and since that day my left arm which was the arm that I was vaccinated has not been the same. I have lost some mobility In my left arm because of the pain that I have. I cannot reach my arm across my body without having a lot of pain and I cannot lift my arm over my head without having a lot of pain. I am getting pins and needles in my fingers in the same arm as the vaccine.  I went to my family doctor they have no idea what's happening no one knows.
Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA182241, 2018SA182253, 2018SA182254, 2018SA182255 and 2018SA182256 (same reporter). This case involves patient (age and gender not reported), who received a 0.5 mL dose of vaccine, which on 01-Jun-2018 reached to 52.8-degree F for 43 minutes and on 04-Jun-2018 product reached 48.2-degree F for more than 30 minutes, before patient received 0.5 ml dose of vaccine IPOL lot N1K921M, expiry date: 14-Nov-2019, via intramuscular route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage (product storage error). It was not reported if the patient had any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: hurts). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles booster it hurts.  Follow up was not possible, as no contact details were available.