chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 19:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CAD" (unspecified if ongoing), notes: CISD/CAD/Lobectomy; "Lobectomy" (unspecified if ongoing), notes: CISD/CAD/Lobectomy; "allergy to antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 21Nov2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient was hospitalized for drug ineffective, covid-19 (start date: 22Nov2022, discharge date: 23Nov2022, hospitalization duration: 2 day(s)). The event "covid 19 treatment" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Nov2022) Unknown result, notes: on 21Nov and was diagnosed with COVID in the ER; (24Nov2022) Negative; (25Nov2022) Positive; (26Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment for the events were Paxlovid/Albuterol/Ativan.  Clinical course: The patient had awful chills, headache, sneezing, fever etc. on 21Nov2022 and was diagnosed with COVID in the ER. The patient was given Paxlovid. On Tuesday (22Nov2022), the patient was admitted to the hospital with chest pressure and pain. The patient was released on Wednesday (23Nov2022) with a clean heart bill of heart health. The patient tested negative for COVID on Thursday (24Nov2022). On Friday and Saturday (25Nov2022 and 26Nov2022 respectively), the patient tested positive for COVID. The patient asked why had five vaccine shots and was still in quarantine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
LEFT ANKLE APPROX 10 DAYS AFTER INJECTION: BUMPY RED RASH, ITCHING, BURNING EVENUALLYSPREAD TO COVER APPROX 4.5" IN DIAMETER . NOW NO MORE ITCHING OR PAIN BUT LIGHTER RED ANDDRY FLAKY SKIN. BASE OF LEFT THUMB AND RIGHT THUMB" APPROX 14 DAYS AFTER INJECTION.  SAME SYMPTOMS AND CURRENT STATUS. SITE OF INJECTION ON UPPER RIGHT ARM:
Redness, heat, tenderness, firmness 10 cm local reaction - 15 min following inj. quickly followed by anxiety, SOB, nausea, shaking and thickness of tongue.
Covid arm on upper right arm (red round area surrounding where shot given, also red area by shoulder blade on right side, with hard knot adjacent to the shoulder blade.  No treatment at this time.  I will call Dr. on Monday.
45 minutes after getting vaccine, starting sweating with increased BP and heart rate, very light headed and body aches all over body.  Unable to take 20 step without having difficulty breathing or feeling very dizzy.  Nausea unable to eat, blurry vision
Patient experienced face stretching/ tightening and lip swelling about 20 minutes after receiving the second Moderna vaccine. Patient was given two Benadryl 25 mg tablets in which the symptoms were resolved shortly after. After symptoms were resolved, patient had blood pressure of 146/101 mmHg and heart rate was 66. Patient was monitored for about an hour from time of vaccination.
Reported starting Friday 2/5/2021 with 10/10 pain on left arm. Difficulty lifting left arm laterally and in front over their head. Sharp pain with lateral movement of arm in left shoulder and neck. Reports taking Tylenol and Motrin Saturday only 1 time. Last Motrin 600mg taken last night at 2100. Reports pain is relieved for a few hours and returns.
pt recv vax JUL97 & JUL97 pt exp mult episodes of vomiting & fever;pt recovered from mult episodes of vomiting & fever;pt given 2nd dose of vax AUG97 & AUG97 exp same sx;
Developed tickle in the throat, was clearing his throat, felt like coming down with a cold, cough. Next night, developed fever and had more coughing. Went to see the doctor on Friday (06/03/2016). Xrays showed Pneumonia in one lung.
Vasovagal Syncope episode: as passing out for a second and the head going down; about half of the medication was injected and could not complete the dose of Menactra; given a partial dose of Menactra in error instead of the prescribed Bexsero vaccine; Initial information received on 23-Oct-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 17 years old male patient who experienced vasovagal syncope episode as passing out for a second and the head going down (syncope) and reported that given a partial dose of Menactra in error instead of the prescribed Bexsero vaccine (MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV) (underdose) and (wrong product administered), while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included two doses of Menactra in 2013 and in 2018. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLUARIX).  On 23-Oct-2019, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported and expiry date: 29-Jan-2021 via intramuscular route in the right deltoid.  On an unknown date, following the vaccination the patient experienced vasovagal syncope episode as passing out for a second and the head going down (syncope). This event was assessed as medically significant.  It was also a case of actual medication error due to vaccine underdose and wrong vaccine administered.  Relevant laboratory test results included:  Blood pressure measurement - On an unknown date: 119/58 [unknown]; on an unknown date: 70/54 [unknown]  Heart rate - On an unknown date: 58 [unknown]; on an unknown date: 51  (Other relevant tests included no lab data.)  Final diagnosis was syncope vasovagal.  As corrective treatment gave water, food (apple sauce), watched and check blood pressure and heart rate.  The outcome of the event was unknown at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC 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.  Information on the batch number was requested.; Sender's Comments: This case involves a 17 years old male patient who experienced vasovagal syncope during vaccination. More details regarding patient's medical history, previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information, the role of the vaccine cannot be assessed.
Varivax vaccine given in Left deltoid SQ. This was the pt's 2nd Varivax, immunized on 8/21/06, Pt noted redness and swelling and itching on evening of 8/22/06.
Patient reported that within one week of SHINGRIX vaccine she began having significant muscle pain. Beginning in low back and progressing to "all over" especially knees, legs and joints. She has seen her PCP and found no reason for sudden onset of muscle/joint pain has been found. Patient is attributing the pain to vaccine.
Information has been received from a physician concerning a patient who was vaccinated with his/her first 0.5 mL dose of Varivax. Subsequently the patient developed shingle-like symptoms. Unspecified medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
ALMOST DIED; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 25-SEP-2021, the patient experienced almost died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost died was not reported. This report was non-serious.  .
it was rpt fr health care facility concerning pt who was vax & subsequently the pt exp a full blown case of measles.
pt recvd vax & w/in minutes pt exp lightheadedness & soreness on arm around inject site & into shoulder; hrs later pt c/o low back & lt knee pain & exp a low grade fever; pt walked w/a limp for five days due to pain;
At 24 hrs. was a fifty cent piece size. Reaction - red, tender, swelling. At 48 hrs., reaction was 7 x 4 cms. Dx'd as cellulitis and given AUGMENTIN.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 23-MAR-2015 the patient was vaccinated with improperly stored VAQTA (strength: 25/0.5 (unit unspecified) lot # K0053253 with expiration date of 10-FEB-2016; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
3x4" red indurated warm, tender mass RUE, hurts to move arm, began within 24 hours after immunization.
0.65ML OF ZOSTAVAX VACCINE WAS ADMINISTERED INTO PATIENTS RIGHT ARM SUBQ @ 12:55PM. Patient complained of itching at administration site after 5 minutes. Area was red with small scratched. Patient denied any other symptoms. After another 5 minutes patient complained of tightness in chest and some difficulty breathing with sweating. Epi Pen 0.3mg administered into patients Right thigh lateral aspect. Patient them escorted to Emergency Room via wheelchair.
Vomiting; Dizziness; headache; Vomiting; This spontaneous report has been received from a consumer regarding to a 11-year-old female patient. The patient's concurrent conditions, medical history, concomitant medication, drug reaction or allergies were not provided.   On 31-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular (dose and anatomical location of vaccine were not provided) lot # R030456, expiration date reported as 23-JUL-2021, for prophylaxis.    On 01-AUG-2020, the patient experienced vomiting, headache and dizziness. On the same date, the patient went to the pediatrician. On an unspecified date in august 2020, the vomiting stopped but, she still had headache and dizziness. On 12-AUG-2020, the patient started vomiting multiple times every day since then. On 15-AUG-2020, the patient went for second time to the pediatrician. On 16-AUG-2020, she went to urgent care and on 17-AUG-2020, she went to emergency room (ER), there she was placed on intravenous fluids for dehydration and discharged home. On 17-AUG-2020, the patient had a blood work and results were negative; also, the patient was tested for COVID-19 but the results were unknown at the time of the report. On 19-AUG-2020, the patient was admitted into the hospital since the vomiting, dizziness and headache continued. At the reporting time, the patient had not recovered from vomiting, dizziness and headache.  The causality assessment between vomiting (onset: 01-AUG-2020), vomiting (onset: 12-AUG-2020), headache, dizziness and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R030456; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No
Pt was seen for his shoulder injury and was determined he was behind in immunizations. Dr. ordered immunization. Pt was given all 3 immunizations. After completion of the third immunization, Pt passed.  Pt feel back on the exam table. Pt was placed flat and recovered quickly. Patient was seen by provider for evaluation. Pt sent home without further incident.
Left arm sore for a couple days after the shot.  Then woke up on day 9 after receiving and had hot, red, swollen, itchy rash.  Rash is getting bigger as the days go on.
Pain at injection site radiating to arms, shoulder and neck.  Aches, chills, hot/cold sweats
About four to six weeks after receiving the third dose (first booster) of Moderna, I started to experience unexplained joint pain. At first I thought I was just experiencing normal aches and pains, but they have continued throughout the past year. I am still seeing a rheumatologist because the pains are still unexplained. I have had multiple counts of blood work and X-Rays, but no one can seem to find the cause to the pains.
Local swelling and redness, hot to the touch, painful to touch according to mother's statements. After leaving clinic, later in the afternoon, patient had some swelling and pain when touched to injection site.
Anaphylactic Reaction, was resolved, took patient to ER; next day follow up reports headache/body aches but otherwise well
11 hours after the shot i spiked a fever of 102.8, very tired.   Then had extreme pain in my joints that evening.  Then the following morning i was short of breath and had burning pain between the breast that went through to the back that only lasted about 2 minutes and went away.  at 1:30 pm i was on my way home while driving and my mouth started to water like i was going to be sick, i became very light headed and felt like i was going to pass out;  Pulled over and began having burning in my chest again.  I drove my self to the hospital which was only ashort distance away.  I had tingling in both my legs and arms
Fussiness, vomiting, lethargy started in the evening of 6/21/19. Presented to hospital on 6/22/19 and admitted with a diagnosis of intussusception. Treated with an air-contrast enema. Discharged on 6/23/19.  Presented to pediatrician office on 6/25/19 with recurrence of symptoms.
7 days, post vax, MMR and Prevnar, pt had a 30 second seizure. 11 days, post vax, of MMR and Prevnar, pt had a 1 1/2 minute seizure. Pt was started on Tegretol. Also diagnosed with dehyration.
Slept through night woke to void felt fine then become diaphoretic, weak and states passed out awoke lethargic and mildly confused for about 5-10min. Mother then took to ER for further eval at 9:00am.
9 doses were administered post excursion; 9 doses were administered post excursion; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event) in a 70-year-old 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. AS7170B) 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 (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion) 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 (9 doses were administered post excursion) and POOR QUALITY PRODUCT ADMINISTERED (9 doses were administered post excursion).    Concomitant medication was not reported.  Storage condition at the time of the excursion was frozen. Temperature noted in that condition was -2 to -18 C. Excursion duration was for 2hrs. Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Events added.
Information has been received from an administering licensed practical nurse concerning a 61 year old retired female with a cardiac pacemaker who on the morning of 18-DEC-2007 was vaccinated SC with the first dose of Zostavax (Oka/Merck) (lot# 658867/1413U) in the left thigh.  Concomitant drug therapy included simvastatin (MSD), SYNTHROID, blood pressure pill (unspecified), vitamins (unspecified), and fish oil.  On 02-JAN-2008 at 19:00 the patient developed little tiny bumps that were reddened and looked like heat.  The patient did not seek medical attention.  No lab diagnostic studies were performed.  The patient was not recovered at the time of this report.  Follow-up information from the reporting licensed practical nurse indicated that there was no illness at the time of vaccination.  The patient's rash was "gone and never hurt and went away about a couple of days ago."  The patient noted that there were "still some signs of rash, faint spots, scar-looking things."  The patient was noted to be recovered on 10-JAN-2008.  Additional information has been requested.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Headache-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: After about 10-15 minutes of vaccination patient stated she was dizzy.  She was given some water to drink.  Then she said her dizziness was getting worse and was having a really bad headache.  I asked if I can call an ambulance for her to take her to ER she refused worrying about the cost.  Her mother was contacted and was notified of the situation.  Once patient started getting worse and started having visual changes with flashing lights, 911 was called immeidately and paramedics took over.
Information has been received from a medical assistant (also reported as healthcare worker) concerning a 20 year old male patient with no drug reactions or allergies who on 01-SEP-2011 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot # 670050/1229AA, expiration: November 2013). There was no concomitant medication. On 01-SEP-2011, post vaccination within one minute, the patient fell to the floor. The paramedics were called and the patient was administered oxygen. The patient was not hospitalized and went home "completely fine" a short while after the incident. The medical assistant also mentioned that the patient fainted with all (unspecified) injections and blood draws. There were no lab diagnostics studies performed. The follow-up information has been received from the medical assistant concerning the patient who on 01-SEP-2011 was vaccinated with the first dose of GARDASIL (lot # 670050/1229AA) on his left arm. The reporter stated that on 01-SEP-2011 after receiving GARDASIL the patient passed out and was given oxygen. 911 was called. The patient regained consciousness and recovered immediately on 01-SEP-2011. Emergency Medical Service (EMS) assisted. The follow-up information has been received from the medical assistant concerning the patient who on 01-SEP-2011 was vaccinated with the first dose of GARDASIL (lot # 670050/1229AA) on his left arm and the first dose of VAQTA (lot #671585/1005AA) on his right arm. The patient was given the GARDASIL and after receiving it the patient passed out. He was given oxygen. The patient fell to the floor was considered to be an other important medical event by the reporter. Additional information has been requested.
The patient is immunosuppressed and received the second booster but instead of receiving 0.25 ml the patient received 0.5 ml
This spontaneous report was received from a medical assistant and refers to an unspecified patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unspecified date, the patient received an improperly stored dose of ROTATEQ orally (lot # M025568 with expiration date at 07-NOV-2017; dose was not reported) for prophylaxis. The administered dose of vaccine was exposed to a temperature of 32 Fahrenheit (F) degrees for 20 hours. There was no previous temperature excursion reported. Data logger was used to track the temperature. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA013777: US-009507513-1612USA010622.
Approximately 4 days after receiving dose #2, patient developed full body rash. He took an OTC allergy medication which cleared up the rash. The rash returned about 24 hours later, then patient took more of the OTC allergy medication and the rash went away again. The most recent dose of the OTC medication was yesterday around 6 pm, so it is unknown if the rash will re-appear later today.
When she came home from work on 11/21/2003 at 18:15, she noticed her left arm was warm, some redness, swelling, tender and had a fever.  Treatment-ibuprofen, augmentin and medrol dose pak. Still ill at time of evaluation.
pt exp lethargic & just wanted to sleep but would awaken w/high pitch scream; pt looked extremely pale & cyanotic; parents told poss pertussis reaction;
The patient experienced severe dizziness and nausea shortly after receiving the vaccine. He was treated with a cold compress. He recovered without incident after about 45 minutes in the pharmacy waiting area.
Fever chill's, sweating, headache, tired, pain in middle of stomach and throwing up bile that was somewhat hot and horrible tasting
Information has been received from a physician concerning a male patient of unknown age. On 25-JUN-2012, 06-DEC-2012 and 04-FEB-2013, the patient was vaccinated with the first, second and third dose of GARDASIL (dose and route was not reported) (Lot # and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Patient given a beyond-use-date Pfizer vaccine. Punctured vial stored at room temperature of 65ºF. Vaccine administered 17 hours past beyond-use-date/time. Patient is doing fine. Will follow-up with patient. Per Pfizer manufacturer safety team, punctured vials good until 24 hours past beyond-use-date stored between 34-86ºF.