chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This was booster - I don't  have information left blank above.  During the night of 10/25, I had chills and felt like I had fever.  The next morning I had chills, nausea, headache, fever of 100.6 - Took 2 CVS Acetaminophen and lots of water - temp normal in afternoon.  10/27 Felt ok and had massage at 1:00 pm followed by Esthetician visit for lash and brow tint at 3:30 - felt dizzy, head felt different, light-headed, Took 2 CVS Acetaminophen at 7:45 pm.  10/28 unstable, head felt strange, took 2 CVS Acetaminophen, felt unsteady at 6:45 am, 10:15 am head felt full, dizzy and had chills in the AM. - 10/29 - felt ok until about 3:15 pm - felt like I had fever - only 98.7 but I felt lousy, that evening I felt warm but better
Pain at injection site during the day and in arm later that night and following day.; Pain at injection site during the day and in arm later that night and following day.; This is a spontaneous report from a contactable consumer. A 58-year-old adult female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Unknown), via unspecified route of administration in the right arm, on 05Mar2021 at 12:00 PM, as 1st dose, single for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications included Multivitamins, ergocalciferol (VITAMIN D) and Amlodipine. The patient was allergic to sulfa drugs. On 05Mar2021, the patient experienced pain at injection site during the day and in arm later that night and following day. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and not diagnosed with COVID-19. The patient was not tested for COVID-19 post vaccination. The patient did not received treatment for the events. The outcome of the event vaccination site pain was recovering and the outcome of the event pain in extremity was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from the Merck Pregnancy Registry for GARDASIL via a medical assistant concerning a 26 year old white female with "kidney problems" who on 08-JAN-2008 was vaccinated IM with a first 0.5ml dose of GARDASIL vaccine (Lot # 659437/1266U) and was " 4 weeks pregnant at the time of the vaccine."  Last menstrual period was approximately 10-DEC-2007.  Estimated date of delivery is 15-SEP-2008.  There were no concomitant medications.  No adverse event occurred.  Laboratory studies performed were "blood work" and an "OB profile" (results not reported).  The patient sought unspecified medical attention.  At the time of the report the outcome was unknown.  Follow-up information was received indicating that on 30-AUG-2008, the patient delivered a normal baby.  During pregnancy, the patient had hydronephrosis and obstructed right ureter.  She also received terbutaline sulfate 2.5 mg every 4 hours on 04-AUG-2008 for contractions.  The patient took prenatal vitamins during pregnancy.  No diagnostic tests during pregnancy.  There were no complications during labor/delivery.  Additional information has been requested.
Fluzone high dose was administered to a 60 year old patient with no adverse event; Fluzone high dose was administered to a 60 year old patient with no adverse event; Initial information regarding an unsolicited valid non serious case was received from pharmacist and consumer or non-health professional via Agency Information  (Reference number: 00812522) and transmitted to Sanofi on 14-Oct-2021.  This case involved a 60-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On 13-Oct-2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Influenza Quadrival A-B High Dose Hv, frequency: once, dose: 0.7mL, Strength: standard, lot UJ733AC, expiry date: 30-Jun-2022]  via an intramuscular route in the left arm for prophylactic vaccination.  This was actual medication error case due to Inappropriate age at vaccine administration and vaccine overdose.  It was reporter "Pharmacist reports fluzone high dose (HD) was administered to a 60-year-old. Patient states it was not worried about repeating because of immunogenicity, however, asks for safety information."  no other vaccines.  At the time of this report the patient was fine and had no adverse events after the vaccination.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or is to be held liable for the occurrence of this medication error. .
Herpes eruption on lip and on roof of mouth. Appeared on Friday, August 31 and Sunday, Sept 2nd.
3-4 minutes after receiving DTaP, IPV, Prevnar and Comvax became lethargic and pale recovered completely in 15 minutes. Assessed by nurse practitioner. felt to be hypotonic , hyporesponsive episode.
Vaccine at 6pm, itching rash on lower trunk and left armpit by 9pm, took Benadryl.  Increasing severity, coverage of body and so I went to Urgent Care Sunday, May 2nd about 3:15 received by iv liquid Benadryl, Pepcid and Prednisone.  Instant relief and rash began to fade, symptoms return with same severity Monday, May 3rd 2:15am, took 3 (20mg) Prednisone pills and 1 (25mg) Hydroxyzine pill as prescribed. Finally started working 6am, took another Hydroxyzine noon.  Rash partly itchy and partly "erythema marginatum", went to Urgent Care 3pm, 4pm giving shot in hip of Kenalog, 8:30 now covered extensively with not itchy all blotchy spots.  Went to ER 9pm - Tues 5/4 4:45am.  Extensive blood test to rule out any infectious bacterial causes.  Elevated white blood cell count appears related to multiple doses of steroids and the cause of the completely "erythema marginatum" non itchy blotches.  Sent home to continue prednisone rx, stop Hydroxyine, resume Benadryl (25mg) 1 every 4 hrs until symptoms resolve.
Pain at injection site 12:44pm  4:25 pm high temperature of 102 took  tylenol. Swelling and pain under left armpit. Felt a lump in my left breast. Feels like someone punched me real hard in my armpit. Took Ibuprofen for swelling. Swelling and pain lasted 3-4 days then subsided and now there is no longer any pain. Don't feel the lump any longer in my left breast.
My lips became extremely dry and red, and the corners of my mouth became cracked and sore. Currently my lips are still affected, and I gave to use lip moisturizer several times daily or they will get worse.
Rash head to toe on body.  Benadryl was given by grandmother and appt to was made at the clinic.
7MAY97 pt recv vax about 10AM;8MAY prolonged constant crying-mom states started shaking all over;very hot to the touch-bright red all over t103 R was giving pt APAP;t105 R later in ER given APAP, cool bath adm hosp
Covid arm, slight swelling, minor temperature at site, minor itching and pain and rash delayed response at injection site. Injection received 1/21/21, did not notice any effect until 2/1/21
Firm, erythemic nodule, approx size of silver dollar. 8/22/11 mother states symptoms have decreased has bad reactions due to allergies from insect bites, stings etc.
Site: Pain at Injection Site-Mild, Systemic: Fever-Medium, Systemic: loss of taste and smell, runny nose and congestion for 1 week-Medium, Additional Details: Pt. had a COVID test one week after symptoms and it was negative
blood pressure went up to 200/ 190; rash on arm; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 07Dec2021, this case now contains all required information to be considered valid.   This is a spontaneous report received from a contactable reporter (consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient. An 83 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left (Batch/Lot number: unknown) at the age of 83 years (as reported) as dose 2, single for COVID-19 immunization. Relevant medical history included: "high blood pressure" (unspecified if ongoing). Concomitant medications included: ATENOLOL taken for hypertension (ongoing); FUROSEMIDE (ongoing); AMLODIPINE (ongoing); LOSARTAN (ongoing); CLONIDINE (ongoing); HYDRALAZINE (ongoing). Vaccination history included: Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (left arm, intramuscular), for COVID-19 immunization, reaction: "mild flu like symptoms" for 1 week after vaccination. The following information was reported: HYPERTENSIVE CRISIS (hospitalization) with onset 30May2021, outcome "recovered" (31May2021), described as "blood pressure went up to 200/ 190"; RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "rash on arm". The patient was hospitalized for hypertensive crisis (start date: 30May2021, discharge date: 31May2021, hospitalization duration: 1 day. The event "blood pressure went up to 200/ 190" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (30May2021) went up to 200/ 190; computerised tomogram: (2021) was all normal. Specific relevant test for thromboembolic events with thrombocytopenia: None. Additional information included: Blood pressure went up to 200/ 190. The doctors could not find any reason for the sudden spike. Patient had a CT scan- all normal.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Developed a rash on back, side, and stomach.  Went to urgent care who identified it as shingles.  Doctor prescribed acyclovir, gabapentin, and lidocaine.
Patient received Pfizer COVD vaccine on 3/25/21 and 4/15/21. On 6/25/22, patient admitted to our inpatient facility with acute respiratory failure and hypoxia secondary to COVID pneumonia. She was admitted in the med/surg  unit and discharged home on 6/27/22.
doses were given beyond the 12-hour mark; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark). On 04-Jan-2022 at 11:00 AM, EXPIRED PRODUCT ADMINISTERED (doses were given beyond the 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. 2 doses from 1 vial were administered 12 hours post-puncture. On 08-Dec-2021 the vial was initially stored in the refrigerator. vial was first punctured on 03-Jan-2022 at 2:45 PM. The vaccine was administrated on 04-Jan-2022 at 11AM.. vial was exposed to room temperature range 8° to 25°C= 46° to 77°F. No treatment medication were provided.   This case was linked to MOD-2022-444869 (Patient Link).
This spontaneous report was received from a consumer refers to her son a 5 year old male patient with allergy to BACTRIM, oats, carrots, peanut oil and bananas. There was no pertinent medical history. On 11-AUG-2014 the patient was vaccinated with the second dose of PROQUAD (Merck) injection, in the left thigh, (lot number, expiration date, route and dosage were not reported). There was not concomitant therapy. The consumer informed that in approximately August 2014 (also reported as within 24 hours) the patient had developed a rash, the size of a half dollar, around the injection site of left thigh. In addition her son had congestion, started coughing and had some difficulty breathing, like he did when he had an allergic reaction. The consumer stated that the nurse at her son's school first noticed his rash and symptoms, also stated that the nurse called to the health department to report the adverse event, since that was where the patient got the PROQUAD (Merck) vaccination. The child was given oral BENADRYL, and was breathing more freely, but some congestion remained. Caller stated that her son's rash was gone, but a bruise remained. The consumer stated that she had not yet called her son's health care provider. Also informed that the patient did not have any adverse effects after the first PROQUAD (Merck). There were not laboratories diagnostics studies performed. The patient sought medical attention by school nurse visit. The outcome of the rash and difficulty breathing was recovered. The outcome of congestion and the bruise was not recovered. The outcome of the cough was unknown. Additional information is not expected because the report refused additional contacted with the physician.
patient received improperly stored vaccine; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information about concomitant medications, pertinent medical history, drug reactions or allergies was not provided.      On an unknown date the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (one dose, lot # S007075, expiration date 06-SEP-2020, route of administration, and strength were not provided) for prophylaxis. The storage temperature was reported as 32.5 degrees Fahrenheit (F) for 8 hours. There was no previous temperature excursion. Digital data logger was involved.
had a stroke afterwards.; This is a spontaneous report from a Pfizer-sponsored program with Regulatory Authority Support, received from a non-contactable consumer (patient's friend). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose (dose number unknown) for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a stroke afterwards. Outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
On 2/1/00, the pt developed a red/hot area 3x3cm on the right arm. The pt sought unspecified medical attention and was treated with Cephalexin and hydroxine. The area greatly improved within 4-6 days and then completely cleared. No further information is available.
This spontaneous report was received from a 72 years old female patient. The patient did not have any concomitant medication, pertinent medical history, drug reactions or allergies. On 13-NOV-2017, the patient was vaccinated with a PNEUMOVAX 23 injection, route of administration was reported as "for Intramuscular or Subcutaneous injection" (dose, lot # and expiry date were not provided) for prevention of pneumococcal disease. On an unknown date in November 2017, the patient experienced pain in left arm from the injection and she had pain generating from her left hip, down to her left leg and she had trouble with walking. No treatment was given for adverse events and no lab diagnostic was performed. The outcome of the all events was reported as not recovered/not resolved. The causality assessment was not provided.
Initial information received on 17-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient with unknown demographics who received a dose of TYPHIM VI injection suspension (Batch number: N1K811M, expiration date: 19-Oct-2019, route and site of administration was not reported) on an unknown date. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to vaccine underdose. It was also a case of exposure via skin contact and needle issue. The needle leaked between the hub and the attachment site of the pre-filled syringe. She said that she had tightened it on the syringe appropriately. That part of the pre-filled syringe dose leaked out and down the patients arm and they did not get a full dose. It was unknown whether patient experienced any adverse event following vaccination. Agency number reported as 100003385. 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 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. List of documents held by sender: none.
Caller states patient started GARDASIL 9 series on 12/12/2022.  Patient received 2nd dose on 1/16/2023 and third dose on 2/15/2023.   GARDASIL 9 lot W000244  Expiration date 8/9/2024 for dose 1 and 2.  GARDASIL 9  Lot 1775827   Exp. 6/27/2024  for do; no advserse event; This spontaneous report was received from Other Health Professional and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 12-DEC-2022, the patient received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W000244, expiration date: 09-AUG-2024, administered intramuscularly (strength, and indication were not provided). On 16-JAN-2023 and on 15-FEB-2023, the patient received the second and third doses of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775827, expiration date: 27-JUN-2024, administered intramuscularly (strength, and indication were not provided) (Inappropriate schedule of product administration). No additional AEs reported.
Patient reported feeling dizzy, lightheadedness, short of breath BP 126/59 P 88 RR 18 Pain, fever, chills, chest pain blood glucose 191
It was reported that 13 days post Varivax (probable cause) and Hep A in same let, developed puffy, red, 2cm shallow palpable mass at site. No fever minimally tender.
vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range, no adverse event; expired ipol vaccine administered to patient, no adverse event; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a Nurse.   This case is linked to cases 2019SA125041, 2019SA125054, 2019SA125008, 2019SA125094, 2019SA125033, 2019SA125066, 2019SA125072 and 2019SA125087 (Same reporter).  This case involves a four years old female patient who was vaccinated with a 0.5 ml dose of expired vaccine IPV (VERO) [IPOL] (lot number N1K931M and Exp. Date 19-Nov-2018) via intramuscular route in the deltoid nos and received dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number and Exp. Date not reported) via intramuscular route in the deltoid nos both on 04-Mar-2019.   The patient's medical history not reported and concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and TUBERCULIN PPD on 04-Mar-2019   .  It was an actual medication error case due to expired vaccine used and incorrect product storage.  It was reported that, vaccines stored at temperature outside the recommended range. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad.  It was unknown whether the patient experienced any adverse event post vaccination.  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.  List of documents held by sender: none.
Onset of hives, 24 hours, post vax, and progressed to severe serum sickness in 4 days. (Low-grade fever, minimal cough at the same time) Pt was hospitalized with high dose IV steroids and prelone taper.
Patient received 0.25ml Moderna booster vaccine and was <18 years of age.  Patient had received pfizer 2 shot series prior.
104 fever; irritability; sleeplessness; body aches; ear infection; hospital visit
Night of shot: Extreme fatigue, muscle aches left side of chest, back, and neck Day 2: Extreme fatigue, muscle aches, joint ache, headache, felt similar to a flu/hangover Day 3&4: Extreme fatigue, muscle aches, joint ache, headache, felt similar to a flu/hangover, ear ache, lymphnodepathy front neck lympthnodes. Hurt to put on deodorant left arm Day 5:Extreme fatigue, muscle aches, joint ache, severe headache, felt similar to a flu/hangover Day 6 &7: fatigue, headache, inner ear pain, increased mucosa production Day 8, 9, 10: increased mucosa production, sore throat resulting in cough and painful to ingest fluids or solids. Failed all exams during this period due to impaired cognitive abilities.
Sudden onset of loud high-pitched tinnitus in right ear approx. one month after the booster.  Resulted in difficulty concentrating requiring medical leave from work, and severe anxiety necessitating medication and CBT.  ENT visit did not determine a clear cause and determined the tinnitus  was not treatable.  Tinnitus has remained consistent since onset.
Injection site became raised, itchy, red, hard and warm to touch. The swelling went down within 24 hours but there is still a bruise or mark and it?s still a bit warm. Occasional itching remains
Patient reports experiencing heart racing, dizziness, shortness of breath, and face tingling on one side while working out 12 hours after receiving her first dose of Moderna COVID vaccine. Pt went to doctor and was diagnosed with bell's palsy.
Site: Swelling at Injection Site-Severe, Systemic: DVT-Severe, Additional Details: Patient presented to office with swelling of right upper extremity occuring after first COVID 19 vaccine dose.  Was sent for duplex study which revealed acute deep vein thrombosis in right subclavian and axillary veins and superfficial thrombophlebitis of basilic vein in right arm.  Pharmacy was contacted 3/10/2021 by MD at hospital to report vaccine adverse event