chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/15/2022 Became ill with flu symptoms. Extreme sweating, aches, pain, sneezing, coughing extremely hard, nausea, vomiting, fatigue. Was on a cruise at the time. Symptoms began 2nd day of cruise. Took Covid test 10/16/2022 which was positive. Symptoms continued non-stop. Returned home on 10/23/2022. Called physician morning of 10/24/2022. Was seen by physician. Took another Covid test which was positive. Provided Paxlovid, prednisone, Augmentin and cough syrup with codeine. Remained ill in bed for two weeks. Revisited doctor as symptoms not going away. Diagnosed with pneumonia at that time.  Cough worsened. Saw doctor again and prescribed a different cough medicine with hydrocodone which worked well. Continued ill until approx. 11/21/2022. Gradually got better. Effective today, 12/21/2022 - Remaining symptoms are cough, "fuzzy" headed; lack of energy, shortness of breath.
RAISED, RED RASH ON LEFT ARM 5 DAYS STATUS POST VACCINATION.  RARELY ITCHED. 3/X4 INCHES
Sleeplessness; exhausted; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the arm left on 09Mar2021 at 11:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included sleep apnea and allergy to walnuts. Concomitant medications included unspecified anaesthetic (MANUFACURER UNKNOWN) started on an unknown date for root canal procedure at dentist and ibuprofen (IBUPROFEN) started on an unknown date for an unknown indication. 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 10Mar2021 at 04:00, the patient experienced sleeplessness. The patient had been unable to sleep for more than a few hours at a time. At first, the patient thought it was psychological (excitement/ anxiety) but this had persisted for weeks and it was unprecedented since the first shot. The patient also reported that he was usually exhausted by mid afternoon or early evening and often took a nap.  The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 30Mar2021 at 09:45 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. 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 reported events. The clinical outcome of the events sleeplessness and exhausted was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
pt recvd vax between 10-12N; pt went home took a nap around 5PM parents woke pt, noticed rt leg swollen, pt unable to sit up or lift leg; stated pt was hot-fever; rx cold packs APPA, severe local reaction per MD to DTP;
This spontaneous report was received from a nurse practitioner and refers to unspecified number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients may have received a possibly improperly stored dose of GARDASIL 9 injection (lot#, expiration date, dose and route of administration were not reported) and other unspecified vaccines. The vaccines were delivered into the office in a brown paper bag at unspecified temperature for an unspecified amount of time. At the time of this report, the vaccines were stored at proper temperature in a cooler on the delivery trunk. It was unspecified if previous temperature excursion occurred. No adverse effects reported. Product quality complaint was not involved. Additional information has been requested.
Patient reported her tongue tingling immediately upon receiving the vaccine injection.  RN assisted patient out of her car and to a rest area.  Pt. was given an injection of 0.3 mg. adrenaline in her right arm..  Pt. was also given a bottle of water and offered a cool compress.  Pt. did not want the cool compress.  RN observed the patient  for  30 min. and advised the patient not to drive herself home.  RN called patient's sister who came and took patient home. RN called patient later that evening and patient stated feeling better and that her sister was still with her.  Pt. reported no more tingling in her tongue or neck area and that she was resting. Patient stated that she was taking  Benadryl p.o. and was feeling better.
Approximately 3 weeks after her second dose, patient had shortness of breath and chest pain, 2 days after onset present to the emergency department and was diagnosed with acute, moderate volume bilateral pulmonary emboli and a left lower extremity DVT (popliteal vein). Treated initially with lovenox and Eliquis followed by Eliquis alone. Discharged after one day. Recovering well. please see earlier comments regarding vein surgery in Feb 2021, past hx of DVT/PE.
Had acute lacunar stroke 3 days after receiving vaccine. Had expressive aphasia, slurred speech and double vision
umbilical hernia; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A child patient received BNT162b2 (BNT162B2), on 27Jul2022 at 17:11 as dose 2 (maroon cap), single (Lot number: FT9142) intramuscular, in left thigh for covid-19 immunisation. The patient's relevant medical history included: "Hx of SARS-CoV2", start date: 18May2022 (unspecified if ongoing); "Constipation", start date: 12May2022 (unspecified if ongoing), notes: Pertinent details: Referred to GI. Concomitant medication(s) included: DTAP intramuscular taken for immunisation, on 30Mar2023 as dose 4, single; INFLUENZA intramuscular taken for immunisation, on 30Mar2023 as dose 2, single. Vaccination history included: BNT162b2 (Dose 1, Single, Time: 17:06, Anatomical site of injection: Right Thigh, Route of administration: Intramuscular, Batch/Lot number: FT9142), administration date: 06Jul2022, for COVID-19 Immunization; Dtap (Manufacturer: Sanofi; No. of previous doses: 3), for Immunization; Influenza (Manufacturer: Sanofi; No. of previous doses: 1), for Immunization. The following information was reported: UMBILICAL HERNIA (non-serious) with onset 30Mar2023, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Specific Relevant Test for thromboembolic events with thrombocytopenia were none.
Redness around vaccine area itchiness, hot and cold sweats light headed and dizziness, vomiting and complete numbness in hand and thumb area no feelings.
9x5 x 5.5 area of warm, tender, swelling & erythema surrounding inj site lt deltoid area-22har p/vax;
Immediate heaviness in arm where vaccine was administered. Moments later a nasal drip and metallic taste in my mouth. Reported symptoms to a medic on site. That evening, experienced muscle aches both arms, legs and lower back), headache, chills, nausea and fatigue. Symptoms continued for the following 24 hours. By Sunday, approximately 48 hours later, symptoms completely resolved  with the exception of slight soreness at the injection site. A red rash on my abdomen and back appeared-slightly itchy but not bothersome. This resolved by the next day.
Patient got a partial dose of Fluzone HD with no adverse event; syringe leaked on her arm with no advese event; Initial information received on 13-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Agency (under the reference 00810589).  This case involves a 67 years old female patient who got a partial dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (underdose) but syringe leaked on her arm (syringe issue).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect FLUZONE HIGH-DOSE QUADRIVALENT (0.6 ml, lot UJ747AA and expiration date: 30-jun-2022) via unknown route in an unknown administration site for prophylactic vaccination.  It was actual an medication error due to vaccine underose and syring leak (same day latency).  It was reported "Consumer states that she just received the HD FLU vaccine 0.7 mL but when it was injected, the syringe leaked on her arm. The nurse thought it was a little bit but the consumer felt it was more than a little. she got a partial dose of Fluzone HD. She states the HCP said she felt she got 0.6 ml of the dose. The vaccine came out of the syringe and ran down her arm."  At time of reporting, the outcome was unknown for the events.  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.
20 minutes after vaccine, child c/o night chills, "burning". Developed erythema and swelling of cheeks and chin. Mother gave BENADRYL with minimal change.
Tingling and burning in arms, neck, chest, and legs. Fever developed that night and body aches. Fatigue the next day along with headache and body aches. Tingling has continued on and off for the past week.
Information has been received from a physician concerning a 65 year old female who in June 2008, was vaccinated with PNEUMOVAX 23. Concomitant therapy included heart medication (unspecified). Two days later, the patient developed walking pneumonia. The patient quickly deteriorated after that was hospitalized and placed on a ventilator. Duration of hospitalization was not reported. The patient was recovering "was doing fine". Walking pneumonia was considered to be disabling, immediately life-threatening and as an other important medical event. Additional information has been requested.
Local reaction - swelling/induration at injection site began day of injection, improving 7/21/14.
Muscle pain and cramping (for at least a week), fever (about a week), brain fog - forgetfulness, inability to hold thoughts, poor memory recall (about a month), exhaustion (about a month), tightness in chest and shortness of breath (about 6-7 months)
Patient was administered the first dose of the Pfizer vaccine 0.5mg IM Rt Deltoid this AM in the Covid-19 Vaccine Clinic.Patient waited 12 min went to change her clothes and come back to the clinic with complaints of hives and feeling warm. Patient had raised red welts on right upper arm. Patient has a history of Anaphylaxis reaction with a Meal Ready to Eat (MRE) in the past, other allergies to grapefruit seed extract with reaction of edema.   Pt has no c/o of SOB or Chest pain, no other swelling at this time. Dr. notified, 0.3mg Epinephrine 1mg/mL (1:1000) given IM Left Deltoid, 25mg Benadryl IM given Rt Deltoid per MD verbal order and anaphylactic protocol. Pt transferred by wheelchair to the ER for further evaluation. Report given to ER RN.
Received H1N1 vaccine at 17:00 and at 18:00 noticed blotchy rash on hands, torso, back and upper thighs. Had low grade temp night before. Next day faint rash still present.
This spontaneous report was received from a Registered Nurse referring to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates, the patients were vaccinated with an improperly stored dose of Oka/Merck VARIVAX with one of these lot #'s reported N026070, expiration date on 20-SEP-2019; lot # N021722, expiration date on 10-AUG-2019; lot # N020686 27-JUL-2019;  lot # N01739 07-JUN-2019 (Strength, route, dose, frequency, and anatomical location were unknown) and an improperly stored dose of Oka-Merck (rHA) PROQUAD with one of these lot #'s reported N02592, expiration date on 18-MAR-2019; N019251, expiration date on 20-DEC-2018  (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F (8.4F ) degrees Fahrenheit for 102 min. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects reported. Lot number N01739 is an invalid lot number for varicella virus vaccine live. Lot number N02592 is an invalid lot number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live. Follow-up Information has been received on 04-APR-2018, from the nurse, with new lot and expiration dates for Oka/Merck VARIVAX for prophylaxis, lot number: N017395, expiration date: 07-JUN-2019, and Oka-Merck PROQUAD lot number: N014948 and expiration date: 11-NOV-2018. The reporter was unsure specifically as to the number of patients who received the vaccinations, identification information was provided for one of the patients; patient who had received a dose of Oka-Merck PROQUAD was a 4 year old (MARRS # 1804USA004248). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA004248.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Oct-2021 at 1:21 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 1:21 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 70.74. Concomitant products were not provided. On 27-Oct-2021, Excursion time was 09 AM, temperature was 29, on 10 AM, temperature was 32, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2 and 4 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021. On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) 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 EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) 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 EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. Vial size was reported as 0.4 ml per vial. Vial did not undergone any temperature excursions.  No treatment information was provided.  This case was reported for patient 14 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Master case
Nausea; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 49-year-old female patient received the first dose of bnt162b2 (COVID-19 vaccine, brand: Pfizer-BioNTech) lot no: EH9899, intramuscular in left arm on 06Jan2021 01:00 at a single dose for Covid-19 immunization in a hospital. The patient medical history and concomitant medications were not reported. The patient was not pregnant and no known allergies. No other vaccine was administered in four weeks. No Covid prior to vaccination and was not Covid tested post vaccination. The patient experienced nausea and headache on 06Jan2021 18:00. The events were reported as non-serious. Treatment was not given for the events. The patient was recovering from the events.
26FEB91 temp 102, seen by MD given antibiotic x 6 days; 2MAR temp 104.6 rash started;
Patient was given an adult dose of TWINRIX vaccine instead of pediatric dose. No adverse side effects.
No additional AE reported; scheduled to receive one dose of PROQUAD and one dose of QUADRACEL, but was accidently administered two doses of PROQUAD; scheduled to receive one dose of PROQUAD and one dose of QUADRACEL, but was accidently administered two doses of PROQUAD; This spontaneous report was received from a licensed practical nurse concerning a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On an unspecified date (reported as at the age of 12 to 15 months), the patient was vaccinated with her first dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route, lot # and expiry date were unknown).  On 09-JUN-2021, the patient  was scheduled to receive one dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and one dose of diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid(QUADRACEL); but was accidentaly administered two doses (1 millilter) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD) (route not reported) lot # U002529, expiration date 24-JUL-2022, for prophylaxis. No additional adverse event reported.
The tinnitus I previously had in my left ear tripled in volume. Then on 5/3/2021, when I had my second dose in the other arm, I developed tinnitus in my right ear for the first time. The right ear tinnitus was a lower volume than the left ear, and resolved after two months. The tinnitus in my left ear has since lowered to about two times its original volume (after two months), but still considerable and leads to daily distress.
Approximately 13 hours after the injection (4:00am on 6/15/21), I woke up from crying in my sleep because I felt so awful.  I had horrible shooting pain in ALL of my joints, shivering, chills, and a headache. These symptoms persisted, and as the days went on, other symptoms began. The following day (6/16/21), I woke up with a migraine. On that same evening of 6/16/21, I started to experience Trigeminal Neuralgia on the right side of my mouth, both upper and lower jaw. The nerve pain was throbbing horribly; it was incessant and nothing would help....ice, heat, Tylenol, nothing.  It felt like I needed a root canal in all of the teeth on my right side, or that I had bitten into something cold, but over and over without stopping. These symptoms persisted without any relief from 6/16/21 until the morning of 6/19/21. On 6/19/21, I still woke up with the nerve pain, but it was less intense. The headache was barely there. The shooting pain in my joints had subsided some, and the shooting pain in my right Trigeminal Nerve had become lesser and more intermittent. I noticed the symptoms slowly dissipating as the days went on. I currently get a little throbbing in my right Trigeminal Nerve approximately 3-4 times per week, but it is much less intense and does not last for more than a few hours. Also, I had site injection pain starting the morning of 6/15/21, which lasted about a week. The injection site was also very hot to the touch for approximately 10 days.
Hives to throat , intense itching and flushing to face and throat within 15 minutes of injection.  Headache started 30 minutes after shot. I then took 25mg of benadryl . Followed with another 25mg of benadryl an hour after that. Within 4 hours post injection I began feeling joint pain, flu like symptoms of fever up to 100.7, chills, sweating, continued headache, facial flushing and redness of my elbows and knees. These symptoms remained intense for 4 days and began to lessen on the 5th day. I treated these symptoms with tylenol rotated with ibuprofen every 4 hours as well as dayquil/nyquil and alka seltzer.  Up to date I continue to feel a lupus flare up of facial flushing with joint pain and redness.