chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 at 01:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 35 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. Patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Oct2022 at 06:00, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Oct2022) Positive, notes: I tested positive on 6am; (12Oct2022) Negative; (13Oct2022) Negative; (14Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid as treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient complained that he felt dizzy and difficulty breathing after 10 minutes in post vac. Patient instructed to deep breath, cold compress and ambulance called, as patient anxiety increased. EMS took over. VS WNL. Patient was not transported to hospital. Parents declined.
Hypertensive to 190/80; shaking; chills; after 30 minutes, BP reduced 159/80; sent to ER; monitored; sent home; resolved, per follow-up call following day.
5 days after initial vaccine, abdominal angina, fevers, found to have evidence of large vessel vasculitis in his abdominal aorta
Received vaccines 8/21/07 - presented 8/23/07 with area of induration 8cm x 6cm and overlying erythema of 4cm x 6cm - in left upper thigh. Due to high prevalence of MRSA in community placed on antibiotics.
I developed the full body rash with pimples and prickly red bumps that resembles measles. It is painless. It spread even more after the second vaccine. I am over two weeks out after the second vaccine and none of the rash has even started to clear up.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 15-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree Centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree Centigrade to 8 degree Centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010758: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010754: US-009507513-1708USA010759: US-009507513-1708USA010760: US-009507513-1708USA010761.
This spontaneous report was received from a certified medical assistant (C.M.A.) and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 10-DEC-2015, the patient was orally vaccinated with an improperly stored dose of ROTATEQ (lot # L004466, expiry date 02-AUG-2016, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
died several hours after receiving a Covid-19 vaccine; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient died several hours after receiving a Covid-19 vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The person had tested positive for the virus (Covid-19) in late Dec2020.  Information on the batch/lot number has been requested.; Reported Cause(s) of Death: died several hours after receiving a Covid-19 vaccine
No additional adverse effects reports; patient was administered improperly stored ROTATEQ; This spontaneous report as received from a vaccine coordinator refers to a 8-week-old female patient. No information regarding patient's medical history, concomitant medications and concurrent conditions was provided.  On 25-FEB-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1658255, expiration date 07-FEB-2021 (route of administration, dose and frequency not reported) for prophylaxis.      Digital data logger was involved. The vaccine was stored at the temperature that was reported as below 2 degrees of C: on 02-MAR-2020 0.8 degrees of C for 5 hours and 9 minutes; 04-MAR-2020 0.9 degrees of C for 11 hours and 05-MAR-2020 -1.3 degrees of C for 9 hours and 29 minutes. The previous temperature excursion happened on 25-FEB-2020 and the temperature was reported as above 9 degrees of C (9.3 degrees of C) for 3 hours 33 minutes and on 03-MAR-2020 below 2 degrees of C (0.8 degrees of C) for 11 hours 39 minutes.  No adverse effect reported.
Starting at approximately 6 am on 8/14/21 I woke up with sever body aches (felt like bones were turning into dust) and chills that lasted about 24 hrs.  On 8/15/21 I discovered I have red plaque rash on both sides of my neck near my collar bone as well as my beast bone and under both breast.  The rash is warmth touch but is not itchy.  My injection site is also red and warm to the touch, about the size of a lemon.  My injection site is also so to the touch.
feeling sick; fever; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (feeling sick) and PYREXIA (fever) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylactic vaccination.    Concurrent medical conditions included Atopic dermatitis. Concomitant products included DUPILUMAB (DUPIXENT) from 23-Mar-2018 to an unknown date for Atopic dermatitis.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced MALAISE (feeling sick) and PYREXIA (fever). At the time of the report, MALAISE (feeling sick) and PYREXIA (fever) outcome was unknown.        Patient experienced similar event after second COVID-19 vaccine.  No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jan-2022: Significant follow up- patient age, suspect product information updated. On 10-Jan-2022: Significant follow up-concomitant medication DUPIXENT added.
Information has been received from a consumer concerning her husband, a 62 year old male with no pertinent medical history and no known drug reactions/allergies who on 13-NOV-2008 was vaccinated with a 0.65 ml dose of ZOSTER (Oka/Merck).  There was no concomitant medication.  The patient experienced injection site reaction liked redness and rash.  The patient's injection site redness and injection site rash persisted.  The patient did not seek medical attention.  No further information is available.
Started w/myalgia and fatigue over days post vaccination. Then developed dizziness, shortness of breath and dry cough 1-2 weeks after the dose. Tested for COVID, negative. Presented to ED w/mild troponin rise to 0.207 and hypoxemia to low 80s. CT chest with diffuse ground glass opacities in every lobe (except right middle lobe). Leukocytosis w/neutrophilia but no fever. Cough is dry, no blood. Cultures pending. Acute hypoxic respiratory failure requiring high flow nasal cannula to keep saturations in mid 90s. No prior history of COPD or lung disease. No ill contacts.
This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. The patients' concomitant medications, concurrent conditions and medical histories were not provided. On unknown dates, the patients were administered doses of improperly stored PROQUAD injection, lot # M022400 with expiration date on 01-NOV-2017, lot # M038861 with expiration date on 13-MAR-2018 and lot # M044718 with expiration date on 07-MAY-2018 (doses and routes of administration were not reported). The administered doses of PROQUAD were reconstituted with sterile diluent (manufacturer unknown) (lot # and expiration date were reported as unknown). Administered doses of vaccines experienced a temperature excursion from -9 degrees Celsius to 8 degrees Celsius, which lasted for 3.5 hours. No previous temperature excursion was reported. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA002924.
lt thigh w/red edematous area 3-4cm around inj site;site warm to touch;pt had shrilling cry & mom states had not been able to comfort x 5hrs;referred to MD-given Motrin
Dizziness; Headache; This is a spontaneous report from a non-contactable nurse, the patient. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 25Aug2021 at 13:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included sciatica and environmental sleep disorder. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received sulfamethoxazole; trimethoprim (SEPTRA) and experienced drug allergy. On 28Aug2021, the patient experienced dizziness and headache. The patient was still experiencing after 21 days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had been tested for COVID-19. On 15Sep2021, the patient underwent COVID-19 via saliva test and the result found to be negative. The clinical outcome of the events dizziness and headache was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Patient came for peds Pfizer, given adult dose of Pfizer covid vaccine. no adverse events at time of vaccination. following up with doctor to let him know and for next steps. Have mom's phone number to update her.
Vaccine given SQ at 1032, rt leg. 1040: This RN in room. Pt C/O itching to site. Site with redness 4.5X5.5cm with 1 cm whelp noted. No other symptoms. Lungs clear. No other hives. 1047: Benadryl 12.5mg given PO. Cool compress applied to site. 1105: Redness decreased 3X3.5cm No hives. No itching. Pt discharged home.
January 13th 1st Pfizer - no side effects Feb 19th 2nd Pfizer - fatigue, body aches x3 days, after that tired  Week of March, noticed bruising easily all over and bleeing a lot after Botox treatment on 3/18, no aspirin use or OTC supplements  Week of March 22, noticed bruising without reason and petechaie, sent message to PCP on 3/31/2021, he gave lab order for CBC and prothrombin  April 2nd, got CBC and prothrombin, results showed low platelets at 25,000 and high MPV at 14.5, everything else was normal  April 3rd, PCP sent me to ER to verify due to low level, labs there verified low platelets at 23,000, put me on prednisone 40mg QD, advised I see hematology  Saw Hematology April 5th, platelets went up to 33,000. All other labs WNL except 11 for white count. NEG hep, hiv, ana, no known cause. Increased prednisone to 60mg.. but could only handle that for 3 days, and went back down to 40mg  Saw Hematology on April 12th, platelets up to 120,000 (almost to normal range), white count high (13), neutrophils high, fever 99.5, rib pain upon pressure  April 13th, CT Scan of chest WNL  April 14th, FULL BODY RASH  Ultrasound of abdomen scheduled for 4/21
A-fib; Acute on chronic heart failure; Pacemaker; Tachycardia; VT (ventricular tachycardia)
Soreness in shoulder joint that has resulted in limited mobility of shoulder joint and arm much like a frozen shoulder due to the injection being placed high on the arm near shoulder joint.
hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrhea, vomiting and hypokalemia; hospitalization due to blood diarrhea, vomiting and hypokalemia; Worsening ulcerative colitis; Worsening ulcerative colitis; This is a spontaneous report from a contactable consumer (patient). A 43 years old female patient received BNT162B2 (lot number: EL3248) second dose on 25Mar2021 (vaccination age 43 years old) on left arm for COVID-19 immunisation. Medical history included Colitis ulcerative. Patient was not Pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received BNT162B2 (lot number: EP6955) first dose on 04Mar2021 (vaccination age 43 years old) on left arm for COVID-19 immunisation. Patient had Worsening ulcerative colitis and hospitalization (for 3 days) due to blood diarrhea, vomiting and hypokalemia. Events occurred on 26Mar2021. Patient received Potassium, Prednisone, Lialda as treatment for the events. Lab test included Nasal Swab on 30Mar2021 with result of negative. The outcome of the events was recovering.
Patient stopped by office today: He received 4 immunizations 2 days ago, 2 on right upper arm, and 2 on left upper arm. On the left deltoid are, where he received Tdap #5, there is blistering in a square-ish pattern, where there was a bandaid, and the the area is not and red, extending down to the lower area of the deltoid muscle. The other injection sites were given bandaids, but no blistering developed at the other sites. He has been active and playful, and is using his left arm without problem. Plan: MOTRIN susp 1 1/2 tsp given po here at 5:05 pm, to repeat q 6-8 hrs, while awake through tomorrow. Mother was advised to purchase BENADRYL syrup and to give it to him as soon as she gets it, and to repeat q 6 hrs while awake, through tomorrow. NEOSPORIN to blistering area. Cool compresses to area. Follow over weekend if symptoms worsen.
incorrect product storage; no adverse event; This spontaneous report was received from a healthcare worker, concerning a female patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.     On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (lot number T028583, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 04-MAR-2023) (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis. The administered vaccine experienced a temperature excursion of 49.6F during a time frame of 32 minutes (product storage error). No additional adverse events were reported.
pt recv vax;flu like sx, fever, chills, gene aching, slept most of 2 days; large,red, hot,localized area;size of 2x3 hard knot 4 days p/ injection;
pt recvd vax & was not feeling well, experience a h/a & devel a chickenpox rash;21SEP95 pt devel gen rash w/50 to 100 vesicles in various stages just on back, fever of 101.8;
Tingling/numbness in lips and nose, spread to hands and ams. Legs felt heavy. BP 155/87, pulse 96, 99% O2 sat.
COVID breakthrough. Patient came to hospital on 12/7/21 for delivery of her baby. She was routinely tested for COVID and resulted positive.
General ill feelings; Severe headache like her head was splitting, very painful; This is a spontaneous report from a contactable nurse via Pfizer Sales Representative. A female patient of an unspecified age received second dose meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration from an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Trumenba for immunization.  It was reported that the patient came in for second dose of meningococcal group b rlp2086 and left the office to run errands with her mother. She came back to office shortly after because she was experiencing severe headache like her head was splitting, very painful. She also complained about general ill feelings. Her vitals were fine, but doctor who was attending to her suggested patient should go to the ER. Outcome of the events was unknown.  Information on the batch number has been requested.
presents to the ED via EMS in cardiac arrest. EMS report patient was in agonal respiration upon arrival and has had no pulse since 2109. Patient had a syncopal episode on the toilet prior to EMS call. EMS notes they gave patient 4 epinephrine, 1 bicarbonate, and 1 Narcan. Patient arrived with a lucas machine in place and intubated. Patient's intubation was verified to be a 7.0 ETT and 23 cm at the lip. Cardiac Activity noted in ED at 2150. See nurses notes for times medications were administered. Further history limited due to unstable vital signs. Pt hypotensive, started and maxed on levophed, epinephrine infusions and additional push dose epi given.  Right femoral central line placed.  Pt began to brady down, was given atropine, ultimately again became pulseless and CPR resumed.  After 2 further rounds of ACLS, total down time approached 1 hour without return of pulse.  On echo, there were occasional agonal beats, but no organized cardiac activity.  EKG and case had been discussed with Dr. Friday and decision was to attempt therapeutic hypothermia prior to second cardiac arrest as EKG showed inferolateral STEMI
Patient had no reaction to the vaccine after administration. Tested positive for COVID 3/24/2023.  Patient expired 4/22/2023
MUSCLE TIGHTNESS; INJECTION SITE RASH,; INJECTION SITE ERYTHEMA; AXILLARY PAIN; Extreme fatigue; Bad headache; felt like the energy has been drained; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (MUSCLE TIGHTNESS), INJECTION SITE RASH (INJECTION SITE RASH,), INJECTION SITE ERYTHEMA (INJECTION SITE ERYTHEMA), AXILLARY PAIN (AXILLARY PAIN) and FATIGUE (Extreme fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (MUSCLE TIGHTNESS), INJECTION SITE RASH (INJECTION SITE RASH,), INJECTION SITE ERYTHEMA (INJECTION SITE ERYTHEMA), AXILLARY PAIN (AXILLARY PAIN), FATIGUE (Extreme fatigue), HEADACHE (Bad headache) and ASTHENIA (felt like the energy has been drained). At the time of the report, MUSCLE TIGHTNESS (MUSCLE TIGHTNESS), INJECTION SITE RASH (INJECTION SITE RASH,), INJECTION SITE ERYTHEMA (INJECTION SITE ERYTHEMA) and AXILLARY PAIN (AXILLARY PAIN) had resolved, FATIGUE (Extreme fatigue) and HEADACHE (Bad headache) was resolving and ASTHENIA (felt like the energy has been drained) outcome was unknown.            No concomitant drug information provided.  No treatment information provided.   This case was linked to MOD-2021-014798 (Patient Link).   Reporter did not allow further contact
Vaginal bleeding; patient also stated that she had common side effects like fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (patient also stated that she had common side effects like fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 011J20A and 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TRAZODONE from 01-Jan-2019 to an unknown date for Insomnia.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (patient also stated that she had common side effects like fatigue). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) had resolved and FATIGUE (patient also stated that she had common side effects like fatigue) outcome was unknown.            Treatment medications were not provided.  It was reported that patient has no history of COVID-19.  Irregular vaginal bleeding within 24 hours of receiving the mRNA vaccine.  Light to medium bleeding, lasting only 1-2 days.     This case was linked to MOD-2021-386798 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Nov-2021: Follow-up received includes Patient information (race, ethnicity, height, weight, pregnancy status), concomitant medications and outcome of event updated
This is a change to my previous statenent. 1.swollen finger, hand and arm. Swollen mouth, tongue and throat, additional inflammatory responses. Followed by secondary amnoria, she was recently diagnosed with POI, starting menopause at 15 years old.
Patient presented to the ED with swollen uvula, swollen face, hives on neck and waist, and severe headache approximately two days after the first dose in the COVID 19 vaccine series.  The patient was treated with diphenhydramine, methylprednisolone, epinephrine, and famotidine.
Patient got first dose Moderna on 04/29/2021. On 05/21/21, he came to pharmacy to pick up refills. He mentioned to pharmacist that he still got rash and blood on the injection site since the day of injection. The size of the rash was like a penny with redness and a small dark spot in the middle probably a small  scab there, He said there was blood there before. No fever no pain. Pharmacist told him to consult his primary care doctor and put ice over the area in the meantime.
Pt exp HIB meningitis 2 wks p/initial immun; had severe vomiting w/no fever; later that day 9DEC mom reported pt had fever 100.5 & diarrhea; 10DEC seen in office; pt was morbid; sen to ER & died several hrs later; dx HIB meningitis;
so far I got the shot for covid a few days ago. All I have noticed so far is that a blister had formed at the injection site and im tired but I don't know/cant tell  if the drowsiness is any different then any other day I would be tired.