chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irregular menstrual cycle; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 2, single (Lot number: EL9261) at the age of 33 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE; CITALOPRAM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 06Jan2021, when the patient was 33-year-old, for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Irregular menstrual cycle". The event "irregular menstrual cycle" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstruation irregular.  Additional information: The patient did not receive any other vaccine in four weeks. Had no COVID prior vaccination. The patient was tested for COVID post vaccination and test type was Nasal swab. The patient had no known allergies and no medical history.
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 59-year-old male patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: en6199), in left arm and on 11Apr2021 as dose 2, single (Lot number: ew0158) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 045j21a) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST, start date: Jan2021; LOSARTAN, start date: Jan2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jul2022) Positive, notes: Recurrence of covid 19 from home test kit on 31Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: It was reported that, treatment drug Paxlovid was received from 21Jul2022 to 25Jul2022 for the treatment of COVID-19.
Large, red, feverish, painful circle on the arm about 4 to 5 inches in diameter and increasing in size over a period of a couple of days. Also a hard knot beneath the surface of the skin.
Starting 5 days after vaccine developed increased swelling and redness around site. Over two day increasingly pruritic and sore, with development of maculopapular red rash around the previously swollen area.  SKin warm in whole upper posterior arm.  Diameter of rash reaction 8cm.
This spontaneous prospective pregnancy report was received from a healthcare worker refers to  22 year old female patient who was 34 weeks pregnant at reporting time. There were no pertinent medical history or drug reactions/allergies. The last menstrual period (LMP) was approximately on 11-SEP-2013. On approximately 05-MAR-2014 the patient was inadvertently vaccinated with her first dose GARDASIL lot # J011272, expire date 21-APR-2016, (dose, route not provided) for immunization at 25 week gestation. Concomitant therapy included prenatal vitamins. The patient did not seek medical attention. The pregnancy outcome was unknown. Action taken with GARDASIL was not reported. Additional information has been requested.
"The patient feels that her arm is on burning and itching, her arm is in pain. She couldn't sleep last night."
Skin  complaint, I have psoriasis, and since the jab, my skin has become 10 times worse, my skin feels like it`s on fire and is very red and itchy.
1:45 pm she received the vaccine. 2:10 pm she started to have the following signs and symptoms; red swollen arms, dizziness, blurred vision, gastrointestinal symptoms,  blood sugar 143, blood pressure 86/40, pulse 87, oxygen 88. We gave diphenhydramine 50mg at 2:16 pm. Then at 2:35 pm her symptoms were not improved her blood pressure was 80/40 so we gave one dose of 0.3mg epinephrine by auto-injector and called an ambulance. Post epinephrine her vision improved but her skin was still red and starting  to itch. She was talking and said she was feeling a little better. She was taken by ambulance to the hospital for additional treatment. There was not reaction visible at the injection site it appeared to  be all systemic.
Pulse dropped to 30. Low pressure too. Brachycardia.  Lost consciousness. Did not seem to be Vasovagal. Saline IV. Blurred vision. Very. Strange. Girl friend said I seemed catatonic for about 5-10 seconds. Cold sweat. Dizziness. Immediate Symptoms lasted about an hour. Injection site very sore 10 hours later. Body pains.
arm soreness; feeling achy; blisters on his hands and arms; Itching; red splotches on the back of his right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th December 2021, 3 days after receiving Shingrix, the patient experienced pain in arm, pain, blister, pruritus and red blotches. On an unknown date, the outcome of the pain in arm, pain, blister, pruritus and red blotches were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, pain, blister, pruritus and red blotches to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and about 3 days later experienced arm soreness and felt achy. The patient also experienced blisters on his hands and arms that caused itching and red splotches on the back of his right arm.  The above symptoms had not resolved. The patient asked GlaxoSmithKline if this was a common reaction and if it was okay to receive the second dose. No lot number or expiration date was provided. Provided medical disclaimer and referred him to his HCP.  The reporter consented to follow-up.
Awakened with rash/hives on chest & abdomen. No other symptoms. Patient did no treatment.
Administration error - 1st flu shot dose received 10/8/2021. 2nd flu shot dose received 10/21/2021.
Two possible TIA events shortly after the vaccine One definite TIA on date noted, another TIA one month later and another within the week.
Information has been received from a consumer concerning her daughter with no known drug allergies or pertinent medical history who "sometime during the week of 17-FEB-2008" was vaccinated with VARIVAX (Oka/Merck). There was no concomitant medication. Subsequently, 2 days after vaccination on approximately 21-FEB-2008 the patient developed a rash and swelling around the injection site. A week after, on approximately 28-FEB-2008 bloody blisters appeared. At the end of the week, the child had about 10-12 chickenpox vesicles and "puck marks." She developed a Scar on or around the injection site. Medical attention was sought, the was seen at the office. There were no labs studies performed. It was reported that the patient recovered 3 weeks after vaccination, on approximately 09-MAR-2008. There was no product quality complaint involved. Additional information has been requested.
Diagnosed with Bell's Palsey. Dr prescribed Prednisone 20MG Tablets, Valacyclovir 1GM Tablets on February 1. 2021. Facial muscles on Left side of face would not move. Currently some of the movement is coming back.  Some of the symptoms were: Left ekye would not close completly, mouth drooped on the Left side, had a bad taste in my mouth that felt like I had drank some very hot fluid, my lips felt like they were swollen.
This spontaneous report was received from a nurse and refers to an adult patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 04-MAY-2017, the patient was vaccinated with a dose of pediatric VAQTA injection, lot # M047658 with expiry date 28-OCT-2017 (exact dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a pharmacy technician concerning a currently 5 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 13-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
PATIENT RECEIVED VACCINES AT 1251PM AND AFTER SHE SAT DOWN FOR OBSERVATION, PATIENT HAD A REACTION. PT STATED SHE BEGAN TO SEE BLACK SPOTS, AND WAS NOT ABLE TO HEAR CLEARLY. DESCRIBED IT AS BEING UNDERWATER. PT STATED SHE  STARTED TO FEEL NAUSEATED, WITH PAIN BEHIND HER HEAD. VITALS WAS TAKEN DURING REACTION WITH DIFFICULTY GETTING BP READING. P-64, O2SATS @100, LIPS PALE WITH SKIN WARM TO TOUCH,AT 1306 PM BLOOD PRESSURE READING AT 116/64, P-88, O2 SATS @98%. COLOR TO FACE AND LIPS VISIBLE (NO PALOR). PT. MONITORED FOR 30 MINUTES AND IS HEARING AND SEEING WELL, NO MRE PAIN TO HEAD. MOTHER ASKED IF DAUGHTER HAD EAEN THIS MORNING AND SHE SAID NO AND NO FLUIDS. ADVISED MOTHER TO GIVE FOOD THAT SHE CAN TOLERATE AND TO HYDRATE. ADVISED MOTHER IF SYMPTOMS RETURN CALL PEDIATRICIANOR NEAREST ER FOR FURTHER EVALUATION. MOTHER VERBALIZED UNDERSTANDING. BEFORE PATIENT WAS RELEASED THE NURSE HAD HER TO AMBULAABOUT 6 5FT UP AND BACK. NO UNSTABLENESS AND NO SYMPTOMS. PAT STATED SHE FELT GOOD. ADVISED MOTHER TO INFORM PEDIATRICIAN OF POST REACTION TO VACCINES. PATIEN AMBULATED OUT THE DOOR ON HER OWN @ 1335PM.
7.5 cm & 8 cm red induration hot to touch cold compresses for 10 min 4x a day.
Patient had intense itching at injection site - left deltoid, approximately 6 hours after injection. Went to bed, and woke up with pain, redness, warmth and swelling from injection site to elbow. Advised to apply ice to area and call if no improvement.
Approx 18 hours later had a vasovagal episode with vomiting; Approx 18 hours later had a vasovagal episode with vomiting; that was then proceeded with fever of 102 for the next 10 hours; This is a spontaneous report from a contactable nurse. This is a 43-year-old female Nurse (patient) reported for herself that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EL9265) on 11Feb2021 at 03:30 pm at 2nd dose, single at left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient's medical history was not reported (Known allergies; NKDA, NKA, Other medical history: None). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL3248 on 21Jan2021 at 03:30 PM at 1st dose, single on eft arm for covid-19 immunisation. Concomitant medications (other medications in two weeks) included sertraline hcl, colecalciferol (VITAMIN D), cyanocobalamin (VITANMIN B12) and OMEPRAZOLE (Prilosec) (therapy date sand indications unspecified). If other vaccine in four weeks; No. Patient approximately 18 hours later had a vasovagal episode with vomiting, that was then proceeded with   fever of 102 for the next 10 hours on 12Feb2021 at 09:00 am. Treatment for AE was not given. Patient did not have covid-19 prior vaccination. Patient was not tested for covid-19 post vaccination. The outcome of events was recovered on an unknown date.  No follow up attempts are possible. No further information is expected.
Pfizer-BioNTech COVID-19 Vaccine EUA Rapid, racing heartbeat - anxious feeling for about 12 hours
Patient remained in store for 30 minutes after vaccination with no reaction. Patient developed hives on neck and chin 2 hours after administration that was resolved by taking 12.5 mg of Benadryl. Patient will return for second dose already having taken Benadryl prior to administration she feels the benefits outweigh the risks. Patient is not completely sure the reaction was due to vaccine as the hives appeared so late.
Information has been received from a physician concerning a female patient between 17 and 18 years old who was vaccinated with Gardasil. The patient fainted after her first administration of Gardasil. She had also had her blood drawn at the same time and also received a dose of Menactra. The patient recovered. No other information was reported. Continued on Additional Page
Blood clot in right ovarian vein; This spontaneous case was reported by a nurse and describes the occurrence of OVARIAN VEIN THROMBOSIS (Blood clot in right ovarian vein) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, ROSUVASTATIN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OVARIAN VEIN THROMBOSIS (Blood clot in right ovarian vein) (seriousness criterion medically significant). The patient was treated with RIVAROXABAN (XARELTO) from 01-May-2021 to 01-Nov-2021 for Adverse event, at a dose of 20 mg once a day. At the time of the report, OVARIAN VEIN THROMBOSIS (Blood clot in right ovarian vein) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that after second dose patient had a blood clot in right ovarian vein. Patient was concerned about booster.  Company comment: This case concerns a 60 year old female patient with no reported medical history, who experienced the serious unexpected event of ovarian vein thrombosis on an unknown date after the second dose of mRNA 1273 Covid-19 vaccine. Information on clinical course was not provided, the patient was treated with Rivaroxaban. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 60 year old female patient with no reported medical history, who experienced the serious unexpected event of ovarian vein thrombosis on an unknown date after the second dose of mRNA 1273 Covid-19 vaccine. Information on clinical course was not provided, the patient was treated with Rivaroxaban. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Engerix-B pediatric dose given to an adult; Engerix-B pediatric dose given to an adult; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 31-year-old male patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 5th April 2024) for prophylaxis.   On 15th June 2022, the patient received Engerix B pediatric. On 15th June 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 16-June-2022 Reporter's Comments:  The nurse reported that on 15th June 2022, an 22 years old male adult received an Engerix-B pediatrix dose, which led to underdose and adult use of a child product. The reporter consented to follow up. Additional supportive information: The age of the patient was captured as per the date of birth reported.
Eight days later had a resting heart rate of 150.  Went to my Primary Care Physician and he put me on Beta Blockers to lower the heart rate:  Metorpolol.
6/1/07 7PM threw up, pale, clammy, crampy - reported bloody diarrhea, discharged 6/3 after given, morphine and IV fluids - also began Asacol - pt has follow up appt with gastroenterologist.  07/02/2007 MR received for a 2 night admission 6/1-3/2007 for c/o rectal bleeding, abdominal cramping, nausea and vomiting.  Pt reports on and off rectal bleeding x 8 months which increased night prior to admission. Treated w/ bowel rest and Asacol. Principal DX: Colitis, probably 2' to ulcerative colitis vs. ischemic colitis. 2' DX:  HTN.  GERD. Hyperlipidemia. Left arm redness after a zoster vaccine. Depression on Lexapro.
A report has been received from a Health Professional concerning a female subject, who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST (intranasal) started on an unknown date for INFLUENZA. It was reported that the FLUMIST was administered to a 50 year old patient. Action taken with FLUMIST was unknown. The outcome of the event of ADMINISTERED TO A 50 YEAR OLD PATIENT was unknown. The report was considered to be non-serious.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication were reported.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.  No treatment medication were reported.      Most recent FOLLOW-UP information incorporated above includes:
Irregular period, 3 weeks after my second vaccine i got my normal period then 6 days later I got it again, the same thing happened the month after and this month my period is not coming as normal.; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Feb2021 (at age of 31-year-old) as dose 2, single for COVID-19 immunisation at Public Health Clinic. The patient medical history and concomitant medications were not reported. Patient was not pregnant at time of vaccination. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982) on 20Jan2021 (at age of 31-year-old) for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced irregular period, 3 weeks after her second vaccine patient got her normal period then 6 days later she got it again, the same thing happened the month after and this month her period was not coming as normal on 09Mar2021. Due to adverse event patient visited doctor or other healthcare professional office/clinic. She was not treated for event. The outcome of event was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report has been received from a certified medical assistant concerning to a 16 year old female patient with historical vaccination with the first dose of MMR (unspecified) on 22-MAR-1999 and the first dose of VARIVAX (unspecified) on 18-MAY-2007. On 25-NOV-2013, the patient was vaccinated with PROQUAD (Merck), (dose, lot# and route not reported). Concomitant medication was not reported. No adverse effect reported. Additional information has been requested.
Hospitalized + COVID 5/7/2022 fatigue, generalized weakness, hypotension, cough, dyspnea treated with Remdesivir
Began experiencing itching all over body approx 2 hours after injection. Itching progressed and child became short of breath. Ambulance called at 800pm and child taken to medical center. Treated with Epi, steroids and BENADRYL. Released at approx 1am.
Bunch of the liquid ran down his arm; Bunch of the liquid ran down his arm; A spontaneous report  was received from a consumer who was a male patient of unknown age, who received moderna's covid-19 vaccine (mrna-1273) and experienced a bunch of vaccine ran down his arm (accidental underdose).  The patient's medical history was not provided. Concomitant medications were not reported.  On 30-JAN-2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 007M20A)intramuscularly for prophylaxis of COVID-19 infection. On 01-MAR-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection  On 0- MAR-2021, the patient reported that when the vaccine was administered to him, a bunch of the liquid ran down his arm and he did not feel pain from the injection. The patient reported that, after the first dose, he experienced fever and headache.   Treatment information for the event was not provided.  The patient received both scheduled doses of mRNA-1273; therefore, action taken response to the events was not applicable.  The outcome of the event, while vaccine administration a bunch of the liquid ran down the arm, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of accidental underdose of mRNA-1273, lot # 014M20A with no adverse events
COVID-19 breakthrough case. Symptoms began: 08/30/2021. Lab confirmed: 09/03/2021.
c/o persistent headache, n/ and dizziness since J&J vaccination on 9 Apr. denies chest pain, sob, v/d/, abd pain.
Onset 3-4 days after receiving vaccines subjective fevers/chills/myalgias & mild HA. On V, D. Seen initially 7/30/10. Seen again 8/12/10 with now sore throat & cough. Labs at that time revealed AST 296 (11-33) ALT 560 (22-68) no phos 461 (40-120) t. bili 1.2 (<1.1).