chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blood in his urine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program.  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 02Feb2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient has blood in his urine, received first dose 02Feb. The patient underwent lab tests and procedures which included urine analysis: blood in his urine on an unspecified date. The outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Vomiting, diarrhea, hives. Per medical record, pt experienced allergic reaction. Pt also experienced dehydration, hyponatremia, and fever.
No additional AEs; CMA calling on behalf of satellite clinic for information re dosing schedule for GARDASIL 9. Caller reports that patient received 1st dose at 14 years and 2nd dose at 15 years. Date of administration is week of 1/30/2023.; This spontaneous report has been received from other health professional concerning to a 15-year-old female patient. The patient's medical history, current conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On an unknown date, the patient received the first (1st) dose at the age of 14 years of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliter (ml),once, (strength, lot number, expiration date, and route of administration were not provided) for prophylaxis.   Then, on 30-JAN-2023, the patient received the 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) over 1.5 years later at 15.5 years of age, at a dose of 0.5 milliliter (strength, route of administration, lot number and expiration date was not provided)(inappropriate schedule of product administration). Therefore, "CMA" called for information regarding the dosing schedule for of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) specifically if patient required third (3rd) dose.   No additional adverse event (no adverse event).
Hives, Rash. Started on Upper Right arm then the next day was lower right arm. Next day and upper left arm. then lower left arm and back. Now a little on face. Seems to spread slowly. Very itchy. Hot water applied relieve the itch. Benadryl doesn't help much. Hydrocortisone cream does help some. I can't really tell if it is subsiding yet.
Reported via Nurse Triage / PCP:  Fainted earlier, eyes rolled back, mouth was drooping. Nausea, weakness, and chills. BP was 107/75, HR in the 70s. Currently alert and resting.  States that patient had his 2nd covid vaccine yesterday AM and then develop chills and clammy skin last night.  Symptoms worsened today and patient became weak and fainted.  Was unconscious for about 5 minutes and while unconscious, mouth was open and drooling and became incontinent and eyes rolled back in head.  Is awake and alert now, but still weak and only able to take 1 or 2 steps.  No chest pain or breathing difficulty and no fever.  Feeling very nauseous.  Caller requesting prescription for zofran.      Yesterday AM 2nd vaccine. Last night chills. This AM feeling weak. Today at 11am he felt weak with ambulation. He fainted. Was unconscious for 5 min. Had drooping of the face. He was unresponsive during this time. Had incontinence of urine. Then became awake but very weak still. Only able to walk a few steps. He is communicating. No chest pain. No current fever. No shortness of breath. BP 107/75 with HR 70. He has been very nauseated. He is drinking only small sips of water. Does not seem like a usually COVID-19 vaccine reaction. Given the LOC with urinary incontinence and sustained weakness, I advised ER evaluation to rule out neurological issues. Pt's daughter in agreement. They will go to ER.  From Emergency Department:  Patient presenting with chief complaint of syncopal episode which was witnessed by his wife.  He reported the got dizzy and lightheaded and then passed out while seated.  The reported duration of his loss of consciousness was somewhat inconsistent, unclear how long he passed out for, there was however no postictal state.  He was not noted have any shaking or seizure activity, he did have an episode of urinary incontinence.  He has not been feeling well ever since receiving his 2nd COVID-19 vaccine.  By the time of my exam patient states that he is completely asymptomatic, he states he is feeling much better after receiving IV fluids.  His lab work is remarkable for a slightly low sodium, compared to his previous levels which were many months ago.  Unclear of the acuity of this, although upon further discussion with the patient he has been drinking large amounts of water since his vaccine trying to stay hydrated.  I advised him to substitute to some electrolyte balanced fluids and to have his sodium rechecked by his PCP to ensure that this is transient.  With negative testing and resolution of his symptoms he is stable for discharge home.  Close return precautions were given.
COVID vaccine was given to a patient who is 17 yrs & 10 months old. It is not indicated for patients under age 18
Period still has not come per the patient,Irregular period; Did not get the period after receiving the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Period still has not come per the patient,Irregular period) and AMENORRHOEA (Did not get the period after receiving the moderna vaccine) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced MENSTRUATION IRREGULAR (Period still has not come per the patient,Irregular period) and AMENORRHOEA (Did not get the period after receiving the moderna vaccine). At the time of the report, MENSTRUATION IRREGULAR (Period still has not come per the patient,Irregular period) and AMENORRHOEA (Did not get the period after receiving the moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pregnancy test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that her last menstrual cycle period was on 21-Nov-2021 before the vaccine and her period usually lasts 10 days at the latest. Now it is 29-Dec-2021, the still not get the period after the vaccine. patient went to ER and done the HPT for the pregnancy test and it was negative that the patient was not pregnant. The patient stated that her period should have come by 21-Dec-2021 and has not gotten her period yet  No concomitant medications reported.  No treatment medications were reported.
burning cheeks; hurt and itchy allergy cheeks area; hurt and itchy allergy cheeks area; This spontaneous case was reported by a pharmacist and describes the occurrence of BURNING SENSATION (burning cheeks), FACIAL PAIN (hurt and itchy allergy cheeks area) and PRURITUS (hurt and itchy allergy cheeks area) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced BURNING SENSATION (burning cheeks), FACIAL PAIN (hurt and itchy allergy cheeks area) and PRURITUS (hurt and itchy allergy cheeks area). On 31-Mar-2021, BURNING SENSATION (burning cheeks), FACIAL PAIN (hurt and itchy allergy cheeks area) and PRURITUS (hurt and itchy allergy cheeks area) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient took Benadryl as treatment for the symptoms.    This case was linked to US-MODERNATX, INC.-MOD-2021-081428 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081428:Crossed linked
Red rash, small injection site lump and itch. Treated with cold compress and diphenhydramine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient received a dose of ZOSTAVAX (lot#, dose, route not reported) that was reconstituted and then left out at "room temperature for 40-45 minutes" before being administered to the patient. No concomitant medications were provided. The pharmacist stated "this was past the 30 minutes given in the prescribing information so the patient was questioning the validity of the dose". No adverse effects were reported. Additional information has been requested.
ADMINISTRATION OF AN EXPIRED MEDICATION; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender of Unknown ethnic origin (age 11 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number PJ3267) (expiration date 26-DEC-2022) 0.1 ml, via nasal route, on 29-DEC-2022.     A unknown administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    The report described a medication error for Flumist Quadrivalent. The reported term was administration of an expired medication (Preferred term: Expired product administered).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Incident occurred from possible inviable covid-19 pfizer-purple dose (booster) being administered to the patient. Patient reported no adverse events other than typical ones from covid vaccine. Patient was offered replacement booster dose & wants to discuss with her doctor.
Swollen (L) arm with redness from upper (L) arm to (L) hand - warm & reddened. 11/11/11 - given ANCEF 1gm IM/KENALOG 80 mg IM fat.
Large indurated swelling on the left deltoid with a circumferential ring of erythema approximately 1 cm out. Warm to the touch. Extensive swelling and lymphadenopathy of the axilla, lateral breast up into the pectoralis muscle and into the latissimus muscle. And I
Fever 101.6 10/23/04. Resolved. 10/25 fever and rash started. No cough rhin. No exposure to varicella, not ill. No oral lesions. Multiple red papules trunk, arms, scalp (few). No vesicles. Approx 40 lesions. 10 mot lesions over next 2 days no vesicles. Not ill.
Presented to ED with productive cough with difficulty breathing.  EMS confirmed hypoxia and placed the patient on 2LNC.  The patient was admitted to the hospital for COVlD-19 pneumonia and nonischemic myocardial injury. His white count was initially 15,000 and it went up to 20,000. We increased his antibiotics and it came back down. He was initially hypoxic needing 2 liters of oxygen and he actually came back down to room air. He has been on Brilinta and Xarelto here in the hospital. We gave him steroids and then he started complaining of acute abdominal pain. He became acidotic. His C02 was 13. He was still hypotensive, even after fluid boluses. He had SIADH. We moved him to the ICU and started him on Levophed. He coded and we gave him several amps of bicarb. We got him back mid his pulse WM good but his blood pressure was 120 on Levophed. Then he started breathing down and he became hypotensive again with a systolic of66. We gave him more bicarb. We consulted Dr. and he agreed because of his COVID and his hypotension, he is a non-surgical candidate. White count popped up to 23,000. We called the family and they wished him to be a DNI/No Code. He was pronounced at I 0:20 on 02/08/2022. He died of sepsis secondary to ischemic bowel secondary to COVID-19 complicated with diabetes
I have been spotting now since May 16th; I have had two menstrual periods since March 18th; This is a spontaneous report from a contactable other hcp (patient). A 38-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 06Mar2021 (Batch/Lot Number: EN6206) as dose 1, single for covid-19 immunisation and medroxyprogesterone acetate (DEPO-PROVERA, suspension for injection), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history was reported as multiple. Concomitant medication included too many. The patient experienced she have had two menstrual periods on 18Mar2021, and she have been spotting now on 16May2021. The reporter stated that she had two menstrual periods since 18Mar2021. She has already applied 2 Mexican Depo Provera injections, also made by Pfizer, hoping to make it stop. She should mention she have been using these injections for about 10 years. she has been spotting now since 16May2021. She can no longer deny this is vaccine related when my sister is having similar symptoms but is not on any meds or birth control. If someone knows what she can do to make this stop she would appreciate some information as she doesn't see anything on your site. The patient was not a hospitalization prolonged. The patient did not receive any treatment for the events. the patient was not diagnosed with COVID-19 prior to vaccination and have not been tested for covid 19. The action taken in response to the event, for medroxyprogesterone acetate was unknown. The seriousness of the events was reported as non-serious. The outcome of the events was reported as not resolved.   No follow-up attempts are possible. No further information is expected.
Patient previously had complete series of 2 doses of Moderna. Patient is not immunocompromised and came to clinic for booster dose of .25mL(50mcg). During first day of Moderna booster administration, we were also still giving full doses to people needing 1st and 2nd doses as well as full 3rd doses for immunocompromised people. We may have given the patient the wrong card to hold identifying them as here for a 1st, 2nd, or 3rd full dose instead of a booster dose, or flagged them incorrectly in our queueing system. The patient was called to or somehow wandered into the stall where full doses are given. We then accidentally gave this patient a full 3rd dose of 0.5mL (100 mcg), instead of the .25mL (50 mcg) dose that we intended to give. Due to the markings on the stalls (boosters given in one area and full doses given in another area) and our conversation around the patient, the patient realized during the observation period that there might have been an error. We confirmed there was an error and discussed it with him, he felt fine during the observation period and did not seem concerned. He finished the observation period and left. We told him we would make a VAERS report and gave him our contact information.
Shingles appeared on nose, face, and eyes 48 hours after vaccine. Shingles still remain 1 week after vaccine.  Treatment is antibiotics.
One of twenty-one cases: A non-serious, spontaneous event of half dose of FLUMIST administered was received from a registered nurse. The event occurred in an eighth grade adolescent male. No medical or drug history was reported for this adolescent. FLUMIST was inadvertently administered in one nostril to 21 children during a flu clinic at an elementary school. The nurse administering the dose had been trained on administering FLUMIST but forgot to take off the divider clip; 21 children received only half a dose. No adverse effects were reported; the event is considered resolved.
Patient reported to pharmacy the day after receiving PneumoVax 23 in the morning and complained of pain in her arm, it was approximately 24 hours since the vaccination was given, upon examining her arm it appeared red and swollen on the biceps on her left arm, patient still had the bandaid on from the previous day on her left deltoid and she had no signs of issues around the actual injection site in her left deltoid. Upon seeing this, I immediately referred her to the Emergency room at our local hospital for treatment.
Myalgia with spasm and knot in left tricep. Jolts of pain and cramping for several seconds.
Patient reports that he began to experience vertigo (the room was spinning), two days after the vaccine was administered. Mom is unsure if it is related but ask that it be reported. Vertigo is beginning to get better now, two days after it started.
Shingles; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (Shingles) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported. It was reported that the patient got shingles. She stated that it started on the back of her neck appearing as a large lymph node, but was itchy. It moved from  the back of her neck to the right side, then to front a little bit. She mentioned it was itchy, rather than painful. She further described it as still a bit scabby. She was diagnosed after going to an urgent care doctor. She was prescribed 1 gram Valacyclovir three times daily, which worked really well.
Arm was sore including the armpit; Shortness of breath when lying down; Arm was sore including the armpit; Redness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness on the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness on the injection site). On 04-Feb-2021, VACCINATION SITE ERYTHEMA (Redness on the injection site) had resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Reporter did not allow further contact
Information has been received from a 76 year old female patient with sulfonamide allergy and with no pertinent medical history who in October 2009 was vaccinated with a single 0.65 ml dose of ZOSTAVAX (Merck) (lot number and exp date unspecified) SC. There was no concomitant therapy. The patient started itching tremendously 4 to 5 days after getting the ZOSTAVAX (Merck) injection. The patient had been to 3 dermatologists. At the time of report the patient's status was not recovered. Follow up information has been received from a registered nurse concerning the 76 year old female patient with pre existing allergy on sulfa and nitrofurantoin who on 08-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck). Two weeks after vaccination, on approximately 22-OCT-2009, she complained of rash. She had seen two dermatologists and stated that she might be allergic to neomycin and then had eczema. Follow-up information has been received from a registered nurse concerning the patient who 08-OCT-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # unknown). Concomitant therapies included vaccination on 23-Oct-2010 intramuscularly into the left deltoid with a dose of FLUZONE (Lot # U3194AA) at 16:26. No illness at time of vaccination. The nurse reported that the patient developed rash in November 2009 (also reported as October 2009) after receiving vaccine which was persistent. Patient had been treated with steroids and cream (unspecified). The patient saw dermatologist. At the time of the report the patient had not recovered. Additional information has been requested.
STRONG SPASMS IN LOWER BACK.  NOT NORMAL. NEEDED TO TAKE STRONG PAIN KILLER. ALSO, NEXT DAY - DIZZINESS AND NAUSEA.
An MA reported that a 34 month old child received Acel-Imune and Prevnar vaccines on 5/2/00 and within 24 to 48 hours, post vax, the child developed an injection site reaction characterized by a red, warm, hard welt at the site of the Acel-Imune administration. This is 1 of 6 pts from this facility who experienced this event following receipt of 3 different lots of Acel-Imune.
This spontaneous report was received from a healthcare student regarding a 70 year old female patient with no pertinent medical history or drug reactions or allergies. On 24-JUN-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # H016230, expiration date 13-NOV-2013) (subcutaneous in the arm, dose not reported). Concomitant therapies included fluticasone, vitamin d (unspecified), desloratadine (manufacturer unknown) and simvastatin (manufacturer unknown). On 25-JUN-2013 the patient developed "a red hard spot at the injection site, with redness that spread down the patients' arm from the injection site to the elbow" after receiving ZOSTAVAX. The reporter also mentioned that the patient stated this area felt hot to touch and it was painful to sleep on the affected side of her arm. The outcome for the above mentioned events was reported as recovering. No laboratory diagnostic studies were performed. It was reported that the patient sought medical attention by calling to the pharmacy. Additional information has been requested.
States woke up at 3am 1/28/2021, with chills, bundled up in multiple blankets but is unable to get warm. Does not have a thermometer but feels as if has an elevated temperature. Left arm and up into shoulder area is extremely painful and aches constantly, pain increases with any touch.
This spontaneous report was received from a nurse refers to a 2 children under the age of 5 years. Medical history was not reported. On an unknown date the patients were vaccinated with expired doses of M-M-R II injection, lot # J012083, expiration date 27-JUL-2014 (route and dosage were not reported). No adverse effects reported. Additional information is not expected because the reporter refused additional contact.