chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sig elevation in previously controlled HTN; chills without fever; extreme fatigue; upset stomach without true nausea and loss of appetite; upset stomach without true nausea and loss of appetite; This is a spontaneous report from a contactable physician (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), via an unspecified route of administration on 11Jan2021 08:30 at a single dose for COVID-19 immunization. Medical history included hypertension, environmental allergies, and COVID-19. Concomitant medication included nebivolol hydrochloride (BYSTOLIC), cetirizine hydrochloride (ZYRTEC), and esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]). The patient experienced sig elevation in previously controlled HTN, chills without fever, extreme fatigue, upset stomach without true nausea and loss of appetite on 11Jan2021. No treatment received for adverse events. The outcome of the events was recovering. Facility type Vaccine was Hospital. No other vaccine in four weeks. The patient was not COVID tested post vaccination.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-418891 (Patient Link).
terrible cough; body aches; 100 degree fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (terrible cough), MYALGIA (body aches) and PYREXIA (100 degree fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (terrible cough), MYALGIA (body aches) and PYREXIA (100 degree fever). At the time of the report, COUGH (terrible cough), MYALGIA (body aches) and PYREXIA (100 degree fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported No treatment drugs were reported
Shortness of breath; Little soreness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Little soreness around injection site) and DYSPNOEA (Shortness of breath) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0291_20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE PAIN (Little soreness around injection site). On 22-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). On 21-Jan-2021, INJECTION SITE PAIN (Little soreness around injection site) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received two vaccines. Prior to the vaccinations, Pt underwent a fingerstick. Pt commented on the amount of blood, but did not state she was feeling unwell. The first vaccine, the flu shot, was administered in the right arm with no complications. The second vaccine, the covid vaccine, was administered in the left arm at 10:15am. The medical assistant turned slightly to retrieve a bandaid when the Pt began to lean forward on the exam table. MA asked if she was alright, but Pt suddenly fell forward off of the exam table. MA tried to grab her left arm, but was unable to. MA was unable to catch the patient. Pt fell and hit the right side of her forehead on the ground. MA immediately notified and brought a doctor. Pt appeared to have a syncopal event presenting with stiff limbs. She was also bleeding from a cut on her right eyebrow. Oxygen was placed by mask at 2 liters. Pt was unconscious for less than 1 minute. When she awoke, she appeared alert and returned to baseline cognitive functioning. Heart rate and respiratory rate were normal with oxygen saturation at 98%.  Pt sat up and was given apple juice and crackers. Pt was monitored by a nurse and the doctor for 1 hour and remained sitting on the floor. Pt stood up after an hour to sit on exam table. Once she was on the exam table, she had a near syncopal event, and paramedics were called. She again returned to her normal baseline cognitive state and again heart rate, pulse ox, and respiratory rate were normal. Patient was transported to hospital by EMS.
Significant post-menopausal bleeding occurred in the weeks following vaccines 2 and 3 of the Pfizer COVID-19 injections. After shot #2, heavy bleeding occurred for more than 20 days. After shot #3 (the booster), for 12 days. I did not consider the vaccine as a factor after the second shot, but am reporting at this time in the event that the data is useful. No other consequential adverse reaction to any of the 3 vaccine shots this year.
expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event; Initial information was received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 79 years old male patient who experienced expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Feb-2023, the patient received a Dose 1 dose of 0.7 ml of suspect influenza quadrival a-b high dose hv vaccine lot UJ765AB via intramuscular route in the left deltoid for Immunization.  On 02-Feb-2023 the patient developed a non-serious event of expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event (expired product administered) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event (expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event).  At time of reporting, the outcome was Unknown for the event expired dose of fluzone high-dose quadrivalent was administered to a patient with no reported adverse event.   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 the 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.
The day after he received his shots, parents noted that he had profound neck/chin swelling, and also on cheeks, arms, and legs.  Denies difficulty breathing, did not appear to have any discomfort, no vomiting, no diarrhea. Fever for about 24 hours day after shots and received Tylenol.   Patient was not evaluated at the time of the symptoms.
This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a child patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by a GlaxoSmithKline representative on behalf of a healthcare professional. The representative received notification via email, that 2 children were experienced adverse reaction after receiving BEXSERO vaccine. The representative was only able to provide the phone number for the healthcare professional and a follow-up call was placed and voice message was left, requesting a call back to provide additional information. No further information was provided. This case has been linked with US2016087331, reported by the same reporter.
>> Oct 19, 2021  9:00 AM wrote: Does the patient have current symptoms of illness? Yes    Date symptoms started: 10/18/21   1.         Does the patient have a fever (subjective or confirmed)? No   2.         Does the patient have a new onset of cough? Yes   3.         Does the patient have a new onset of shortness of breath? No  If Yes: Is the patient having difficultly breathing or in distress? No   4.         Additional symptoms: Headaches and Congestion or runny nose
pain at site of injection, sudden onset of chills/sweats, feverish, fatigue, body aches , nausea, lightheaded, feeling unwell. Recovered following day with exception of a flat reddened rash developed to torso area, may be fever related.
He had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (He had a sore arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic (He's diabetic). Concomitant products included GLIPIZIDE and SEMAGLUTIDE (OZEMPIC) for Diabetic.    On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (He had a sore arm). At the time of the report, PAIN IN EXTREMITY (He had a sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment details were reported.  Company comment- This case concerns a 48-year-old male patient with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred 1 day after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-389689 (Patient Link).; Sender's Comments: This case concerns a 48-year-old male patient with no relevant medical history, who experienced the unexpected event of Pain in Extremity. The event occurred 1 day after receiving the first dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Two days after receiving H1N1 vacc. extreme pain in joints and muscles, could not walk but short distance. Primary care Dr. sent me to a Rheumatologist - complete work up for Lupus and other related diseases. None of tests were positive. Have continued to have severe knee, wrist, hand, feet and leg pain. Have had steroid inj. with some relief but pain returns. Also suffer weakness, no stamina. I have lost my past way of life and am confined to home most of the time.
Redness and swelling on site of shot. Felt warm and had a fever 2 days ago.
Infant received flu vaccine 5 days ago. Dose given was 0.5mL, instead of the typical 0.25 mL dose.  Mom has noted child has been fussy, irritable, has loose stools, decreased appetite and low grade fever. No emesis. No rash. No local swelling at injection site.
3 days after the first dose, pain in stomach that stopped after a few hours. 3 days after the second dose, appendicitis was diagnosed and surgery done.
Information has been received from a physician concerning a patient who on 04-NOV-2008 was vaccinated with VAQTA vaccine. Subsequently the patient experienced rash at the injection site where VAQTA vaccine was given. The patient sought medical attention with an office visit. At the time of reporting, the patient has not yet recovered. No product quality complaint involved. No further information is available.
Pt recv vax on 4/5/99; on 4/7/99 pt exp fever (104), frequent stools
TENDERNESS ON NIGHT OF 02/21/22. REDNESS AND TENDERNESS MORNING OF 02/22/22. WARM TO TOUCH, RED AREA ABOUT 3x2 INCHES. PT USED TOPICAL BENADRYL, BY MOUTH ALEVE, TOPICAL ARNICA. TOLD PT 02/23/2022 TO  DRAW CIRCLE AROUND AREA TO MONITOR SPREAD OF REDNESS, TAKE BENADRYL BY MOUTH, AND APPLY ICE
10 days following vaccination the patient developed: Profound lactic acidosis Neurologic decline Respiratory failure Hypotension
Worst headache in 5 years 102 fever, muscle aches in both arms and calves, upset tummy
Patient given vaccine, within 30 seconds became sweaty, shaky, pale, dizzy, complaining was dizzy and nauseous, had shallow breathing. EpiPen was administered within 2 minutes and 911 was called. Paramedics arrived, patient's BS and BP was good. Had nothing to eat or drink prior to the shot.  Was deemed okay but taken to Salem Hospital anyways. Had no car but patient was taken with paramedics to hospital.
Bilateral upper arm pain(non specific), leg, and knee pain, nausea, headache. All symptoms persist since shortly after vaccine.
10-22-2014 PREVNAR 13 - Rt deltoid. 25 headache - fatigue. 11-6 saw PCP - increased headache, increased fatigue - loss of appetite, wt loss, nauseated - prescribed depression meds. 11-9 feeling a lot worse, stop meds - (not depressed). 11-11 saw PCP - questioned PREVNAR 13 - possible cause of symptoms - (treated dog bite). 11-24 symptoms worse - Rx prescribed - levofloxacin 750 mg - (? no fever, cough or any new symptoms). 12-03 feeling worse - saw PCP - chest x-ray done because of Rt chest pain with deep breathing, S.O.B., - Dx pneumonia, sent to E.R. Admitted to hosp. Received 2 or 3 IV antibiotics. 12-6 dc'ed - being followed by pulmonary spec. 2-18 filing report to CDC - still not back to normal.
Patient was administered KINRIX vaccine IM without incident. KINRIX is not recommended for children above the age of 6 years.
Right Side of Face numb, Right arm slightly numb. Two days later I had a high blood pressure reading taken at home 138/96 (very high for me). After three days the symptoms went away.  Today 12/3/2009 the right face is numb again - prompting me to make this report.  No other symptoms.  I have not taken my blood pressure again.
Pt had received pfizer for all prior doses, then got moderna for last 4th booster dose. A few days later he started to develop paraesthesias/numbness in the hands/fingers. He gradually developed ascending weakness over the next month, ultimately affecting his tongue and speech. He was ultimately unable to speak or walk. he was ultimately hospitlized for his symptoms and diagnosed with Guillain Barre syndrome and was treated with IVIG, and his symptoms significantly improved, he was able to be discharged and returned to ambulation.
This spontaneous report as received from a nurse practitioner refers to a 13 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 05-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperautre excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reprots from the same reporter. Additional information has been requested.
+diffuse maculopapular rash s/p vaccines on Tuesday 03/17/2015. Mild fever 1st day followed by diffuse rash yesterday slight decreased appetite but good UOP (10x/day) and normal stools. +fussy per parents-->seeming itchy. Rash worse over site of injections in thighs (patch-like erythema) and present on trunk as well as arms/legs, elbows. Discussed with Pediatrics (per PCP, + mild rash seen around umbilicus prior to vaccines-->looked at rash today and notes now significantly more diffuse c/w exacerbation). May give decadron for severe rash (do not feel necessary in this case). Cautioned against Benadryl as under 6 month of age-->but may be okay to trial topical Benadyl (small quantities-->encouraged to avoid for now-->trial emollients only for now such as Aquaphor and rash should be self-limited. Precautions given to seek med attention if any worsening symptoms, shortness of breath. Voice understanding and agree with plan.
Product apparently leaked out of a Covid-19 prefilled syringe; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.    The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe) and NO ADVERSE EVENT (No adverse event). At the time of the report, SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe).  For Pre-filled Syringe, the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for SYRINGE ISSUE (Product apparently leaked out of a Covid-19 prefilled syringe).    Concomitant medications were not reported.  The Device problem code for Spikevax syringe include FDA code, code A050401 which include Fluid Leak. The Spikevax syringe device was malfunctioned and the type.  No treatment information was provided by the reporter.   Reporter did not allow further contact
4 days following 1st COVID vaccine, pt developed erythema migrans vs cellulitis vs insect bite to left lower back. ? Lyme disease, treated with doxycycline, began resolving in 3 days after start of doxycycline. No other systemic signs and symptoms at that time.
Patient presented to pharmacy on 5/29/21 with cold sore/blisters around mouth. Lips were also noticeably red. Patient was seeking treatment for Valacyclovir/Acyclovir from pharmacy. Patient says the blisters occurred after he got the vaccination. Instructed patient to see PCP or if urgently needed to go to the emergency room.
injection site pain (muscle very sore with decreased range of motion) tiredness headache feeling unwell
Pediatric dose was given to adults mistakenly; No Adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No Adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Pediatric dose was given to adults mistakenly).    Concomitant medication not reported.  051B22A was kept in the freezer upon receipt of shipment on 1 Aug 2022 and individual vials were put in the refrigerator on the day of use. Pediatric dose was given to adults mistakenly and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose.    Treatment medication not reported.
Heavy fever - 102.8 degrees; Body aches; loss of taste; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on left arm on 13May2021 at 13:30 as single dose for COVID-19 immunization. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, unknown whether the patient had been tested for COVID-19. No known allergies. Concomitant medication were not reported. The patient previously took the first dose of BNT162B2 as single dose for covid-19 immunization. The patient experienced heavy fever-102.8 degrees, body aches and loss of taste on 14May2021 at 12:00. The treatment was not taken. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Physician incorrectly administered vaccine. Instead of receiving the second dose Pfizer monovalent she gave me bivalent
After approx 22 hours, a bit chilled, tired; After approx 22 hours, a bit chilled, tired; Went home, dosed a bit, have 99.4 f temp; This is a spontaneous report from a contactable Other-HCP. This 63-year-old male Other-HCP (patient) reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular at left arm on 12Jan2021 02:00 AM at single dose for COVID-19 immunization. Medical history was none. Concomitant medications included diltiazem, tamsulosin. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 21Dec2020 08:00 AM for COVID-19 immunization. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. On 13Jan2021 00:00 AM (after approx 22 hours), patient had a bit chilled, tired; he went home, dosed a bit, had 99.4 f temp. No treatment was received. Outcome of events was not recovered.    Information on the lot/batch number has been requested.
high fever, convuls, encephalopathy, scream, contacted 911 amb came actual scream (animal like) happened on 9th day, a/that swollen leg, sz, fever;
Facial/lip swelling and numbness, itchy ears, eyes, and skin around mouth.
4:11 pm tightness and swelling of throat; 4:30 pm anaphylaxis - s/sx swelling of throat and tongue, difficulty swallowing, dysphonia, hypertension, low saturation, hoarseness; 4:35pm  Tx Epinephrine 0.3 mg IM,  ECG, Benadryl 75 mg IV, 5:05pm  transport to hospital, ECG, 5:15pm ECG, 5:35 pm famotidine IV, methylprednisolone sodium succinate IV Have had chronic dysphonia since.