chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle aches, headache, rash covering large portion of upper arm where injection given.  Aches and headache lasted three days. Rash lasted 8 days.
Arm and shoulder pain and restriction of movement. Ongoing. Doctor visit on 11/5/2015 Prescribed pain medication.
First miscarriage, 06/2021 Second miscarriage, 08/2021
Flushed feeling and mild headache.  Medical attention not sought.  Resolved on own in a couple hours.
WORSE ASTHMA ISSUES; BODY ACHES; SLEEPLESSNESS; TASTE STILL OFF; SKIN IRRITATIONS; COVID 3 TIMES; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on unspecified date for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced worse asthma issues never went away, body aches, sleeplessness, taste still off, skin irritations, and had Covid 3 times after vaccine (Dose number in series 2). As per the patient, "Had vaccine 2xs worse asthma issues never went away. Body aches, sleeplessness, taste still off, skin irritations etc the list goes on...had Covid 3xs after vaccine. Useless experiment on us all. Pfizer doses, J&J useless, Moderna gets you sick" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from worse asthma issues, and taste still off, and the outcome of body aches, sleeplessness, skin irritations and covid 3 times was not reported. This report was non-serious. This case, involving the same patient is linked to 20221238315. This report was associated with product quality complaint: 90000263666.
0756:15 minutes after immunization she stated that she felt itchy. Her back felt itchy. Hives were noted on her left arm. Felt she was going to pass out.  0800: Taken to ED. Evaluation revealed tachycardia, c/o throat constriction, wheezes heard on auscultation of lungs, hives noted on chest. Treated with Decadron, Benadryl, Famotidine and Ativan. She was observed for 5 hours before being discharged.
Pt recvd vax & 7 hrs later devel generalized itching; the next morning exp a sprinkle of hives on neck & back; pt was seen by nurse in nursing school; pt recvd 2nd dose of vax w/o any side effects;
Patient stated that she had soreness and pain in her arm for the past 2 months. She had a doctor do an ultrasound on her arm to see if there was a clot or damage to the joint (and that came back normal with no issues).
Fatigue, nausea, vomiting, diarrhea, chills, fever, sweats, skin sensitivities
This spontaneous report as received from a physician via a company representative refers to patient of unknown age and gender. On an unspecified date, the patient was vaccinated with (Oka/Merck) VARIVAX, (lot #, expiry date, dose and route not reported). On an unknown date, the patient experienced rash and visited the emergency room, but was not admitted. The outcome of rash was reported as recovering. The patient had contacted the physician's office on an unspecified date. This is one of several reports from the same source. Additional information has been requested.
patient received 2 injections of MENACTRA, one at 11 years and second at 18 years old with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other healthcare professional via phone at a call center as a Global Medication Inquiry on 25-Nov-2020.  This case involved a 18-year old male patient who received two injections of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (MENACTRA), one at age of 11 years and second at age of 18 years old with no adverse event (inappropriate schedule of product administration).  Past vaccination(s) included MENACTRA at 11 years of age.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2020, the patient received a second dose in series of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 mL once (lot number: U6787AB, expiry date: 11-Aug-2021) via intramuscular route in the left arm for prophylactic vaccination (Inappropriate schedule of product administration) (latency same day).  This is a true medication error case since there was an inappropriate schedule of vaccine administered..  At the time of reporting, the patient did not experience any 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 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.
Pt recvd vax & several hrs later exp malaise,chest pain & fever over 104 was admitted to ER.
patient passed out less than 5 minutes after pfizer covid shot administered. 911 was called and paramedics responded. patient's blood sugar was low and they gave him glucose gel. patient was alert and coherent but they decided to take him to the hospital to be checked out
Large raised bump following second dose of second shot. It?s hard and hot to the touch... it?s also very itchy around the parameter of the injection site.
The second fall he hit his head and had to go to ER; causing my husband to fall twice in one week; dizziness causing my husband to fall twice in one week; walking with walker and assistance; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on Aug2021 11:00 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included aneurysm from Apr2015 to an unknown date He was a survivor of a brain aneurysm with subarachnoid hemorrhage. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Aug2021 13:00, 1 week after vaccine, the patient had onset of dizziness causing to fall twice in one week on an Aug2021. The second fall he hit his head and had to go to emergency room (ER). Hospitalized for 1 night. Still dizzy and walking with walker and assistance on Aug2021. The adverse event resulted in patient to visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Aug2021 covid test post vaccination: Nasal Swab, in ER. The patient received treatment with neuro test and Antivert for dizziness. The seriousness of the event was considered as Hospitalization, Disability or permanent damage. Since the vaccination, the patient had been tested for COVID-19. Outcome of the event was not resolved.
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 02/17/22 at 2:45PM. Patient has not reported to Medical Clinic with symptoms at this time.
No additional adverse events; Wrong vaccine administered; Inappropriate age at vaccine administration; Product label confusion; This spontaneous case report has been received from a practice lead, referring to a 17 years-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug and/or allergy reactions were provided.  On 30-SEP-2021, the patient was inadvertently vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter administered intramuscularly (strength, vaccination scheme, anatomical location of administration, were not reported; ; lot # S023646 has been verified as valid lot number and expiration date reported and established as 31-MAR-2022)  for prophylaxis (wrong product administered, product administered to patient of inappropriate age).   The patient was supposed to received meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (strength, dose, vaccination scheme, route and anatomical location of administration, lot number and expiration date were not reported) for prophylaxis, The reporter confirmed the patient did not received meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) and is scheduled to receive it at a later date. The customer reported since the products both had meningococcal on the box (product label confusion). No additional adverse event was reported. No further information was reported.
Sore joints. Contracted COVID-19 in March 14,2022. -Sinuses -Severe Headache
PATIENT REFERS GENERAL MALAISE WITH DIZZINESS AND HEADACHE AFTER VACCINATION.
Pt recvd 1st dose of Engerix-B & "several hrs" p/inject pt exp rash, itching, abdo pain & clay colored stools; events resolved in 24 hrs;
Feel worse than when had COVID-19 after the 2nd dose; Diarrhea after the 2nd dose; Fatigued after the 2nd dose; Chills after the 2nd dose; Throwing up after the 2nd dose; Fever of up to 102 F after the 2nd dose; Worst headache ever after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose) and VOMITING (Throwing up after the 2nd dose) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. d44d21a and 025c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose), VOMITING (Throwing up after the 2nd dose), PYREXIA (Fever of up to 102 F after the 2nd dose) and HEADACHE (Worst headache ever after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, FEELING ABNORMAL (Feel worse than when had COVID-19 after the 2nd dose), DIARRHOEA (Diarrhea after the 2nd dose), FATIGUE (Fatigued after the 2nd dose), CHILLS (Chills after the 2nd dose), VOMITING (Throwing up after the 2nd dose), PYREXIA (Fever of up to 102 F after the 2nd dose) and HEADACHE (Worst headache ever after the 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102 f (High) 102 F. On an unknown date, SARS-CoV-2 test: positive positive (Positive) positive.
According to the mother, Pt developed rash on Lt anterior thigh, the site of H1N1 Influenza vaccine injection.  Over the next week, the rash spread to include the left trunk, right post leg, arms, and palms.  No associated sxs.
Went to ED after vaccination reaction - diagnosis: Anaphylaxis  CHIEF COMPLAINT:  POSSIBLE ALLERGIC REACTION (ptjust had 2nd COVID vaccine. c/o voice changes and changes in swallowing. pt is able to maintain secretions at triage. )  DIAGNOSIS at time of disposition:  1. Anaphylaxis, initial encounter  This is a 49-year-old female that presents emergency department 1 hour after receiving her 2nd COVID vaccine (pfizer), and states that she waited her 15 minutes after receiving the shot and felt fine.  She then reports that when she got to the car she started feeling some chest tightness a bit of more difficulty with her breathing and felt like her throat was scratchy and a bit tight as well.  She has had complications with taking the flu vaccine as well as a tetanus shot.  Where she has had rashes then enlarged lymph nodes.  But never this reaction.  She has never been hospitalized or brought to the ER due to anaphylaxis.  She does not use an epinephrine pen at home.  Patient states before the shot she was feeling well.  She does not have any systemic symptoms like fever, nasal congestion or sore throat.  Patient also denies any recent episodes of vomiting or diarrhea. This patient came in the emergency department was concerning signs and symptoms for anaphylaxis.  The patient was immediately given a dose of IV Solu-Medrol 125 mg, IV Benadryl 50 mg, and 20 mg of IV Pepcid.  Patient was placed on cardiac monitor.  I went back to re-evaluate the patient she was feeling significantly improved within a short period of time.  Patient was monitored in our emergency department for most 2 hours.  Patient's symptoms had resolved.  Patient was comfortable being discharged home.  Patient has several allergies in her history.  Patient was sent home with a prescription for prednisone as well as Pepcid.  Patient also given a prescription for an epinephrine pen and told and instructed on how and when to use this.  The patient is going to have someone pick her up as she was instructed that the Benadryl can make her very drowsy and a would be rather unsafe to drive.  She was going to contact a family member to pick her up.  Patient will return if she has any more symptoms
Information has been received from a consumer concerning her daughter, who on an unspecified date was vaccinated with a first dose of GARDASIL (lot #, dose and route not reported). The mother reported that on an unspecified date her daughter experienced vomiting within 12 hours of receiving her first dose of the vaccine. The vomiting had not stopped since then. The consumer reported that her daughter had 90% of the post-marketing side effects in the prescribing information. On an unspecified date her daughter experienced a 30 pound weight loss and could no longer eat anything with gluten, sugar, preservatives or carbohydrates. She was starting to experience numbness in both feet. At some unidentified time her daughter was in bed for 5 months. She also reported that her daughter had a toxic level of aluminum in her system. She was hospitalized for 17 days; lab diagnostic studies included biopsy, spinal taps and unspecified blood tests (results not provided). At the time of the report the patient had not recovered from the adverse events. Vomiting, weight loss, could not eat anything with gluten, sugar, preservatives or carbohydrates, numbness in her feet, was in bed for 5 months and toxic level of aluminum were considered to be disabling and immediately life-threatening. This is one of several reports received from the same source. Additional information is not expected.
Information has been received from a registered nurse concerning a 7 year old female who on 11-JAN-2001 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck) (lot # 635604/1150K). Additional suspect vaccination included a first doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (lot # 636658/1161K). Concomitant vaccination included a dose of pneumococcal vaccine, pneumococcal 23V polysaccharide vaccine (manufacturer unknown) (lot # 472046). On 08-MAY-2007, the patient presented to the office with an itchy rash that started at school, the patient had no fever. Symptomatic treatment was administered. On 11-MAY-2007, the patient returned to the office with the rash which became infected. The patient was treated with Augmentin. The patient's status at the time of the report was unknown. No further information was provided. Additional information was obtained. The registered nurse reported that on 11-JAN-2007, the patient was also vaccinated with a dose of Prevnar (Wyeth, lot # 472046). It was reported that the patient "came to the office" on 08-MAY-2007 with a rash that started that morning "AM" (time of vaccination unknown). The patient had no fever. The patient was diagnosed with varicella vaccine breakthrough. There were no complications. On 11-MAY-2007, "became infected." The patient was treated with "amoxicillin and hydrocortisone." Additional information has been requested.
Felling tired, low energy, mild muscle aches Cleared up in less than 24 hours.
lt thigh swollen (inj area) 1 day p/vax, warm compress PRN, APAP;
The vials initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022; Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vials initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 12-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vials initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vials initially stored in refrigerator on 10-Jun-2022 and administered on 12-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient weight was reported as 145.8  No concomitant medications were reported.  It was reported that, the pharmacy has sent Moderna COVID-19 vaccines on 10-Jun-2022 and on the same day the vials were initially stored in refrigerator, but vaccine was given to the patient on 12-Jul-2022. The patient administered vaccine after the 30 days use date.  The vials did not undergo any temperature excursions. No adverse event reported by the patient.  No treatment medications were reported.
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   28 doses of vaccine were administered  (18OCT2021) after being stored in a refrigerator for 33 days. 2 of these were first doses, 5 second doses, and 21 third doses for immunocompromised individuals. All doses were administered by intramuscular injection from lot number 005C21A. None of these patients had reported symptoms to the contact or received any known treatments. 2 doses 20SEP2021 18OCT2021 Concomitant medications was not provided by the reporter Treatment information was not provided
Dizziness at around 10:10 PM. Rested in bed as treatment. Unknown outcome yet
pt recv vax & devel an inj site rxn characterized by a golfball size area of redness, swelling & warmth;the rxn was described as cellulitis;pt self treated w/applications of ice & recovered w/in 5 days;
Scalp hair loss starting July, 2021. Monthly dermatology  appt starting October, 2021 with subcutaneous steroid scalp injections
Injection site soreness. Muscle aches in both thighs. Menstrual spotting on 1/28 & 1/29.
drug ineffective; they both got sick and tested positive for Covid-19; This is a spontaneous report from a Pfizer sponsored program via a non-contactable consumer (wife of patient).   A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an unspecified route of administration, on 23Mar2021 as a single dose for COVID-19 vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller and her husband received first dose 23Mar however, they both got sick and tested positive for Covid-19. After being in the hospital for a while they were told to quarantine. The clinical outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021531128 Original Case : 2021531128
severe chills extreme body aches arms and legs can hardly walk low grade fever fever 101. stomach pain sharp pain in stomach headache