chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling and redness at the injection site; swelling and redness at the injection site; fever; This is a spontaneous report from a contactable other health professional (medical assistant) on behalf of physician. A 11- year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA, Lot Number: T66104, Expiry date: 31Dec2019, NDC number: 000510001), via an unspecified route of administration on an unspecified date at single dose in deltoid right for immunization at age of 11 years old, hpv vaccine vlp rl1 9v (yeast) (GARDASIL 9, Lot Number: R029117, Expiry Date: 10Jul2021, NDC number: 0006412101), intramuscularly on the same day at unknown dose in deltoid left for immunization. The patient medical history was not reported. Concomitant medication included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA, Lot Number: U6153AA, Expiry Date: 21Mar2020, NDC number: 4928158958), intramuscularly on an unspecified date (within 4 weeks prior to the first administration date of the suspect vaccine) at unknown dose in deltoid right for immunization. The patient previously took amoxicillin and experienced amoxicillin allergy. The patient experienced swelling and redness at the injection site and fever on 02Aug2019. The doctor advised the patient's mother to administer Motrin and Tylenol as needed for fever, lots of liquids, and an ice pack. The outcome of the events was not resolved. Causality between events and suspect vaccine meningococcal group b rlp2086 was reported as yes (related).
pt recvd vax 530PM severe rash occured 1145PM;tightness in chest; 2 DPH given immed 15mins later pt fell asleep; in the AM everything was OK;
Fatigued/felt tired; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued/felt tired) and VACCINATION SITE PAIN (Sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced FATIGUE (Fatigued/felt tired) and VACCINATION SITE PAIN (Sore arm). At the time of the report, FATIGUE (Fatigued/felt tired) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-365820, MOD-2021-365922 (Patient Link).
No additional AE; The nurse called to evaluate the potency of an expired ROTATEQ vaccine that was administered to a patient; Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 01-FEB-2022, the patient received rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as directed for the prevention of rotavirus, lot number: T028130 with expiration date 28-JAN-2022 (strength, dose and frequency were not reported) that was expired (expired vaccine used).  The nurse called to evaluate the potency of the expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ).
pharmacist told me he gave it to me in my vein / I know this is not going to be effective!; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (received 1st dose on an unknown date in November 2020 and experienced pain, refer case US2021AMR116857).   In January 2021, the patient received the 2nd dose of Shingles vaccine (intravenous). In January 2021, unknown after receiving Shingles vaccine, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine in vein which led to intramuscular formulation administered by other route. The patient did not experienced pain. The reporter mentioned that, it was not going to be effective. This case has been linked with the case US2021AMR116857, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116857:Same reporter
fever of 101 F; muscle aches; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer reported similar events for herself and 5 patients. This is 4th of 6 reports. This consumer reported for a patient that:  A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine,, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever of 101 f, muscle aches.  The patient underwent lab tests and procedures which included body temperature: 101 fahrenheit on an unknown date. The outcome of the events were unknown.   Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021157330 Same reporter/ drug/ event for different patients
Pneumovax booster administered 2/29/2012 and accidentally revaccinated with Pneumovax on July 12, 2012. Patient c/o of increased shoulder and joint pain (hx rheumatoid arthritis. Treatment = Use pain meds prn and continue prednisone. Monitor for fever. Any SOB, rash go directly to ED.
Initial report was received 26 July 2011 from a health care professional. A four-year-old male patient had received a fourth dose intramuscular right thigh injection of DAPTACEL, lot number C2955BA and a second dose intramuscular injection (site not reported) of FLUZONE No Preservative 2008-2009, lot number UT2782AA on 21 October 2008. On 03 July 2011, approximately 32 months after vaccination, the patient received a PCR-nasal swab test. On 05 July 2011, test results were positive for Bordetella pertussis. The patient had no concurrent illness and he had not been taking any concomitant medications at the time of vaccination. Outcome was not recovered. Documents held by sender: None.
Vaccines given 7-27-11. On 7-28-11, pt seen re complaint of rash & itching all over body, upper lip swelling. Rx'd prednisolone 15mg/5mL syrup & hydroxyzine Hcl 10mg/5mL syrup.
Rashes on the inner left arm close to injectiion site and patient has being using rubbing alcohol
I remained in vaccination site for 15 minutes. Upon leaving and walking to vehicle I felt itchiness and tingling in throat. Upon visual inspection there was a quarter inch red ring around throat. I did not experience any shortness of breath or chest pain of difficulty speaking. I drove down the street to Pharmacy and bought Benadryl and took 50mg PO. There were no further side effects other than a normal expected sore arm.
1 week delayed development of diffuse urticarial rash. Pruritic pink plaques developed on all 4 extremities almost exactly 1 week after administration of Moderna Covid 19 vaccine. Treated with antihistamines orally and topically. Treated with topical corticosteroid ointment. Resolved after 3-4 days.
Expired vaccine doses administered/Patients received expired vaccines/Expired vaccines administered/Vaccinated some patients with vaccines that were expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered/Patients received expired vaccines/Expired vaccines administered/Vaccinated some patients with vaccines that were expired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     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. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered/Patients received expired vaccines/Expired vaccines administered/Vaccinated some patients with vaccines that were expired). In October 2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine doses administered/Patients received expired vaccines/Expired vaccines administered/Vaccinated some patients with vaccines that were expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on  09-Oct-2021. Vaccine was administered from 11-Oct-2021 to 26-Oct-2021. No concomitant or treatment medications of any patient reported.
Patient reported swelling and redness in right arm day after administration of vaccine. Patient instructed to take antihistamine orally and ibuprofen orally OTC and follow up with Dr if swelling does not subside. Patient has latex allergy important to note vinyl gloves were used. Tried to follow up next day with patient, no answer.
Shingles. I had chicken pox as a 5 year old and the vaccine didn't exist at that time. I've never before had a shingles outbreak  but got my first one a week after the Janssen COVID-19 vaccine. No other logical explanation other than it being triggered by the shot.
9-17-15 Flu vaccine given 5 pm. 9-17-15 Late evening noticed redness around Band-Aid. 9-18-15 In morning red "band" on arm with raised bumps no fever. 9-22-15 Almost completely resolved.
This spontaneous report was received from a nurse practitioner, referring to a 67-year-old female patient. It was reported that the patient was not pregnant at the time of this report and that the patient was allergic to "sulfa". The patient's medical history was unknown by the reporter. Concomitant medications included meclizine, levothyroxine sodium and lidocaine patch.   On 23-SEP-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) intramuscular on her left arm for prophylaxis (reported as "routine, previous vaccination"), (lot# S018405 has been verified to be a valid lot number,and expiration date on 23-MAR-2021 :dose, strength and frequency were not reported).    On 25-SEP-2019, the patient complained at the nurse office that she was experiencing a rash and swelling at the injection site that extended to her left breast. Additionally, it was reported that the patient refused steroids.   On 07-OCT-2019, the patient was admitted to an unknown hospital for one night where she complained of dizziness, blurred vision and severe headaches; the patient received meclizine (also reported as concomitant medication) and cefuroxime axetil (FUROCEF) (reported as FUROCET) and was seen by an opthalmology . There were no laboratories or studies performed and the events were not related to cancer, overdose or a congenital anomaly.   At the time of this report, the patient was not recovered from the events. The causality assessment between the vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) and the events, was not provided. It was reported that all events incurred in a significant disability or incapacity for the patient.
pt recvd vax 27OCT93 & exp low grade fever; t102.5; fever to 104.7 to MD; pt had rash exp due to MMR; mom says pt not same since hosp stay;
On the evening of 12/14/2001, she refused to drink or eat, and just lay around. No rashes or low but had a low grade fever. The next day the high fever started. Went to ER with a fever of 105 deg. F. (rectal temp). The fever resolved two days after.
diarrhea; Fever; body ache; headache; FLU; severe cough; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body ache), HEADACHE (headache), INFLUENZA (FLU), COUGH (severe cough) and DIARRHOEA (diarrhea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN (body ache), HEADACHE (headache), INFLUENZA (FLU), COUGH (severe cough) and PYREXIA (Fever). On an unknown date, the patient experienced DIARRHOEA (diarrhea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency and CITRUS LIMON JUICE (LEMON JUICE) at an unspecified dose and frequency. At the time of the report, PAIN (body ache), HEADACHE (headache), INFLUENZA (FLU), COUGH (severe cough), DIARRHOEA (diarrhea) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (reaction). At the time of the report, VACCINATION SITE REACTION (reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt was given 5-11yr COVID Bivalent Booster instead of 12+ Bivalent Pfizer booster. MD and family aware. No need to dose patient again. No adverse effects
10 month old received Hep A 7/9/14 inadvertently. Had fever, loss of appetite, emesis, diarrhea the next day seen in Emergency 7/14/14, urine culture negative fever 103.2 degrees seen in doctor's office 7/15/14 follow up.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: IM given in right thigh, after 10 minutes pt developed small papular rash on right leg and to lesser extent on left leg.-Mild, Additional Details: Pt was reassessed and given 2.5 ml of Benadryl, rash only appeared on lower ext. Pt continued to be active with no other symptoms.  Pt was watched for additional 20 minutes after initial 15minutes.  no other symptoms arose. Discussed with parent signs and symptoms to watch for over the next 24 hours and seek medical help if necessary.
Myalgia, Arthralgia, sore arm, chills, low grade fever Narrative:  Other Relevant History:
2 days after seasonal flu shot (thimerosol free because I was 8 months pregnant) Chills, Nausea, achiness all over body, Achiness and nausea lasted 2 days.
Left arm began to swell and warm to touch on 2/22/03. Child began complaining of tenderness in left arm on 2/22/03 PM. Mother reports that arm was swollen to her shoulder on 2/23/03. Mother took child to ER on 2/23/03 and ER doctor Dx'd child with encapsulated site to left arm and treated with Keflex antibiotic. Mother arm looked better on 2/24/03.
This case was reported by the mother of a consumer and described the occurrence of fever in a 6-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent vaccination included HIB (manufacturer unspecified), live attenuated human rotavirus vaccine (manufacturer unspecified) and pneumococcal vaccine (manufacturer unspecified) all given on 18 January 2011. There were no concurrent medications. In the late morning on 18 January 2011 the subject inadvertently received a dose of KINRIX in an unknown thigh. On 18 January 2011, less than one day after vaccination with KINRIX, in the evening, the subject experienced slight fever. The fever resolved the same day. Administration of KINRIX was also a maladministration (asymptomatic/child too young) and wrong vaccine administered. The child should have received his 3rd dose of PEDIARIX. He received hepatitis B vaccine recombinant (manufacturer unspecified) the following day, 19 January 2011, to complete his coverage. Attribution of fever to treatment with KINRIX was not known.
20 minutes, post vax, pt developed chest pain, difficulty breathing, edema of lips and eyelids and was treated with Albuterol Nebulizer. SC Epinephrine 0.3cc !:1000, PO Prednisone 60mg; SC Benadryl 50mg.
Fever 104.1, body aches, arm very red huge knot and very itchy , started period.
Information has been received from a physician concerning a 13 week old male who on 20-AUG-2008 and on 21-OCT-2008 was vaccinated with the first and second doses of ROTATE. No problems were reported. A product quality complaint was not involved. Additional information has been requested.
ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 11/21/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
PATIENT IS COMPLAINING OF ARM PAIN 8 MONTHS AFTER FIRST INJECTION.  SHE SAID SHE HAS TROUBLE RAISING HER ARM ABOVE HER SHOULDER.
An attorney reported that a male patient received injections of Hib-Titer (haemophilus B conjugate vaccine (diphtheria crm 197 protein conjugate)), Acel-Immune (diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) and Tetramune (diphtheria and tetanus toxoids and pertussis vaccine absorbed and haemphilus b conjugate vaccine (diphtheria crm197 protein conjugate)) vaccines as part of his childhood immunizations. It is alleged that, as a result of the toxicity from the thimerosal and the mercury and/or other heavy metal in the vaccines, he had the following symptoms:  severe learning disabilities, impairments in social relatedness, language and communication difficulties, abnormal movements, sensory dysfunction, depressions, anxiety, hearing loss, severe bowel dysfunction, and other severe health disorders. The reporter also stated that the patient was exposed to heavy metals from emissions from a chemical plant. These events were considered medically important. No further information was available as of the date of this report.
Dizziness, temporary shortness of breath, has to lay down as for vasovagal response, tingly abs temporarily, nausea 10 minutes
Cold sore on roof of mouth and on inner lower lip; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 42-years-old female patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 at 12:15 (Batch/Lot Number: EW0172) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at Pharmacy or Drug Store (42-years-old at the time of vaccination). Patient received first dose of (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 10Apr2021 12:00 (Batch/Lot Number8729) for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing and there were no allergies. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE SODIUM), fluoxetine hydrochloride (PROZAC), ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Post or prior to the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01May2021, the patient experienced cold sore on roof of mouth and on inner lower lip. Patient did not receive any treatment for the event. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Extreme chronic fatigue, dizziness, muscle weakness, joint pain, headaches, diaphoresis, nausea, skin rashes, hot flashes, primary amenorrhea (failure to start period before age 16), and cyanosis. Symptoms increasing over the last 4 years. Year Round all star athlete prior to vaccination.
Local reaction - redness of upper half of arm after DTaP # 5. No fever.
That night had  golf ball size lump on arm - iced and better. At bedtime feeling crummy, ran a fever all night, headache, nausea. Slept most of the next day...just didn't feel well.
About 20 minutes after receiving immunizations had syncopal episode and fell onto concrete outside clinics, V/s normal, hadn't eaten that day, Dad states this happened with labs being drawn. Blood sugar 120mg 1dl random
Between Aug90 + Nov90 pt vax w/ hepta B which was expired material.  No adverse reaction.
Headache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.
Patient had Pfizer Covid vaccine on 1/13 and 02/03. She experienced rash and blisters on her feet each time.
I ran fevers ranging from 103.7 to 102 for 5 days. I had muscle aches, malaise, headaches and dizziness. I am still having "brain fog" to this day. Once I was afebrile I learned there were several days for that time period I did not remember. I am still experiencing headaches and brain fog.
Patient developed pain at injection site day after administration. She removed band aid 2 days later and stated area dark in color and "itchy". Pain subsided in 3 days but area remained dark and small "bumps" appeared and disappeared on and off for 3 months, dark area remained at all times. Went to PCP in Dec but didn't show him. Called office 2/3/14 to report symptoms. Given methylprednisone pack and OTC antifungal cream to use for 10 days. Instructed to f/u with her dermatologist if symptoms persist. F/u 2/24/14 area better but still present. Instructed to f/u with her dermatologist.
pt recv vax 28OCT97 & 9NOV97 pt devel redness in the area of vax, lesion on arm, shoulder, abd, & one on each leg, as well as itching & burning of the arm lesion;
The grandmother reported that her son called and told her the baby started jerking all over and his eyes rolled back which lasted seconds. The pt was going to the pediatrician today.
Approximately 5-10 after vaccination,  pt began to feel lightheaded, became diaphoretic and pale and felt like he was going to pass out. Pt was lowered to the floor and placed in trendelenburg position. Vitals stable.  Pt reported fingers feeling number.  EMS was called and pt was evaluated and released. Pt remained at clinic being monitored until he was completely back to baseline.