chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blisters allover my body; Worst fever in my life; Chill and shivering; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th June 2022, the patient received the 2nd dose of Shingles vaccine. In June 2022, 3 hrs after receiving Shingles vaccine, the patient experienced blister, fever and chills. On an unknown date, the outcome of the blister, fever and chills were recovered/resolved.   It was unknown if the reporter considered the blister, fever and chills to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-JUN-2022 Reporter's Comments:  This case was reported by a patient via interactive digital media. The patient got second Shingles vaccine on Monday of reporting week and three hours later the patient got blisters allover his/her body. The second day the blisters gone, and the patient had the worst fever in life with chill and shivering which was recovered third day. Additional supportive information: The follow-up would not possible as no contact details were available
Administered DTaP in right deltoid 4/14/03. Pt's mom called clinic 4/16/03 - stated right upper arm red, swollen, enlarged lymph node in axillary. Took to PMD 4/16/03.  Dx - localized reaction.
suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
left arm itchy; injection site big bump; painful; extra tired; slept more than usual; tingling in the left arm all over; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included hashimoto's disease, acid reflux and knee surgery (on right knee). The patient was allergic to dust, pollen, gluten and mold allergy that caused hay fever. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN) and spironolactone (SPIROLACTON). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 06:00, the patient had "COVID arm" syndrome and had left arm itchy, injection site felt like a big bump in arm (vaccination site lump) and felt quite painful when pressed, extra tired and slept more than usual and had tingling arm all over. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events left arm itchy, injection site big bump in arm (vaccination site lump) and quite painful when pressed, extra tired and slept more than usual and had tingling arm all over were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
14 year old white female with exercised induced asthma and a bactrim allergy and a history of depression, acne, premenstrual syndrome, and headaches, who presented to the office on 04/05/2005 for a well child visit and was vaccinated intramuscularly in the left arm at 15:00 with a first dose of Hepatitis B virus vaccine.  There was no concomitant medication.  However, the report indicates the patient has taken fluoxetine hydrochloride in the past.  On 04/06/2005 the patient experienced vomiting, 3 to 4 times, bad headache, lightheadedness and slight fever.  The patient is reported as recovered.  Unspecified medical attention was sought.  No product quality complaint was involved. No additional information is expected.
Information has been received from a RN who is a mother of a 13 month old male child who on 01Oct03 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC). On 10Oct03, the pt was positive for B antigens and positive core antigens for hep B. The physician stated that this was not a result of the vaccination with hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) and that he was probably exposed. The reporter also mentioned two female siblings; one was vaccinated with hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) and developed hep B surface antibody quantitative non reactive (WAES310USa02340); the other female sibling was vaccinated with hep B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) or hep B recombinant (yeast) and had negative titers (WAES0310USA02339). Additional information has been requested. Follow up 03/03/05: Lot number for vaccine number 1 was not provided.
This case was reported by a other health professional via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX. On 12th April 2018, the patient received SHINGRIX. On 12th April 2018, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping. In April 2018, the patient experienced fever, injection site rash and injection site swelling. On an unknown date, the outcome of the fever, difficulty sleeping, injection site rash and injection site swelling were unknown. It was unknown if the reporter considered the fever, difficulty sleeping, injection site rash and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient did not have a spleen. The patient experienced a series of reactions including a bump and rash at the injection site, he could not sleep at all on Thursday night and he experienced a low grade fever.
unresponsive, pale, diaphoretic, SBP 80s HR 50s
6 months after vaccine has an AFib episode. I have never had a problem with my heart. After visit with Cardiologist he confirmed AFib and heart murmur. Had echocardiogram on 12/10. Waiting on results.
Developed generalized hives this AM (6/8/07) Rx with Benadryl, per mom - same thing occurred 1 wk after HPV #1 and HPV #2
Varicella vaccine break through.  Diagnosed with varicella on 11-26-07.  Had 25 vesicles.  No fever.
several hr p/vax pt turned pale/grey when taking bottle; staring 4 mins-then OK; slept but woke pale again; adm to hosp; No further problems; no sz noted; neuro consult-dx hypotensive/hyporesponsive rxn to pertussis;
Patient called and stated that at about 3pm his eyes became bloodshot and started mattering.  His face was warm and he had nasal congestion.  He did not take his temperature but said he felt feverish.  He took Tylenol at 3pm and again about 6 hours later when he went to bed.  He woke up without symptoms.
This spontaneous case reported by a consumer, describes the occurrence of paresthesia (tingling in fingers after 1st dose), hypoesthesia (numbness in fingers after 1st dose), rash (rash on face after 1st dose), hypoesthesia (numbness on face after 1st dose) and pain (body aches after 1st dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 019B21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Apr 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced hypoesthesia (numbness in fingers after 1st dose), rash (rash on face after 1st dose), hypoesthesia (numbness on face after 1st dose), pain (body aches after 1st dose) and hypoesthesia (arm feels numb after 1st dose). At the time of the report, paresthesia (tingling in fingers after 1st dose), hypoesthesia (numbness in fingers after 1st dose), rash (rash on face after 1st dose), hypoesthesia (numbness on face after 1st dose), pain (body aches after 1st dose) and hypoesthesia (arm feels numb after 1st dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, treatment information or list of concomitant medications.
it was rpt fr HCP concerning a pt who was vax in 1996 & in 1999 pt x/ multiple rashes w/more than 20 but less than 50 lesions on body & scalp. no further info avail
chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced CHEST PAIN (chest pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Chest pain, at a dose of UNK dosage form. At the time of the report, CHEST PAIN (chest pain) had resolved.        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.   No Concomitant medications and treatment medications was reported.
Pt. started feeling pain in Left leg on 12/08/21, presented to the hospital 12/20/21 with increasing left leg pain and new shortness of breath and hypoxia, dx. with  DVT bilateral lower extremities, extensive in Right lower extremity. Large burden bilateral pulmonary embolism, hypoxia.
Evening of 2/19, developed chills, 100.1 fever, fatigue, lasted for 24 hours
Provider gave nurse instructions to administer immunizations to patient. Noticed in chart patient was on ROTARIX schedule. Administered ROTARIX along with other vaccines. When inputting data into patients chart RN noticed that that was the third dose of the vaccine and that it only calls for a two dose schedule. Supervisor notified immediately as well as provider.
whole arm hurt; arm hurt more than after 1st vaccine; night sweats; fever of 102F; Headache; Chills; body was all achy; Under his arm he had a swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F), HEADACHE (Headache), CHILLS (Chills), MYALGIA (body was all achy) and LYMPHADENOPATHY (Under his arm he had a swollen lymph node). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (whole arm hurt), PAIN IN EXTREMITY (arm hurt more than after 1st vaccine), NIGHT SWEATS (night sweats), PYREXIA (fever of 102F), HEADACHE (Headache), CHILLS (Chills), MYALGIA (body was all achy) and LYMPHADENOPATHY (Under his arm he had a swollen lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.
in about 5 hours after the shot, I started having very strong chills, body aches, headache, nauseous,  eyes hurt, abdomen pain. Symptoms continued for about 20 hours (bed rest, not capable to do anything). horrible headache at night time. No fever. Felt chills and feeling hot sweating during the night. Took Tylenol 2 times. dull pain in the shot area, pain distributed under arms around breasts. tender breast and nipples on 3rd day (Sun) after the shot. Lost appetite for about 2 days (body weight 3 pounds less).
Finally diagnosed with CIDP,  Progressive difficulty walking and with balance. Need a walker, have progressed from a cane which was needed after first booster October 2021. Foot numbness pain tingling and burning. Have had several falls and broken bones. Currently housebound.
No adverse event; Expired vaccine administered to a 10 month old patient, Dose administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a 10 month old patient, Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a 10 month old patient, Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a 10 month old patient, Dose administered after 30-day Use By Date) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to a 10 month old patient, Dose administered after 30-day Use By Date).    Concomitant medications details were not reported by the reporter. Patient age was reported as 10 months. Vial was initially stored in the refrigerator on 09-Mar-2023. Vial size was reported as 2 ml. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715994:Patient 02
Janssen COVID-19 Vaccine EUA 19 hours after injection chills, headache, heaviness on chest and dizzy did not feel better until 10 hours later. symptoms gone but still very tired.
Information has been received from a certified nurse midwife concerning her daughter's friend a 26 year old female with no pertinent medical history reported who on unspecified dates was vaccinated with the first and second doses of GARDASIL. After 2 doses of GARDASIL, the patient experienced an atypical squamous cells of undetermined significance. A PAPANICOLAOU test was performed which was positive for HPV. The friend's physician has recommended a cervical biopsy. Additional information has been requested.
On day of shot she developed a quarter-sized red ring around vaccine site that was slightly painful.  Next day 9/18/21, it was a 2" diameter ring that was raised and hot for 4 days.  It was itchy and she took OTC Benadryl.  Beginning on 9/26/21 she got a red rash on both arms with small red bumps that are itchy.  She has an appointment with her physician, on 9/28/21.  She continues to take Benadryl for the itching.
Macular papular rash over torso, no pain or fever. Site swollen on left arm.
Pt. had a mild pustular/cellulitis at (B) deltoids. Note that 1st injection on (L) deltoid "leaked" out so she had a second injection of new vaccine/needle in (R) deltoid. "Shoulder injury related to vaccine administration".
Metallic taste; Metallic smell; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 15Mar2021 at 15:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and Minerals nos, Vitamins nos (PRENATAL VITAMINS) since an unknown date for an unknown indication and unknown if ongoing. On 15Mar2021 at 15:15 the patient experienced metallic taste and smell. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the events metallic taste and smell were recovered on an unknown date in Mar2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Within 72 hours of vaccine administration, hypothermia, shock like episode, recorded temperature 93 degrees F.  Nurse follow up on 10/05/04 states: "Hepatitis, Sepsis, Impending liver failure."
Information has been received via telephone from a Doctor of psychology concerning her son who on an unspecified date, was vaccinated with a dose of MMR II (Lot #, dose and route not reported). On an unknown date, the doctor of psychology reported that after received the MMR II her son became "blue and had projectile vomiting". The psychologist stated that her son was admitted to the hospital (date unspecified). The psychologist stated that her son recovered on an unspecified date. This is one of several reports received from the same source. Additional information is not expected.
Pt. came in 02-25-09. States she had pain, swelling and itching lasted 2 weeks after injection (given 11/3/08). She didn't do anything then and about a week ago on the injection site was red and itching, she scratched, and bleed and she is worried. The doctor hold her to put on Vaseline. It healed after a week. I called MERCK and relate info and follow up with Pt. She is fine now 4/11/09
Bad rash popped-up in various places. Started on thighs, spread to lower legs, toes, arms and forehead. Treated with Benadryl, Cortizone-10 and ibuprofen. The rash lasted for 1 week before going away completely.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) currently has COVID-19.         No concomitant medications were reported.  On an unknown date, the patient had received the 1st booster dose of COVID-19 vaccine. On an unknown date, the patient had received the 2nd booster dose of Moderna COVID-19 vaccine, Bivalent.  No treatment medications were reported.   Reporter did not allow further contact
This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. A 64-year-old female patient of unknown race received PREVNAR 13 for immunization at single dose in 2016 via unspecified route of administration. Medical history included Oxygen consumption since 2011 and ongoing, chronic obstructive pulmonary disease, lung neoplasm malignant, cardiac disorder, hypothyroidism, spinal operation, walking aid user and dyspnoea ongoing.  Concomitant medications were unknown. The patient experienced pneumococcal pneumonia on unknown date which was specified as  cough every day using nebulizers, short of breath (oxygen 24/7), delirious, fatigue and fever. The patient was hospitalized for the event from 07Mar2018 to 19Mar2018. The outcome of the events was recovered as according to doctor the pneumonia was cleared from lungs. It was mentioned that she is now dealing with a mass on her Kidney, which MRI has been ordered as a mass was found on kidney while in hospital in March. She has a walker to get around. She also said her brain has been affected and can't remember things like she used to. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to a 19 year old patient of unknown gender. There was no medical history or concurrent condition reported. On 21-AUG-2015 the reporter inadvertently administered a pediatric dose of VAQTA (dose, route and lot # were not reported). There was no concomitant medication reported. No adverse effects were reported. Additional information has been requested.
Within a day, I developed some more symptoms similar to the first shot. Fever rose on the right side. Ear started to close again, except this time, I couldn't open it. I talked to the doctor to make sure it was something similar to what happened before. Did an in- person visit with her nurse, found it wasn't sinusitis. Indicated I could go back to work, and since it was a known side effect for me to just keep an eye on it. They offered steroids again, but they noted it was counterproductive. As far as I know, it was pretty good. It has gotten better in February, but it's still discharging and still opens and closes on the right, but it's getting better. The first one also had some brain fog, and for this one, there was a little brain fog. Been feeling better in the last 2-3 weeks since then. Process of recovery is still ongoing. I started the allergy shots again, so that may be having an effect as well (noted in medications).
Lymph node inflammation, shaking chills, joints pain, muscular pain, headache, fatigue
Swollen, painful lymph node under arm pit.  Fever.  Chills. Achy.