chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccinated with a lot number that just expired 2 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated with a lot number that just expired 2 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Number of doses/vials: 7 doses.  Date the vial was initially stored in the refrigerator 09-Jul-2022. The vial did not undergone any temperature excursions.  No treatment medication was reported.
fever, n/v, lethargic, pain in lt arm, blister @ site of vax;
patient had a syncope episode immediately after vaccine given. Woke easily within minutes of episode. Vitals stable after episode, evaluated by provider, waited an additional 20 minutes to make sure no further reaction and was released with mom.
On the 09 of May I woke up with a head cold and went to the doctor to get tested was positive for Covid.
Pt recv vax on 10/21/98; on 10/23/98 pt exp pleurisy; pleural effusion
Guillain-BarrE syndromE; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and COVID-19 VACCINE UNKNOWN. On an unknown date, immediately after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. A physician informed me that one of her patients received her 1st dose of Shingrix along with a dose of COVID at a pharmacy.  This patient experienced Guillain-Barre syndrome shortly after the doses.  The doctor said she believes it could have been the COVID dose. The doctor told patient not to receive 2nd Shingrix dose.  The doctor said, she thought the patient already reported this incident and did not have the patients information available.
Spots on back; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (Spots on back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lupus erythematosus.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced RASH MACULAR (Spots on back). At the time of the report, RASH MACULAR (Spots on back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient used an unspecified steroid cream as treatment for the event.
general fatigue (sleepiness), muscle aches, headache, left arm sore - 2-3 days and then the symptoms resolved
Information has been received from a school nurse concerning a child who on approximately 08/29/2001 was vaccinated with a dose of varicella vaccine. On approximately 08/31/2001, the pt developed chicken pox. Additional info has been requested.
The next day after patient got the vaccines, patient had fever, chill and feel fatigue. Patient had to stay in bed for the whole day and next day she feels better. Patient is worried about receiving the second dose Shingrix.
Over the first 6 hours after the injection I had slow evolving and subtle (very mild) symptoms of muscle aches and headaches.    By dinnertime they became stronger along with chills- off and on.  Went to bed and woke up on day 2 with strong symptoms of headache, muscle/joint aches, chills, deep fatigue, fever (never got higher than 100.6º), queasiness. By dinnertime they were starting to ease up.  Woke up the next morning and all symptoms were gone except for some lingering fatigue. By afternoon I was completely back to normal and felt great.
A report has been received from a Health Professional concerning a 12 year old, male subject, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on an unknown date. Registered nurse reported that a patient received FLUMIST on 02-Oct-2013 and again on 22-Oct-2013. The patient indicated he had not received a flu vaccination but they realized after looking at his chart that he had Patient has not reported any symptoms. The outcome of the event of patient received FLUMIST on 02-OCT-2013 and on 22-OCT-2013 is unknown. The report was considered to be non-serious.
I was feeling bad June 30 AM. I took a home test that was negative. Lots of fatigue and diarrhea cough and congestion later that day, I was positive. 07/1, Followed up with a PCR test that confirmed my findings from the day before. Called my doctor and prescribed medication and said give it a week and call me back if it doesn't get better. I was in isolation for five days. July 3, my wife tested positive. Friday I was in recovery even walked a little over five miles and was feeling fine. 07/9, Weird that I was recovering and out of nowhere as soon as I completed the prescription, I started having congestion and a weak stomach with diarrhea and fatigue. I called my doctor and county hospital. I was unsure why the symptoms came back. The county health department told me to act as if I was re-infected. PCP told me it's the same illness it was roller-coaster.
Mom phoned today and had been 1 wk since receiving vaccines. Now still has a knot, no redness, no heat, no pain.
PT AND MOM CAME AND REQUESTED A PFIZER VACCINE - SAID CHILD WAS 12 YEARS OLD-- AFTER VACCINE WAS ADMINISTERED AND TECHNICIAN WHO ADMINISTERED VACCINE CAME BACK INTO PHARMACY WITH PAPERWORK, WE NOTICED CHILD WAS NOT YET 12 YEARS OLD. CALLED MOM AND SPOKE WITH HER, SHE SAID CHILD IS "ALMOST 12" SO SHE THOUGHT IT WOULD BE OK. I ADVISED HER THAT SINCE THE VACCINE IS NOT YET APPROVED FOR CHILDREN UNDER 12 TO WATCH FOR ADVERSE EFFECTS AND TO CONTACT THE DR OR ER IMMEDIATELY
Vaccine is given more than 30 days from storage and is expired/the vaccine was placed in the refrigerator on 24JAN2022; Pharmacy gave Moderna COVID-19 vaccine past its 30 day beyond use date to 21 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 day beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine is given more than 30 days from storage and is expired/the vaccine was placed in the refrigerator on 24JAN2022) in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 030H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 day beyond use date to 21 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine is given more than 30 days from storage and is expired/the vaccine was placed in the refrigerator on 24JAN2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy gave Moderna COVID-19 vaccine past its 30 day beyond use date to 21 patients) and PRODUCT STORAGE ERROR (Vaccine is given more than 30 days from storage and is expired/the vaccine was placed in the refrigerator on 24JAN2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 24-JAN-2022. The vial did not undergone any temperature excursions. The Pharmacist does not know which dose this patient received the invalid dose on and wrote an expiration date of 24-MAR-2022 on the Moderna COVID-19 vaccine instead of 24-FEB-2022. No Concomitant information was reported. No Treatment information was reported. The Pharmacist did not have any other adverse events or side effects to report.
Booster; Rheumatoid arthritis flare up; Bones were achy; patient had flu; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4170198-00 (AbbVie).  A 67 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150509) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown, Dose:2), for Covid-19 Immunization; Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown, Dose:1), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; BONE PAIN (non-serious), outcome "recovered" (2021), described as "Bones were achy"; INFLUENZA (non-serious), outcome "recovered" (2021), described as "patient had flu". The action taken for upadacitinib was unknown. Therapeutic measures were taken as a result of rheumatoid arthritis.The patient had no other relevant history and had No known allergies. It was unknown if the patient was enrolled in a covid-19 vaccine trial.  Causality for rinvoq (upadacitinib): The reporter's causality for the event(s) of bones were achy like patient had flu unknown onset and bones were achy like patient had flu unknown onset with rinvoq (upadacitinib) was no reasonable possibility. The reporter's causality for the event(s) of rheumatoid arthritis flare up with rinvoq (upadacitinib) was a reasonable possibility.  Causality for pfizer biontech covid-19 vaccine (Tozinameran)(tozinameran), unknown: 1)bone pain (bone pain): Causality as per reporter (drug/vaccine) : possible 2)flu (influenza): Causality as per reporter (drug/vaccine): possible 3)rheumatoid arthritis flare up (rheumatoid arthritis): Causality as per reporter (drug/vaccine): not reported   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current information available, the events mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2.
about a week later at night- slight ringing in my ears, my doctor  E and T specialist - hearing test. Its now worst. bad chills started 3 weeks after the vaccine. it lasted 36 hrs.
Received expired ACTHIB vaccinations with no reported adverse event; Initial information received on 25-Aug-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2021SA284000 (CLUSTER).  This case involves a 1 years old female patient who received expired dose of HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s), and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL 13 VALENT VACCINE) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination.  On 24-Aug-2021, the patient received a 0.5 mL fourth dose of suspect HIB (PRP/T) VACCINE lot UJ351AA, expiry date- 09-Aug-2021 via intramuscular route in the left thigh for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported, "If baby was delivered: delivery date and if baby experienced an adverse event ? Inform that they will be receiving a follow up questionnaire ? If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA requirement.  At time of reporting, no adverse event was reported.   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. 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.
Patient was given first dose of COVID Vaccination on 6/23/2021 and was given second dose of COVID Vaccine 14 days later on 07/07/2021
Information has been received from a healthcare worker referring to 4 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with M-M-R II, (lot # L015279, expiration date 30-APR-2017, dose, dose # and route unknown) which were improperly stored. The vaccines were stored under 49 F for 1 hour and had been back in range. The vaccines were not out of range before. No adverse event reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in August 2017, the patients were vaccinated with VARIVAX lot # M009768, expiration date 24-MAR-2019. Concomitant therapies included sterile diluent. On an unknown date in August 2017, the patients experienced incorrect product storage. Additional information has been requested. Sender's Comments: US-009507513-1708USA012778.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 25Jun2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "BPH" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE; BUPROPION HCL XL; FINASTERIDE; TADALAFIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral details reported as COVID 19 Treatment, treatment start date was 18Jul2022, treatment stop date was 23Jul2022 and indication was treatment of COVID-19. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
11/7/07-had wheezing after vaccine after leaving clinic.  11/13/07-face & ears swollen with blisters, rash over body, wheezing, dizziness, blurred vision, mom took to ER.  11/15/07-wheezing, face swollen, back to ER.  Back to school 11/19/07.
April 2023 developed cough that lasted several days.  Headache, fluid retention in lungs, fever.
Information has been received concerning a male who post vaccination had an adverse reaction. Unspecified medical attention was sought. There is not any more information, additional information has been requested.
Shortness of breath when doing regular low effort activities.  Elevated heart rate at all times.  Went to ER Thursday 15 APR, had an EKG and chest X-Ray.  X-ray came back normal, lungs fine.  EKG confirmed the elevated heart rate some arrhythmia.  Was told to follow up with regular doctor.  Had follow up appointment friday 16 APR remotely, doctor recommended returning to ER to check for blood clots/pulmonary embolism.  Had another EKG, same as day before.  Had CT scan, no blood clots.  Sent home for rest, told was having an adverse reaction to the COVID Vaccine.
I began experiencing vertigo on around 3/2/2021 at about 10:30PM. As I lay in my bed, whenever I moved my head, the room began spinning. The room also spun whenever I tried to get up from my bed. The dizziness was so bad my husband gave me a walker, because I was unable to move around without holding onto something. The vertigo got progressively worse every day until finally on 3/12/2021, I couldn't stop vomiting. I had to go to the ER at a local healthcare center. I was given Zofran to treat the vomiting and prescribed meclizine to treat the vertigo. I underwent bloodwork, a COVID-19 test, and a chest X-ray. I tested negative for COVID-19, and the bloodwork indicated my neutrophils were very elevated. No abnormalities were detected in the chest X-ray. The vertigo got progressively better each day afterwards. By the time I got my second Moderna injection on 3/26/2021, the vertigo was gone. When I got my second dose of Moderna, I didn't have a recurrence of vertigo.
Received an expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 030B21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-543924, MOD-2022-543811 (Patient Link).   Reporter did not allow further contact
BODY ACHE; TREMORS; DIZZY; CHILLS; MUSCLE ACHE; FEVER; HEADACHE; This spontaneous report received from a parent concerned a 22 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included anxiety, augmentin allergy, and non-smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced body ache. On 03-APR-2021, the subject experienced tremors. On 03-APR-2021, the subject experienced dizzy. On 03-APR-2021, the subject experienced chills. On 03-APR-2021, the subject experienced muscle ache. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications included: acetylsalicylic acid, and ibuprofen. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99.8 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tremors on 03-APR-2021, and had not recovered from muscle ache, body ache, fever, chills, headache, and dizzy. This report was non-serious.
muscle and joint pain, described as being sore; fever; diarrhea; fatigue and being tired; headache; muscle and joint pain, described as being sore; chills started a couple of days ago; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore) and CHILLS (chills started a couple of days ago) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN, PARACETAMOL (ACETAMINOPHEN EXTRA STRENGTH), LISINOPRIL, PIROXICAM (PAXIL [PIROXICAM]), ARIPIPRAZOLE (ABILIFY), COLECALCIFEROL (VITAMIN D3) and VITAMIN B COMPLEX for an unknown indication.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced CHILLS (chills started a couple of days ago). On 19-May-2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore) and PYREXIA (fever). On an unknown date, the patient experienced MYALGIA (muscle and joint pain, described as being sore). At the time of the report, DIARRHOEA (diarrhea), FATIGUE (fatigue and being tired), HEADACHE (headache), ARTHRALGIA (muscle and joint pain, described as being sore), CHILLS (chills started a couple of days ago), PYREXIA (fever) and MYALGIA (muscle and joint pain, described as being sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7 degrees.. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications are reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Followup document contains about the lab test.
Patient received a J&J shot around 11 am. She was in the observation area for a 1 hour observation per patient request due to her reaction to the Moderna vaccine in March (patient reported shortness of breath and throat swelling but did not seek emergency care). After about 40 minutes, she complained of dizziness and appeared pale and diaphoretic. She was lowered to the ground and legs were propped up on a chair. She did not lose consciousness. Patient was then assisted to a wheelchair and then over to the gurney. She complained of chest tightness that began when she was lying on the ground. Patient was advised to go to the ER for a workup due to cardiac history and chest tightness. She wanted to wait a while to see how she felt. She rested for another 20 minutes and said her chest tightness subsided a little but was still present and had moved to the left side of her chest. She agreed to go to the ER and was transported via wheelchair. VS: 142/78 HR 75 99% on RA.