chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone Quadrivalent was in transit for too long but had already given to five patients/No AE; Initial information was received on 21-Sep-2020 regarding an unsolicited valid non-serious case received from an other health professional (medical assistant). This case involves five patients who received FLUZONE QUADRIVALENT (lot UJ446AA and 18-Mar-2021) which was in transit for too long via unknown route at an unknown administration site for prophylactic vaccination (product storage error). The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided. It is a case of potential medication error due to incorrect storage of drug. At the time of report 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 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.
nausea second day after administration of second Moderna Covid-19 vaccine; chills and shivers second day after administration of second Moderna Covid-19 vaccine/shivers second day after administration of second Moderna Covid-19 vaccine; flu like symptoms second day after administration of second Moderna Covid-19 vaccine; lack of concentration second day after administration of second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea second day after administration of second Moderna Covid-19 vaccine), CHILLS (chills and shivers second day after administration of second Moderna Covid-19 vaccine/shivers second day after administration of second Moderna Covid-19 vaccine), INFLUENZA LIKE ILLNESS (flu like symptoms second day after administration of second Moderna Covid-19 vaccine) and DISTURBANCE IN ATTENTION (lack of concentration second day after administration of second Moderna Covid-19 vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, LISINOPRIL and ATORVASTATIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced NAUSEA (nausea second day after administration of second Moderna Covid-19 vaccine), CHILLS (chills and shivers second day after administration of second Moderna Covid-19 vaccine/shivers second day after administration of second Moderna Covid-19 vaccine), INFLUENZA LIKE ILLNESS (flu like symptoms second day after administration of second Moderna Covid-19 vaccine) and DISTURBANCE IN ATTENTION (lack of concentration second day after administration of second Moderna Covid-19 vaccine). The patient was treated with ONDANSETRON at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea second day after administration of second Moderna Covid-19 vaccine), CHILLS (chills and shivers second day after administration of second Moderna Covid-19 vaccine/shivers second day after administration of second Moderna Covid-19 vaccine), INFLUENZA LIKE ILLNESS (flu like symptoms second day after administration of second Moderna Covid-19 vaccine) and DISTURBANCE IN ATTENTION (lack of concentration second day after administration of second Moderna Covid-19 vaccine) outcome was unknown.        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.
Heart flutters; chest muscles cramping with chills; chills; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route in left arm on an unspecified date single dose for covid-19 immunization at 70-year-old. Medical history included inflammatory bowel disease (IBS), osteoporosis, fibromyalgia. No known allergies or covid prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient previously received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in right arm for covid-19 immunization at 70-year-old. The patient experienced heart flutters and chest muscles cramping with chills on 14Oct2021 04:00 with outcome of recovered, no treatment received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diagnosed and treated for Covid and pneumonia on July 26th and received the antibody infusion on the 27th after being ill for 11 days. Following the infusion I experienced several new or worsening side effects, fever, chills, severe headache, muscle/body aches and tinnitus that lasted several days.  Recovery from illness too approximately 6 weeks.  December 13, 2021, went to urgent care for evaluation of some adverse effects from Pfizer COVID-19 vaccination that received on 12/6/2021.  Her symptoms started the next day on 12/7/2021 and include fever up to 102, chills, fatigue, myalgias, headaches, brain fog, occasional rapid heart rate, fluttering sensation in chest. feeling very thirsty, red dry eyes, trouble concentrating.  Symptoms did not improve for 11 days.   January 4th, 2021 received the second Pfizer vaccine and began experiencing side effects the next day.  I am now having different side effects following the second vaccination. Besides a fever, fatigue, tinnitus, headache and head pressure following the second dose, approximately two days later I started having some noticeable stomach issues that have not gone away. Stomach seems like it is not emptying and feels full most of the time. Feeling of fullness even after eating very little.  Abdominal pain and bloating, lack of appetite and decreased amount of stool passage. Pressure headaches since this started as well. Symptoms continue to exist as of 1/14/21.
Pt. reports (L) deltoid and arm soreness x 3 days following vaccine. Pt. states 'persistent lightheadedness and headaches unrelieved by Ibuprofen with slight double vision.'
Approximately 1 week after receiving the shot, the injection site and about 2 inches around it in every direction started to itch, my skin turned red, the area is swollen, and it aches (off-and-on)
1/27/2021 and 1/30/2021chills and headache @ noon on. 1/30/2021 also had gut cramping. 1/27/2021 through 1/30/2021 I was also very tired and napped for hours.  I slept and covered up and the chills and headache abated.
Patient c/o face/chin/cheek heaviness.  12:54 BP 150/70, P 58, R 28 PO2 98% 13:07 BP 130/65, P 58, PO2 98% 13:15 BP 120/60, P 60, O2 98% 12:58 Still some face heaviness 13:01 Still some face heaviness 13:05 Still some face heaviness 13:10 Starting to feel better 13:12 Heaviness disappeared, feels better 13:15 Heaviness disappeared, feels better   Pat. completed 15 minute wait. Was on 30 minute wait after shot. Sought care when feeling face/chin heaviness.
very deep sharp pain in my bones; My hands was so painful, I could not raise my hand; My hands was so painful, I could not raise my hand; my left finger specially the big one is very painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: BONE PAIN (non-serious), outcome "not recovered", described as "very deep sharp pain in my bones"; PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious), outcome "not recovered" and all described as "My hands was so painful, I could not raise my hand"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "my left finger specially the big one is very painful".  Additional information: The patient experienced a very deep sharp pain in my bones inside my body. Her hands was so painful, she could not raise her hand. Her left hand, left finger specially the big one is very painful, it has not even gone. The reporter stated that she just want to report the Pfizer vaccine side effect that she had when she had the vaccine. The reporter stated just planning to go to the hospital because the pain has not stopped.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received shots on Monday.  Complained of tenderness on Tuesday evening with limited movement mom noticed swelling on Wednesday morning shoulder to elbow.  Arm reddened elbow to shoulder.  Lump about the size of a fifty cent piece.
Two days following injection I was light headed, loosing balance and room circling.  vertigo.   Symptoms went away next day, but today the symptoms are back and worse... this is day 4.  I am also nauseated and lack of appetite.   I am afraid to walk without holding onto a wall for furniture.   I had three previous injections with no problems, this was my second booster shot.  Is this unusual and how long may it last?
Stomach ache; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No relevant medical history. No Known drug allergy.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) outcome was unknown.            No Concomitant medication were reported. It was reported that the drug HUMIRA was ineffective with outcome unknown. It was unknown whether the patient was enrolled in COVID-19 vaccine clinical trial. No treatment drug were reported.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 06-NOV-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
This spontaneous report was received from a nurse and concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 01-SEP-2017, the patient was vaccinated with one dose of improperly stored M-M-R II rHA, injection, lot # M045400, expiration date: 14-NOV-2018, for prophylaxis (route of administration was not reported). Concomitant therapy included sterile diluent (MERCK) which did not undergo a temperature excursion. The vaccine underwent a temperature excursion between 47 to 77 Fahrenheit degrees for 14 hours. No previous excursions were reported. Digital data logger was involved in recording the excursion. No adverse effects were reported.
Fever (101.5), chills/shaking, confusion/delirium, lethargy, complaint that "my yawns are making my body itch"; most symptoms subsided by morning.
Pt recvd vax 4MAY93 & 7MAY93 seen in office w/localized marked erythema of the dorsum of rt leg; no pain, no fever;
Generalized rash - blaunching macular.  Benadryl, 1 dose.
This spontaneous report was received from an radiology technician, regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were unknown by the reporter. On 06-FEB-2019, the patient received an expired dose of ROTATEQ lot # N013992 with expiration date 27-JAN-2019, taken orally (dose, strength and frequency were not reported) for prophylaxis. No adverse effect was reported.
Raised red & itchy spots (hives?) on my chest and stomach which lasted for about 2 1/2 months.  The severity of the rash varied throughout that time. I was mostly able to resist the urge to scratch  I contacted my Dr who recommended Benadryl, but I never felt the need to take it.
Patient develops mild hives and flushing of the neck and face approx. 1 hour after receiving dose #1 of the Pfizer-BioNTech COVID-19 vaccine.  She self-ambulated to the clinic where she was assessed, vitals taken (which were stable), and offered an injection of Benadryl 25mg IM, which she accepted.  Patient was continually monitored and reassessed 15, 30, and 60 minutes after her arrival at which time she was starting to feel better, less flushed, with a visible reduction in her mild hives.  Patient was released to her own self-care and stated she would be calling her husband to pick her up from work.
Injection site red and irritated 5 days after vaccination was given. Patient advised by her PCP to take Benadryl.
High fever, chills, body aches,dizzy, nausea, head aches, sweating
Mom says 2/10/10 - swollen place on face - know on cheekbone & knot behind ear - saw MD @ clinic - C/T placed on antibiotics LEFTIN X 10 dye; after 6th day increased facial swelling - saw Dr. again - clinic. Went to hospital after - also saw another Dr. at clinic. Given antibiotic by mouth there. Stopped LEFTIN (info from pt's mom by phone).
Patient reports at 2 AM the morning after the injection she began to have itching and some swelling that morning, she states her right eye became matted as well.  Patient applied warm compressed to the eye and was had a telehealth visit with her MD.  Patient was told it was not caused by the vaccine.  Patient was given Antibiotic eye drops to apply 4 times daily (2 drops each eye).   At this time her right eye is better, there is still some redness in the lower eye lid at this time.
within 24 hours of receiving the vaccine, noticed being tired and achy. 2nd toe on the Right foot was swollen and red.
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Rash at injection site
Left UE has been sore the day after injection. Around 24 hours later, headache, more sore, tired and just want to have quite.
After my second COVID vaccination (05 Nov 2021), I had break-through bleeding (I am a perimenopausal and get limited menstruation). This has continued since 06 Nov 2021, periodically getting heavy. Some days the flow required hourly changes of the highest absorption materials and included golf ball to fist size clots. After over a month, I have become anemic. Looking for help with this issue, I was told that it was not uncommon after the COVID vaccine and usually resolved within 3 months.
This spontaneous report as received from a Healthcare Worker refers to a currently 46 year old female patient with hypertension, depression and obesity and no known allergies. On an unknown date the patient was vaccinated with MMR II (dose, route, lot # not provided). It was reported that the patient had titers drawn on an unspecified date for proof of immunity of measles, mumps and rubella. The results of the titers were delivered to the physician's office on 30-APR-2014. The mumps titer was 0.85 antibody units per mL. The patient's vaccination history was unknown. No other adverse effect reported. There was no treatment given for the event, no intervention to prevent serious criteria and no PQC involved. The outcome of the event described as: "a patient had drawn on an unspecified date for proof for immunity of MEASLES, MUMPS and RUBELLA. The MUMPS titer was 0.85 antibody units per mL" was unknown. The causality between the upper mentioned event and MMR II was not specified. Additional information has been requested.
Dizziness, Headache and decreased appetite, low grade fever-99.0 and a "little" bit of numbness in her fingers. Denies swelling or redness at site of injection or changes in behavior and no other s/s of serious reaction. I advised to take pt to ER for evaluation d/t to mom is concerned.
Client's sister called crying and said the family just found out yesterday that Client had died some time last week. The last time any family talked to him was on the 19th of January, missed calls show on the phone on the 21st. His last internet search was sternum pain. . She will also call the Agency and report this. The vaccine isn't in Registery at this time, do I don't know the lot number but she said he was due back in one month. She said he was very healthy and ran triathalons.
Patient reports she developed a shingles outbreak approximately 4-5 days after receiving the first dose of the Moderna COVID-19 vaccine series. She reports that she was seen by her physician and was treated with 2 weeks of steroids and antivirals as a result
PATIENT STATED SHE HAS BEEN DIZZY SINCE SHE RECEIVED HER FIRST PFIZER VACCINATION  9/21/21, THE VACCINE IS REQUIRED FOR HER EMPLOYMENT AND SHE WISHED TO GET HER SECOND DOSE, ABOUT 15 MINUTES AFTER HER DOSE SHE CAME BACK TO THE PHARMACY HYPERVENTALATING OR HAVING A PANIC ATTACK (WE CALLED 911) AFTER ABOUT 5 MINUTES OF ATTEMPTING TO CALM THE PATIENT SHE CLAIMED SHE COULD NOT BREATHE, WE ADMINSTERED A DOSE OF EPINEPHRINE, SHE CALMED FOR ABOUT 5 MINUTES AND STARTED HYPERVENTALATING AGAIN, THE PARAMEDICS THEN ARRIVED AND STABALIZED THE PATIENT AND TRANSPORTED HER TO THE HOSPITAL
From initial information received on 07MAY2003 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 44 year old female pt received a TD ADS ADULT, administered intramuscularly in the left outer arm on 17APR2003 at 2:10 PM. Five days after the injection, the pt developed a fine, tender nodule 1cmx2cm at the injection site. The adverse event onset data was also reported as 18APR2003. Per the reporter, the vaccine may have possibly been given subcutaneously. It was also reported that the pt was given other vaccinations on the same day, but the products were not listed on the source document. It was reported that the pt recovered from this event.
stated that she noticed on her forearm that she red lines like her veins; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: ERYTHEMA (non-serious) with onset 15Apr2021, outcome "not recovered", described as "stated that she noticed on her forearm that she red lines like her veins".  Additional information: The patient got her second dose of vaccine and last night noticed on her forearm that she had red lines like her veins. Stated that she still has them this morning. Stated that they were not raised or anything. The patient wanted to know if she needed to go get checked.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
exposed to temperatures below 32 degrees F. Vaccines; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked 2019SA192700 and 2019SA192699 (same reporter)  This case involves a 12 months old male patient who received dose of vaccine HIB (PRP/T) VACCINE lot UI969AAB (Expiry date 04-Apr-2020) via intramuscular route in unknown administration site. On 28-Jun-2019.  It is an actual medication error due to incorrect product storage.   It was reported that received vaccines that were previously exposed to temperatures below 32 degrees F.  At the time of reporting, no adverse reaction 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 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.  List of documents held by sender: none.
feeling warm, no actual fever, body pain, injection site pain, tiredness   concervative treatment
COVID infection following COVID vaccine series "Refers hx covid vaccines x2" Date & location unknown 1/3 COVID swab result: 1/3 pt cc: sore throat exposure: unknown 12/26 SARS-COV-2 Variant Sequencing: pending 12/26 pt admit ED cc: cough dx: Acute Viral Syndrome, COVID-19 LOS: 1 day
tiredness; This is a spontaneous report from a contactable consumer, the patient, via the sponsored program. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. Medical history included multiple myeloma for which the patient had taken a few unspecified immunosuppressant therapies. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced a little tiredness. The patient underwent laboratory tests on an unspecified date (3 weeks after the second vaccine) which included an antibody test with the following result: no antibodies, thus, the patient stated the vaccine did not work for him. The clinical outcome of tiredness was unknown.  Information about lot/batch has been requested.
A few days later, I started experiencing dizziness and then debilitating headaches. They lasted about 3 weeks before I sought treatment. I went to the Urgent Care where they did a physical, CT Scan and an MRI and all were normal. I was treated with a Toradol injection and 800mg Motrin. The headaches got better and eventually went away.   I also must note that I gave blood around the time I got the vaccine, but I've never had any issues before.