chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Right sided Bell's Palsy. Onset on 3/15/21. Presented as hyperacusis, pain around right ear, numbness and loss of sensation over right face, facial deviation while smiling and weakness of muscles of facial expression including difficulty closing right eye. Started course of steroids and Antivirals after seeing ENT. Symptoms not yet resolved on 3/16/21 with weakness of right face prominent. No other systemic complaints.
Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical  History information was provided by the reporter.  Concomitant products included THYROID for Thyroid cold nodule.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VISION BLURRED (Blurred vision). At the time of the report, VISION BLURRED (Blurred vision) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe body pain, I had to be carried inside to bed. Every time I move I?m in tears. Nausea, terrible headache. But the body pain is soo bad
Rapid heartbeat (92-regular 54), sweating, dizzy, took 6 Nitroglycerin sl tabs to treat.
About a month following the second COVID vaccine shot on 4/17/21, the paralysis on the left side of my face started, about 5/17/21. I was concerned and went to the Urgent Care af few days later and they persciribed me coricosteriods and an antiviral. I informed them that I received a COVID vaccine shot a month previous but there was no response to that concern of mine. They asked if I recently had shingles or stress related life events. I informed them that I had shingles about a year previous and that I just started a new job.
Client stated "arm freezing" after 1st Moderna COVID vaccine. Went to the doctor's and was told it was due to the placement of the shot. They received a steroid shot with improvement.
Approximately 30 minutes after receiving flu shot, experienced facial numbness, swelling, body-wide hives, flushing, itching, wheezing and coughing. Went to ED for BENADRYL, steroids, Albuterol and PROTONIX.
I had chills for 2 hours. headache. fever of 101.6. vomiting all over the place. I couldn't even drink a sip of water. cramps. leg pain. pain inbetween my shoulders. I could barely stand up, I was very weak. I went to the hospital and got a few shots to help with the vomiting. (Finigan) and medicine for the cramps  and muscle aches.  Fatigue and headache still lingers.
patient received ActHIB that was diluted with diluent which had expired; Initial information received on 03-May-2019 regarding an unsolicited valid non-serious case received from a other health professional by phone.  This case involves a 5 months old male patient who was vaccinate d with 0.5 ml expired second dose of HIB (PRP/T) VACCINE [ActHIB] (Batch number: UI860AAA and expiry date: 09-Jan-2019) via unknown route in the left thigh on 12-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) on an unknown date.  It was a case of actual medication error due to expired vaccine used because patient received ActHIB that was diluted with diluent which had expired.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   Documents held by the sender: none.
06/10/2021 Pt, per EMS report pt had his second covid vaccine shot, started having bad reaction, ems on scene, pt GCS 10, spo2 92% RA, hypotensive. at home pt having bad reaction, vomiting, defecated. Pt on gurney moaning, shaking answering questioning. Per MD, CT results show multiple Pulmonary emboli
Had a knot in her arm, it looks like a lump where she got the shot; Cannot stick her arm above her chest; Pinched nerve in the neck; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Had a knot in her arm, it looks like a lump where she got the shot), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot stick her arm above her chest) and MUSCULOSKELETAL DISCOMFORT (Pinched nerve in the neck) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 031M20A and 038K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Was taking asthma medicines).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION SITE MASS (Had a knot in her arm, it looks like a lump where she got the shot) (seriousness criterion hospitalization), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot stick her arm above her chest) (seriousness criterion hospitalization) and MUSCULOSKELETAL DISCOMFORT (Pinched nerve in the neck) (seriousness criterion hospitalization). At the time of the report, VACCINATION SITE MASS (Had a knot in her arm, it looks like a lump where she got the shot), VACCINATION SITE MOVEMENT IMPAIRMENT (Cannot stick her arm above her chest) and MUSCULOSKELETAL DISCOMFORT (Pinched nerve in the neck) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product included asthma medications. It was reported that she had a knot in her arm, it looked like a lump where she got the shot. She cannot stick her arm above her chest, she had a pinched nerve in the neck. Had to go to the hospital and everything was okay besides her arm.
Diarrhea; Joint pain; Arm pain at injection site; Nausea; This is a spontaneous report from a contactable consumer (patient). A 57 (unspecified unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm on 05Feb2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received COVID-19 vaccine on 05Feb2021 and experienced diarrhea, joint pain, arm pain at injection site, and nausea on unspecified dates. The patient wanted to know if these are side effects of the vaccine. The patient took Imodium for diarrhea. Outcome of the events was unknown. The events were assessed as non-serious.   Information on the lot/batch number has been requested.
Patient had a mild rash 5 inches below the injection site. Area was not red, but felt hard. Patient does not present with any fever, and seems alert. This is probably just a minor reaction.
Atypical ramsay hunt symdrome on right side.  Vertigo started on 7JAN, tinnitus and hearing changes on 8 JAN, vertigo worsening 7-10 JAN, leading to significant headache, nausea and vomiting with complete PO intolerance, leading to ER visit on 13 JAN for fluid rehydration, medications (anti-vertigo, anti-nausea, steroids).  CT Head unremarkable, CT soft tissue neck showed lymphadenopathy along with inflammation of right parotid consistent with acute parotitis.  CXR normal. Labs relatively normal. Physical exam demonstrated vesicular lesions on right external ear and canal consistent with Ramsay Hunt syndrome. ENT evaluated and concurred.  Audiology testing on 13 JAN demonstrated right mild-moderate sensorineural hearing loss.  Patient discharged with Valtrex, PO prednisone, antivert.
23FEB95 p/school felt bad, t103.5 c/o h/a; 24FEB95 home from school t99; APAP form inc temp w/relief of h/a & inc temp; 26FEB95 rash on trunk & arms (t99.2 on 27FEB95); DPH for itching;
Noticable weakness in both thighs on 11/14/09. On 11/15/09 severe thigh pain, diffculty walking, sitting etc. Pain continues through this date (11/16/09). Called employee health department 11/16 - scheduled for a follow up appointment 11/18.
Child seen at another facility on 10/04/95 and given varivax (no lot # available to us). Seen by us today and has approx. 20 varicella lesions. Rash began on 11/21/00. Appears to be healing chickenpox.
Information has been received from a nurse concerning an 8 year old female who was vaccinated with a second dose of varicella virus vaccine live (Oka/Merck) (lot# 657001/0338U). Subsequently, the patient experienced local injection site reaction about 5-6 centimeters in diameter, raised and very hard to touch. Medical attention was sought. The patient was treated with Benadryl (manufacturer unspecified). Subsequently, the patient recovered from local injection site reaction, raised and very hard to touch. No product quality complaint was involved. Nurse also reported that another 5 patients who are of at least 4 years of age also experienced a similar reaction to their second dose of varicella virus vaccine live (Oka/Merck). Additional information has been requested.
I had a fever cold, chills and I was achy all over. I didn't notice my heart rate at the time, but I did notice later on that my heart rate was elevated. So, I called my doctor and was told if my heart rate didn't get over a certain number, I was ok. I also took the shingles vaccine in April 2021.
Blood clots; hospitalized each time and his body parts were amputated; This is a spontaneous report from a contactable consumer received via a Pfizer Sponsored Program. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date was not reported) via an unspecified route of administration on 19Mar2021 as dose 1, single and on 09Apr2021 as dose 2, single and on 02Oct2021 as dose 3 (booster dose), single for COVID-19 immunisation. The patient medical history was not reported. The patient has been taking unspecified concomitant medications. No other prior vaccinations. It was reported that, on an unspecified date in 2021, every time he got a vaccine, he ended up getting blood clots. With those blood clots, each time he was hospitalized and had to get an amputation. At the time of report, he had done three amputations and was still hospitalized. The last time, he was hospitalized on 03Oct2021, a day after he got the booster shot. The patient wanted to know if there is anything that can be done about it or if there is a study or if that's normal. The outcome of the events was not recovered.  The lot number for [BNT162B2] was not provided and will be requested during follow up.
I had no complications after receiving the vaccine. I began to not feel well on 12/26/2022 as I had a terrible night and not able to sleep. I tested positive for COVID-19 on 12/29/2022. I had contacted our primary care doctor when my husband tested positive for COVID-19 and we both got prescription for PAXLOVID. As of today, I continue to have head congestion and hearing loss from head congestion.
THE PATIENT PASSED OUT AND HIT HIS NOSE ON THE FLOOR FOLLOWING ADMINISTATION OF THE VACCINE.  HE CUT HIS NOSE AND HIS EYEBROW.   THE EMS CAME AND HE REFUSED TO GO TO THE HOSPITAL.  HE LATER WENT TO THE EMERGENCY ROOM WITH HIS FAMILY AND HE WAS RELEASED.  HE IS RESTING COMFORTABLY AT HOME.  HIS FAMILY SAYS HE DOES NOT HAVE A PRIMARY CARE PHYSICIAN TO REPOT THIS TO
Few hard small pimples in their face; Swelling at the injection site; Injection site hurt; Injection site got red; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red). At the time of the report, ACNE (Few hard small pimples in their face), VACCINATION SITE SWELLING (Swelling at the injection site), VACCINATION SITE PAIN (Injection site hurt) and VACCINATION SITE ERYTHEMA (Injection site got red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The consumer stated that she received second dose of Moderna vaccine on 03Feb2021. She experienced swelling at the injection site, and it got red and hurt.   The consumer stated that around a month ago or maybe a little longer she noticed a few hard small pimples on the face.  No concomitant product use was provided by the reporter.   No treatment medications were reported.     This case was linked to MOD-2021-073303 (Patient Link).
the patient received an expired dose of Proquad; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.   On 28-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) 0.5 ml, lot number S002496 was verified to be valid, expiration date reported and validated as 23-JUL-2020 (route of administration was not provided) for prophylaxis.   It was not reported if the patient experienced any additional adverse effects.
Mother called: C/O Red Rash on Back/and/Legs. T. 100.3 Cranky. Tylenol advised For discomfort
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 62 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Obese" (unspecified if ongoing); "Thyroid cancer" (unspecified if ongoing); "Heart arrhythmia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Clinical course: Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 14Apr2023 to 18Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300172194 same reporter/patient, different product/ event.;
After receiving Hep A #2, HPV #9, client stood up to exit, fell forward brushing nurse shoulder then to floor. Small chip to (L) front tooth. Mom notified. Ice and TYLENOL provided. Grandma here to take home. Went to dentist.
Cough; REACTION TO MODERNA COVID SHOT; SINUS ISSUES; EAR CLOGGED; First dose 1-Nov-2021 and second dose 1-Feb-2022; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), IMMUNISATION REACTION (REACTION TO MODERNA COVID SHOT), SINUS DISORDER (SINUS ISSUES), EAR DISCOMFORT (EAR CLOGGED) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 1-Nov-2021 and second dose 1-Feb-2022) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) for an unknown indication and COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   On 01-Nov-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Feb-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient received dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient experienced COUGH (Cough), IMMUNISATION REACTION (REACTION TO MODERNA COVID SHOT), SINUS DISORDER (SINUS ISSUES), EAR DISCOMFORT (EAR CLOGGED) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 1-Nov-2021 and second dose 1-Feb-2022). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, COUGH (Cough), SINUS DISORDER (SINUS ISSUES) and EAR DISCOMFORT (EAR CLOGGED) was resolving and IMMUNISATION REACTION (REACTION TO MODERNA COVID SHOT) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose 1-Nov-2021 and second dose 1-Feb-2022) outcome was unknown.            The reporter's causality for the evens of cough, sinus issues and ear clogged with Co-suspect Imbruvica (Ibrutinib) was probable whereas not reported with vaccination adverse reaction (Immunisation reaction). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Marked bruising at injection site = 3cm in diameter. Redness, swelling, firm warm tissue below injection site - area approx 10 cm x 8cm - Symptoms resolving
This spontaneous report as received from a nurse refers to a 26 year old female patient. No information on patient's medical history or concurrent conditions was provided. On 23-APR-2015, the patient was vaccinated with the first dose of GARDASIL 0.5 ml, intramuscularly, lot # reported as K010547 (which was invalid), expiration date 08-APR-2017. Concomitant medications included: LORYNA 3 mg (reported as MORYNA. On an unspecified day in 2015, after receiving the first dose of the vaccine, the patient called the physician's office to report headache, fever, vomiting, and loss of appetite. No treatment was provided to the patient. On unspecified date in 2015, the patient fully recovered. On 30-APR-2015, the patient received the second dose of GARDASIL, and then called the physician's office on 10-MAY-2015, to report headache, fever, vomiting, and loss of appetite again. No treatment was provided to the patient. At the time of this report the patient was recovering. No lab diagnostics studies were performed. The patient sought medical attention via calling the physician. It was not specified by reporter if the therapy was discontinued. The causality between reported episodes of headache, fever, vomiting, and loss of appetite and GARDASIL was not provided. Additional information has been requested.
A week after receiving my first Moderna COVID vaccine (Dec 25), I started developing redness, pain, and tenderness over both ears.  I watched my symptoms.  I received my second dose of Moderna 1/24/21, and the ear symptoms and pain got progressively worse following, and migrated to both ear canals.  I was seen by my PCP where the possibility of infection was raised.  I was started on doxycycline for acne on my face, which did not have any effect on my ear symptoms, and was switched to Augmentin without much benefit. I also received some ear drops and was referred to see ENT.  I began developing lower extremity weakness, tremors, numbness and tingling, shakiness while walking down stairs, pain in my lower back and back of head, increased forgetfulness, brain fog, difficulty expressing, exhaustion, blurry vision, and joint pains in my ankles, knees, and wrists.  I was seen by ENT 04/01 and was told that my ears did look red and inflamed, but not infectious.  I was instructed to take NSAIDS for pain and some wax over my tympanic membrane was removed.  I had a follow-up visit on 04/15 and audiometry noted normal hearing.  I was started on a course of prednisone.  I had worsening of my neurologic symptoms, requiring hospitalization 04/22-04/28.  In the hospital I was noted to have hypotension due to unclear etiology.  I was worked up in the hospital by neurology and rheumatology.  After being discharged, I have been further worked up by rheumatology, and neurology.  I have also seen an immunologist and have an appointment scheduled to see cardiology.  I continue to have all symptoms, which all fluctuate in severity.  I started taking meloxicam for the ear pain with some relief.  I was then started on a low dose prednisone taper by rheumatology, which I am currently still on, and have just started taking plaquenil for ?vaccine induced relapsing polychondritis.
ALLERGIC REACTION WAS RASH IN BLOTCHES AND HIVES THAT MOVED ALL AROUND THE BODY, SEVERE ITCHING. DIZZINESS, WEAKNESS, TIREDNESS, HOT AND COLD FLASHES ALL CONTINUEING FOR  NOW THE 6TH DAY FOLLOWING VACCINE.
Per nursing note in patient's chart:  pt walk in c/o pain in the rt arm.since yesterday pm.he said he receive pnuemonia shot in the rt arm with pcp visit and it started to burn and he was unable to raise his rt arm and he felt febrile.he is c/o burning sensation rt arm.  Patient was treated with benedryl
Severe Headache, next day 1/21/2010, severe headache, high fever, dizziness & shaky.
termperature excursion-vaccine not viable according to manufacturer; no event; This spontaneous report was received from a nurse and refers to a 12-year-old female patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 27-JUN-2023, the patient was vaccinated with a hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that was exposed to temperature excursion, in the left arm, lot number W011455 with expiration date 11-DEC-2024 (dose and route were not reported) for prophylaxis (product storage error). No event was reported.   This is one of several reports from the same source.; Sender's Comments:  US-009507513-2307USA009456: US-009507513-2306USA013096: US-009507513-2307USA009456: US-009507513-2307USA009680: US-009507513-2307USA009660: US-009507513-2307USA009636:
Pt. complained of abdominal cramps, diarrhea, tiredness x 2 days.