chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Heart pounding for hours and dizziness would come and go for weeks at a time. In late December palpitations started with chest tightness and difficulty breathing, which lasted a few weeks. Prescribed propranolol to take as needed, which didn't seem to help too much. Symptoms continue to come and go. 2 days ago I started having some tingling/falling asleep of my left leg and left arm that lasted for an hour and a half, at least once a day. No diagnosis has been made - blood levels have been good, chest x-ray showed nothing, heart monitor and EKG showed normal heartbeat patterns.
Employee stated he was dizzy. Later stated he "felt funny swallowing". Sent to the emergency room.
pt recvd 5cc instead of 0.5cc dose & 24 hrs post inject devel severe h/a & flu-like sx; treated w/APAP; resolved gradually; feeling better now as of 24MAR92;
hives everywhere, temp 103.8, chills, chest pain, felt like ants on her body, took motrin and felt terrible til 1/24.
Vacant and fixed expression, blank stare which resolved the following morning. Red, itchy, inflamed rash on entire chest.
Swelling, redness and tenderness to left arm. 6x6cm area where MMR and IPV were given.
Headache, Arthralgia, Fever,  Fatigue, chills, injection site pain and swelling Narrative:
Sore injection site 3+ days  Fever 24 hours  Chills 24 hours  Headache 36 hours  Higher than typical heart rate while sleeping first 24 hours
Depressed state; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depressed state) and FATIGUE (Fatigue) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Bipolar disorder.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second 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) Citrate free. In 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced DEPRESSION (Depressed state). In 2021, FATIGUE (Fatigue) had resolved. At the time of the report, DEPRESSION (Depressed state) was resolving.            No concomitant medications were reported. No treatment drugs were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt. received vaccine from intern pharmacist, as she proceeded to waiting area, she began to feel itchy nose, shortness of breath, and mild cough.  911 was called. as she waited her son in law bought her Benedryl 25mg and she took it.  when 911 arrived all vitals well within range and she was stable. 911 left and pt did not go with them, she went home.  pt stated that she usually takes allergy medications and had forgotten yesterday.
Got covid; more than 42 days for administration of second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Got covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got covid) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). At the time of the report, COVID-19 (Got covid) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) 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.   Concomitant medication use information was not provided by reporter. Treatment medication mention treatment for COVID NOS.  Company Comment: This is a case of inappropriate schedule of product administra tion and concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 and was hospitalized. The event of COVID-19 occured unknown number of days after the first dose of Spivax vaccine. The event of inappropriate schedule of product administration was  more than 42 days for administration of second dose. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of product administra tion and concerns an unknown age male patient with no relevant medical history, who experienced the unexpected serious event of COVID-19 and was hospitalized. The event of COVID-19 occured unknown number of days after the first dose of Spivax vaccine. The event of inappropriate schedule of product administration was  more than 42 days for administration of second dose. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax in not affected by this report.
I do not recall having a reaction to the vaccine.  I started feeling symptoms on 09/29/2022. I tested positive on 09/30/2022 for COVID-19 with a home test. I contacted my doctor and got the prescription  Lagevrio . I only took it once because I had nasal stuffiness that lasted two hours.
I tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 25Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she had received her first shot Pfizer vaccine on 25Mar2021 and then she tested positive for COVID on 01Apr2021 and then she was supposed to get her second shot the 15th which was Thursday, last Thursday (as reported) and she was unsure of, how if she had to get it or what was the current timeline on that and she could not really find information out there for people who gotten it in between and not people who would gotten it and then are trying to receive the first dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a 63 year old female patient with ragweeds allergy, mold allergy, CLINORIL allergy and dry eyes. On 27-MAR-2014 the patient was vaccinated with zoster vaccine live (manufacturer unknown), route not provided. Other suspect therapy included REFRESH OPTIVE and REFRESH OPTIVE ADVANCED. No concomitant medications were reported. Consumer reported that she had started REFRESH OPTIVE was started over 20 years ago (unspecified date). Dose regimen was one to two drops to eyes, used morning and evening. REFRESH OPTIVE ADVANCED was started on 17-MAR-2014. Dose regimen was one to two drops to eyes, used morning and evening. On 18-MAR-2014, patient reported eyelids started to itch, which patient attributes to allergies. Non-medical treatment was reported as cold washcloths on eyelids for itching. Patient's eyelid skin became red and raw, which patient attributed to wiping eyelids with wet washcloths. Patient also noted using new hair product which she thought might have caused the reaction. Patient washed her hair twice to remove product. On 17-MAR-2014, patient started REFRESH OPTIVE ADVANCED and reaction worsened. On 18-MAR-2014, patient discontinued FRESH OPTIVE. Patient reported having itching around the nose, neck and ears, but no rash, red ears, and a burning sensation to skin and around eyes. On 20-MAR-2014 and 21-MAR-2014, these events "got really bad", and patient called pharmacist and the manufacturer of the zoster vaccine live (manufacturer unknown) vaccine and was told the reaction was not due to the vaccine. No treatment was required for reported events, and patient wanted it noted that she did not think events were related to use of eye drops and plans to see a dermatologist. It was unknown if FRESH OPTIVE ADVANCED was continued. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
This is a spontaneous report from a contactable physician via Pfizer Sales Representative.  An adult patient of an unspecified gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient received PREVNAR 13, but was hospitalized at some point afterwards for communicate acquired pneumonia on an unspecified date with outcome of unknown. The information on the lot number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
SEVERE FACIAL SWELLING, PATIENT WENT TO ANOTHER FACILITY 24 HOURS AFTER VACCINE ADMINISTERED AND WAS TREATED WITH AN INJECTION AND A STEROID DOSE PACK PER HER REPORT.  SHE PRESENTED TO OUR VACCINE CLINIC FOR HER SECOND INJECTION AND REPORTED THE REACTION.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (dose, route, lot # unknown) on 16-JUL-2010 and the second dose of GARDASIL (dose, route, lot # unknown) late on 23-NOV-2011. The patient was not experiencing any known symptoms. Additional information has been requested.
Acute psoriatic response approximately 6 weeks after second injection. No prior history with psoriasis.
33YO FEMALE WITH HX OF FAINTING WITH NEEDLES P/W DIZZINESS IMMEDIATELY AFTER THE VACCINE.  PT TRIED TO WALK IT OFF WHILE SHOPPING IN THE MALL BUT WITH MILD LIGHT HEADEDNESS.  DESCRIBES SIMILAR SYMPTOMS SHE FREQUENTLY HAVES WITH MULTIPLE FAINTING.   UKNOWN REASONS FOR THE FAINTING WITH MULTIPLE DIAGNOSTIC STUDIES BY HER PCP.  SHE DENIES SYNCOPE TODAY. PT WAS PLACED IN TRENDELNBURG WITH SIGNIFICANT IMPROVEMENTS. PT ATE GOLD FISHAND DRANK APPLE JUICE. VITALS : t-BURG- 1656; 89, RR 18; 118/69. 100% SITTING 1706;  76, 115/71; 99% SITTING 1712;  74; 107/73; 100%  PT WALKED OUT ON HER OWN FEELING MUCH BETTER WITH NO SYMPTOMS.  TIME RELEASED 1715
Immunization site: swollen, induration, erythema, and local liproline increased. Tenderness at site.
pt recv vax 17JAN97 & no contact w/individuals w/chickenpox can be proven;pt tx @ another hosp ER w/supportive care & IV therapy, p/devel chicken pox sx of bumps on back rash, fever & stiff neck;
A rash developed on the inside of  upper left arm a few days after first shot. Within a few weeks it had spread to lower arm. It began to clear up slightly prior to second shot. After second shot it spread to right arm, back, buttocks, legs, stomach, and chest over a month's time.  Was prescribed Fluocinonide 0.05% ointment, Mycophenolate 500MG tablet, and Hydroxyzine HCL 25MG tablet
Fatigue, vomiting, fever, chills, for 1 day, the following day extremely swollen lymph nodes under left arm
The patient is complaining of right shoulder pain after receiving the vaccine.  She said after the initial vaccine soreness went away she continued to have shoulder pain when moving her arm across her body or reaching behind her head.
This spontaneous report as received from an Administrator/Office Manager refers to a 1 year old patient. The patient's concurrent conditions and medical history were not reported. On 12-JUN-2018, the patient was vaccinated with a dose of PROQUAD (strength, dose and route of administration were unknown) with lot # N020620 and expiration date of 22-JAN-2019 and with VARIVAX (strength, dose and route of administration were unknown) with lot number N030571 and expiration date of 31-OCT-2019; both for prophylaxis. Concomitant therapies included sterile diluent (MRK) and PREVNAR. The patient was supposed to received M-M-R II (strength, dose, lot number, expiration date and route of administration were unknown) instead of measles, mumps, rubella and PROQUAD. No adverse effects were reported.
Patient felt nauseated shortly after receiving vaccine and did vomit. Patient was monitored and given a cold pack and cold water to drink. She felt better after her 30 minute wait.  Patient did have anxiety with vaccines and needles listed on consent form.
Swollen lymph node in left jaw and axilla  Jaw pain (unable to completely close mouth)
Approx 10 minutes after vaccine administration patient became very clammy and stated "everything went black" she stated her throat was becoming tight. She was very pale. I text the MD on site to come to vaccine area. Vital signs recorded, HR 82, BP 112/78, O2 saturation 98%, she was afebrile. Dr. arrived and examined the patient. At 1042 he ordered Benadryl 25mg, IM and Methylprednisolone 62.5 mg IM. Benadryl 25mg IM was administered at 10:43 and Methylprednisolone 62.5mg IM administered at 10:49.  The patient symptoms began to improve. Vital signs were repeated several times and remained stable. The patient was monitored until 13:10. She ate lunch and ambulated to the bathroom. She stated she was fine and was discharged in a stable condition.
I am experiencing pain in my testicles. Very sore and tender to touch. appear to be somewhat swollen.; I am experiencing pain in my testicles. Very sore and tender to touch. appear to be somewhat swollen.; I am experiencing pain in my testicles. Very sore and tender to touch. appear to be somewhat swollen.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administration date 18May2021 10:00 (Batch/Lot number: unknown) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 ({product=COVID 19, lot_unknown=True,, administration_date=27/Apr/2021,, dose_number=1}]), administration date: 27Apr2021, for COVID-19 immunization. The following information was reported: TESTICULAR PAIN (non-serious), TENDERNESS (non-serious), TESTICULAR SWELLING (non-serious) all with onset 18May2021 20:00, outcome "recovering" and all described as "I am experiencing pain in my testicles. Very sore and tender to touch. appear to be somewhat swollen.". It was unknown if therapeutic measures were taken as a result of testicular pain, tenderness, testicular swelling.  Additional Information: The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient was experiencing pain in testicles. Very sore and tender to touch. appear to be somewhat swollen. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Local reaction at injection site, minor swelling, warm to touch, pink in color. Located on left deltoid area. Per patient it doesn't hurt any longer, only discomfort when touching. Pt given ibuprofen.
Extreme itching around waist and hips and thighs started around 4:00 pm the day after receiving the first dose of vaccine and still continuing today 3/01/2021
Patient presented to hospital to receive her first dose of Pfizer COVID vaccine on 10/18/2021 at 11:18am. After being observed for 30 minutes, she stated that her tongue was tingling/numb. She has had allergic reactions to medications in the past and normally takes Benadryl which works. She was given Benadryl 25mg liquid by mouth and after 20-25 minutes, she was stable.  She later returned to the Emergency department around 1300 as requested by her primary care provider a her tongue and face are numb. She was given IM SoluMedrol. She was then stable once again and was discharged.
Bell's Palsy; Missed second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the vaccine). The patient was hospitalized from 20-Apr-2021 to 22-Apr-2021 due to BELL'S PALSY. The patient was treated with VALACICLOVIR at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bell's Palsy) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of the vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment provided to the patient with unspecified steroids.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This report also refers to a case of Product dose omission issue for mRNA-1273, lot unknown with no associated AEs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. This report also refers to a case of Product dose omission issue for mRNA-1273, lot # unknown with no associated AEs.
Weakness; Swollen tongue; Lips cracked; Toes were numb; Cold feet; Tingling fingers; sensation of hotness and coldness; Dizziness; shortness of breath; Headache; Sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), DYSPNOEA (shortness of breath), HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat) and ASTHENIA (Weakness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CLONAZEPAM, GABAPENTIN, FAMOTIDINE, PRAVASTATIN, CALCIUM and TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-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 experienced DIZZINESS (Dizziness), DYSPNOEA (shortness of breath), HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat), ASTHENIA (Weakness), SWOLLEN TONGUE (Swollen tongue), CHAPPED LIPS (Lips cracked), HYPOAESTHESIA (Toes were numb), PERIPHERAL COLDNESS (Cold feet), PARAESTHESIA (Tingling fingers) and FEELING OF BODY TEMPERATURE CHANGE (sensation of hotness and coldness). At the time of the report, DIZZINESS (Dizziness), DYSPNOEA (shortness of breath), HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL COLDNESS (Cold feet), PARAESTHESIA (Tingling fingers) and FEELING OF BODY TEMPERATURE CHANGE (sensation of hotness and coldness) outcome was unknown. Unknown          The treatment history was not provided.
Pfizer Dose 1 2/28/21 (EN6203 Pfizer Dose 2 3/22/21 (EN6208) Pfizer Dose 3 9/30/21 (ew0177) Covid Positive 1/20/2022  1/20/22: Patient is 80-year-old female past medical history significant for chronic AFib, status post ppm, chronic venous insufficiency, essential hypertension, chronic back pain, OSA   Presented to the ED with generalized weakness of 1 week duration.  Patient endorses the progressively started to feel generalized weakness to the extent not able to do her daily activities.  Patient also has associated feeling of "warms crawling under her skin"  Patient went to her PCP and dose of gabapentin was increased to 300 mg 3 times daily   Currently patient complains of severe neck and back pain scale 6-7/10  In the emergency room patient was found to have low sodium of 116, potassium of 1.9.  Urine sodium need be less than 20 and urine osmolality 168.  Nephrology consult was obtained by ED and recommended to give 3% of 50 cc normal saline and admitted to the floor  1/27/22: Pt is an 80-year-old female past medical history significant for chronic AFib, status post ppm, chronic venous insufficiency, essential hypertension, chronic back pain, OSA  Presented to the ED with generalized weakness of 1 week duration.  Patient was then admitted with severe hypotonic hyponatremia, severe hypokalemia, essential hypertension, chronic AFib, s/p ppm, history of OSA, history of chronic neck and back pain as well as advanced degenerative lumbar spine disease.  Nephrology consult was obtained in the ED and patient was given 5% normal saline in the ED; patient was then progressively monitor for sodium correction; serum sodium corrected appropriately.  Patient carvedilol was changed to metoprolol per Renal recommendations.  Patient had urinary retention and was required to be catheterized and failed voiding trial requiring indwelling catheter.  Patient found to be physically deconditioned and discharged to SNF we with the recommendation to follow with PCP, Cardiology as outpatient  FSA showed Zenker's Diverticulum.  Patient has been having difficulty swallowing for the past few months.  Patient wants to follow up with GI outpatient.  Continue soft diet.  Patient also had COVID-19 with no symptoms. Repeat COVID test has been negative
Nurses' right arm became reddened, swollen, itchy, and had several welt formations.
Pt just got administered a 2nd High-dose Fluzone vaccine. No reactions happened.
INADVERTENT ADMINISTRATION OF AFLURIA (FLU VACCINE) WHEN PT REQUESTED ZOSTAVAX. PT HAD PREVIOUSLY RECEIVED FLU SHOT APPROX 4 WEEKS PRIOR, NOT GIVE AT PHARMACY. APPROX 20 HOURS LATER, PT NOTED "SWELLING".
Pt states feeling dizzy post-shot. Also complaining of tachycardia. Pt appears mildly anxious. SBP checked = 174. Patient states she has high blood pressure. HR checked 80, appears regular. Patient given benadryl.
Patient's reaction(s) noted during COVID vaccine observation period:  hives and redness/itching to sides of abdomen. No sob, chest pain noted.   Actions Taken: Vital signs taken, observed for 30 minutes. Advised to monitor rash at home and take antihistamines as needed. Patient verbalized understanding.  Disposition:  Home
Patient received SHINGRIX shot on 4/12/18. 3 hours later, began sweating, feeling lightheaded, and fainted for a few seconds. After resting, felt okay. Had diarrhea the next day for 1 day.
Menses came early, two days after the shot. My next menstrual cycle was also very short 19 days.