chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and HEADACHE (headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (headache). On 17-Mar-2021, the patient experienced COVID-19 (COVID-19). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 antibody test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Information has been received from a 36 year old female consumer with an allergy to compazine and a history of chicken pox who in approx. November 2000 was vaccinated with a first dose of hep b vaccine recombinant. Concomitant therapy included Ziac and Zoloft. Subsequently, the pt started to experience flu-like symptoms. She reported that she developed achy joints, cough, fever and sour throat. It was reported that this lasted for one week. On 05/10/2001 she received a second dose of hep b vaccine recombinant and experienced all the effects again. No further info is available.
Fever, aches, hives, swollen throat and tongue. Hydroxyzine HCL 10 mg (not incredibly effective), benadryl, Tylenol Next day, still swollen throat and tongue but no hives, fever, or aches
My injection spot was swollen, right, & red yesterday morning. I put a cold compress on it. I cannot lay on it. I was short sleeve as suggested to keep the area cool. I took two Tylenol last night before I went to bed.
Pt had a near syncopal event after the injection. She became pale, light headed BP 102/60. She lied down for 20 min and improved
today my mouth got numb; throat swelled until i took A Benadryl; For 3 days i have Been getting hives daily; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 14Apr2021 at 13:30 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, it was unknown whether the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 35-year-old), as a single dose for COVID-19 immunisation.  On 23Apr2021, the patient had been getting hives daily for 3 days and on 27Apr2021 (reported as today), patient's mouth got numb and throat swelled until the patient took Benadryl. The patient had no allergies at all before this shot. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events mouth got numb and throat swelled and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event getting hives daily, mouth got numb and throat swelled was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Shivering began night after vaccine was administered and recurred 3 nights after 2100. Chills and mild fever (1-2 hrs) overnight along with shivering.
1. Intramuscular blood clot diagnosed 7/2/21.  2. Myocarditis / mildly enlarged heart diagnosed 7/2/21
This spontaneous report as received from a pharmacist refers to a 74-year-old female patient. The patient did not have any drug reactions and allergies. No information regarding the patient's pertinent medical history or concomitant medications was provided. On 21-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration and expiration date were not provided; lot # M037653). On 31-MAR-2017, the patient experienced localized swelling, redness, itchy and warm to touch at the injection site. Pharmacist advised the patient to place ice on the area and to see her primary care physician. No other treatment was given for the adverse events. No laboratory diagnostics studies were performed. The outcome of the adverse events was unknown. The relatedness between all adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Swollen mouth - patient had this reaction long time ago 10-15 years ago per patient, received vaccine due to covid situation advised by doctor per patient. Dose given 04:19 pm 12-01-21, about 5 minutes after reaction started. Epipen was given, and 5:02 pm, patient recovered and was able to walk out. Called patient 7:05 pm to see how she was doing, patient stated she was fine.
Tumorigenesis of Diffuse Large B cell Non-Hodgkin's Lymphoma. Initial diagnosis in September 2021 after suffering from unusual pain in mid-section. Scans showed widespread lymphoma. Underwent rounds of chemo and radiation. Received Covid-19 booster shot on November 9, 2021 at urging of medical doctors in order to continue chemotherapy and "qualify" for other treatments. Getting a booster Covid-19 shot was not negotiable if she wanted to continue being treated. Subsequent scans showed a remarkable increase and spread of the disease from scans just prior to receiving Moderna booster. Deceased on March 13, 2022.
devel severe h/a 2 hrs p/inj, weak; no strength, lt arm sore in joints shoulder wrist & elbow the next day rt arm shoulder & wrist & rt hip knee & ankle became sore; saw MD
IMMEDIATELY AFTER PATIENT RECEIVED HIS VACCINE, HE FELT NAUSEOUS. PATIENT SAT DOWN AND SOON AFTER SITTING, STARTED SEIZING (HIS FATHER REPORTS ARMS CONTRACTING AND SHAKING). PATIENT DOES NOT REMEMBER THE EVENT. UPON REGAINING CONSCIOUSNESS, THE PATIENT SAID HIS FACE FELT FUNNY BUT THERE WAS NO THROAT SWELLING OR SIGNS OF ALLERGIC REACTION. PATIENT LAID DOWN WITH HIS FEET UP FOR ABOUT 15 MINUTES AND REPORTED FEELING MUCH BETTER. NO OTHER SIGNIFICANT EVENTS OCCURRED DURING THE OBSERVATION PERIOD. PATIENT DENIES A HISTORY OF PREVIOUS ALLERGIC REACTIONS OR REACTIONS TO VACCINES.
Left arm started itching from the elbow down and ring and little finger and lateral edge of hand went numb.  Now neck is achy.  Numbness comes and goes sporatically.  Patient has tried ice packs with no relief.
Bad flu like symptoms with gradual onset.  Severe body aches and pain in joints (legs, both arms, feet, hands and fingers) also muscle aches by evening. Got worse with each hour that passed. Also, had strong headache pain  and some chills but no fever. Was unable to sleep and took some Tylenol at 2:30 am on April 2nd (approximately 15 hours after Moderna vaccine injection).
Mom reports that 2 weeks after receiving L arm SQ vaccination, patient developed swelling, bruising and darkening bump of the arm. Was taken to the ER and diagnosed with Molluscum Contagiosum in which the ER providers attributed to patient receiving vaccinations. Sent home to self-monitor and allow to self-treat.
Inflammation and throbbing in hands; Inflammation and throbbing in hands; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 11Mar2021 at 05:15 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included thyroid disease - Hashimoto and thyroid (thyroid disorder NOS). The patient had a history of allergy to penicillin. Concomitant medications included levothyroxine sodium (LEVOXYL) from an unknown date for thyroid (thyroid disorder NOS). The patient previously received sulfur on an unknown date and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient experienced inflammation and throbbing in hands. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included the process of X-ray of right hand and blood work. On an unknown date in 2021, the patient underwent lab tests and procedures which included X-ray of right hand, blood work and the results were unknown. The clinical outcome of the events inflammation and throbbing in hands was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
He got the fever, it has reached 103.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 03Aug2021 (Lot number: EW0169) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 04Aug2021, outcome "recovering", described as "He got the fever, it has reached 103.5". The event "he got the fever, it has reached 103.5" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: The patient stated, I took three of my teenager yesterday to get the COVID Vaccine. Well their ages are 13, 14 and 17 and my 14 year old, exactly 24 hours after taking the vaccine he got the fever, it has reached 103.5. I have given him Ibuprofen and I give him 500 (Further clarification was unknown) Ibuprofen and it didn't go down much, it just go down to 102 and then it went again to 103.5 (Hence Ibuprofen was captured as suspect) and I have given him Tylenol (treatment) and right now it's 101. I am like a little concern I don't know should I wait and see if it continues (voice not clear) or should I take him to the ER because I went through the similar situation when I took the first dose back in Mar and my temperature was 105. The patient was informed about Pfizer Medical information department and was provided with the number. Patient was advised to reach out to nearest Emergency room in case of any medical emergency  Follow-up attempts are completed. No further information is expected.
nodule formed at the injection site; the injection along with localized pain; reddened, warm area remained around the injection site; reddened, warm area remained around the injection site; This is a spontaneous report from a contactable nurse (patient). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899) intramuscular on right arm on 18Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included the medications the patient received within 2 weeks of vaccination: Amlodipine, hydochlorathiazide, bupropion hydrochloride (WELLBUTRIN), zolpidem tartrate (AMBIEN). The patient previously took albuterol sulfate and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020, a nodule formed at the injection site about 12 hours after the injection along with localized pain. The nodule started to disappear, but a reddened, warm area remained around the injection site. The reddened area is about the diameter of an egg. It has been about 72 hours since the injection. No treatment was received for the adverse event. Events outcome was not recovered.
Swollen lymph noted above the clavicular line on the right (covid shot on right arm) noted after a day i got the covid 19 vaccine; This is a spontaneous report from a contactable nurse reported for herself. A 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot unknown: true, lot unknown reason: unable to locate or read the details) intramuscularly at right arm on 08Jan2021 at 07:30 AM at a single dose for COVID-19 immunization. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot unknown: false) intramuscularly at right arm on 20Dec2020 at 11:30 AM at a single dose for COVID-19 immunization. No allergies to medications, food, or other products.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient was not pregnant at the time of vaccination. The patient experienced adverse events included swollen lymph noted above the clavicular line on the right (covid shot on right arm) noted after a day she got the covid 19 vaccine. She still could feel it at the reporting time. The event start date was reported on 09Jan2021 at 12:00 PM. The event was reported as non-serious. No treatment received for event. The outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
PT received Anthrax #4 on 1/21/03. PPD in left arm. PT c/o dime size redness, warm to touch with knot and puscular area to site. Increased itching at inject site with numbness after shower. Motrin and warm compresses applied with siege and relief. 1/22/03 in arm increased red, warmth and decrease in size to approx 4 cm x 4 cm. PT state has less with itching w/out drainage. Seen in immunization at medical facility with units to use Motrin in warm compress and be seen in AM if worse. 6 cm by 6 cm with redness with warmth noted to site.
for the first 2 days extreme left arm muscle pain, inability to properly move arm, hot to the touch, with some swelling.  After symptoms went away.  Starting 3 days after injection, I developed extereme weakness, chills, low grade fever (100.2 or below), hypersensitivity to touch of the skin, with some bouts of nausea.
Sudden onset atrial fibrillation, started at 1200 hours did not convert to normal sinus rhythm until 2200 hours. Tachycardia (140-170s), dizziness, palpitations, shortness of breath,
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 43 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC, start date: 06Jul2017, stop date: 26Jan2023; METFORMIN, start date: 04Jan2017, stop date: 26Jan2023; LISINOPRIL, start date: 15Aug2017, stop date: 26Jan2023; CHLORTHALIDONE, start date: 26Jan2017, stop date: 26Jan2023; CENTRUM, start date: 17Oct2017, stop date: 26Jan2023. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 14Jan2023 to 19Jan2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient initially had a sore arm following vaccine and up until 05/18.  On the morning of 05/18, she states she experienced a "spot" on her arm where she was administered the vaccination.  On the morning of 5/19, she woke up with hives all over her body.  She then called her doctors office to report the hives and was told to take 50 mg of benadryl.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient said she had tingling in her fingers and arm immediatly after injection
Had J & J vaccine no unusual side effects? Did moderna booster developed blood clot in Radial Artery
Wife calls to report onset of blue bruising at site of injection and "clear fluid soaking the bandage pad and running 2 inches down patient arm"
very tired; sore arm; This is a spontaneous report from a non-contactable other healthcare professional. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unknown) via unspecified route, as unknown, single dose on 22Mar2021 for COVID-19 immunization (at the age of 36-years). Medical history included chronic myeloid leukaemia, pancreatitis acute, Chronic Idiopathic urticaria, MALS released post op complications (bleeding), hepatic ischaemia, cholecystectomy, VATS decussation bil lungs, plurex bil lungs and ongoing idiopathic urticaria. The patient's concomitant medications were not reported. On unspecified date it was reported that patient experienced very tired & Sore arm. The clinical outcome for the event was unknown.  Follow up needed, further information has been requested.
The patient came into our pharmacy in the morning on 3/24/18 (the day after his first SHINGRIX injection) complaining of itching and sensitivity on his arms and back. The patient says the symptoms/reaction onset began in the late afternoon the day before on 3/23/18 after he arrived home from receiving the SHINGRIX injection. The patient says his wife had been rubbing over-the-counter hydrocortisone 1% cream on his back to try to help with the itching but that the area is very sensitive, so it is hard to allow her to rub the cream onto his skin. I told the patient to not use the hydrocortisone cream for now due to the sensitivity. The patient says he was not experiencing a rash, redness, hives, or problems breathing and that the area of itching and sensitivity appeared normal. I asked the patient if he took any pain medication such as TYLENOL or ibuprofen. The patient said he already takes ibuprofen for other body aches/pain. I asked to see the injection site, and it appeared normal with no rash, redness, swelling, etc. The patient said he could not think of anything else that would cause his itching. The patient asked if he should go to an urgent care/clinic since his doctor's office is closed for the weekend. I then asked the patient the severity of his reaction and he replied that he thinks it is severe. Since the patient replied severe, I instructed him to go see a doctor today (the day he came into the pharmacy complaining of the reaction). I will follow up with the patient tomorrow, 3-25-18, to see if he went to a clinic/urgent care and the outcome of the visit. I told the patient I will contact his primary care physician on Monday, 3/26/18, and that he should call his primary care doctor regarding the situation/treatment as well. The patient said he will follow-up with me on Monday, 3/26/18, after speaking with his doctor.
PATIENT CALLED BACK ON 12/15/22 EXPRESSING CONCERNS WITH HAVING ADVERSE EFFECTS (INCULING FEVER AND COUGH) 2 DAYS FOLLOWOING RECEIVING HIS FLU VACCINES. NO PCR OR FLU TEST HAS BEEN DONE.
Bi-Valent Vaccine given inadvertently for 2nd dose instead of mon-valent.
Initial consumer (patient) report received on 13 Jan 2011: This patient with vaccination history of H1N1 vaccine without any events was vaccinated with seasonal influenza vaccine (manufacturer and batch number: unknown) on an unknown date. She experienced mild sore throat and run down feelings on unknown date. The outcome and causality of the events were not reported.
This spontaneous report as received from a other health professional refers to unspecified patients of unknown age. On unknown dates the patients were vaccinated with single doses of improperly stored GARDASIL 9 lot # N004798, intramuscular for prophylaxis. No adverse effects were reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9.    Additional information has been requested.
I was unable to stand or walk. When trying to walk I was tripping over my feet and falling. I had to be held up. I could not walk or stand on my own and I was extremely dizzy when upright.
This spontaneous prospective pregnancy report was received from a 21-year-old female patient who refers to herself. The patient did not have any pertinent medical history, concomitant therapies and drug reactions or allergies. On 05-JAN-2018, the patient was vaccinated with a dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) to prevent HPV. On an unknown date, there was a pregnancy test performed which confirmed pregnancy. On 23-JAN-2018, it was confirmed that the patient was pregnant at the time she received GARDASIL 9 injection. The patient became pregnant with last menstrual period (LMP) date of 22-DEC-2017 and estimated delivery date (EDD) of 28-SEP-2018. At the time of the report, the patient's pregnancy gestation was 5 weeks. The patient was vaccinated in first trimester of pregnancy. The patient did not experience any side effects. The patient did not seek medical attention. No treatment was given for the event. The outcome of pregnancy was pending.
Initial misuse report receive from a healthcare professional on 17 May 2013. It was reported that 2 doses of ADACEL were administered to a patient a day apart (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Patient received two vaccines in our pharmacy on 5/30/18. Engerix B (NDC 58160-0821-43) in her left arm and SHINGRIX (NDC 58160-0829-03) in her right arm. Patient came in on 5/31/18 stating that her right arm had swelling, redness and was itchy. She stated she had already taken Ibuprofen which seemed to be helping and was directed to continue that as well as OTC hydrocortisone if the itching continued. She was also told to follow up with her PCP if the reaction got any worse. Patient was satisfied with this information.
Vaccine 3  Heart rate increase 20 beats per minute at rest  and walking or exercising for 72 hours.  Day 4 post  booster  - had heart palpitations/irregular beats  every 30 seconds for  24 hours  , slowly decreased  until ending on day 6
Patient experienced swelling and redness on arm of injection. Reported from shoulder to elbow along with heat on arm and minor fever (not checked).