chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Armpit on the arm injected is swollen; swollen lymph nodes. Following my first dose of Pfizer on Sept. 15 I?ve been feeling a bit light headed. My chest feels heavy. No sharp pains just occasional dull pains in my chest.  It feels as though I?m having circulation issues. My fingers and toes go from ice cold to warm and tingly throughout the day.  I returned to work where I?m required to do quite a bit of standing and I blacked out.  I was checked out by EMTs at the airport and sent home. Told to go home and rest and if my symptoms worsened to be seen by a doctor. I have since started taking 81mg of aspirin and it?s alleviated my symptoms a bit but still not feeling well.
I missed my period but have felt all of the pre-period symptoms which include tenderness of breast, cramps, bloating, etc.  My ovaries also feel swollen or tender but no period.   It is now more than 10 days late.
Patient developed chills, T: 40 degree C, stiffed body, chest discomfort, nausea. Approximately 3 hrs after administration of BEXSERO and GARDASIL seen at ER. Treated with dexamethasone, TORADOL, ZANADOL.
Information has been received from a licensed practical nurse concerning a 61 year old male patient who on 5-FEB-2009 at 13:25 was vaccinated with the first dose of ZOSTAVAX (Oka/Merck) (Lot number 663637/1705X) SQ in the left arm. On 5-FEB-2009 in the evening post vaccination, the patient experienced redness, rash and pain at injection site, later noted in the upper left arm. On 16-FEB-2009, the patient went to an urgent care center and they told him that he had shingles and the only treatment was to prescribe something for the pain. Additional information has been requested.
Noticed after taste in my mouth; dry throat within 5 mins of the injection; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 11:00(at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy to pollen from trees/grasses and suffered anaphylaxis after eating food from another country. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); both for unknown indication and start date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 08Apr2021 at 11:15, the patient noticed after taste in mouth and also experienced dry throat within 5 mins of the injection. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event after taste in mouth and dry throat within 5 mins of the injection were recovered on an unknown date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
By 1am on 8/6/21, severe chills, body aches, fatigue, abdominal pain, nausea, severe vomiting, muscle aches, bitter/metallic taste, and anorexia for 24 hours. Currently still having metallic taste in mouth, anorexia, and fatigue.
11/15/09 she came to the ER noting 2-3 days of gradually increasing weakness and numbness in her hands and feet which made ambulating difficult and in need of assistance. 11/15/2009 - 3 hours prior to arriving at the ER, pt mentioned that she had vomited and started to feel worse. 11/16/2009 - The patient seems very groggy. According to documentation, she has received several doses of DILAUDID overnight. Additionally, the patient has had an enterococcus UTI and Dr. of infectious disease has been following her. The patient was moved to the unit yesterday for concerns of worsening respiratory mechanics and weakness. Patient takes Dicyclomine, Atenolol, and Amitriptyline for Fibromyalgia and hypertension.  LODINE and PERCOCET were administered in ER. The plan is to continue Atenolol, decrease Amitriptyline to 25 mg at h.s giving small dose of Clonazepam in order to help the patient sleep. Will get negative inspiratory flows and vital capacities b.i.c. Medications in the hospital included Amitriptyline 25 mg po q.h.s., IV fluids, LOVENOX 40 mg subcu qd, ZOFRAN prn, LEVAQUIN 500 mg IV q24 h, Hydromorphone 2 mg q4h prn IV, Tizanidine 2 mg pot id, Clonazepam 1 mg po q h.s., Docusate Propoxyphene with acetaminophen 1 q4h prn, Atenolol 25 mg q a.m. immunoglobulin infusions. 11/19/2009 - The patient had a negative inspiratory force of -60 mm of mercury and a FEC or forced vital capacity of 20 liters. Possible LOVENOX DVT prophylaxis, physical therapy consultation, and if she does developed hypoxemia or her pressures worsen a possible arterial blood gas. Patient has some crackles in her left base and a chest X-ray is warranted. Monitor her q6 h FVC and MITH and MEPTH.
PATIENT'S RIGHT ARM BECAME RED AND SWOLLEN, PATIENT SAID SHE TOOK BENADRYL CAME INTO PHARMACY ON 8/15/2017 I OBSERVED ARM STILL APPEARED RED BUT SWELLING HAD GONE DOWN.
Itching on face, cheeks, scalp, moved down to hands; swelling in tongue at back of throat; heart racing; "winded"
2FEB91 temp 105R, convuls taken to ER, had slight cough, non productive, rhinorrhea; vomited, no diarrhea was told poss virus; No ear infect;8FEB91 temp 101R playful but weak;
Patient received her Pfizer COVID 19 booster shot. remained in the area but returned to the department to report she has a headache (which she had before she came - reported by mom later), chest feels weird- she could not describe the exact feeling, she was dizzy, feeling hot and sweaty, Pt was monitored for an hour. During that time patient drank water and used ice packs to cool herself. After the hour pt stated she felt much better. discussed with Dr. Okay for discharge. Advised she could take Claritin, Allegra or Zyrtec when she got home and to rest the remained of the day.
redness, puffiness, around both eyes. Tx meds-Benadryl, Orapred. F/U 1-2 days.
Informatino has been received from a clinical medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical histories or drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with improperly stored doses of ZOSTAVAX (lot # L006392 with expiration date 25-MAY-2016; dose and route were not reported). No adverse effects were reported. This is one of the several cases from the same reporter. Additional information has been requested.
On day 32 (April 15, 2021) post second COVICD- 19 vaccination patient started to develop slight paralysis of the left side of his face ( mouth, cheek) and eye was also feeling heavy/fatigued.  On  April 21, 2021 patient was directed to go to local ER for examination to rule out stroke.
This spontaneous report as received from a pharmacy technician regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On unspecified dates, unspecified patients were administered with improperly stored doses of VARIVAX (lot # L013824, expiry date : 21-APR-2017) (Strength, dose and route of administration were not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent(STERILE DILUENT MRK) lot # N007550, expiry date : 03-MAY-2018 (Concomitant). Temperature excursion was reported from 15 degrees Fahrenheit (15°F) to 46 degrees Fahrenheit (46°F) for 15 hours. There was no previous temperature excursions. The call was due to data logger. No adverse effects were reported. No product quality complaint was involved. This is 1 of 2 reports from the same reporter.  Additional information has been requested.; Sender's Comments: US-009507513-1706USA002754:
PATIENT CALLED ON 10/25/2021 TO STATE THAT SHE STARTED TO HAVE NUMBESS IN HER VACCINATION ARM. FIRST IT STARTED WITH THE ENTIRE ARM AND THEN IT TRAVELED DOWN TO JUST HER FOREARM AND THEN IN HER FINGERS. SHE DID STATE THAT SHE WAS SLOWLY STARTING TO GET FEELING BACK IN HER ARM BUT STILL FELT SLIGHTLY NUMB ON 10/25/2021. PATIENT DID CALL HER PCP AND WAS INSTRUCTED TO WATCH FOR INCREASING NUMBNESS.
This spontaneous report as received from 2 healthcare workers refers to unspecified amount of patients of unknown age and gender. On unspecified date between 10-MAY-2014 and 23-JUN-2014, the patients were vaccinated with GARDASIL injection (lot # H020901, expiration date 05-JUL-2015), 0.5ml, intramuscularly, that underwent a temperature excursion. No adverse effect reported. This is one of the several reports from the same source. Additional information has been requested.
A non-serious spontaneous report of barrel was broken near the white spray nozzle was received from a health professional concerning an adult female. The product broke when she went to administer the dose it seemed to shoot out of the patient's nostril. The nurse thought that she had not given the dose properly and upon administration of second portion of the dose the liquid squirted back at the nurse and covered her glasses. The nurse felt only fine mist on her face. When she removed the sprayer from the patient's nostril she did see a small half moon shaped crack in the glass at the white tip of the sprayer right on the bend. The sprayer had not been dropped or mishandled. The office keeps their doses in the refrigerator in the original packaging and pulls out the sleeve to remove only the necessary doses, then replaces the tray back into the packaging and puts it back into the refrigerator. There was no adverse event associated with this product complaint; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
rxn began approx 2hrs p/vax;exhibited the following sxs-reddened eyes w/thick discharge; sore throat & nose w/congestion & a feeling of oppresive discomfort in the chest;diff breathing;took an allergy pill & sxs resolved w/in 24hrs;
PATIENT STATED THAT THE EVENING OF THE DAY SHE RECEIVED THE MODERNA BOOSTER, SHE STARTED FEELING NAUSEA AND PAIN IN THE ARM ALONG WITH FEELING TIRED. THE FOLLOWING DAY AFTER RECEIVING THE VACCINE, SHE NOTICED SWELLING AND REDNESS IN HER ARM. SHE REPORTED THE EFFECTS ON 11/30/21.
pt recvd vax for prophylaxis & 9 days later, exp hives on neck & upper back & chest;later exp hives over entire body;exp also, back,leg & hand pain along w/ flu-like sxs;tx w/ prelone x 4 days; hives have subsided;
9/29/15 Temp at 11am 99? Lethargy. 9/30/15 Temp 101 deg lower area of left arm by elbow red and fevery. 10/1/15 Reported left arm above elbow red and fevery. Painful to touch. 10/2/15 Condition improving dark pink in colorr. 9cm x 5 inch including elbow red.
Moderna - 3rd shot Approximately 3 hours after shot - muscular pain at injection site, soreness left side of body, chills , felt warm - headache. Morning of 5th still headache. Took ibuprofen twice during day (200mg) - gel tablet - no help. Morning of 6th - still headache - took 400mg - pain resided - low dull thud of pain still in left side of head. *Morning of 6th noticed swollen lump area under left arm pit - jelly like , approximately 3" x 4" in size, tender to touch - seemed to lesson in size as day progressed. No similar reaction / event experienced with 1st and second shot - also protracted headache not experienced fist & second shot. Will not am at 2300M in elevation this location (Asmara - Eritrea)
Client reports swelling in ankles and all fingers. Client reports itching all over body. No rash or hives reported at this time. Client reports soreness near site of injection, but no redness or swelling.
Reported fever of 101.8 when awoke later the same day of receiving vaccine- "felt  like I was hit by a truck". "Slept it off and felt better" next day. Reported is breastfeeding-she contacted physician who recommended to stop breastfeeding secondary to receiving high dose flu vaccine.
Extreme fatigue, Bad body aches, mild headache.  From about 1Am on Wed. May 19 , Very restless all night, not  able to sleep. Fatigued all day. Took two 2Hr. naps, then slept from 9PM to 8:40AM.  May 20th feeling pretty normal now.
Patient began feeling chills, achy and pain under ribs shortly after returning home from receiving influenza vaccine.  Patient also began to feel chest tightness next day and went to hospital next morning (10/18/2003).  Patient reports feeling much better but still feels chest tightness (10/28/2003).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose number unknown (booster), single (Lot number: GH9702) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Manufacturer unknown), for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2022, outcome "unknown", described as "Chronic stomach pain"; URINE ABNORMALITY (non-serious) with onset 2022, outcome "unknown", described as "Foamy urine"; NAUSEA (non-serious) with onset 2022, outcome "unknown"; PROTEIN URINE PRESENT (non-serious) with onset 2022, outcome "unknown", described as "Tested positive for protein in his urine"; WHITE BLOOD CELL COUNT DECREASED (non-serious) with onset 2022, outcome "unknown", described as "his white blood cell count is low". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient has received the Pfizer Booster, the Bivalent Booster (Clarified as: Pfizer Covid-19 Vaccine Bivalent) approximately, three to four weeks ago and subsequent to receiving that Booster he has had foamy urine and chronic stomach pain and nausea. He tested positive for protein in his urine and his white blood cell count was low. Those were the only changes.  No follow-up attempts are possible. No further information is expected.
pt recv vax 230DEC96 & exp hives which progressed to angioedema initially w/shot;pt required 3 MD visits (several specialists) & tx w/steroids & antihistamines caused the sx to improve but they did not resolve;
Patient developed a red circle a little bigger than a quarter around the injection site.  She indicated that it was itchy and warm to touch.
The first 24 hours up to 48 hours following vaccine booster, left arm soreness, fatigue. Approx 10 days later on 1/25, left sided altered sensation of tongue, 24 to 30 hours later on 1/26, left sided numbness and tingling along with altered taste/sensation with left side tongue. An additional 24 hours later on 1/27, left sided facial muscle paralysis began in addition to above mentioned taste and numbness of tongue and face. Unable to make facial expressions on left side only
3 patients (all adults so over 18 years old), 2 males plus 1 female, were administered the Pfizer covid vaccine that had been stored outside of EUA prescribing information guidelines.; 3 patients (all adults so over 18 years old), 2 males plus 1 female, were administered the Pfizer covid vaccine that had been stored outside of EUA prescribing information guidelines.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "3 patients (all adults so over 18 years old), 2 males plus 1 female, were administered the Pfizer covid vaccine that had been stored outside of EUA prescribing information guidelines.".  Additional information: This pharmacist reported similar events for 3 patients. This is 2nd of three reports. This pharmacist reported for an adult female patient. 1 of the refrigerators temperature monitors were not working for about 3-4 hours, he believes the undiluted Pfizer covid vaccines were at room temperature (55F) for a total of 4 hours maximum. After they were taken out of the refrigerator, they were administered to 3 patients.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021523525 same reporter/drug/event, different patient;US-PFIZER INC-2021530570  same reporter/drug/event, different patient
I'm not sure which flu vaccine clinic uses.  I Discussed with allergists, pediatricians the safety of flu vaccine given that it was a bad season and was advised it was safe.  However, within hours, he felt feverish and had arthralgias.  He continued to have joint pain, fatigue, headaches for a month and was reported by teachers to be sluggish and slower than usual.  Since that vaccination, he was sick more than well for the next 3 months and got influenza twice anyway 1 month and then 2 months later without any mediation of the symptoms.  He spent more time ill this winter than ever before and I credit that with his immune system being weakened by the flu vaccine.
This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored RECOMBIVAX HB (lot #, expiry date was not reported). No adverse event was reported. The outcome of the events were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
My husband had test positive for COVID-19. I had a lo-grade fever, it felt like I had no Cartlidge in my body, it felt like sand rubbing in between my joints, headaches, hot, cold chills, congestion, coughing. I took a home COVID-19 test that came back positive, I called my doctor and was prescribed Paxlovid that I started immediately. I did feel better, but the brain fog COVID-19 brain took a while to get over.
DIARRHEA; WEAKNESS; THREW UP EVERY TIME (VOMITING); NAUSEOUS; RIGHT KIDNEY IS HURTING; COULD NOT GET OUT OUT OF BED; SUPER ACHY; HEADACHES; FATIGUE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: history of chronic urinary tract infection, penicillin allergy (rash and hives), macrodantin allergy (rash, hives, captured as drug allergy), bactrim (rash and hives, captured as drug allergy) non-smoker, and non-alcoholic The patient had no drug abuse or illicit drug usage.  The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number 206A21A, expiry: Unknown) dose was not reported,1 total, administered on 03-SEP-2021 for prophylactic vaccination on her right arm. No adverse events were reported (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, expiry: 11-APR-2022) dose was not reported, 1 total, administered on 14-DEC-2021 at noon (12:00) for prophylactic vaccination as a booster dose on her left arm (dose number in series 2). No concomitant medications were reported.  On 14-DEC-2021, the patient experienced headaches, and fatigue in evening (dose number in series 2). Patient reported that super achy and headache worsened throughout that evening (dose number in series 2). On 15-DEC-2021, the patient could not get out out of bed (dose number in series 2). Patient was nauseous and threw up every time (vomiting) (dose number in series 2). Patient could drink water, but would gag and throw it back up and claimed that her right kidney was hurting (dose number in series 2). On 16-DEC-2021, the patient experienced diarrhea, and weakness.(dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from threw up every time (vomiting), and nauseous on 15-DEC-2021, and headaches on DEC-2021, and had not recovered from fatigue, could not get out out of bed, right kidney is hurting, weakness, diarrhea, and super achy. This report was non-serious.
sore arm x1 day; swelling and redness x2 days; swelling and redness x2 days; This is a spontaneous report from a non-contactable healthcare professional. A 36-year-old patient with unknown gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 20Apr2021 at 11:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 20Apr2021, the patient experienced sore arm for one day and swelling and redness for two days. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event sore arm was recovered on 21Apr2021 and that of swelling and redness was recovered on 22Apr2021.  No follow-up attempts are possible. No further information is expected.
COVID Vaccine Breakthrough Case  Moderna Dose 1 2/24/21 (010A21A) Moderna Dose 2 4/8/21 (019B21A) Moderna Dose 3 11/4/21 (lot NA) COVID Positive 12/1/21 Hospitalized 12/1/21-12/3/21  12/3/21: 92 yr old female switched from observation to acute status.  12/11/21: LABS SHOWED ANEMIA AND AKI COMPLICATING CKD. CXR SHOWED ATELECTASIS AND RIGHT LUNG INFILTRATE. Discharge Status:improved.  SHE WILL CONTINUE PT/OT AT THE NURSING HOME.
Possible breakthrough infection   *1st dose administered at pharmacy *2nd dose administered at  Health Care Facility
Pt admitted on 3/31 with a PMH of multiple myeloma, ESRD on peritoneal dialysis and presented with chest discomfort and weakness post fall at home.  Pt found to have severe thrombocytopenia.  Pt was found to be COVID positive due to pre-testing prior to bone marrow biopsy.
This spontaneous report was received from a pharmacist and refers to a 42 year old pregnant female patient. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, as a child, the patient was vaccinated with M-M-R II (dose, route of administration, anatomical location, lot# and expiration date were not reported). The number of M-M-R II doses that the patient received and dates of administration were unspecified. Concomitant therapies were not reported. Approximately in January 2015 (reported as "approximately 1 month ago") serologic testing was completed and showed that the patient had no immunity to Rubella. The patient did not seek medical attention and no treatment was given for the event. The patient did not recover from the event. The relatedness between M-M-R II and the event was not reported. Additional information has been requested.
SYMPTOMS: body aches, weakness, fatigue all day, left eye swollen shut with white discharge and pain in eyelid appearing day after vaccination and lasting one week; has improved  but not yet resolved.  Took course of zithromax (ZPAK) and children's claritin (2 doses upon symptom onset).
Immunization given 3/17/06. Mother noted reaction, redness, swelling of arm 3/18/2006. On 3/22/06 affected arm increased reaction 4x4 inches raised, reddened, swollen, some warmth, and itching. On 3/22 MD ordered Zyrtec syrup 1 tsp x 5 days, ice pack PRN, and anti itch cream Prn. MD not certain if reaction VS scratching by child, as cause of redness, etc. No antibiotics ordered. No fever noted.
Pt recv vax on 12/1/97; on same day pt exp local rxn of redness, swelling & soreness