chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immunisation. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), topiramate (MANUFACTURER UNKNOWN), ethinylestradiol; norethisterone acetate (JUNEL) and vitamin D (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. Medical history included migraines. The patient did not have any known allergies to medications, food, or other product. Prior to vaccination, the patient was 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 vaccination. On 23Mar2021, the patient experienced red circle on skin at injection site, lump under skin at injection site and continues to be sore three days after injection. No therapeutic measures were taken as result of events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vaccination site rash, vaccination site pain and vaccination site lump were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
REDNESS ON THE UPPER LIP, SCALE AND ITCHING IN THE AREA.
Client received MODERNA dose at 16 years old. Age indication for MODERNA is 18 years old. NO S/S, TREATMENTS, OUTCOMES REPORTED.
This spontaneous case reported by a consumer, describes the occurrence of erythema (red arm), pyrexia and myalgia (sore arms) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced erythema (red arm), pyrexia and myalgia (sore arms). At the time of the report, erythema (red arm), pyrexia and myalgia (sore arms) outcome: unknown. Concomitant medication include blood pressure and pain medication for unknown indication. No treatment medication reported. This case linked to MOD-2021-046513 (patient link).
My legs began to swell and feel weak, with tremors 2 weeks after the shot.  So far, all tests have been negative for the cause.  I'm still having the same symptoms.
Initial report received from a healthcare professional on 07 November 2012. A female patient (age and date of birth were not reported), whose medical history included PCN (Penicillin) and latex allergy, and illness at the time of vaccination was reported as unknown, concomitant medications was not reported, had received a dose of TYPHIM VI (batch number, dose, number in series, route and site of administration were not reported) also received Anthrax vaccine other manufacturer (batch number, dose number, route and site of administration were unknown) on 05 November 2012. On 05 November 2012, 15 minutes after receiving the vaccines the patient started coughing. The reporter was concerned whether it was bronchospasm. The patient corrective treatment details were not reported and laboratory details were reported as unknown. The patient's outcome was unknown at the time of this report. List of documents held by sender: None.
Redness, warmth, and swelling to injection site of DTaP right deltoid. Reported via pts mom via PH on 09/30/2005. NP ordered pt mom to give Benadryl, Tylenol and use ice. to follow up with MD if continues or worsens. Pt had a previous 5th dose of DTaP at another provider on 01/16/2003. Therefore this was the 6th dose and not 5th dose of DTaP.
mild clonic sz w/in 1 hr p/1st DTP vax; pt recvd the next 2 injections DT peds w/no problems;
Narrative: Altered mental status, speech, and motor function requiring evaluation and potential treatment if stroke Symptoms: TIAStroke & HYPERtension
Fever 100 degrees, chills, extreme sleepiness, nausea, vomiting 36 hours in duration
Patient passed away between 3/30/21 and 4/1/21 at home.
My Husband is positive/husband tested for COVID19 on 02JUN2021./ On 05JUN2021 his PCR test was positive./a rapid test on 06JUN2021 and it was also positive; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (My Husband is positive/husband tested for COVID19 on 02JUN2021./ On 05JUN2021 his PCR test was positive./a rapid test on 06JUN2021 and it was also positive) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Antibiotic therapy on 07-Jun-2021.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced COVID-19 (My Husband is positive/husband tested for COVID19 on 02JUN2021./ On 05JUN2021 his PCR test was positive./a rapid test on 06JUN2021 and it was also positive). At the time of the report, COVID-19 (My Husband is positive/husband tested for COVID19 on 02JUN2021./ On 05JUN2021 his PCR test was positive./a rapid test on 06JUN2021 and it was also positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Polymerase chain reaction positive: 05-jun-2021. On 02-Jun-2021, SARS-CoV-2 test: 06-jun-2021 Positive. On 02-Jun-2021, SARS-CoV-2 test positive: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment with Regeneron was reported by the reporter.
Flu Shot received left deltoid 10/31/2001. Spot Bandaid applied to site. Client returned to HC 11/02/2001 c/o redness, local pruritis, chest tightness has history of multiple allergies. Hydrocortisone cream to area and ice, need to see PMD ASAP.
Shortness of breathe after slight physical activity; Persistent diarrhea; fatigue; Coughing/cough symptoms; chest pain; Pain; received DOSE 1 and DOSE 2 of bnt162B2 on same day; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received bnt162B2 (BNT162B2, solution for injection, Batch/Lot Number: ER8729), on 06Apr2021 07:30, via an unspecified route of administration in right arm, as DOSE 1, SINGLE for covid-19 immunization (age at vaccination: 48-year-old). The patient medical history included: continuing diabetes and psoriasis. The patient had no known allergies. Since the vaccination, the patient was not tested for COVID-19 and did not have COVID prior vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medication within two weeks of vaccination includes: Mucinex (1week) and Methyl prednisolone (1week). The patient also received dose 2 on same day bnt162B2 (BNT162B2, solution for injection, Batch/lot number: EW0170) was administered 06Apr2021 at 07:30 via an unspecified route of administration in right arm, for covid 19 immunization. Patient past drug history was reported was reported as none. On 08Apr2021 at 06:00 after two days of getting the vaccination, the patient started coughing and had chest pain. He had Difficulty breathing. Next day pain disappeared, how-ever chest pain and cough continued. On 29Apr2021, he had persistent diarrhea, had fatigue and still have chest pain and cough symptoms. He experienced shortness of breath after slight physical activity. The patient treatment included: Tylenol once for Difficulty breathing. The outcome of the events (Coughing/cough symptoms and chest pain, Persistent diarrhea, Fatigue, and Shortness of breath after slight physical activity) was not resolved. The outcome of the event Pain was resolved on an unspecified date.  Follow-up attempts completed. No further information expected.
I had high pressure before.  Three days after the vaccine my blood pressure went up more.  I had to take days off from work.  It got better.  Then months down the road.  My bladder does not hold.   My feet and legs hurt when I am sleeping.
A few minutes after vaccination patient turned pale and eyes started closing.  Patient seems to have fainted.  Patient was then in and out of consciousness over the next 5 minutes.  Patient was given water and was able to drink.  911 was called immediately, and a cop escorted her out of the pharmacy area and to an ambulance outside
Case number PHEH2014US001202 is an initial spontaneous report from a nurse received on 14 Jan 2014. This report refers to a male child. The patient received FLUVIRIN (batch number 1308401, expiry Mar 2014) intramuscularly on 09 Jan 2014. The nurse stated that patient was under the age of four and received FLUVIRIN. No further information was reported.
Patient went to local emergency room with a rash around injection site and swollen arm 4 days after the J&J one time vaccine. She  had been taking Tylenol and was given ice packs.
Redness and soreness, tenderness around site of injection. Pink and warm to touch on 10/28/2005 but patient states the redness is going away. On the left side of right arm 7 1/2 inches pink at the posterior side and 3 inches pink to the anterior side still warm to touch. Less tender today than on Wednesday night.
Rash developed on her trunk, given a dose of Benadryl and rash faded.  Upon wakening 11/10/2009 rash on her arms and trunk, more Benadryl given.
Moderna  For 4 days after getting vaccinated, unbalanced dizzy spells, fell while getting up off of my bed, no appetite, sore swollen lymph nodes under right arm. Injection site sorry and swollen for 5 days.
Pt recv vax on 9/8/98; on 9/15/98 pt exp tingling then numbness in thumb, index &middle fingers of right hand; right upper extremity pain.
sore arm, headache, fatigue  Vomiting and nausea from 32 hours after injection to approximately 56 hours after injection
Imediately upon driving home a large lump appeared under left side of ear along jaw line(lymp node swollen) another lump node swelling on left elbow and another smaller one on right elbow.   Pain in the stomach with violent diarhea.   Muscle aches with increased fibromyalia pain and tremor worst at night.  Fibromyalgia symptoms which have been less for years have increased and not going back to normal.   Tremor has increased in actiivity.  Due to Dr. going to a VIP doctor, cannot get into see him notified him of this the swelling in left arm  in December 2020.  Due to Covid cannot get in to new doctor till August 2021.  The fibromyaliga increase in pain is something I thought I had to put up with, but thought this should of been told because if people with these types of illnesses should not get certain vaccines.   I am now petrified to get the Covid vaccine due to my pain.  Will discuss with my heart doctor and new doctor when I get in.
Patient that tested positive with COVID after getting the COVID vaccine; Patient that tested positive with COVID after getting the COVID vaccine; This is a spontaneous report from a non-contactable consumer or other non-health care professional received from a Pfizer-sponsored program.  A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient tested positive with COVID after getting the COVID vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain; Redness; Sore arm; Fever; Tiredness; was in bed for 2 days with shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced pain, erythema, pain in arm, shivering, fever and tiredness. On an unknown date, the outcome of the pain, erythema, pain in arm, shivering, fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain, erythema, pain in arm, shivering, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient reported for herself. The patient received the vaccine in her left arm.  The patient reported that she had the common side effects that she read in article for about 2 to 3 days.  The patient experienced tiredness, fever, sore arm, redness, pain and was in bed for 2 days with shivering  Lot and expiration date were not requested. The reporter did not consent to follow-up.  The patient stated in her medical facility that they do not have a primary physician.
100 Fever.  Aches and chills.  Weakness in legs.  Passed out three times. Lasted 24 hours.
This spontaneous report was received from the patient's mother concerning her 13-year-old daughter. The patient's pertinent medical history, concurrent conditions, and concomitant therapies were not reported. The patient did not have known allergies or drug reactions. In 26-OCT-2016, the patient was vaccinated with the first dose of an unidentified Merck GARDASIL or GARDASIL 9; 0, 2 months and 6 months; intramuscular (IM) injection (Lot #, expiration date were not provided), for the prevention of human papillomavirus (HPV). The reporter stated that her daughter was diagnosed with Crohn's disease after receiving her initial injection of GARDASIL or GARDASIL 9 and because of it,  she sought medical attention from her pediatrician. On an unspecified date, a blood and fecal laboratory test were performed (results not provided). Later, on 05-DEC-2016, an endoscopy and a colonoscopy were performed (results not provided), and subsequently on 12-DEC-2016, an upper gastrointestinal (GI) exam was performed (results not provided). The reporter stated that her daughter was placed on treatment with PENTASA and prednisone (manufacturer unknown) (unspecified date, strengths, and doses) to treat Crohn's disease; and in addition, the patient was scheduled to start on infusion therapy with Remicade (manufacturer unknown) (unspecified dose, strength, and dates) also for the treatment of Crohn's disease. At the time of this report, the patient was recovering from the event of Crohn's disease. The causal relationship between the event of Crohn's disease and the therapy with GARDASIL or GARDASIL 9 was not provided. No product quality complaint was involved. Upon internal review, the event of Crohn's disease was determined to be medically significant. Additional information has been requested.
On 08/26/2021  in the morning around 10:00AM I wasn't able to get out of my bad. I was completely out. I didn't understand what my wife was telling me. We called EMS to the hospital  because I was dehydrated due to the fact that I couldn't drink anything. They gave me breathing treatments every six hours. They did all kinds of blood test.  I stayed in the hospital for 2-3 days. They didn't prescribed me any thing new. They advised me to continue taking my regular meds. This happened through out all the COVID-19 vaccines. About 1-2 weeks I started feeling better.
Measles, Fever - Information has been received from a lisensed practical nurse concerning a 12 month old caucasian male patient with a history of otitis media, and pre - existing conditions of a tongue disorder and asymmetry of his ears who in approxiamately 1996 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  On 31 may 1996 the patient developed a measles type rash.  Unspecified medical attention was sought.  Follow up information from a physician indicated that on 31 May 1996 the patient developed a fever and severe rash.  The patient was seen by a physician an 05 Jun 1995 with a rash consistent with mealse.  Three weeks post onset, the patient recovered.
fatigue; upper respiratory infection; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2018-2019 season) for prophylaxis.   On 30th October 2018, the patient received Fluarix Quadrivalent 2018-2019 season (intramuscular) .5 ml. On 1st November 2018, 2 days after receiving Fluarix Quadrivalent 2018-2019 season, the patient experienced fatigue. In November 2018, the patient experienced upper respiratory tract infection. On 21st November 2018, the outcome of the upper respiratory tract infection was recovered/resolved. On an unknown date, the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the fatigue and upper respiratory tract infection to be related to Fluarix Quadrivalent 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she received a dose of Fluarix last year. The patient started feeling fatigued and it took several weeks to resolve.  The patient developed an upper respiratory infection on 2nd November 2018. The reporter consented to follow up.
Red and itchy rash on some parts of the body for seven thru eleven days. No treatment just Mupirocin (Bactroban) 2% oint, Clindamycin (Cleocin T) 1% and Triamcinolone Ace 0.1% and until rash dries.
Pt diagnosed with redness and swelling in both thighs. Inflammatory reaction vs mild  cellulitis. Pt treated with Augmentin.
Pt had a local reaction to flu vax on (R) deltoid. Injection site was very red and hot to the touch size approx 4 1/2 x 3 inches.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (woke up with sore arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 030A21A) for COVID-19 immunization. No medical history reported. On Mar 16, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19vaccine), intramuscular; 1 dosage form. On Mar 17, 2021, patient experienced  pain in extremity (woke up with sore arm). At the time of the report,  pain in extremity (woke up with sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications provided. Treatment included a heating pad.
Patient came in for Adult series booster 30mcg/.3ml and was administered 0.3ml of undiluted pediatric dose. (~43mcg)
1" X 1/2" welt above injection site, which was improperly administered on side/back of thigh instead of front.  Red scaly rash up leg under cheek.  Also shed live virus, resulting in shingles outbreak in myself the day following the injection.
This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 1 day after receiving SHINGRIX, the patient experienced swelling arm, gastrointestinal disorder, feeling hot, clamminess, headache, skin discoloration and felt faint. On an unknown date, the outcome of the swelling arm, gastrointestinal disorder, feeling hot, clamminess, headache, skin discoloration and felt faint were recovered/resolved. It was unknown if the reporter considered the swelling arm, gastrointestinal disorder, feeling hot, clamminess, headache, skin discoloration and felt faint to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a receptionist in the office for herself. The age at vaccination was not reported, but it could be either 53 or 54 year of age. The patient experienced less arm swelling, gastrointestinal issues, hot and clammy and severe headache and feeling like going to pass out and the family members said the patient was gray and green in color, which was lasted for 48 hours. This case has been linked with US2018GSK130129, reported by same reporter.
On the next day after administration of vaccine, pt developed hives and swelling in her legs, symptoms resided 10/10/18.
DEVELOPED HEADACHE, FEVER, CHILLS, BODY ACHES, NAUSEA. RESOLVED BY MORNING OF 12/31/20
No further AE details.; a small portion of the product actually reaching the patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies and drug reactions were not reported.  On 01-SEP-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 milligram, once, lot #W034364, expiration date: 20-JUN-2025, administered for prophylaxis (strength, and route of administration were not provided). A non-company needle and syringe were used to pull out product from the vial and that the needle was not completely attached resulting in a small portion of the product actually reaching the patient (also reported as a full dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was not administered to a patient) (incorrect dose administered). No further AE details.
JOINT PAIN; LOW GRADE FEVER; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included tachycardia, bactrim allergy, flagyl allergy, and keflex allergy, and other pre-existing medical conditions included bactrim, flagyl, keflex allergy, when taken hives occurs with one, and c. diff with hospitalization occurs with the other. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included propranolol for tachycardia. On 10-APR-2021, the subject experienced joint pain. On 10-APR-2021, the subject experienced low grade fever. Treatment medications (dates unspecified) included: oxycodone/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, and low grade fever on 11-APR-2021. This report was non-serious.
RECIEVED 6/27 SYMPTOMS STARTED 2 DAYS LATER STARTING WITH CHILLS EARLY IN THE MORNING AND BECAME DELIRIOUS AND WAS PICKED UP BY AN AMBULANCE AND TAKEN TO THE HOSPITAL. EMERGENCY ROOM BROUGHT FEVER DOWN AFTER A COUPLE HOURS. INFECTIOUS DISEASE DR SAID THAT THE PATIENTS SYMPTOMS WERE CAUSED BY SHINGRIX SHOT. PATIENT WAS TREATED WITH ANTIBIOTICS IN THE HOSPITAL AND STATES THAT HIS ARMS/LEGS BECAME SWOLLEN. PATIENT STATES THAT HE GAINED 20 POUNDS OF WATER AND AS OF 7/11 PATIENT IS BACK TO NORMAL WEIGHT BUT WHILE BEING TREATED GOT ANOTHER FEVER. PATIENT RECIEVED BACTRIM UPON RELEASE FROM HOSPITAL. PATIENT GOT ANOTHER TEMPERATURE AFTER LEAVING HOSPITAL. CELLULITIS WAS IN THE PATIENTS LEFT ARM BUT THE SHINGRIX SHOT WAS GIVEN RIGHT ARM. CELLULITIS IS NOW ALMOST GONE AND BEING TREATED WITH THE PRESCRIBE BACTRIM FROM BEING RELEASED. PRIMARY CARE DR WAS THE PRESCRIBING DR FOR THE BACTRIM THE PATIENT IS TAKING. PATIENT STATES THAT HIS SISTER SAYS HE HAS CELLULITIS NOT THE HOSPITAL. HE THEN CALLED HIS PRIMARY CARE PHYSICIAN  PRESCRIBED BACTRIM. HOSPITAL DID NOT RELEASE PATIENT WITH MEDICATION
Arm Pain, Tenderness upon moving/touching. 2-3 hour onset after vaccination and continuous  Severe Chills around 1:00am (l15 hours post injection) -- > uncontrollable shaking and tensing of almost all extremity (arms,legs, neck, and back) muscles. Sudden onset, lasted for 20mins