chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Marked loss of balance (not vertigo), muscle pain, mild headache, lassitude; took acetaminophen.
Information has been received from a medical assistant and the patient's mother, for GARDASIL, a Pregnancy Registry product, concerning an 17 year old female with depression (diagnosed 3 years ago) and history of a cyst on her ovary (diagnosed 2 years ago) who on 21-APR-2009 was vaccinated with a first dose of GARDASIL (lot number 661846/1312X) (injection site and route not reported). There was no concomitant medication. Prior to receiving the vaccination, the patient had a negative urine pregnancy test (approximately 21-APR-2009), the patient's mother reported that on 04-MAY-2009 the patient started complaining about bad cramps that were so bad that she started to cry. The patient's mother called the physician who advised the patient be taken to the hospital for evaluation. The patient was brought to the emergency room but she was not admitted to the hospital and she was diagnosed with an ovarian cyst. The patient's mother said a blood pregnancy test, a urine pregnancy test and an ultrasound determined the patient was pregnant. As of 05-MAY-2009, the patient was five weeks, 4 days pregnant (LMP 26-MAR-2009, EDDD 31-DEC-2009). The patient had an appointment with an OBGYN. The patient's bad cramps (ovarian cyst) persisted. Additional information has been requested.
Pt recv vax on unspecified day;post vax pt exp fever, edema/induration of vax site
tingling & painful sensation Narrative: As reported by employee on 6/23/2021: ********************************************* "Tingling/painful sensation in left hand (index and middle fingers) and left foot- administration side (left arm both doses)."
always got the flu, sometimes twice; Initial information received on 22-Oct-2020 regarding an unsolicited valid non-serious case from a non-healthcare professional via social media.  This case involves a patient of unknown demographics, who always got the flu, sometimes twice (influenza), while he/she received influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concurrent condition and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine (batch number and expiry date unknown) at an unknown dose via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient got the flu shot gor years always got the flu, sometimes twice (influenza), No more flu shots for them. Haven't had the flu since.  No lab data was reported.  It was not reported if the patient received any corrective treatment.  At the time of report, event outcome was recovered for flu.  There will be no information available on the batch number for this case.
Sore arm lasting for an extended period of time but pain migrated to chest area. Patient still experiencing pain.
PARTIAL DOSE ADMINISTERED; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced partial dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose administered was not reported. This report was non-serious.
Patient reports as soon as vaccine was given, tingling of Left leg, Left arm, Right leg, itching of Left arm and Left leg.  He also stated he felt a sensation that "went through his stomach".
After receiving the flu shot (H1N1 & Seasonal combination (preservative free)), later that night I felt numbness in the left side of my face and have a red patch on my cheek. I received the preservative free shot since I am currently breastfeeding. I still feel numbness in my cheek and the red patch hasn't gone away yet.
Whole left side is sore; Whole left side is sore.-  mostly sore in the arm at injection sight.; Left butt cheek felt sore like "I" received a shot there, but "I" didnt; Some joint pain in left elbow, knee and foot; Little tired; Little brain fog; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included melatonin (MANUFACTURER UNKNOWN), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC) and colecalciferol (VITAMIN D3); all for unknown indication from unknown dates and unknown if ongoing. The patient received the shot in the left arm and on 21Apr2021 at 03:00 whole left side was sore. The patient was mostly sore in arm at injection site but left butt cheek felt sore, like received a shot there, but the patient had not. The patient also had some joint pain in the left elbow, knee, foot, also little tired and seen to have a little brain fog. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 14Apr2021, the patient underwent SARS-COV2, RNA (PCR) test via nasal swab and the result was negative. The clinical outcome of the event left side sore, mostly sore in arm at injection site, left butt cheek feels sore, joint pain in left elbow, knee and foot, little tired and little brain fog was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
within one hour of administration of Fluarix, he was extra tired.  He went to a restaurant with his parents and had a small amount of applesauce, but soon started to cough, get red in the face, and get hives.  The altered behavior, i.e. fatigue, preceded the applesauce.  He went to urgent care; described as "coughing, covered with hives and drooling, and was wheezing"; received antihistamine, epinephrine, and prednisolone.  He quickly improved and was discharged home on prednisolone within two hours of arrival.    He saw an allergist four days later who  thought anaphylaxis to the vaccine was likely.
The syringe loosened; Some of the vacine filtered through; Most of the vaccine was given to the patient; A spontaneous report  was received from a pharmacist concerning a male patient of unspecified age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and while vaccine was administered, syringe loosened, some of the vaccine filtered through and most of the vaccine was given to the patient.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 19-Jan-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 19-Jan-2021, during vaccine administration, the syringe had loosened and some of the vaccine was filtered through. The patient stated that he felt a liquid on his arm, but however the vaccinator believed that the events occurred after he pushed the plunger and most of the vaccine was already given to the patient. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.  The outcome of events while vaccine was administered, syringe loosened, some of the vaccine filtered through and most of the vaccine was given to the patient were considered resolved on 19 Jan 2021.; Reporter's Comments: This case concerns a male patient of unspecified age who received their first dose of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection and while vaccine was administered, syringe loosened, some of the vaccine filtered through and most of the vaccine was given to the patient.  There were no reported adverse events associated with the event of while vaccine was administered, syringe loosened, some of the vaccine filtered through and most of the vaccine was given to the patient.
Patient received 4 vaccines during appointment. Patient's guardian,  authorized 2 of the 4 vaccinations (Tdap and Meningococcal). Patient's guardian  was present during administration of the vaccines. After the patient and her guardian left the office, it was found that the guardian only authorized the 2 vaccines. Health Department left voicemail on guardian's cell at 4:31 PM. Health Department spoke to guardian on Friday, August 11 at 8:25 AM. Guardian stated outrage regarding the administering of the 2 other vaccinations and requested documentation regarding her consent. Side effects and vaccine appropriateness explained. Requested documentation and educational materials were placed in the mail today at 9:05 AM.
Pt with dermatitis (wheals) after 2 week Hep B # 3 immunization. Treated with Benadryl then Zyrtec.
Body aches, low grade and fatigue starting 21 hours following 2nd Moderna COVID vaccination. extreme pain, swelling, redness, warmth 2 inches below injection site approximately 3 inches in diameter starting approximately 30 hours following injection. currently 48+ hours out from vaccine, no improvement in skin reaction.
I started experiencing muffled hearing in my right ear the next day.  It's as if the ear is clogged like after being sick with a cold.  I also liken the feeling to having water in the ear after swimming.  There is no pain and I can hear.  It's been like this for 5 days now.
Pt received DTAP #5 and post vax, there was a red induration.
redness, warmth, swelling where shot was given;vomiting, diarrhea, crying;taken DPH, baby pain reliever advil, cold packs;
This spontaneous report as received from a Licensed practical nurse refers to a 37 years old female (staff member) who on 01-NOV-2012 cut her finger on a piece with a prefilled syringe of VAQTA that broke during the administration of the vaccine. During a product quality complaint follow up call, the nurse confirmed that the prefilled syringe was RECOMBIVAX HB (lot # reported as H00849, exp date: 28-FEB-2015) pediatric formulation rather than VAQTA. The nurse stated that she misspoke during the initial report. The finger administer was cleaned and bandaged. No lab diagnostic test was performed. At the time of the report, the patient was recovering. This is one of the several reports of the same source. Additional information has been requested.
Fever of 102.3, very sore arm, nauseous very fatigued, hurt all over, lasted 36 hours.
Left arm numbness and tingling at infection, pt. wearing restrictive shirts. She thinks that she may have constricted her blood flow during injection. She exhibited no other symptoms. Denies CP, SOB, LOC, stated that she feels fine to go home. Patient has full range of motion. Patient left facility by self.
Patient was given a Kinrix (DTaP/IPV) combination vaccine instead of the Daptacel (DTaP) vaccine.  He was also given a Ipol (Polio) vaccine and Hepatitis A and Influenza vaccines.  So, he received Kinrix off-license and also received a dose of polio vaccine.  He did not have any adverse effects.
Patient was c/o menstrual bleeding at 11 am today 10/04/21. She did state she was having pain at the injection site at 3 am today--10/04/21
pt had large localized rxn on rt upper hip 25cm x 15cm area red, swollen, indurated, tender to touch, warm to touch w/no other sx
Received Boostrix instead of Hep B vaccine; boostrix administered to infant; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 8-week-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24th October 2022, the patient received Boostrix .5 ml. On 24th October 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     Additional Information: GSK Receipt Date: 24-OCT-2022 Reporter's Comment: The reporter was a medical assistant from a medical office.   The reporter stated that, a patient received Boostrix instead of Hepatitis B vaccine. Lot number and expiration date of the Boostrix was not obtained Additional Supportive Information: The reporter stated that, a patient received Boostrix instead of Hepatitis B vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Pt. received vaccine on 3/9/11, called pharmacy on 3/13/10 to report a rash on face and back that felt "like a sunburn." That day he visited a physician who determined it was a likely allergy and prescribed PREDNISONE 20mg x 3d.
This case was reported by a physician and described the occurrence of arm swelling in a 60-year-old female subject who was vaccinated with Influenza vaccine (GlaxoSmithKline). The subject's medical history included diabetes. On 16 September 2009, the subject received a dose of Influenza vaccine (unknown, right arm). On 16 September 2009, 8 hours after vaccination with Influenza vaccine, the subject experienced arm swelling. The physician reported a subject received a flu vaccine (unsure of specific flu vaccine, but was positive it was a GSK vaccine) on 16 September 2009. Within approximately eight hours of receiving the vaccine, the subject developed a severe local reaction, clarified as swelling at the injection site that has worsened into swelling over a larger portion of the arm including the deltoid and shoulder area. At this time, the subject has been into the office to see the physician on 17 September 2009. The physician feels the event is worsening and is most probably caused by the vaccine received. The physician does not plan to administer any further flu vaccines to this subject in the future. At the time of reporting the event was worse. The physician considered the event was probably related to vaccination with Influenza vaccine. Follow up information was received on 16 November 2009 via the reporting physician. The physician determined that the subject had a factor deficiency (acquired factor X deficiency) totally unrelated to the influenza vaccine. The subject developed a large hematoma from the vaccine because of the factor deficiency and not due to the influenza vaccine.
Within 5 minutes after Fluzone influenza vaccine administration on 10/26/05 at about 8:50pm, patient reported a tingling sensation in her right ear and right side of face.  She explained that this has happened before on 2 other occasions after administration of influenza vaccinations.  She further explained that the right side of her face, head, & neck went numb for several hours on the previous occasions.  She also said that once she did not have this reaction after an influenza vaccination.  She did not report any breathing difficulty or the like type of allergic reactions. Because of the 2 previous occurences, she was not concerned about this reaction, and after about 15 minutes she left with her husband.  She also mentioned that her 1st cousin (blood relative) also had this same reaction after an influenze vaccination once.  Patient also mentioned that she wanted the vacccination in her right arm because she had a left breast mastectomy.  Patient said that her doctor also witnessed this reaction during one of her previous influenza vaccinations.
arm was sore; J&J vaccine on 09/Mar/2021, first dose of Moderna vaccine on 09/Aug/2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) and INTERCHANGE OF VACCINE PRODUCTS (J&J vaccine on 09/Mar/2021, first dose of Moderna vaccine on 09/Aug/2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (J&J vaccine on 09/Mar/2021, first dose of Moderna vaccine on 09/Aug/2021). On 10-Aug-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (J&J vaccine on 09/Mar/2021, first dose of Moderna vaccine on 09/Aug/2021) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.            It was reported that patient received a dose of J&J vaccine on 09-MAR-2021, lot number: 1305029 for COVID-19 vaccination. No relevant concomitant medications were reported.  No treatment information was provided.
2hr p/vax, stiffness lt jaw then to shoulder than down arm ending w/numbness in fingers;also started in hip, knee;numbnes in feet;6hr later sx disappeared;sx lt side only jaw first;
Scratchy throat; Little dizzy for a few moments; Fever; Chills; Exhausted with no energy; This spontaneous case was reported by a patient and describes the occurrence of THROAT IRRITATION (Scratchy throat), ASTHENIA (Exhausted with no energy), DIZZINESS (Little dizzy for a few moments), PYREXIA (Fever) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 17-Oct-2022, the patient experienced ASTHENIA (Exhausted with no energy). On 20-Oct-2022, the patient experienced THROAT IRRITATION (Scratchy throat), DIZZINESS (Little dizzy for a few moments), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Scratchy throat, at an unspecified dose and frequency. On 18-Oct-2022, ASTHENIA (Exhausted with no energy) had resolved. At the time of the report, THROAT IRRITATION (Scratchy throat), DIZZINESS (Little dizzy for a few moments), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            No concomitant medications were provided.  The day of receiving the vaccine the patient was exhausted with no energy which went away the next day. Patient took some excedrin which helped with the scratchy throat. She had not discussed her symptoms with her HCP.
Initial report received from a healthcare professional on 19 NOVEMBER 2014.  A 63-year-old male patient had received an intramuscular first dose of FLUZONE QIV, (batch number UT159AA) in left deltoid on 31 OCTOBER 2014. The patient had no illness at the time of vaccination and no known allergies. On an unspecified date, the patients complained of pain at the injection site. The patient had pain from day one, with stiffness, a throbbing pain in the injection site area. Visual inspection showed no redness, swelling or bruising. The patient was taken to emergency room and was evaluated. Corrective treatment was not reported. No laboratory tests were performed.  At the time of this report, the patient outcome was unknown. Documents held by sender: none.
-fever that began about 12 hours after the shot, got up to 103 degrees F, achey teeth, severe headache  -took aleve and helped reduce the fever and aches after 12 hours
pt devel 10x12cm hot erythematous rash under & over rt shoulder, back had erythematous papular areas/rxn noted 7PM 6MAY97;seen by ped clinic on 8MAY97 advised to apply ice & given DPH for rash;
2 doses of ADACEL was administered to a patient 6 weeks apart with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered 2 doses of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] 6 weeks apart with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Aug-2023, the patient received Dose 1 of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot number: U766GAA) (Expiry date: 08-Mar-2025) (with an unknown strength) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). On 29-Sep-2023 he/she also received  Dose 2 of the same vaccine (lot number: U766GAA) (Expiry date: 08-Mar-2025) via unknown route in unknown administration site.  On 29-Sep-2023, the patient was administered 2 doses of Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine 6 weeks apart with no adverse event (extra dose administered) (latency: 1 month 14 days).  It was reported, Pharmacy director asks for safety data and recommendations following the administration of 2 doses of ADACEL to a patient 6 weeks apart, first dose was given on 15Aug2023, the second one was given on 29Sep2023. This situation is reported as a medication error due to 2 doses of ADACEL was administered to a patient 6 weeks apart.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Tender thigh muscles, fever, Rhinorrhea x 1 Day. Swollen quadriceps with erythema at injection site (right leg). Orders MOTRIN/TYLENOL as needed. Thinking pertussis reaction.
Second dose of Pfizer vaccine was given 1/10/2021 around 9:30 AM. I woke up at around 6:30 AM on 1/13/2021 feeling well.  While I was changing, I noticed a diffuse maculopapular rash on my torso back thighs and upper arms.  The rash was very pruritic.  I took some Benadryl which did not seem to help the itchiness and made me sleepy.  By Thursday, most of the rash on the torso was gone, but the rash had spread more to my forearms, lower legs, feet and hands.  There was some mild edema of the hands, I had some mild fatigue, and temperature check was slightly elevated around 99 degrees F.   By Friday, most of the rash was gone and I had some remaining itchiness of feet and hands.  Saturday I was back to normal.