chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had her #2 Pfizer vaccine 6/7/21. 6/8/21 pt describes waking up with mild headache and fatigue.  Standing at bathroom sink brushing her teeth felt nauseous, then fainted.  Woke seconds later when MOC (who heard "thud" of pt hitting ground) roused her.  Pt woke with mild TTP at back of head assuming she hit her head on a door knob. During drive to The Hospital ER, pt reports drinking some juice started feeling a little better.  Upon arrival, they advised Urgent Care instead of ER and again provided a juice box. The Hospital Urgent Care drew blood for BMP, performed EKG, and PE noting only abnls to be hyperglycemia at 166 and TTP at L occiput.  Pt was dischg'd to home in good condition.  6/9/21 she woke with a slight headache that is since resolved despite walking to lunch in 90+ degree heat and working at library.  MOC reports her complexion has returned to normal today (was pale yesterday). Pt reports she has been hydrating very well since visit.  Currently pt reports feeling 100%.
expired MENACTRA was administered to a patient, no AE; Initial information received on 23-Jun-2021 regarding an unsolicited valid non-serious case from a pharmacist and physician via Regulatory Authority (under reference number: 00653585).  This case involves a 16 years old female patient who was administered with 0.5 ml expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Total, lot U6575AA and expiration date: 08-May-2021) via unknown route in unknown administration site for prophylactic vaccination on 23-Jun-202 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   It was a case of an actual medication error due to expired vaccine used (same day latency).  Reported that the caller would like to know what to do next regarding matter.  At time of reporting, the outcome was unknown for the reported event.  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.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-DEC-2018, the patient was vaccinated with an expired dose of ROTATEQ vial, lot # N013885, which had expired on 09-DEC-2018 (concentration and exact dose were not reported). No known adverse effects were reported.
After 2 hrs of vaccination, started with itching of face and arms and had strange rash on both lower arms - a red streaked line which disappeared in 10 to 15 mins. And within 4 hours got generalized itching on body -face, scalp, ears,eyes, legs, arms and body. Also had a feeling of something stuck in the throat.  Was up all night due to the itching and the discomfort in the throat! By morning around 6 am it subsided. Had the shot around 7.45 pm previous night
1/20/2017: 16:50, HPV #3 was administered to deltoid while pt. was sitting on exam table. She bent over after vax was given. She was pale and fainted for a few seconds. Had mild trembling for a few seconds as she recovered. Back to baseline within a few minutes. Vital signs and pulse ox normal. Was observed for greater than one hour and D/C to home. Suspect vasovagal reaction to vaccine. No complications. Did not need any intervention except close observation.
I did feel sick for about 30 hours after the shot. A very, very sore arm, headache and felt nauseous. I didn't feel like eating or even watching TV. Just stayed in bed most of Sat.   I have a gum infection and it intensified the pain in  my gum.    I now feel OK I'm scheduled for a appt with an periodontist Tues AM. I usually take an antibiotic 1 hour before my appt. Do you think it is safe to take an antibiotic on Tuesday morning
I had like spotting some like menstural spotting; I had cloudiness and everything; I had like vaginal pain; bleeding and like vaginal discomfort; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old female patient received 1st dose of bnt162b2 (Pfizer Covid 19 vaccine,Batch/Lot number was not reported), intramuscular, administered in Arm Left on 20May2021 17:45,at the age of 39 years old, as Dose 1,single for covid-19 immunization.Medical history included covid-19 from Apr2021 to an unknown date.Concomitant medications included vitamin d nos  taken for an unspecified indication, start and stop date were not reported.The patient experienced she had cloudiness and everything on 20May2021,she had like spotting like menstural spotting on 22May2021, she had like vaginal pain on May2021, bleeding and like vaginal discomfort on May2021.The patient underwent lab tests and procedures which included covid-19: negative on 2021.When asked about weight,the patient stated that she maybe like 160 pound,expiry date was not reported for the vaccine.The patient had not received any other vaccine prior to the covid19 vaccine.The patient didn't received any treatment for the event.  Information related to batch/Lot no. was requested.
Administered tetanus diphtheria toxoid vaccine 6/18/14. Developed pruritis and rash about 24 hrs later. Also (L) and (R) knee pain. Seen in urgent care 6/23/14. Rash better, but still itchy with some spots on hands. Knee pain improving. In progress of recovering.
This spontaneous report was received from a male patient of unknown age, reporting on himself. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On an unknown date ("a few years ago"), the patient was vaccinated VARIVAX for prophylaxis (dosage information, lot number, route and anatomical site of vaccination were not informed). Other suspect therapies included Merck sterile diluent. On an unknown date ("recently"), the patient had "titers done" and was informed that "he was negative for varicella. Subsequently, In July (unknown year) the patient received another dose of VARIVAX for prophylaxis (dosage information, lot number, route and anatomical site of vaccination were not informed). Then, on an unspecified date, the patient completed a 2nd titer. And the titer was also negative. The patient also stated that he was immunosuppressed, however, he did not confirmed if he was immunosuppressed at the time of receiving either vaccine. At the time of report, the outcome of antibody test negative and immunosuppression was reported as not recovered. The causality assessment between antibody test negative and immunosuppression and VARIVAX was not provided. Upon internal review the event immunosuppression was determined to be medically significant.
Pt presents with 6x6 red area over Prevnar injection area. Has lump size of pea. Pt without pain.
Body Aches, Severe Headache, Chills & Shivers, Sweats, Nausea, Fatigue  Lasted 3 days
The patient is a 40 yo healthy female with a history of Bells palsy x3, 2009, 2012 & 2015.  Her 2015 episode is 37 days after her IIV receipt. Temporal correlation is unknown  to 2009 episode. 2015 episode is unlikely to be related (83 days after Tdap and 297 days after last IIV).
Date these symptoms started was 1/27/2021:  About 12 hours after injection, developed fatigue and slight nausea as expected.  Oral temperature 98.0.  Commuted to work without issue. ~ 1400: As day progressed, nausea subsided, but fatigue grew more profound and developed pain in the right subscapular area with exertional shortness of breath walking any length of time. (Injection of initial and second doses were both in right deltoid). 1540 - 1800: Fatigue increased, developed a burning/tearing pain with every yawn and deep breath from the top of my trachea into both left and right mainstem bronchi and radiated to right arm.  It literally felt like someone was trying to tear out my bronchial tree with each breath. 1800: Arrived home and medicated self-medicated with Motrin 400mg. 1800 -2030: rested at home with still some breathing pain, no shortness of breath, but incredibly tired. 2045: Went to bed and slept for the next 12.5 hours without any issued during the night. 0800: Woke up nearly all symptoms were gone, only some minor residual fatigue.  No breathing pain, no nausea, no subscapular pain. I did not seek medical attention for symptoms, nor did I contact my provider. I experienced fatigue and a headache with the first dose, but no other symptoms.  I never experienced fever or chills
Rec'd flu vaccine 11/07/2006. Woke up 1/08/2006 arm red, swollen, warm to touch. Seen in office diagnosed with cellulitis treated with Keflex.
Monovalent vaccine administered for a booster on 9-1-22. Bivalent booster authorized by FDA on 8/31/22. Patient contacted, will return for bivalent booster in 2 months.
Shortness of breath/trouble catching her breath/Couldn't take a deep breath; Slight little bit of a fever; Sweating; Increased heart rate (>100bpm); This is a spontaneous report received from a contactable consumer (patient's father). A 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 12Apr2021 (on Monday) as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were not provided. After receiving the vaccine, she was fine during the day but the last 2 nights she was not had effects during day, however she had serious side effect, when she lays down to go to sleep, she experienced shortness of breath, trouble catching her breath, the inability to take a deep breath, trouble breathing, it does not match with the information given by the representative, because it did not happen within 4 hours so the reporter does not believe it was an allergic reaction, a slight little bit of a fever, sweating, and increased heart rate around 115 or 117 (>100bpm). The patient underwent lab tests and procedures which included increased heart rate (>100bpm) as 115 or 117. The outcome of all the events was reported as unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Started having a really bad cold, with fever, sore throat and congestion. Took an at home COVID-19 test and it was positive. Talked to Dr. and was prescribed PAXLOVID and told to rest. Took another home COVID-19 test on 09/10/22 and it was negative.
07/22/02 3.5 X 2 inches (per pt report) redness, warm to touch, itching of injection site. Office visit that day. 9 X 6 cm area noted ice area, Take Motrin 600-800 mg every 6 hr, 7/25/02 reported as being better.
On days 1-4 post-dose 1, had low-grade fever, chills, myalgia, arthralgia, and headaches. The headaches are not as common, but consistently had chills, myalgia, fatigue, and the low-grade fever. Treatment was only with (OTC Tylenol 500mg) One tablet twice daily as needed.
pt recvd vax 14AUG92 & approx 2 hrs following vax exp pain in arm & pain @ inject site which radiated up into neck; devel neck stiffness w/dec ROM; x-ray of cerival spine showed degenerative changes; exp tenderness in the muscles of neck
received extra dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 19-year-old female patient who received Men B NVS (Bexsero) (batch number M7455, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2022, the patient received the 3rd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 15th July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment: Nurse reported that a patient inadvertently received an extra dose of Bexsero (a third dose). The reporter consented to follow-up via postal mail. Additional Supportive Information: The patient inadvertently received an extra dose of Bexsero, which led to extra dose administered.
eyes and around the eyes looked like swollen; felt itchy; full body rash; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (eyes and around the eyes looked like swollen), PRURITUS (felt itchy), RASH (full body rash) and HEADACHE (headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRURITUS (felt itchy), RASH (full body rash) and HEADACHE (headache). On 01-May-2021, the patient experienced EYE SWELLING (eyes and around the eyes looked like swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, EYE SWELLING (eyes and around the eyes looked like swollen), PRURITUS (felt itchy), RASH (full body rash) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment: Patient took the BJ's generic of Benadryl (antihistamine) medication to help with the sign and symptoms.
Two weeks subsequent to receiving the second dose of Engerix B, the pt developed rheumatoid arthritis. The most recent information received, reports the condition of the pt is ongoing.
Developed HSP on 10/25/09 initially. Symptoms resolved and then recurred on 11/19/09 after receiving flu vaccine. Symptoms included characteristic purpuric rash, abdominal pain, vomiting, hematuria, protienuria.
This spontaneous report was received from a healthcare worker regarding a patient of unknown age and gender. Information on the pertinent medical history, concurrent conditions and drug allergies of the patient were not reported. On 29-AUG-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # J013394, expiry date25-AUG-2016. via intramuscular route. Additional information has been requested.
8/15/18 - Scalp psoriasis appeared (itching and scaling). Examined by MD/Dermatologist 9/26/18. Psoriasis had spread to other parts of body. Rx: topicals. 12/18/19 ACITREN Rx'd.
Patient is a healthcare provider here in the clinic.  Patient requested that the vaccine be administered in right hip (buttock).  It was explained to the patient that the vaccine  needs to be given in the arm or thigh.  Patient refused arm due to "not enough meat there"
Information has been received from a health professional concerning a 31 year old female who was vaccinated with pneumococcal vaccine 23 polyvalent (dose unknown) (lot 636158/1456K). Concomitant therapy, that day, included influenza virus vaccine. On 11/7/01, the pt developed signs of bruising and a large nodule at the injection site. The pt did not complain of pain. The pt was monitored for 10 minutes while an ice park was applied and ibuprofen administered. At that time, the pt's nodule "went down a little bit". As of 11/12/01, the pt's nodule was still present and there was still a small amount of bruising. Additional information has been requested.
visible and palpable lymphadenopathy in  L axillary and L supraclavicular regions
A week after I have really bad hives and bad itching all over my body. I have a dr appointment tomorrow to check me out
Sedation, Myalgia, Arthralgia, Fever, chills, esophageal and stomach spasms
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL (lot number not provided). Subsequently the patient began her menstrual period and did not stop bleeding for two months. Additional information has been requested.
patient stated her heart was racing and hand was numb. HR was 160/149, HR 155.  After about 15 min, her HR decreased to 109 and she was feeling better.  I recommended she follow up with her pcp
Acute diarrhea that began approximately 7 hours after MMR vaccine.  It began at 7pm and continued throughout the night, saturating her bed and clothes 3-4 times per night.  Continued diarrhea 12x day for 3 weeks.  No vomiting or dehydration, continued drinking goat milk and water. Began giving probiotics 4x a day to replace gut bacteria.  Stopped goat milk 4 days into diarrhea and tried Nutramigen formula in case of lactose intolerance.  No changes.  Dr. told me to go back to using goat milk, possibly try gluten free.  We tried gluten free and continue to do so, with very little change.  Weight has been stable with introduction of fattening gluten free snacks.  Nearly 4 weeks later, we still have 3-4 diarrhea diapers per day.  Have been to hospital for pediatric gastroenterology testing.
a patient experienced a health nightmare rapidly after three doses of GARDASIL/can no longer attend school, spend time with friends or walk long distances; can no longer walk long distances; had suffered severe adverse reactions; This spontaneous report was received from a vaccine consultant via social media and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown dates, the patient received three doses of unspecified human papillomavirus (HPV) vaccine (route of administration, lot# and expiry date were not reported) for prophylaxis. It was not specified if the patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). On an unknown date, the patient experienced a health nightmare rapidly after three doses of HPV vaccine. She could no longer attend school, spend time with friends or walk long distances. It was reported that the patient suffered severe adverse reactions. The outcome of the events and the causality assessment were not provided by the reporter.  Upon internal review, the event of health nightmare was considered to be disabling.
Information has been received from a nurse concerning a 17 year old female who on 11-JUN-2007 was vaccinated with Gardasil. On 11-JUN-2007, immediately following the injection, the patient developed a headache. The patient sought unspecified medical attention. It was reported that the patient said that she felt better before leaving the office. Additional information has been requested. Information has been received from a nurse concerning an 18 year old female with a history of migraines and exercise induced allergies/asthma who on 11-JUN-2007 was vaccinated with a first dose of GARDASIL (lot # 657868/0523U) in the left arm IM. On 11-JUN-2007, immediately following the injection, the patient developed a headache. The patient sought unspecified medical attention. It was reported that the patient said that she felt better before leaving the office. Follow-up information was received. The patient's age, medical history and concurrent conditions were updated. The headache lasted for 3 to 5 minutes in duration. On 11-JUN-2007 the patient had recovered. Additional information is not expected.
This is a spontaneous report from a contactable other HCP received via a Pfizer sales representative. A female patient of an unspecified age receive TRUMENBA, (batch/lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the young lady had facial swelling after she had vaccine 1 year ago, didn't know if allergic reaction. The outcome of the events was unknown. The information on the batch/lot number and expiration date has been requested.
Patient has been complaining of left hand paresthesias since receiving her COVID-19 vaccination.  She received her first dose in her left upper extremity on 3/12/2021.  Paresthesias began 4/8/2021. She had her second vaccination on 4/11/2021 in her right arm and reports one episode of right paresthesia on 5/5/2021. Describes paresthesias as numbness and tingling and have been constant since onset in left hand.  She at times will even have a sensation of bugs crawling across her body.
Initial report received from health care professional on 16 Dec 2009: The caller stated that the patient received on 0.5 ml of Novartis H1N1 vaccine on 01 Dec 2009. On 09 Dec 2009, she had another 0.5 ml of Novartis H1N1 vaccine instead of FLUVIRIN. No adverse effect was reported. Following an internal review on 29 Jan 2010 of the data received on 16 Dec 2009 the following correction was made: The suspect drug was recoded to S-OIV FLUVIRIN.
elevated body temperature/fever; he has developed joint soreness; Muscle soreness; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history was none. Concomitant medication(s) included colecalciferol (VITAMIN D) and cyanocobalamin (VITAMIN B 12) both taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient was asking if it would be normal to have an elevated body temperature or fever without him feeling that he has a fever. Patient had looks from 2 different government agencies that took peoples temperatures as precaution, they had to check his temperature twice but patient did not verify the temperature reading from those agencies. He is concerned since he would have to go to a nursing home to visit his relative and they are strict about the body temperature of visitors. On 28Feb2021, the patient has developed joint soreness and muscle soreness. The patient underwent lab tests and procedures which included blood test: blood work is clean in a good way, body temperature: elevated, and laboratory test: his labs are clean all on an unspecified date. Therapeutic measures were taken as a result of joint soreness and muscle soreness which includes took ginger tea and green tea and he felt noticeable relief. The 2nd dose of vaccine was scheduled on 13Mar2021. He is a healthy man, his blood work was beautiful. The outcome of the event elevated body temperature/fever was unknown, for the joint soreness was recovering while for muscle soreness was recovered.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
TENDERNESS AT INJECTION SITE AND DEFINED, HARD LUMP ON LEFT DELTOID (WHERE RECEIVED INJECTION) BEGINNING APPROXIMATELY 1 WEEK AFTER FIRST INJECTION.