chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-JUN-2017 the patient was vaccinated with ROTATEQ lot # M031802 for prophylaxis. On 2017 the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006507.
Tingling in L side of face began within 30 min. Ultimately dx with Bells palsy after smile went crooked and cont'd numbness/tingling L side of face, L ear and dull pain behind L ear. Hoarse voice set in roughly 24 hours later and still active. Began prednisone 3 tabs daily Monday 1/18
Red Swollen knot, itchy and Feverish at the injection site. 5in diameter.  Lasted for 2 to 3 days.   Went completely away, then returned about a week later as red swollen knot, slightly feverish , no itching.  3 in in diameter.  Also, about a week later, the glands in my neck and throat were swollen slightly .
2:50pm started with chest pressure and heaviness. 2:52pm shortness of breathe, honked and there was a delay of paramedics. Took 2 pumps of inhaler. Did not work. EMT loaded me on the stretcher out of my car in the ambulance. Gave albuterol mix in nebulizer. Went into full anaphylaxis on the way to ER. 4 epi in the arm did not help 2 benedrylm shots to the arm did not help. I was on 5L oxygen until the epi was mixed with albuterol to pen airways. Anaphylactic episodes continued every 5 hours for 2 days, then became every 12 hours, then 24 hours, then 12 hours. Steroids, Claritin, antacid, albuterol epi mix have helped managed episodes. Still currently in the hospital.
Info has been received from a registered nurse concerning a 51 y.o. female w/allergies to PCN, sulfa, ibuprofen (Motrin) and codeine and a history of anaphylaxis related to ibuprofen who on 5/23/02 was vax'd w/Hep B vax recombinant. Concomitant suspect therapy, received during the same visit, included typhoid vax, Hep A vax, diphtheria toxoid/tetanus toxoid and yellow fever virus vax live. Other concomitant therapy included "clorpheniramine", estrogens conjugated (+) medroxyprogesterone acetate (Prempro), vitamin E, ascorbic acid, folic acid, calcium (unspec'd) (+) vitamin D (unspec'd), cyanocobalamin and multivitamins (unspec'd). On 5/23/02, 2 hrs post vax's, the PT developed a thick tongue and itching of the throat and tongue. Subsequently, the PT was treated w/prednisone and an antihistamine (unspec'd). The PT did seem medical attention. Add'l info has been requested.
Rash left arm; This is a spontaneous report from a contactable consumer (patient). A 84-years-old patient of unspecified gender received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via an intramuscular route on 17Feb2021 at 14:30 (at the age of 84-years) as dose 2, single in the right arm for covid-19 immunisation. The patient medical history included low heartbeat from 06Jan2021 to 07Jan2021 and pace-maker implanted. The patient concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283, Exp date: 30Apr2021), via an intramuscular route on 27Jan2021 at 14:00 as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced rash left arm on 19Feb2021. The patient did not receive treatment for events. The outcome of the events was recovered on Feb2021. Follow-up attempts are completed. No further information is expected.
Info has been received from a physician concerning a 5 year old white male student who on 12/18/00 was vaccinated with a 1st dose of varicella virus vaccine live. Concomitant vaccination included a 4th dose of Hib-Titer, given in the left thigh. There were no other concomitant medications. On 3/16/05, the pt developed severe chickenpox. He had greater than 114 lesions in his left arm alone. Unspecified medical attention was sought. The pt also had cellulitis on the dorsum of his right foot requiring oral antibiotics. It resolved well, but the pt does have significant scaring. It was reported that the pt subsequently recovered. There was no product quality complaint involved. The physician considered the pt's severe chickenpox and cellulitis to be other important medical events. No further info is expected.
Vaccine affecting her immune system; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Head cold" (unspecified if ongoing), notes: Before the first shot she had a head cold. The patient's concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Vaccine affecting her immune system".  Additional information: Reporter asks can the vaccine affect immune systems? Reporter states before the first shot she had a head cold, then she went and took the vaccine and thought it might be covid, she only took the first shot and never the second. Reporter states her head cold was not clearing up. Reporter states she talked to friends who never had allergies, but they had Covid so it wasn't clearing up either. Reporter states she was reading a little about that it might enter an immune cell. Reporter states she usually gets over a cold in 2 or 3 days, but it is still lasting. Reporter asks if she would have the same problem if she did not get the vaccine? Caller states as soon as she got a head cold she got the vaccine, and would it have cleared up if she had not gotten the vaccine and did it affect her immune system; is it related?   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
cold; This is a spontaneous report from a contactable female consumer (patient) via Pfizer sponsored program. A female patient of unspecified age reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient wanted to know if the location she got her first dose of the covid vaccine would still be giving the vaccine today due to past week of bad weather. Also wanted to know if patient would be able to take her second dose of the covid vaccine due to her having a cold due to bad weather on an unspecified date. Clarified that the patient did not have any side effects from her first dose of the covid vaccine. Faxing due to having a cold symptom after receiving the first vaccine. Outcome of the event was unknown.  Information about lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
This case was reported by a healthcare professional (also the subject) and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject noted a recent needlestick injury. No details were provided. On unspecified dates the subject received 1st dose, 2nd dose, 3rd dose, 4th dose, 5th dose and 6th dose of ENGERIX B. It was reported that the subject had been through two courses of vaccination with ENGERIX B and had not responded. No further details were provided.
Seen on April 14 after injection on April 5.  states that the site  looks like it is red itchy, Redness' looks like a bite, at the site of the injection. states she applied cortisone and took benadryl. She was advised to use ice, hydrocortisone cream, and benadryl. observe for now and follow up if symptoms persist, increase redness or increase warmth. Of note, patient did receive second dose of Moderna vaccine on May 3, unclear if any rxn to this dose.
redness and itching developed around a previous scar near the injection site that started about 24h after 2nd vaccine--continues about the same--worsens when moving around and becoming hot
patient to received Gardasil vaccine and the patient was given Trumenba instead; patient to received Gardasil vaccine and the patient was given Trumenba instead; This spontaneous report was received from a physician via other company, referring to a unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and  concomitant medications were not provided.   On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis.  It was reported that on an unspecified date the physician ordered the patient to received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)   vaccine and the patient was given two doses of meningococcal vaccine b rfhbpa/fhbpb (TRUMENBA) (0.5 ml) instead (wrong product administered and interchange of vaccine products).
During the week following the vaccines, patient was lethargic and irritable.  Within the week, he also began twitching during diaper changes.  The twitching started in his legs and gradually moved to his entire body.  We took him back to his family doctor who told us that he was fine & this reaction was normal. We ended up taking him to the emergency room two weeks later because we thought he was having seizures.  He was diagnosed with cerebral palsy.  Prior to his vaccinations, patient was a fully functioning, normally developing infant.
arm gets a little sore; Initial information was received on 21-Oct-2021 regarding an unsolicited valid non-serious social media case received from a consumer/non-healthcare professional.  This case involves Adult and unknown gender patient who experienced arm gets a little sore (pain in extremity) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm gets a little sore (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I have gotten my Flu shot over 20 years . Just my arm gets a little sore. Get mine next week at the Doctors office."  It was unknown if the patients experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patients received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on the lot number for this case.
achiness; lots of chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness) and CHILLS (lots of chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced PAIN (achiness) and CHILLS (lots of chills). At the time of the report, PAIN (achiness) and CHILLS (lots of chills) had resolved.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2021: Follow up includes; Reporter information, Patient details, event verbatim and outcome updated.
Severe Muscle pain,Excruciating pain on the Left hand side; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe Muscle pain,Excruciating pain on the Left hand side) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Severe Muscle pain,Excruciating pain on the Left hand side). The patient was treated with FLUCONAZOLE (SOLONA) at an unspecified dose and frequency. At the time of the report, MYALGIA (Severe Muscle pain,Excruciating pain on the Left hand side) outcome was unknown. Not Provided    No relevant concomitant medications reported.
This spontaneous report as received from registered nurse refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. On 24-OCT-2014, the patient was vaccinated with ZOSTAVAX  lot # J007854, expiration date- 28-SEP-2014, 0.65 ml, subcutaneous. No concomitant medication was reported. The nurse reported that on 24-OCT-2014, expired dose of ZOSTAVAX was administered. No adverse effect was reported. The outcome of expired dose of ZOSTAVAX was administered was unknown. No further information was provided. Additional information has been requested.
Initial symptoms were normal (chills, fever, fatigue) and stopped in a day. Over next few weeks, began having tingles all over both legs, including a burning/throbbing sensation in my calves. I also noticed any physical exertion could lead to extreme light-headedness where I felt like I was going to pass out. This stopped within a few days. By week 3, I began having pretty significant (and constant 24x7) joint pain in both knees, making it difficult to walk. I have never had issues with my joints before and am healthy / active / young. I did not change anything about my routine or life, and my doctor agreed it was likely from the vaccine so I am reporting it here. The joints in my fingers also become painful if I spend too much time typing or on the phone. It's now 2 months of this joint pain and really hoping for some relief soon. Please contact me or my doctor if you have any thoughts or updates!
Urticarial rash to arms 5 min after vaccine given resolved within 1 hour.
Migraine and nausea. Dizziness. 6/2/2021 Severe body aches. Migraine around the entire head. Chills. Fever. Pelvic pain with sharp pains shooting down the thighs into knees and calves. Button feeling heavy as if birthing a child. Back pain and severe lower back pain leading to the tail bone. Cramping as if the my cycle is ongoing.
Lowest temperature was -17C degrees.Total excursion time was for 63 hour and  45 minutes, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via the Agency (Reference number- 00316028) and transmitted to Sanofi on 14-Oct-2020.  This case is linked to cases 2020SA290000, 2020SA288477, 2020SA288422 and 2020SA288639 (same reporter).  This case involves a 70 year old female patient who received a 0.7 ml dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]  (lot: UJ450AA, expiry date: 30-Jun-2021) (Strength = High Dose) once via unknown route in the left deloid for prophylactic vaccination. Along with IPV (VERO) [IPOL], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM], HIB (PRP/T) VACCINE [ACT-HIB] and TUBERCULIN TEST [TUBERSOL] on 09-Oct-2020 reached lowest temperature of -17 C degrees. Total excursion time was for 63 hour and 45 minutes (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.  It was an actual medication error due to the Product storage error temperature too low.   At the time of reporting, the patient had no adverse 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 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.
Recipient reported having itching, rash/hives all over body and swelling in hands feet and tonsils. This began about 45 mins after receiving vaccine and progressively got worse throughout the day. She reported it to her primary health care physician and myself. She took Benadryl same day and said she felt better the following day.
This spontaneous report was received from a physician refers to a female patient of unknown age. The physician noted an unspecified female patient was administered her one and only dose of GARDASIL (Lot # was not reported) intramuscular about two weeks ago (Approx. on 15-MAR-2013) . About 10 days after that administration of GARDASIL (Approx. 25-MAR-2013), the patient experienced abdominal pain, diarrhea, vomiting and nausea. No treatment was given for events. Concomitant therapies included ALDARA. The patient sought medical attention in the office. The outcome of abdominal pain, diarrhea, vomiting and nausea was unknown.The relation between events and GARDASIL was unknown. Additional information has been requested.
TINY RASH; SORE ARM; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood transfusion, and concurrent conditions included epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced sore arm. On 11-APR-2021, the subject experienced tiny rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm, and the outcome of tiny rash was not reported. This report was non-serious.
Patient received IM injection and felt weak, nauseated, and shaky after 15 minutes  Resolved after 2 days
His first dose was on 10/14/2020 and the second (booster) was given on 11/9/2020, 26 days later. 0.5 ml was given each time. First use of Fluzone Quad with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional and transmitted to Sanofi on 08-Jan-2021.  This case involved a 1 year old male patient who received his first dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] on 14-Oct-2020 and the second (booster) on 09-Nov-2020, 0.5 ml each time, 26 days later instead of 28 days (inappropriate schedule of product administration). It was the first use of FLUZONE QUAD.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  It was a case actual medication error due to inappropriate schedule of product administration (latency 26 days post the prior dose).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was 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 had contributed to or was to be held liable for the occurrence of this medication error.   There would be no information available on batch number for this case.
Starting off, I had a runny nose, cough, sore throat, chest congestion, and extreme fatigue and tiredness. I decided to take an at-home COVID-19 on 01/25/2023 after realizing my symptoms, and my test came back positive. I called my doctor and had a telehealth visit; he prescribed Paxlovid. Within 6 hours, I felt a definite improvement. Within a week of treatment, I was feeling much better and improved.
Large swelling in lower armpit on right side.  There is no pain or tenderness.  I'm assuming it's related to the vaccine.  I first noticed the swelling Saturday evening about 12 hours after receiving it. There is no change to the swelling on Sunday.  will seek care if no improvement in a few days. I had no issues with the first two.
Palpitations, BP 113/78, HR 115 - treated with prone position, resolved at BP 122/91, HR 111
Extreme pan at the site of injection. Could not life arm  up and down or side to side after 3 weeks post shot.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL9269), on 02Mar2021 as dose 2, single (Lot number: EN6205), on 03Oct2021 as dose 3 (booster), single (Lot number: CWO187) and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Penicillin Allergy" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid from 26Jun2022 to 30Jun2022 as treatment of COVID-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and BNT162B2.
This case was considered medically important. Information regarding Prevnar was received from a health care professional regarding a 4-month-old female patient who experienced tachycardia and temperature elevation to 104 degrees F. The patient received the second dose on 19-Jan-2007. On 19-Jan-2007, the patient developed an elevated temperature of 104 degrees F and tachycardia within a few hours of receiving Prevnar. The child was treated with Tylenol. The fever and tachycardia resolved within 24 hours. No additional information was available at the time of this report.
(L) deltoid painful. Moderate swelling informed mom to give TYLENOL prn and cool compresses to site.