chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called on-call provider 10/23 to report weakness, fever, and fatigue.  Presented to PCP's office on 10/28 with fever of 102, weakness, and fatigue.  Fell in parking lot of hospital and was hospitalized for 4 days due to fever and weakness.
Headache, fatigue, high heart rate, high blood pressure (as high as 180/90)
Administered a Tdap (Boostrix) vaccination to a 6 year old by accident; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included DTaP vaccine (patient was fully vaccinated with DTaP).   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter's medical group recently administered a Tdap (Boostrix) vaccination to a 6 year old patient by accident, which led to inappropriate age at vaccine administration. Hence, the reporter was asked to contact PV safetyin order to find out if there were any known risks associated with giving the Boostrix vaccine to a 6-year old patient; more so than just the typical risks associated with using the vaccine in an adult patient. The child was fully vaccinated with DTaP and didn't really need a tetanus booster at all, hence the reporter's group were just trying to determine whether there was additional harm  that could have been caused by giving the patient a boostrix shot, or if it was just a benign mistake that they could avoid in the future.
Initial case was received on 29 March 2010 from a healthcare professional. A 24 year old female received an intramuscular injection of ADACEL (Sanofi Pasteur Inc. lot number UF499BA, Sanofi Pasteur Ltd. Lot number C3107) on 04 March 2010. At the time of the vaccination the patient was pregnant. Her last menstrual period (IMP) and estimated date of confinement (EDC) were unknown. She had no previous pregnancies, no known allergies, no concomitant medications and no medical history. At the time of this report she had no adverse event. Follow-up information was received on 07 May 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient experienced a "ruptured tubal pregnancy" on 20 April 2010. No further information was provided. The patient was reported to recover on an unspecified date. Documents held by sender: None.
patient was texting husband about second dose and began to cough uncontrollably. vital signs:  13:21 hr-98, resp- 12, bp-137/89 o2- 98%. 13:28 hr 93, resp 12, bp 140/97, o2 99%, 13:35- hr 97, resp 18, bp 142/91 o2 98%.  wheezing noted with dry cough and she was holding her throat.  epi pen adminisitered in right thigh at 13:31.  no rash or hives noted.
Dizziness, chest tightness. Laid supine for 30 minutes while repeatedly check blood pressure.
PFIZER-BIONTECH COVID-19 VACCINE EUA.  ADMINISTRATION ERROR:   Resident received a total of 3 doses. On 5/3/21, resident was vaccinated with form showing only 1 dose of COVID-19 vaccine received. Later found that resident had already been vaccinated on 3/22 and 4/12 with Pfizer Covid19 vaccine.  No adverse events reported to date.
Menveo inappropriately reconstituted; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA583A, expiry date 31st August 2022) for prophylaxis.   On 22nd August 2022, the patient received Menveo. On 22nd August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The registered nurse reported that one day before the reporting date, a patient received the the powder (MenA) portion only of Menveo diluted with sterile solution and another patient received the liquid portion of Menveo (MCWY) diluted as well with sterile solution.  It was unknown which patient received each part of the vaccine. The reporter mentioned that the patients were a female and a male but it was unknown which one received the powder portion or the liquid portion. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received Menveo vaccine which was incorrectly reconstituted, which led to wrong solution used in drug reconstitution. This case is for 2 of 2 linked patients reported by same reporter.; Sender's Comments:  US-GSK-US2022122727:Same reporter
Pain & stiffness causing loss of sleep and inability to raise arm to the side, asked for advice, recomended pain reliever on 11/17/2013 and a visit to doctor.  Patient said would probably go tomorrow.
Loss of eye contact, social withdrawal, jerking of the body, repetitive movements, restlessness, hyperactivity, unable to concentrate, auditory processing issues, sensory dysfunction, high anxiety, loose stool/bowel disturbances.
SHINGLES; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
FINGER TIPS GETTING HOT; FINGER TIPS GETTING NUMB; INSIDE OF LEFT ARM EXCRUCIATING PAIN; COULDN'T WALK DUE TO SWOLLEN  ANKLES; COULDN'T WALK DUE TO SWOLLEN ANKLES; SHORTNESS OF BREATHE; HOT AND SWEATY; PAIN ALL OVER BODY; EXTREME CHILLS; REALLY COLD; HEADACHE; This spontaneous report received from a patient concerned a 45 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included headaches. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 12:30 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced shortness of breathe. On 11-APR-2021, the subject experienced hot and sweaty. On 11-APR-2021, the subject experienced pain all over body. On 11-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 11-APR-2021, the subject experienced extreme chills. On 11-APR-2021, the subject experienced really cold. On 11-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced couldn't walk due to swollen ankles. On 16-APR-2021, the subject experienced finger tips getting hot. On 16-APR-2021, the subject experienced finger tips getting numb. On 16-APR-2021, the subject experienced inside of left arm excruciating pain. Treatment medications (dates unspecified) included: tramadol, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breathe on 11-APR-2021, and hot and sweaty, couldn't walk due to swollen ankles, couldn't walk due to swollen ankles, extreme chills, really cold, and headache on 12-APR-2021, was recovering from pain all over body, and had not recovered from inside of left arm excruciating pain, finger tips getting hot, and finger tips getting numb. This report was non-serious.
Patient complained of difficulty breathing. Lost consciousness. HR 43, BP 140/80. Administered Epi at 2:35pm. Taken to EMS bay. HR 72, BP 118/80, O2 100%, resp. 20 at 2:45pm. Patient elected to travel with family to ED.
Information has been received from a physician concerning a 25 year old female who on 24-OCT-2007 was vaccinated IM with the first dose of Gardasil (Lot #658560/1062U). Concomitant therapy included ethinyl estradiol/norgetimate (TRINESSA), acyclovir (ZOVIRAX) and influenza virus vaccine (unspecified). On 24-OCT-2007 the patient experienced anaphylaxis and rash 5 minutes after vaccination. Subsequently, the patient recovered from anaphylaxis and rash after being treated with 2 shots of Decadron and Benadryl. The physician considered these events to be life threatening. Additional information has been requested.
Mother of pt states "hives" developed within 15 minutes, post vax; treated with Benadryl at 12:50. Infant observed and discharged at 13:00 from ER and sent home with Benadryl.
Developed severe red hot rash form chin to chest while in 15 minute monitoring.  Post Vaccination EMS on site.  Administered IV and IV Diphendramine.  Transported to Medical center ER.  ER administered Solu Medrol & Pepcid.
Right away my tongue got tingly just like with the first one, then shortly after my arms got all tingly and I felt weak and dizzy. 30mins later I got terrible chills and my teeth were chattering and I felt very dizzy but it eased up after a few hours. Very quickly after the shot I instantly felt completely dried out like I had no moisture in my body and had to constantly drink water. That night severe body pain settled in and I woke up in the morning with a fever of 101.1.  The severe body pains all over and headache lasted for 2 days, the fever was on and off for 1 day. The 3rd day all the lymph nodes in my body swelled up and 2 weeks later are still very swollen. There is so much pain and pressure in my face, neck, and chest and I'm always dizzy and have headaches. and it feels like I am being squeezed in my face so that even my teeth hurt and it's hard to chew because my jaw is so tight. 15 days since the shot it shows no sign of letting up.
101.8 fever, mild nausea, muscle aches, and moderate headache persisting at present through 25 hours post dose
This spontaneous report as received from a unspecified healthcare provider refers to a 11 year old patient. On an unknown date, the patient was vaccinated with expired PROQUAD (Merck) (lot # and expiry date not provided) by an unspecified healthcare provider. No concomitant medication was reported. It was reported that PROQUAD (Merck) had an expiration date of over two months ago. No adverse effects reported. No product quality complaint filed. Outcome of the event was unknown. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EP-6955), in left arm, on 08Apr2021 as dose 2, single (Lot number: EP-6955), in left arm and on 16Dec2021 as dose 3 (booster), single (Lot number: FL3197) at the age of 53 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had no known allergies. Patient received other medication (Theraflu) in 2 weeks. Patient was treated with oral Paxlovid (lot number: GC4774) from 12Sep2022 to 16Sep2022 for COVID-19. Patient was getting better but began to feel worse upon taking Paxlovid, extreme coughing and congestion occurred although no fever. Orange/bloody mucus after taking Paxlovid also.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
chorioamnionitis; patient was pregnant during vaccination; Initial unsolicited literature report received from a healthcare professional on 18 June 2015.   This case is linked to case ID's: 2015SA090249, 2015SA090258, 2015SA090259, 2015SA090257, 2015SA090260 ,2015SA090262. (same literature, reporter and event).  This case involves a pregnant female patient (age not reported) who experienced chorioamnionitis (amniotic cavity infection), after she received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HUMAN PAPILLOMA VACCINE (HPV4) (exposure during pregnancy).  Data regarding this pregnancy were received prospectively.   The date of last menstrual period was not reported. Gestation period was unknown  The estimated due date was not reported.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) and a  dose of suspect HUMAN PAPILLOMA VACCINE not produced by Sanofi Pasteur (lot number and expiry date not reported) both via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious chorioamnionitis (amniotic cavity infection) (unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and HUMAN PAPILLOMA VACCINE. This event was assessed as medically significant.  It was a case of vaccine exposure during pregnancy (latency same day).   Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  Pregnancy outcome was unknown at the time of report.  The event outcome was unknown for chorioamnionitis.  Batch number has been requested for suspect product for this case.  Follow up information received on 19-Apr-2021 regarding an unsolicited valid serious case received from other healthcare professional via health authorities (under reference number: 583525).  Report type of the case updated (unsolicited literature to unsolicited non-literature), seriousness for event exposure during pregnancy updated (serious to non serious) and narrative updated accordingly; Sender's Comments: This case concerns a pregnant female patient (age not reported) who presented with chorioamnionitis after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (unknown manufacturer) and HUMAN PAPILLOMA VACCINE (other manufacturer). The time to onset was unknown. There is, however, no information regarding patient's condition at time of vaccination, past history and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed. US-SA-2015SA090249:CLUSTER US-SA-2015SA090257:CLUSTER US-SA-2015SA090258:CLUSTER US-SA-2015SA090259:CLUSTER US-SA-2015SA090260:CLUSTER US-SA-2015SA090262:CLUSTER
Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; Headache not too bad but hot nauseated 24 hours after injection; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) intramuscular in the right arm on 11Jan2021 07:30 AM at a single dose for Covid vaccine. Medical history included high BP. The patient had no known allergies. Concomitant medications included lisinopril, colecalciferol (VITAMIN D), vitamin B complex (B COMPLEX), calcium, and cetirizine hydrochloride (ZYRTEC) (other medications in two weeks). The patient had no other vaccine in four weeks. The patient experienced headache not too bad but hot nauseated 24 hours after injection on 12Jan2021 08:00 AM. Treatment was not received for the events. The patient had no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the events was not recovered.
Developed fever of 101-103, violent chills, uncontrolled shaking and extreme headache.  Lasted 3 solid, then fever began to drop day 4, but headache persisted along with sweats and violent chill. No real appetite.  Also experienced body ache, but not as bad as other symptoms.  No, or little bowel movement during this time.  On day five (today) urine output is dark, but went 18 hours without Tylenol.  Piot to that i need 2 extra strength Tylenol every 5 hours for 4 days straight.  No nausea or vomiting associated with any of this.  I have extreme fatigue due the extreme headache pain keeping me awake.  Headache on the left and right side of the head, not front or behine the eyes, more over the ears.  Today I just feel wiped out by it all, but much improved.  I have never had any reaction to any vaccines previously, including allergy, flu, shingles and pneumonia.
Developed shingles 5 days later in mouth, lips, chin, ear, gums, down the throat, fever.
Rash started to break out within 36-40 hours after taking the vaccine. It lasted 18-19 days after the vaccine. With a lot of itching and it looked like chicken pox.
severe abdominal pain, went to ER, diagnosed with Gastritis. Pain improved with prilosec, maalox , tums and IV fluids. No h/o gastritis in the past.
Daughter woke up with a stomach ache and severe arm pain in the opposite arm of shot. By afternoon she had a 102 degree fever, stomach ache, headache, and the lymph nodes under both armpits were swollen the size of a golf ball.
suspected vaccination failure; Shingles / into eye; Double dose vaccine / got it / One year later got shingles / lots of people like him; So bad / lots of people like him; Scabs have healed / lots of people like him; Still has nerve damage with daily attacks / lots of people like him; This case was reported by a consumer and described the occurrence of suspected vaccination failure in an unknown number of adult patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), shingles, feeling bad, scab and nerve damage. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster, shingles, feeling bad, scab and nerve damage were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, shingles, feeling bad, scab and nerve damage to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The age group was selected as adult as per vaccine indication. It was reported that lots of patients got shingles so bad he and covered from hairline, across eyebrow, eyelid and into eye. The patient also experienced scabs and nerve damage. This case was considered as suspected vaccination failure as detail regarding time to onset and laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case had been linked with US2021AMR101272 and US2021AMR104425, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case. US-GLAXOSMITHKLINE-US2021AMR104425:Same reporter. Husband's case. US-GLAXOSMITHKLINE-US2021AMR101272:Same reporter. Reporter's own case.
This case was reported by a nurse via sales rep and described the occurrence of localized itching in a 56-year-old female patient who received SHINGRIX (batch number FZ3ND, expiry date unknown) for prophylaxis. On 17th October 2018, the patient received the 1st dose of SHINGRIX. On 17th October 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On 18th October 2018, the patient experienced localized itching. On 19th October 2018, the patient experienced red rash, blister and blotchy rash. On 24th October 2018, the patient experienced skin peeling. The patient was treated with benadryl (nos) (Benadryl). On 23rd October 2018, the outcome of the red rash and blotchy rash were recovered/resolved. On an unknown date, the outcome of the localized itching, blister and pain in arm were recovering/resolving and the outcome of the skin peeling was unknown.  It was unknown if the reporter considered the localized itching, red rash, blister, skin peeling, pain in arm and blotchy rash to be related to SHINGRIX. The reporter was a health department nurse who's colleague experienced the symptoms after vaccination. The patient was vaccinated on Wednesday. On Thursday night, 1 day after vaccination, the patient had itching starting on her feet. On Friday, 2 days after vaccination, the patient had red blotchy rash appeared on feet, arms and hands and was blistered up. The patient took Benadryl those days to deal with symptoms. On Monday, the symptoms had greatly improved. On Tuesday, the rash was completely gone. At the time of reporting the patient also felt like her feet were going to peel. The patient had a rash like this been reported with SHINGRIX. The patient took Benadryl in those days to deal with symptoms. The reporting nurse agreed to follow up.
pt recv vax 20JUL98 & 8hr later 20JUL98 pt devel a migraine like h/a w/weakness & hyperreflexia in legs;
Rash, blistering, In scalp, neckline, back of neck, burning sensation, right side and back of head. Painful.
Rash on bicep of injection, bump/hard where rash was, giving off extreme heat that lasted for 3-4 days
Achy; Thirsty; Extremely weak; Sweating; Intense arm pain at site of injection; Tired; Fever; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 49-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Apr2021 13:00 (Age at vaccination: 49-years-old) as dose 2, single for covid-19 immunization. Medical history included back pain, allergies to Dog dander, Peanuts, Dust all from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 in Left arm on 30Mar2021 03:45 PM for covid-19 immunization. Patient did not receive other vaccine in four weeks. Patient did not receive Other medications in two weeks. Patient was not diagnosed with covid prior to vaccination. On 19Apr2021 16:45 patient experienced Extremely weak, thirsty, Sweating, Intense arm pain at site of injection, achy, tired, fever. Patient did not receive any treatment for the events. Patient was no tested for covid post vaccination. The patient underwent lab tests and procedures which included body temperature: fever on 19Apr2021. the outcome for the events was reported as not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Following day after the shot felt sore all over my body and my arm was painful all day. It wasn?t until after work that I felt chills and took my temperature and I had a fever of 100.4. I did not take any over the counter medicine to help with the pain.