chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 minutes after the second dose, patient developed headache, lightheadedness, dizziness, shortness of breath/anaphylaxis.  Transferred to ED, and experienced chest pain, SOB, tightness in throat.   Patient was sent to the emergency department.  Received 25 mg Benadryl prior to arrival as prophylaxis.  Received Combivent in the ED, and symptoms improved.  Patient was observed for 4 hours in the ED.  Eventually patient was discharged home.
HYPOTENSION 2/18/2022 ANEMIA DUE TO ANTINEOPLASTIC DRUG  HYPOTENSION 2/18/2022 DM 2 W EYE MANIFESTATION  HYPOTENSION 2/18/2022 HYPERCALCEMIA
shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 14-JAN-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine), the pt suffered shingles (herpes zoster). As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of pt'' condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. In addition, as a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of herpes zoster was not recovered. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).  Herpes zoster was considered a disabling event by the reporter.
Patient woke up at midnight, and started vomiting everywhere. No fever or other symptoms. Lasted for a couple minutes with intermittent vomiting, then she was fine.
This spontaneous report was received from a certified medical assistant and refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 04-AUG-2017, the patient was vaccinated with improperly stored dose of M-M-R II injection (lot # M036544 (also reported as M023895), expiration date: 15-AUG-2018; dose and route of administration were not reported). The dose of the vaccine was reconstituted with properly stored sterile diluent (MERCK) (also reported as STERILE WATER DILUENT) injection. The reporter stated that the administered dose of M-M-R II was stored at temperature 10.2 degrees Celsius for 39 hours 45 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA003879.
Pain in muscle, injection site. Next evening a rash appeared all around injection site and upper arm swelled to a very noticeable size.  Could easily tell it was swollen especially when compared to other arm.
Patient reported 1.5 hours after receiving the Bivalent on his left deltoid, he started to have tingling and pain on the tips of his fingers on both hands, his tips of fingers are tender to touch. RN triaged the patient, denies any SOB. Pt is sitting next to the RN for observation.
Rush ( red and swollen skin rush ) around the stomach area, under groin area, and down the inner parts of the legs all the way to the knees; warmth and very itchy.
Two dark pink spots on arm on day 2.  My arm felt like it was pulsing. As the days have passed the color has gotten lighter but the mark has gotten longer. It is now day 10 and I have a pink mark on my arm that is 4 inches long and 2.5 inches wide. Lighter pink than before. My are still is sore.
patient was given the Dtap/IPV portion of PENTACEL and did not get the ActHIB part, no AE; Upon Internal review a signification amendment was performed on 04-Jun-2021, to change the product code of Pentacel from 242 to 520.  Initial information received on 14-Dec-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 2 months old female patient who was given the first dose of DTAP/IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] (Lot number UJ336AAA and expiration date 05-Jul-2021) and did not get the ACT-HIB part, via intramuscular route in the right thigh for prophylactic vaccination on 10-Dec-2020 (Product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, ROTAVIRUS VACCINE and PNEUMOCOCCAL VACCINE for prophylactic vaccination.  It was a case of actual medication error due to inappropriate reconstitution technique (same day latency).  Physician stated that an employee gave the DTAP/IPV portion of PENTACEL. She wanted to know how to proceed, to give them just an ActHIB or another Pentacel. The physician stated that an employee at the office gave the DTaP/IPV portion of Pentacel on 10-Dec-2020.  At the time of report, no adverse event was reported.  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.
Information has been received from a physician concerning an 18 year old female with pertinent medical history and drug reaction/allergies not reported who on 29-DEC-2006 was vaccinated with the first dose of Gardasil (Lot #654885/1424F), injection, 0.5ml. Concomitant medication was not reported. ON 29-DEC-2006, the patient developed hives within hours of receiving the first dose of Gardasil. The physician reported that the hives became more generalized within 24 hours. On 29-DEC-2006, therapy with human papillomavirus vaccine was discontinued. Subsequently on an unspecified date, the patient recovered from hives. Additional information has been requested. This is in follow-up to report (s) previously submitted on 2/14/2007.  Information has been received from a physician concering his daughter an 18 year old female with pertinent medical history and drug reactions/allergies not reported who on 29-DEC-2006 was vaccinated with the first dose of GARDASIL (lot #654885/1424F), injection, 0.5 mL.  Concomitant medication was not reported.  On 29-DEC-2006, the patient developed hives at the injection site within hours of receiving the first dose of GARDASIL.  The physician reported that "the hives became more generalized within 24 hours" and the patient "then developed hives on her trunk and knee the next day."  On 29-DEC-2006, therapy with human papillomavirus vaccine was discontinued.  Subsequently 48 hours after the vaccination, the patient recovered from hives.  Additional information has been requested.
Swollen lymph node near injection site; Head ache; Tired; Slightly nauseous; Sore arm; 3rd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 10:45 (Lot number: Fh8027) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: Ep6955), for covid 19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: El3247), for covid 19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 10:45, outcome "unknown", described as "3rd dose"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Swollen lymph node near injection site"; HEADACHE (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Head ache"; FATIGUE (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Tired"; NAUSEA (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Slightly nauseous"; PAIN IN EXTREMITY (non-serious) with onset 22Nov2021 15:00, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of lymphadenopathy, headache, fatigue, nausea, pain in extremity. No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of depression in a female patient who received influenza vaccine. On 20th October 2015, the patient received influenza vaccine unspecified. On 20th October 2015, less than a day after receiving influenza vaccine unspecified, the patient experienced depression. On an unknown date, the outcome of the depression was not recovered/not resolved. It was unknown if the reporter considered the depression to be related to influenza vaccine unspecified. Additional details were received as follows: The patient reported that, she received flu vaccine and since then she feels depressed. The patient reported, she believes that the flu vaccine might be the reason for the depression. The reporter stated that, she will call back within the business hours.
Passed out; MARKETING PROGRAM NAME NOT AVALIABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4351305-00 (AbbVie).  A 73-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at citrate free, subcutaneous for colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (First Dose, Route of Admin: Intramuscular), administration date: 20Feb2021, when the patient was 72-year-old, for COVID-19 immunization; BNT162b2 (Second Dose, Route of Admin: Intramuscular), administration date: 12Mar2021, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 02Apr2022, outcome "unknown", described as "Passed out". The action taken for adalimumab was unknown.  Additional information: Patient stated that he was not drinking enough water and went out into the heat. He went to sit and instead fell backwards and scraped his head. He was taken to the emergency room and told he was dehydrated. He adds, because he took his 4th Pfizer booster the day before he was told the booster might have played a role in his fainting. After getting fluids in the hospital he reported feeling good. The reporters causality for the event of passed out was not reported.  Abbvie's opinion is that there is no reasonable possibility that the event of passed out, unknown onset related to Humira (ADALIMUMAB).  The reporter's assessment of the causal relationship of "passed out" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Nausea, fatigue, muscle weakness, runny nose. On Friday 11/6/2009 a deep cough was developed.
COVID Positive test; COVID Positive test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Apr2021 as dose 1, single (Lot number: ER8730), in left arm, on 24Apr2021 as dose 2, single (Lot number: EW0171), in left arm and on 29Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 39 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Food: Shellfish Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jan2023, outcome "unknown" and all described as "COVID Positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jan2023) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19.
pt's son recvd vax 29JUL95 & 12AUG95 mom exp h/a that went down spine;15AUG95 devel pimple-like rash on forehead;w/in a few days rash spread face, back, stomach & underneath breast;also devel whitehead-like pimples in mouth, sore throat;
I have tried ibuprofen and massages and nothing works I don?t have insurance and like I stated I never had these issues before getting the vaccine
THE PATIENT RECEIVED  JANSSEN COVID 19 VACCINE IN THE LEFT ARM. I RECOMMENDED TO SIT FOR 15 MINUTES TO OBSERVE THE PATIENT. PATIENT REQUESTED TO USE THE BATHROOM IN THE PHARMACY RIGHT AFTER VACCINE.  PATIENT CAME BACK FROM THE BATHROOM SAYING THAT HE FAINTED AND FELL IN THE BATHROOM AND SLASH OPEN THE LEFT SIDE OF HIS CHEEK WAS BLEEDING A LOT AND HE FELT DIZZY AND NAUSEA. HE FAINTED THE SECOND TIME ON THE FLOOR. 911 WAS CALLED PROMPTLY. POLICE AND AMBULANCE CAME TO GO TO THE HOSPITAL.
During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses".  Additional Details: He called to receive his third dose of Pfizer COVID-19 vaccine, he received his second dose on 14Sep, he also calls on behalf of his wife who also wanted to received the third dose of the vaccine. During the call he mentioned that neither he nor his wife can walk well and because of that he cannot go away from the site where he received his first two doses. Agency: e-transmitting probable AE noticed during documentation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer vaccine was diluted with NS 0.9% Bacteriostatic which is not recommended for use with this vaccines. Reported to Pfizer and CDC. As per recommendation from CDC, affected dose should be repeated. Pt was notified and all questions answered. Pt is refusing to repeat dose due to side effects she experienced after the 1st administration.
Received vaccine H1N1 at 15:00 and developed lightheadedness, dizziness, chills later that evening, hot and cold all over, occas. cough x 48 hours. 12/9/09 Medical records received. Prenatal records. EDC: 2/10/10. OV 11/13/09 Pt c/o decreased fetal movement, dizzy, lightheaded after vax. DX: viral illness.
INCONSISTENT TIMING OF PERIODS; WORSENED MENSTRUAL CRAMPS; DRAGGING FOR AN ENTIRE WEEK; WORSENED HEADACHES; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced inconsistent timing of periods, worsened menstrual cramps, dragging for an entire week, and worsened headaches. The action taken with covid-19 vaccine was not applicable. The outcome of the inconsistent timing of periods, worsened menstrual cramps, worsened headaches and dragging for an entire week was not reported. This report was non-serious.
Post vax, pt became pale and faint. Pt was laid down with cold cloth to forehead. BP checked then rechecked in 15 minutes to give a normal measurement. Paleness resolved. Pt called office 2 days later to state she was alright.
Started with small red spot which continued to grow.  Fever began the evening of 9/26.  Area was hot, tender, and began feeling queasy.  Went to doctor on 9/27 and diagnosed with cellulitis.  Prescribed 100MG  Doxycycline twice a day and returned for check up on 9/29.  Prescribed Sulfamethoxazole  tmp ds, valacyclovir hcl 1 gram, ranitidine 150 mg, and hydroxyzine pam 50 mg.  Return to Dr. daily until cleared.  Taking Tylenol for pain.
Pain at injection site. Severe headache. Vomiting after meal.  IBuprofen one at onset of arm pain and headache  4:30 am  One at  at 1 pm One at 8 pm Table spoon of Honey to relive  coughing
hives for 9+months  severe reaction in the form of very itchy, red, hot hives if taking antihistamines  started with red dots on palms red dots on palms and feet hives/bug bite looking very large itchy raised bug bite looking spot on body: side of calves, knees, shoulders, stomach, arms
Swelling about three times the size of my normal arm; red and hot-to-the-touch.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 77 year old male vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
Lump at injection site; developed lump at injection site very sore and itchy; developed lump at injection site very sore and itchy; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 11:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma, high blood pressure, hypothyroidism, anxiety, prediabetes and penicillin allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), telmisartan (MANUFACTURER UNKNOWN) and venlafaxine hydrochloride (EFFEXOR); all for unknown indication from an unknown date. The patient previosuly received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 17Mar2021 at 11:45 (at the age of 51-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. On 09Apr2021 at 7:00, 48 hours post second vaccination, the patient experienced lump at injection site very sore and itchy. The patient reported that no meds were taken. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events lump at injection site very sore and itchy were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Woke up early morning of March 18 with nausea/vomiting  for 12+ hours (Often induced by motion: sitting up, standing, shifting position.), sweating, chills/shaking, headache, weakness, loss of appetite.  Received Rx for anti-nausea medication.  Symptoms improved by morning March 19. Headache, unsettled stomach, tiredness, and loss of appetite persisted. By March 20 almost back to normal, still suffering a slight headache, tired with an unsettled stomach.  Appetite returned.  Did not record a fever during the entire episode.
Swelling, redness, tenderness, and hot to touch.  She noticed that it was swollen and tender this morning when she woke up.  Took Benadryl.