chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date 4th July 2020) for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced fever, headache and general body pain. On an unknown date, the outcome of the fever and general body pain were recovered/resolved and the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the fever, headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: It was unsure of exactly when the symptoms began after vaccination. Vaccination was given on Friday and patient discussed the symptoms on Monday, saying all but headached resolved.
Information has been received from a certified medical assistant concerning a 69 year old female with hypertension, hyperlipidaemia, osteoarthritis and drug hypersensitivity to VIBRAMYCIN who on 10-JUL-2007 was vaccinated IM into the right deltoid with a 0.5 ml dose of PNEUMOVAX (Lot # 655212/0699U).  Concomitant therapy included LIPITOR, atenolol, PAXIL, NEXIUM and trazodone HC1.  On 11-JUL-2007, the patient experienced injection site reaction described as swelling of the right arm, "hard" arm, erythema which extended to the elbow and difficulty lifting the arm.  Medical attention was sought and the patient was ordered on ice and ibuprofen.  On 14-JUL-2007, the symptoms resolved.  The medical assistant is requesting a lot check.  This is one of three reports from the same source.  Additional information has been requested.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the research center and was released.
No additional AE; Caller reported AE on behalf of patient who was administered improperly stored VARIVAX. TE Filed (Case #02506183). No symptoms reported. Obtained consent to contact HCP. Additional AE Filed (Case #02506185). No additional AE/PQC.  Product Name: VARIV; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter, lot #X010534, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion in 27.3/ 14 degree Farenheit up to 46 degree Farenheit for 1 hour 59 minutes and no previous excursions. No additional adverse event was reported.
received a dose that had expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received Men B NVS (Bexsero) (batch number ADXA87AZ, expiry date 31st January 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 17th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 17-Jun-2022 Reporter's comments: The patient received a dose of Bexsero which was expired. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The patient received expired dose of Bexsero, which led to expired vaccine used.
fainted on Thursday 12Aug 5 days after receiving his second COVid shot; This is a spontaneous report from a contactable consumer (mother of the patient).  A 15-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not provided), via an unspecified route of administration on 07Aug2021 as dose 2, single for covid-19 immunization. There was no medical history (no prior medical issues). There were no concomitant medications (was on no other medicines). It was stated that, on 12Aug2021, 05 days after receiving second covid shot, the patient fainted. Event took place after use of product. The outcome of the event was unknown, at the time of report.  Information on the Lot/batch number has been requested.
Swelling; Hardness; Pink Dots; Moderna Vaccine Administered in right Thigh; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), INDURATION (Hardness), MACULE (Pink Dots) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in right Thigh) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 03-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in right Thigh). On 11-Feb-2021, the patient experienced SWELLING (Swelling), INDURATION (Hardness) and MACULE (Pink Dots). On 03-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Moderna Vaccine Administered in right Thigh) had resolved. On 15-Feb-2021, SWELLING (Swelling), INDURATION (Hardness) and MACULE (Pink Dots) had resolved. Not Provided          Concomitant information not provided. Treatment included  "Cortizone-10" - Self medicating to try to alleviate symptoms. "Cold Compress" - Self medicating to try to alleviate the symptoms   This case was linked to MOD-2021-037401 (Patient Link).
1st vaccine 1/26/21; 2nd vaccine 2/19/21; developed chest pain 2/22/21 and went to ED and admitted to hospital, DX: Chest pain, unspecified type  R07.9 786.50
Flu and pneumovax administered in right deltoid on 11/21/2007. On 11/23/07 complained of tenderness and reddness at the injection site extending toward the elbow.
Positive for COVID.; Positive for COVID; Fever; Chills; Headache; Cough; This is a spontaneous report from a non-contactable consumer (patient). A 63-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, on 21Apr2021 (Lot Number: ER2613) as dose 2, single; on 31Mar2021 (lot: ER2613) as dose 1, single, both at the age of 63-year-old for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. The patient experienced fever, chills, headache, cough on 06Oct2021 and positive for COVID on 07Oct2021. The patient underwent lab tests and procedures which included Nasal Swab Antigen Rapid: negative on 07Oct2021; Nasal Swab PCR: positive on 07Oct2021. No treatment received. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Patient almost passed out, got very white.  We gave her water, talked to her to calm her down.  Took her BP 100/62 (she said her BP always ran low), called EMS because she was having vision issues and numbness in her hands.  EMS came and she said she was better, they checked her out, she refused to fill out a report and they left.
Said she felt hungry at 15 minutes prior to leaving the post vaccination area,  offered crackers...stated she was well enough to leave. Came back stated she was unwell... 16 minutes post vaccination.  She complained of palpitations, flushing & shortness of breath, little chest pain that resolved with vagal maneuvers and encouragement. Initial vitals: BP 186/96, initial hear rate by palpitation 180, on monitor 170, RR 26, O2 sat 92% on room air EMS called & patient transported to ED department Vitals at departure with EMS: BP 176/96, HR 120, RR 20
This patient did not have a reaction to this medication. Pt had Primary Pfizer gray top given on 11/11/2022 and was coming to get the second primary vaccine today 12/02/2022.  Instead, she was given the Bivalent Pfizer by accident.  Provider notified.
Significant arm soreness and generalized body aches about 9-10 hours after the vaccine. Lasted about 24 hours and prevented me from performing daily activities or working.
Given second Monkeypox vaccine 9/26/22, experienced facial paralysis 9/27/22.  Went to urgent care, no PCP
unconscious for 3-4 minutes; neck pain; dizziness; vomiting; fell down; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: Unknown), via an unspecified route of administration on an unspecified date as UNKNOWN DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced on an unspecified date it was reported she would also like to know if this is something she should see a doctor for and what can she take to make the neck pain go away. Caller stated she received the vaccine around 1-2pm it was really crowded and she experienced dizziness around 3 am after receiving the vaccine and she also had vomiting and she fell down. She stated she was unconscious for 3-4 minutes after becoming dizzy and falling down and she did not have these symptoms prior to receiving the vaccine. The clinical outcome of the events were unknown.  Information about batch/Lot number has been requested.
Covid arm (itchy rash about an inch in diameter and an inch or so below the injection site).
Patient c/o itchy raised red rash 24 hours after receiving varicella vaccine.
Significant site pain after nearly 2 weeks (12 days) pt had pain upon  raising arm. no redness, swelling or warm to the touch.
This initial spontaneous case was received on 24-Nov-2017, from other-health professional, concerning a 3-year-old male patient. On 24-Nov-2017, the patient was administered with FLUCELVAX QIV (dose 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195243 and expiry date: Jun-2018). It was reported that no adverse events were noted after vaccination. The reporter considered this case as non-serious.
neck pain; shoulder pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), ARTHRALGIA (shoulder pain) and HEADACHE (headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B120-2A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced NECK PAIN (neck pain), ARTHRALGIA (shoulder pain) and HEADACHE (headache). On 18-Jan-2021, NECK PAIN (neck pain), ARTHRALGIA (shoulder pain) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This case was reported by a nurse practitioner and described the occurrence of vertigo in a 45-year-old female subject who was vaccinated with hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis. Concurrent medications included Atenolol and Atorvastatin calcium (Atorvastatin) for unspecified medical conditions. On 17 August 2005 the subject received the first dose of Twinrix (lot AHABB078AA). At an unspecified time following receipt of the first dose of Twinrix, on 17 August 2005, the subject experienced vertigo, malaise and headache. The subject was seen at a physician's office and was treated with meclozine (Meclizine) and paracetamol (Acetaminophen). At the time of initial reporting, 22 August 2005, the events were ongoing. The nurse practitioner considered  the events to possibly be related to vaccination with Twinrix. On follow-up received from the nurse practitioner on 28 September 2006, the nurse noted the subject was a male. The events had resolved completely. ON an unspecified date, Twinrix was reintroduced without incident. In the nurse practitioner's opinion, the events may have been associated with a concurrent illness.
3-4 hours after injection, patient experienced numbing on (R) upper arm, where injection was given. Pain spread down arm to lower extremities. Emergency room doctor - did not think shot was cause, they found a cyst in her abdomen.
Right arm pain from wrist to shoulder the day following the vaccine, for just a few hours.; This is a spontaneous report from a non-contactable consumer, the patient. A 90-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 09Feb2021 at 11:30 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right  arm on 21Jan2021 at 11:30 (at the age of 90-years-old) as a single dose for COVID-19 immunisation. On 10Feb2021, the patient experienced right arm pain from wrist to shoulder the day following the vaccine, for just a few hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event right arm pain from wrist to shoulder was recovered on an unknown date in Feb2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a consumer and described the occurrence of autism in a 1 year old male subject who was vaccinated with hepatitis B vaccine (manufacturer unspecified) for prophylaxis. The reporter is an acquaintance of the subject. A physician or other health care professional has not verified this report. On 8/24/2001, the day the subject was born, he received the 1st dose of hepatitis B vaccine, lot number not reported. At one year of age, on an unspecified date in 2002, the subject experienced symptoms of autism. On an unspecified date on or before, 2/3/2006, the subject was diagnosed with autism. The outcome of the autism was not reported. Comment: Autism was assessed as medically serious by manufacturer (OMIC).
After both of my Moderna vaccines (April 28 and May 26) I had delayed ovulation for two cycles and then had shortened luteal phase both times. My first cycle had an ovulation day of CD25 and a luteal phase of only 12 days. My second cycle had an ovulation day of CD23 and a luteal phase of only 11 days. My ovulation typically happens at CD19 and my luteal phase is always 14 days long. A luteal phase under 14 days means a possibly fertilized egg doesn?t have time to attach to my uterine wall, which is an issue with fertility. My last cycle had a normal ovulation day, but my luteal phase still was under 14 days, falling at 13 days. I can?t say for certain if the issues are resolved, since I?m currently in my luteal phase of my current cycle and am at day 9 of my luteal phase.
immed p/vax pt lost consciousness & sz lasting approx 15-20sec;supportive treatment & eval;
12/31/2021: - Event occurred after 2nd series of  2 doses  vaccines. 69 year-old female presents to the emergency department with her son for nausea vomiting and increasing weakness. Reports some shortness of breath as well and  increasing lower extremity edema. Hx of lt lung cancer. Pt has had 4 series of COVID vaccine moderna.  Also has had a booster on 11/2021.   Has a history of lung cancer and recent PET scan showed increasing mass size in her left lung.
muscle aches; chills; This case was reported by a physician via call center representative and described the occurrence of muscle pain in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date unknown) for prophylaxis.   On 16th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced muscle pain and chills. On an unknown date, the outcome of the muscle pain and chills were recovered/resolved.   It was unknown if the reporter considered the muscle pain and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional did not provide expiry date of Shingrix. After vaccination with dose of Shingrix, the patient experienced muscle aches and chills for 1 week. The patient refuses to receive 2nd dose of Shingrix.
Local dermatitis masculo papular, non-tender, non-puritic, approximately 24 hours after vaccine.
Several months post vax, pt developed acute lymphoblastic leukemia. The pt has been on maintenance chemotherapy since the diagnosis. In recent weeks, pt has been exposed to varicella. On approximately 6/26/01, pt developed chickenpox and was hospitalized. MD noted the child's rash was very atypical and the lesions were not "umbilicated." He reported that the case was very mild. The child had less than 200 lesions and no fever or other signs or symptoms. The pt was treated with antibiotics. The question the MD had was "Is this child a primary vaccine failure, or did he have some waning of his immunity due to his chemotherapy?" The outcome of the pt was not reported. Upon internal review, ALL was considered to be an other important medical event. Addtl info has been requested.
One to two days post vaccination, the patient experienced pain and swelling to his left upper arm.  The area has a four inch circumference and was erythematic. He also had a fever of 103 degrees F.
swollen 3 inch under injection site; vaccination site itch; vaccination site warmth; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (vaccination site itch), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE SWELLING (swollen 3 inch under injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included LINACLOTIDE, ATORVASTATIN, ESTRADIOL, CALCIUM, FAMOTIDINE, OMEPRAZOLE and GABAPENTIN for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site itch) and VACCINATION SITE WARMTH (vaccination site warmth). On 15-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swollen 3 inch under injection site). On 18-Jan-2021, VACCINATION SITE PRURITUS (vaccination site itch), VACCINATION SITE WARMTH (vaccination site warmth) and VACCINATION SITE SWELLING (swollen 3 inch under injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Benadryl and antibiotics.
This is a spontaneous report from a Pfizer sponsored program Regulatory Authority (CEP 159558). A contactable consumer (patient) reported that, a 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on 25Feb2021 (at the age of 59-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included asthma from an unknown date and unknown if ongoing reported as, she is an asthmatic person. Concomitant medications included salbutamol (ALBUTEROL HFA) and salbutamol sulfate (INHALERIN) both taken for an unspecified indication, start and stop date were not reported. The patient experienced developed a little cough on an unspecified date. Patient stated that, "I got the first dose of the Pfizer covid vaccine on 25Feb2021. I'm an asthmatic and take medications every day for my asthma. I developed a little cough after the first dose of the vaccine, and I feel much better now. I use albuterol solution in a breathing machine, and I use some inhalers too.  I'm scheduled for the second dose on 18Mar2021 and want to know if I'll be able to get it. Patient said, my doctor knows about my asthma and wants me to get the vaccine." Further it was reported that, patient received the 1st dose on 25Feb2021 and scheduled to get her 2nd dose on 18Mar2021. However, she mentioned she is an asthmatic person and due to her asthma, she developed a little cough, and was currently taking medications Albuterol solution and few inhalers. She asked, if she is still allowed getting the 2nd dose prior to the medications that she is taking. She clarified that she was fine after receiving the 1st shot. Therapeutic measures were taken as a result of developed a little cough. Outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recvd vax & exp a rash on arms & legs w/in 2hrs p/vax; h/o allergies:yeast/milk/wheat/oats/rice/corn/eggs/beef/pork/chicken;pt recovering p/1wk;
Patient states worst of side effects started about 11:20pm that night. Patient went to bed after getting home about 8pm. Patient had pain that started in arm where she got shot, then hurt in right leg, and then left leg and arm. Patient passed out at one point, causing her to fall and hit head on bathroom floor. She did not seek any medical attention at that time and has not since her vaccine. She had extreme thirst from 8pm until 3am. She could not sleep due to pain.  Patient was foggy after that for several days, but she is back at work today and feels much better. Patient doesn't think she had fever. She did have a lot of hot/cold flashes. Patient states she is entering information into the VAERS online system herself since she knows all her symptoms. Patient is wanting to speak to someone that knows about Mold toxicity and if it correlates to the covid Vaccine. She states she had the same symptoms when she had mold toxicity before. States she had a mold toxin dump at that time where she lived and was given an IV which caused symptoms to stop.  Patient states she will look up someone if she needs to and does not want the provider to do any leg work. She has several books and has ordered more. When this occurred before, she had hyperbaric oxygen therapy and believes this pushed toxins out of her cells into her body