chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 5:45 he was very white, appeared to be barely breathing and was limp. He did not respond to noise or physical stimulation. He was more responsive in ER but lethargic and had a weak cry. On 02/21/2002 mom said he was still pale and quieter than usual. Instructed to take into the physician's office. He was seen in the doctor's. Pt seems he has recovered but did have an adverse event.
Caller is a medical assistant calling to report a temperature excursion.; Product Name: ROTATEQ / Dose/Frequency: 0.5 ml; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 14-DEC-2020, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), at a dose of 0.5 milliliter (incorrect dose administered), administered by oral route (formulation, strength and vaccination scheme were not reported; lot number S040483, which has been verified to be valid, expiration date reported and validated as 19-JUN-2021), and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), administered at a dose of 0.5ml (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T001206, which has been verified to be valid, expiration date reported and validated as 06-MAR-2022), both vaccines were administered as prophylaxis, and experienced temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA008083:
Pt recvd vax 130PM started screaming @ 7PM lasted 3 hrs or longer;
This was my booster shot- 1(st dose 12/18/20; 2nd dose 1/7/21).  Approximately 9 hours after receiving the vaccination, I recognized that I was having restless sleep; I was up just about every hour.  I experienced body aches, minor chills, and a dull headache.   (of note, I had no side effects after the 1st dose, only a dull headache after the 2nd dose).  The booster seems to have been worse than the other doses and should serve for justification to evaluate titers on the vaccine.  If my titer was high enough, I would have avoided the booster.
sinus infection; This is a spontaneous report from a contactable consumer (patient) also received via Pfizer sponsored program.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE, dose 2 via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient experienced sinus infection on an unspecified date. The patient called and mentioned that he had called earlier and spoke to someone who had a lot of questions, and was transferred to the "medical department". The patient had received the 1st and 2nd dose of the PFIZER-BIONTECH COVID-19 VACCINE on 12Mar2021 and 02Apr2021 respectively. He mentioned that he was currently under antibiotics (Augmentin) due to sinus infection during the 1st and 2nd dose and so he wanted to ask if it would interfere with the efficacy of the vaccine and development of antibodies. He wanted to talk with a medical representative. The patient was informed based on PFIZER-BIONTECH COVID-19 VACCINE revised documents dated 06Apr2021, no information was found on interaction with antibiotics, and was referred to HCP for guidance/The call was cold transferred and was provided number. Case considered as serious (medically significant). The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
No additional adverse events.; multiple doses of VAQTA administered since temperature excursion that occurred 16JUN202; This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies and concurrent conditions were not provided.  On 27-JUN-2022, the patient was vaccinated with 1 dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, prefilled syringe, lot # U012678, expiration date 18-JAN-2023 (exact dose, dose number, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered hepatitis a vaccine, inactivated (VAQTA) underwent temperature excursion that took place on 16-JUN-2022 with 8.5 Celsius degrees for 10 minutes. Previous temperature excursion took place on an unknown date in May 2022 with 8.8 Celsius degrees for 11 minutes. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2207USA004234: US-009507513-2207USA004244: US-009507513-2207USA004698: US-009507513-2207USA004700: US-009507513-2207USA001345: US-009507513-2207USA004691: US-009507513-2207USA004690: US-009507513-2207USA004688: US-009507513-2207USA004679: US-009507513-2207USA004695: US-009507513-2207USA004697: US-009507513-2207USA004709: US-009507513-2207USA004710: US-009507513-2207USA004712: US-009507513-2207USA004714: US-009507513-2207USA004715:
This case was reported by a consumer via call center representative and described the occurrence of flu symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced flu symptoms, tiredness, groggy, injection site erythema, pain in extremity and injected limb mobility decreased. On an unknown date, the outcome of the flu symptoms, tiredness, groggy and injection site erythema were recovered/resolved and the outcome of the pain in extremity and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the flu symptoms, tiredness, groggy, injection site erythema, pain in extremity and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient felt mild flu symptoms and was tired and groggy for the first two days which then resolved. The patient also reported that her arm was red at the injection site, it did not hurt to the touch but it ached which resulted in not always being able to turn it; it ached or hurt deep inside the arm right around the injection site. The reporter provided the consent for follow up.
Slight fever (99.3); muscle/joint aches; muscle/joint aches; congested cough; tachypnea; nausea; malaise for about 12 hours 60 hours; This is a spontaneous report from a non-contactable nurse. An adult female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscular on 22Dec2020 11:00 at single dose at left arm for COVID-19 immunization. Medical history was none, no known allergies. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Dec2020 23:00 (11:00 PM), the patient experienced slight fever (99.3), muscle/joint aches, congested cough, tachypnea, nausea, malaise for about 12 hours 60 hours after injection. The events were non-serious per the reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Dec2020.  No follow-up attempts are possible. Information about lot/batch number could not be requested.
Currently still pregnant, received vaccine 10/12/2022, pregnancy related complications 11/2022 in second trimester. Currently in third trimester
c/o feeling tired, dry mouth and slight headache after leaving post-vax observation.  Hx breast cancer, CHF and HTN.  Hx frequent h/a.  Newly dx NIDDM that is diet controlled.  Had early am appt and did not eat breakfast.  No reaction to dose 1.
Patient was under the 15 minute post-vaccination observation period when she presented with signs and symptoms consistent with an anaphylactic reaction. Facility administered Benadryl, then an EpiPen, and called 9-1-1. Patient was brought to the hospital.
expired 5/25/21, administered on 6/15/21; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number unknown, expiry date 25th May 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th June 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th June 2021, unknown after receiving Infanrix and Infanrix 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 details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Infanrix vaccine, which led to expired vaccine used. No further information was reported.
Significant right thigh swelling noted 48 hours after vaccination without pain, discomfort, or inability to bear weight. Tactile fevers x 48 hours.
patient experienced flu after taking flu shot; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves a patient (age and gender not specified) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
arm is hurting after getting the second dose of Moderna covid19 vaccine; headaches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm is hurting after getting the second dose of Moderna covid19 vaccine) and HEADACHE (headaches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for an unknown indication.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 29-Apr-2021, the patient experienced MYALGIA (arm is hurting after getting the second dose of Moderna covid19 vaccine) and HEADACHE (headaches). At the time of the report, MYALGIA (arm is hurting after getting the second dose of Moderna covid19 vaccine) and HEADACHE (headaches) outcome was unknown.            No treatment was provided.
Patient given 2nd dose of Moderna vaccine in accordance with protocol instructions after giving first dose to 17 year in error previously
I had discomfort the first few days with the booster. Then on July 7th, 2022 I started feeling like I had a bad cold. I took a home test for COVID and it came back positive. I went to the pharmacy and did a test there through the drive through, and it came back the next day positive. I was sneezing, coughing, headache, and it felt like a huge head cold. I did not have trouble with my lungs or coughing. When I started to feel better, then around 2 days after that I started having stomach problems, heavy fatigue, and coughing began. Today, July 12, I feel much better. So in total the symptoms lasted around 10 days.
I have Genital herpes for about 30 years with very few outbreaks.  The 2nd does of the vaccine caused an outbreak.  I have on hand the medication to treat it so I did not go to the doctor but started on acyclovir and it is clearing up.
This study case was received from the investigator in a trial on 19 August 2011. A 22-year-old male subject received on 11 June 2011 received the following vaccinations: an injection of ACAM2000 (lot number not reported), and Anthrax vaccine (manufacturer and lot number not reported). The subject has no significant medical history. On 25 June 2011, the subject had an abnormal electrocardiogram (ECG) and a normal troponin I. The subject's echocardiogram was not available. On 25 June 2011, the subject was diagnosed with other and unspecified acute pericarditis. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
pt exp severe abd pain-crying fetal position;resolved spontaneously;several other episodes during evening & noc;taken to hosp ER;adm for simple reduction & incidental appendectomy; dx: intussusception
Patient has large area of erythema measuring 6 cm in diameter with a 3cm induration in the center.
N/V/D  fever, chills, HA started within 6 hours of vaccine. pt has continued to have extreme  fatigue and loose stools.
Information has been received from a nurse practitioner concerning a male patient, with no pertinent medical history or drug allergies, who in the year 2000 was vaccinated with a dose of PROQUAD (Merck) (manufacturer unknown), (dose, lot # and route not reported). There was no concomitant medication. The nurse practitioner reported that eleven years ago the patient received a dose of a combination of MMR and varicella (manufacturer unknown) and developed a rash on his body. She did not know if the product was PROQUAD (Merck) but knew that it was the same combination. The patient received the vaccine in another state and the nurse practitioner did not know the name of or contact information for the attending physician at the time. The patient received BENADRYL for the rash and recovered after a few days. No lab diagnostics were performed. No further information is available.
Local reaction about 10cm diameter redness and swelling at injection site. Mildly pruritic and mildly tender.
Information has been received from a registered nurse referring to an unknown number of patients. On unspecified dates the patients were vaccinated with doses of GARDASIL (confirmed not GARDASIL 9) (dose and route not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
fussy, crying, screaming since 18AUG; seen in office 27AUG93 w/neg px x/crying w/movement & stretch of neck; pt also not sleeping or eating well;
felt a pinch for second shot but that was it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt a pinch for second shot but that was it) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concomitant products included FOCUSFACTOR, ACETYLCARNITINE HYDROCHLORIDE, BIOTIN, CALCIUM, PHOSPHORUS, THIOCTIC ACID (JUVENON) and GINKGO BILOBA for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (felt a pinch for second shot but that was it). At the time of the report, PAIN (felt a pinch for second shot but that was it) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Additional concomitant medications  included Blood Flow 7. No treatment information was provided.
COVID-19 Treatment; COVID-19 Treatment; Dose 1,2,3 are Moderna vaccine and Dose 4,5 are Pfizer vaccine; 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 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 71 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03May2022 at 12:30 as dose 4 (booster), single (Lot number: FM0698), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Jan2021 as dose 1, single (Lot number: 0122L20A), in left arm, on 07Feb2021 as dose 2, single (Lot number: 012M20A), in right arm and on 24Oct2021 as dose 3 (booster), single (Lot number: 062E21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "seronegative rheumatoid arthritis" (unspecified if ongoing); "cancer" (unspecified if ongoing). There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022 at 12:00, outcome "unknown", described as "Dose 1,2,3 are Moderna vaccine and Dose 4,5 are Pfizer vaccine"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective with Paxlovid from 12Dec2022 to 17Dec2022.
Mom describes "red, swollen, warm to touch area" on left arm where vaccines where administered approx. size of a fist.
Pt tested Hep B Sag pos, then when retested 4/27/2012 tested negative; no other pos labs seen.
Pt. had phlegm/develop congestion, started losing voice. Reaction did not worsen. No trouble breathing.
Caused? By Moderna booster.  First COVID-19 jab was J&J April 2021. First had painful swollen glands for about 3 days starting 12/1. Then developed severe rash very itchy all over chest on 12/5.
My research results indicate that I am experiencing an allergic reaction known as COVID Arm.   This include redness covering most of my forearm of the injection site, warm to touch and mild itching.
fever w/sz activity in early AM 15JUN; seen in ER & adm w/t103.9;
Information has been received from a healthcare worker referring to unspecified number of patients. The reporter stated unspecified patients had received GARDASIL 9 (dose, route unknown), as a booster dose, after receiving GARDASIL (dose, route unknown). No adverse effects were reported. Additional information has been requested.
Balance was off a little; A little fever of 101.5 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance was off a little) and PYREXIA (A little fever of 101.5 degrees Fahrenheit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A, 013L20Q and 013L20Q) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, the patient experienced BALANCE DISORDER (Balance was off a little) and PYREXIA (A little fever of 101.5 degrees Fahrenheit). At the time of the report, BALANCE DISORDER (Balance was off a little) and PYREXIA (A little fever of 101.5 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2021, Body temperature: 101.5 (High) little fever of 101.5 degrees Fahrenheit.         No concomitant product was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-370402, MOD-2021-374893 (Patient Link).
Patient (5 yr old Female) received the immunization afternoon 7/15/08.  Mother noted significant swelling that same night.  Child complained that the area was still sore the next evening.  Parents found area red and swollen (approx 8 inch diameter) around injection sight.  Mother returned patient to doctor's office morning of 7/18/08.  Severe swelling and redness from knee to top of the thigh (approximately 10 - 11 inches).  101 degree fever with pain.  Doctor informed mother that the reaction was "normal" and prescribed cold compress and Benadryl.  Second opinion from nursing staff is that this is not a "normal" reaction.  Father reports to VAERS.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a 65 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 24-JUN-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 vial, strength reported as 25/0,5 (units not provided) (dose and route of administration not reported) (lot number K004930 and expiration date 06-MAR-2015). There were no adverse effects reported. Additional information has been requested.
20Mar98 pt recv vax & exp mild coughing,irritability & 101t. 3 other pt also reported WAES98032507,98040054,98040055
VERY VERY SORE IN RIGHT ARM WHERE SHOT WAS GIVEN.. SIGNIFICANTLY MORE SORENESS THAN USUAL.. AND ITCHING ALL OVER.. IT HAS BEEN COMING AND GOING AT RANDOM PLACES. MAINLY ARMS, CHEST, AND LEGS.. NO TREATMENT YET FOR IT. I GOT THE SHOT LAST NIGHT SO WILL GIVE IT A FEW DAYS. I HAVE NEVER HAD IT ITCH BEFORE UNTIL THIS TIME. I AM POSITIVE THAT IS WHAT IT IS COMING FROM THOUGH AS IT STARTED AN HOUR AFTER THE SHOT AND IS CONTINUING STILL AND I HAVE NOT DONE ANYTHING DIFFERENT..