chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a expired vaccine 16 Apr 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16 Apr 2022) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in February 2022. Concurrent medical conditions included Diabetes.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16 Apr 2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose number was reported as Dirst booster.  No concomitant medication were reported.  No treatment medication were reported.   This case was linked to MOD-2022-549193 (Patient Link).
FAINTED; BLOOD PRESSURE WAS LOW; This spontaneous report received from a consumer concerned a 31-year-old female patient. Initial information was received on 13-APR-2021 and processed with additional information received on 20-APR-2021 via telephone log.  The patient's height, and weight were not reported. The patient's medical history included flu shot in OCT-2020 without any side effects, gestational diabetes during pregnancy 6 years ago, and gave normal birth. The patient is a non-smoker and does not consumer alcohol. No surgery or injuries were reported. The patient did not have any prior clotting disorder or family history of clotting disorders. The patient did not have vericose veins. No allergies were reported.  The patient received vaccination with JANSSEN COVID-19 VACCINE (covid-19 vaccine ad26.cov2.s) (suspension for injection, route of admin not reported, batch number: 206A217, expiry: UNKNOWN) dose was not reported, 1 total, administered on right deltoid muscle on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported as it was reported that patient did not take any medications.  On 11-APR-2021, the patient received the vaccine and within 3 minutes, she felt dizzy and fainted and was taken by Emergency Medical Services to a hospital. Her vital signs were taken (pulse rate, blood pressure, and oxygen saturation) and patient was found to be hypotensive (the husband did not recall blood pressure level). When blood sugar was being tested using a needle for a prick, the blood was not coming out. Her blood sugar was normal at 129 and electrocardiogram was normal. The patient was given intravenous fluids and released home after 6 hours without any other treatment. The patient has been doing well since the release from the hospital ED and no further complaints were reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainted and blood pressure was low on 11-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: The case concerns a 31-year -old female who experienced low blood pressure 3-4 minutes after Janssen Covid-19 vaccine was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. Patient's height and weight were not reported. Medical history included resolved gestational diabetes. The patient had no history of allergic reactions or reactions to a flu vaccine (last one received OCT-2020). No concomitant medications. Post vaccination the patient felt dizzy, could not sit on the chair and fainted and was taken to Emergency Room.  Her blood pressure was low and she experienced hot flashes and watery eyes. Her blood sugar was 129 and electrocardiogram was normal. The subject was given IV infusion and was released from the ED without any medication. Symptoms of low blood pressure and fainting are known anxiety related reactions to immunization and given temporal relationship are considered likely related  to Janssen vaccine administration.
High pitched ringing in my ears began on the dates listed on this form. It has not yet subsided.
Information has been received from a pharmacist concerning a 64 year old female patient who on 14-MAY-2012 was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 669863/0365AA, expiration: 09-JUN-2012) (dose and route not reported). The patient developed a "rash", described as 3 inches around, pinkish red and itchy at the injection site (no pain). The pharmacist did not know how soon after vaccination the patient developed the "rash". On 16-MAY-2012 the patient contacted the pharmacist. No lab diagnostics studies were performed. No treatment was given for the adverse events. At the time of the report, the patient did not recover. Follow-up information has been received from the pharmacist concerning a 64 year old female patient with no illness at time of vaccination who on 14-MAY-2012, 14:35, was vaccinated with the first dose of ZOSTAVAX (Merck) (lot # 669863/0365AA, expiration: 09-JUN-2012) (s.c., dose not reported). On 17-MAY-2012, 16:45, the patient reported that rash was around injection site 3 inch around, itchy but no pain. The pharmacist told the patient that it was possible injection site adverse reactions and she might see doctor if it was too much concern to her. The pharmacist checked with patient on next day found she is fine but still had pinkish rash. Later the patient said rash was gone after 4 days. The patient took BENADRYL. No relevant diagnostic tests and laboratory data. Additional information is not expected.
Red sore lump developed around site the day after administration. Area grew the day after that approx 3 inch area, warm and painful to the touch. Pt consulted w/Dr. on that day. Area decreased the next day.
COVID 19 symptoms and a positive test was confirmed on 1/6, employee noted previous exposure to positive family members Narrative: Employee noted exposure to COVID prior to presenting for 1st dose of vaccine on 1/5/21. On 1/6/21 employee reported the onset of symptoms and was tested and was confirmed COVID positive that day. Positive result was reported to employee health on 1/8/21. Employee Health continued to track employees progress and was informed of the need for hospitalization on 1/14/21. Course of hospitalization noted the need for intubation and significant issue with comorbid condition (rheumatoid arthritis). Employee died on 2/9/2021. Unable to confirm a direct connection to Vaccine vs. COVID infection, but felt it should be reported.
PATIENT RECEIVED INCORRECT VACCINE FOR AGE GROUP. AT TIME OF VACCINATION, PATIENT WAS 12 YEARS OLD AND PFIZER 0.2ML DOSE IS INDICATED FOR 5-11 YEARS. NO SYMPTOMS OF REACTION OBSERVED OR DOCUMENTED. ERROR DETECTED IN QUALITY ASSURANCE AUDIT.
itching; Bright red spot below the injection site (2 by 4 in) which is hot to touch; Bright red spot below the injection site (2 by 4 in) which is hot to touch; Body temperature of 99.0 F; tiredness; SORE ARM; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to the company on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (SORE ARM), PRURITUS (itching), INJECTION SITE WARMTH (Bright red spot below the injection site (2 by 4 in) which is hot to touch), INJECTION SITE ERYTHEMA (Bright red spot below the injection site (2 by 4 in) which is hot to touch) and PYREXIA (Body temperature of 99.0 F) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (SORE ARM), PYREXIA (Body temperature of 99.0 F) and FATIGUE (tiredness). On 27-Feb-2021, the patient experienced PRURITUS (itching), INJECTION SITE WARMTH (Bright red spot below the injection site (2 by 4 in) which is hot to touch) and INJECTION SITE ERYTHEMA (Bright red spot below the injection site (2 by 4 in) which is hot to touch). On 26-Feb-2021, FATIGUE (tiredness) had resolved. On 27-Feb-2021, PAIN IN EXTREMITY (SORE ARM) and PYREXIA (Body temperature of 99.0 F) had resolved. At the time of the report, PRURITUS (itching), INJECTION SITE WARMTH (Bright red spot below the injection site (2 by 4 in) which is hot to touch) and INJECTION SITE ERYTHEMA (Bright red spot below the injection site (2 by 4 in) which is hot to touch) outcome was unknown.            Concomitant medications were not reported. Treatment details were not reported.
pt diagnosed positive for COVID 1 day before presents to ED per PCP request; c/o fever, chills, cough x 4-5 days; hyperglycemic; HX CAD, Kidney transplant 2013, HTN, DM; O2 requirements worsened requiring mechanical ventilation and proning; multiorgan failure; placed on DNR; condition worsened and pt died in the hospital
Patient reported localized pain and stiffness at administration site as well as swelling in the axillary region starting the evening following administration. The Morning of 1/19/15 the patient reported swelling of the left side of face and upper lip. She did not report any difficulty breathing. The patient went to her primary care physician and received a steroid shot as well as a prescription for a steroid dose pack. She was also instructed to take diphenhydramine.
patient reports lump in throat, and needing to clear throat.  Denies difficulty swallowing or breathing.  Benadryl given at 1:16pm.  Patient reports improvement in symptoms at 1:24pm
At 1:00am on 01/18/2021, I awakened to and had sustained chills, rigors, fever to 101.7, pulse ox 92,  and low-grade cough and headache for 5 hours; after ibuprofen and a return to sleep , I awakened with a drenching sweat but former symptoms above were largely gone.
a bit weak; temperature over 100; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (a bit weak) and PYREXIA (temperature over 100) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 010A21A, 010M20A and 013L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2022, the patient experienced ASTHENIA (a bit weak) and PYREXIA (temperature over 100). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 19-Oct-2022 at an unspecified dose and frequency. On 20-Oct-2022, ASTHENIA (a bit weak) and PYREXIA (temperature over 100) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2022, Body temperature: temperature was over 100.         No concomitant medications were reported. The patient took an Advil, went to bed and woke up fine. No symptoms with the first 3 doses   This case was linked to MOD-2022-682333 (Patient Link).
patient became symptomatic - wheezing, SOB - and tested positive for COVID during hospitalization.
Initial report was received 03 September 2008 from a health care professional.  A nine-week-old male patient with no medical history, received a first dose, intramuscular left thigh injection of PENTACEL, lot number C3175AA and a first dose of "ROTOTECH", lot number 0301X orally, on 13 August 2008 and two days later, developed an "excema" like rash on his left leg at the injection site which spread to his left ankle and left arm.  The patient was evaluated by their physician on 18 August 2008 at which the patient was afebrile however, the eczema like rash described was noted to be slightly dry and waxy.  Corrective treatments included cortisone and "UCERIN" cream which were ineffective.  The rash subsequently spread to the patient's right left and persisted on all areas described at the time of the report.  The patient's mother had been taking clonazepam while breastfeeding.  No further information was provided.
Day after injection-Chills, headache, nausea, body aches, diarrhea, dizziness, fainting, temperature. 2nd - 3rd day- headache, fatigue, slight temperature, tightness in chest
fever beginning day 2 after vaccination of at least 100.5 and up too 101.5 continuing through day 6; headache, muscle aches and soreness; fatigue; malaise; general unwell feeling; unable to exercise with normal intensity
PATIENT RECEIVED UNDILUTED PFIZER COVID-19 VACCINE (5-11 YEARS) ORANGE CAP (NDC 59267105504). TREATMENT AND OUTCOME UNKNOWN. UNABLE TO REACH PATIENT OR CAREGIVER
Parent reports that when his pajamas were removed this morning around 8am. she noticed hives on his legs (both) and Rt. arm. No other symptoms. Called child's doctor and was told how to handle them - giving him an oatmeal bath.
Infantile spasms began a few weeks following vaccine. Currently patient has 15+ clustered 5-10 spasms each day. Patient has gone backwards as far as mental and social development. He has also lost vocabulary.
I had chills, diarrhea, vomiting, racing heart, sweats, weakness, body aches and a fever of 100.8.
Joint pain in arm, shoulder, hip, and leg on side of injection site; joint pain in arm, shoulder, hip, and leg on side of injection site; Joint pain in arm, shoulder, hip, and leg on side of injection site; fever of 99.8 F; Headache; Constipation; Sweating, so much sweating; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration (left arm) on 10Feb2021 (13:00) (at the age of 32years) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL3247), via an unspecified route of administration on 20Jan2021 (12:00PM) (at the age of 32years) for COVID-19 immunization. The patient has no medical history; no allergies to medications, food, or other products. Concomitant medication included vitamin B complex (VITAMIN B) also reported as "B vitamin supplement" taken from an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Feb2021, the patient experienced joint pain in arm, shoulder, hip, and leg on side of injection site. The patient woke up with fever of 99.8 F that ended approximately 03:00 PM on 11Feb2021. The patient also experienced headache, constipation and sweating, so much sweating. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of event fever was recovered on 11Feb2021; the outcome of other events was recovered on an unspecified date. This case is non-serious.
PAIN ALL OVER THE BODY; FEVER; CHILLS; VOMITING; This spontaneous report received from a consumer concerned a 32 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 10:48 for prophylactic vaccination.  No concomitant medications were reported.  On 12-APR-2021, the subject experienced pain all over the body. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 12-APR-2021, and had not recovered from pain all over the body, fever, and chills. This report was non-serious.
Developed a continuous cough for several days. Visited Emergency Room at local Medical Center. Doctor diagnosed bronchitis. He gave me a breathing treatment, and prednisone. Prescribed albuterol, amoxicillin, loratadine, and prednisone.
Kinrix was administered to a 4 month old; Pt was supposed to get the polio vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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 patient received Kinrix at the age of 4 months old instead of Polio vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Grandmthr. states pt received vax. on Monday. Thursday pt developed low grade temp and full body rash; was sent home from school. Went to ED however didn't stay = wait too long. Referred to Peds - Peds instruction was if rash not better by Monday to go in to be seen; does not feel related to vax.
Immunizations given 11/2/04. On 11/4/04, broke out in hives all across upper shoulders and buttocks. Afebrile.
This spontaneous case was initially received on 05-JAN-2016. This case report was received from a(n) Health Professional and concerns a(n) 59 years old male patient. Weight: 224 pounds. Height: 5'7 inches. Concurrent medical condition(s), medical and drug history: The patient had a medical history of Drug reaction/allergies: penicillin. The follow drug history information was reported: Penicillin (indication: -, Reaction; Drug reaction/allergy). For concomitant medication and therapy dates refer to the appropriate report sections. Suspect drug(s), timing and conditions surrounding the onset of reaction(s)/event(s). The patient received AFLURIA. Indication not reported on 07-DEC-2015 - unknown stop date, Batch no: not provided, Route of administration: not provided, Dose: no information provided. Additional suspect drug(s): ZOSTAVAX, Batch: L029484, start date 07-DEC-2015). Indication: Prevention of shingles. On 15-DEC-2015 to 22-DEC-2015, the patient received ZOSTAVAX (batch L029484). Reaction(s)/event(s) and outcome: On an unknown date, after starting/treatment with AFLURIA the patient experienced Shingle outbreak on roof of mouth which was confirmed by the doctor (non serious, outcome: Recovered/Resolved), Blisters on the roof of his mouth (non serious, outcome: Recovered/Resolved). Action taken: N/A. Event treatment: The doctor recommended a mouthwash and told to take l-lysine. Rechallenge/Dechallenge information: N/A. For relevant test results see appropriate report section. Please add other relevant test results manually as appropriate. Reporter's assessment: The doctor assessed the causality as certain/highly probably in relation to ZOSTAVAX, and the events as non-serious.
Approximately 8 hours after receiving the PREVNAR 13 shot I had a terrible headache that lasted 36-48 hours; and left me bed-room confined. I recovered and seemed ok. However, I started to note that occasionally, particularly associated with an alcohol drink I got a headache. I reported to my doctor and he said don't worry and don't drink. The frequency of the headaches slowly increased. After many appts and test it was determined that I developed a Migraine Headache Syndrome. I see a neurologist and he has prescribes meds that help but I continue to get 10-15 headaches a month. The medical community just thinks this happened however, I wanted to find out if there are any other cases or reason that have been reported after seniors receiving PREVNAR 13. Most importantly, are there any other treatment options.  Migraines are considered chronic and the treatment is to find the triggers and reduce if possible. This condition has lasted over 3 years and there is much additional information available. What I need to know is if PREVNAR 13 has caused Migraines and then be directed to those who understand. If there are no other cases that would be helpful to know.
within 24 hours post vaccination patient developed extreme malaise and fatigue.  No rash.  No documented fever.  Gradual improvement, however as of report date patient still reporting symptoms.  Note:  Patient did not leave country due to reaction.
Vaccine received 10 AM. At 9 PM the same day had terrible shivers for about 3 hours. Slept until 7 AM the next day, had juice, went back to bed and slept until 4:30 PM without waking. After that, I was fine.
Edema and erythema of arm where injection given started within 24 hours of injection. Treatment: Keflex, Benadryl and Motrin.
Developed hypothyroid symptoms: hair loss, brain fog, constipation, trouble swallowing, fatigue
patient receiving his IMOVAX day 7 dose on day 8 with no adverse event; Initial information received on 11-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 27 years old male patient who experienced patient receiving his imovax day 7 dose on day 8 with no adverse event while receiving vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-May-2022, the patient received a  dose of suspect RABIES (HDC) VACCINE lot T1E321M (expiry date: unknown)  via intramuscular route in unknown administration site for Immunisation.  On 11-MAY-2022 the patient developed a non-serious patient receiving his imovax day 7 dose on day 8 with no adverse event (intentional product misuse) 8 days following the administration of RABIES (HDC) VACCINE.  Action taken with RABIES VACCINE (IMOVAX RABIES) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient receiving his IMOVAX day 7 dose on day 8 with no adverse event).  At time of reporting, the outcome was Unknown for the event patient receiving his imovax day 7 dose on day 8 with no adverse event.
Ascending paralysis that began with foot drop, severe fatigue, frequent falls, that lasted one month and is still causing falls and paralysis. He received inpatient IVIG treatment and PT/OT.
Few days after first shot/dose in left arm, my fingers started tingling and going numb few times a day everyday since and up until second shot/dose on Feb 5th 2021 , even did it on same day while in 15 min holding period. Informed nurses they had me wait another 30 mins. Today is Feb 9th 2021 and still have the tingling and numbness in left fingers , has been only left fingers .
Patient got home and started feeling funny so she took a shower and was no better, was having pain and numbness in the right arm and right back pain. Husband brought her back to office. There was no redness or warm to touch but the patient stated she could move arm so per FNP-BC patient was directed to ER.