chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe headache; Chills; Extreme fatigue; Body aches; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age (age: 59; Unit: Unknown) and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On 04Feb2021, the patient experienced severe headache, chills, extreme fatigue, body aches. It was reported that side effects experienced on 5 hours after treatment, Chills developed 10 hours after injection, Extreme fatigue developed 8 hours after injection, resolved after a night of rest, body aches developed 8 hours after injection and Still feeling the symptoms after 22 hours from injection. The outcome of events Severe headache, Chills and Body aches was not recovered, and the outcome of event Extreme fatigue was resolved on an unspecified date in 2021.  Information on the lot/batch number has been requested.  Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Developed esotropion of right eye and exotropion of left eye with gait abnormalities day after vaccination
Administered vaccinations past the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccinations past the expiration date) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccinations past the expiration date). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered vaccinations past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported that that some patients who received the expired vaccine had reported flu-like symptoms after receiving the vaccination but she did not have details on that. No treatment details provided.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. No relevant medical history of the patient was reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, strength and route of administration were not reported) dose 1 and approximately 5 years afterwards, he was vaccinated with the second dose of PNEUMOVAX 23 (lot number, strength and route of administration were not reported). No concomitant medications were reported. It was reported that the patient was vaccinated with 2 doses of PNEUMOVAX 23 before 65 years of age. There were no adverse effects reported. There was no product quality complaint involved. The outcome was unknown. Additional information is not expected because there pharmacist did not want to be contacted about this report.
1. Swelling at the site of injection (Large area )no fever or chills. 2. Waist high (right) went to the ER for severe pain CT anglo done to rule out AAA was neg. Blood work ok UV neg KUB neg.
severe muscle aches, all over body pain, light headed, chills, sweats, fatigue, weakness
Nose irritation, runny nose, Sneezing, painful coughing, sore chest and lungs, awful headache, extremely tired and weak, cold chills, loss of appetite.
Received shot at 5pm on March 15.   On morning of March 16 around 6am, felt achy.  Nauseous by 8am.   Progressed to chills and worse aches. I took Tylenol and tried to take a nap.  But I was too cold to sleep. This is still day one.  I have not contacted the pharmacy or my doctor.  Hoping this is over by tomorrow, although I see it could last 2-3 days.
CAN'T WALK AFTER GETTING THE VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (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 and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced can't walk after getting the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of can't walk after getting the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211058708.
Started getting hives all over body. Hives would move from location every hour or so. My PCP recommended I take Citirizine. Im still taking Cotirizine because hives will come back if I stop.
Day 1- 8/31/13 - No symptoms; Day 2- 9/1/13 - Intense body ache all over shot site-sore and hot slept all day; Day 3 - 9/2/13 - Shot site - red-hot-itchy no fever-no breathing problems - sore hot arm for 5 days, sore arm-itchy.
Patient return after administration of Flu vaccine with feeling a little light headed and complaining of burning at flu shot site.  No rash noted at this time.  No treatment noted. Observed for 15 minutes after she returned.
Pt. stated she had red bumpy rash like area on back portion of (L) arm.
Within 5 minutes of administration, sweating, headache, nausea, right arm pain and right arm swelling, dizziness, severe back pain and leg pain, and ringing in both ears. Within 20 minutes of administration, numbness and tingling in all extremities: both arms and both legs and pain in the buttocks. health clinic: Within one hour elevated pulse, elevated blood pressure, dry mouth and sore throat, scratchy  throat. Return to  Emergency Room: Within 12 hours of administration heart palpitations, irregular heart beat, abdominal pain, chest pain, chest pressure, continuous belching, severe pain in both arms and both legs, severe headache.
Right arm swollen, itchy, and has hives. Constant clearing of throat. Per standing order pt advised to wait 20 mins.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported  On 04-JAN-2017, the patient was vaccinated with expired a dose of ZOSTAVAX 0.65 ml, subcutaneously, lot number L037797, expiration date 30-DEC-2016. Additional information has been requested.
Sunday evening Nov 5th, he developed a high grade fever, 101.4 and rose to 102.6, parent gave him some fever reducer and that helped but several hours later in the middle of the night, he woke up vomiting. Fever was persistently high through the day and patient went to the emergency department with his father. He still has a persistent cough. Parent is still seeking treatment.
Pain in arm, radiating into back. Vomiting onset 2nd day after shot. No fever.
Fever of 103.5 at 0130 in the AM on the day after the shot, that would not go down w/ Tylenol, Motrin or tepid baths.  Fever stayed around for 3 days, then he got a rash.  The rash is slightly raised, non circular pinkish areas that cover his back, arms, chest and stomach.  Patient is also very very irritable and at times inconsolable which is not a normal behavior for him.
It was reported that an 18 year old female received a Rabies Imovax ID vaccination on December 7, 1999. Shortly after the vaccination the patient developed generalized hives, itching and throat swelling.  Reportedly the pt recovered from this experience.
Fever, chills, severe swelling left arm with redness, pain, light-headed, dizzy, weak.
RECEIVED 2.5 ML OF THE VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported, administered on 21-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-NOV-2021, the patient experienced received 2.5 ml of the vaccine. On 21-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5 ml of the vaccine and off label use was not reported. This report was non-serious. This case, involving the same patient is linked to 20211202250. This case, from the same reporter is linked to 20211219926, 20211219871, 20211220146, 20211220262, 20211220250, 20211220152, 20211220145, 20211220155, 20211220916, 20211219681, 20211220152, 20211220145, 20211220155, 20211165041, 20211200723, 20211200752, 20211200769, 20211201046, 20211201228, 20211201963, 20211202193, 20211202207, 20211202246, 20211202371 and 20211165041.
Arm swelling, greater than baseball size. Area hard and hot to touch. Area painful. Started on oral antibiotics.
Pt is 25w3d gestation. Pt in today to receive 2nd dose Pfizer vaccine. Nurse administered 0.3ml from Pfizer vial labeled from pharmacist that had not been diluted. Pt monitored for over approx. 45 minutes. Spoke with DOC  with patient and her spouse listening on the her phone. Informed patient of s/s to monitor for. Dr. instructed to  hydrate with lots or h2o, take Tylenol for aches/chills/soreness at injection site, monitor for rash of skin, and to notify MD or go to ED for any severe reactions.  Pt stated she was fine, not experiencing any side effects but worried about unborn fetus. Pt was given appts for video visits with PCP at 330pm and next Thursday with Dr. at 845am. Pt left premises in stable condition.
inadvertently administered an expired dose of daptacel/ no adverse event; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 months old female patient who inadvertently administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. There was no concomitant medication or other vaccines.   On 29-Apr-2019, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5190AA, expiry date: 24-Apr-2019 via intramuscular route in the left thigh.  It was an actual medication error due to expired vaccine used. Nurse inadvertently administered an expired dose of Daptacel. The patient experienced no adverse event.  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.  List of documents held by sender: none.
In late March, started experiencing right side headache that persisted. After 2 weeks, experienced double vision that persisted for 2 days. I went to eye dr and was told I had sixth nerve palsy. Went to ER. No sign of stroke. Stayed in hospital for a few days and received one dose of anti-biotics.  I'm still experiencing double vision. Had another CT scan and spot was still there. Drs think it is a cranial lesion. I will be meeting w/ a Neuro-surgeon to get lesion removed.
Source of report and patient demography: This heath authority case was initially received on 16-Mar-2016. The case report was received from a health authority and concerns a 26 years old female patient who was on 'TB' medication at the time of vaccination. Weight: not provided, height not provided Concurrent  medical condition(s), medical and drug history: The patent has a medical history of Latex - rash and lamictal - unknown. 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 on 11-Jan-2016 - unknown stop date, Batch no: U54205, route of administration: intramuscular, dose: 0.5 ml, on the left arm. Additional suspect drug(s): The patient also received ADACEL on 11-Jan-2016, indication: indication not provided, batch no UI543AA, Route of administration: intramuscular, dose: 0.5 ml, on the right arm. Reaction(s)/event(s) and outcome: On an unknown date, after starting / treatment with AFLURIA and TDAP vaccines, the patient experienced FLUVAX (L) deltoid - redness and induration at time of injection (non serious, outcome: recovered / resolved) which were already resolved when patient returned to clinic for another visit. The patient also had TDAP (R) deltoid - skin colored bumpy, non-itchy rash around injection site (non serious, outcome: recovered / resolve). The patient reported these on 20-Jan-2016. For relevant test results see appropriate report section. Reporter's assessment: The health authority assessed the events as non-serious. Case causality: possible for the AEs of the left deltoid (AFLURIA arm), and  unrelated for the AEs on the right deltoid (TDAP arm).
A consumer report has been received. The report concerns a 1 year old, Female consumer, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 Millilitres. FLUMIST quadrivalent (intranasal) started during Sep-2015. The mother of patient reported that her a 17 month old girl received the FLUMIST quadrivalent from her HCP she also reported that since she received the FLUMIST quadrivalent her daughter has had a runny nose, and congestion and stomach cramping, and constipation. The outcome of stomach cramping, runny nose, constipation, congestion and 17 month old girl who received the FLUMIST quadrivalent (inadvertent administration) is unknown. The report was considered to be non-serious.
Covid vaccination possible reaction/using restroom twice a day/having hard time moving bowel; Inflammation of in small intestine and ileum; This spontaneous case was reported by a consumer and describes the occurrence of DYSCHEZIA (Covid vaccination possible reaction/using restroom twice a day/having hard time moving bowel) and ENTERITIS (Inflammation of in small intestine and ileum) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 17-Aug-2021, the patient received third 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) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and dose of ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced DYSCHEZIA (Covid vaccination possible reaction/using restroom twice a day/having hard time moving bowel) and ENTERITIS (Inflammation of in small intestine and ileum). At the time of the report, DYSCHEZIA (Covid vaccination possible reaction/using restroom twice a day/having hard time moving bowel) and ENTERITIS (Inflammation of in small intestine and ileum) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Stool analysis: Abnormal levels were slightly elevated. In 2021, Ultrasound ovary: Abnormal. Shadow on right ovary. In August 2021, Blood test: Abnormal Levels were slightly elevated..         This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. No concomitant medication was reported. No treatment medication was reported.
Vesicular single dermatome rash consistent with shingles. Previous case of varicella as child with documented titer markers.   No eye, face, ear involvement. Rash is located around the T6 distribution on the left.
PT Complaining of numbness to her left arm approx.. 10 minutes after receiving her first dose . Pt denied any S/S of an anaphylactic reaction. Pt's only complaint was of  numbness isolated to the arm and hand. Good Movement and sensation to left arm noted.
PB 140/98, PO2 98%, HR 77. Nausea, gagging, no swelling in throat/face. Feeling better.
jaw pain; stomach nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw pain) and NAUSEA (stomach nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B214 and 030A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphedema (Lymphedema of left arm) in 2002. Concurrent medical conditions included BRCA2 gene mutation (BRCA II gene positive) since 2009. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), ZINC and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN JAW (jaw pain) and NAUSEA (stomach nausea). At the time of the report, PAIN IN JAW (jaw pain) had not resolved and NAUSEA (stomach nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Cardiac stress test: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications such as eye vitamin which patient takes daily. No treatment medications were provided by the reporter. On 01-APR-2021 patient visited doctor's office.   This case was linked to MOD-2021-041204 (Patient Link).
FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. 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: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious. This case, from the same reporter is linked to 20210438448, 20210437846 and 20210438524.
Date the vial was initially stored in the refrigerator on 01-April-2022 and administered on 20-April-2022; Expired vaccine given to 6 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 6 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-April-2022 and administered on 20-April-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    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 (Expired vaccine given to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-April-2022 and administered on 20-April-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to 6 patients) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 01-April-2022 and administered on 20-April-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient received second booster dose. The vial initially stored in the refrigerator on 01-Apr-2022. The vaccine expired on17-April-2022. The vial did not undergo any temperature excursions.   No treatment information was provided.
Shortness of breath. EMT's call and they checked on patient and patient walked out on own and is fine.
Pt previously hospitalized 2/27 - 2/28 for cellulitis of left humerus area (site of fx and repair May 2005) for Abx tx, received Pneumovax 23 at discharge.
Patient noted nasal congestion on March 10, 2021 that lasted until March 11, 2021, no other symptoms Gets tested weekly at her college nursing program March 15, 2021 she tested positive Repeat test on March 18, 2021 also positive
Pain in movement of arm, frozen shoulder, difficulty moving arm and lifting items.  Pain continues after 4+ weeks with no improvement.
Pain at injection site 04/12/21 Pain at injection site, headache, fatigue since Tuesday 04/13/21 Diarrhea & elevated temperature 04/15/21
Narrative:  Patient received Moderna vaccine #1 on 3/19- reported malaise, headache and chest pain the next 48 hours. By 72 hours post vaccine, symptoms had completely resolved. Patient did get the second vaccination.
I had aches all over 2 days after 2nd vaccination on 4/5/21.  Within a week, I had constant pain in my left knee and a little in my right.  I'm in constant pain which is not relieved with Tylenol, ice or heat compresses, epsom baths, light exercise, or stretching.  At night I have trouble sleeping because my knee is so painful.  Several times I've almost fallen.  My lower back is also bothering me because I can't walk normally and am putting even pressure on my knees, legs, and back.  Prior to the second shot, I was having this kind of ongoing pain.  It has severely limited my ability to get around and I often use a cane so I won't fall.
Five or six days after first Moderna C19 injection, skin eruptions (similar to boil or pimple except that fluid that expressed was clear (sterile?) and sticky, not like pus.)  These skin eruptions presented only on the right side of my body, opposite of injection.  Locations and (quantity) include right rib cage ½ way between arm pit and waist (2-3), anterior of right leg, shin, and thigh (6-8), anterior of right arm, upper and lower (3-4), and in right eyebrow (3-4.)  These eruptions resolved 5 ? 6 weeks after injection. Ten to twelve days after first Moderna C19 injection, malaise, lethargy, headache, brain fog, achy joints, poor sleep, heart flutters, pressure in chest, shortness of breath.  These symptoms have persisted.  These symptoms were not at all present in the 12 months prior to Moderna C19 injection. Physical exam by doctor performed Nov. 1, 2021.