chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; achy shoulders and neck; achy shoulders and neck; This is a spontaneous report from a contactable consumer. A female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Jan2021 the patient had Fatigue, achy shoulders, and neck. the patient received any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient been tested for COVID-19 was unknown. The outcome of the events was recovering.
2 episodes of body shivering, tremble-reported to MD & was told to observe-parent feels possible rxn to hep B vax;
25OCT93 felt sick when got up 5AM; went to restroom & everything went black; had Bm & broke out in a cold clammy sweat; was ashey & BP dropped 100/60 had achy feeling of shoulders, stayed cold; MD thought had rectal bleeding;
Two days after being vaccinated I developed floaters in my right eye. This continued for 2-3 days and then my eye sustained a detached retina. I require a emergency surgery to save my vison. A week later I had to have a second surgery to complete the repairs of the detached retina.  6 weeks later vison is not restored to where I was prior to the detachment.
Mixing error occurred, patient may have received only diluent. Patient was revaccinated 05/05.
Started itching and breaking out in hives on upper torso area. By next morning it had spread to other parts of my body. Took BENADRYL regularly to help with the itch but the welts continued. 11/4 bottom lip extremely swollen, welts on face, scalp, body. Dr called in prescription for Prednisone and recommended continuing BENADRYL.
FEELING LIKE SINUS INFECTION; HEADACHE; NIGHT SWEATS; PAIN IN LEFT EYE; BURNINIG IN  BOTH EYES; PINK EYE; MUSCLE ACHES; FEVER; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included glaucoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23/JUN/2021) dose was not reported, administered on 07-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced night sweats. On 08-APR-2021, the subject experienced pain in left eye. On 08-APR-2021, the subject experienced burninig in both eyes. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced pink eye. On 09-APR-2021, the subject experienced feeling like sinus infection. On 09-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from night sweats on 10-APR-2021, and muscle aches on 09-APR-2021, had not recovered from headache, and feeling like sinus infection, and the outcome of pain in left eye, burninig in both eyes, fever and pink eye was not reported. This report was non-serious.; Sender's Comments: v0- Medical assessment comment is not required as per standard operating procedures, as case is assessed as non-serious.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 19-year-old female patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ACETYLSALICYLIC ACID (BABY ASPIRIN).    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Sep-2020 and the estimated date of delivery was 14-Jun-2021. On 02-Oct-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2020, Pregnancy test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.
Fever, chills, cold hands, pain in legs, weak, headache, stomachache, shortness of breathe
Patient received a Moderna booster (0.25 mL), when he had never received the first two vaccinations.
Patient received Covid 19 Janssen vaccine, about 10 minutes after administration patient started to get really hot. We applied cold clothes to the neck and head and patient felt like she was going to vomit so we also gave her a bag just in case she got sick. She started looking very pale so we layed patient on floor. She started to panic that she wasn't going to go to work and eyes were rolling in the back of head. Called 911 for patient and I stayed with patient, I took her blood pressure which was normal. Patient became fully alert again and stated she was feeling a little better. The ems checked her blood pressure and blood sugar and released the patient.
Vaccine leaked out of the injection site./the patient had the vaccine administered and some of it leaked out of the site; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE EXTRAVASATION (non-serious), outcome "unknown", described as "Vaccine leaked out of the injection site./the patient had the vaccine administered and some of it leaked out of the site".  Follow-up (12Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
patient came to pharamcy with red hot to touch sore,itchy  arm just below injection site , patient advice to take some antihistamine and visit his dr .
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 07-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expirations date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 180 hours (sum of hours in excursion). The vaccine status was reported as in "excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Recieved 2nd shot on Thurs. Swollen red and tender upper left arm starting 28 hours after second shot and still present, warm to the touch.. About 30 hours after shot had chills, headache and body aches, no fever, horrible nightmares on second night. Felt better Sat around noon but arm still red and tender.
2 minutes after MMR administered, client's tongue and lips began to swell. Client became lethargic and nausea was noted. Adm. 1cc Benadryl. 10 minutes after adm. client vomited. 20 min. after adm., client was transported to ER for treatment and observation. At ER, client was treated as if anaphylactic reaction occured, observed for 2 hours and released to home.
The next day he had a headache and felt tired. He had an elevated temp between 99-100 degrees so he came home from school. That night he had a lump under his left armpit and it was sore. I gave him Motrin. It helped him. On 11/20/2021 we went to see Dr. He was diagnosed with preseptal orbital cellulitis. He was put on antibiotics of Bactrim and Cefdinir.
Large eruption of skin over deltoid in region of vaccination for a several week duration. Treated with topical steroids.
PATIENT EXPERIENCED MINOR SWELLING IN ARM AT THE SITE OF INJECTION WITHIN 5 MIN OF RECIEVING THE VACCINE. SYMPTOMS HAVE SUBSIDED SINCE THEN
Syncopal episode reported by pt. Seen in ER with cellulitis at injection site (R) delt diagnosed, several hours after injection.
Choking Post nasal drip Severe headache Fatigue GI disturbance Nausea Frequent bowel movements Profound Bloating and gas for 6 days
Speech regression and emotional withdrawal within a month of vaccine, diagnosed with severe developmental delay at age 2 1/2. Autism Spectrum Disorder, behavioral problems, digestive problems (starting at 1 yr 1 mth old constant constipation or diarrhea and unexplained swelling of her stomach due to air retention at 2 1/2 years).
red patch 2" x 2" at edge of injection site; not itching : not raised; a little warm to the touch: no other symptoms, did not seek medical attention
After patient was vaccinated and observed for 15 min, he was leaving the facility when he was witnessed by security to get wobbly legs and fell to the ground. Patient was unable to get up and was assisted to triage area where Dr. saw the patient. Initial BP 171/115, P90, O2 Sat 99%...~10 min later BP 157/115, P90. Patient was vaccinated at 9:45am, was witnessed falling to ground at ~10am. Seen and evaluated by MD and AMR, released to Ambulance for transportation to hospital @~1030
Potential injection site swelling.   Note from MD: Possible bleeding from blood vessel. Site with small amount of hemorrhage. No action needed. Follow up with primary care provider if needed.
PATIENT PASSED OUT LOST CONSCIOUSNESS ABOUT 2 TO 3 MINUTES .
pt recvd vax 4MAR93 & approx 4 hrs p/devel a severe react w/extreme fussiness, vomiting,loss of appetite & a hive like rash on chest as well as a fever; 5MAR93 devel pain in rt leg; when crawling, dragged leg out to the side; x-rays nl;
13 doses administered on 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 25-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED. On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported.   No treatments medications was reported.  Moderna vaccine was pulled from the freezer on 13 Oct 2021 with a use by date of 12 Nov 2021 (30 days storage viability in the fridge). The Moderna Vial did not have an expiration date on it. However, the Moderna Vial Expiration Date Checker states that this lot number had an expiration date of 24 Oct 2021. The expired vaccine was administered to patients on 25 Oct 2021 and 26 Oct 2021.    Most recent FOLLOW-UP information incorporated above includes on 28-Oct-2021, follow up received contain no new information.
Breakthrough COVID-19 case. Hospitalized 5/31/2021 for unknown duration. I25.10-Atherosclerotic heart disease of native coronary artery without angina pectoris** I13.0-Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease** N18.31-Chronic kidney disease, stage 3a** J44.9-Chronic obstructive pulmonary disease, unspecified** J22-Unspecified acute lower respiratory infection** R26.2Difficulty in walking, not elsewhere classified** M62.81-Muscle weakness (generalized)** G89.4-Chronic pain syndrome** F33.1-Major depressive disorder, recurrent, moderate** H35.3221-Exudative age-related macular degeneration, left eye, with activechoroidal neovascularization
a couple of hours after injection her entire upper arm started to swell and become hot to the touch. over the course of days it traveled down to her lower arm and part of her hand
Numbness, cold sensation, and sensitive to touch on left upper thigh night of injection. 1 day after injection, patient had same feeling on right wrist. Patient was vaccinated on left arm.  Headache was also present day 5 post injection. Patient also reports fatigue since vaccination.
This case was considered non-serious. From follow up information received on 2/28/05 this case was considered serious based upon medical judgement (OMIC). No seriousness criteria was reported. From initial information received on 2/2/05 from the patient regarding an adverse event occurring in the USA, it was reported that this 62 year old female patient received FLUZONE, lot number U1440AA, administered IM in the left arm on 10/4/04. 32 days later, on 11/5/04, the patient experienced decreased platelets. She reported that her platelets have been falling at a rate of 20,000 every two weeks. The patient has not recovered from this event. From additional information received on 2/28/05 from the responsible physician, it was reported that the patient's platelet count on 11/5/04 was 115,000. The patient had completed consolidation chemotherapy in early 2004, following a diagnosis of acute myeloid leukemia in July of 2003. Examination on 11/5/04 was essentially normal and the patient was considered to be in continued remission status. The patient was reevaluated on 12/2/04 to monitor for evidence of relapse and a drop in her platelet count. It was noted at that time that she had felt fine, except for a viral syndrome. She had also developed some herpes stomatitis at that time and was treated with Famvir. Her platelet count was 96,000. On 12/17/04, the patient was seen again by a physician for repeat blood counts and evaluation. It was noted that she had recently had an upper respiratory infection. A physical examination was normal and her platelet count was 78,000. On 1/7/05, the patient was evaluated for a six week history of thrombocytopenia. Examination showed no evidence of bleeding or fever and the patient denied any other complaint at that time. Her platelet count was 57,000. She was seen again four days later, on 1/11/05, for a bone marrow aspiration and biopsy. Her platelet count at that time was 66,000. Her bone marrow study was reviewed and appears to be consistent with no evidence of leukemia. The patient was scheduled for a repeat blood count in four weeks.
Left deltoid swelling, erythema and pain which occurred about 4 hours after injection. Pt was seen in clinic on 12/5/14 - Recommended BENADRYL 25 mg 4 hrs. Symptoms improved, and resolved when pt was seen again on 12/8/14.
Extreme soreness in left arm immediately after injection then slight fever/chills around 8:00p.m. day of injection.  Chills became severe around 8:30 p.m. and lasted approximately 1 1/2 hours--uncontrollable shaking involved  then subsided somewhat during the night.  Also vomited. Temp 102.4.   Took 2 Tylenol 500 mg each.  Slight fever, muscle soreness, tiredness, weakness persisted through next day.
got both shots, 6 months later had shingles/ suspected vaccination failure; terrible case of shingles on my face, neck and shoulder; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 6 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient stated that vaccine does not work for everyone. The patient received the series of both shots and 6 months later had a terrible case of shingles on face, neck and shoulder. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Extreme pain and swelling of left arm at injection site; Extreme pain and swelling of left arm at injection site; weakness in left arm; burning sensation on some parts of left arm and shoulder; chills; Fever; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 24-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 01Mar2021 14:45 as DOSE 1, SINGLE for covid-19 immunization (24 year when vaccinated). The patient medical history was not reported. Concomitant medication included ibuprofen (IBUPROFEN) taken for an unspecified indication, from an unknown start date, calcium carbonate (TUMS [CALCIUM CARBONATE]) taken for an unspecified indication, from an unknown start date. The patient was not diagnosed with COVID-19 prior to the vaccination. On 01Mar2021 22:00, 8 hours after vaccination the patient experienced extreme pain and swelling of left arm at injection site, weakness in left arm, burning sensation on some parts of left arm and shoulder, fever and chills. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was reported as not recovered.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were inadvertently vaccinated with RECOMBIVAX HB (lot#, strength, dosage, frequency and route unspecified), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
C/O dizziness, feeling faint, pale and diaphoretic, heart palpitations, vomiting, and fever 102.5.
low grade fever on 30JUN92 bitten by ferrel cat that was not captured; f/u h/a & nausea also;
Rapid Heart Rate, Light Headed, Headache, Sore Arm at Injection Site
EXPIRED VACCINE IS ADMINISTERED DUE TO MISUNDERSTANDING WHEN STABLISHING THE EXPIRATION DATE IN THE "PRIVATE" REPORT.
About 3 1/2 hours after DTAP shot, 1 hour of inconsolable crying & screaming, mild fever. Gave Tylenol (after calling doctor).
BODY ACHES; SHAKING; NEUROLOGICAL SYMPTOMS; HEADACHE; This spontaneous report received from a patient concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to antibiotic, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-APR-2021, the subject experienced body aches. On 06-APR-2021, the subject experienced shaking. On 06-APR-2021, the subject experienced neurological symptoms. On 06-APR-2021, the subject experienced headache. On 06-APR-2021 17:00, treatment medications included: ibuprofen, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shaking, neurological symptoms, and headache on 06-APR-2021. This report was non-serious.
swollen raised red rash at injection site with some pain. I have taken tylenol and benedryl.  will continue to take for one more day before contacting hospital.
Sensitivity of the skin; feeling not so hot; Very tired; Had a headache; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Sensitivity of the skin), FEELING ABNORMAL (feeling not so hot), FATIGUE (Very tired) and HEADACHE (Had a headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061F21A, 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced FATIGUE (Very tired) and HEADACHE (Had a headache). On an unknown date, the patient experienced SENSITIVE SKIN (Sensitivity of the skin) and FEELING ABNORMAL (feeling not so hot). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, SENSITIVE SKIN (Sensitivity of the skin), FEELING ABNORMAL (feeling not so hot), FATIGUE (Very tired) and HEADACHE (Had a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2021, Heart rate: 104-105-106 (High) 104-105-106 and 114 (High) pulse being 104-105-106, and as they talked, she said it went to 114.Patient said it is usually around 70. She noticed it in the morning, when it was around 95, and then it kept increasing..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-365171 (Patient Link).