chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, regarding a female patient of unknown age. The patient's medical history and historical or current medications were unknown by the reporter and she had no listed drug reactions or allergies. On 07-NOV-2017 the patient was administered a dose of ZOSTAVAX (reported as 19400 PFU) for prophylaxis, with product lot # N023328 and expiration date 22-NOV-2018. The dose, route of administration and anatomical location were not provided. As other suspect therapy it was reported the sterile diluent used to reconstitute ZOSTAVAX, which dose, route of administration, lot # and expiration date were unknown. After the vaccination, the patient developed localized itching, redness, heat and circular marks around the injection site. It was unknown by the reporter if the patient received treatment or sought medical attention for the events. The pharmacist also reported that both ZOSTAVAX and sterile diluent did not undergo a temperature excursion. The recovery status of the patient by the time of the reporting and the association between the suspect products and the event were unknown.
Pt reports having patches of itchy skin all over his body happening a few weeks after receiving his covid booster.
fast heartbeat at night intermittently since receiving dose 2; Tongue felt like it was burning; Sore on the tongue; Light fever; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (Tongue felt like it was burning), GLOSSODYNIA (Sore on the tongue), HEART RATE INCREASED (fast heartbeat at night intermittently since receiving dose 2) and PYREXIA (Light fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-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) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Light fever). On 13-Feb-2021, the patient experienced TONGUE DISCOMFORT (Tongue felt like it was burning) and GLOSSODYNIA (Sore on the tongue). On an unknown date, the patient experienced HEART RATE INCREASED (fast heartbeat at night intermittently since receiving dose 2). On 11-Feb-2021, PYREXIA (Light fever) had resolved. At the time of the report, TONGUE DISCOMFORT (Tongue felt like it was burning) and GLOSSODYNIA (Sore on the tongue) had resolved and HEART RATE INCREASED (fast heartbeat at night intermittently since receiving dose 2) outcome was unknown.            Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD21-031476 (Patient Link).
Patient  came in for the 2nd Hepatitis B vaccine and received the pediatric dosage instead of the adult dosage. This error was just discovered when he was to be scheduled for his 3rd hepatitis B vaccine (has not had the 3rd shot yet).
According to the patient and her father, she complained of pain at the injection site and abdominal pain. After walking to the respite area and sitting down, the patient experienced a syncopal episode, becoming unresponsive for "a few seconds." After regaining consciousness, the patient appeared pale, but showed no sign of respiratory distress. The patient was able to walk to an exam room, where vital signs were measured and found to be normal for her age. Her skin color returned to normal, and after 30 minutes all symptoms had resolved.
CHILLS/ SHIVERING; FATIGUE; JITTERY; SHAKY; LOW  BLOOD SUGAR; MUSCLE CRAMPS  LIKE MENSTRUAL CRAMPS/ MUSCLE  CRAMPS CONSTANTLY ACHING; FEVER; EXTREME MUSCLE PAIN; VOMITING; NAUSEOUS/ NOT JUST  NAUSEA WANTED TO THROW UP AND  DID; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: JANSSEN1805029 expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced vomiting. On 09-MAR-2021, the subject experienced nauseous/ not just nausea wanted to throw up and did. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced jittery. On 10-MAR-2021, the subject experienced shaky. On 10-MAR-2021, the subject experienced low blood sugar. On 10-MAR-2021, the subject experienced muscle cramps like menstrual cramps/ muscle cramps constantly aching. On 10-MAR-2021, the subject experienced fever. On 10-MAR-2021, the subject experienced extreme muscle pain. Laboratory data included: Body temperature (NR: not provided) 99.9. On an unspecified date, the subject experienced chills/ shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, nauseous/ not just nausea wanted to throw up and did, fatigue, jittery, shaky, low blood sugar, muscle cramps like menstrual cramps/ muscle cramps constantly aching, fever, and extreme muscle pain, and the outcome of chills/ shivering was not reported. This report was non-serious.
Round red area 50-cent size, warm to touch on right arm below deltoid. Denies pain. Mom has been putting cold compresses today
This study case was received from the investigator on 30 November 2011. A 30-year-old male subject with an unknown medical history was found to have Cardiomyopathy 25 days after he had received on 10 July 2011 ACAM2000 (lot number, route and site of administration not reported). The subject had also received on 09 July 2011 ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported). The subject's Troponin I, ECG, Lumbar puncture and MRI of the brain, spinal cord and heart were not available. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
she developed tingling of her feet bilaterally within 15 minutes and feeling like pins and needles of legs and then arms; Limbs felt heavy; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu shot, administration date: 13Oct2021; Bnt162b2 (Dose 1), for Covid-19 Immunisation. The following information was reported: PARAESTHESIA (non-serious) with onset 02Dec2021, outcome "unknown", described as "she developed tingling of her feet bilaterally within 15 minutes and feeling like pins and needles of legs and then arms"; LIMB DISCOMFORT (non-serious) with onset 02Dec2021, outcome "unknown", described as "Limbs felt heavy". The events "she developed tingling of her feet bilaterally within 15 minutes and feeling like pins and needles of legs and then arms" and "limbs felt heavy" were evaluated at the physician office visit.  Additional Information: Soon after the COVID vaccine dose 2 she developed tingling of her feet bilaterally within 15 minutes. This has been on and off feeling like pins and needles of legs and then arms. Limbs felt heavy and had to leave school early today. She was evaluated by neurology today who reassured the family. But they remain concerned about the symptoms and possible etiology. Optional Information: No known relevant comorbidities. Event took place after use of product.  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 experienced runny nose, sore throat, watery itchy eyes. One day later, patient experienced watery, burning/stinging eyes, fever of 102 degrees F., fatigue and flu like symptoms.  All remains persistent.
Positive test after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive test after 1st dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced COVID-19 (Positive test after 1st dose). At the time of the report, COVID-19 (Positive test after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
The student received the flu shot R deltoid, became pale, emesis x1, no loss of consciousness. Able to ambulate.
Ringing in my ears first noted about 4-5 months after dose #2. I wasn't sure if it was related but the ringing in my ears has worsened and gotten louder since 2 weeks after the Booster dose. I have seen that COVID exposure can cause this but was not sure if the vaccine can and just wanted to report my symptoms since it worsened. To my knowledge I have not had COVID.
Patient tested positive for COVID 19 on 7/15/2021-developed headache, congestion, fever, chills on 7/13/2021
- on the arm that got the vaccine O2 was significantly lower than left arm. Inconsistent with one another. One low, one stable. Lowest 85-low 90s at night while other arm was in 99s.  - blood in stool/ghost pill/diarrea/vomiting  - bruising after vaccine on side of breast (purplish dark red) we have a picture of needed.  - multiple swollen lymph nodes  - slight loss of taste, medicine/salty taste
First week had headache, nausea, dizziness with room spinning. Starting the second week had a Crohn's flare with abdominal pain and diarrhea, which has continued. Hospitalized due to dehydrating and low potassium, given steroids, fluids, and potassium supplement.
1) Fussing, inconsolable crying for 2 days. 2) Significantly decreased appetite for 2 days. 3) Loose stools/diarrhea for 1 day.
Patient stated she experienced eyes swelling shut, itchy throat and roof of mouth, swelling to the inner portion of her mouth with some difficulty breathing, coughing, chest tightness. Localized reaction to injection site at left arm of redness and swelling with warmth to touch x3 days. Patient phoned emergency room and was advised to use benadryl for treatment.
Presented on 4/27/21 (5 days after 2nd dose of Pfizer COVID vaccine) with acute onset of chest pain around 7am the same morning.  Testing ultimately confirmed the diagnosis of acute pericarditis.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of ROTATEQ (lot # K001198 with expiration date 25-OCT-2015, lot # L004453 with expiration date 27-MAY-2016, K022990 with expiration date 26-JUN-2016; dose and dose numbers were not reported) orally, which were exposed to temperatures outside of the recommended range. No adverse effects were reported. Thi sis one of several cases from the same reporter. Additional information has been requested.
Itchy eyes; Redness on the face; Rash just below her neck and above her chest; blotchiness but no hives; Readministered the vaccine to the patient thinking the first vial was empty; A spontaneous report received from a consumer concerning a 66-year-old female patient who received the first dose of Moderna COVID-19 vaccine and where the patient felt the needle go in but didn't feel the liquid and had developed itchy eyes, redness on the face, rash just below her neck and above her chest, and was readministered the vaccine to the patient thinking the first vial was empty.  The patient's medical history was not provided. Patient's concomitant was not provided.    On 12-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in her right arm (Batch #: 024M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 12Feb2021 patient experienced itchy eyes, redness on the face, and a rash just below her neck and above her chest. There was "blotchiness but no hives". She had the same type of reaction as she does to orange peels. She had no trouble breathing. She took some diphenhydramine hydrochloride to help. The nurse also re-administered the vaccine to the patient thinking the first vial was empty and as the patient felt the needle go in but didn't feel the liquid.  Action taken with mRNA-1273 in response to the events were not provided.   The outcome of events itchy eyes, redness on the face, rash just below her neck and above her chest were unknown at the time of this report. The outcome of events the patient felt the needle go in but didn't feel the liquid was considered resolved on 12-Feb-2021 and readministered the vaccine to the patient thinking the first vial was empty were considered resolved on an unspecified date in Feb-2021.; Reporter's Comments: This case concerns a 66 year old, female patient, who experienced a non-serious unexpected event of eye pruritus, erythema, rash macular, after receiving first dose mRNA-1273. This report refers to a case of overdose for mRNA-1273 (lot # 024M20A), with no associated AEs. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Pt began complaining of inability to catch his breath. This was 5 and half hours after receiving 1st dose of vaccine. He became unresponsive. CPR was initiated, 911 arrived and took him to ER. He was given numerous doses of epinephrine, and other advanced cardiac life saving meds, as well as intubated, and all life save measures given over the course of an hour. He was pronounced dead at the emergency room by the ER physician.
Patient received two immunizations yesterday: pneumovax and HD influenza vaccine. She called this morning and stated she woke up at 1:30 this morning and had chills. She stated she proceeded to take a shower and while she was in the shower she was sitting on her shower chair because she felt dizzy and she slid off her chair and "blacked out". She also reported lack of energy, nausea, and vomiting and generalized weakness. She also stated that she tweaked her back a few days ago and didn't know if that was contributing to her weakness. I advised her to make sure she was staying hydrated, resting, and make sure she had someone there to keep an eye on her. She stated her husband was there and taking care of her. She did say that she was feeling a little better but still was a little nauseated and dizzy. I also made sure she called her provider to notify them of her reaction and "black out." Patient did report being on Eliquis and I advised her that having any type of fall while on that type of medication could be detrimental and was essential to follow up with her doctor. She voiced understanding and stated she would call them after speaking to me.
PAIN IN THE LEFT LEG; IMPROVEMENT FROM FIBROMYALGIA PAIN, MUSCLE ACHES AND PAIN WITH 80 TO 90% RELIEF; SOAPY TASTE IN THE MOUTH; MILD NAUSEA WITH ON AND OFF; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included blood clot in the left leg at the age of 18, and concurrent conditions included asthma, fibromyalgia pain, muscle aches, and pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced soapy taste in the mouth. On 02-APR-2021, the subject experienced mild nausea with on and off. On 05-APR-2021, the subject experienced improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief. On 06-APR-2021, the subject experienced pain in the left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the left leg on JUN-2021, and mild nausea with on and off, had not recovered from soapy taste in the mouth, and the outcome of improvement from fibromyalgia pain, muscle aches and pain with 80 to 90% relief was not reported. This report was non-serious.
This spontaneous report has been received from a physician referring to a 4 year old male patient. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. Approximately in 03-MAY-2018 reported as ("3 weeks ago"), the patient was vaccinated with GARDASIL 9 (strength, dose, route, anatomical location, lot number and expiration date were not provided) for prophylaxis. On the same date the patient also received poliovirus vaccine inactivated (unspecified)(POLIOVIRUS VACCINE INACTIVATED (UNSPECIFIED)) and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) (+) TE). It was reported that the patient received in error an GARDASIL 9 that was intended to be administered to another patient (drug administered to patient of inappropriate age and wrong drug administered). No adverse effects were reported. This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-1805USA012398:
Moderna vaccine was administered outside of facility- reported by patient  ACUTE RESPIRATORY FAILURE 10/28/2021 ATHEROSCLEROSIS OF AORTA ACUTE RESPIRATORY FAILURE 10/28/2021 HYPOTENSION
red, itchy, tender, swollen giant hives around a few inches from injection site; red, itchy, tender, swollen giant hives around a few inches from injection site; red, itchy, tender, swollen giant hives around a few inches from injection site; red, itchy, tender, swollen giant hives around a few inches from injection site; A spontaneous report was received from a consumer concerning a 41-year-old female patientwho received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red, itchy, tender, swollen giant hives around a few inches from injection site.  The patient's medical history not provided. The concomitant medications were not reported.  On 10-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot: 012L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 20-JAN-2021, the patient noticed red, itchy, tender, swollen giant hives around a few inches from injection site. The event swollen giant hives around a few inches from injection site was assessed as serious as per IME list. Labs were not reported. Consumer took Benadryl at 10:30am to treat symptoms.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events red, itchy, tender, swollen giant hives around a few inches from injection site was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Same day as vaccine shot arm pain at injection area and fatigue that evening at around 8pm. Following 26hrs had headache, body ache, chills, low grade fever 99.4, Increase in arm pain at injection site, and fatigue. treated with ibuprofen 400mg every 4-5 hrs. 31 hours later all injection, all side affects but some residue site injection pain have gone away.
SCIATICA; DRUG ADMINISTERED AT INAPPROPRIATE SITE. Information has been received from a nurse practitioner concerning a female patient who on 19-DEC-2006 was vaccinated IM into the dorsogluteal muscle with a dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). There was no concomitant medications. On 19-DEC-2006, the patient experienced sciatic nerve pain (noted that when the patient was vaccinated the sciatic nerve was hit).  The pain went up her back and then it crossed over to the middle onto the left back. The pain occurred right after the injection.  It was noted that there was no bruising or inflammation. Unspecified medical attention was sought.  No laboratory diagnostic studies were performed.  At the time of this report, the patient had not recovered. No product quality complaint was involved.  Additional information has been requested.
None. Covid vaccine expired 11/22/2022 but given 12/19/2022.
Pt was seen 12/12/17 for dose #2 of Men B imm. Pt was immunized at 2:30pm. Around 9pm pt states she began to feel pain and swelling on the site of the immunization. Pt feels fingers numb and there is redness and swelling about 3 inches around the immunization site.
Hypotonic, hyporesponsive episode mimicking an non-tonic, afebrile seizure. Pt had a period of apnea (approx. 2 minutes; per parent) that resulted in cyanosis.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unspecified dates, the patients were vaccinated with improperly stored M-M-R II (unknown strength and route). Concomitant medications were not reported. No adverse symptoms were reported. The outcome of the event was unknown. There was no product quality complaint involved. This one of the several reports from the same reporter. Additional information has been requested.
Complaining of numbness, tingling down left arm into hand and intermittent shooting pains.  Reported today, but states it has been happening since the injection.
Patient had swelling and redness of arm at the injection site. She spiked a fever the night after given the shot
sore injection site left arm; headache; fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm), HEADACHE (headache), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.   This case was linked to MOD-2021-285667 (Patient Link).