chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was reported. On multiple unspecified dates, the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX, lot number L028284, expiration date: 28-OCT-2016 and lot number L029483, expiration date: 06-NOV-2016, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccines underwent a temperature excursion of -13.1 degrees Celsius for 40 hours. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
vaccine administered as if it had a preservative; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (vaccine administered as if it had a preservative) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.   No treatment information was provided.   Reportedly, a provider realized that they had been treating Moderna vaccine as though it had preservative. A preliminary spreadsheet (with the affected doses administered, with the lot numbers and time from vial opening) was sent.   The patient in question received the vaccine that was punctured 11 days earlier.; Sender's Comments: This is a case of Expired product administered (Expired vaccine used) for this patient of an unknown gender. Reportedly, the patient received the vaccine that was punctured 11 days before administration which is considered to be Expired product administered. No adverse events were reported at this moment. The company causality for this event is as not applicable. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Mildly numb at sight of injection, feel numb; it was sore; "It's a sharp stinging pain at injection site, stinging in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (Mildly numb at sight of injection, feel numb), VACCINATION SITE PAIN (it was sore) and VACCINATION SITE PAIN ("It's a sharp stinging pain at injection site, stinging in arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030B21A) for COVID-19 vaccination.     No Relevant Medical History was provided.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-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 VACCINATION SITE HYPOAESTHESIA (Mildly numb at sight of injection, feel numb), VACCINATION SITE PAIN (it was sore) and VACCINATION SITE PAIN ("It's a sharp stinging pain at injection site, stinging in arm). At the time of the report, VACCINATION SITE HYPOAESTHESIA (Mildly numb at sight of injection, feel numb), VACCINATION SITE PAIN (it was sore) and VACCINATION SITE PAIN ("It's a sharp stinging pain at injection site, stinging in arm) outcome was unknown.            No Concomitant Medications were provided. No Treatment Medications were provided.   This case was linked to MOD-2021-264317 (Patient Link).
Head ache, site pain, and swollen top lip. On 6/09/21, a pimple developed on the swollen part of the lip. (Unknown if this is related to vaccine)
AFTER VACCINATION EARLIER IN DAY, SAME EVENING PATIENT REPORTS FEVER OF 101 AND 102 WHILE TAKING IBUPROFEN. PATIENT CONTINUED WITH FEVER FOLLOWING DAY OF 102 WITH IBUPROFEN USE. ON THIRD DAY UPON COUNSELING, PATIENT REPORTS FEVER WITH SORE THROAT WHILST TAKING IBU 400 MG Q6H BUT REPORTS FEELING BETTER THAN PAST TWO DAYS. PATIENT REPORTED TO MD AND MD OFFICE COUNSELED AND TOLD PATIENT COMMON SIGN/RXN OF VACCINE.
Lymph node upper armpit (where arm connects to shoulder) extremely sore, swollen.   For one week pain continued and  progressed down inner arm to elbow.  There is a yellowish stripe, like a bruise, that runs down inner aspect of arm to elbow.  Elbow area is still slightly sensitive now, 3 weeks later. Tylenol taken for pain.
After receiving first dose of pediatric Pfizer, patient became diaphoretic and lost consciousness for less than 30 seconds approximately 10 minutes after receiving the dose. Patient was assisted to laying position by nurse, then oxygen saturation was obtained (99% on room air), and blood pressure obtained (110/78). Approximately 5 minutes after patient lost consciousness, patient sat up with minimal aid from nurses and drank can of juice and bag of animal crackers. Mother at patient side during incident. Patient left building with mother approximately 25 minutes after incident. Nurse instructed mother to contact EMS if any further incidents occur.
pain immediately after that has subsided. 11 days later site itching, pain, red and swollen
Pediatric dose was given to adults mistakenly; Moderna COVID-19 vaccine administered to patients post temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    Concomitant Medication use information was not provided by reporter.  It was reported there was a temperature excursion between 26 May 2022 to 30 Sep 2022 and lot AR5186C was affected between 08 Sep 2022 to 27 Sep 2022. AR5186C was previously reported. Pediatric dose was given to adults mistakenly and were reported and each patient that received the error dose, with instructions to re-vaccinate 2 months from the initial error dose. 051B22A was kept in the freezer upon receipt of shipment on 01-Aug-2022 and individual vials were put in the refrigerator on the day of use.  Treatment Medication use information was not provided by reporter.  This case contains information for the 94th of 104 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-669791 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-669791:Master Case
Client broke out with a red, blotchy rash on his head, neck and core body that was noticed immediately following administration of all vaccines. Client's body was radiating heat. He c/o tightness in his right arm but no breathing difficulties of any kind. 0.3 ml of epinephrine was administered subcutaneously in client's left deltoid; within minutes, the redness was gone completely. Paramedics  were called, client was assessed, and client was sent home with Benadryl.
(R) arm red, raised, warm to touch. Started 24 hours after inj. Given KEFLEX.
A serious, post-marketed study report of intussusception and viral syndrome was received from a study investigator concerning a 31-month-old male (PID 27395430), who is enrolled in the MI-MA162 study. On the day of FLUMIST vaccination, "cough and nasal congestion x two weeks-resolving" and eczema on the toe and finger were noted. No concomitant medications have been reported. The subject received FLUMIST on 08-Jan-2008. On the same day of receipt of FLUMIST, the subject complained of abdominal pain. The subject was seen at a clinic and abdominal pain was assessed as benign and possible constipation. There was no report of fever, vomiting or diarrhea. The following day the subject was seen in the emergency room due to persistent vomiting. Intravenous hydration was done, subject became stable and was discharged home. On 10-Jan-2008, the subject was seen back in the emergency room due to persistent abdominal pain and vomiting "green color" fluid and was subsequently admitted to the hospital. The subject pointed to his right side as the site of abdominal pain and stated having the pain every 30-45 minutes. The subject's weight was noted to have gone down from 35lbs on 08-Jan-2008 to 33 lbs on 10-Jan-2008. At the time of exam, the abdomen was noted to be soft with decreased bowel sounds and mid-right side palpable mass. A KUB (kidney, ureter, bladder) xray showed opacification on the right mid area consistent with intussusception. Other laboratory findings included white blood count = 15.7; hgb = 13.6; platelet count = 469; neutrophils = 80; lymphocytes = 17; urine ketones = 40; bilirubin, total = 0.1 and aspartate aminotransferase = 68. The subject underwent an attempted reduction by barium enema but was unable to reduce the intussusception. The subject was then transferred to the operating room and underwent surgical reduction of intussusception without bowel resection. Following operative reduction of his intussusception, the subject developed a short episode of post-operative pain and low grade fever of 101.9 degrees Fahrenheit which was felt to be consistent with a viral prodrome and as such resolved spontaneously without antibiotics or further invasive therapy. The subject made a generally uncomplicated recovery and was discharged on 13-Jan-2008. The events were considered resolved on 15-Jan-2008. The study investigator assessed the severity of the events as moderate and provided a causality assessment of possibly related for the events of intussusception and viral syndrome. Follow-up information received on 27-Aug-2009 clarified the onset date of the events to meet serious criteria as 10-Jan-2008.
Heart attack; anxiety; This is a spontaneous report received from a contactable reporter(s) (Lawyer).  A male patient received BNT162b2 (BNT162B2), on 04Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1), administration date: 01Apr2021, for Covid-19 Immunization; BNT162b2 (Dose 2), administration date: 22Apr2021, for Covid-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (hospitalization, medically significant), outcome "unknown", described as "Heart attack"; ANXIETY (non-serious), outcome "unknown". The patient was hospitalized for myocardial infarction (hospitalization duration: 5 day(s)). Therapeutic measures were taken as a result of myocardial infarction.  Additional information: On 04Aug2021 (Second patient name withheld) went to receive the covid vaccine. He received his first dose on 01Apr2021 and his second dose on 22Apr2021. After 7 months began to experience the side effects of the Pfizer vaccine. Additionally, based on insureds actions, reporter client received a heart attack, was in the ICU for 5 days and developed anxiety during this time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed herpes zoster of the L leg and meningitis despite being vaccinated (08/20/2004; 3/2/2009) with varicella vaccine.  This occurred when patient was 16 years old (neearly 10 years post last dose of vaccine). Admitted to hospital and required IV acyclovir.  VZV was identified as vaccine strain by CDC.  Similar case recently reported with 2 cases from hospital.
Patient called and stated after her vaccine she felt fatigued the next day. She then later started to experience slight numbness around the injection site than she said has radiated to the roof of her mouth on the same side as the injection. She states the roof of her mouth feels similar to that of when a dentist uses novocaine before a procedure. She does not state any lingering pain. Recommended patient call her PCP for follow up, no signs of allergic reaction. The reaction was currently active when she called.
during bath @ 630PM on 20NOV92 pt upper arm red & swelling; by next AM arm lt was red & swollen from elbow to shoulder; given APAP throughout; lump @ inject site;
Leg pain; Leg discomfort; Cramps; Joint pain; Muscular pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Leg pain), LIMB DISCOMFORT (Leg discomfort), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, SIMVASTATIN and ATENOLOL for an unknown indication.   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 an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain), LIMB DISCOMFORT (Leg discomfort), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain). The patient was treated with Physical therapy for Pain in extremity; Physical therapy for Limb discomfort; Physical therapy for Muscle spasms; Physical therapy for Arthralgia and Physical therapy for Myalgia. At the time of the report, PAIN IN EXTREMITY (Leg pain), MUSCLE SPASMS (Cramps), ARTHRALGIA (Joint pain) and MYALGIA (Muscular pain) outcome was unknown and LIMB DISCOMFORT (Leg discomfort) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) X-ray showed no arthritis or sciatica.         No concomitant and treatment medications were reported. Patient reported physical therapy to treat the condition.
10/7/08 - Pt received Pneumonia vaccine left arm,  pt also received Flu vaccine right arm. 10/10/08 (1600) - TC from pt w/following info:  Wed 10/8/08 - sx's began w/nausea, low-grade fever, "passed out momentarily" - went back to bed and stayed home from work rest of the day.  Back to work Thursday (10/9/08). Friday 10/10/08 - left arm "red, hot area approx. 8" (even wrapped around a little)."  Pt has taken Motrin & Tylenol since Thursday.  She states she had a "little cold" prior to vaccines, however, doesn't recall having a fever or other sx's.
Following injections of H1N1, HPV, Varicella, & PPD vaccines; pt experienced a syncopal episode. Dr called into room and assessed pt until pt was back to baseline.
shivering, very cold couldn't get warm and insomnia as well as pain at injection site
After seeing the PA  at the doctors office, I was diagnosed with Shingles  on my left lower back which he prescribed 800 Acyclovir and for one week and 300 mg gabapentin one a day for 30 days. my symptoms were very painful, tingling, rash, headache and chills. As of today, my rash is starting to fade away but still have pain from shingles
I am experiencing a metallic taste in my mouth, I am having trouble tasting my food and cannot taste some foods at all.
Heart palpitations over the course of 3+ months. Comes in waves. First 3 months were a local maximum in frequency and intensity.
abdo pain/emesis 12" x 5"; sore lt deltoid w/red blotchy tissue, flat all above occurred @ noon; pt c/o abdo pain this AM, prior to immun;
w/in 5min of vax rasied, rash devel on lt upper arm around areas of immun;pt observed for 10 more min-rash spreading;pt seen by nurse @ clinic;DPH given;rash began to disappear p/2 days;
Pt recvd vax 27OCT92 & immed following vax exp pain & weakness in shoulder & extending to lt hand; also exp lt arm pain upon awakening; Pt was seen by MD 5JAN93;
After receiving the vaccines, my daughter began to have fevers ranging from 100.4-103.5 F. She was given Ibuprofen and Tylenol throughout the fever. But on the evening of 10/1/15, she experienced a seizure where her eyes rolled back and her arms and legs began to shake. She was unresponsive throughout the episode which lasted about 5-8 minutes, which still continued on route to the local ER.
On 7/13/00 between 4-5PM the pts body tensed for about 2 minutes, then then the pt experienced 5 minutes of lethargy. The pt was afebrile. The pt was seen in the ER immediately after the incident. The temp in the ER was 101.4. No signs or symptoms of seizure since then.
Information was received from an unspecified source regarding a patient, demographics unknown, who on an unknown date, was vaccinated with VARIVAX (Merck) (lot# J003221, expiration date 25-MAR-2015 (reported as expiration date of 15-AUG-2015), which had been improperly stored. Follow up information has been received from the nurse who called and stated all patients (who received VARIVAX (Merck) that was exposed to unknown temperatures for 4 hours) have been revaccinated. No symptoms reported. This is one of several reports from the same source (linked MARRS#: 1311USA000056, 1310USA014891, 1310USA014881, 1310USA014883, 1310USA0014888, 1310USA015417, 1311USA000071, 1311USA000012, 1310USA014858, 1310USA014850, 1310USA014870, 1311USA000289, 1311USA000282, 1310USA014874, 1310USA014861, 1310USA004866, 1310USA014868, 1310USA015422, 1310USA015165. 1311USA000069. 1310USA015424, 1311USA000058, 1311USA000064, 1311USA000021. 1311USA000020, 1311USA000022. 1310USA015101, 1310USA014853. 1311USA000075, 1310USA004895, 1310USA015113, 1311USA000059, 1311USA004931, 1311USA000065. 1311USA000739, 1311USA000040, 1310USA015096, 1311USA000642, 1310USA014958, 1311USA000072, 1310USA015127, 1311USA000053, 1311USA000085, 1311USA000741, 1311USA000744, 1310USA015134, 1311USA000083, 1310USA015141, 1311USA000006, 1311USA000005, 1310USA014900, 1310USA015268, 1310USA015264, 1310USA014896, 1310USA014909, 1311USA000627, 1310USA015396, 1310USA015270, 1311USA000637. 1310USA014962, 1311USA000039, 1311USA000037, 1311USA000034, 1311USA000022, 1311USA000002, 1310USA014897, 1309USA011086). Additional information is not expected.
Initial solicited report received from market research on 05 October 2015 from a consumer in study. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported, manufacturer unknown). Medical history and concomitant therapies details were not reported. The subject felt uncomfortable on an unspecified date. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
I woke up in the early morning hours with a fever of 101 degrees & horrible body aches.  I also had a bad headache & sore arm. I had the fever all day & finally was able to get my fever to  lessen after about 24 hrs. (After taking Tylenol & Advil throughout the day.). The following day, I have a very large red welp at the injection sight & a slightly upset stomach.... though I feel a lot better.
On 8/28 he developed discoordination (he was walking into walls). Was sent to hospital and diagnosed with a type of GUILLAIN BARRE Syndrome.
fever; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MYALGIA (body aches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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. On an unknown date, the patient experienced PYREXIA (fever) and MYALGIA (body aches). At the time of the report, PYREXIA (fever) and MYALGIA (body aches) outcome was unknown.            No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-317617, MOD-2021-317634.
iintense itching all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (iintense itching all over body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 006C21A)) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (iintense itching all over body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 30-Apr-2021, PRURITUS (iintense itching all over body) had resolved. Not Provided          No concomitant medications were reported
Pt. experienced severe fatigue, chills, 3" x 3" raised, area which is hot to the touch, approx. 24 hrs. after receiving the ADACEL. After 12 hours woke up in full body sweat with improvement of body aches. Injection site not as sensitive to the touch, but remains swollen, firm to the touch & itchy.
Information has been received from a 49-year-old female registered nurse with no pertinent medical history or allergies, who in 1993 or 1994 was vaccinated with a second dose of Recombivax HB (manufacturer unspecified)Concomitant therapy included hormonal contraceptives (unspecified). After receiving the second vaccination, the patient experienced shortness of breathe, slurred speech, elevated heart rate (over 130) and elevated blood pressure. The patient was seen in the emergency room but was not admitted. An EKG was performed but no results were reported. Subsequently, the patient recovered from the reaction on her own, no medication or treatment was required. No product quality complaints were involved. Additional information has been requested.