chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches at 3pm, severe body pain starting at 6 pm on 3/25/10 later that night extreme weakness and had fever 102-103 did not check temperature. Started and lasted all day Thursday 3/25/10. Remained in bed all day until Sat unable to move until Sat night 3/27/10. Sunday normal.
No additional AE; Multiple Patients were administered Improperly Stored; This spontaneous report has been received from a registered nurse to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On unknown date in  October 2022 (also reported as 05-OCT-2022, 06-OCT-2022, 07-OCT-2022, 10-OCT-2022, 11-OCT-2022, 12-OCT-2022, and 13-OCT-2022) the patient was vaccinated with improperly storage dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number: W010874, expiration date on 12-OCT-2024, lot number: W006721, expiration date on 12-OCT-2024). All of the vaccines were administered as prophylaxis (strengths, doses, routes of administration, and anatomical sites of injection were not reported).   The administered doses of the vaccines were stored on 25-JUL-2022, at a temperature of -47.5 degrees Fahrenheit (F), during a time frame of 5 minutes. (Product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.  This is one of several reports from same reporter.; Sender's Comments:  US-009507513-2210USA010278:
Myalgia, Arthralgia, Fever, Diarrhea, stomach ache Narrative: The evening she received the vaccine, patient reported injection site pain that radiated to her neck. The following day, she reported experiencing a fever of 100.4 (F), body aches, stomach ache and diarrhea. She denies having received any treatment.
I woke up at 3:00 am with a SEVERE, PAINFUL muscle cramp in my left lower extremity from my left hip down to my left foot and toes.  The cramp was excruciating !!!   I was NOT  able to get out of bed  for two hours after several tries.  When I was able to get out of bed, I was unable to bear weight on my left leg and foot.  The SEVERE cramp was not relieved by me attempting to "walk it out".
Approx. 2 hours after vaccinations small hive developed near injection site, L. Leg.  On 10/27/2011 hive approx. size of "silver dollar".  Benadryl given, .25mg.  On 10/28/2011 hoarseness, runny nose, cough developed, hive still present.  Benadryl, .25 given.  On 10/29/2011 Hive and redness nearly gone, pt. still has head cold per mom and is back in school today.  Mom states was told be nurse at E.R. that reaction was a severe reaction to the Hep A vaccine.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 15-JAN-2018 (also reported as "yesterday"), the patient received a dose of VARIVAX lot # N014631, expiration date on 11-MAY-2019, for prophylaxis; as well as a dose of PROQUAD Non-valid lot #N037010, for prophylaxis. Both vaccines were reconstituted with a sterile diluent (MERCK) (strengths and routes of administration were not provided). No adverse effect was reported.
Information has been received from a physician assistant concerning a 19 year old female who in approximately July 2008, was vaccinated with a second dose of GARDASIL vaccine (yeast) (route and administration site not reported). Two days past the vaccination, the patient had symptoms of pancreatitis. the patient went to the emergency room where the ER physician diagnosed her with gallstones and indicated that it was affiliated with the GARDASIL vaccine (yeast). Subsequently, the patient recovered from gallstones. Additional information has been requested.  1/2/09 Reviewed hospital medical records of 7/5-7/11/2008. FINAL DX: acute pancreatitis; possibly gallstone pancreatitis; Gardasil may have contributed; anxiety & depression; high BMI. Records reveal patient experienced nausea, acute abdominal pain.  GI & surgery consults done.  Progressed well w/conservative treatment & d/c to home on continued oral antibiotics.  To f/u w/surgery for elective cholecystectomy.
Pt experienced a rash that was comprised of a 6cm raised circular erythema accompanied by pruritus reportedly greater than 10 cm on initial onset by pt.
whole body turned bright red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (whole body turned bright red) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 02B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced ERYTHEMA (whole body turned bright red). At the time of the report, ERYTHEMA (whole body turned bright red) outcome was unknown.            No concomitant medications reported by investigator No treatment medications provided by the reporter.   Patient had an appointment with doctor right after being vaccinated. While the patient was examined by his Doctor, he reports that his whole body turned bright red.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: significant follow up appended contains, first and second dose lot number were added and updated action taken
On 6-10-08, mother stated child had fever for a week after immunizations on 4-14-08.  4-24-08 labs done.  4-14-08 follow up for otitis media, bronchitis on 3-31-08.
Developed severe injection site pain extending to head, entire arm, and chest wall the night of the injection. Developed severe fatigue lasting 7 days. Developed severe headache and diffuse joint pain lasting 5 days. Developed toe ulcerations. Developed vertigo and significant word finding issues, as well as sleep disorder. Time course was 8 days in total.
Information has been received from a registered nurse concerning a 8 week old male patient with no drug reactions/allergies and no pertinent medical history who on 06-JAN-2012, was vaccinated with a first dose of ROTATEQ, (lot number 668906/1476Z, expiration date 01-AUG-2012), (dose, route not reported). Concomitant therapy included PREVNAR 13 and PENTACEL given in 06-JAN-2012, at the same office visit as administration of the first dose of ROTATEQ. On 06-JAN-2012, the patient developed a fever shortly after his first vaccination with ROTATEQ. The fever resolved on 09-JAN-2012. In January 2012, the patient then became fussy and was spitting up. On 11-JAN-2012, the patient began to vomit. There was no treatment given for becoming fussy, spitting up and vomiting. At the time of the report the patient's outcome was not recovered. No laboratory diagnostics studies were performed. Additional information has been requested.
This spontaneous report as received from a certified medical assistant (C.M.A.) refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# K010224, expiration date 13-MAY-2016, route of administration default to oral, dose and frequency were not reported). Concomitant medication was not provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Bivalent vaccines have undergone several temperature excursions and have been administered to patient; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Sep-2022 at 11:21 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Sep-2022 at 11:21 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant product reported by the reporter.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.  Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.   No adverse reactions were reported for any of the patients at the time of the report.  No treatment medication reported by the reporter.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Concurrent conditions and medical history were not reported. On 24-FEB-2015 the patient was vaccinated with a dose ZOSTAVAX subcutaneous injection, 0.65 ml subcutaneously (batch/lot# and expiration date not reported). Concomitant therapies were not reported. The pharmacist informed that the patient called to report that she developed a red injection site rash on 25-FEB-2015, which extended to her elbow on the next day, 26-FEB-2015. It was also reported that on that day, the patient developed an injection site swelling "up to the size of a baseball". The outcome of the events was reported as not recovered. The pharmacist did not provide a causality assessment. The reported stated that there was no intervention in order to prevent serious criteria, the patient did not die, the events did not cause a significant disability or incapacity, no hospitalization was required, the experience was not life-threatening and it was not an overdose. Also, no Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient called me today to let me know she experienced nerve pain down to her right heel after her flu shot.  The injection site had no soreness other than the day of.  She is a retired ER nurse and said my technique was fine and I gave it to her in the right location.  She is thinking something in this year's Fluad didn't agree with her system.  Also her husband was given the same exact shot and he had no reactions.  She wanted to let me know.  She is considering the none senior dose next year to avoid this from happening again.  Also she wanted the lot number to report to CDC.
Information has been downloaded from web (US-CHIRONMA-PHHY2014US170482). Information has been received from an other health professional referring to a 12 year old female patient. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were unknown. On 29-SEP-2014, the patient was vaccinated with GARDASIL (1 dosage form, lot # J015378, expiration date was auto-generated as 09-APR-2016) intramuscularly, M-M-R II (1 dosage form, lot # J005846, expiration date was unknown) subcutaneously, MENVEO (1 dosage form, lot # M14055, expiration date was unknown) intramuscularly, HAVRIX (1 dosage form, lot # 9H9R4, expiration date was unknown) intramuscularly, poliovirus vaccine inactivated (vero)(IPOL) (1 dosage form, lot # J13821, expiration date was unknown) subcutaneously and ADACEL (1 dosage form, lot # U4875AA, expiration date was unknown) intramuscularly, all for immunisation. On 29-SEP-2014, the patient experienced anxiety, crying, decreased strength in hands moving to legs, nausea, numbness in hands moving to legs, throat fullness and trouble breathing. The outcome of all the events was reported as recovered. All the events were considered to be suspected to MENVEO by the reporter. The causality assessments between all the events and other suspect products were not reported by the reporter.   All the events were considered to be medically significant. Sender Comments: Reported events are lsited and based on the reported time-to-onset (10 minutes), possible causal association cannot be excluded, however coadministered vaccines confound causality assessment. Case will be reassessed after more details are available.
Highest temp of 101.9, chills, muscle and general fatigue, joint pain, headache and stomach cramps
Patient fainted and hurt his hip on a shelve. We monitored his BP/pulse initially and at 5mins, gave him water and juice to drink to get his blood sugar back up and bandaged his cut on his hip. We continued to monitor him to ensure he was ok for about another 10 mins.
8/1/11 pt called had hepatitis B second shot on 7/29/11. States 7/29/11 that night after getting vaccine had fever, shaking, chills, Max temp 102.2 oral, diarrhea, vomiting, body aches and headache. Rested yesterday, ate toast drinking fluids, popsicles, states took in at least 32 ounces fluids toast, still had diarrhea about 10 liquid stools with nausea, no emesis. Feeling better today, headache very mild rates 1-2/10, body aches, no fever, temp 98.8 oral, no dizziness, no pain. She is convinced this is from hep B vaccine and declined appt to be seen. 8/2/11 I spoke with patient who states the nausea started almost immediately after receiving the Hep B injection on 7/29/11. Her symptoms were the worst on Saturday night (7/30/11) with nausea, vomiting and diarrhea most of the night. Today pt states she is much better, almost back to "normal".
Minor heart flutter; This is a spontaneous report from a contactable consumer.  A 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 43-years-old via an unspecified route of administration, administered in arm left on 10Mar2021 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  Medical history included allergies: sulpha drugs from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient experienced minor heart flutter on 10Mar2021 20:30. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown result on 24Jan2021 (covid test type post vaccination Nasal Swab). The patient recovered from the event on an unspecified date in Mar2021.  Information on batch/lot number has been requested.
Ten minutes after the vaccine was administered, I began to taste it in the back of my mouth, a metallic-type taste and felt tingling around my mouth. I had been sitting in the post-vaccine observation area during this time looking at my telephone. I approached the nurse's desk and reported what I was experiencing and was taken to another room where I was put in a wheelchair and vital signs were taken. By now I think I became very anxious and fearful and my heart felt like it was pounding at 104. My BP went to 188/79 which is high for me and I felt SOB. I truly think the VS symptoms were related to anxiety, but I continued to have the taste in my mouth and my tongue felt like sandpaper. I was given 50 mg BENADRYL and observed for 30 minutes.  After that amount of time, I felt better and safe to leave the hospital.  Today, 1/14/2021, I have felt excessive tiredness and mentally dazed with diarrhea.  No temperature, slight nausea this morning, and no vomiting. My left arm is only moderately sore. Now, at 7:30 pm I am feeling better and feel that I can work tomorrow.  Honestly do not know if it was an adverse reaction or excessive anxiety. I do not have anxiety disorder.
Arm at site of injection is described as a hard welt, size of about a silver dollar pancake. Very hot to touch.
Information has been received from a physician concerning an approximately 68 year old female patient who on 19-APR-2007 was vaccinated SC with 0.65 ml dose of Zostavax (Lot #656606/0033U). There was no concomitant medication. On 06-MAY-2007 the patient experienced varicella like rash on back, trunk and arms. A diagnostic laboratory "PCR test" was undertaken on unspecified date. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Few tough symptoms; 1st dose Janssen, Booster dose Moderna; Mild symptoms; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Mild symptoms), ADVERSE EVENT (Few tough symptoms) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Janssen, Booster dose Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Janssen, Booster dose Moderna). In December 2021, the patient experienced UNEVALUABLE EVENT (Mild symptoms). On an unknown date, the patient experienced ADVERSE EVENT (Few tough symptoms). On 03-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Janssen, Booster dose Moderna) had resolved. At the time of the report, UNEVALUABLE EVENT (Mild symptoms) outcome was unknown and ADVERSE EVENT (Few tough symptoms) had resolved.            No concomitant medications were reported. No treatment details were reported.  On an unspecified date following vaccination with Janssen COVID-19 vaccine (Dose number in series 1), the patient experienced few tough symptoms (unspecified) and afterwards felt fine.  The patient received booster dose of vaccine mRNA 1273 (dose number in the series 2), following vaccination patient experienced mild symptoms(unspecified).
Bad pain starting at injection sight (left deltoid) and radiating down to wrist, lasting about 2 hours
Peeling around mouth, tongue. Tingling of hands and feet, lightheadedness. Pt. is improving.
Raised on face, neck, back, arms, chest and stomach; Flushed on face, neck, back, arms, chest and stomach; Itchy on face, neck, back, arms, chest and stomach; Throat felt itchy/Throat felt scratchy/ Throat felt raw; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Apr2021 at 15:00 (at the age of 40-years old) (Batch/Lot Number: ER8734) as DOSE 1, SINGLE for Covid-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing, back pain from an unknown date and unknown if ongoing, allergies to cross reactive foods and latex allergy from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines four weeks prior to the vaccination. The patient experienced raised on face, neck, back, arms, chest and stomach; flushed on face, neck, back, arms, chest and stomach; itchy on face, neck, back, arms, chest and stomach; and throat felt itchy/throat felt scratchy/ throat felt raw all on 13Apr2021 at 16:00. The events resulted in emergency room or urgent care. Therapeutic measures were taken as a result of rash papular, flushing, pruritus, and throat irritation which included IV benadryl, solumedrol, Pepcid, and normal saline. The outcome of the events rash papular, flushing, pruritus, and throat irritation was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.
I started getting symptoms the week before tested. I thought I had a cold with no fever. I was lethargic, runny nose, cough, ear aches, headache, and nauseous and diarrhea . I took an at home COVID-19 test that was positive. I contacted my doctor and I was not prescribed an antiviral medication due to the symptoms being over 5 days. My symptoms are still active and lingering at times. I am still nauseous with not eating as well and headaches. I have memory issues as well like a brain fog. I also do not sleep well and wake up all through the night. I went to my gastroenterologist and had some tests done. He could not determine whether my issues are COVID-19 related. I did also get COVID-19 on 12/22/2021 which was not severe and was like a cold.
local reaction of redness, swelling, warmth to touch; 14FEB92 f/u no addtl event info known; unk if recovered; provided pt details;
Upper mid-back pain following vaccination. Pt reported back, within 8 hours for evaluation. No rash or difficulty breathing.
Narrative: COVID infection following COVID vaccine series 01/25, Pfizer, dose #1 02/16, Pfizer, dose #2 10/05 COVID swab, result: detected 10/02 pt cc: cough, diarrhea, fever, loss of taste or smell, rhinorrhea exposure: unknown 10/02 SARS-COV-2 Variant Sequencing result: pending
pt recv vax OCT94 & 1 or 2 days p/vax pt devel pain in shoulder joint;required MD visits & physical therapy;pt recovered;
Pale, diaphoretic (reacted this way in past with other vaccines) - placed in gurney. Juice provided. Vitals within normal limits.