chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning her 17 year old daughter who on an unspecified date was vaccinated with the first dose of HPV rL1 6 11 18 VLP vaccine (yeast).  In November 2007 the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast).  The patient experienced fever and flu like symptoms after both of the doses were given.  The third dose has not yet given to the patient.  Subsequently, the patient recovered from fever and flu like symptoms.
Experienced dyspnea and tachycardia during strenuous activity multiple hours following immunization administration.  Evaluated by EMS and found to be in mild respiratory distress.  Workup in the local emergency department negative for pulmonary embolism, acute coronary syndrome, chest x-ray negative.  Responsive to albuterol.  Low-grade fever.  Thought to be reactive airway.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 2:51 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.02.  Concomitant products were not provided.  On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.    Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt vaccinated with DTP/MMR/OPV on 4DEC90 URI noted w/temp 100.8; Presented to ER w/temp 104.5 & otitis media.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck), lot # L015047 with expiration date 29-APR-2017, (strength, dose, frequency, route and anatomical location were not reported), which was improperly stored. Other suspect and concomitant therapies were not reported. No adverse events were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Approx 5 hrs p/recvd immun pt devel local erythema swelling & extreme tenderness @ site of DTP inject; Refused to bear w/ wgt on leg x 2 days; high pitched shrill crying accompanied this; lasted 24 hrs;
I got COVID on 05/08/2022. So, I was on a cruise ship. I got chills, headache, congestion and they were all mild. I didn't think I had COVID, I thought it was jet lag. When I got to the resort, they quarantine for 5 days and then I had a lot of fatigue. Since I had come back, I been a dizzy and it feel like the room is spinning. I have tested myself and I have been negative for 2 days. I had a Doc visit and my doctor prescribe me some meds and I pick them up today 05/16/2022.
Pt has latex allergy rcvd FLUMIST began with itching to nose, face, mouth. Recv'd 50mg BENADRYL P.O. Stayed 1/2 hour after BENADRYL given. Nurse Practitioner on call spoke with parent advised since patient feeling better. Leave. Has EPIPEN at home - give if necessary & call 911. Go directly to hospital. Left clinic -> home.
I got tested positive for covid; Pain in arm; Fatigue, super tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got tested positive for covid), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue, super tired) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included INSULIN ASPART (NOVOLOG), INSULIN DEGLUDEC (TRESIBA), BUSPIRONE, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), METOPROLOL and FLUDROCORTISONE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue, super tired). On 06-Feb-2021, the patient experienced COVID-19 (I got tested positive for covid). At the time of the report, COVID-19 (I got tested positive for covid), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (Fatigue, super tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
2 shingles shots, had shingles/ suspected vaccination failure; shingles; simplex; rash; This case was reported by a consumer via call center representative 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 and gabapentin for shingles, herpes simplex and rash.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and gabapentin at an unknown dose 3 times daily. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, herpes simplex and rash. The action taken with gabapentin was unknown. On an unknown date, the outcome of the vaccination failure, herpes simplex and rash were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, herpes simplex and rash to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received 2 Shingles shots and had simplex. The patient had shingles this bad and now it was over 11 months. The patient also had rash but not open sores.  The patient was treated by his/her registered doctor plus specialist (neuro specialist) and was taking Gabapentin 3 times a day for over 2000 pills. The patient asked that why after taking the 2 shingles shots did he/she had it for this amount of time. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
pt recv vax 17MAY97 & 28MAY97 pt devel a rash;
The night of the vaccine I woke up at approximately 1am with a very bad headache. I took ADVIL and drank water. The headache continued the next day and I have been experiencing them just about everyday since. I have felt very fatigued and have had frequent body aches that come and go. I have been resting, taking ADVIL and drinking a lot of water. I noticed small red spots on my trunk today, 15Mar2017, and immediately contacted my Supervisor.
Swelling L upper arm w/ pain, redness, low grade temp. The medical record received on 3/3/04 indicates final dignosis was cellulitis. The rrecord also noted that this was most likely a vaccine reaction to the pertussis portion of DTaP.
Injection...+3hours Shoulder hot, swelling...Treated with ice and tylenol....+3days area of involvement 17cm x 18cm, treated with ibuprofen 600-800mg three times a day
WHEN GIVING THE VACCINATION, LIQUID LEAKED OUT BETWEEN THE NEEDLE HUB AND THE LUER LOCK SYRINGE.  WE BOTH NOTICED THAT THERE WAS WETNESS LEAKING DOWN HER ARM.  AT THE TIME I DID NOT REVACCINATE.  I VERIFIED WITH THE CDC THAT I COULD REVACCINATE AND CALLED THE PATIENT WHO WILL BE COMING IN NEXT WEEK.
Pt had 3 short tonic/clonic seizures within 72 hours of DPT. 1st occurred in less than or equal to 6 hours post vaccine. Pt. has had febrile seizure previous reaction to vaccine. (Dad gives vague history and had denied previous side effects was seen in ER and diagnosed with strep  Nurse follow up on 06/30/04 states: "Complete."
Started feeling warm, late that evening was having nausea, vomiting. Left deltoid injection site was fine. She started feeling weak. The following morning she could not walk. 911 was called and she was brought to ER.
Arm pain after 1st dose; Fatigue after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain after 1st dose) and FATIGUE (Fatigue after 1st dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024m20a and 040a21a) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-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 (Arm pain after 1st dose) and FATIGUE (Fatigue after 1st dose). At the time of the report, PAIN IN EXTREMITY (Arm pain after 1st dose) and FATIGUE (Fatigue after 1st dose) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.  Action taken with respect to mRNA-1273 was not applicable.  Additional information added by the patient was that they were trying to conceive but had to postpone IVF because her hormones were all over.   This case was linked to MOD-2021-213764 (Patient Link).
Hospitalization- admitted on 2/14 for appendicitis and peritonitis; had appendectomy. Discharged on 2/18
Employee arrived for vaccine following nonimmune titer.  Employee was given dose #2 today when she only needed 1 dose which she previously received on 2/27/23.  Employee denied pregnancy - no known allergies.  Pt. did not have any reaction, but was given an extra dose of MMR.
itching began 25APR98 itching began on head;had some itching of chest, arms & legs;skin bumpy not red;MD gave pills possible steroids per pt;
Start scratching the next day. Small raise red areas on the arm, back of arms, back of ankles, elbows, knees top of foot. Went to family Dr. received 2 steroid injections.
Sleeping wake up--arms & legs up in air stiff; eyes rolled back; stopped breathing--did this 5-6 times night p/shot;
reporting a patient was administered expired IPOL , with no reported adverse event; Initial information was received on 02-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 6 years old male patient who was reporting a patient was administered expired IPOL, with no reported adverse event after receiving IPV (Vero) [IMOVAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Mar-2023, the patient received a dose 2 of 0.5 ml of suspect IPV (Vero) (Suspension for injection) (lot U1A451M, Expiry date : 20-Feb-2023) (strength was unknown) via intramuscular route in the left deltoid for immunization.  On 01-Mar-2023 the patient developed a non-serious event of reporting a patient was administered expired ipol , with no reported adverse event (expired product administered) (latency: same day) following the administration of IPV (Vero).  No lab data reported.  Action taken :not applicable.  At time of reporting, the outcome was Unknown for the event reporting a patient was administered expired ipol , with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I experienced severe tingling/burning pain in upper arm after first injection. This did after several weeks get better but never completely go away. After several weeks after injection I started experiencing burning/tingling pain in bottom of feet and left hand. In April after working my right arm experienced severe tingling/burning pain from upper arm to fingers. This did get better but never completely went away. Over next months the pain worsened In Sept I went to physician, had nerve tests done , now scheduled for surgery to try to attempt to relieve the pain. My left hand / arm has also slowly gotten worse and will have surgery on it. Going to get follow up on my feet with neurologist.
PT recd 3 doses of vax 5JUL90, 6AUG90, & 7JAN91; PT did not seroconvert;
Narrative:  Patient Received the Moderna Covid Vaccine at 1355. Due to the Patient's medical history, he was listed to be monitored for 30 minutes by the nurse administering the vaccine. Patient noted to be in his own wheelchair and a catheter drainage bag was noted hanging from the side of his chair (cloudy yellow urine noted). Patient was accompanied by family (daughter and spouse). At approximately 1424, Patient c/o feeling sick to his stomach. This nurse noted Patient made a slumping motion in his wheelchair. Patient's vital signs were assessed immediately-results 99.9(oral)-58-16-80/51 (Sitting- Right Arm) Sats 94% on Room Air. Small beads of sweat noted to Patient's forehead; however, Patient remained alert and was able to respond to questions when this nurse questioned him. Patient denied pain...no distress noted. Spouse and daughter reported that Patient has a history of HBP. Family denied history of seizures, heart disease or diabetes, and also stated that Patient has not eaten since this morning. Elevation of lower extremities initiated, along with sips of H2O and a cool towel to forehead. 143-VS reassessed, results P-58-R18-BP140/55 (Right Arm). Sats 93% on Room Air. 1434-EMS notified. EMS arrived on site at 1439. Patient assessed by EMS staff and transported off station, via stretcher at 1446.
Information has been received from a nurse concerning two female patient's in their early 70's who were vaccinated subcutaneously with ZOSTAVAX and developed shingles after receiving the vaccine. Follow-up information was received from a physician which reported that a 73 year old white female patient with allergies to Lyrica, Ceftin, Vancomycin and Sulfanoamides who on 13-SEP-2006, was vaccinated subcutaneously into the left arm with ZOSTAVAX. On 25-AUG-2008, the patient developed a cataract in her left eye and developed eye pain and saw an ophthalmologist and was diagnosed with shingles at her right temple and eye brow area, treated with acyclovir. This is one of several reports from the same source. No further information is available.
Following vaccination, the pt experienced a loss of taste and smell. As of 8/24/00 the symptoms persisted.
pt reported to pharmacy of shoulder pain lingering for a few weeks after receiving flu shot. after seeing orthopedic md, md diagnosed her with bursitis from flu vaccination. md prescribed meloxicam to help with inflammation and pain. pt reported to pharmacy during vaccination administration, pharmacist was standing and may have administered it too high on the deltoid muscle.
This spontaneous report was received from a nurse practitioner referring to an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and drug or allergy reactions were not provided. On an unspecified date in April 2018, the patient was inadvertently vaccinated with a dose PROQUAD, subcutaneously (strength, dose, dose number, lot number and expiration date were not reported), for prophylaxis; instead of an intended unspecified vaccination. Concomitant therapies included a sterile diluent (lot number and expiration date were not reported). No adverse events were reported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:47 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.98.  Concomitant products were not provided.  On 15-APR-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-APR-2021, vial was moved to clinic on 15-APR-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-MAY-2021.  On 15-APR-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
4/22 fussy tactile temp, increasing abdominal pain, bloody stool 4/24 ultrasound = intussception
Right deltoid swelling, warmth, erythema and painful to touch. Took MOTRIN 800mg last dose 3/6/11.
High fever, nausea, vomiting, headache,  body aches, chills,
The patient was administered the Moderna  Covid-19 vaccine on 1/14/2021. The patient reported experiencing arm pain around the injection site during the 2 days following the vaccination. The patient reported experiencing hip pain and trouble with her legs on 1/21/2021. On 1/22/2021 the patient reported not being able to stand without bracing. The patient visited a doctor on 1/25/2021 and there was suspicion for inflammation of the spinal cord leading to the patient being prescribed prednisone for 6 days. The patient visited the doctor again on 2/2/21 and another course of prednisone was initiated. The patient reports that she can stand from a sitting position without help getting up about half the time and that she had no such trouble standing prior to the vaccination. The patient returned to the second vaccination clinic on 2/11/2021, which was  4 weeks after receiving the first dose, to report her symptoms. The patient was not administered the second dose of the Moderna Covid-19 vaccine.
3.5 months of prolonged fatigue, headaches, malaise, night sweats, balance issues since Covid vaccine and not improving.
expired dose of Menactra was given with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Global Medical Information (Reference number- 00737725) and transmitted to Sanofi on 24-Aug-2021.  This case involves an unknown age male patient who vaccinated with a 0.5mL (total) dose of an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (solution for injection) [lot U6690AA and expiry date 23-Aug-2021] via intramuscular route at an unknown administration site on 24-Aug-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, past vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  Reporter would like to know what is to be done in such a scenario.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt reported being sweaty, dizzy and fatigued about 5 minutes after receiving vaccine. Heart rate 80, BP 110/78 resp rate 22 SPO2 98%. Pt felt better within 15 minutes and was asking to go home. Was allowed to leave and advised if any further issues, she should go to ED
Soreness in arm, 101.3 temperature, joint/muscle pain. High temperature through 4:25 pm 9/19/19.