chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to a 43 year old male patient. On 21-JUL-2014 the patient was inadvertently vaccinated with PROQUAD (merck) (dose, route and lot # were not reported). No adverse effects reported. Additional information has been requested.
After receiving Menactra and Adacel, pt felt well. Had previously eaten in day. Walked to reception and had syncopal episode
Taking vaccine during pregnancy, with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 31 years old female patient who was exposed to vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] in context of taking vaccine during pregnancy, with no reported adverse event.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Taking vaccine during pregnancy, with no reported adverse event occurred at 5 weeks of pregnancy and the patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 5 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE.  The date of last menstrual period was reported as 16-Jun-2022. The estimated due date is 23-Mar-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.   On 09-Jul-2022, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (strength was unknown, lot UT7682KA and expiry date was unknown) via intramuscular route in the deltoid nos for Prophylactic vaccination.  On 09-Jul-2022 the patient developed a non-serious event of taking vaccine during pregnancy, with no reported adverse event (maternal exposure timing unspecified) (Latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken :not applicable.  Outcome: Unknown  Additionally, at time of reporting, the pregnancy was still ongoing.
Less than 24 hrs after injection site where administered extremely tender, unable to lift arm. 24 hrs after fever began at 99 degrees, extreme fatigue, muscle weakness, headache, some joint ache. 48 hrs after temp of 101 degrees, 76 hrs after temp of 100 degrees. Low grade temp continued for several days. Saw doc on 3rd day. Instructed to take BENADRYL.
Began with Rt sided headache 3 days after vaccine.  Pain began radiating into the shoulder and neck.  Resulted in neck surgery 12/24/09.  Symptoms worsening post op with leg and knee weakness b/l, chronic fatigue, occasional slurred speech, intermittent tingling to hands and episodes of tachycardia.  Has been referred to a neurologist for follow-up.
No adverse event; Dose administered after 30-day Use by Date to 7 patients; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date to 7 patients).    Concomitant medication details not reported by the reporter. It was unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details was not reported by the reporter. This case contains information for the 5th of 7 patients described by the reporter    This case was linked to US-MODERNATX, INC.-MOD-2023-721391 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721391:Patient 1 out of 7 patients
Soreness at injection site. After about 12 hours, a small red  rash began to appear. Body aches, exhaustion, headache, loss of appetite, nausea. 24 hours later, the red rash extended further and a lump formed. Very sore to the touch and difficult to lift arm.
This case was reported by a other health professional via sales rep and described the occurrence of rash in a 30-year-old patient who received TWINRIX adult. On an unknown date, the patient received TWINRIX adult 1 ml. On 7th July 2016, an unknown time after receiving TWINRIX adult, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. Additional details were provided as follows: The age at vaccination was not reported. The sale representative called on behalf of healthcare professional and did not have any additional information.
Redness and tenderness on the injection site. Started with a small redness about 3cm diameter then slowly progressed to about 6-8cm after few days. As of July 5, the area oo about 6-8cm is still red but not sore.
Slight Nausea 20 mins about 10:15 - 10:20 AM after injection vomiting about 5:00pm Nausea for about 2 hrs after vomiting. sore arm for a day after injection Small itchy Bumps/Rash, over entire back for two or three days after inection
Patient complained of shoulder pain on morning of 12/30, first thought to be from "sleeping wrong". Continued having nagging shoulder pain, and 1/12 diagnosed with possible Parsonage-Turner Syndrome of right upper extremity
Nausea day of injection. Face flushing, mid trunk with rash, raised injection site. Episodes of nausea day after. Severe nausea and emesis, muscle aches and weakness 2 days after. Unable to tolerate intake until 21:00 that noc.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. In 2015 (reported for all vaccines as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of (Merck) PROQUAD (dose and route were not reported), which underwent supported temperature excursions. The patient might have received the following lot numbers and expiration dates of (Merck) PROQUAD: lot# L002419 with expiration date 23-JUL-2016 or lot# reported as L005293 with expiration date 17-AUG-2016. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer Covid-19 Orange top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial (Adolescent age 12 and older) preparation and administration instructions. 1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml The dose given out of this vial was 0.3 ml The children (age 5-11) received 0.3ml x 41.9 mcg/ml = 12.6 mcg Pfizer case # int00506363
Varicella vax 1/28/98. Confirmed active Varicella 11/22/99 by Dr.
After receiving a COVID vaccination, patient experienced mild SOB, tongue swelling and tingling. She was treated with Benadryl while she was at the vaccine site.
the patient did not urinate for entire day/urine retention; dehydrated/dehydration; migraine; constipation; This spontaneous report was received from the patient's mother referring to a 13 years female patient. The patient was not pregnant. The patient had no medical history. The patient was allergy to azithromycin and cefdinir (OMNICEF). Concomitant medications included other unspecified medications.  On 07-JUN-2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route was reported as injection; dose detail, strength, lot# and expiration were not provided) for prophylaxis. On 30-SEP-2016, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route was reported as injection, lot # L038503, expiration date 18-DEC-2017; dose detail and strength were not provided) for prophylaxis.         In October 2016, the patient did not urinate for entire day, was dehydrated, and was experiencing a migraine. The patient went to emergency room with a length of stay of one to two days. The patient was hospitalized the second time in January 2017 with symptoms of migraine, dehydration, urine retention and constipation, for two days. The patient was then hospitalized once each in February and March 2017 again for migraine, dehydration, urine retention and constipation for two to three days per incident visit. The patient received many unspecified medications for treatment. On unspecified dates, many unspecified lab tests and blood work were performed. The outcome of the events was reported as not recovered.  The causality between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, urine retention was determined to be medically significant.  AEQIR routine was initiated since the patient was requesting lot check.
No Adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 12-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor. No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 1st out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739843, US-MODERNATX, INC.-MOD-2023-739848, US-MODERNATX, INC.-MOD-2023-739857, US-MODERNATX, INC.-MOD-2023-739859, US-MODERNATX, INC.-MOD-2023-739861, US-MODERNATX, INC.-MOD-2023-739862, US-MODERNATX, INC.-MOD-2023-739864, US-MODERNATX, INC.-MOD-2023-739863, US-MODERNATX, INC.-MOD-2023-739867, US-MODERNATX, INC.-MOD-2023-739868, US-MODERNATX, INC.-MOD-2023-739839, US-MODERNATX, INC.-MOD-2023-739851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739843:Patient 5 US-MODERNATX, INC.-MOD-2023-739848:Patient 7 US-MODERNATX, INC.-MOD-2023-739857:Patient 12 US-MODERNATX, INC.-MOD-2023-739867:Patient 10 US-MODERNATX, INC.-MOD-2023-739868:Patient 11 US-MODERNATX, INC.-MOD-2023-739861:Patient 14 US-MODERNATX, INC.-MOD-2023-739864:Patient 9 US-MODERNATX, INC.-MOD-2023-739863:Patient 16 US-MODERNATX, INC.-MOD-2023-739862:Patient 15 US-MODERNATX, INC.-MOD-2023-739859:Patient 13 US-MODERNATX, INC.-MOD-2023-739839:Patient 4 US-MODERNATX, INC.-MOD-2023-739851:Patient 8
The medical assistant did not attention that the Hib vaccine was not available in the refrigerator and mistakenly applied pentacel confusing the vaccine at the time of documenting in the chart they Patient check that it was the wrong vaccine and reported to the Provider
Minor bruising on 4/10, slight rounded rash around injection site.  Iced area for 20 minutes.   Rash went away after 24 hours.  Small bruise present.  Developed another rash encompassing entire upper arm on 4/17, red, swollen, hot to the touch.  Entire area very sore.  Felt a bit fatigued.  Took antihistamine, motrin, and iced area most of the day on 4/17 and 4/18.  4/19 - rash is receding but still area very painful to the touch, hot, sore, inflammed.
PFIZER COVID VACCINE 2ND DOSE ADMINISTERED 11 DAYS EARLIER THAN SCHEDULED. VACCINATING NURSE WAS NOT AWARE OF FIRST DOSE GIVEN.  PATIENT WAS MONITORED AND NO ADVERSE SIDE EFFECTS  WERE NOTED.
Conjunctival hemorrhage encompassing 2/3 of right eye; examined by ophthalmologist; resolving now; no loss of vision or any other problem
Redness, swelling, pain. Went to MD on 11/01/2019 and treated for cellulitis with medrol and cefprozil.
Afternoon or evening of 8/4/15 Pt was at store with parent. Had 5-7 min of vertical and horizontal nystagmus and limpness. No fever. Taken to nearby fire station and transport to ER. Normal EEG and MRI. No active findings on neuro exam. ER asked that we report.
epilepsy with complex focal seizure; POTS/headache; headache; Information has been received from a lawyer referring to a 15-year-old female patient regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (strength, dose, lot# and route unknown) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), headache and epilepsy with complex focal seizure. Reported date of injury was unspecified date in 2009. The outcome of the events was not reported. The causality assessment was considered as related by the lawyer.  Upon internal review, epilepsy with complex focal seizure was determined to be medically significant.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
Had night sweats, chills, and body aches during the night after the vaccine was given. Had fatigue and body aches next morning.
It shortened my typically 25-26 day cycle by about 4 days. My period came several days earlier than expected.
Pt received injection of VARIVAX 8/24/11 returned to office 8/26/11 with 11 1/2 x 8 cm red slight warm area at injection site. Mom states 8/25 injection site red, warm, size of goose egg. Per MD reaction vs cellulitis. Tx KEFLEX - BENADRYL, warm soak.
No additional AEs were reported; The healthcare worker reported that 14 patients received possibly improperly stored vaccines due to lack of temperature readings; Spontaneous information has been received from a healthcare worker concerning to a patient of unknown age and gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  A possible temperature excursion was reported for some stored vaccines due to the freezer temperature was not recorded since 10-JAN-2022.  On 04-APR-2022, the patient was administered a improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # T028582, has been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast), expiration date reported and validated as 04-MAR-2023) (route of administration and anatomical location were not provided) as prophylaxis (product storage error). No additional adverse events were reported (no adverse event).  This is one of 14 reports from the same reporter.
Narrative:  89 year old male admitted on August 11 2022 with chills, productive cough, and fever with mild hypoxia. He had received Moderna vaccine x 4 on January 21 2021, February 17 2021, August 31 2021, May 4 2022. He was treated with remdesivir 200 mg x 1 then 100 mg daily x 3 days and dexamethasone 6 mg IV daily x 5 days. He clinically improved and was discharged home on 8/16/2022.
pain at the injection site, pain in the entire arm with paresthesia, loss of range of motion of the arm and weakness.
Client denied sensitivity to latex, bananas, kiwis, avocados, European chestnuts and also denied sensitivity to Hep-B vaccine components and any adverse reactions to vaccines. The next AM, approx. 20 hours, post vax, he reported to me that his hands were very swollen and itchy. 3 hours later, he had head to toe hives. Recommended he not use latex gloves again and to consult his MD.
On May 22, 2022, patient woke up and his left leg was numb.  He thought he was having a stroke and went to the emergency room. He was hospitalized for 3 days while they ran tests to see what was causing it (CT scan, lab work, MRI of the neck).  They were unable to determine the cause and referred him to a neurologist.  The neurologist  ran 5 MRIs and many labs without finding anything and referred him to an infectious disease doctor.  The infectious disease doctor ran several labs and could not find anything that would have caused this and referred him back to the neurologist.  The neurologist did a spinal tap, then sent him to an oncologist.  The oncologist did a second spinal tap and said no cancer.  Patient went back to the neurologist who said that there was nothing they could do and would have him follow-up in 6 months.  He went back to Dr. (his PCP) because of his ears sounding like he is in a barrel.  Dr. gave him a steroid shot and advised him to have a VAERS report submitted.
Patient presented to second dose mass Moderna vaccination drive through clinic. Patient did not have an appointment but reports they were supposed to return for second dose. Paperwork given to complete which was checked off that patient had received Moderna previously. Patient did not mark through this or make any comment to the nurse administering that they had not received Moderna originally. The nurse gave immunization appropriately based on paperwork that patient filled out and per patient request. Upon coming back to the department and entering in the shot in  it would not let us enter as it reports that the first dose was Janssen vaccination. Upon going back through paper records we found that patient was given Janssen vaccination on 3/12/2021. Verified with nurses working the clinic on 3/12/2021 where Janssen and Moderna were both being administered and they reported that they were sure that paperwork was correct in the fact that they ask everyone a second time which vaccine they wanted and confirmed before administering. Unfortunately some who received Janssen overheard the instructions that were being given to those who received Moderna in the same building and chose to come back to the second dose clinic.
8 days after vaccine given (1st dose), urticaria around site of injection which resolved within 24 hours with 180mg fexofenadine.
I had soreness at the injection site & I had a break through Covid case with extreme fatigue, fever, no appetite felt very very week with a cough as well, SINGULAIR helped with breathing.
cough along with phlegm which is annoying; congestion; sore; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (cough along with phlegm which is annoying), NASAL CONGESTION (congestion) and MYALGIA (sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MYALGIA (sore). On 13-May-2021, the patient experienced PRODUCTIVE COUGH (cough along with phlegm which is annoying) and NASAL CONGESTION (congestion). On 13-May-2021, MYALGIA (sore) outcome was unknown. At the time of the report, PRODUCTIVE COUGH (cough along with phlegm which is annoying) and NASAL CONGESTION (congestion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Patient came to emergency department after receiving second dose of COVID-19 vaccine, unknown which manufacturer as occurred prior to emergency department visit, with worsening neck pain. Wound up being treated for possible anaphylaxis and intubated. He was intubated around 12 hours after the vaccine.