chrisvoncsefalvay/vaers-outcomes huggingface dataset:
huge red patch; Arm pain; itchy; Headache; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm pain), PRURITUS (itchy), HEADACHE (Headache) and INJECTION SITE ERYTHEMA (huge red patch) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A MSTDT and 023M20A) for COVID-19 vaccination.     Concomitant products included LETROZOLE 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 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain), PRURITUS (itchy) and HEADACHE (Headache). On 09-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (huge red patch). On 28-Jan-2021, PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) had resolved. At the time of the report, PRURITUS (itchy) and INJECTION SITE ERYTHEMA (huge red patch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable patient took treatment medication with steroid ointment and concomitant medication   This case was linked to MOD-2021-101442 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Completed ADR Form
"felt like it went to the bone"/like a "bee sting"/needle felt big and long; Usually "feels perky" but feels "like crap".; No energy; Feeling faint; Left arm was sore; Fatigue; Muscle pain; Chills; Nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint) and VACCINATION SITE PAIN (Left arm was sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0341F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disorder (he takes prescription medications for his heart and diabetes) and Diabetes.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, the patient experienced VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint), VACCINATION SITE PAIN (Left arm was sore), FATIGUE (Fatigue), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, VACCINATION SITE DISCOMFORT ("felt like it went to the bone"/like a "bee sting"/needle felt big and long), FEELING ABNORMAL (Usually "feels perky" but feels "like crap".), ASTHENIA (No energy), DIZZINESS (Feeling faint), MYALGIA (Muscle pain), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown and VACCINATION SITE PAIN (Left arm was sore) and FATIGUE (Fatigue) had not resolved.            He stated he is acting like "an old man". He stated he had not treated the events with any medications. The caller stated he was taking prescription medications for his heart and diabetes (names of medications not reported).   This case was linked to MOD-2021-396348, MOD-2021-396362, MOD-2021-396362 (Patient Link).
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 30-JUL-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, subsequent to inoculation, the pt was treated for herpes zoster. The pt had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Janssen COVID-19 Vaccine EUA. 0900: patient reports dizziness 0903: BP 97/58, HR- 44, 02 RA 99%. syncopal episode occur. S/SX seizure/posture (15 seconds), diaphoretic. DOD aware, paramedics called 0905: AxOx4. BP 98/60, HR 60, O2 98% 0905: medics arrive to vaccine clinic. EKG done + STEMI. Patient transferred via gurney to ambulance for higher level of care, Allergy to COVID-19 vaccine documented in Allergies activity, Patient advised to discuss second dose considerations with a clinician Patient transferred via ambulance to ER 0940: patient arrival at ER. BMP, CBC w/auto Diff, Troponin I, ED EKG-CernerCV,  Diagnosis: Syncope, Patient advised to follow up with primary care physician within 1-2 days
Swelling in the left armpit; Dose 1 on 11May2021 and Dose 2 on 24Jun2021; This is a spontaneous report from a contactable other healthcare professional, the patient. A 38-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185) via an unspecified route of administration in the left arm on 24Jun2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the left arm on 11May2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 25Jun2021, the patient experienced swelling in the left armpit. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of event swelling in the left armpit was recovered on an unknown date in 2021.
- Sudden loss of hearing in left ear on April 10 (5 days after second COVID shot) upon waking up in the morning around 8:00 am.   - Loss of hearing was becoming more pronounced, so I went to the doctor for an exam on 4/14.  Dr. could not determine cause of hearing loss.   Scheduled an audiology exam and appointment with ENT for 4/15.  Doctor prescribed oral steriods to try and save hearing.   While I was at the pharmacy waiting for my Rx, I suddenly developed vertigo around 5:30 pm, which resulted in being sent to the ER.  I could not stand, felt faint, and was vomiting excessively.   - At the ER, was given lots of anti-nausea medication.  Eventually, the tests determined that there was nothing obviously wrong in my brain (aneurysm, stroke, tumor, etc.), and the medication stopped the vomiting such that I was able to be discharged around midnight.
Employee reports to this writer that within 2 minutes of vaccine recieved she experienced dizziness, felt presyncopal,, facial flushing, throat pressure, had elevated BP, itchy cheeks, nausea, chest pressure. Went to ER where they treated her like she had an anxiety attack. No epi given.  Patient consulted with her own private ENT?allergist Dr. the next day who states it sounded like a reaction and prescribed Xyzal
Four hours after the vaccine had no strength and could not walk at all. in addition all the pains he had before escalated so he needed very strong pain relievers. Also lack of comprehension when we got the ER.
Nurse states: While setting up the current station with supplies and equipment, I opened the caps of both the normal saline and Pfizer vials, wiped both tops using a different alcohol wipe and obtained a new 1mL syringe with 25g needle. 1mL of air was pulled back into the syringe and injected into the normal saline bottle. The normal saline bottle was then inverted upwards and 1mL of diluent was pulled back into the syringe and injected into the new vial of Pfizer. The same step was repeated a second time with 0.3mL of air injected into the normal saline bottle, 0.3mL of normal saline pulled back into syringe and injected into the vial of Pfizer. The vial was then inverted 10 times to ensure both the vaccine and saline was thoroughly mixed. But nurse noticed when administering that she was short a number of doses that should have not been left over if vial was diluted correctly or the correct dosage was administered.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with ROTATEQ lot # K015831, expiration date 18-APR-2016 (route was not provided). Concomitant therapy information was not provided. On unknown dates, there was incorrect product storage as improperly stored ROTATEQ was administered to unspecified patients. There was no adverse event. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. The outcome of incorrect product storage and no adverse event was unknown. This is one of several reports received from the same source. Additional information has been requested.
positive antigen test; positive antigen test; This is a spontaneous report received from a non-contactable Physician. The reporter is the patient. A 27-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Patient did not have other medication in 2weeks. It was reported that day 6 after completion of Paxlovid (day 11 after positive antigen test) developed rhinorrhea, and antigen test was again positive (after negative on day 7). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive; (unspecified date) Negative; (06Jun2022) again Positive. Patient received Paxlovid from 27May2022 to 31May2022 for Treatment of COVID-19. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the reported events drug ineffective and Covid 19 cannot be completely excluded.
Child had redness and edema around the injection site, significant swelling of leg even 2 days, later, warm to touch advised parents to put warm compress on site. Patient has rxn 3 PEDIARIX before, but this is the first DTaP.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On 18-AUG-2014 the patient was vaccinated with PNEUMOVAX 23 injection form-STR, lot #, unknown, expiry date, 11-JUL-2014 (other details unspecified). No concomitant therapy was reported. On 18-AUG-2014 the patient received an expired dose of PNEUMOVAX 23. No adverse events were reported. No product quality complaint was filed. The patient did not seek medical attention. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to the therapy with PNEUMOVAX 23. Additional information has been requested.
Vax was wrongly injected into shoulder instead of muscle. Pt 's shoulder became inflamed, kept doing active exercise for shoulder. during covid could not go to dr. until earlier this year and  referred to orthopedic surgeon   did MRI.
10 min. after vaccine - small pang of soreness through left arm, went away after a couple of seconds 7:30 PM the same day - Grade 3 fever (102.9 degrees), intense chills, joint pain, minor headache, loss of taste and smell, coughing fits. Threw on lots of blankets, drank some water, and took two Tylenol pills. 10:30 PM the same day - while on Tylenol, fever dropped to 101.9. Kept taking Tylenol until I went to bed at around 1 AM. 9 AM on Sunday 3/7 - 101.2 w/out Tylenol, no chills or coughing, minor headache. Symptoms faded away over the course of the rest of the day. Back at 100% on Monday 3/8.
16 vials of Menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees F, due to the refrigerator door accidentally being left ajar; Initial information received on 21-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient with unknown demographics who had 16 vials of menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees f, due to the refrigerator door accidentally being left ajar while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with unknown dose lot U70878AA (6 vials) via unknown route in unknown administration site for immunization.  On 20-JAN-2022 the patient had 16 vials of menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees f, due to the refrigerator door accidentally being left ajar (product temperature excursion issue) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (16 vials of Menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees F, due to the refrigerator door accidentally being left ajar).  At time of reporting, the outcome was Unknown for the event 16 vials of menactra that were our of range for 21 hours reaching a maximum temperature of 52.3 degrees f, due to the refrigerator door accidentally being left ajar.   Additional information was received on 23-Feb-2022 from a other health professional:Case updated from non case to valid case.
leaky needle with what he thinks is the full dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT DOSE ADMINISTERED (leaky needle with what he thinks is the full dose) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (leaky needle with what he thinks is the full dose). At the time of the report, INCORRECT DOSE ADMINISTERED (leaky needle with what he thinks is the full dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 06-APR-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments:  US-009507513-1802USA001558.
I had a slight anxiety feeling like fast heartbeat during my 15 minute wait time but not alarming. I left and continued my day but felt increasingly itchy and hours later developed a few hives.  I took a Zyrtec and after a few more hours it all went away,  For the next few days I had tiredness, joint pain and some chills. Completely better after a week.
A few hours after vaccine, sore arm for the next twenty-four hours. No side effects followed until Day 9 and still lingers today. Pain and rash first appeared below injection site. The location has spread in size to five or so inches and includes the site, and above on to the shoulder.
Two days after the second Pfizer injection developed profound fatigue, brain fog, shortness of breath, and frequent PVCs. This persisted for ten weeks, confirmed via Holter Monitor. Still battling fatigue and brain fog.
Possible vaccination with 1.5 dose instead of 1 dose; vaccination adverse reaction; A spontaneous report was received from a consumer, concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) 1.5 dose instead of 1 dose.(PT: Accidental Overdose) with an associated unknown side effects (PT: Vaccination adverse reaction)  The patient's medical history was not provided. No relevant concomitant medications were reported.    On unspecified date in February 2021, the patient received one of the two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date in February 2021, the patient received 1.5 dose of vaccine instead of 1 dose.  Vaccination adverse reactions was reported by the patient after being given the vaccine. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event received 1.5 dose instead of 1 dose was considered resolved. The outcome of Vaccination adverse reactions was not reported; Reporter's Comments: This report refers to a case of accidental overdose for mRNA-1273 (lot # unknown) with an associated vaccination complications (unspecified) reported.
Day 4 after shot - both eyelids were sensitive to touch.  Severe pain in both knees. Day 5 both eyelids were puffy and swollen.  Severe pain in both knees. Day 7 - both issues had subsided but still discomfort
c/o pain radiating down lt side of chest wall 1 day p/vax, nausea, dizziness, SOB;?anginal or rxn to flu shot;pain subsided in 1-2 days;
Hives all over her chest Felt sick, tired, no fever, light headed.  Started next day and started feeling better 3 days later.
One week after vaccine, injection site became extremely swollen (approx. 2"x3" induration), burning hot to the touch, tender & itchy, arm became numb. General malaise, low grade fever. Site reaction spread down arm, went to urgent care & was told it may be cellulitis & was given antibiotics & told to go to ER if it continued to spread. It spread outside of line that was drawn the next day so I went to ER. They did nothing & told me remain on antibiotics & to see allergist & PCP. Reaction continued to spread, arm/hand numbness & general feeling of illness, slight fever continued for approx. 2 weeks following vaccine. Site reaction fully subsided visually by 1/26 (began 1/15). Allergist suggested it was severe immune reaction to vaccine. Felt generally unwell for approx. 5 weeks following vaccine. Was told I should not get second dose or any covid/flu vaccines in the future. I have history of poor reaction to vaccines/site reactions.
101 deg temperature, measured by ear temp device; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 70-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The medical history included allergy to penicillin.  Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medication for blood pressure within two weeks of vaccination. On an unknown date in Apr2021, the patient experienced 101 degree temperature which was measured by ear temp device. On an unknown date in Apr2021, the patient underwent body temperature test and tested with a temperature of 101 deg(unspecified unit). Therapeutic measures were not taken as a result of the reported event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event 101 deg temperature  was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.