chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with GARDASIL (Lot #, expiration date, dose and route of administration not reported) that had been improperly stored. No adverse events reported. Additional information is not expected, because the reporter did not wish to be contacted.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for dyslipidemia, cva, ventricular tachycardia s/p ablation, ischemic cardiomyopathy, coronary arteriosclerosis. PT was 74 years of age at time of death. Received 2nd dose pfizer 4/10/21. Per note on 4/21/21, patient was brought to a outside entity hospital with a CC of "Cardiac Arrest" . Received bystander CPR and brought via EMS. No further information regarding cause of death documented.
Patient experienced extended episode of syncope and temporary discontinuation of respiration approximately 8 minutes after vaccination.
Muscle Pain; Joint Pain; Malaise; Nausea; 10 days of weakness  after first dose of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of muscle pain in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2020, the patient received the 1st dose of Shingrix. On 26th July 2020, less than a day after receiving Shingrix, the patient experienced muscle pain, joint pain, malaise, nausea and chills. On an unknown date, the outcome of the muscle pain, joint pain, malaise, nausea and chills were recovered/resolved.   It was unknown if the reporter considered the muscle pain, joint pain, malaise, nausea and chills to be related to Shingrix.  Additional details were reported as follows: The patient received the first dose in right arm. She described her side effects as muscle pain, joint pain, malaise, and nausea.  She had recovered but wanted to know if she should get the second injection and how long would the efficacy of the vaccine last.  The reporter wanted to know how long would the efficacy of the vaccine last. The reporter did not consent to follow up.
This spontaneous report as received from a medical assistant refers to 4 year old patient of unknown gender. Medical history and current conditions were not reported. On 13-JUL-2017, the patient was vaccinated with improperly stored PROQUAD (lot # M043306, expiry date: 24-APR-2018) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiry unknown). The vaccine was stored between -14 Celsius degrees (C) to -10 C with timeframe 6 hours 31 minutes. During previous temperature excursion vaccine was exposed to a temperature range of -14 C to -10 C for 538 hours 52 minutes. No adverse effects were reported. Digital data logger was involved. No product quality complaint was reported. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1708USA001467: US-009507513-708USA001338: US-009507513-1709USA005542: US-009507513-1709USA006807: US-009507513-1709USA006809: US-009507513-1709USA006813: US-009507513-1709USA006815: US-009507513-1709USA006816: US-009507513-1709USA006819: US-009507513-1709USA006820.
Bexsero mennigicoccal B was given in error instead of the Menveo ,
After receiving first dose of Pfizer COVID-19 vaccine, patient stated "I don't feel okay" Patient remained conscious and aware. Patient denied pain, SOB, chest pain or other medical complaints. Patient reported feeling lightheaded, that she only had a smoothie to eat today. Patient was moved to the recliner chair and was accompanied by her mother the entire time. Patient was given orange juice. Patient tolerated oral fluids, stating that reported feeling had gone away. Patient was monitored and ate a small snack. Patient reported feeling fine. Patient was going to remain with mother for remainder of the day and advised to call 911 if she experienced any distress.
My period came early, which it has never done before. It came on April 20th when it wasn't supposed to come until the 27th. It started out as spotting, then became heavier. It has since become lighter in flow but I am still bleeding as of 03May2021. Color is inconsistent compared to other cycles. It ranges from bright red to rust color red.
neck of vial was broken from where it was weak and someone in the office cut her finger on it; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case from a physician.   This case involves patient of unknown demographics who while opening the new box after delivery on 29th, had a finger cut as the neck of vial was broken from where it was weak and also as the delivery contained shattered vial in center, while he/she received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment(s), vaccination(s), concomitant medication(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 (lot U6827BA and expiration date 18-Feb-2022) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious finger cut as the neck of vial was broken from where it was weak  (limb injury) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Other case details reported regarding product details: Number of units affected- one vial , but was requesting the entire box of five to be replaced as the reporter doesn't feel comfortable using them and the broken vial was kept in the box ; Is dose not used or not available- not used and available ; Whether product is available for return- yes ; Broke or cracked during preparation or use- no; Received broken or cracked in the carton- yes; Was there any damage to the carton upon receipt- no ; Was there any product residue in the carton- no ; Were there any signs of damage to any other vial in the carton- not that he can tell.  No laboratory date reported.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event limb injury.  there will be no information on the batch number for this case.
While screening the patient for the 2nd dose, she told me that she had trouble breathing around midnight the night that the 1st dose was administered. She said she was having anxiety and she thinks it might have been from that. Her father offered to take her to the hospital but she declined. She drank a lot of water and woke up fine the next morning. I deferred the 2nd dose until she consults with a physician. She currently has no PCP.
Red and Swollen thigh (site of shot), uncontrollable screaming crying, pain and tenderness.
Sudden hearing loss; Ear ringing; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (Sudden hearing loss) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced TINNITUS (Ear ringing). On 10-Mar-2021, the patient experienced SUDDEN HEARING LOSS (Sudden hearing loss) (seriousness criterion medically significant). At the time of the report, SUDDEN HEARING LOSS (Sudden hearing loss) and TINNITUS (Ear ringing) had not resolved.  Concomitant medications were not reported. Treatment received in response to the events was not reported. Company Comment Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Minor cold like symptoms that progressed into worse cold like symptoms with pink eye & migraines.  Cold like symptoms: cough, sinus congestion & drip, sore throat & congested ears Still have symptoms currently. Symptoms kind of get worse & better but never fully go away.
Strange and rare side effect; Swollen lymph node; "Virchow's" lymph node that was swollen; This spontaneous case was reported by a consumer and describes the occurrence of METASTASES TO LYMPH NODES ("Virchow's" lymph node that was swollen), VACCINATION COMPLICATION (Strange and rare side effect) and LYMPHADENOPATHY (Swollen lymph node) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 031A21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.  On 02-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced METASTASES TO LYMPH NODES ("Virchow's" lymph node that was swollen) and LYMPHADENOPATHY (Swollen lymph node). On an unknown date, the patient experienced VACCINATION COMPLICATION (Strange and rare side effect). At the time of the report, METASTASES TO LYMPH NODES ("Virchow's" lymph node that was swollen), VACCINATION COMPLICATION (Strange and rare side effect) and LYMPHADENOPATHY (Swollen lymph node) outcome was unknown.     Patient stated that the lymph node sends a signal when it get swollen and was an indication of abdominal cancer.   No relevant concomitant medications were reported.  No treatment information was provided  Company Comment: The only reported events in this case are non-serious, hence no CC is required.   This case was linked to MOD-2022-440527 (Patient Link).; Sender's Comments: The only reported events in this case are non-serious, hence no CC is required.
Patient states 20 minutes after receiving the injection she began having a scratchy throat and began having shortness of breath.  She also developed some itching to the site.  She presented to the Emergency Department and noted to have hoarseness but no severe dyspnea.  Patient was given steroids and Benadryl.  Her symptoms did not worsen and she was discharged home.
Same day on the vaccine I noticed swelling on the vaccine site. Two days later I started feeling my throat swollen I had my lymph node swollen on my neck & under the jaw line everything was on the left side as the vaccine. It started to become very painful 6 days later I went to the urgent care and they gave me antibiotics to treat it. It was a 2 week treatment once I finished it about 5 days later I had to go again because it started to happen again I went in to get more. Now a couple a weeks ago its starting again but I have not gone to the urgent care anymore I'm just watching it and hoping it goes away. If it does get worst then I will be going again.
This spontaneous report as received from a register nurse in physician's office refers to a 17 year old female patient. On 12-DEC-2012 the patient was vaccinated with first dose of GARDASIL (lot number unspecified) intramuscularly. On 14-MAR-2013 the patient was vaccinated with second dose of GARDASIL (lot number unspecified) intramuscularly. The outcome of the patient was unknown. It was unknown if the patient had sought medical attention. Additional information has been requested.
Injection site soreness and redness. Chills, body ache headache and fever. Ski  Hurt to the touch. Very uncomfortable.  Low grade Fever of 99.5 started around 5 am approx 13 hours after vaccination. 16 hours later  at 8 am, it was 101.4, then  101.9, 102.1. I took Tylenol 2 tablets 500mg every 4 hours. By 3 pm it was 102.9. I took ibuprofen. 800mg 1 tablet. Fever went down to 101.4 and by 7 pm it was 98.6. By 11 pm it was 99.5 and climbing again. Took 2 Tylenol 500 mg each. 100.3 by midnight
Within a few days of first shot, I developed a sort of numbness/tingling/cold feeling in my 2nd and 3rd toes on my right foot. Over time the symptoms have spread and I developed small sores on my feet. I also am feeling some slight tingling and cold feelings in my hands/fingertips but no blisters at this time.
Patient state that she felt tingling of her left arm the day flu shot was administered then it started soaring to the point where she had a limited mobility in her left arm due to severe pain. Patient received cortisone shot at Drs office on 11/2/09.
On Jan 7, 2021, in the evening, I noted new discomfort at the injection site.  There was a 3 x 4 cm area of erythema and induration.  The area was warm to touch with pain on deep palpation.  Also a faint macular rash on anterior chest wall.  I took loratadine 10 mg shortly there after with improvement in rash on chest.  The injection site reaction remained and continues to cause discomfort.
I got my booster on Monday around 12:30 pm.  They said it was okay to get Pfizer even if you got Moderna for your first 2 shots.  I felt weird (fatigued and dizzy) so I went to bed early like 8:30pm.  I fell asleep and what I remember was feeling like I was trapped in someone else?s body, in another world AND I couldn?t wake up. When I could finally wake myself (which it felt like FOREVER) I had to run to the bathroom to vomit.  I took ibuprofen and went back to sleep.  The following day, Tuesday, I felt tired all day even though I had gotten  almost 12 hours of sleep.
macularpapular rash devel over inject site 1 day p/shot given;
Vaccine 4/8 @ 3:15 pm  Local injection site pain 4/8 @ 6:30 pm 4/9: upon waking (6 am) pain and local heat at injection site; all over muscle pain; all joints in pain; temporary fever over 99 F briefly 12 pm - 12:30 pm 4/10: upon waking (7:30 am) all pain gone other than knee discomfort. knees appeared normal, but had fluid buildup preventing full range of motion. Knee fluid and inability to kneel due to pressure and pain persisted through 4/13.  Began taking ibuprofen 400 mg 4/13 morning at 4 hours intervals. Noted reduction in swelling of right knee after 5 hours. No change in left knee.  4/14: noted minor reduction in knee swelling of left knee upon waking at 6 am. Consulted NP 4/14 @ 9:30 am. She suggested increasing dose to 800 mg every 8 hours for up to 5 days, wrapping knees for compression and ordered an ultrasound for blood clots
pt recv vax APR96 & 24MAY96 or 25MAY96 pt devel a typical rash;
Two nights in a row, 04/07 and 04/08, woke up with rapid heart rate (fluctuating from 85-110 bpm) and felt dizzy, fatigued, feverish, sweaty, shaky and about to pass out. Could have been hyperventilating in sleep because of rapid heart rate. Required about 2 hours of attention to reading, yoga and relaxation to get to sleep. On morning of 04/08, heart rate was still high (78-95) for resting, which is usually in the 50s or 60s. GI disturbance led to frequent bowel movements and the whole condition resulted in malaise and feeling of impending doom. A feedback from acute anxiety as a result of symptoms could be involved. Also involved is the diphenhydramine I took at 9 pm on 04/07 to treat hay fever and acute insomnia. Night if 04/08 was more manageable. But it interrupted sleep with strong disturbances that felt like spasms in prefrontal cortex coming out of sleep. More likely it was movement in sinus congestion that triggered a startle response while exhausted from work. It was bad timing to have the shot during a very busy work week.
some of it spilled out during administration - about half of the vaccine was administered; some of it spilled out during administration - about half of the vaccine was administered; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (some of it spilled out during administration - about half of the vaccine was administered) and DEVICE CONNECTION ISSUE (some of it spilled out during administration - about half of the vaccine was administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No Adverse Event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (some of it spilled out during administration - about half of the vaccine was administered) and DEVICE CONNECTION ISSUE (some of it spilled out during administration - about half of the vaccine was administered). At the time of the report, UNDERDOSE (some of it spilled out during administration - about half of the vaccine was administered) and DEVICE CONNECTION ISSUE (some of it spilled out during administration - about half of the vaccine was administered) had resolved. Not Provided      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.
a headache pounding currently taking 1000 mg of tylenol every 6 hours
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: After shot told patient to sit by pharmacy for monitoring, patient refused and walked around store. Patient fell and hit his head, loss consciousness for 3 seconds, woke up and threw up. Insturcted patient to sit by pharmacy for 30 minutes, patient refused and walked to car. Walked patient to car and spoke to girlfriend. Spoke to mother on phone as well, she informed me he has a history of anxiety with shots and needles and ALWAYS faints after a vaccination (usual reaction).
*Dose #1 on 4/23/21: caused an acute pinging headache about 5hrs after shot and high fever overnight. The second day around 11:30AM I had severe nausea and vomiting all morning, on top of the muscle/joint pain, and severe tiredness leading to sleeping for two days. *Dose #2 on 5/14/21: No nausea or vomiting and mitigated acute headache by taking lots of water and Ibuprofen to reduce to a mild pinging headache the day of. The second day same time as before 11:30AM severe muscle and joint pain, chills, and severe tiredness resulting in a deep sleep for 12+ hours. Second does no nausea or vomiting but body chills were new and muscle/joint pain more sever than dose #1.
SORE ARM; FREEZING; 99F TEMPERATURE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: 09-JUN-2021) dose was not reported, administered on 18-MAR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the patient experienced freezing. On 18-MAR-2021, the patient experienced 99f temperature. Laboratory data included: Body temperature (NR: not provided) 99 F. On 19-MAR-2021, the patient experienced sore arm. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on MAR-2021, and freezing, and 99f temperature on 19-MAR-2021. This report was non-serious.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot # L042817, expiration date: 14-JUN-2017. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 23.2 degrees Fahrenheit for cumulative time of 842.6 hours. Data logger was involved. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Additional information has been requested.
Pregnancy (30 days after second  Moderna vaccine) with in date, correctly placed, and fully functional IUD. Subsequent miscarriage in which a surgical D & C had to be performed for a missed miscarriage.  Amenorrhea and infertility sustained for 7 months in combination with uterine endometrial lining noted to be fairly thin at 5.5 mm during ultrasound with no plausible explanation or cause.
Full body aches and pains. Slept for 4 days. Severe headache, dry heaves, constipation, coughing and congestion. Could not eat, only sip water. Equilibrium loss when walking to bathroom.
fatigue; This spontaneous case was reported by an other and describes the occurrence of FATIGUE (fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Previously administered products included for an unreported indication: COVID-19 VACCINE (PFIZER-BIONTECH COVID-19 VACCINE).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.            This case was linked to MOD-2021-073533 (Patient Link).
My Mother, at 92, almost 93, was given the Booster shot on Oct. 12.  Although she had the start of Dementia, Mom was still Mom.  After the booster, Mom went into a spiral downfall.  The Dr. diagnosed her with Organic Brain Syndrome.  My mother passed away Nov. 6, 2021.  She had stopped eating, was in pain, could not speak from approximately Oct 22 - Nov 6.  Organic Brain Syndrome is triggered by too many toxins in your body.  At 92, her body was not equipped to take such a powerful vaccination and my sisters, nurse and I believe the Booster pushed her into a toxic state that escalated her untimely death.
One week after first SHINGRIX dose, I developed about 5-6 fluid-filled vesicles on the mucous membrane lining the inside of my mouth. As of today, (April 25), the vesicles are slowly resolving but are still present.
Patient received vaccine (ZOSTAVAX) on 5-27-10 (L) SQ arm. On 5-30-10 reports to pharmacy with red, raised rash at injection site and says it is itchy.