chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administrated /batch recall on March 29 2021/ recall 10feb2021; administrated /batch recall on March 29 2021/ recall 10feb2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th September 2022) for prophylaxis.   On 29th March 2021, the patient received Shingrix. On 29th March 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: Health care professional reported that the patient was administered with recalled Shingrix vaccine lot, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This is 1 of the six cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Same reporter. US-GLAXOSMITHKLINE-US2021169133:Same reporter US-GLAXOSMITHKLINE-US2021169134:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter
Vomiting started around 1 am the following morning lasting until 5pm. Severe head ache and body aches still happening and hives broken out on chest.
Headache , Fever 102,  Nausea, Faint, Body/Muscle aches (lasted for 2 days)
Herpes Zoster rash from below umbilicus to right flank and right lumbar area started on 3/7, seen on  3/10 d/t spreading; treated with acyclovir; no exposure to chicken pox or zoster
His oxygen dropped to 88%; Upper bronchitis infection; words wouldn't go together; snoring a lot; COPD; Bronchitis, upper bronchitis infection; Sleep apnea; Meory issues, words wouldn't go together; This spontaneous case was reported by a consumer and describes the occurrence of OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease (from 10 years.).    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced OXYGEN SATURATION DECREASED (His oxygen dropped to 88%) (seriousness criteria hospitalization and medically significant), UPPER RESPIRATORY TRACT INFECTION (Upper bronchitis infection), DISORGANISED SPEECH (words wouldn't go together), SNORING (snoring a lot), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), BRONCHITIS (Bronchitis, upper bronchitis infection), SLEEP APNOEA SYNDROME (Sleep apnea) and MEMORY IMPAIRMENT (Meory issues, words wouldn't go together). At the time of the report, OXYGEN SATURATION DECREASED (His oxygen dropped to 88%), UPPER RESPIRATORY TRACT INFECTION (Upper bronchitis infection), DISORGANISED SPEECH (words wouldn't go together), SNORING (snoring a lot), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), BRONCHITIS (Bronchitis, upper bronchitis infection), SLEEP APNOEA SYNDROME (Sleep apnea) and MEMORY IMPAIRMENT (Meory issues, words wouldn't go together) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, Oxygen saturation: 88% (Low) oxygen dropped to 88%.         No concomitant medication was reported.  Patient had a follow up with Doctor and appointment at a Pulmonologist. His Oxygen dropped so fast they rush him Oxygen and pushed him in a wheel across the street to the hospital. He never had any issues with in the past 8 years.   Treatment medication was not provided by the reporter.  Company comment:This case concerns a 68-year-old, male patient with previous relevant medical history of Parkinson´s disease, who experienced the unexpected event of oxygen saturation decreased. The event occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of Parkinson´s disease remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This case concerns a 68-year-old, male patient with previous relevant medical history of Parkinson´s disease, who experienced the unexpected event of oxygen saturation decreased. The event occurred 1 day after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of Parkinson´s disease remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report
Numb right side of face cheek down to under chi and lip, like after dental visit. Lasted about 45 minutes. Next day, on 9/16/2016, symptoms returned about 2:00, more left side of face and chin area involvement. Decided to look on CDC site for info on Flu vaccines. Concerned when I saw online there may be latex in the vaccine. Possible reaction ? Or something else wrong?
My whole body broke out in to a rash; I am breaking out in to hives; My neck is just swelling, like my throat closing up; My neck is just swelling, like my throat closing up; This is a spontaneous report from a contactable consumer or other non healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 03Aug2021 (Batch/Lot number was not reported) as DOSE NUMBER, UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced whole body broke out in to a rash, breaking out in to hives causing urticaria, had the neck swelling, like the throat closing up and throat tightness on Aug2021 with outcome of unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I was at the front desk setting up a follow-up date for my daughter's second shot for Hepatitis A vaccine when I turned my head toward her and it seemed she was coming toward me.  I noticed that there was no recognition in her eyes (a vacant stare) and as I went to grab her because she kept coming towards me (she was falling)she fell to the floor.  Her arms and legs immediately extended straight and her hands were shaking.  Her eyes rolled back in their sockets.  As I screamed for someone to help me, the doctor came and requested oxygen.  Doctor asked if my daughter was allergic to latex, which I informed him that I did not know.  She then came to and the doctor and myself moved her back into a room.  Doctor checked her pulse and gave me a bag of ice for the bump on her head.  After about 20-30 minutes, the doctor and nurse came in and checked on my daughter again.  We sat her up at which time my daughter stated she felt pressure on her chest as she was breathing.  Doctor checked her heartbeat and had the nurse give my daughter Benadryl.  About 30 minutes later, they checked on her and we left.  I stayed home to monitor my daughter (returned home around 2:30 p.m. - her appointment was at 11:00 a.m.)and she  slept for about 3 hours.  This morning (2/14/06) her head is sore and she stated she felt that she was moving in slow motion or that her body was lethargic.
skin warm to touch, area red & swollen with rash present 2x3 inches;
Developed a high fever within 24 hours of the immunizations. Was taken to hospital where the doctor stated it was most likely a reaction to the immunizations.
A 5-year-old patient who was vaccinated with pediatric Pfizer FL8095. After the inoculation he was crying in his mother's arms the child gets dizzy and does not respond. At that moment the paramedic takes the minor in her arms and he begins to answer and call his mother. Vital signs were taken quickly: Pulse-97, Temp-95.0, B/P- 90/60, Breaths-19, SPO2- 95%. Was observed for 30 minutes according to Dr. instructions. At the time of the patient's discharge he was stable and conscious.
no adverse effects; Inappropriate administration schedule; This spontaneous report was received from a registered nurse and refers to a 19-year-old patient on unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction or allergies were not reported.  On 25-JUN-2014, when the patient was 14 years old, 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) (exact dose, site and route of administration, lot# and expiration date were not reported). On 16-AUG-2019, 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), lot# 1602284, expiration date: 26-SEP-2021 (exact dose, site and route of administration were not reported). No adverse effects were reported.
On 03/31/2019, the patient has 2 presyncopal events with no loss of consciousness and complaints of headaches and dizziness. We pushed fluids for possible dehydration. On 4/1/2019 the patient attempted to attend school, I was called by nurse and the patient was sent home with complaints of headache and dizziness. On 4/1/2019 seen by nurse practitioner at pediatrician?s office who did orthostatic vital signs. No significant change in blood pressure but 20 point increase in heart rate. Diagnosed with dehydration and told to come back if not resolved. We pushed fluids and salt. Continued complaints of headache and dizziness on 4/2-4/3/2019 and unable to attend school or tolerate upright position before verbalizing need to lay down. Returned to pediatrician office 4/3/2019 seen by a different nurse practitioner. Orthostatic vital signs rechecked with heart rate at 120 in office. We were sent to the hospital for outpatient EKG. The patient continued with headache,  dizziness and inability to tolerate out of bed. On 4/5/19 phone call from nurse practitioner report EKG showed sinus arrhythmia, being referred to pediatric cardiologist. Cardiologist diagnosed postural orthostatic tachycardia syndrome on 4/11/2019. Treated with fludocortisone. We questionedWorsening of symptoms after second dose. Increased heart rate, blood pressure, decreased concentration, and fatigue. Added metoprolol and pyridostigmine.
allergy symptoms; sensitive to food; nauseous; rash on her face; Redness on the injection site; rash on the injection site; tired, fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food), RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site) and INJECTION SITE RASH (rash on the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concurrent medical conditions included Consciousness loss (Due to her mast cell disorder that makes her really sensitive.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (tired, fatigue). On 29-Mar-2021, the patient experienced RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site) and INJECTION SITE RASH (rash on the injection site). On an unknown date, the patient experienced HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food) and NAUSEA (nauseous). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (allergy symptoms), FOOD ALLERGY (sensitive to food), RASH (rash on her face), INJECTION SITE ERYTHEMA (Redness on the injection site), INJECTION SITE RASH (rash on the injection site), FATIGUE (tired, fatigue) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications includes Allergy medicine, thyroid medicine.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19-APR-2021 Contains Updated Patient demographic details, Anatomical Location, Added Concomitant Medications, Added new events.
pain, joint aching, chills, fever, headache, sore arm, sore throat, nauseated, diarrhea
Immediately after receiving  the  vaccine:  had  headache,felt full body aches and extreme fatigue , severe arm soreness and  could not lift arm up to the side
Inconsolable crying x 7 days without fever, no symptoms w/ acute illness. CBC normal, ESR 12, CRP <1. Ibuprofen 4cc (80mg) PO TID x 5 days.
lump under left arm size of orange, fever, chill, headache, vomituing
Pain and numbness, weakness of bilateral extremities.  Presented with numbness and burning of bilateral lower extremities which began 4 days after receiving flu vaccine and progressively worsened.  Hospital admission- CT head and brain MRI was unremarkable except for possible sinusitis with mucosal thickening that was incidentally noted.  She was treated for possible sinus infection during admission as well.  She had a cervical MRI showing increased T2 of C6-C7.  This was thought to be transverse myelitis triggered by her flu shot and she was treated by neurologist with steroids and IVIG treatment.  She is on gabapentin 100 mg 3 times daily to be decreased after 2 weeks to twice daily and eventually stopped once paresthesias resolve and Klonopin at night for insomnia.  She developed urinary incontinence during her stay and lumbar MRI was unremarkable, treated with Diflucan for possible yeast adenitis/vulvitis.
Off work since 10/22/10. I received my flu shot 10/13/10. Became very fatigued that day. On 10/22/10 to Dr for sinus infection. On 10/29/10 to Dr sinus infection worse - 2 series of antibiotics. Hemoglobin 9.2 on 10/29/10 - to 6th Dr 11/1/10 (put on iron). Having colonoscopy and endoscopy on 11/9/10. Still very fatigued.
I'm writing to report what occurred to me after my last flu vaccine shot. I have received the same shot before, usually at my doctor's office or a place of work. Sometime in the last few days of December 2004, I received permission to receive it from our local DPH branch. I received a flier, which noted that I received "inactivated influenza vaccine 5/24/2004". Within three days of receiving the shot I became ill with progressive symptoms of a quite severe flu episode with fever, malaise, chills, aches, respiratory symptoms, etc. Although I was well before the shot, I have come to think I had the virus before the shot was administered. I would probably have expected in such case to have had a milder case of flu. I also wonder to what extent the vaccine might not have given me all my symptoms. I have consistently relied on this vaccine every year but have wondered what to do for the upcoming season. I also wonder if there might have been something wrong with the lot of the vaccine available in 2004.  Thank you for your attention to this matter.
Same day as the vaccination, 02/25/2021 in the evening I started to feel woozy. After the shot I had mini COVID on the checklist: diarrhea , fatigue, nausea migraine, I was pretty sick, lasted for 3 or 4 days. But the fatigue, and the diarrhea , and migraine continue as of today (the migraine stopped 2 months ago) Right now I am on short term disability. My pancreas has stopped work and I am now taking Creon 3600 units.  I now have high blood pressure , I take Lisinopril 20 mg at bedtime. I wasn't taking this medication before the Moderna Dose 2.  In addition, I am on Bentyl 10 mg , helps stomach pain, mesalamine 1.2 grams, 2 tablets every morning for inflammation.  Bephenoxylate-atrop12.5-0.025 for diarrhea. Budesonide 3 mg steroid, prednisone for possible Crohn's.  PRN Zyprexa for Sleep, which I never had a problem sleeping.
Pt stated on 5/25/2000, woke up he had severe headache, non-productive cough, joint pain, neck stiffness, lower back pain, chills, fatigue, 102 fever, loss of appetite, denies redness or hives. On 5/30, not feeling better, MD stated he was probably having reaction to vax, prescribed Zyrtec.
Patient with 3 COVID vaccines who admitted for acute kidney injury and also tested detected for COVID with hypoxia. Provider note: "COVID: -patient has a cough but no other symptoms at this time -supportive care -respiratory isolation -no need for COVID directed therapies at this time   8/23 patient is becoming hypoxic, started on Decadron, CTA pulmonary artery-no evidence of pulmonary    embolism, atelectasis of the right middle lobe   8/24 evaluated by speech therapy no significant risk of aspiration Added incentive spirometer, Elevated BNP, checked echocardiogram, normal LVEF. Patient's oxygenation improved, and is being discharged on room air".
During screening, pt did not mention any hx of passing out from shots.  I gave her the flu shot, approximately 5 minutes later, a coworker came running to tell me that she had passed out in the office lobby on the couch. A man was standing next to her, and I asked him to hold her head. Her eyes were rolling and she was pure white and sweating, and had a pulse. It seemed like she may have had a seizure as well. Receptionist called 911, and after about 4 minutes she came to and asked to sit up.  We put a cold paper towel on her forehead to help cool her down and she began to tell us this had been happening to her since she was a child. She said the flu shot really hurt her. The fire dept arrived first and spoke to her asking if she wanted to go to the hospital, etc, she said no, and they took her blood pressure. The paramedics arrived and took over, and when they went to prick her finger to do a blood sugar test, she said " I don't feel good" and passed out again, but this time had a more noticeable seizure. They took her by ambulance to hospital. Office staff reported that she had passed out at work about a month ago, however, they never saw it happen twice in a row. Her mom was called to meet her at the hospital.
Information has been received from a 67 year old female with arthritis, osteopenia, high cholesterol, high blood pressure as well as allergy reaction to blood transfusion and IPV dye and drug reaction to antibiotic concerning herself who in October 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # is not available). Concomitant therapy included simvastatin, TOPROL XL TABLETS, CELEBREX, ramipril, BENTYL, alendronate sodium (MSD) and NASACORT. It was reported that after a few days (around 20-APR-2009 or 21-APR-2009) the patient developed a pimple like bumps on her right arm, 2 bumps and 1 was bigger than the other and they looked like pustules and they were red and very itchy. The patient spoke to her niece who was a nurse and described the bumps to her and she mentioned that it might be a chicken pox. The patient occasionally get hives because she was just sensitive to a lot of things, but these bumps looked different from her usual hives." At the tie of reporting the patient was not recovered. Follow up information was received on 04-MAY-2009 from the patient by phone stated that her physician did a scraping of the bumps on her arm and it came back negative. Additional information has been requested.
Hospitalized 11/10/2021; COVID-19 positive 11/10/2021; fully vaccinated  Discharge Provider: MD Primary Care Provider: PA Admission Date: 11/10/2021 Discharge Date: Nov 22, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia [R09.02] Acute hypoxemic respiratory failure due to COVID-19 [U07.1, J96.01] COVID-19 [U07.1]   HOSPITAL COURSE: This is a 57-year-old male who presented with weakness shortness of breath and fever to the emergency room on November 10.  He had had the Johnson & Johnson vaccine on October 22. Symptoms were present for 5 days prior to admission.  He had an outpatient COVID test at pharmacy which was positive.  In the emergency room his pulse oximetry was 86% on room air, and he initially was requiring 3 L of oxygen with a saturation of 93%.  Chest x-ray showed bilateral pulmonary infiltrates consistent with COVID.   He was treated with remdesivir and dexamethasone and nasal cannula O2.  He had Lovenox for DVT prophylaxis.  His oxygenation continued to worsen during his hospital stay and he was placed on high-flow nasal cannula oxygen which was required at an FiO2 as high as 90% with a flow rate of 50 liters/minute on November 15. After that he had gradual improvement and by discharge his oxygen requirement was from 6-10 L. in the 3 days prior to discharge he was treated with aggressive IV Lasix diuresis and high dose IV corticosteroids to try to improve his oxygenation, but had no affect.   He was discovered to have new onset asymptomatic atrial fibrillation on the day of discharge  which range with a heart rate ranging from 80s to 1 teens.  His blood pressure was only about 100 systolic, so the decision was made to do rate control with digoxin which does not cause hypotension.  He was also placed on Eliquis at discharge and was placed on an outpatient cardiac monitor for 14 days (ZIO patch) to determine how much atrial fibrillation he was experiencing.
This is an 86-year-old with a history of hypertension, diabetes, and obstructive sleep apnea among others, who presents with expressive aphasia.  He continues to have expressive aphasia, so some of the history is supplemented by his daughter at the bedside and the medical record.  He is also using a note pad to write notes, but his handwriting is difficult to read.  The patient is ordinarily very active and walks several miles a day.  He woke up at 8:00 a.m. this morning and felt fine.  He went to take his daily walk when he noticed right upper extremity numbness.  He then developed expressive aphasia.  Family members noticed right-sided facial drooping as well.  About 5 days ago, the patient received his 3rd COVID vaccine (booster).  Family members noted after receiving his 2nd vaccine, he also had right upper extremity numbness.  Those symptoms lasted a few hours before resolving.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384, exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.