chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE. No PQC.; Patient was administered both improperly stored RECOMBIVAX HB and improperly stored ROTATEQ; This spontaneous report was received from a Medical Assistant referring to patient, of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 01-NOV-2021, the patient was vaccinated with an improperly stored doses (Product storage error) of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) thimerosal status free,  lot # T032918, expiration date reported as 12-NOV-2022 for prophylaxis (dose,  and route of administration were not reported) and a dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot #: 1742078, expiration date: 06-JUL-2022 for prophylaxis (dose was not reported).   The administered doses of the vaccines experienced a temperature excursion 62.2 Fahrenheit for 6 hours. Additionally, it was mentioned that the vaccines experienced previous temperature excursions from 36°F to 46°F (46.07°F) for 15 Minutes There was no adverse effect reported.  No product quality complaint was involved.
States a few minutes of receiving first Covid vaccine (Moderna) complaints of swelling, burning, and itching on L arm which progressed to left neck and ear. Went to see HCP immediately and received Benadryl and steroid shot. Feeling better day after receiving vaccine.
Patient received both moderna COVID-19 vaccines on 03/29/2021 and 04/26/2021 respectively. Patient denied receiving any dose COVID-19 vaccine prior to vaccinating with Janssen COVID-19 vaccine on 08/03/2021.  Pharmacist found out about moderna COVID-19 vaccines while documenting the vaccine administration. Patient didn't return any phone call.
Routine annual employee flu vaccination (R) 1510 deltoid 0.5 ml IM with rapid response - no anxiety, pallor, tachycardia, restlessness - refusal at 1st by staff member/client of emergency SRI with return of color, decreased pulse, decreased anxiety followed by another rapid episode of pallor, anxiety, tachycardia. ).5 ml Epinephrine SQ given 15:25 hrs just prior to ambulance arrival - transport to ER for further Rx - O2, Benadryl, fluids.  10/15/2007 MR received for ER visit 10/03/2007 with DX of Reaction.  Pt presented to ER with onset of light-headedness, tunnel vision, palpitations and feelings that her heart was racing and just not feeling right within a few minutes of receiving flu shot. Similar reaction to bee stings and shrimp in past. Epi and Benadryl given at the scene.  PE WNL. No true signs of anaphylaxis, cardiac ischemia, or hypoglycemia.  D/ C home.
This spontaneous report as received from a physician referred to a female patient in her early 20's years with none drug reactions/allergies. The patient's current condition included attention deficit disorder (ADD). The patient was vaccinated IM with the first dose of 0.5 GARDASIL (lot # (0420AE, Exp Date: 01-DEC-2014) at an unspecified facility prior to September 2009. On 19-SEP-2012 the GARDASIL. Concomitant therapy included unspecified medication for ADD. On 19-SEP-2012 the patient developed syncope, while she was still in the physician's office, after receiving the second dose of GARDASIL. A red, blistered area was also noted on her right, lower leg after receiving GARDASIL. Oral fluids and cool compresses applied to the patient in the office. It was unknown if the red, blistered area on the leg was present before receiving GARDASIL. The syncope had resolved prior to the patient leaving the physician's office, but the status of the patient's right, lower leg was unknown. Additional information has been requested.
Next day after 1st shot, right calf was sore for 1-2 days.  Next day after 2nd shot, right calf was sore again.  This did not go away but worsened until swollen and painful. An ultrasound about 6 days after the 2nd shot showed negative for DVT.  Swelling & pain got much worse over the weekend. An emergency room visit on 9/20 found a DVT just under the right knee.
Redness and erythema around left arm with pain - concerning for cellulitis Right arm with some erythema, - appears improved
Per mom, the day after the flu vaccine (10/30/18) patient developed a fever. It got up to 101.9. Pt was more lethargic too. Symptoms and fever resolved the next day (10/31/18).
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  COMPLEX PARTIAL EPILEPSY W SECONDARY GENERALIZATION EPILEPSY, GENERALIZED CONVULSIVE, INTRACTABLE EPILEPSY, UNSPECIFIED
Sudden onset mild lightheadedness with mild dizziness, moderate tiredness (NB: patient works an overnight shift regularly. Had slept for approximately 11 hours straight prior to onset of symptoms. Symptoms appeared within 2.5 hours of waking). Continued mild pain at injection site. Patient laid down again and ultimately slept a further three hours.
Pt erroneously received expired Pfizer dose on 12/1/21. Staff contacted Pfizer to inquire if this lot batch were still viable at the time of vaccination provided.  Following discussion with Mfr, pt did not need to be revaccinated as Pfizer Mfr had stability data to support this excursion for 1 day post expiry from manufacturing data.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 45-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Caller was an Office Manager. She stated that because their facility had not been able to download the digital data logger for the months of Dec2021, Jan2022, and Feb2022, they have been put on hold by the agency at the moment and cannot administer the Moderna COVID-19 vaccine to patients until an assessment by the agency was made.  There have been no power outages that would have impacted the Moderna vaccine. However, she reiterated that because her facility was unable to download the digital data logger, they will need to treat this issue as a temperature excursion.  No adverse event reported.
Stomach problems; Intestinal problems flared up /Diarrhea; Two Autoimmune diseases flared up; Fibromyalgia flared up; Heard swooshing sounds in her head during fever; Headache; Fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up) and TINNITUS (Heard swooshing sounds in her head during fever) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0281721A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia (Autoimmune diseases flared up indicated fibromyalgia) and Intestinal functional disorder NOS (Autoimmune diseases flared up indicated intestinal problems(Diarrhea)).   On 12-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up), TINNITUS (Heard swooshing sounds in her head during fever), HEADACHE (Headache) and PYREXIA (Fever of 102.5). At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems), DIARRHEA (Intestinal problems flared up /Diarrhea), CONDITION AGGRAVATED (Two Autoimmune diseases flared up), CONDITION AGGRAVATED (Fibromyalgia flared up), TINNITUS (Heard swooshing sounds in her head during fever), HEADACHE (Headache) and PYREXIA (Fever of 102.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Body temperature: 102.5 (High) Fever of 102.5.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient had classic vasovagal ~10 minutes post vaccine. BP 70, pulse 40. Quickly returned to 105/70 and pulse 80 with no intervention. Glucose 102 by FS.
11 days after shots he developed a rash of raised bumps which began on arms and legs and buttocks and the next day had bumps on torso. Cheeks, red, no bumps Dr in ER said it was from MMR vaccine. Referred to Dr today. T99.5-100 since 5/28/07.
debilitating uterine/ menstrual cramps without period that significantly disrupt sleep and physical activity since 11/10; has not resolved; taking tramadol and additional celebrex/ tylenol to manage pain level
Pfizer Dose 1 5/28/21 (EW0183) Pfizer Dose 2 6/25/21 (EW0183) COVID Positive 1/1/22  1/1/22: Patient is very tired, retching, not able to communicate  the time of my examination.  Most of the history is obtained by personal review of records. Patient is 66-year-old lady with intellectual disability.  She is a resident at a group home.  She also has diabetes mellitus.  Had cerebral hemorrhage in past.  History of weakness and multiple falls for last few days. Was evaluated in emergency department on 12/27/2021 following a fall and was diagnosed with UTI.  She has facial bruising from previous fall.  She is on ciprofloxacin.  Urine culture has grown pansensitive E coli.  Had multiple falls again on 1/1/2022.  Is not able to ambulate because of generalized weakness.  She has severe nausea and had multiple bouts of emesis.  Denied chest pain or abdominal pain.  See tested positive for  SARS-CoV-2.  1/4/22:  Bilateral viral pneumonia :  Oxygen will be supplemented as needed.  Noninvasive positive-pressure ventilation as needed.    Positive for  SARS- CoV-2 :  Remdesivir, and antibiotic will be administered.  Liver functions will be monitored. Inflammatory markers will be monitored   Generalized weakness:  Will get physical therapy, occupation therapy consults.  Social services consult for discharge planning needs   Intractable nausea and vomiting:Resolved  SLP evaluated and will diabetic diet.   Large stool burden with probable fecal impaction: Abdominal series confirms. Pt tolerated bowel regimen and having regular bowel movements   Non-insulin-dependent diabetes mellitus with neuropathy  : Started on sliding scale insulin.  Resumed home meds   Recent pansensitive E. coli  urinary tract infection  : As noted above patient is now on IV Levaquin
ALLERGY SYMPTOMS; This spontaneous report received from a patient concerned a female of unspecified age. 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: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced allergy symptoms. Laboratory data (dates unspecified) included: COVID-19 (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of allergy symptoms was not reported. This report was non-serious.
I first got a bad headache and dizzy. They brought me back behind a curtain with an emergency person. I got very dizzy and nauseous after that. They had me lay down on a cot. About 30 minutes after I received the vaccine, they brought me out to my husband?s vehicle in a wheelchair. By that time, I was so dizzy that I could hardly stand by myself. I was told to call my primary care doctor. My husband called them while we were headed home. My tongue was swollen a little. We decided to go to my father in law?s home, since he is a doctor. By the time we got there, I was coughing. We were still on hold for a nurse at my primary care doctor?s office. I started getting hives on my chest and neck and wheezing around the same time. We left before seeing my father in law to go home and use my nebulizer. For the moment, I used my inhaler, which doesn?t work as well. Once we got to my driveway, a nurse from my PCP office said to go straight to the emergency room. I spent the night at the hospital that night and was treated for an allergic reaction, which resolved the issues. I continued medications at home after leaving the hospital the following day.
Injection site redness - redness in quarter size diameter from injection point-warm skin in area of injection.
Patient is a 65 y.o. female patient of Physician No with history of Asthma, Afib, cerebral palsy, CKD, Chronic respiratory failure, on 2L NC, HTN and seizure disorder who presented to local Hospital with AMS   Covid-19 virus infection Chronic hypoxic respiratory failure COPD Date of onset of symptoms: 2-3 days Symptoms present on admission: AMS Date of covid positive test: 02/06/23 Vaccination status: vaccinated Imaging: CXR unremarkable Oxygen requirements on admission: Chronic 2 L NC Current oxygen requirements: 2 L NC Medical therapy: not indicated Consultants following: None Anticipated special isolation end date: 02/15/23 Continue Home QVAR, Spriva, albuterol as needed   Hypernatremia--resolved Hypokalemia--resolved Na 150, K 2.4 on presentation Potassium replacement ordered in ED, Continued on admission Mag 3.3 Na 145, k 3.4 at discharge Magnesium 2.2 Continue to monitor electrolyte   Acute encephalopathy Hx of cerebral palsy Likely 2/2 infection with electrolyte imbalance (hypernatremia, hypokalemia) WBC 17.76--15.85 UA unremarkable for UTI related etiology CXR non acute TSH 1.4, ammonia 36, UDS negative and folate/B12 normal.  CT head without acute abnormality.  Continue Delirium precautions Monitor for clinical improvement   AKI on CKD stage 2-3 Baseline creatinine 1.0 Creatinine 1.31 on presentation Avoid nephrotoxic agents Treated with Gentle IVF hydration Cr 0.81 today
Fever, fussy, uncomfortable. 102.1 at home 101.2 at clinic app. Tx: TYLENOL, MOTRIN 1-2 days. Failure to bear weight, acting like her legs hurts with touching legs, not wanting to walk/crawl. Expect 1-2 days of sx. (Evaluated by NP).
PT C/O ERYTHEMA, SWELLING, PAINFUL WITH MOVEMENT TENDER TO TOUCH. RIGHT ARM
Pain in arm. Infection, chills, vomiting. Severe pain in left arm/shoulder requiring hospitalization for 5 days.  Imaging at hospital showing swelling, crystals in shoulder.
The patient received a concentrated dose of Pfizer.  The vial was diluted by the tech with only 0.2 ml of NaCl instead of 1.8 ml.  The patient was fine and did not suffer any side effects.
Rash and hives on face, shoulders , back and  upper torso.  Hands itch.   Symptoms started  with  in 48 hours
FIRST DOES MODERNA 2/5/21, UNABLE TO RECEIVE 2ND DOSE AS SCHDULED D/T RADIAITON TX. MED CONSULT AWARE AND PT RECD 2ND MODERNA TODAY.
This spontaneous report was received from a physician referring to a 66 year old male patient who was also a physician. The patient's medical history included chickenpox. The patient had no history of herpes zoster or herpes zoster ophthalmicus. The patient's concurrent conditions were not reported. On 30-JAN-2016, the patient was vaccinated with a dose of ZOSTAVAX in the shoulder (lot#, dose, route of administration and frequency were unspecified). Concomitant medications were not reported. On 02-FEB-2016, the patient experienced pain in the right scapula, tingling without rash and swollen for 2 days. On an unknown date in 2016, the patient experienced shingles after receiving ZOSTAVAX. It was stated that the patient sought for medical attention by visiting the doctor's office and that the adverse events were not significant disability or incapacity or life threatening and that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of the musculoskeletal pain, injection site swelling and paresthesia was reported as not recovered. The outcome of the herpes zoster was unknown. The relatedness of ZOSTAVAX with the adverse events was not reported. Additional information is not expected as all follow up information has been received.
High fever, crying, screaming, pink at entry point like bug bite, spots/rash all over body, lumps behind ears on skull, rash on trunk left side
I woke up at 2:00 am and was dizzy and rolled over and was dizzier with Vertigo - couldn't sit up I couldn't stand up or walk. Son took me to ER - Medical Center - and they put me on an IV and gave me Meclizine. Kept me for obsevation for 36 hours as it was not subsiding (the vertigo). Ruled out stroke with CT scan. They sent me home with Meclizine and I'm still taking it. I get Vertigo every day still.
Severe itching and swelling at injection site, followed by upper airway congestion and rhinorrhea that continued for weeks. 4 days following vaccine she required an inhaler for wheezing. 5 days after vaccine she developed generalized hives. She has been treated by her personal physician with antihistamines, inhalers and steroids.
Headache, Myalgia, Diarrhea,  chills Narrative:
On February 10, 2021, I saw my PCP at the time. Then in March, I saw him again and he was talking about referring me to the neurologist. April 2, 2021, I had a stent placed in a heart artery. Between the time that I talked to the PCP in March for a referral to the neurologist and seeing my new PCP in June was when I began experiencing different symptoms than what I was getting sent to the neurologist for. It started with a slight numbness on the left side which was the result of prior back surgery years ago. Original symptoms were slight numbness on the left side. In June, new PCP referred me to the doctor the original PCP had suggested. In June I was experiencing more symptoms and I had little events where I would be sitting and from the center of my back to my head would be a warm sensation coming up then it would go away. And that happened 2-3 different times. After that feeling, I noticed increased and more pronounced numbness and my ability to walk decreased. I went to the neurologist in August 2021 and she suggested getting an MRI done of my neck and brain. MRI done on August 30, 2021. The MRI came back that I had a lacunar stroke event and we didn't know when this occurred. Currently doing physical therapy right now. Neurologist is considering doing another MRI. Have another follow up later this year 2022.
No adverse event, administered Rotarix vaccine at 15 weeks and 4  days; recommendations not after 14 weeks and 6 days.
After the patient was vaccinated - we went to add his vaccination record to the Immunization Registry only to find that he had received a flu shot from his primary care provider on 09/20/2021 already.  So the patient received two doses of the Influenza vaccine within 2 weeks of each other.
Swelling, inflammation, itchiness at injection site. swelling of submental lymph node. symptoms started 5 days post-injection, peaked at 7-8 days post-injection. subsiding by 10 days post injection. In all, minor "Moderna-arm" side effect, but wanted to report anyway. Submental lymph node swelling was maybe worth documentation.
Stroke; Hemorrhagic Stroke; Intermittent bradycardia; thrombotic stroke; Intracranial hemorrhage; aneurysm; This case was reported by a lawyer and described the occurrence of stroke in a female patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 24th April 2022) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix on 14 February 2020 and 22 May 2020 for Prophylaxis. The patient had stroke , the date of injury was 22 may 2018. On Emergency department visit patient reported intermittent bradycardia and she was no longer opening eyes to voice or even noxious stimuli. Differential diagnoses consider for patient includes intracranial hemorrhage, Aneurysm, Thrombotic stroke and carotid dissection.
Patient lost consciousness became diaphorec.  Blood pressure 90/60.  Pulse 60.  Patient diabetic as per niece. Paramedics called blood sugar. 247 patient transported to ER.
Already 6 weeks since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Already 6 weeks since first dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Already 6 weeks since first dose). On 21-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Already 6 weeks since first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.   Patient received first dose of Moderna vaccine on 21Jul2021 (Lot number: 037C21A) and was scheduled for her second dose on 01Sep2021, but it was cancelled due to bad weather. Patient was exposed to COVID and got tested on 01Sep2021. Results were negative.
patient stated the next day after the vaccine, she was itching internally for two days and the left armpit had a stabbing pain
Began developing compression in front of head Saturday morning. By mid afternoon began feeling nausea, dizzy, foggy brain, fatigue, compression in upper body, muscle aches, and chills. This continued for several days with an added headache. After the 2nd day my left arm also became sore. I took nothing- just rested.  The foggy brain has continued for 10 days, at the time of this report. I continue to be light headed and easily get winded. I still have compression in the center of my forehead.