chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 09-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist and also additional information was received on 09-Jan-2019 from a Pharmacist. This case involves a 37 years old patient of unknown gender who received vaccine TYPHIM VI (batch number: N1K811M, expiry date: 19-Oct-2019) (dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of Syringe issue as she went to screw on the needle the plastic part of the syringe fell off. It was also reported that she thinks the end cap was rubber and she twisted it off and still has the syringe and cap to return. It was not reported if vaccine was administered or not. List of documents held by sender- none.
VACCINE INDICATED FOR 18 YEARS OF AGE OR OLDER. PATIENT IS 16  YEARS OLD. AT TIME OF REPORT NO ADVERSE EVENTS REPORTED BY THE PATIENT.
This is an instance of breakthrough COVID-19 disease after which death occurred. I also uncovered a likely vaccine administration error while looking into this adverse event.   The individual was vaccinated with the Pfizer product on 09/13/2021, 10/22/2021, and 11/05/2021. The first 2 doses were administered at the facility indicated in Item 17 of this form, but the third dose seems to be a deviation from protocol and was administered at a Pharmacy in a city that the individual does not live in.   The individual presented to Emergency Dept for cough and shortness of breath on 01/03/2022 and was discharged 01/04/2022. The individual tested positive for COVID-19 on 01/03/2022. The individual reported a symptom onset of approx 12/29/2021. They were transported to Emergency Dept again on 01/08/2022; it appears they were dead on arrival. Death date was 01/08/2022.
left arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received dose 1 around November of 2018.).   On 24th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 24th April 2019, 2 hrs after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient reports arm soreness which began a few hours after the dose the patient experienced a sore arm. It went away after a few days.  Two weeks after vaccination , the patient reports the arm soreness returned, and now intermittently comes and goes. The reporter did not consent to follow up
received an expired dose of Bexsero; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number unknown, expiry date February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-June-2022 Reporter's comment: The physician reported that a patient received an expired dose of Bexsero. The vaccine expired in February, but the expiration date and lot number were not available. Consented to follow up via postal mail. Additional Supportive Information: The patient received expired Bexsero which led to expired vaccine used.
Hospital Course:  Patent is a 91 y.o. female with history of dementia, DM and HTN who presented to Hospital.  Patient presented with nausea vomiting and GI losses.  Patient nausea and vomiting has improved.  She was eating and tolerated diet.     During patient's stay the following problem addressed     COVID-19 infection Persistent nausea and vomiting Vaccination status unknown and date of onset unclear with confirmed positive on 1/10/23  GI symptoms present but no hypoxia or clear evidence of PNA on radiographic studies No indication for remdesivir and steroids.   Patient continued to have nausea vomiting despite treatment so far. She has been on PPI IV, Zofran PRN and Reglan scheduled per GI She is being discharged on a PPI and reglan LFT, Lipase normal  CT AP on 1/10 non acute.  Continue gentle hydration, advance diet as tolerated. Has been Monitor Qtc , GI following,  continue to slightly improve. Patient nausea has improved since yesterday.   Hypertension, benign. BP not controlled On metoprolol,   amlodipine was added BP still high but better than was yesterday. Needs to be further adjusted in ECF.     Dementia without behavioral disturbance, psychotic disturbance, mood disturbance, or anxiety Alzheimer's dementia Chronic presentation w/o evidence of acute delerium present  Continue established Namenda/Aricept and avoid Narc/Benzo therapy Maintain sleep/wake cycle and encouraged daytime cognitive therapy   Prolonged Qtc keep Mg > 2,  keep K > 4 S/p Mg IV 1 gm and IV KCL 40 Meq  Monitor on tele Repeat EKG, Qtc 493   Type 2 diabetes mellitus without complication, without long-term current use of insulin (HCC) A1c - 6.2  hold Lantus d/t hypoglycemia and poor eating for now, re started on dextrose 0.45 @ 75 ml/hr on 1/22  AKI on stage 3b chronic kidney disease (HCC) Creatinine on admission 1.47, it is 0.8 Resume home diuretics as able Follow-up labs
mom reports fever inc to 105 off & on from 10AUG93 to 12AUG93; fine, red rash over body, vomiting, persistent crying for over 3 hrs, irritable; called MD 10AUG93 ordered APAP & warm baths; seen by MD 430PM;
Dizziness, nausea, tired 10:05am HR 124, R20, SaO2 99% BP 140/100 10:20 am HR130. R20, SaO2 99%, BP 136/83 Transport to  ( Client given option to have friend pick up and decline)
About 5-6 hrs. after flu vaccine pt. got extremely sick, weak, and passed out landed on bathroom floor & was there when she woke up - unknown how long this lasted.
I started having Diarrhea and was fatigue that began the morning after the vaccine at 05:48 1/9/21  and continued throughout the day hourly until the following day 0030 1/10/21.
A cluster of 7 itching blisters appeared about an inch and a half from teh injection site. Treated with cortisone cream and blisters resolved by 10/26/09.
A history of pain in my leg became exacerbated. I never take pain meds but I needed them for this. I went to see the doctor because the pain was much different. I saw him in the middle of May after the shot. At first I thought it was totally unrelated but this was much worse than I ever had and is continuing to get worse. Initially my sports medicine doctor ordered an MRI. Then I started having really bad pain and the doctor ordered a CT and the scan showed stenosis. The physical therapist that I was sent to indicated that I had a lot of inflammation. She stated that it could be caused by the vaccine. The pain in my leg is affecting my life. I had an epidural completed today but I am still having issues with walking. My symptoms became really bad on April 26.
Report of swelling / redness with warmth to (Rt) thigh within 2 hours or less of receiving immunizations on 07/23/13. Area gradually within 48 hours returned to "normal". Ct. with increased fussiness, decreased appetite and low grade fever. 08-08-13 fluid filled vesicles in linear pattern on (R) thigh/forehead/face.
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   They had a carton of vials in the fridge which was put in there from the freezer on 01-Sep-2021.   No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-352611 (Patient Link).
Tenderness, swelling, induration and increased warmth right injection site increasing over 24 hours post injection.
COUGH, FATIGUE, CONGESTION AND RUNNY NOSE  Contact with and (suspected) exposure to covid-19  Fatigue, unspecified type  Cough  Acute pharyngitis, unspecified etiology
lowest temperature reached was 1.6 dregrees Celsius / total time out of range was 2 hours and 30 minutes / wasn't a consecutive time frame / patients received the vaccines involved in the excursion; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number J7H4D, expiry date unknown) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) (batch number 1659422, expiry date unknown) for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) (batch number DR7158, expiry date unknown) for prophylaxis and MENACTRA (batch number U6919AA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B, HPV vaccine, PREVNAR 13 and MENACTRA. On an unknown date, unknown after receiving Engerix B and HPV vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: This case was reported by a nurse. The age at vaccination was not reported. The nurse reported that the patient received Engerix B,HPV Vaccine,Prevnar 13 and Menactra. Caller stated about temperature excursion with a vaccine. Also stated that it dropped bellows 2 degrees for 2 hours and 30 minutes and that it wasn't consecutive. The agend said the only number that showed up when the caller stated was the caller confirmed the details provided by the transfer agent. Caller confirmed she was calling to obtain stability details. The caller clarified the lowest temperature reached was 1.6 degrees Celsius. She confirmed that the total time out of range was 2 hours and 30 minutes. It wasn't a consecutive time frame. She said patients received the vaccines involved in excursion. The caller does not have any patients information with her to provide. Nurse clarified that patient received 4 different vaccines that given that day so just provided lot or batch numbers.
Intense tinnitus flare up; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Intense tinnitus flare up) and VACCINATION SITE PAIN (Sore arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Tinnitus (for 15 years) and Sinusitis. Concomitant products included CLONAZEPAM for Anxiety, STEROIDS from an unknown date to 11-Jan-2021 for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced TINNITUS (Intense tinnitus flare up) and VACCINATION SITE PAIN (Sore arm). At the time of the report, TINNITUS (Intense tinnitus flare up) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included clonazepam at an unknown dose in night via an unknown route for tinnitus.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Patient's underlying tinnitus is considered a risk factor for tinnitus flare up.
within minutes after receiving the Moderna vaccine in her right deltoid she began to develop tingling and type sensations on the left side of her mouth, left side of her face, left side of her neck, left shoulder and left upper anterior chest. She was given first one Benadryl 25 mg tablet and then a short time later a second one at the pharmacy. She rested there for 30-60 minutes and had no further adverse reactions. The nurse practitioner there is thought she was safe to go home but should seek additional care if she worsened or failed to improve. 2 hours later having not improved she sought care at an urgent care center which decided that she would be better taking care of at an emergency department. She followed through on this suggestion and was seen and evaluated for chest pain. At no time did she have significant swelling of her tongue, lips or oral mucosa. At no time did she have significant chest tightness or difficulty breathing. No time did she develop hives or other rash. She comes to our office here today 2 days later with persistent soreness and some mild to moderate tenderness in the left pectoral region and the left side of her neck and trapezius region. Her neurologic exam is normal her oral exam is normal her respiratory and cardiovascular exams are normal.
This case was reported by a pharmacist and described the occurrence of jaundice in an infant male subject whose mother was vaccinated with FLUARIX (GlaxoSmithKline). The reporter was the subject's mother. On 5 November 2008 the subject received unspecified dose of FLUARIX (transplacentary at 21 weeks gestation). The subject was born at 38 weeks gestation with no birth defects noted via cesarean section. The infant weighed nine pounds, 12 ounces, was 20.5 inches in length and had APGAR scores at one minute and five minutes of less than seven (exact score unknown). The infant had no respiratory problems. At an unspecified time after receiving FLUARIX transplacentary, the subject experienced jaundice. The reporter did not consider the jaundice to be serious. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Irregular heart rate. Experiencing atrial tachycardia.  Started after my first dose of covid 19 vaccine.
pt recvd flu vax 23OCT95 & devel pin in proximal aspect of arm in axillary aspect of same arm as vax (pain next day)
Lower back started having spasms a week after vaccination.  Chiropractor and Dr. felt that this could have been from the heavy metals in the vaccination settling in my lower back.  I completed 2 rounds of Acupuncture and the symptoms subsided.  Approximately 4 weeks ago, around Feb 23, 2020, my lower back had severe muscle spasms on my right lower lumbar region.  I was able to get them to subside and went to the chiropractor that week.  After 2 more weeks of lower back pain, muscle spasms.and pain radiating down my sciatic nerve into my leg and ankle with my hamstring and calf muscle spasming, I went to my acupuncture doctor and she stated that these spasms could be from the vaccination and suggested that I file a report just in case.  I had a muscle spasm on my left side lumbar region on 3/18/2020 and immediately the pain started radiating down my left leg.
pt recvd vax; devel fever to 103.3,lasted for 12 hrs; f/u: pt exp elev Pulse rate of 180bpm
Swollen painful lymph node in left arm (near arm pit) persistent for 4 days so far; unable to put arm all the way down
Vaccine expired 8/5/06 was administered 8/8/06 no adverse effects occurred, discovered on chart review.
Patient mother took him to Pediatrician due to redness on Right upper arm. Dr. diagnosed as cellulitis prescribed BACTRIM 4tsp x10days.
Patient expressed fear of needles that he has had since an infant.  Approximately 15-20 seconds after injection, client slumped his head, eyes dilated, diaphoretic.   Rapid response called,, BP 90/49, ice packs applied, assistance provided as the client became alert and oriented , Verbalized that he would like some water. Still diaphoretic, second ice pack applied.  Put in a wheelchair to transport to a stretcher.0741 EMT arrived. Blood sugar 135, O2 saturation 97 percent. BP109/50.   0745: BP 105/58 0750 BP 107/60, provided client with hydration. 12 ounces of water consumed.   States he does not want to go to the hospital and declines to go to the hospital.  Speaks with wife. She confirms that he "passes out after vaccinations" and has done this most of his life.  States it did not happen with his last flu shot, so they thought this would be okay.   0810 States he feel fine and is not dizzy.  BP 120/62
Hives on her arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced URTICARIA (Hives on her arm). At the time of the report, URTICARIA (Hives on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was taking unspecified concomitant medications No treatment was provided.
Symptoms were the ones described by the SHINGRIX site as listed below. In addition, this morning (7/29/2018) I woke up and my left eye socket was swollen and my lips were numb. Additionally both of my eye sockets were very sore. Listed from the SHINGRIX website: Pain, redness, and swelling at the injection site; Muscle pain; Tiredness; Headache; Shivering; Fever; Upset stomach; Severe allergic reactions are less common and include: hives, swelling of the face/throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. If you experience any of these reactions, seek medical attention immediately.
Arm soreness; Administered moderna vaccine that was in pre drawn syringe for over 6 hours; A spontaneous report was received from a nurse concerning a 164 patients (88 Females and 76 Males) of unspecified age (40 to 80 years), who received Moderna's COVID-19 vaccine (mRNA-1273) and most of them experienced arm soreness. All patients were administrated with vaccine that was in pre drawn syringe for more than 6 hours.  The patients' medical history was not  provided by the reporter. Concomitant medications were not reported.  On 24 Feb 2021 to 25 Feb 2021, prior to the onset of the events, the patients received their first of two planned doses of mRNA-1273 (Lot number: 014M20A ) unknown route of administration in the unknown site for prophylaxis of COVID-19 infection. 164 doses were administered from vaccine that was in pre drawn syringe for more than 6 hours. It was reported that a VAERS report was filed.  The last dose administered was reported as 2.5 hours after 6 hour mark.    On unknown date, after receiving mRNA-1273, the patient experienced arm soreness.    Treatment for the events were not included.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of arm soreness was unknown and for 164 doses were administered after 6 hours mark  was considered resolved.; Reporter's Comments: This report refers to a case of expired product administrated for mRNA-1273, lot #014M20A, which occurred for 164 patients. Additionally, most of them experienced arm soreness. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Around 48 hrs after injection I experienced right sided weakness/numbness in leg and arm, pressure in right eye, right face numbness. Went to urgent care and they referred me to Hospital. Had CT scans and MRI without contrast, MRI w/ contrast, ultrasound, and ECHO done over next three ER visits. Had about 4-5 episodes of right sided weakness/numbness with inability to walk on right leg.  Dr.s said migraine with aura, and inflammation of cervical and lumbar discs and prescribed Mobic 15mg as for 30 days. Haven?t had an episode since completing  Mobic but do get occasional headaches which I never get headaches before.
Vaccine administration error.  It is suspected that a 1/2" needle syringe  was used instead of a 1" needle syringe.
NUMBNESS FROM BOTH ARMS SITE TO FINGERS. FATIGUE FOR 2 DAYS CHEST TIGHTNESS
Red rash, tongue swelling, nausea, vomiting, diarrhea, muscle cramps, dizziness, fever, chills.  Took Benadryl tablets about an hour after receiving the vaccine.  Took Tylenol for the fever.  Took some nausea medication during the night about 6 hours after receiving the vaccine to stop the vomiting.
This case was reported by a pharmacist via call center representative and described the occurrence of chickenpox in a 52-year-old male patient who received SHINGRIX (batch number 3Z53C, expiry date 13th March 2021) for prophylaxis. On 24th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 28th November 2018, 4 days after receiving SHINGRIX, the patient experienced chickenpox, influenza-like symptoms and rash. The patient was treated with MEDROL dose pack and medication unknown (Cream (Medication Unknown)). On an unknown date, the outcome of the chickenpox and rash were not recovered/not resolved and the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the chickenpox, influenza-like symptoms and rash to be related to SHINGRIX. Additional details were provided as follows: The patient received his SHINGRIX on left arm. He reported flu like symptoms and he developed a rash on his face and chest. The patient was referred to his doctor that same day (28th November 2018) to rule out an allergy to the vaccine. The patient's physician prescribed a cream and MEDROL dose pack. The day before reporting the patient followed-up with the pharmacist and reported that he still had the rash and he was diagnosed with chicken pox. The reporter gave consent to follow up.
Approx 30 min after immunizations, pt noted to be coughing more by mom and had wheezing. Was in lab for blood draw and sent back to our office to evaluated. Had wheezing bilat - resolved with albuterol nebulization.
My second shot was on a Thursday, felt fine.  Woke up on Friday with the typical aches, low- grade fever (100.9),  headache, fatigue, and nausea that everyone else is describing. Did not take any Tylenol or advil.  Pushed fluids and napped. Saturday I felt better but not 100 %.  Rested, hydrated and took ibuprofen on Saturday evening. Sunday morning, I felt much better but noticed a  sore in my left nare.  I applied acyclovir cream.  I can get cold sores when stressed, not sleeping or too much sun.  An hour later I notice a cold sore on my upper lip, then my lower lip.  Mid -morning I have 5 cold sores. Sunday evening I notice a 6th cold sore under my nose.  I have been hydrating and applying acyclovir to each sore almost every hour.  I am writing this report to inform you of the cold sores since I have not heard that they are an expected reaction.  I did not call my doctor.