chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This report refers to a 6 month old male patient enrolled in a study. On 08-MAY-2014, the patient was enrolled and vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015, dose 1, 2 ml, oral. On 11-JUL-2014, the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 2, 2 ml, oral and on 12-SEP-2014 the patient was vaccinated with ROTATEQ lot # J012954 exp date: 31-MAR-2015 dose 3, 2 ml, oral. On 16-SEP-2014 the patient experienced gastroenteritis. On 26-SEP-2014, the patient was admitted to the hospital for gastroenteritis. The parents reported a 10 day history of vomiting and diarrhea. The admission was thought likely due to prolonged viral gastroenteritis with possible post infection lactose intolerance. On presentation to the emergency department (ED), the patient was afebrile and vital signs were stable. Physical exam was significant to dehydration with dry mucosa membrane and crying without tears. While in the ED, the patient received 20 cc/kg bolus of normal saline, ZOFRAN and was the started on maintenance intravenous fluids (IVF). On 26-SEP-2014, the following lab test were performed: complete blood count: white blood cells 17.1, platelet 432.000, hemoglobin 14.3, Differential: 13 segmented neutrophils, 60 lymphocytes and 22 variant lymphocytes; metabolic panel Sodium 136 mmol/L; Chloride 110 mmol/L; potassium 4.0 mmol/L; Carbon Dioxide 17 mmol/L; urea nitrogen 9 mg/dL; creatinine 0.3 mg/dL; Calcium 10.8 mg/dl and glucose 92 mg/dL. On 27-SEP-2014 the following lab test were performed: Urine culture 100.000 Colonies/ml Escherichia Coli,10.000-100.0000 Colonies/ml Mixed flora and stool culture no salmonella, Shigella or Campylobacter isolated, No E. coli O157:H7 Isolate; Fecal leukocytes absent. After rehydration overnight, he had improvement in activity and tolerated multiple feeds of PEDIALYTE off fluids. He was discharged home on 27-SEP-2014 and recommended primary care follow-up within 1 week. It was recommended that feeding include PEDIALYTE with reintroduction of formula as he tolerates. The patient was seen by PCP on 01-OCT-2014 and symptoms had resolved. The outcome of gastroenteritis was reported as Recovered. The event was not unexpected. This event is possibly related to vaccine ROTATEQ but more likely related to a viral gastroenteritis, per the opinion of investigator. Twin sibling (also enrolled in study) had wild gastroenteritis symptoms at the same time. Note that in package insert diarrhea and vomiting are solicited symptoms that can occur after vaccine ROTATEQ. Also in package insert gastroenteritis was reported as one of the more common following vaccine ROTATEQ. Additional information is not expected.
1220p- received IM vaccine  1130p- woke up with shortness of breath, chills/rigors, and moderate body aches.  Afebrile at this time.  Took Tylenol 1000mg PO and went back to sleep.  1/9/21- 945a- Body aches had been improving but progressively getting worse at this time.  Tylenol 1000 mg PO taken again.  Remained afebrile.  245p- Chills started again, body aches continued.  Temp= 100.6.  Tylenol 1000mg PO taken.  1/10/21- 630a woke up for the day and continued to have body aches. Temp = 100.9, took Tylenol 1000 mg PO.   730a- reported symptoms to work occupational health and told could return when afebrile without Tylenol and cleared by them. Will continue to monitor symptoms.   730p= Chills and body aches continued. Temp= 101.9. Took Tylenol 1000mg PO and went to bed for the day.
The day after receiving the first dose of the Pfizer vaccine, she developed a headache behind her right eye that never went away. Then on Wednesday morning, March 31st (two weeks after receiving the first dose), she was found in bed by my mother, unable to walk or talk, her face was drooping, she was very sweaty, and had defecated on herself. My mother called the ambulance. She was transported to Hospital where it was determined she had suffered a massive hemorrhagic stroke. She was immediately transported by ambulance to another Hospital. She spent one day in ICU and then was put on palliative care. She died around 12/N on Friday, April 2nd, two days after the stroke.
Patient received the PNEUMOVAX vaccine 11/17/18. She returned to the pharmacy 11/18/18 with redness, swelling, and pain in throughout the left arm (injection site). The pain and swelling started the night of the injection and progressively got better over 24 hours. The patient was advised to apply a cold compress to the area and take OTC TYLENOL and ADVIL for treating the pain. The patient was also advised to see their physician if the arm was not better within 48 hours of the injection.
12/ 14/ 2021 enlarged lymph nodes, swelling in right arm, right underarm, and right elbow, and right breast, runny nose, sore throat, migraine, body aches, night sweating, fatigue
PATIENT PASSED OUT IMMEDIATELY AFTER RECEIVING VACCINATION. HE WAS ONLY OUT FOR LESS THAN 10 SECONDS AND THEN CAME TO. WE CALLED EMS TO CHECK HIM OUT. THEY WERE TO OUR STORE IN LESS THAN 5 MINUTES , CHECKED HIS VITALS, AND CLEARED HIM. HE IS FULLY RECOVERED NOW.
Information has been received from a health professional concerning a 45 month old female who on 12JUN2002 was vaccinated with a dose of varicella virus vaccine live. On 24MAR2003 the patient developed break through chickenpox. It was unknown if medical attention was sought. No product quality complaint was noted. It was also noted that 12 other patients were vaccinated with  a dose of varicella virus vaccine live and developed break through chickenpox. Additional information has been requested.
Large edematous nodule approx 9cm on left anterior thigh at immunization site. Occurred 6-7 hrs after administration and persisted for 36 hours. Treated with ice, Benadryl and hydrocortisone. Office evaluation on 3/31/04 reveals 2.75 cm
Left arm at injection site was red, warm to touch, inflamed and very painful as well as fever, and chills. Within 3 days, the redness, swelling and heat had spread to below the elbow however the fever and chills went away. Spoke with doctor's office on 12/6/2014 and were told it was just a reaction, he should be fine however by 12/07/2014 it was worse, then on 12/08/2014 spoke directly to the doctor who wanted to see him right away, he was then told he had cellulitis and placed on Keflex.  After approx. 1 1/2 weeks the arm was returning to normal.
I have  had osteoarthritis for over 25 years and both the FIRST and Second injections of Shingrix resulted in terrible joint pain in my back, both knees, my wrists, feet, shoulders.  This kind of pain is not MENTIONED on any of the Shingles/ Shingrix sites. After the first injection this pain lasted a full 2 days so I'm expecting to endure this that length of time after this second shot.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 1:28 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 1:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  patient was given dose from vial that was stored in an ultracold freezer which is colder than they should have been. The vaccine was stored in an ultra cold freezer at minus 82 degrees Farenheight  The Excursion duration was reported as 1 month.  No treatment medication was provided by the reporter.
Patient reported feeling dizzy 10 minutes after receiving the vaccination. His vital signs were taken at 1100: BP 11760, HR 49, 02Sat 94%, T 98.6 which is consistent with his baseline. Patient wife stated "he has a vascular problem in his brain and he gets dizzy spells like this at home." Veteran was  instructed to remain seated for a few more minutes. Patient reported feeling shaky and was given 4oz of orange juice. His vital signs were retaken at 1125: BP 138/63, HR 54, 02Sat 96%, Blood glucose 164. Provider consulted. After symptoms resolve and pt. history reviews, patient was sent home at 1130.
approx. 9 days after patient broke out in urticaria all over body, no fever. Rash progressed and itched
Client was given a Moderna instead of Pzifer Covid Vaccine  and the client was 16 years which is too ypung.Pfizer can be given at 16 years and Moderna is 18 years old .
At the time on injection it burned for about 2 days, now 2 years later it itches with a lump at the shot sight and small rash.
Incorrect product storage; no additional AE reported; This spontaneous report was received from a medical assistant and refers to a 15-months-old male patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous for prophylaxis (dose, frequency, and anatomical injection site were not reported; lot number was reported as T007359, and upon internal review was determined not to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date was reported as 29-AUG-2021); with the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (Vero), tetanus toxoid (KINRIX) intramuscular (IM) (lot number 7595K with expiration date on 30-DEC-2021); with the first dose of Hib conj vaccine (tet toxoid) (ACTHIB) IM (lot number NJ165AAA with expiration date on 29-MAY-2021); with the fourth dose of pneumococcal 13v conj vaccine (CRM197) (PREVENAR 13) IM (lot number CN0615 with expiration date on April 2022); and with the first dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (INFANRIX) (lot number D2KX9 with expiration date on 26-NOV-2021) (for those four vaccines doses, frequencies, indications and anatomical injection site were not reported).  On an unknown date, the mentioned vaccines had a temperature excursion in freezer. No previous temperature excursions were reported. No digital data logger was involved. No adverse reaction was noted with the patient.  This is one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008314: US-009507513-2008USA009256: US-009507513-2008USA009257: US-009507513-2008USA001768: US-009507513-2008USA009259:
Pt with history evan's syndrome and chilblain's lupus with stable platelet count x 5 years. 48 hours post vaccination first dose pt had routine platelet count found to be 15k. Since that time he has had three hospitlizations for refractory thrombocytopenia. He has received extended high dose prednisone, rituximab x 4, cellcept, IVIG x 2 and NPlate. Currently still refractory. No other cause identified. Planning for Eltrombopag admin
I had an ablasion years ago but still have infrequesnt periods due to beginning menopause. I had cramping followed by almost two days of bleeding and then it stopped.
The patient felt nauseated and wanted to throw up fifteen minutes after the vaccination.   The patient did not eat breakfast or lunch and she could not throw up anything, but felt like she needed to throw up and got flushed in the face.  We offered her ice cold bottled water, a cool paper towel for her forehead, and a trash can to use just in case she needed to vomit.  We offered to call 911 and she and her husband refused us to call 911.  We offered an epi-pen injection and she refused to be injected.  She waited another fifteen minutes and got up from her chair and said that she felt much better and not nauseated anymore.  She wanted to go home.  Her husband drove her home.
Patient received a Pfizer vaccine booster dose on the morning of 11/18 that had expired on 11/17 @ 1730. No adverse effects or events were noted in future documentation
Moderna COVID-19 Vaccine EUA: Soreness at vaccine point of arm, mild flu-like symptoms about 16 hours after shot, aching joints (especially at arthritis areas).  Took ibuprofen. Felt 100% normal about 42 hours after injection.
This spontaneous report as received from a pharmacist via a field employee refers to a 67 year old male patient. On 14-MAR-2014 the patient was vaccinated with ZOSTAVAX (lot# unknown, strength, dosage, route and indication unknown). On unspecified date, in 2014, the patient developed sores in his mouth that "looked like thrush" after receiving ZOSTAVAX. The patient was treated with VALTREX and the sores resolved within a few days. The causality between the event and ZOSTAVAX was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Mom became so weak that she couldn't stand or walk without falling down. She seemed unable to control her legs and feet and was unable to sit up unassisted. She was admitted to the hospital on February 11, about 36 hours after receiving the vaccine. She had elevated levels of troponin, but all other cardiac tests came back normal. She had no other abnormal test results. Today, February 13, is the first day she has been able to walk a few steps and sit up without assistance.
Patient was administered the vaccine and within a couple of minutes (1-2 minutes) reported feeling nauseated and collapsed into mother's arms while sitting down. Patient remained seated at all times and did not lose consciousness.  Within a couple of minutes patient was fully alert and emergency doctors and nurses came to scene to help patient elevate his feet. Juice was provided to patient to help him feel better. Within 10 minutes after vaccine administration patient reported feeling fine and left the scene. A follow-up call was made to patient and 9/9/2020 and patient reported no other adverse events after the syncope incident. Doctor was also contacted on 9/9/2020 and given description of events.
busy due to pandemic 1st Shot in 6/19/2021 2nd in 5/28/2022; This case was reported by a consumer and described the occurrence of social problem in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 19 June 2021).   On 28th May 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced social problem. On an unknown date, the outcome of the social problem 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: 29-May-2022 Reporter's Comments: The case was reported by patient. The patient stated that he/she was off schedule for getting Twinrix vaccines. The patient was very busy during last year due to pandemic and simply forgot. The patient asked how many more shots and how many weeks the patient should wait to complete my Twinrix series. Additional Supportive Information: The patient received 2nd dose late due to pandemic which led to social problem.
This spontaneous report was received from a nurse regarding to unspecified number of patients of unknown age and gender. Patient demographics were not provided. Information on their concurrent conditions, medical history and drug allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 lot # L029113, expiry date 27-MAR-2017 (dose, frequency, route and anatomical location were not specified) (incorrect product storage). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccine was stored at cumulative minimum temperature of -40.3 degree Fahrenheit for 193 hours. There was no previous temperature excursion performed. This is one of several reports received from same reporter. Additional information has been requested.
Noticed itching and blotchy skin afternoon following day of injection. Prescribed with Benadryl 10/30/03. 10/31/03 spoke with pt, redness much better itching nearly gone.  Area of rash 6 inches in diameter at worst point.
My skin broke out on my face. There were little fine bumps. My skin was red and uncomfortable. It got really dry and red. It was bad for days and it started to flake. I called my dermatologist she asked if there was anything I had been doing different and I said no. I went and saw her and by that time it cleared up and she told me to use hydrocortisone and Cetaphil. It lasted from that Tuesday and started to dry up that Saturday. This hasn't happened before, and the only different thing was my vaccination.
Full trunk rash, treated with, Benadryl, Pepcid, Zyrtek, Medrol tapering dose pack
Client had a Grand Mal seizure on 12/28/06.  Client didn't have a history of seizures before this. Medical records state sleep apnea, snoreing.
The night of the vaccine fever like symptoms started and lasted for several days. The more concerning symptoms were on day 3 when running my heart all of a sudden started beating really hard and fluttering causing me to stop and catch my breath. The ongoing issue from days 3-6 have been muscle fatigue in odd places such as forearms (no abnormal forearm exercises or excessive use). Simple tasks like cleaning pan causes forearms to seize up and feel over worked or cramped. Electrolyte drinks and other vitamins are also being taken with a health diet to eliminate potential for side effects.
Pt recvd Engerix-B & 1/2 hr following vax had mild pulmonary congestion, hot, palpitations & raised BP; tx relaxation, cold water;
2 drops came out from needle and hub; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 6th February 2023, the patient received Menveo. On 6th February 2023, unknown after receiving Menveo, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the nurse administered Menveo vaccine to a 12 years old patient in which the 2 drops are came out from the needle and hub. The healthcare professional does not know if the part of the liquid was touched to the arm of the patient. No other information was available of the vaccine. The reporter did consent to follow up. Additional supportive information: The patient did not receive the full dose of vaccine as there was a 2 drops are came out from the needle and hub, which led to Incomplete dose administered.
Approx 24 hr after - develop redness; itching; swelling burning; hardness lump which became softball size. On Monday after started BENADRYL - took for 2 days - stopped on Wed - itching; burning had stopped - more like a bruise; (black & blue).
administration of VARIVAX which was stored at -11.1 C; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-SEP-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S003447 with an expiration date of 04-FEB-2021, 1 injection (formulation, strength, exact dose and route of administration were not reported) for prophylaxis. The temperature excursion was reported as stored at -11.1 Celsius for 4 hours and 30 minutes. There was no previous excursion reported. A data logger was used to capture the temperature excursion. The outcome was not reported.
This spontaneous case, initially received from other non-health professional on 08-Oct-2018, concerns a 29-year-old, adult pregnant patient. The patient had no historical condition. The patient had one previous pregnancy. There were no maternal and paternal medical history relevant to the pregnancy. The patient's concomitant medications included an unspecified thyroid medication and Prenatal vitamins for unspecified indications. On 01-Oct-2018, the patient (at 36 weeks of gestation period) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported). On 02-Oct-2018 (reported as Tuesday), one day after vaccination, the patient woke up feeling stiff and by the evening, she needed help from her husband to stand up. The patient had slight fever and her heart rate was 130 (increased). On 05-Oct-2018 (reported as Friday), the patient could not get up without assistance and was still stiff and sore if she laid down or stood up. On 06-Oct-2018 (reported as Saturday), the patient was almost better, but her hands and forearms felt very weak and stiff and it was hard to grasp anything. On 07-Oct-2018 (reported as Sunday), the patient's forearm was still weak, and it was hard for her to grip the steering wheel and she was getting tired for a while. At the time of this report, the patient was recovering from pain upon movement, activities of daily living impaired and slight fever. The outcome of the events stiffness, decreased ability to grasp, impaired driving ability, hands weakness and tiredness were not reported. The patient's estimated date of delivery was 05-Nov-2015. The reporter assessed the case as non-serious.
ZOSTAVAX given 3/18/08. Pt called 3/19/08 describing a rash on abdomen confined mostly to left side (red, papular) with one site to the right of midline. The rash was not sore or itchy. Advised patient to contact physician immediately.
On 06/05/2017 at 3:14 PM received MENVEO and TDAP IM. 3:20 PM escorted to front for check out. 3:24 PM client and mother went to leave and she became syncopal - did not lose consciousness. Pale/diaphoretic 3:25 placed into waiting room chair and feet elevated to another chair - provided wet papertowel to forehead, cold water to drink BP 68/45 with HR 67. 3:30 PM Repeat BP 84/56 HR 68 3:35 PM color returned to face/ lips pink BP 85/70 HR 70 3:45 PM repeat BP 101/70 HR 63. Client and mother were explained vaso vagal response and adverse reactions as described in the VIS received prior to the vaccination. Felt well enough to leave - left with mother.