chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATEINT CAME IN FOR 1DOSE COVID VACCINE. PATIENT WAS 12 YEARS OLD AND RECIEVED THE DOSAGE 0.2MG, WHICH IS FOR 5-11 YEAR OLDS, INSTEAD OF THE 0.3 MG WHICH IS RECOMMENDED FOR PATIETN 12 YEARS AND UP. PATIENT HAD NO ALLERGIC REACTIONS, TOLERATED THE VACCINE WELL AND LEFT THE CLINIC AFTER THE RECOMMENDED 15 MIN MONITORING TIME.
After temperature excursion, vaccines were administered with no reported adverse event; temperature excursion due to Refrigerator malfunction, Max/low temperature reached: 31.928 F for a duration of labelled 15 mins with no reported adverse event; Initial information received on 11-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 15 patients and reporter reported temperature excursion due to refrigerator malfunction, max/low temperature reached: 31.928 f for a duration of labelled 15 mins with no reported adverse event and after temperature excursion, vaccines diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel], haemophilus type B (HIB)  (PRP/T) vaccine [ACT-HIB], diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] and diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine [Quadracel] were administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, dosage, strength, expiry date- not reported), also received a dose of suspect haemophilus type B (HIB)  (PRP/T) vaccine Powder and solvent for solution for injection (lot number, dosage, strength, expiry date- not reported), also received a dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (lot number, dosage, strength, expiry date- not reported), and received a dose of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine Suspension for injection (lot number, dosage, strength, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization).   Caller reported,  temperature excursion due to refrigerator malfunction, max/low temperature reached: 31.928 f for a duration of labelled 15 mins with no reported adverse event (product storage error) (unknown latency) on 31-Mar-2023 for vaccines diphtheria-2/tetanus/5 AC pertussis vaccine; haemophilus type B (HIB)  (PRP/T) vaccine; diphtheria-15/tetanus/5 AC pertussis vaccine; and diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) vaccine and after temperature excursion, vaccines were administered with no reported adverse event (poor quality product administered) (latency- same day). No human error was involved.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt c/o chest pains about 3-4 hrs. after shot.  Then began with body aches,fever, chills, and errythemia of R upper arm the next morning.  By Wednesday morning symptoms were worsening and family took her to ER when fingernail beds were turing blue.  BP in ER 81/55.  Md felt she was starting to go into shock.  WBC count 24.9  in ER at 2 pm on 01/31/07.  Admitted to Acute Care.  WBC on 02/02/07 was 10.6. Highest oral temp in ACF was 101.3.  02/16/2007  MR received from hospital admission of 5 days for a progressive, worsening reaction to Pnumovax.  Pt. presented to the ER with flu-like symptoms (fever of 101'F, dizziness, chills) and severe right shoulder pain. HPI: The evening following pneumovax, pt. began to experience "chest tightening". The following morning the arm was swollen and sore with decreased ROM.  She had a temp. of 101' and felt dizzy.  Later that day it was noted that she was experiencing nailbed duskyness which prompted the trip to the ER.  BP upon arrival was 81/51.  The right shoulder showed erythema and prominent tenderness upon PE. Treated with triple antibiotics with improvement. Impression:  Severe allergic infectious process to the right shoulder after pneumovax.  Cellulitis/abscess could not be ruled out.
Breakthrough case admission after two vaccines Moderna 5/13/21 Lot# 044B21A;  Moderna 6/10/21 Lot# 050C21A
one day of feeling crummy after second dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (one day of feeling crummy after second dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer, Benign renal neoplasm (a benign mass on her left kidney), Stevens Johnson syndrome (after getting a facial after being in sun and also receiving radiation for breast cancer.), Radiation therapy and Chemotherapy (radiation and chemotherapy treatments for breast cancer 14 years ago.). Concurrent medical conditions included Immunocompromised (underlying autoimmune conditions and is considered immunocompromised due to a past medical history). Concomitant products included COLECALCIFEROL (VITAMIN D3) for Osteoporosis, LACTOBACILLUS ACIDOPHILUS (ACIDOPHILUS PROBIOTIC), AIRBORNE, FEXOFENADINE HYDROCHLORIDE (ALLEGRA), FLUTICASONE PROPIONATE (ALLER FLO), ALPRAZOLAM, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS), DOXEPIN, CLONAZEPAM (KLONOPIN), PITAVASTATIN CALCIUM (LIVALO), MULTIVITAMIN [VITAMINS NOS], ESTROGENS CONJUGATED (PREMARIN), ZOLPIDEM, DENOSUMAB (PROLIA) and CHONDROITIN SULFATE, GLUCOSAMINE (MOVE FREE [CHONDROITIN SULFATE;GLUCOSAMINE]) for an unknown indication.    On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING ABNORMAL (one day of feeling crummy after second dose). On 02-Mar-2021, FEELING ABNORMAL (one day of feeling crummy after second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details was provided.  Patient reports experiencing one day of "feeling crummy", but felt better the next day.  Doses were administered in the patient's right upper arm, which was her dominant arm, due to lymphadenopathy in her left arm as a result of radiation and chemotherapy treatments for breast cancer 14 years ago.   This case was linked to MOD-2021-356856, MOD-2021-356902.
9 days after varicella vaccine pt developed redness and warmth of the injection iste. 2 small papules below that
During 15 minute observation period, patinet fell from chair to carpeted floor with seizure lasting 4 mintues, airway maintained, EMS activated.  Patient continues to have intermitent seizures till EMS arrived.  Left with EMS.  Chart review shows no arrival to a ED so unknown to patient outcome.  Hx of mutiple ED and hospital admissions due to seizures.  Patient notes states not always taking medications due to her work.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and gender who on 08-AUG-2014, was vaccinated with GARDASIL, 0.5 ml, intramuscular. The healthcare worker, reported that GARDASIL that underwent a temperature excursion has been administered. No adverse effect reported. No further information was provided. The outcome of GARDASIL that underwent a temperature excursion has been administered was unknown. The reporter considered incorrect product storage to be not related to GARDASIL. This is one of several reports from the same source. Additional information has been requested.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Concurrent medical conditions included Congenital adrenal hyperplasia. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FOLIC ACID, LEVOTHYROXINE, PROGESTERONE and ESTRADIOL (ESTROGEN).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 21-Jul-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  nineteenth week of the pregnancy. The delivery occurred on an unknown date.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There were three previous pregnancies of the patient. On 6-AUG-2018, patient was pregnant and the outcome was live full time birth and Second pregnancy was on 10-Feb-2020 which was a miscarriage and the outcome resulted in spontaneous abortion. The current pregnancy details included her date of menstrual period (25-Aug-2020) and date of positive pregnancy test was on 12-Nov-2020. The estimation date for the conception was on 02-Nov-2020 and estimated due date for the pregnancy of the patient  was on 21-Jul-2020. Additional information concerning this pregnancy was included IVF- identical twin boys.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Corrected Dose number to 1, Para to 1, Number of Fetus to 2 (identical twin boys), Removed Delivery Date; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Admitted for chest pain after receiving Moderna vaccine.  Diagnosis of myocarditis suspected from Vaccine.  Cardiology consult metoprolol
c/o "feeling sick for a week"; treated at clinic Saturday, 6/19,  for UTI and prescribed antibiotics; c/o generalized muscle pain/aches since 6/16/2004;  positive for diarrhea and fever. Received an EKG, labs, and chest Xray. Diagnosis of Obstructive jaundice and SIRS. Transferred to higher level of care with specialty in house.
Had positive COVID-19 by PCR result on 4/15/21, >2 weeks after 2nd COVID vaccination. Asymptomatic, known exposure to COVID positive person.
Dizzy, light headed, burning sensation on the chest. And 2 min after c/o throat tightness w/ difficulty breathing.
Pt vaccine site lower than intended. As a result patient received vaccine subcutaneously and because of this the patient has a red bump on their arm.
a 7 years old male patient received a dose of Adacel in NOV-2018 and DEC-2018/No AE; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a seven years old (8 years, 5 months, 23 days also reported) male patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] in Nov-2018 and Dec-2018 (lot number and expiry date not reported) via unknown route in unknown administration site.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A), HEPATITIS B VACCINE (HEPATITIS B VACCINE) on NOV-2018 and PARACETAMOL (PEDIATRIX).  It was an actual medication error due to inappropriate age at vaccine administration.  Adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
onslaught of flu sx fever, sore throat, cough, aching joints;last 1wk;no professional tx;
fatigue, chills & fever, muscle aches, minor headache beginning approx 12 hours after vaccine administered and continued until approx 36 hours after administration
No additional AE details available; stored outside of recommended range have been administered to patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date between 28-JUN-2022 and 01-JUL-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, administered for prophylaxis (lot #W006585, expiration date: 23-AUG-2023; strength, dose and route of administration were not provided). On 28-JUN-2022, excursion occurred, the vaccine had been stored outside of recommended range at 6 F up to 14 F for 50 mins and 14 F up to 46 F (15 F) for 30 mins. There was no previous temperature excursion. No additional adverse event (AE) was available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000553: US-009507513-2207USA000470: US-009507513-2207USA000775: US-009507513-2207USA000561: US-009507513-2207USA000544: US-009507513-2207USA000552: US-009507513-2207USA000563: US-009507513-2207USA000765:
Diarrhea; Vomiting; Vaccine Failure; This case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 2-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number G7XE3, expiry date 13th February 2020) for prophylaxis.   Co-suspect products included Rota (Rotarix lyophilized formulation) (batch number 273FR, expiry date 15th February 2020) for prophylaxis.   On 5th December 2018, the patient received the 1st dose of Rotarix lyophilized formulation (oral). On 13th February 2019, the patient received the 2nd dose of Rotarix lyophilized formulation (oral). On 19th June 2019, 196 days after receiving Rotarix lyophilized formulation and 126 days after receiving Rotarix lyophilized formulation, the patient experienced vaccination failure (serious criteria GSK medically significant), diarrhea rotavirus (serious criteria hospitalization and GSK medically significant) and vomiting (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and diarrhea rotavirus were unknown and the outcome of the vomiting was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, diarrhea rotavirus and vomiting to be related to Rotarix lyophilized formulation and Rotarix lyophilized formulation.  Additional details were provided as follows: The patient developed symptoms but got worse and was sent to the hospital. In June 2019, the patient was admitted and on 23rd June 2019 was discharged. On 24th June 2019, the patient was seen in the office for a post hospital follow-up. heir diarrhea at that time had lessened, but was ongoing. The patient was diagnosed with rotavirus in the hospital The reporter was okay with follow up. This case was linked to case US2019117687, reported by same reporter.
Patient said that a few hours after receiving the vaccine, her right lower leg began burning. The pain was on/off and got worse when she would stand. She reported no swelling, redness, or excruciating pain. She will follow up with a physician or a hospital.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 30-DEC-2016, the patient was vaccinated with a expired dose of VAQTA, lot number L034381, expiration date 21-DEC-2016, (dose number, route and anatomical location were not reported), for prophylaxis. No adverse effects were reported. No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information is not expected because consent for follow up was not given.; Sender's Comments: US-009507513-1701USA009558: US-009507513-1701USA001773:
11-30-15 pt. received MMRV vaccine without incident. 12-18-15 pt developed a quickly spreading macular pap non-vesicular non-inflamed diffuse rash with distinct boundaries on torso spreading to extremities. Afebrile.
vaccine given 6-27-07 Mom came in 6/28/07 swelling and redness around Proquad injection site (R) thigh 4.5 cm some swelling around IPV site (L) thigh 3.6 cm. 6/29/07 area of redness (R) thigh 7cm redness-allergic reaction-given Atarax.
Approx 24-36 hours after first covid-19 vaccine shot (PFIZER) my right hand went numb never lost any strength to the hand but had no feeling. The hand stayed numb for approx. 2 months.
Pt devel red welts (5-10cm) & itching @ inject site p/recvd flu vax;
During the first 3-4 days after receiving my 2nd Pfizer dose, I felt what I would consider normal side effects, which were fever, slight shortness of breath, body aches, and fatigue. However, about a week after receiving the 2nd dose, I began coughing non-stop and arguably uncontrollably. I saw Doctor about this, she heard the problems I was having, and has since prescribed me with an Albeuterol inhaler, Tefflon pearls as a cough suppressant, and prescription strength Flonase spray (for a build up of fluid in my ears). She also said to get some Allegra-D ovc medicine incase of allergic reaction to the vaccine. I've had to use my inhaler every morning and every night..never needing an inhaler before in my life.
Having trouble breathing, severe pain in ribs, went to ER on 12/31 diagnosed with costochondritis. Within 30 days of vaccine got pregnant, ended up miscarrying. 3rd vaccine on April 21, 2010 sick ever since. Fever, aches, chills, sore throat, runny nose, mucus, extreme fatigue, headaches, blurred vision, rash on arm, did get rash at injection site with 3rd vaccine but that went away within 3 days. Went to Dr. end of May 2010 thought I had strep, antibiotics did nothing. Went back June 9, 2010, diagnosed with a possible ear infection and given antibiotics. Tested for Mono which came back positive.
Fever of 106.9 at its highest Fever over 103 for two days Nausea Headache
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Seizure-Medium, Additional Details: Patient experienced two episodes of lightheadedness/sweaty/seizure like-tremors for 2-3 seconds. Patient was pale and responsive right away. EMS was called and Patient was evaluated, no blood pressure, blood glucose issues noted. Vital signs were within normal limits. EMS recommended follow up at local hospital. Patient's parents declined transport to ER but would follow up at ER.
My son started having a fever next day after the shot, but I thought it would go away. It stayed for a while and my son was very down, meaning he was not playful like his usual self. He started not saying much and then completely stopped saying any words and having tantrums and screaming all the time.
Large pink circle (2.5 inch diameter)  developed 6 or 7 days post injection.
Patient reports a quarter-sized, pink and tender circle appearing where she received the first vaccine 7-10 days after first dose. Patient states it was mild reaction that resolved on it's own. She states it was there for a "day or two" after vaccine and appeared again 7-10 days later "as if she had just received vaccine."
6 weeks pregnant at time of vaccine, due date 3/22/2022.  Instant burning and pain in arm following injection, which radiated to neck and down arm. Sweating and hot all over, increased heart rate, then dizziness,  facial numbness, nausea and fainted for a minute.
After child got KINRIX and MMR-V 10-15 min's. started to C/O hands and feet feel hot/itchy and were bright red, followed by breaking out with hives on face and generalize on body (arms, torso, legs). Patient given BENADRYL with good effect. W/I 1 hour of taken BENADRYL.
Day after, sore arm, very tired. On 3/11/2021 woke up with sore arm, redness and swelling around injection site and achy arm all the way down arm to wrist. Also tired, slept most of day.
Eye swelling, wheezing, itching. Tx: Solu Medrol 125mg, Pepcid 40mg po, and Benadryl 50mg po.
The evening of the shot (4/3/21), about 6 hours after, I felt very sharp pain under my left armpit that can only be described as if somebody stabbed my side with a knife. Also experienced tightness/soreness across the left side of my chest and an isolate sharp pain on my left side if touched. The pain continued for a month and did not go away when I finally sought treatment. Pain continues to current day of this filing (10/6/2021)
This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer reported for herself. A 63-year-old female patient received PREVNAR 13, via an unspecified route of administration this past year (2017) (could not recall when) at single dose for immunisation. The patient medical history and concomitant medications were not reported. Patient got pneumonia about 5 weeks ago (Oct2018). She was not aware the type of pneumonia. Also she was taken to the hospital by ambulance so she did not know the name/information of the physician. She was hospitalized for about 5 days and had just now started to feel better. She had other comorbidities such as heart failure during this time. The outcome of pneumonia was recovering, of heart failure was unknown.
Had H1N1 vaccine on 11/17. On 11/18, moderate - severe LLQ abdominal pain, malaise, and decreased appetite. Pt dehydrated and listless on exam. TYLENOL given was sent to ER for IV fluids. Vomited 1x on way to ER. Symptoms resolved in ER no IV given in ER pt alert active wit no symptoms in office on 11/19/2009.
This spontaneous report was received from an office manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies was reported. On unknown dates, the patients received improperly stored doses of VARIVAX (doses and routes of administration were not provided) lot # M039317, expiration date: 20-SEP-2018. The vaccines were reconstituted with sterile diluent (lot# and expiration date were not provided). No adverse effects were reported. The vaccines and the diluent were stored for 3 hours and 30 minutes in the temperature between -9 and 8 degrees Celsius. There were no previous temperature excursions. Digital Data Logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013230: US-009507513-1704USA012451: US-009507513-1704USA013229: US-009507513-1704USA013737.