chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; The patient was administered with improperly stored VAQTA; This spontaneous report was received from a certified medical assistant (CMA) referring to a 4-year-old female patient.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 25-NOV-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated (VAQTA) (lot # S007770, expiration date: 24-JUL-2020, strength, dose number, anatomical location and route of administration were not reported) for prophylaxis (product storage error). It was reported that the vaccine was exposed to the temperature above 47 degrees Fahrenheit/9 degree Celsius (9.3 Celsius) for 23 minutes. The previous temperature excursion were at the temperature above 47 degrees Fahrenheit/9 degree Celsius (10.7 Celsius) for 33 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.7 Celsius) for 36 minutes, at the temperature above 47 degrees Fahrenheit/9 degree Celsius (8.9 Celsius) for 15 minutes and at the temperature above 47 degrees Fahrenheit/9 degree Celsius (9 Celsius) for 12 minutes. The call was because of a data logger. No adverse event was reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S007770; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-1910USA012749:
This case was reported by a pharmacist via call center representative and described the occurrence of skin indentation in a male patient who received SHINGRIX. In March 2018, the patient received SHINGRIX. In March 2018, immediately after receiving SHINGRIX, the patient experienced skin indentation. On an unknown date, the outcome of the skin indentation was unknown. The reporter considered the skin indentation to be probably related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported to anyone. The patient received SHINGRIX on the left arm. The pharmacist reported that the patient experienced skin indented prior to the needle piercing the skin. The QA was ruled out. The registered pharmacist did follow the instructions for admixing and preparing.
At the time of the second shot I found out I was pregnant that morning (4 weeks along). The estimated due date was January 12, 2022. The baby had a strong heartbeat at 7 weeks and at 8 1/2 weeks. However at 13 weeks had passed away due to cysts on the brain and back of the neck. Chromosome testing was done and the baby, my husband, and myself all came back without any chromosome issues. I had a miscarriage at 13 weeks after having both doses of the COVID 19 vaccine in the early month of my pregnancy.
Confusion, Dizziness, Headache, Sedation, shortness of breath, facial numbness, ear plugged, arm pain, chills Narrative: Noted brief SOB and dizziness 15 minutes after vaccine administered on 1/7/21- symptoms lasted several seconds. Later that day noted numbness and tingling of left cheekbone and left ear felt "plugged" - symptoms lasted ~ 10 minutes. Noted sore arm for several days starting 1/7/21. On 1/8/21 felt foggy, with some difficulty processing information, increased fatigue, and chills. Left work early on 1/8/21. Noted intermittent headaches 1/7/21 - 1/9/21. Patient with history of positive COVID test 11/23/20.
Pt claims she has pain around the injection area, inflamed, very tired, pt got KEFLEX rx from doctor.
ROTATEQ had a TE and then was administered; This spontaneous report was received from a medical assistant, referring to a 10 weeks old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # U021367, expiration date 07-MAR-2023, dose, and strength were not provided) had a temperature excursion. Then, on 04-APR-2022, was administered to the patient orally for prophylaxis (product storage error). The vaccine experienced temperature excursion of 47 Degree Fahrenheit for 6 minutes and 50 seconds. No other issue or concerns noted.
Narrative: Third and booster dose of Moderna Covid Vaccine was administered as a full dose of 0.5ml instead of 0.25ml to patient. No adverse events were reported by patient during 15 minute observation period or after that time. Patient is not immunocompromised.
11-28-05 Several hours later, fatigue, cold sweat, shaking, nausea, vomiting and diarrhea had to stay in bed 4 days ER on day 5 doctor visit day 7. 12-31-05 I felt like I was die. 1-1-06 Hospitalized. 1-4-06 Infectious disease doctor found blood deficiency that was triggered. I now need transfusions every 4 week plus medications to keep me from vomiting continuously. 2/2/06 Medical records reviewed stated patient experienced unsteady gait, both chronic & acute streptococcal skin infection w/multiple lesions, UTI, hypogammaglobulinemia, chronic urinary insufficiency, diarrhea, fibromyalgia, tachycardia NOS, IBS, depression, sleep disturbance, restless leg syndrome, migraine headaches, endometriosis, mitral valve prolapse, pituitary tumor (s/p surgery).
Got a cold from daughter; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Got a cold from daughter) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03621A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced NASOPHARYNGITIS (Got a cold from daughter). At the time of the report, NASOPHARYNGITIS (Got a cold from daughter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Patient got Flu shot,  I felt bone so pulled out a bit before injecting. About a month later patient came in and said shoulder was sore and still had radiating pain from injection. Referred to MD.
delayed cutaneous hypersensitivity reaction  Narrative: Onset 8 days post vaccination. Duration 5 days on right arm.
Palpitations, chest tightness that has been intermittent, occurring 5-6x/day and lasting 30 minutes before resolving spontaneously since she received the vaccine. She says she has had similar palpitations in the past, with a negative medical workup
I received Gardasil at approximately 1pm on July 6, 2007. The morning after receiving my first dose of Gardasil I experienced severe flu-like symptoms. I had a fever, the chills, was nauseous, and achy all over. This lasted approximately 24 hours.
No adverse event; HCP states that they administered 16 shots to patients after their expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 048L21A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was unknown if patient had any relevant medical history conditions, allergy, concomitant diseases and risk factor.     In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP states that they administered 16 shots to patients after their expiration date).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. The intact cartons of 0.5 ml of were initially stored in the refrigerator and the thaw dates were the same as administration dates as 01-Sep-2022 ,25-Aug-2022, 04-Aug-2022, 26-Jul-2022 and 19-Jul-2022. The vial did not undergo any temperature excursions. No treatment medication was reported. This case is reported for patient 12 out of 16 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-739796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-739796:Master case
this is a 79-year-old male patient with multiple medical problems as listed below came into the ER as he was having worsening shortness of breath the patient has a history of nonalcoholic cirrhosis and gets paracentesis periodically scheduled for paracentesis on 2 1 but he started having shortness of breath and so he came to the ER to get paracentesis patient had covert positive on 01/17 was treated Decadron and REM the severe at hospital prior to his cardiac catheterization and a would that of paracentesis tear shortness of breath which got apparently was in last few hours so he came to the emergency room in ER the paracentesis is done patient is again positive for covert as is except aches expected to x-ray suggestive of pneumonia she is given empiric antibiotic insert bed for the management of fall of double he feels very weak he states that he was taken off the metformin recently he does not remember his medications and he is on 7-10 medications denies any chest pain but has a heaviness on the chest
The patient developed a bad case of chicken pox and later developed a secondary infection of pox and went to the emergency room. The patient was given Keflex and Benadryl. Additional information has been requested.
This spontaneous report as received from a 85 year old female patient with unspecified reactions/allergies to: either MACROBID or clarithromycin otherwise not specified; OMNARIS, allergies to bee stings, and with chronic cough refers to herself. The patient's medical history included dizzy spells and tuberculosis (TB) history. On 18-OCT-2014 the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot#, expiration date not reported). Concomitant therapies included losartan potassium (manufacturer unknown (reported also as: Losartin)), metformin, simvastatin (manufacturer unknown) and ZYRTEC. On 19-OCT-2014, the patient experienced itching. On 20-OCT-2014 the patient experienced red rash at the injection site. The patient reported also that the skin felt smooth at the injection site. The patient reported also that her husband received ZOSTAVAX and did not experience an injection site reaction. There was no treatment given for the events. The outcome of events was unknown. The patient sought medical attention and contacted pharmacy where she received ZOSTAVAX and was advised to contact her physician. The relatedness between the therapy with ZOSTAVAX and the reported events was not reported. Additional information is not expected since there is no consent to contact the physician.
THE PATIENT WAS INJECTED WITH AN EXPIRED DOSE.  THE VIAL WAS ORIGINALLY OPENED ON SATURDAY 10/14/2023.  THE PATIENT WAS INJECTED ON MONDAY 10/16/2023. THE PATIENT WAS INJECTED WITH ANOTHER DOSE FROM A FRESH VIAL.
Information has been received from a nurse concerning a 25 year old female with a penicillin and BENADRYL hypersensitivity who on 10-SEP-2007 was vaccinated intramuscularly into the right hip with a 0.5 ml first dose of Gardasil (Lot #658558/1061U). There was no concomitant medication. On 10-SEP-2007 at 11:48 the patient experienced an allergic reaction with generalized pruritus for 2 weeks. The patient went to the emergency room and she was treated with an unspecified shot to help and released that day. The patient mentioned that she had also switched her laundry detergent around the same time of vaccination, but had switched back, and the itching persisted. There were no laboratory or diagnostic tests performed. On 24-SEP-2007 the patient had recovered. Additional information is not expected.
Pain in right leg in joint area; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in right leg in joint area) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced ARTHRALGIA (Pain in right leg in joint area). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in joint involving lower leg, at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Pain in right leg in joint area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medication used was Allergy medication (Unknown).  Patient also experienced pain radiating to the left leg that he doesn't knowif it is coming from vaccine or not.   This case was linked to MOD-2021-251377 (Patient Link).
Rash began 5/19/2004, diagnosis Roseola 5/18/04.
This is a spontaneous report from a contactable consumer reporting for herself. This 22-year-old female patient received the first single dose of TRUMENBA via an unspecified route of administration on 02Mar2015 at 10:30 AM. The patient medical history was not reported, no illness was present at the time of vaccination. Concomitant medication included ALLEGRA 180 mg once a day orally. On 02Mar2015 in the evening the patient experienced bad chill, severe headache, overall sense of fatigue, lack of energy, injection site rash. She did not have to go to the medical doctor or to the emergency room due to the reported events. The patient did not recover from severe headache, she recovered from bad chills, overall sense of fatigue, lack of energy, injection site rash on 05Mar 2015. Follow-up attempts completed. No further information expected.
Aches, fever, shivers, fatigue, cough, 4x3 inch red mark 3 inches from injection, all lasted until 06:00 18 November 2018.
chills, body aches, nausea, vomiting and fatigue. starting at 7 pm on the  27th till  12pm on the 30th.
Is pregnant yes/delivery date 02Sep2021/ gestational period 24weeks; throat and tongue swelling, confusion/disorientation,; throat and tongue swelling, confusion/disorientation,; throat and tongue swelling, confusion/disorientation,; throat and tongue swelling, confusion/disorientation,; This is a spontaneous report received from a contactable consumer. This 42-year-old consumer (patient) reported for herself.  A 42-year-old (pregnant) female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0162, Expiration date: unknown), via unspecified route, administered on the left arm 17May2021 (at the age of 42-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Patient took other vaccine Fisher Titus on the same date. The patient medical history includes asthma, undiagnosed chronic issues with swelling, heart palpitations, vertigo, exercise intolerance. Past drug event includes urethane induced drug hypersensitivity. The patient had history of allergies with latex allergy, latex cross reactive foods allergy egg allergy, dust allergy, allergy to moulds, mite allergy, allergy to animals. Concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with covid and since the vaccination the patient has not been tested for covid. No other vaccine received within 4 weeks prior to vaccination and no other medications received with in 2 weeks of vaccination. On 17May2021 after the vaccination, the patient experienced throat and tongue swelling, confusion/disorientation. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Treatment was received with Zantac and Zyrtec. The outcome of the events was recovered in 2021.  No follow-up attempts possible. No further information expected.
Soreness at injection site started 3 hours later. Fever over 100F, aching muscles, nausea, fatigue, headache all started at 7am the next day.
Red swollen upper arm -> started to resolve in 2 days but patient felt it might be moving lower on arm. MD diagnoses as cellulitis. Tx with doxycycline.
Patient had extreme pain from her neck down to her fingers on the left side since the day she got the vaccine. She started getting a rash down her left arm on 04/09 and vesicles on her left first and second digits (thumb and index finger).
Per Dr, pt went home and developed hoarseness in voice and rash on back; no difficulty breathing or swallowing. Mom took daughter to ER.
Patient is a 72 y.o. male patient with history of     type 2 diabetes hypertension BPH and a heart murmur presented to local Hospital with worsening shortness of breath   Acute hypoxemic respiratory failure Sepsis POA due to COVID pneumonia COVID-19 pneumonia Covid-19 Virus Infection Date of onset of symptoms: 11/12/2022 Symptoms present on admission: Shortness of breath Date of covid positive test: 11/8/2022 Vaccination status: vaccinated Imaging: Bilateral multifocal airspace disease chest x-ray Oxygen requirements on admission: Nonrebreather mask Oxygen requirements: was on  HF now on NC Medical therapy: steroids,  remdesivir and received a dose of Tocilizumab  Consultants following: Infectious disease Anticipated special isolation end date: 11/22/2022 Patient is doing well, on RA, hypoxia resolved,  Discharge home stable on decadron.    Loud heart murmur Location and provocation suggest MR Could be causing pulmonary congestion/CHF Echocardiogram, EF of 53% AS bicuspid.   Lactic acidosis Presented with LA of 7.5 Resolved down to 1.9   Acute kidney injury on chronic kidney disease stage IIIb Baseline cr is 2.5-2.6, presented with cr of 3.13 Improved back to 2.6>2.78>2.5   Acute on chronic normocytic anemia Hemoglobin down to 7 baseline is close to 10 No evidence of bleeding at this point Iron studies completed on July 2022 showed iron 30 ferritin 16 iron saturation 7% and TIBC 446 suggest iron deficiency anemia Will guaiac stool and consider GI consultation if positive Hg at 8.1 Type 2 diabetes mellitus On Lantus daily A1c 5.9 on 11/4/2022 Will cover with sliding scale   BPH Continue Flomax   HTN On metoprolol succinate 25 mg daily
This spontaneous report has been received from a pharmacist concerning a 32 year old female patient. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 05-JUN-2017, the patient was vaccinated with the first dose of VARIVAX with lot number M009766 and expiration date on 23-FEB-2018 (dose, route of administration and anatomical location were not provided) for prophylaxis. On approximately 12-JUN-2017 (reported as "1 week later"), the patient experienced a rash on both arms and neck, "little spots like chicken pox." (rash vesicular). At the time of reporting, the patient had recovered from the rash vesicular. It was reported that the rash lasted for two weeks, and no treatment was provided. The causal relationship between VARIVAX and the event was unknown.
Broke out in hives. Mom unsure if rash started on Sunday 7/20 or after vaccine 7/22. Mom had documented picture of hives. No respiratory distress.
Initial report was received 13 October 2011 from a health care professional. A 40-year-old female patient who had a history of left temporal pain, tinnitus, and facial tingling and paraesthesia in 2010 following an Influenza vaccination, had received an intramuscular left deltoid injection of FLUZONE No Preservative 2011-2012, lot number UT447AA on 06 October 2011 and one day later, she developed a runny nose, itchy eyes, and flu-like symptoms. On 12 October 2011, six days after vaccination, she developed left temporal pain, increased ringing in her ears, and tingling and paraesthesia of the face and lower lip. The event required a doctor's visit; it was not reported if treatment was required. The patient had been taking TOPRAMAX concomitantly. According to the reporter, the patient's neurologist approved vaccination. Outcome was unknown. Documents held by sender: None.
I felt really bad, my nose was stuffy, bad cough and headaches. After taking two doses of Paxlovid I felt fine. I was very tired and I felt like I had a case of the Flu.
Breakthrough COVID-19 + . Known unprotected exposure at home, developed sore throat, congestion and cough. Pfizer COVID-19 vaccine received 1/6/21 and 1/29/21.
Complaining of flu-like symptoms, nausea, vomiting, diarrhea, chills and malaise for 1 day, post vax.
Headache, Nausea, hot cold flashes, fever, dizziness, foggy thought and trouble concentrating
This case was reported by a physician via call center representative and described the occurrence of vertigo in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown. It was unknown if the reporter considered the vertigo to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a retired physician who himself was patient. The age at vaccination was not reported. The healthcare professional did not want to provide address and date of birth.
Patient did not have adverse event, but we are reporting that patient received the pediatric dose vs the adult dose.  We have communicated with the manufacturer, per their guidelines according to disease control, we are to revaccinate with the correct dose and continue with the series where patient left off.  We were told to not count the subdosing injection as part of their series.
Pt. had progressive redness and swelling that started soon after injection.  At day four, we saw here with marked swelling and erythema from the mid upper arm to the lower arm.  The area was painful, hot and red.  Pt. was treated with steroid and antibiotic. follow up scheduled in three days.
Large area of redness from (R) elbow up to right deltoid region. Very painful and swollen. Injection site is hard to the touch and very warm x 3 days.
Information has been received from a physician concerning a 4 year old male patient who on 26-MAY-2009 was vaccinated SC with the first dose of VARIVAX (Merck) (Lot #: 662382/1758X). The physician reported that on 29-FEB-2012 the patient was diagnosed with shingles of the right leg. The patient was then treated by the primary physician. Treatment given for the event included ZOVIRAX 200 mg/5ml - 8 ml by mouth 4 times a day, and BENADRYL (unspecified dose). At the time of the report, the patient was recovering. Follow-up information has been received from a medical assistant refers to the patient. The patient was vaccinated with the first dose of (Merck) VARIVAX (lot number 662382/18758X) subcutaneous on 26-MAY-2009 and developed shingles after his 4 years old brother had chickenpox. The patient did have a second dose of (Merck) VARIVAX after his episode of shingles at unspecified time. Additional information has been requested.
swollen lymph nodes under jaw -- left side much more swollen than right side; swollen lips and gums - top worse than bottom