chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluzone Quad had given to a patient which was delay in shipping time, no AE; Fluzone Quad had given to a patient which was delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA317566, 2019SA320727, 2019SA320728, 2019SA320731 and 2019SA320729 (same reporter).  This case involved a 17 years old male patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number-UJ3058A, Expiry date- 20-Jun-2020) via an unknown route in an unknown administration site on 11-Nov-2019, which was delay in shipping time.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   It was a case of actual medication error due to incorrect product storage and product shipment delay. Vaccine was invalid due to prolonged shipping time.  At the time of reporting, no adverse event was reported.  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 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.
1st dose 31Mar2021; 2nd dose scheduled today (10Aug2021); fast breathing; felt that her throat was closing; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY RATE INCREASED (fast breathing) and THROAT TIGHTNESS (felt that her throat was closing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced RESPIRATORY RATE INCREASED (fast breathing) (seriousness criterion medically significant) and THROAT TIGHTNESS (felt that her throat was closing) (seriousness criterion medically significant). On 10-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 31Mar2021; 2nd dose scheduled today (10Aug2021)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 31-Mar-2021, RESPIRATORY RATE INCREASED (fast breathing) had resolved. On 10-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 31Mar2021; 2nd dose scheduled today (10Aug2021)) had resolved. At the time of the report, THROAT TIGHTNESS (felt that her throat was closing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Patient was scheduled for second dose on 10-Aug-2021.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events of throat tightness and respiratory rate increase, a causal relationship cannot be excluded. This report refers to a case of Product administration error  for mRNA-1273, with no associated AEs; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of throat tightness and respiratory rate increase, a causal relationship cannot be excluded. This report refers to a case of Product administration error  for mRNA-1273, with no associated AEs
rashes over her arm, stomach, upper thigh and legs; This is a spontaneous report received from Pfizer sponsored program,  from a contactable consumer (Patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 for COVID-19 immunization as dose 1.  The patient had rashes over her arm, stomach, upper thigh and legs on 16Mar2021. The outcome of had rashes over her arm, stomach, upper thigh and legs was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Fever and chills - Fever of 102 F 10 hours after injection / reduced to 99.8 F 16 hours after injection Moderate pain in the injection arm Redness and swelling at the injection site Fatigue Muscle pain Headache
Left deltoid cellulitis s/p immunization 9/26/03, 48 hours after placement. Red, swelling, heat prod.
This spontaneous report was received from a licensed practical nurse and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On 23-MAR-2017, the patient was vaccinated with a dose of RECOMBIVAX HB (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis. Additionally, on the same date, the patient was also vaccinated with a dose of PEDIARIX (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided) for prophylaxis. No adverse symptoms reported. Additional information has been requested.
patient presented with left facial tingling, nausea and left jaw pain 6 days after receiving Moderna Vaccine, first dose. Exam negative for  bacterial illness or extended weakness but CT ordered to RO cva. She did have bells palsy following childbirth(first child)
SOB, FEVER, WEAKNESS, POSITIVE COVID TEST, RESPIRATORY FAILURE, CARDIAC ARREST
FATIGUE; HEADACHE; SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache and sore arm was not reported. This report was non-serious.
Localized erythema and swelling of right thigh. Treated with abx and BENADRYL.
I tested positive for COVID-19 on 01/28/2023. The onset was a strong headache, overall achiness, and cough (which turned into a lingering cough later on) and no fever. It was pretty debilitating. That cough had lingered, but I was done with symptoms after a week. I went to an urgent care center and they gave me a prescription for Paxlovid and Benzonatate. I did go to my doctor to address the cough, and she mentioned that it may take a while. I'm still taking the benzonatate. I'm basically recovered, just still dealing with the lingering cough.
Awoke from sleeping at 11:30PM on day the shot was administered with chills, headache, and body aches.  She took her temperature and noted a fever of 102 degrees.  She stated that it felt like flu symptoms.  She took Nyquil and Aleve as treatment.  She felt better when she awoke on 06/29/2005, but still had headache and body aches.  She felt completely recovered when she awoke on 06/30/2005.
My nephew was infected, and I was in contact with him last week and three days later I started having sob, headache, ache cough sinus congestion postnasal drip flu like symptoms. I haven't had a fever at all. On Friday May 20 I took a home test then call my Dr about getting PCR test and they referred me to the urgent care and they don't have them at my PCPS office. They did a rapid at the urgent care it was negative, and they sent off samples for the PCR and it was also negative. They instructed me to rest and to push fluids. They told me they were unable to do anything without a positive test.  Called my Dr and they thought I do have COVID but I was testing too soon for a positive test. The Dr said she was going to treat as if I had COVID  I was put on an antibiotic and cough syrup. I have an inhaler that I take it whenever my asthma starts to act up.
Immediately when I got this dose the arm itched and then my body felt a cold rush, a minute or so after my knees down and elbows down felt cold and numb and I felt pins and needles in my hands and feet. I went home and two or three hours later I felt the peripheral neuropathy had faded and I experienced headache and fatigue and muscle soreness Saturday and Sunday. On Sunday night the hands and feet felt numb and tingly again and it has not subsided yet, the hands and feet and part of my forearm has been tingling and feeling numb all day today consistently. I have motor skills I just have very cold hands with pins and needles yet it is not in pain.  All other symptoms have resolved . I am hoping to get some advice or information on this side effect.
Swollen lymph nodes in right armpit right after vaccine received and this lasted for 2 to 3 weeks. One week later noted eczema type rash from right armpit to right elbow that is still present.  No history of eczema.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported No treatment medication was provided
UNSPECIFIED AUTOIMMUNE DISORDER WAS BEING MADE WORSE; PAIN WAS MADE WORSE; This spontaneous report received from a consumer via other manufacturer Novavax concerned a 59-year-old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient's concurrent conditions included: unspecified autoimmune disorder and pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total, administered on 09-APR-2022 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 59 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified autoimmune disorder was being made worse, and pain was made worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unspecified autoimmune disorder was being made worse and pain was made worse was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20221016458- covid-19 vaccine ad26.cov2.s-unspecified autoimmune disorder. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Arm that got the shot has been feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN ( Arm that got the shot has been feeling sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jun-2021, the patient experienced VACCINATION SITE PAIN ( Arm that got the shot has been feeling sore). At the time of the report, VACCINATION SITE PAIN ( Arm that got the shot has been feeling sore) outcome was unknown.            No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.   Reporter did not allow further contact
Severe reaction to second shot, might be an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Severe reaction to second shot, might be an allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced ALLERGY TO VACCINE (Severe reaction to second shot, might be an allergic reaction). At the time of the report, ALLERGY TO VACCINE (Severe reaction to second shot, might be an allergic reaction) outcome was unknown.
severe headache, muscle pain, joint pain, chest pain, palpitations, high blood pressure, shortness of breath, dizziness, faint, severe injection site swelling, severe eye redness and dryness, left facial numbness, numbness and tingling of extremities, irregular and heavy menstrual bleeding, rash, bruising of lower extremities.
Patient reported to our office with full body rash and itching that started the day before. Patient is under observation, it is being reported as patient is still in the clinic
Left arm soreness at the injection site; foggy feeling; This is a spontaneous report from a contactable consumer. This 47-year-old consumer (patient) reported for herself. A 47-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 01Mar2021 14:45 (at the age of 47-years-old) as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) within 2 weeks of vaccination included spironolactone; iron; multivitamins. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced left arm soreness at the injection site, foggy feeling on 01Mar2021 16:45. The patient did not receive any treatment. Outcome of the event was recovered, at the time of this report. No follow-up attempts are needed. No further information is expected.
Patient was mistakenly give high dose flu vaccine. Not indicated for this age. Sequiris Lot 346336 Exp 5-2023
Extremely high glucose following the vaccine. I'm staying 225-275 no matter the activity or insulin dose. This was not mentioned in the list of adverse side effects. This condition was present after dose #1, but much worse after dose #2.
feels like I have the flu; sharp little pains; crabby throat; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feels like I have the flu), PAIN (sharp little pains) and OROPHARYNGEAL DISCOMFORT (crabby throat) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     Concomitant products included EZETIMIBE (ZETIA), ZINC, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like I have the flu). 11-Feb-2021, the patient experienced PAIN (sharp little pains) and OROPHARYNGEAL DISCOMFORT (crabby throat). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (feels like I have the flu), PAIN (sharp little pains) and OROPHARYNGEAL DISCOMFORT (crabby throat) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication also include Natures's Bounty Hair Skin and Nails. Action taken with the mRNA-123 in response to the events is not applicable.
Initial and follow-up information has been received from a Nurse Practitioner for the pregnancy registry for GARDASIL From a nurse practitioner concerning a 16 year old female patient with a history of no previous pregnancies who on 18-AUG-2008 was vaccinated with a 0.5 mL second dose of GARDASIL (LOT # 659964/1878U) while she was pregnant. The estimated conception date is 01-JUL-2008 and the estimated delivery date is 24-MAR-2009. The nurse reported that on 18-JUN-2008 the patient received a 0.5 mL first dose of GARDASIL (LOT # 659653/1448U). A healthcare worker in the Nurse Practitioner's office reported that the patient had no prenatal care until she was 5 months along. She delivered her baby 2 months premature. The baby had reflux issues and slow weight gain. Her neurological status was within normal limits. She did confirm that there were no congenital anomalies and the baby was, otherwise, normal. Upon internal review, premature was determined to be an other important medical event. No further information is available.
Patient stated she felt her heart was beating fast.  Her heart rate returned to normal at approximately  1010 am.  VS at 09:57 am: HR= 98, BP= 176/99, O2 Sats RA= 97%.  VS at 09:59 am: HR= 88, BP= 155/92, O2 Sats RA= 97%.  VS at 10:00 am: HR= 93, BP= 134/86, O2 Sats RA= 97%.  VS at 10:15 am: HR= 87, BP= 138/89, O2 Sats RA= 98%
I got the vaccine on Tuesday morning. On Thursday morning when I woke up, the skin around my left eye was red (like in a rash) and the eye was swollen. By Friday morning, my other eye was swollen as well and I developed a rash on my upper right chest (very close to the collar bone). By Saturday morning, my symptoms had worsened slightly. I went to urgent care to see a doctor at 1 PM. They were not sure if this was a reaction to the vaccine. They asked me if I had exposure to poison oak, I didn't (although I do have severe allergy to poison oak). They recommended taking Allegra 180mg twice a day. Doctor recommended taking the second dose of the vaccine per plan on 4/20 but starting Allegra 1 day before that and continue to take it until 3 days later. I have occasional itching but no pain.
patient received a Imovax injection 1 day late, No AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demographics who received a RABIES (HDC) VACCINE [IMOVAX RABIES] injection 1 day late (lot number, expiry date were not reported) via an unknown route in an unknown administration site on an unknown date.  Medical history, medical treatments, vaccinations and family history were not provided.  It was a case of actual medication error due to the inappropriate schedule of vaccine administered. It was reported that the a patient received a Imovax injection 1 day late.  At the time of reporting, the patient had no adverse event.  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 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.
patient was given expired vaccine/ no AE; Initial information was received on 23-Jun-2021 regarding an unsolicited valid non-serious case received from a Other health care professional via Agency (Reference number- 00653450) and transmitted to Sanofi on 23-Jun-2021.  This case involves a four-year-old female patient who was vaccinated with 0.5 mL (once) (total) dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].(injection) (lot number UJ325AAA, expiry date 13-Jun-2021) via intramuscular route in right arm on 22-Jun-2021 for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of reporting, patient had no adverse event.  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 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.
Vaccine caused chicken pox as diagnosed by Dr. Temp of 102.8, small blister like bumps all over body.
Within a few days after vaccine had large rash across chest along with small hives and very itchy skin. This resolved after a few days after taking antihistamines (Diphenhydramine). About 2 weeks after vaccine I experienced significant chest pain, shallow breathing, very tense neck muscles, heart pounding at times, could not sleep or find position that would give any relief. Thought it was possible onset of a heart attack but was not experiencing any pain down left arm at all. Took both asprin and antacids which did not seem to grant much relief. By morning the symptoms became more manageable so I did not seek medical care. It took about 5-6 days for symptoms to fully resolve. Have not experienced any of the same symptoms since.
Information has been received from a company representative concerning an adult female who was vaccinated with a dose of Varicella virus vaccine. The pt received three doses of Varicella virus vaccine live, but she also has not seroconverted. Unspecificied medical attention was sought. No further available.