chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning an 18 year old female with urinary frequency, obesity and hypertension, a history of tonsillitis and no drug allergies who was intramuscularly vaccinated with the first and second 0.5 ml doses of GARDASIL on 16-JUL-2007 and 22-DEC-2008 (1st lot # 656372/0243U, 2nd lot # 651044/0548X), respectively.  Concomitant therapy included YASMIN.  On 22-DEC-2008 the patient had a negative early pregnancy test and on 29-DEC-2008 it was positive.  It was also reported that the urine analysis positive for protein, and a complete blood cell count was performed.  No other adverse effects were reported.  The patient was seen for medical attention.  Additional information has been requested.
Metallic taste in mouth right after that shot.  Flu like symptoms for the next 36 hours including fever, chills, soreness/body aches and headache.
Pt came in with 3 x 4" red area at injection site. Area was warm to touch.
On May 3, 2021 notice an increase in migraine headaches were far worse than she has ever had. The migraines are continuous and they have not stop. Had to take her medications daily which is not supposed to be taken every (Topamax).
Extreme back aches, extreme nausea, slight headaches, and fatigue. Took Advil which helped side effects but was still in pain for three days after vaccine.
Patient came to ER and admitted on 10/8/21. This 88 year male with a history of obesity, retired farmer, who has been discharge after treatment of UTI, dehydration weakness.  He was at nursing home.  Started having hematuria from what he describes and he was found to be hypotensive and concern about infection.  He was sent to the local nursing home and was transferred here for treatment of sepsis.  He was initially in ICU.  Improved with fluid boluses.  Blood cultures later on showed positive for Pseudomonas.  He was treated with antibiotic for 14 days. He was ready to be discharged on that aspect but then he became afebrile.  COVID 19 test was positive.  He has already been vaccinated.  He was transferred to COVID isolation. He did not require any oxygen.  He was observed and clinically improved. Discharged on 11/4/21
2/11/15 - started with red eyes per mom, 2/12 - started Kw/ runny nose, cough and fever 101.5 that AM, very grumpy (told had B/L OM-started on ZITHROMAX and dexamethasone for croup. 2/15 - started with red rash on neck, torso and has spread - fever broke 2/15. 2/16 - rash got worse. 2/17 - rash spread to arms and legs.
Initial information received on 11-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three-months old male patient who received a dose of PENTACEL on 05-Sep-2018 (lot number, route and site of administration, expiry date not reported). The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL 13 VALENT VACCINE for Immunisation; and ROTAVIRUS VACCINE for Immunisation. This is actual medication error case due to inappropriate reconstitution technique (reported as nurse administering the powder portion of PENTACEL with sterile water instead of the required diluent). It was not reported if any adverse event occurred. 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. Documents held by sender: none.
fever of 103; aches; chills; headache; This is a spontaneous report from a non-contactable consumer (patient's sister). A adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unspecified date for COVID-19 immunization. It was unknown whether the patient received other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 10Feb2021 at 02:00, the patient woke up with fever of 103, aches, chills and headache. The patient texted the reporter that she reported the symptoms to her physician as well. It was unknown whether the patient received any treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain), PAIN (Generalized aching), INFLUENZA (Flu) and MOBILITY DECREASED (Mobility decreased) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product VALPROATE SEMISODIUM (DEPAKOTE) tablet for an unknown indication. Concurrent medical conditions included Abstains from alcohol (Abstains from alcohol), Tobacco user (A pack of cigarette a day (started 1976)) since 1976 and Drug allergy (Antidepressants allergy). On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VALPROATE SEMISODIUM (DEPAKOTE) (Oral) 500 milligram. In May 2021, the patient experienced PAIN IN EXTREMITY (Leg pain), PAIN (Generalized aching) and INFLUENZA (Flu). In June 2021, the patient experienced MOBILITY DECREASED (Mobility decreased). In May 2021, PAIN IN EXTREMITY (Leg pain), PAIN (Generalized aching) and INFLUENZA (Flu) had resolved. In June 2021, MOBILITY DECREASED (Mobility decreased) had resolved.  No concomitant medications were reported. Indication was reported as chemical imbalance. No treatment medications were reported. This case was linked to MOD-2022-629405 (Patient Link).
Right deltoid pain started while still in office. Other symptoms lead to ED visit. 7:11 PM: Patient is a 16 YO male with history of allergies and asthma presents to the Emergency Room complaining of allergic reaction vaccination. Presents pediatrician's office today and received 2 - meningococcal vaccinations between 4 and 430. Approximately 1 hour later he began the 2 shiver, had a slow onset headache, felt cold, and had multiple bouts of nausea vomiting. He has no stridor drooling, no abnormal behavior, no new numbness or weakness, no shortness of breath or retractions, no chest pain, no angio or periorbital edema and in no acute distress.
Significant fatigue and diarrhea experienced the morning after receiving the second dose. This only lasted for ~10 hours. No fever or other symptoms. Felt fine that evening.
Mild Shingles outbreak on right thigh.  Odd sensations in thigh began approximately Dec. 8th; developed rash approximately, Dec. 14th; diagnosis confirmed by physician on Dec. 21st. Patient is recovering.
J&J COVID-19 Vaccine EUA beginning 5 hours after vaccination, I developed nausea that lasted 2 hours, chills that lasted 12 hours, aches that lasted 16 hours, and a 104-degree fever that lasted throughout the night but was gone by morning. Acetaminophen helped alleviate these symptoms.
Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Medical assistant calling to report they administer some vaccine past the BUD (17Feb2023) to 20 patients.).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 9 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master case
Approximately 10-15 minutes after injection, patient stated that he was feeling some discomfort in his chest. He denied shortness of breath initially, denied any tingling of lips, swelling of tongue or throat. Out of an abundance of caution, patient was immediately escorted to urgent care in adjoining building for evaluation.
patient was given expired tdap, with no reported adverse event; Initial information received on 17-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced patient was given expired tdap, with no reported adverse event, while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE suspension for injection lot U6518AA with expiry date (11-May-2021) (unknown dose, formulation via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient developed a non-serious event "patient was given expired tdap, with no reported adverse event "(expired product administered) (latency same day) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient was given expired tdap, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event patient was given expired tdap, with no reported adverse event.
patient reports feeling unwell after vaccine and then development of chest pain.  chest pain persisted until office visit on  4/28/2021.  also with headache that improved with ibuprofen.  chest pain worse with breathing.  patient was subsequently advised to go to ER on 4/28/2021 given persistent and worsening chest pain after COVID vaccine.
Initial misuse report received from a healthcare professional on 23 May 2015. A patient received an expired dose of MENACTRA. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: none.
Approx 7 mins after shot administered pt. and daughter returned to pharmacy check out area. Pt. complained of nausea/lightheadedness. I carried (pt) back into administration room and sat her down. I gave her a bottle of H2O, fanned her, and monitored her. Pt. felt better after 20-25 mins and left pharmacy.
mom states started having t102 that noc, neck was stiff for 24 hrs; pt layed around & was limp for about 2 days; pt also cried alot;
: Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; : Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008730: US-009507513-2107USA008731: US-009507513-2107USA008732: US-009507513-2107USA008729: US-009507513-2107USA008728: US-009507513-2107USA008727:
constricted throat; Body and muscle aches; Feverish, but no fever; Body and muscle aches; the pins and needles feeling, and the red hands; pins and needles feeling, and the red hands; burning and tingling sensation in the legs and back; burning and tingling sensation in the legs and back; the pins, needles, and burning sensation on the bottom of her feet; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Batch/Lot number:ER8730 & Expiry date not reported) via unspecified route of administration in left arm on 26Mar2021 16:10 (at age of 55-year-old) as dose 2, single for COVID-19 Immunization. Patient medical history and concomitant medications not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Batch/Lot number: ENG202, Expiry date not reported) via unspecified route of administration in left arm on 26Feb2021 (at age of 54-year-old) as dose 1, single for COVID-19 Immunization. On 26Mar2021, Patient experienced had a severe reaction, but it did not require and epipen. She ended up in the emergency department and required Benadryl as she had a constricted throat. Her symptoms resolved as soon as she received Benadryl and steroids via IV. Patient after returning home she had severe body aches and muscle aches to the point that getting to the bed from her recliner was difficult, and she was down all weekend. She felt feverish but did not have a fever. She checked her temperature, and it was 98F. On an unspecified date in Mar2021, Caller states she had pins and needle feeling, and burning and tingling in her legs and back. In addition to the bottom of feet, she also had pins, needles, and a burning sensation that lessened as of this morning. Caller states the pins and needles feeling, and the red hands are ongoing since the first covid19 vaccine, on26Feb2021, and are persisting since the second covid19 vaccine. Caller states the burning and tingling sensation in the legs and back were ongoing since the first covid19 vaccine and worsened since the second covid19 vaccine. Caller also states the pins, needles, and burning sensation on the bottom of her feet started 3 weeks after the first covid19 vaccine, on 19Mar2021, and the sensation worsened after the second covid19 vaccine and was ongoing. Patient was referred to allergist. Patient underwent lab test and procedure include body temperature was 98F on unspecified date. Treatment received for constricted throat. The Outcome of events was constricted throat recovered on 26Mar2021, Feverish, but no fever recovered on 27Mar2021, body aches and muscle aches are recovering, and other events are not recovered.     No follow-up attempts are possible. No further information is expected.
joint pain in his shoulders, fingers and knees; overall pain; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0151, expiration date unknown) via an unspecified route of administration in the arm right on 04May2021 at 13:00 at age of 63-year-old for COVID-19 immunization. Medical history included depression. Patient previously received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: Ew0170, expiration date unknown) via an unspecified route of administration in the right arm on 15Apr2021 at 02:00 PM at age of 63-year-old for COVID-19 immunisation. Patient previously received acetylsalicylic acid (ASPIRIN ) and experienced stomach reaction. There was no other vaccine in four weeks. Concomitant medications included sertraline hydrochloride (ZOLOFT). After the second dose, patient had about 3 days of muscle pain and overall pain. Then within 10 days, patient started having joint pain in his shoulders, fingers and knees. Knees got better after a week or two but shoulder pain in his left side and fingers got more severe for 2 month afterwards. Then gradually lessened to a tolerable level. And now, 5 months later he still had pain in his fingers and shoulders. Patient never had shoulder pain or hand pain before. His right hand got the worst of it and his left shoulder after that. Most of the pain in his fingers were concentrated in the first joints from the tip of fingers. The events didn't result in emergency room visit or physician office visit. Onset date of the events was reported as 20May2021 at 12:00AM. No treatment received for the events. Outcome of the events was recovered with sequel. Patient had no COVID prior vaccination. Patient was not tested for COVID post vaccination.
flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (flu symptoms). At the time of the report, INFLUENZA (flu symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Patient described development of a localized rash around the injection site area. She described it as uncomfortable, with a tingling sensation at the site. She said the rash started to fade, but then came back and has stayed there since the injection (now over a month ago).
A report has been received from registered nurse, concerning a 3 year old, female patient. The patient's medical history and concomitant medications were not reported. On 26-Sep-2012, the patient received FLUMIST to one nostril, half dose. The outcome of the event of half dose of FLUMIST administered was unknown. The report was considered to be non-serious. Corrected report 06-Dec-2012: Coding of event 'half dose of FLUMIST administered' changed from inappropriate dose of vaccine administered to Vaccine underdose, narrative updated, reporter details corrected.
My throat is so soar; I can't talk; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (My throat is so soar) and OROPHARYNGEAL DISCOMFORT (I can't talk) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (My throat is so soar) and OROPHARYNGEAL DISCOMFORT (I can't talk). At the time of the report, OROPHARYNGEAL PAIN (My throat is so soar) and OROPHARYNGEAL DISCOMFORT (I can't talk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
My mother started breaking out in blisters that erupted and caused sores on her entire body including groin area within 1 week of getting the third vaccine by Moderna.    Tx: Was seen by several doctors in the ER; Due to the increase COVID numbers we could not get an appointment with a dermatologist and her PCP retired. We cleaned the wounds with antibacterial soap, dried the areas, covered them with xerofoam, non-sticky gauze 3-4 times a day. The blisters would burst and caused her clothing or whatever she was sitting on to stick to her skin which was painful to remove.  Time of course: November 2021 to January 2022  Outcome: Death
31 weeks 4 days at time of vaccination & adverse event; EDD 9/5/17. Pt c/o localized erythema and pruritus around site of injection. Pt did not call provider. Pt took BENADRYL on her own and found decrease in symptoms. Topical hydrocortisone provided no relief. Small healing wound/scab at site of injection where pt states that she "scratched".
I started having a sore throat last Sunday on December 04, 2022. It was still sore by Tuesday the 6th so I went in and got tested for strep throat. My symptoms were sore throat and fatigue. I also tested negative for COVID-19 on December 5th and 6th. The Strep swab was also negative. It lasted until Friday December 09, and I developed congestion that same day and retested for COVID again but was negative. My sore throat was gone but I was congested and had a little bit of a cough since December 09th. I was 30 weeks. I am now 31 weeks pregnant. My estimated due date is February 13th. The doctor did not recommend any medication due to the pregnancy. I do feel like I have completely recovered, and I was able to return to work.
swelling, hot, achy, sore rt arm;advised pt to apply cold compresses & f/u w/pvt MD if condition worsens;