chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The adverse event is that this patient was accidentally given a 4th dose of Pfizer covid vaccine today, 7/11/22, when it is not authorized for her age group. The patient came in and requested her booster and was given a booster before realizing she was not eligible as she had already received her booster dose on 12/21/21. She is not immunocompromised. Patient was made aware and instructed to let us know any adverse reactions she may experience.
headache; weakness - I don't have by strength back; dizziness; very thirsty; Foggy brain and felt bad call day; extreme chills; severe muscle pain; fever; nausea; diarrhea; sweating; woke me up at night; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Foggy brain and felt bad call day), ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness), DIARRHOEA (diarrhea) and HYPERHIDROSIS (sweating) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), SLEEP DISORDER (woke me up at night), CHILLS (extreme chills), MYALGIA (severe muscle pain), PYREXIA (fever) and NAUSEA (nausea). On 20-Mar-2021, the patient experienced FEELING ABNORMAL (Foggy brain and felt bad call day). On 23-Mar-2021, the patient experienced ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness) and THIRST (very thirsty). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency; WATER at an unspecified dose and frequency and ELECTROLYTE SOLUTIONS [ELECTROLYTES NOS] at an unspecified dose and frequency. On 21-Mar-2021, SLEEP DISORDER (woke me up at night), CHILLS (extreme chills), MYALGIA (severe muscle pain), PYREXIA (fever) and NAUSEA (nausea) had resolved. At the time of the report, FEELING ABNORMAL (Foggy brain and felt bad call day), ASTHENIA (weakness - I don't have by strength back), DIZZINESS (dizziness), DIARRHOEA (diarrhea), THIRST (very thirsty) and HEADACHE (headache) outcome was unknown and HYPERHIDROSIS (sweating) had resolved.            No Concomitant medications was reported
2nd day after vaccine exhaustion, nausea. Those were done in a couple of days.; 2nd day after vaccine exhaustion, nausea. Those were done in a couple of days.; Same time jaw pain and tightness started along with "my" very mild tinnitus at least doubling.; Same time jaw pain and tightness started along with "my" very mild tinnitus at least doubling.; Same time jaw pain and tightness started along with "my" very mild tinnitus at least doubling.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 16:30 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (VITAMIN D), multivitamin (unspecified), probiotics (unspecified) and zinc (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates and unknown if ongoing. On 12Apr2021 at 00:00, 2nd day after vaccine, the patient experienced exhaustion and nausea. Those were done in a couple of days.  Same time the patient also experienced jaw pain and tightness which was started along with very mild tinnitus at least doubling. These second set of symptoms were there after more than 2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhaustion and nausea was resolved on an unknown date in Apr2021, while that of the events jaw pain and tightness which was started along with very mild tinnitus was not resolved at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Red rash, swelling hot, blisters spread across entire deltoid and nausea, headache    Called to report to Dr
Received 2 dose Wednesday at 4:00 PM. By then next afternoon (Thursday) my arm was sore particularly at the injection sight at my left deltoid, with some diffuse soreness shoulder to elbow laterally.  By that same afternoon and evening I had chills and aches and started to feel run down.  That evening my temperature was slightly elevated around 99.3 degrees.  Some chills and aches, and feeling run down persisted the next morning (Friday) , I slept most of that morning and until 1::00 PM.  Mostly felt better by that evening and fine by the next day (Saturday).  The arms soreness also subsided by Saturday. As a side not with my first dose 4 weeks earlier my only symptom was soreness at the injection site for 3 days (more significant than I have experienced with other vaccines, including the flu vaccine.)
Swelling the height and width of a tennis ball. Very hot over 99.8 degrees on arm. Extremely  painful. Could not even touch without screaming.
6 days after my second dose on Oct 10th, I got horrible cramps and got a second period. It was 14 days after my period I had already. I should have been ovulating but instead I got my period. My cycle has always been regular no matter what stress I was under. I never had two periods in one month. I do not take any medications or birth control pills. This was a direct link to the vaccine.
increased blood pressure for 7 to 10 days after the second dose from 130-135 normal to 155-165
technician gave vaccine to the patient without mixing with nacl patient  is having fever and rm pain started at  night
This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 04-DEC-2014, the patient was vaccinated with his first dose of GARDASIL (lot number, expiration date and route and site of administration were not reported). On 25-FEB-2016, the patient was vaccinated with second dose of GARDASIL 9, lot number L045711, expiration date 08-MAY-2017 (route and site of administration were not reported) and on 02-MAR-2017 the patient was vaccinated with third dose GARDASIL 9 lot number M041212, expiration date 21-JUN-2019, (route and site of administration were not reported). No adverse effects were reported. No further information was provided. Additional information is requested.
Skin became very dry excoriated. Opened into dermal layer bleed. Swelling and itching. Skin remains swollen and dry.
drowning in her throat; Headache; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (drowning in her throat), HEADACHE (Headache) and FATIGUE (exhausted) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concomitant products included DESOGESTREL (CELEA), ALUMINIUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETICONE (PEPSID), CLONAZEPAM (KLONOPIN), BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VITAMIN D NOS for an unknown indication.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced THROAT TIGHTNESS (drowning in her throat), HEADACHE (Headache) and FATIGUE (exhausted). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-May-2021, THROAT TIGHTNESS (drowning in her throat), HEADACHE (Headache) and FATIGUE (exhausted) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Approximately 30 minutes post-vaccination, patient reports neck stiffening (difficulty moving neck side to side). Kept rubbing, took tylenol and then slept. neck was sore for 2 days
no adverse event; vaccine used which were beyond the 30-Day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccine used which were beyond the 30-Day beyond use date).    Concomitant products were not reported.  It was reported that the 30 day beyond use date of lot 056m21a was 12-May-2022.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non significant Live Follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Headache, Myalgia, Fever, Diarrhea, chills, chest tight Narrative: Fever 103.4, headache, myalgia, diarrhea, chest tight, chills; tylenol/advil; resolved.
Very sleepy ,body aches and fever(99.9 degrees) for 3 days. Body is still sore especially on right side of body.
This spontaneous report was received from a Nurse practitioner referring to an unspecified number of patients of unknown age and gender. No concurrent or medical condition was reported. On an unknown date, 3 doses of improperly stored GARDASIL Lot # K011562, expiration date: 08-APR-2017, dose, route, frequency and anatomical location were not reported, were administered to unspecified number of patients. No concomitant medication was reported. No adverse event was reported. No further information was provided. No product quality complaint reported. This is one of several cases received from the same source (MARRS numbers 1508USA001815, 1508USA005093). Additional information has been requested.
Initial report was received from a consumer, who was the patient, on 16 October 2012. A 30-year-old female patient received an injection of INFLUENZA VACCINE, manufacturer unknown, (lot number, route, site, side and dose in series not reported) on an unspecified day in October 2011. On an unspecified day in October 2011, within 24 hours of vaccination, the patient developed preterm labor at 33 weeks gestation. The patient was hospitalized for five days. Laboratory or diagnostic testing was not reported. Treatments included bed rest and intravenous Magnesium Sulfate. Illness at time of vaccination was reported as none. Current pregnancy history was not provided. Last menstrual period was not reported. Estimated date of delivery was reported as 03 December 2011. The patient delivered a full term baby on 03 December 2011. The patient's outcome was reported as recovered. Documents held by sender: None.
Patient developed a raised, red, pinpoint, itchy, rash on her body approximately 11 days after receiving MMR, Varicella, and Vaqta vaccines.
Sudden onset of left side facial numbness approximately 6 weeks after shot.   Progressed to loosing taste on left side of tongue and face.
Shortly after the 2nd vaccine I started feeling like my throat was closing and I couldn't breath. I went to my doctor, Endocrinologist, ENT, Gastroenterologist and also visited the ER. I have had constant throat spasms and feeling of not being able to breath every since the second shot with no resolution to my side effect. I am still seeking help to resolve the issue if possible.
On August 24th child started vomiting and diarrhea and was inconsolable. That evening started with bloody diarrhea. Transferred by ambulance to regional hospital due to intussusception - unable to reverse through air barium enema x 3. Had surgery to repair intussusception on August 25th.
Pt. was seen on 10-23-10 for laceration repair and needed a TD shot. On 10-25-10 pt. came in c/o red rash on arm where TD was given.
severe muscle pain; joint pain; low grade fever of 99.4-99.6F; chills; nausea; bad headache; dry heaves; arm hurting; This spontaneous case was reported by an other health professional and describes the occurrence of   in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (previously diagnosed with COVID).    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dose every 4 hours.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2020, Body temperature: 99.4-99.6 (High) low grade fever of 99.4-99.6F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided
Patient was given Pfizer bivalent booster for the first dose instead of the first dose Pfizer monovalent
Severe joint pain, muscle aches, extreme fatigue; increased anxiety.  Also, I was incredibly sad and I do not know why; I just began crying and getting agitated for no apparent reason.
minimal discomfort; redness in a 2 x 3 inch area on her left arm/red and a little raised; redness in a 2 x 3 inch area on her left arm/red and a little raised; itchy; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (redness in a 2 x 3 inch area on her left arm/red and a little raised), SWELLING (redness in a 2 x 3 inch area on her left arm/red and a little raised), PRURITUS (itchy) and VACCINATION SITE PAIN (minimal discomfort) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (redness in a 2 x 3 inch area on her left arm/red and a little raised), SWELLING (redness in a 2 x 3 inch area on her left arm/red and a little raised) and PRURITUS (itchy). On an unknown date, the patient experienced VACCINATION SITE PAIN (minimal discomfort). At the time of the report, ERYTHEMA (redness in a 2 x 3 inch area on her left arm/red and a little raised), SWELLING (redness in a 2 x 3 inch area on her left arm/red and a little raised), PRURITUS (itchy) and VACCINATION SITE PAIN (minimal discomfort) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by patient  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow-up information received on 28-JUL-2021 contains significant information outcome updated.
UNCONTROLLABLE CRYING FROM 2:30 PM UNTIL 3:30 AM. VOMITING AFTER EATING. KICKING LEGS AND ARCHING BACK. FEVER OF 100.9. GAVE TYLENOL STARTING AT 2:30 EVERY 4 HOUR FOR PAIN AND FEVER. BABY IS STILL VOMITING AFTER EVERY FEEDING MORE THAN 48 HOURS AFTER VACCINATIONS.
Patient called approx. 7 hours after vaccine administered complaining of itching, but no hives and feeling like her throat was closing, "but it's not"; instructed patient to go to ER if she felt like she couldn't breathe.
Developed chills, body aches, site swelling, redness, & pain the nov after receiving TDAP. AVONEX taken 8/16/12 - feeling better.
an expired dose of IPOL was administered to a patient with no adverse event; Initial information received on 16-Mar-2021 regarding an unsolicited valid non-serious case received from the other health care professional (HCP) via Agency (Reference number- 00521683).  This case involves a six months old male patient who received an expired 0.5mL third dose of IPV (VERO) [IPOL] Strength: Standard, lot number: R1B25, expiry date: 13-Mar-2021 via intramuscular route in the right thigh on 16-Mar-2021for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) via oral route, DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP), PNEUMOCOCCAL VACCINE CONJ (PCV) and HEPATITIS B VACCINE for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting patient had no adverse event.  Causality: not reported, Reporter can be contacted by Sanofi: Yes Potential Product Technique Complain: No. Caller with questions on whether dose needs repeating. Caller with questions on adverse reactions to expect. Pasteur Adverse Event Reporting Refunds/ Credits will not be issued due to adverse events. Emergency Room/ Doctor Visit and date: well visit 16-Mar-2021, Reporter relationship: HCP. Product: Used.  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.
patient had no adverse reactions after getting vaccination. she waited in the health dept for 15 mins after receiving vaccine and had no problems.  I also spoke to this patient on 11/15/22 and she had no reaction/issues from the vaccine
patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 10:35 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 10:41 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-Apr-2021 at 10:35 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021. The vial with lot number 007C21A was initially moved to the fridge on 19-Apr-2021 and proposed beyond use date was 19-May-2021 On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1 PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Vomiting, fever. Parents reported bulging fontanelle but it resolved before she was seeen in offive at 9 am.
Lethargy, muscle aches, headache, disoriented without memory of incidents, urinary incontinence, agitation, loss of balance. Treated symptoms at home with assistance and reported to pharmacist. By the way, symptoms subsided the next am except for muscle aches.
rash & itching all over , face felt flush, fast heartbeat  B/P 180/104 arm sore later that night & headache Given Benadryl 1 dose by employee health nurse  then went to urgent care and received: 80mg Depo Medrol IM given in clinic. Start 40mg Prednisone daily for 3 days. Zyrtec 10mg daily as needed for itching. For your blood pressure, recommend taking medication and rechecking BP in 1-2 hours.
extreme tenderness & tingling in lt arm, lt neck, lt chest & lt thigh;tingling over entire body;felt feverish;
The morning of 9/5, right arm was swollen, red, hot to touch, and he had a fever. Swelling progressed from his shoulder to forearm and, by evening, his right arm was 1 1/2 times the size of his left.  Fever went up to 102 degrees F.  Parent administered Tylenol alternating with ibuprofen. Fever was gone by the end of the day 9/7. The swelling began to go down on 9/6.  He had completely recovered by 9/9/2015.
pt recv 2 doses of vax & donated blood 27DEC94 & it was noted that pt liver enzymes were elevated;pt did not relate this elevation to vax & recv 3rd dose of vax FEB95;condition will be followed by MD; liver enzymes returned to nl by 1