chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRADYCARDIA; RAPID ATRIAL FLUTTER; RAPID ATRIAL FIBRILLATION; TACHYCARDIA; SHORTNESS OF BREATH; DID NOT FEEL WELL; This spontaneous report received from a patient concerned a 66 year old white and Hispanic or Latino female. 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: 1805031, and expiry: UNKNOWN) dose was not reported, once total, administered on 10-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported.  On 10-MAR-2021, patient had echocardiogram and the rhythm was normal. On 29-MAR-2021, the patient experienced rapid atrial flutter which became rapid atrial fibrillation and had tachycardia and shortness of breath. On same day patient was hospitalized for monitoring and On 30-MAR-2021, the patient developed bradycardia. It was stated that patient was bouncing between tachycardia and bradycardia which he never experienced before. Also patient stated that if symptoms doesn't resolve he had to have cardioversion procedure. On 31-Mar-2021, patient got discharged from hospital. It was reported that patient's medical doctor was aware about the adverse events and cardiologist does not know about the administration of vaccine. It was also reported that clinician who administered the vaccine to patient advised to take Motrin. Treatment medications (dates unspecified) included: Motrin(ibuprofen) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rapid atrial flutter, rapid atrial fibrillation, shortness of breath, tachycardia, and bradycardia, and the outcome of did not feel well was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210424129-Covid-19 vaccine ad26.cov2.s-Atrial fibrillation, Bradycardia and  Atrial flutter. These events are considered not related. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
June 17th-fever; June 18th-rash, itching started on thighs. Pt counted 25 lesions spreading to her Dr. over the phone and started using Hydrocortisone cream and Benadryl every 6 hours; 7/18/05-still reports lesions.
She started having dizziness, fatigue, tingling in arms and swollen tounge.  She went to ER was given steroids and benadryl was told was an allergic reaction to vaccine, never to have another.
felt sick; couldn't eat; couldn't hold anything down; irritation on bottom of stomach; joint pain; pain in shoulder; pain in elbow; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ILLNESS (felt sick), EATING DISORDER (couldn't eat), ABDOMINAL DISCOMFORT (couldn't hold anything down), ABDOMINAL DISCOMFORT (irritation on bottom of stomach) and ARTHRALGIA (joint pain) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included WATER, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for an unknown indication.    On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced ILLNESS (felt sick), EATING DISORDER (couldn't eat), ABDOMINAL DISCOMFORT (couldn't hold anything down), ABDOMINAL DISCOMFORT (irritation on bottom of stomach), ARTHRALGIA (joint pain), ARTHRALGIA (pain in shoulder) and ARTHRALGIA (pain in elbow). At the time of the report, ILLNESS (felt sick), EATING DISORDER (couldn't eat), ABDOMINAL DISCOMFORT (couldn't hold anything down), ABDOMINAL DISCOMFORT (irritation on bottom of stomach), ARTHRALGIA (joint pain), ARTHRALGIA (pain in shoulder) and ARTHRALGIA (pain in elbow) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown normal.         Patient reported he has a previous injury on his arm. On 03-APR2-021 symptoms lightened up. Action taken with mRNA 1273 in response to event was not applicable.   This case was linked to MOD-2021-231678 (Patient Link).
Pt c/o chest pain approx. 1 d post vaccines. To ER on 7/27/02 with c/o "racing heart" and substernal chest pain. Rec'd Albuterol without improve. PO Prednisone. To f/u with Cardiology and PCP upon D/C.
p/vax pt fell back in mom arms, eyes shut;low snoring noise;aide put pt on floor;curled up in a ball, not breathing;911 called;pt woke up & looked surprised;started crying;almost fell asleep;was stiff;to ER;sz or loss of consciousness
Information has been received from a physician concerning a 21-week-old female with no medical history who on 16-JAN-2007 (lot #655174/0848F) and 30-MAR-2007 (lot #656187/1237F) was vaccinated PO with the first and second 2.0 mL doses, respectively, of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  They physician reported that on 11-APR-2007, the patient developed intussusception.  The physician noted that there was no adverse event involved after the patient was vaccinated with the first dose.  At the time of this report, the outcome was unknown.  Upon internal review, intussusception was determined to be an other important medical event.  Additional information has been requested.12/20/07-records received for DOS 4/11-4/14/07-DC DX: Intussusception. Reduced by Barium contrast enema. Acute episode of vomiting, nonbloody nonbilious, approximately 20 episodes of emesis and an episode of abdominal pain. Lethargic, tachycardic with poor peripheral perfusion. Following enema patient passed a current jelly stool in ED.
Nausea, vomiting, diarrhea, redness and swelling at site.
Patient received dose 1 of the Pfizer COVID vaccine (lot FK5127) at approximately 1115. At 1124, RN approached the patient and mother to inquire about how he felt. The patient reported feeling nauseous. RN transferred patient to zero-gravity chair. PHN and Paramedic approached to assess. At 1125, vital signs: blood pressure 98/72, respirations 12, O2 100%, pulse 96. Patient placed supine. Patient reported improvement in symptoms, no longer nauseous. Patient appeared pale; denied diaphoresis, blurry vision, pain, dizziness. Patient's mother reported he had eaten breakfast and was well hydrated. Patient has no allergies, no medical conditions, and takes gummy vitamins. No history of fainting. Patient reported anxiety to needles. At 1133, PHN offered Benadryl, mother declined. PHN educated patient's mother on remaining for 30min monitoring since report of symptoms, on following up with provider, and ER precautions. Patient sat up and drank water provided by Paramedic. At 1137, vital signs: blood pressure 96/68, pulse 84, O2 100%, respirations 22. Patient reported symptoms had resolved. PHN noted improved skin tone color. At 1140, patient stood up unassisted, continued to report no symptoms. At 1142, patient left with mother, against medical advice of remaining for 30min monitoring from time of reporting symptoms.
SWELLING AT INJECTION SITE; REDNESS AT INJECTION SITE; SORENESS TO THE INJECTION SITE OF THE LEFT ARM; This spontaneous report received from a health care professional concerned a 99 year old female. 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: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUN-2021, the subject experienced soreness to the injection site of the left arm. On 02-JUL-2021, the subject experienced swelling at injection site. On 02-JUL-2021, the subject experienced redness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from soreness to the injection site of the left arm on 22-JUN-2021, and had not recovered from swelling at injection site, and redness at injection site. This report was non-serious.
Baby has not been eating well, sleepy, but not sleeping like she usually does, high pitched screams & crying that is inconsolable, patchy rashes on legs, arms and face, still currently being affected.
1 of 2 pts vaxed from the same lot# exp an inject site react; local area was hot to touch 24 x 19 cm induration w/redness; pt states area itchy; no systemic react;
PATIENT SAID 3 DAYS AFTER VACCINATION SHE DEVELOPED A RED, BUMPY RASH ON HER RIGHT TEMPLE. IT WAS HOT TO THE TOUCH BUT DID NOT ITCH. THROUGHOUT THAT DAY IT HAD SPREAD TO THE RIGHT SIDE OF HER FACE. NO OTHER SYMPTOMS OR MEDICATION. I INSTRUCTED HER TO TAKE BENADRYL AND USE HYDROCORTISONE CREAM, AND GO TO ER IF SHE HAS ISSUES BREATHING, WHICH SHE DID NOT AT THAT TIME. CALLED BACK ON 11/1/17 TO CHECK IN BUT HAD TO LEAVE A MESSAGE.
Bleeding since September 3rd. Have an IUD.; This is a spontaneous report from a contactable nurse, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Sep2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Sep2021 at 18:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date (prior to the vaccination, the patient was diagnosed with COVID-19). The patient had no known allergies. Concomitant medications included pantoprazole sodium sesquihydrate (PROTONIX), sucralfate (MANUFACTURER UNKNOWN) and amoxicillin, clavulanate potassium (AMOX-CLAV 875) and unspecified IUD; for unknown indications, from unknown dates and unknown if on going. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since 03Sep2021 at 11:30, the patient experienced bleeding. The patient had an IUD and did not get periods, so that was odd for her. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bleeding since 11:30 on 03Sep2021 and did not get periods was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Within one minute of vaccine, patient starting shaking, saw stars, and became systemically flush. She was alert and able to talk. Upon blood pressure monitoring, she had tachycardia. 911 was activated. She was responsive the entire time and declined diphenhydramine. She was transported to an area hospital for monitoring.
The symptoms consist of a rash, redness, hardness, and warm to touch,  with a nodule around the left deltoid. There is also numbness in the left hand. The report also include pain when moving the left arm up and down. The employee was instructed to go to urgent care. I spoke with pt. at 1410 and she had not went to the provider.
Leg pain; nerve pain on the left foot; A spontaneous report was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced leg pain and nerve pain on the left foot. The patient's medical history was reported as history of Lyme disease. Patient is also asthmatic and has COPD. No relevant concomitant medications were reported.    On 12-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 13-JAN-2021, one day after the dose of injection, the patient experienced leg pain and nerve pain on the left foot. No Laboratory details provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events leg pain and nerve pain on the left foot was Unknown.
Day 2, Large red circle below injection site with hard swelling in the middle. Tender and itchy. On Day 3, the swelling went down, the circle turned more to a rash witha couple blotches. Less tender, less itchy.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 06-JUN-2017 the patient was vaccinated with an improperly stored dose of VARIVAX lot # L040419 with an expiration date 14-OCT-2017 for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA004091: US-009507513-1707USA000412: US-009507513-1707USA000410: US-009507513-1707USA000411: US-009507513-1707USA000407: US-009507513-1707USA000409:
On the left side of forehead, keep getting a pins and needles feeling.; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.   A 35-year-old male patient received bnt162b2 (BNT162b2), administered in right arm, administration date 29Sep2021 at 14:30 (Lot number: EW0151) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Superficial punctate keratitis" (unspecified if ongoing), notes: Thygeson and "Milk allergy" (unspecified if ongoing), notes: Known allergies: Milk. Concomitant medications included unspecified pre workout HTLT.  The following information was reported: PARAESTHESIA (non-serious) with onset 05Oct2021 at 16:30, outcome "not recovered", described as "On the left side of forehead, keep getting a pins and needles feeling". The event "On the left side of forehead, keep getting a pins and needles feeling." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that pins and needles feeling lasted about 3-5 seconds and could happen from a couple times an hour to nothing for hours and it just happened randomly.  Follow-up attempts completed. No further information expected.
Pharmacy refrigeration malfunctioned at some point last night/early this morning. COVID Pfizer vaccinations were moved to another refrigerator. Management/leadership was told that vaccines remained viable to give. Staff was permitted to give scheduled vaccines by this communication. Two Pfizer booster vaccinations were given in the morning. Soon thereafter management/leadership was informed that affected vaccines should not be given.
Mom reports that the patient had a vaccine (PEDIARIX) on her right side and later that day 7/31/17, they went home and she began shaking on the left side. She also had rapid eye movement. The event went on for several seconds and then stopped. Pt was lethargic after the event and recovered quickly.   The next day mom reports that she had another event similar to the first one, but she had full body shaking which looked like a seizure. Rapid eye movement and mom says she had seen a seizure before and this went on for about 20 seconds and stopped. Again the patient was postictal (lethargic)  she recovered quickly. Mom did not report fever. Mom reported this to our office during the next visit ( four month well child visit).
since having the vaccine i have been experiencing, SOB with chest tightness, tachycardia.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Healthcare facility consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the Dept of Public Health and Environment on a compliance improvement plan and has been reinstated vaccination privileges.
Initial information received on 09-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 70 years old female patient who received vaccine FLUZONE HIGH DOSE (batch number: UJ044AA, expiry date: 04-Jun-2019, dose, dose in series and site of administration were not reported) via unknown route (reported as intramuscular or subcutaneous) on 08-Nov-2018 with a 5/8 inch needle instead of a 1 inch needle. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as no other vaccine. It was a case of medication error due to Needle issue. No adverse event was experienced. 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. Documents held by sender: none
Dizzy after the first dose of the vaccine; Felt very sick/Sick as a dog; 102 degree fever after first dose of the vaccine; He felt dizzy and thought he was going to fall over; This is a spontaneous report from a contactable consumer (patient).  A 52-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8732 ), at single dose via an unspecified route of administration on 29Mar2021 for covid-19 immunization (at the age of 52 years). Medical history included ongoing asthma (had for 20-30 years), diabetes (from 2018 and ongoing but on and off since 2018), covid-19 from Jan2021 to an unknown date (No Investigation Assessment), motor vehicle accident he had in 2002- took Naprosyn and it helped. States that before all of this he had lost (weight) pounds and been eating very well. The patient's concomitant medications were not reported. Previously, the patient had flu vaccine and he got the flu every time he got it (Vaccination Date: 2002 or 2003). No other products. After the first dose of the vaccine, on 29Mar2021 he had a 102degree fever a few minutes after the shot and was dizzy. He felt dizzy and thought he was going to fall over on an unspecified date in Mar2021. On 29Mar2021 he felt very sick; dizzy after first dose of the covid vaccine and stated that he sat for a bit after his shot. Paramedics there who took his temperature and that it was 101 point something; close to 102. They told him to go home and relax and take Tylenol. States he went home and took Aleve as therapeutic measure and felt better. It lasted one more day then went away. The patient underwent lab tests and procedures which included body temperature: 102 on 29Mar2021 it was 101 point something; close to 102. Rest relevant tests were none. The Outcome for fever, dizzy and felt sick was recovered on 30Mar2021; for going to fall over was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Stomach ache 20 minutes after leaving clinic; developed into severe abdominal cramping; mouth began to salivate, induced vomiting; bowel movement and vomiting every 20-30 minutes; severe diarrhea; could not hold any liquids.
Patient presented for 2nd dose of Moderna Covid Vaccine. While withdrawing the  needle from patient's  arm after injection of vaccine, some of the medication was expelled from the syringe and dripped down the patient's arm. The patient insisted on being given another injection. This staff spoke to the patient and advised that we have no data re what to expect by giving her a 2nd injection. Permission for 2nd injection was given by physician who oversees quality, and repeat injection administered. The patient was taking photos of the nurse while he was performing the injection and this is thought to have contributed to the medication error by causing him anxiety. Both doses were documented in the medical record.
Started off with anxiety that gradually got worse. Along with fatigue, mild fever (99.7), sweats, chills, pain in my left arm where the shot was given, weakness in legs, general malaise, confusion, brain fog, loss of appetite.
dizziness; headache; Nausea; vomiting; fatigue; chills; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anemic and Cyclic vomiting syndrome (CVS(Cyclic vomiting syndrome)).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting), FATIGUE (fatigue), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), NAUSEA (Nausea), VOMITING (vomiting), FATIGUE (fatigue), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided. no treatment taken
Hives to face per patient's report and itching to skin of trunk and arms. Pt managed symptoms with BENADRYL.
Myalgia, fatigue Narrative: myalgia and fatigue the day after the second dose; missed work due to reported symptoms
Face got red and hot. Fingers felt numb. Arms and hands swollen. Pt was given BENADRYL at strong hospital, 2 hours later her throat started to close, prednisone given. Discharged home.
This spontaneous report was received from a licensed Practical Nurse refers to multiple patients of unknown age and gender. Concurrent conditions, medical history and concomitant therapies were not reported. Approximately in June 2016 (reported as "27-JUN-2016 or 28-JUN-2016"), the patients were vaccinated with improperly stored doses of (temperature: 28 F, time frame: 3 hours and 42 minutes) GARDASIL 9 (# lot M004116, expiry date 12-OCT-2017, dosing details not provided). No adverse effects were reported. Digital data logger was involved. There was no previous temperature excursion. No product quality issue was involved. This is one of two reports received from the same reporter. Additional information has been requested.
Dose 1 on 2/1/2021, dose 2 on 2/21/2021.  Symptoms of cough, malaise/fatigue and weakness on 06/15/2021.  Diabetes Type 2- not well controlled ON LONG TERM MAINTENACE TREATMENT FOR MELANOMA.  Pneumonia possibly due to COVID-19. Patient had received 2 doses of Pfizer COVID vaccine in February of 2021. COVID positive test on 6/23  Exposed to daughter (vaccinated, symptom onset on 6/21/2021).