chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous, non-serious report received from a patient. A patient, of unspecified age and sex (height and weight not reported), received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# unknown/not reported) dose, start therapy date not reported, for immunization. No medical history or concurrent conditions reported. The company was unable to perform follow-up to request batch number. No concomitant medications reported.  On an unspecified date, patient experienced freezing, sore arm, headache and nausea. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from freezing, sore arm, headache and nausea.
Pain, swelling Rt upper arm, occasional numbness - can move arm. Few papules at vaccine site. Low grade temp 100.1 oral.
chest discomfort; Felt like fast heart rate at times; chills; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730), via an unspecified route of administration in the left arm on 26Mar2021 at 19:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. The patient did not receive any medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration in the left arm on 05Mar2021 at 19:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021 at 05:30, the patient experienced like fast heart rate at times, chills, tiredness, chest discomfort. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of fast heart rate, chills, tiredness and chest discomfort were recovered with sequelae.    No follow-up attempts are needed. No further information is expected.
The patient experienced no symptomps from previous administered doses; patient who was administrated the first two doses of GARDASIL 9 on unspecified dates over 1 year ago is being administered a third dose of GARDASIL 9 on 1/28/2020; This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history and concomitant medications was provided.  On an unspecified dates (reported as over 1 year ago), the patient was vaccinated with the first two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency, route and site of administration, lot # and expiration date were not provided) for prophylaxis. On 28-JAN-2020, the patient was vaccinated with third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R021634, expiration date 08-MAY-2021, intramuscular (strength and site of administration were not provided) for prophylaxis. The patient experienced no symptoms from previous administered doses. The outcome was unknown.
client complained of dizziness after receiving 2nd dose of Pfizer Covid Vaccine. Within 2 mins of receiving vaccine client informed RN she was feeling dizzy. Client able to transfer by herself from chair to wheelchair. RN pushed chair to observation room where EMT  assumed care. PHN  joined EMT. Client alert and oriented. Per client feeling warmth, dizzy, dry mouth. Vitals at 1434: blood pressure: 110/80, pulse 86, oxygen 98%. Medical history: diabetes, COPD, bipolar depression, glaucoma, and retinopathy. EMT gave client water. Current medications: latuda, metformin, timolol, travatan, eyedrops, novalog, basaglar, and jenuvia. Per client did not have any reaction to first dose. Client informed we would continue observing for 30 mins. 1439 client stated dizziness was improving. 1443 vitals: blood pressure: 130/80, pulse 85, oxygen 99%. Per client dizziness improving. 1448 vitals: blood pressure: 132/82, pulse 85, oxygen 100%. Client stated feeling warm again and clammy. PHN asked client to lower mask and assess skin color. Face flushed, client denies shortness of breath. Per client warmth feeling worsening, PHN offered Benadryl. Client stated not driving, insurance transport would take her home. 50mg Benadryl given orally at 1454.  Vitals: blood pressure 126/80, pulse 83, oxygen 98%. Vitals 1500: blood pressure 124/82, pulse 81, oxygen 100%. Client stated feeling better. Still warm feeling, dizziness improving. 1505 vitals: blood pressure: 122/82, pulse 83, oxygen 98%. Per client more improvement, stated starting to "feel sleepy". 1510 vitals: blood pressure 120/78, pulse 87, oxygen 97%. Per client dizziness resolved, skin color back to normal, no flushing noted. ER precautions given. Transport arrived at 1530, unable to get last set of vitals. Per client feeling much better, client asked to be wheeled to transport car due to tired feeling. PHN and EMT accompanied client to bus. Client able to stand up from chair with no complaints. Able to walk into vehicle by herself with steady gait.
arm to ache; arm difficult to move; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient asked if it was common for his/her arm to ache and be difficult to move after 2nd dose of Shingrix vaccine. No further details were provided.
pain in the left arm,; burning sensation at the site of the injection on her left arm; swollen lymph nodes in left arm; mild fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm,), VACCINATION SITE PAIN (burning sensation at the site of the injection on her left arm), LYMPHADENOPATHY (swollen lymph nodes in left arm) and FATIGUE (mild fatigue) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm,), VACCINATION SITE PAIN (burning sensation at the site of the injection on her left arm), LYMPHADENOPATHY (swollen lymph nodes in left arm) and FATIGUE (mild fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain in the left arm,) and LYMPHADENOPATHY (swollen lymph nodes in left arm) was resolving and VACCINATION SITE PAIN (burning sensation at the site of the injection on her left arm) and FATIGUE (mild fatigue) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable.
1st Dose - Severe bruising for more than 5 weeks. They weren't able to give me my second dose in the same arm because of it. Slight "normal" flu like symptoms after, "zings" in my spine, fatigue etc. What is concerning me now the last few months is my heavy & shallow breathing and chest pain. I recently started feeling pain in the artery of my neck on the left side and as well as my left arm. I also have swelling in my ankles which is not normal for me.
Repeated involuntary movements of neck, takes tongue all the way out from his mouth. When asked he said he is not doing it, it just happens.
On 19:30, sudden onset of dizziness, felt like she was going to pass out, hands shaking, hands ice cold, broke out in perspiration, felt weird and skin was clammy. Had a headache before going to bed and took Advil. The next morning, had a headache and hands still cold, clammy and feeling not right. Did not go to school. Slept all day and felt better in the afternoon after sleeping.
Shortness of breath that I could not from one room to another. My Oxygen has dropped to lower 90's and I am now being referred to a Kidney doctor because I am spilling protein. My blood pressure has continued to increased and my diabetes is now out of control.
This spontaneous child prospective pregnancy report was received from a 32 years old pregnant licensed practical nurse reporting on her second female fetus. On 27-MAR-2014 the patient's mother was vaccinated with one dose of GARDASIL through injection (unspecified dose once), lot number and expiration date were not reported. The patient's mother got pregnant with estimated date of conception 07-APR-2014 (reported as she conceived a few days before or after 07-APR-2014) and Last Menstrual Date LMP estimated as of 24-MAR-2014. Pregnancy outcome was pending. On approximately 28-JUL-2014 (reported as "ultrasound was done at 18 weeks of pregnancy") the ultrasound revealed that the fetus had middle bone missing from her pinky finger. Despite GARDASIL the fetus was also exposed to mother's other concomitant medications via transplacental route of administration (progesterone, FLAGYL, clindamycin vaginal cream and terconazole vaginal cream, probiotic, vitamin D and prenatal vitamins). The outcomes of missing middle bone from her pinky finger(s) was unknown. The relatedness between GARDASIL and the events was not reported. The event of missing middle bone on her pinky finger was considered as congenital anomaly. This report is linked to MARRS# 1410USA010188 (Parent-Child Link) and MARRS# 1410USA101329 (sibling). Additional information has been requested.
pt had high pitched, unconsolable crying for approx 6 hrs; treated w/APAP; FMD called felt it was a react to DTP & advised getting ped Dt in the future;
wrong with the syringe; most of the vaccine dose went down the patients arm; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (most of the vaccine dose went down the patients arm) and DEVICE CONNECTION ISSUE (wrong with the syringe) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced ACCIDENTAL UNDERDOSE (most of the vaccine dose went down the patients arm). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (wrong with the syringe). At the time of the report, ACCIDENTAL UNDERDOSE (most of the vaccine dose went down the patients arm) had resolved and DEVICE CONNECTION ISSUE (wrong with the syringe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up received non significant fax number added.
about to have open heart surgery; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (about to have open heart surgery) in an 80-year-old male patient 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 CARDIAC DISORDER (about to have open heart surgery) (seriousness criterion medically significant). At the time of the report, CARDIAC DISORDER (about to have open heart surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was 80 years of age and stated his husband "needs a booster dose as he is going to have open heart surgery"  Concomitant medication use was unknown Treatment information was unknown  This case involves an 80-year-old male subject with no information about the medical history who was supposed to have open heart surgery for an undisclosed cardiac disorder. No details were provided about previous mRNA-1273 vaccinations. The request for a booster vaccination makes it likely that 2 doses had been given before.   The benefit-risk relationship of mRNA-1273 was not affected by this report.; Sender's Comments: This case involves an 80-year-old male subject with no information about the medical history who was supposed to have open heart surgery for an undisclosed cardiac disorder. No details were provided about previous mRNA-1273 vaccinations. The request for a booster vaccination makes it likely that 2 doses had been given before.   The benefit-risk relationship of mRNA-1273 was not affected by this report.
diarrhea; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 14Jan2021 at 15:30 (at the age of 70-year-old) (Lot Number: EK9231) as single dose for COVID-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced diarrhea on 27Jan2021 at 07:00 with outcome of not recovered. The event was considered as non-serious and resulted in Doctor or other healthcare professional office/clinic visit. The patient stated that "two weeks to the day of the first vaccine diarrhea started and it has continued for three weeks". The patient did not receive corrective treatments.  The patient was not pregnant. The patient had not had COVID-19 prior to vaccination and she was not tested for COVID-19 after the vaccination.
A patient's parent thought she was over 12 years old and filled out the form with a wrong DOB saying over 12years old. She was  given one dose Pfizer Covid -19 vaccine but no side effect was reported.
Facial swelling especially around eyes with sneezing and excessive tearing of eyes, approx 1 hour after injection. 50mg Benadryl taken by mouth per order of Dr, eye swelling gradually decreasing.
Gross hematuria with clots. AKI with elevated creatinine to 2.18 (Baseline <1.0).  UA with moderate blood, positive nitrite, moderate LE, >50 rbcs Urine lytes WNL, Pr:Cr 3.3, Al:Cr 1,245 C3/C4 WNL  US with mildly echogenic kidneys, a nonspecific indicator of medical renal disease.  No hydronephrosis. Thick-walled nondistended urinary bladder.  Hgb decreased to 12.9 from 15 Pt underwent a kidney biopsy, pathology is still pending. He received aggressive IVFs and was monitored for 2 days. He was discharged following the kidney biopsy. At that time he was still having hematuria although it was improving and his hemoglobin was stable.
pt became stiff-pupils dilated-had starring effect-had high pitched cry unable to console settled down p/2 hrs; slept fitfully-cried in sleep; wouldn't nurse;
Received vaccination sometime after 4p.m. To left arm Saturday, 04/06/2019, next morning around 8:00a.m. Going into,shower noticed painful lump on left side of neck which had not been there before. Researched online and saw that this is a possible rare occurrence so am reporting it.  I took TYLENOL 500mg and one ALEVE both 04/06/19 and 04/07/2019, There are actually two lumps, only painful to touch.
About 6-7 hours after receiving the vaccine, I started to develop hives around my body, including on feet, stomach, ears, face, back, and legs. I had fever and chills, muscle aches, joint pain,  headaches,  and nausea later that night as well. The next morning, my left eye was swollen, left side of tongue completely swollen, lips swollen, and left side of throat closed (anaphylaxis). I took prednisone, Benadryl, and Tylenol to relieve the symptoms, and the swelling around my left eye, tongue, throat, and lips went away. Throughout the day, more hives have developed around my body and face, including my right eye.  I am continuing to take Benadryl and Tylenol and finish doses of prednisone. The fever and chills, muscles aches, joint pains, hives, headache, and nausea are still present.
This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant), LETHARGY (lethargy), HYPERSOMNIA (Felt very sleepy), MALAISE (Did not feel good at all.) and VACCINATION SITE REACTION (Reaction at the injection site) in a 38-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Dec-2020 and the estimated date of delivery was 29-Sep-2021. On 11-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On an unknown date, the patient experienced LETHARGY (lethargy), HYPERSOMNIA (Felt very sleepy), MALAISE (Did not feel good at all.) and VACCINATION SITE REACTION (Reaction at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 11-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, LETHARGY (lethargy), MALAISE (Did not feel good at all.) and VACCINATION SITE REACTION (Reaction at the injection site) outcome was unknown and HYPERSOMNIA (Felt very sleepy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound foetal: heartbeats detected (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient took Tylenol for the treatment of the events.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Updated IRD for the case.
Arthralgia Injection site soreness, back ache and full body aches Narrative:  Day 1-2 injection site soreness and body aches
Arm swelled up around injection site. Swelling has gone down some. Now it is just itchy and has bumps. Patient has applied hydrocortisone cream today to site.
Information has been received from a physician concerning a patient who was vaccinated PO with a 2.0 ml dose of Rotateq (no lot# provided) (dose of series unknown). Subsequently the patient experienced intussusception. The patient sought unspecified medical attention. Subsequently, the patient recovered from intussusception. There was no product quality complaint. Upon internal review, intussusception was determined to be an other important medical event. This is one of two reports from the same source. Additional information has been requested.
Baby had continuous cry x 3 hrs the night p/immun - not comforted by APAP-local rxn w/some bruising 3/4" size x 1wk;
headache on temple area; feel like throw up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache on temple area) and NAUSEA (feel like throw up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HEADACHE (headache on temple area) and NAUSEA (feel like throw up). On 15-Mar-2021, HEADACHE (headache on temple area) and NAUSEA (feel like throw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Headache was reported to be in one side of the head in temple area. No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
I received the vaccine at around 5:23pm, and then about 11pm the same night I was awoken from sleep by terrible body shivers. I managed to doze off for about an hour before I was woken up again by a migraine at midnight; dozed off again, and woke up at around 2 am with a mild fever (around 99.3 degrees). Sometime between the migraine and fever I began to develop terrible body aches as well. The first 24 hours were the worst as I was completely bedridden. The next day, 4/8/21, was better, but the body aches and migraine persisted all day while the fever broke late morning. The third day (today, 4/9/21) everything is feeling better but the migraine is still a persistent issue.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unspecified dates since 05-JAN-2017, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number M025193, expiration date 21-MAR-2019 and lot number reported as M036058, expiration date 19-MAY-2019 (dose and route of administration were not provided) for prophylaxis. The reporter had not been informed of any adverse effects. Administered doses of LIQUID PEDVAXHIB were exposed to a temperature excursion between 32°F and 36°F (34°F) for 3 hours and 3 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments: US-009507513-1702USA010194: US-009507513-1702USA010195:
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 62-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced fever and general body pain. The patient was treated with ibuprofen (Motrin Ib). On an unknown date, the outcome of the fever and general body pain were recovered/resolved. It was unknown if the reporter considered the fever and general body pain to be related to SHINGRIX. Additional details were reported as follows: The pharmD reported that the reporters cousin, experienced high fever and body aches following SHINGRIX which he received about 2 months before the date of reporting. The symptoms were delayed occurring that night after 9pm following the injection earlier that day. The reporter was unsure how long the symptoms lasted but they had since resolved. The patient treated these symptoms with motrin or ibuprofen. The reporter consented to follow up.