chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day after receiving her booster shot, she felt light-headed a lot the day after; they didn't have school that day due to a holiday. She has been taking high blood pressure for some years due to diagnosis of high blood pressure some years ago. Every time she tried getting up just to be active in the day, she didn't have much energy to stand up so I decided to take her blood pressure to check just in case. When we checked her blood pressure, it read 120/59 and 99bpm. We tried to get her hydrated and eat; later that evening, we checked her BP again and it stayed the same but her heart rate increased. The next morning, 97/43 was her blood pressure and 89bpm heart rate; she insisted on going to school so we allowed her. When she got to school, I called the nurse to check her measures again, and they read 115/58 and 117bpm heart rate. I picked her from school and checked it and it read the same so we called her cardiologist and they advised for her to stop taking her blood pressure medication. The next morning, we checked her blood pressure again and it read 97/52 but steadily increased during the day. We went to the cardiologist 01/27/2022 for an appointment out of concern. They performed an echocardiogram and EKG, but the results came back normal. They put her back on her on BP medication (only Lisinopril), and had a follow-up appointment 2 weeks later. They increased the dosage of the Lisinopril and currently she's still being monitored with a follow-up appointment beginning of March. Last night (02/23/2022) we checked her measures and it read 143/84 and 78bpm heart rate, so we're just constantly watching her activities and checking her measures until then.
Reported by mother 8-8-07: itchy sensation left upper arm on 8-2-07. Red area left upper arm on 8-5-07. Red area now 5" high, 6" wide and warm to touch. Denies fever. Normal use of arm. No visit/exam by HCP. Reported by father on 8-10-07: site improving.
Patient began feeling anxious like her heart was working harder. She has a neurologic condition that causes her to have syncope with left arm parthesias. Patient felt overall off.
Cough; Chest hurt; This is a spontaneous report from a contactable consumer or other non hcp. A 99-years-old female patient received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution of injection Lot Number: EN6207), via an unspecified route of administration on 12Mar2021 10:00 as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 12Mar2021 at 18:30, the patient experienced cough and chest hurt. It continued all day Saturday and was gone by Sunday morning. The patient was asking if she can take second one or not. The patient also asked who should not get the Pfizer vaccine. The clinical outcome of the events was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
12/24 - 12/27 = soreness and muscle pain mostly. No other symptoms 12/28-29 - Tender... becomes increasingly sore to touch, growing hot and itchy 12/30 - Red bumps/rash emerge around injection site; growing hotter and more itchy  12/31 - Redness and swelling grows, muscle tissue becomes hotter and more hard, about 2" in diameter 01/01 - Redness and inflamed area is larger now.. 3" across, 4" high, with increased heat, pain/soreness.
Fever, no appetite, and diarrhea that started on Saturday August 15 and Monday, August 17 she has rashes all over her body.
This spontaneous report as received from a medical assitant, refers to a currently 5 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored M-M-R II, (which had a lot # of N014486 and an expiration date of 10-MAY-2019; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excusions and the aformentioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Intense upper respiratory infection lasting over two weeks, possibly RSV, interfacing with asthma; excessive mucus production, severe cough, wheezing.  No fever.  Home-tested negative for COVID.
Per mom of patients boyfriend, "patient collapsed/fainted on her sidewalk and they called 911." This was told to me around 6pm on 05/11/21. I called Pam back at 8:30pm and asked if any new info and she said that patient had been rushed to hospital and she had no other information.
I had the TB vaccine scar there and it is very swelled too; [injection site] very warm; Vaccination site pain /  pain in the application site; area surround my vaccine application is red; [injection site] swelled /  the area is a regular oval shape.; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (I had the TB vaccine scar there and it is very swelled too), VACCINATION SITE WARMTH ([injection site] very warm), VACCINATION SITE PAIN (Vaccination site pain /  pain in the application site), VACCINATION SITE ERYTHEMA (area surround my vaccine application is red) and VACCINATION SITE SWELLING ([injection site] swelled /  the area is a regular oval shape.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. LOT3002332.) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TUBERCULOSIS VACCINES.    On 31-May-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 PERIPHERAL SWELLING (I had the TB vaccine scar there and it is very swelled too), VACCINATION SITE WARMTH ([injection site] very warm), VACCINATION SITE PAIN (Vaccination site pain /  pain in the application site), VACCINATION SITE ERYTHEMA (area surround my vaccine application is red) and VACCINATION SITE SWELLING ([injection site] swelled /  the area is a regular oval shape.). At the time of the report, PERIPHERAL SWELLING (I had the TB vaccine scar there and it is very swelled too), VACCINATION SITE WARMTH ([injection site] very warm), VACCINATION SITE PAIN (Vaccination site pain /  pain in the application site), VACCINATION SITE ERYTHEMA (area surround my vaccine application is red) and VACCINATION SITE SWELLING ([injection site] swelled /  the area is a regular oval shape.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No treatment medications were provided by the reporter. Patient do not know if is because of the vaccine or something else. Patient had TB vaccine scar at the Moderna vaccine Injected site and it is very swelled too
Issue with the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Issue with the booster shot) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Issue with the booster shot). At the time of the report, VACCINATION COMPLICATION (Issue with the booster shot) had not resolved.            No Concomitant product use was reported.  During the call, the patient mentioned that there were more people with this issue with the booster shot and that the reaction was not going away.  No treatment information was provided.   This case was linked to MOD-2022-438837 (Patient Link).
Severe pain in left axilla, left breast radiating to scapula with painful, palpable enlarged lymph nodes, beginning to subside 1 week out after local treatment with ice alternating with  heat, NSAIDS and several days of a broad spectrum antibiotic
Breakthrough case admission after 3 vaccines Moderna 3/10/21 Lot# 030A21A;  Moderna 4/8/21 Lot# 017B21A;  Moderna 11/18/21 Lot# 034F21
Patient received second dose of Pfizer vaccine on 9/3/21. On 9/4 reported tactile fever. On 9/5 complained of bodyaches. Was taken to a local hospital with mid-sternal chest pain on 9/6. There, troponin was found to be elevated (value not documented) and was transferred to another hospital.  Patient was discharged the following day and instructed to follow up with cardiology.
pt recv vax;devel "bad" HA which gradually worsened;next am exp n,v,loss of appetite & general malaise;T 99.6;meds given;exp also lightheadedness & a 20-25cm area of redness & induration noted at inject site;
the administration of an expired Rotarix dose to a 2 month old female patient.; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number K2FM7, expiry date 04-JUL-2023) for prophylaxis.   On 07-JUL-2023, the patient received Rotarix lyophilized formulation. On 07-JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced expired vaccine used (Verbatim: the administration of an expired Rotarix dose to a 2 month old female patient.). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-JUL-2023 A Doctor of medicine (MD) called to report the administration of an expired Rotarix. The health care professionals (HCP) asked how to proceed with this patient. Patient received a dose of Rotarix on July 07, 2023 which was expired on July 04, 2023, which led to expired vaccine used. No side effect was reported. The reporter was not requested for follow up.
Fever 100; Aches /joints hurt; Headache; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: ER8739), via an unspecified route of administration in right arm on 22March2021 at 19:15 as a single dose for COVID-19 immunisation. Medical history was not provided. Concomitant medication was not provided. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to vaccination. On 23March2021, at 19:45 the patient experienced fever 100 (unit and reference range was not provided), joint ache, and headache. The patient did not receive any treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of fever100, joint ache and headache was not recovered. No follow up attempts are needed. No further information is expected.
Pain, itching, erythema on right side of face and neck, including around the eye. Some crusting also occurred.
While I was waiting after getting shot for the 15 mins, it shot out blood after the stuck me and my arm was hurting. The technician said it was normal. Sent me home. The next next day I went to work and my arm was hurting intensely that I had to hold my arm. I apply ice for couple days and heat, I also massaged it. I kept the arm moving so it would not stiffen up on me.
a case of varicella zoster virus vaccine-associated meningitis;   Information has been received from the authors in a published literature article title as stated above and refers to a 12-year old female. The patient's pertinent medical history, concurrent conditions, or drug reactions/allergies were not provided.  On an unspecified date in 2006, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, strength, route and anatomical location of administration, lot number and expiration date were not reported) as a varicella immunization. The patient was also vaccinated in 2009 with varicella virus vaccine live (Oka/Merck) (VARIVAX) (fully immunized).   On an unspecified date, the patient presented to an urgent care facility with 4 days of acute onset sharp right upper extremity pain and 1 day of rash over the right arm and shoulder.  At urgent care, she was diagnosed with shingles and sent home on a course of valacyclovir (dose and frequency not reported). It was stated that she tolerated one dose of valacyclovir that evening (exact date not provided), but subsequently developed fever to 100.2 grades Fahrenheit, severe headache, photophobia, nuchal rigidity, and mydriasis.  At that point, she presented to the emergency department where her exam revealed a tired-appearing but neurologically intact girl with photophobia and nuchal rigidity and a nonp-ruritic erythematous, blanching maculopapular rash in the C5-C6 dermatome distribution of the right upper extremity. On an unspecified date, her headache and mydriasis had resolved and she denied nausea, vomiting, abdominal pain or altered mental status  On an unknown date, a workup revealed cerebrospinal fluid (CSF) studies concerning for viral meningitis with lymphocytic pleocytosis (63) and elevated protein (units and results not reported). Blood cultures, CSF cultures, and urinalysis were sent, and empiric ceftriaxone and acyclovir were started at an unreported dose. On day 1 of admission, varicella zoster virus (VZV) was detected on meningitis/encephalitis PCR of cerebrospinal fluid; however, serum polymerase chain reaction (PCR) was negative for VZV. Ceftriaxone was discontinued after 48 hours of negative blood and CSF cultures and acyclovir was increased to1500 mg/m2/day.   The patient was discharged on day 4 of admission on a 14 day course of intravenous acyclovir. Following discharge, sequencing assay of the CSF revealed the vaccine strain of VZV as the etiology of her meningitis (herpes zoster meningitis). However, at the reporting time the outcome of the herpes zoster meningitis and was unknown.   The authors concluded that reactivation of vaccine-associated VZV is exceedingly rare in immunocompetent pediatric patients. But, the combination of a dermatomal rash with signs and symptoms of meningitis in a child should lead one to suspect this rare but important cause of meningitis.  Upon internal review, herpes zoster meningitis was considered medically significant.   A copy of the published article is attached as further documentation of the patient's experience.
PATIENT WENT TO THE HOSPITAL AFRAID THAT SHE HAS A BLOOD CLOT.
Information has been received from a medical assistant referring to a 12 year old male patient with none pertinent medical history or drug reactions/allergies. The patient was vaccinated with his first dose, second and third dose of GARDASIL (first dose: lot# J009243, expire date: 23-APR-2016; second dose: lot # J012212, expire date: 18-FEB-2016; third dose: lot# J015378, expiration date: 09-APR-2016), intramuscularly (dose unknown) on 31-OCT-2013, 03-JAN-2014 and 07-MAY-2014, respectively. Concomitant therapies included CLARITIN. On 29-JUN-2014, the patient experienced double vision, headaches, and unspecified joint pain "for three days" prior to visiting the physician (02-JUL-2014). A magnetic Resonance Imaging (MRI) was performed on an unspecified date on which "something" was seen. This caused the patient to be referred to the emergency room. From there, the patient was admitted to the hospital, where he was diagnosed with multiple sclerosis on an unspecified date. The double vision, headaches, and joint pain resolved without any specific treatment, and patient was discharged from the hospital on an unspecified date. The patient was just being watched for now in regard to the multiple sclerosis. The relationship of the multiple sclerosis and GARDASIL was not reported. Upon internal review, multiple sclerosis was considered to be medically significant. Additional information has been requested.
SHORTNESS OF BREATH; HEADACHE; NAUSEA; BODY ACHES; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included anxiety, and covid-19, and concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive.  On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced nausea. On 10-APR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, body aches, nausea, and shortness of breath. This report was non-serious.
vaccine was administered from punctured vial that had been punctured for 5 days; A spontaneous report was received from a healthcare professional concerning a 78-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with the vaccine from a punctured vial that had been punctured for 5 days.  The patient's medical history was not provided. The concomitant medications reported included oxygen, lisinopril, hydrochlorothiazide and metformin.  On 17 Jan 2021, a vial containing mRNA-1273 was punctured.  On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 028L20A) intramuscularly for prophylaxis of COVID-19 infection. The patient was administered with vaccine from the punctured vial that had been punctured for 5 days. No adverse events were reported. No treatment was reported.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the event, administered with the vaccine from a punctured vial that had been punctured for 5 days was considered resolved on 22 Jan 2021.; Reporter's Comments: This case concerns a 78-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot#028L20A), reporting Expired product administered without any associated adverse events.
pt recvd vax & devel redness, swelling & warmth in the arm of inject site;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2015, the patient was vaccinated with a dose of improperly stored MMR II, lot # K024035, expiration date: 26-NOV-2016, (dose, dose number, route of administration and injection site were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Wrong vaccine administered. Child was mistakenly given Hepatitis A instead of Hepatitis B at 2 month visit.
Seven weeks after my second Pfizer vaccine I developed 5 hard lumps in my left arm pit.  Also my left nipple developed one lump.  All lumps were very sore.  I used hot compresses and Tylenol for discomfort .
Information has been received from a nurse practitioner concerning a 17 year old female with a history of allergic reaction to antibiotics (Ceclor) who on 25-MAR-2008 was vaccinated IM with the first 0.5 mL dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included a dose of HAVRIX (inactive) (GlaxoSmithKline) and a dose of MENACTRA (Sanofi Pasteur). On 25-MAR-2008 the patient intially came in for family planning (to get birth control pills)/ The patient said she had normal periods and no skipped period from 28-FEB-2008 to 06-MAR-2008. The patient denied unprotected sex and was using condoms. During a vaginal exam (part of family planning) by the nurse practioner, it was found the patient had "Trichomonas." The nurse practioner wanted to treat the patient with Metronidazole and did a pregnancy test to make sure it was okay to give this medication. The pregnancy test was positive. Other lad diagnosic studies performed included: hemoglobin (results not provided) and dip stick urine for glucose and protein (results not provided.)  The patient's outcome was not reported. There was not product quality control involved. Follow-up information has been received through the pregnancy registry which reported that the pregnancy test was performed on 25-MAR-2008. An ultrasound was performed on 30-APR-2008 and was normal and on 26-JUN-2008 a serum alpha fetoprotein test which was normal. The patient was prescribed promethazine hydrochloride (PHENERGAN) for nausea. Additional information has been requested.
Patient fainted about 10 minutes after receiving the injection. She struck her head when she fell.
Patient started to feel weakness, fatigue, light headed, nausea, diarrhea, headache, and Dizziness after receiving an anthrax shot, Friday April 18th 2008.  The patient was told to take Tylenol, drink fluids, and rest.
Information has been received from a nurse concerning an 18 year old female waitress with a history of panic attack and anxiety issues who on 21-MAY-2007 was vaccinated with a 0.5 ml first dose of Gardasil.  Concomitant therapy included REMERON, LAMISIL and LAMICTAL.  On 19-JUN-2007 the patient experienced multiple episodes of dizziness.  It was reported on one occasion she felt light-headed, weak, blurry vision and headache while working a 12 hour shift.  She was taken to the emergency room.  In June 2007 the patient had a physical and blood work which were normal.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007.  Initial and follow up information has been received from a nurse and a healthcare professional (HCP), concerning an 18 year old female waitress with a history of panic attack and anxiety issues, who on 21-MAY-2007 at 4:00 pm, was vaccinated in the right deltoid, with a 0.5 ml, first dose of GARDASIL (lot #657622/0388U).  Concomitant therapy included REMERON, LAMASIL and LAMICTAL.  There was no illness at the time of vaccination.  On approximately 04-JUN-2007 ("two weeks later").   She "started having syncope."  On 19-JUN-2007 the patient experienced multiple episodes of dizziness.  It was reported on one occasion she felt light-headed, weak, blurry vision and headache while working a 12 hour shift.  She was taken to the emergency room.  In June 2007 the patient had a physical and blood work which were normal.  The HCP indicated the syncope lasted for up to a month, and required visits to the ER and office;  she indicated the patient had recovered on 09-JUL-2007.  The HCP added the patient had not received the second vaccination, since "she will be going to college."  Additional information is not expected.
2/02/2021 developed shingles ( herpes roster) first time in my life. Severe pain, red bumps on right back and front
After receiving the fourth dose, I had severe flu like symptoms that lasted about 5 days. Then, two weeks after receiving my 4th dose of the Moderna Vaccine, I had a breakthrough case of COVID-19.