chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A 12 month old female completed the series of Prevnar injections in February 2001. The patient was not receiving concomitant therapy and she had no preexisting illnesses at the time of vaccination. In July 2001 (at the age of 17 months), the patient was hospitalized for Streptococcal pneumoniae osteomyelitis. An unspecified culture was positive for streptococcus pneumoniae. Follow-up information received on 08/03/01 indicated that the child was previously well and considered up to date on her Prevnar vaccinations having received her 3rd dose in 02/01. She presented in June 2001, with a 2 day history of fever between 102 and 103 deg. F. and favoring her left leg. She was seen in the ER on day 2 of illness where examination revealed a blood culture positive for Streptococcus pneumoniae, "mildly" elevated white blood cell count with no shift, and increased erythrocyte sedimentation rate. Ultrasound of hip on day 2 and bone scan on day 3 were negative; however, an MRI on day 4 was positive. A repeat blood culture on day 5 was negative. She was initially treated with IV nafcillin, then switched over to ceftriaxone for 1 week. She then began oral amoxicillin with plans to continue treatment for three weeks. As of 08/03/01, plans were to repeat the bone scan at the end of antibiotic treatment for further evaluation. The S. pneumoniae isolate was not serotyped; however, arrangements were being made to have this done.  Follow-up information was received from the original reporter on 08/15/01, which provided the lot numbers and dates of Prevnar doses administered. Also, the patient's birthday was provided; the patient was 15 months of age (several days shy of 16 months) when the events occurred (06/17/01). The following patient had no preexisting illnesses at the time of the vaccination and had no history  of adverse events following previous vaccination. The reporter also noted that the patient received Varivax (MSD) and Engerix B (SKB) vaccines within 4 weeks of receiving Prevnar, but dates were not provided. The patient recovered.
This spontaneous report as received from a nurse refers to a 9 months 2 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) oral, ROTATEQ lot # K016313, exp. 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information has been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Pt c/o dizziness, flushing/sweating, lightheadedness.  Denies any other rxn/allergy, prior rxn, or prior medical hx.  Juice and water provided.  Pt stable and released from vaccination site.
Vaccine administered 10/27/12. On 10/30/12 patient called to report she has a 1/4" raised, hot, palm-sized swelling at site of injection. Itches.
Per patient he has heart palpitations and some heart racing after the first covid vaccine dose on 4-20-21 he proceeded to then get the 2nd vaccine which further exacerbated the heart racing on 5-20-2021.
Patient called pharmacy on 10/17/2018 to inquire/inform pharmacy of residual pain and discomfort in arm where Tdap vaccination was administered. The patient also claims to have some limited mobility in the corresponding arm. The patient also received an influenza vaccince (FLUCELVAX) in the opposite arm on the same date of service with no issues to report. In addition to reporting this adverse event via the VAERS reporting tool, an internal patient safety report will be submitted with pharmacy in prescription requiring patient follow up within 72 hours as well as communication with the physician with which our standing protocol exists.
felt dizzy; diarrhea; A spontaneous report was received from a consumer concerning, a 39 years old Female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced dizziness and had diarrhea.  The patient's medical history was not provided.  On 27-Jan-2021, Prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 27-Jan-2021 the patient experienced dizziness and had diarrhea.  Concomitant product use was not provided by the reporter.   No Laboratory details was provided.  No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome of the event was unknown
Fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 101.8 (High) 101.8 degree F.     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 relevant concomitant medications were reported. No treatment information was reported.
swelling in arm pit/Swollen lymph nodes; noticed irritation and soreness under his arm which he thought it was like the vaccine was radiating under his arm; booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Lot number: FH8030) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (first dose , LOT: EL0142, first dose injected in his arm), administration date: 08Jan2021, when the patient was 41 years old, for COVID-19 immunization; Bnt162b2 (second dose , LOT: EL9265), administration date: 28Jan2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 30Dec2021, outcome "not recovered", described as "swelling in arm pit/Swollen lymph nodes"; AXILLARY PAIN (non-serious) with onset 30Dec2021, outcome "unknown", described as "noticed irritation and soreness under his arm which he thought it was like the vaccine was radiating under his arm". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Patient reported this morning he woke up and showered and noticed pretty significant swelling under his arm pit. He says he had done no treatment other than stretching his arm, it was swollen lymph nodes.   No follow-up attempts are possible. No further information is expected.
Patient admitted to hospital on 7/31/2021, with symptom onset beginning on or about 7/28/2021. Hx of chronic hypoxic respiratory failure due to COPD from a long smoking history.
The patient has shoulder pain, leg weakness and insomnia. The patient is being treated with Naprosyn and Klonopin.
Injection site was uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Injection site was uncomfortable) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included CALCIUM, FISH OIL and MAGNESIUM for an unknown indication.    On 01-Apr-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 VACCINATION SITE DISCOMFORT (Injection site was uncomfortable). At the time of the report, VACCINATION SITE DISCOMFORT (Injection site was uncomfortable) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has no health conditions.  Treatment information was not provided.   This case was linked to MOD-2021-325608 (Patient Link).
Administered expired vaccine to the patient, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to the patient, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Vaccine manufacture date of expiry reported was 09-Nov-2021.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document included no new information.
I woke up in middle of the night to go to the restroom I had pain in my arm and noticed I had a lump the size of a golf ball. I saw rash on my areola going towards my armpit. The lump lasted about 2 weeks and the rash resolved in about 24 hours. I had my last period April 27th, I am currently 2 months past due with my menstrual cycle. My PCP ordered blood work and I've had two ultrasounds done to try and see what I haven't had a menstrual cycle. I also have pain in my lower right abdomen, I've had a test done to check my appendix, but they are fine.
Pain behind the eyes (eye ache) started the day after the injection following a night of intense fever and chills.  Ibuprofen is not very effective in reducing pain.  Eye ache reduces with rest, but no long term improvement after 1 month.
I went home has usual because it's Tuesday Bingo night and I do nothing on Tuesday if go to the Doc. and just beccasue I work with the Seniors, on this day. I felt fine my ussual self happy and care free, I started couching about 2 days later and my Chest started hurting, Monday the 18th I remember cause I thought I had gotten COVID-!9 again. I actually told my Dr. the next day In called saiding that I may have gotten COVID-19 again, He told me I more than like still had at the time, because I was coughing. But I had no Chest Pain until the following week I started having CHEST PAINS. My Doctors said that my Chest Pains were cause do to my Coughing, but that not the way it felt to, there's something else wrong and I knew it. I went to my Doc. and he give me medinice for the coughing and some prednisone breathing and some mortin for the pain, the coughing started to subside, but was still coughing just not has much, the pain in mt chest continued to hurt and started to getting worse, so bad I had to go tothe E.R. on July 31,2022. They help me by giving me a shot of Morphine for the pain which was only temporay, it did.nt start working untilIwas moving around, they too give me prenisone for breathing I told them too that it's not mt Breathin but my CHEST HURTS. so I toke the meds and the coughing is notso bad but my Chest has been hurting ever since.I am in PAIN right now has I write is information, just here recently I went back to the E.R. on Aug. 16,2022 for Chest Pains so bad I was in Tears, the Hurt that I felt was so unbearable, they say that there's not much they can do for me, because they are not LISTENING it's my CHEST that HURTS not mt BREATHING , and I DID NOT feel like this UNTIL I GOT MY SECOND VACCINE OF MODERNA, this is the only time that my CHEST as been HURTING ME. THey did all the testing on both occasion's EKG, CAT scan, Blood work seeing if there are any Blood clots, Chest EX-rays, any and every things to do, testes and the rest they did STILL they CAN NOT DETERMINE what IS WRONG I AM IN PAIN!!!!!!!!! PLEASE listen to Me I CAN NOT WORK I am begin Evicted for none payment of rent I was going to start a NEW Job but I can not becasue of the CHEST PAINS, I need the pain meds to just surivie day-to-day, I was driving a CAB but returned it because of the PAIN IJN MY CHEST. I would not be taking the time out of your busy schedule for some rambling MESS, Iam in Pains and only after receving your VAccine of Modrena hae I been so SICK PLease Listen to me I am SICK SICK SICK!!!!!!!!!. Tere is no Herat disease in my faimly IM not having a STROKE HEART ATTACK, nothing like that LEASE HELP ME>
he tested positive for COVID-19 on 20Nov2021 after being exposed to another person; rash on his head, arms, back at the top of his feet and a little on his left nipple; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 13Nov2021 (Batch/Lot number: unknown) as dose 1, (tris) single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 20Nov2021, outcome "unknown", described as "he tested positive for COVID-19 on 20Nov2021 after being exposed to another person"; RASH (non-serious) with onset Nov2021, outcome "unknown", described as "rash on his head, arms, back at the top of his feet and a little on his left nipple". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information: For the body rash they gave him some antihistamine and lotion which kept it from spreading. The patient is scheduled to receive his second dose of Pfizer Covid Shot For Children Between 5 and 11 on 04Dec2021.  Description of Product Complaint: Consumer called regarding patient who was reporter child. The patient was administered first dose of Pfizer covid Shot for children between 5 and 11 on 13Nov2021. They received an email that the patient had been in contact with a someone who tested positive for Covid. On 20Nov2021 the patient had a fever and was tested for COVID on 20Nov2021, 21Nov2021 and several other times and COVID test was positive for COVID-unable to clarify which COVID test or tests were positive or if all were positive.
2nd MMR given 6 days after first.  Patient made aware that immunization given too soon.  No immediate negative reaction evident.  MMR circular, and doctor consulted, no recommendation at this time.
Aches, soreness, sore throat, headache, chills, fever, sluggishness
Rash on body, high temperature at hospital (104), at office 99.2 (rectal), runny nose, anorexia.
The patient ended up with a dispersed rash on her body; a big, red, swollen, hard area about 4 inches in diameter at the injection site; it was itchy all over; a big, red, swollen, hard area about 4 inches in diameter at the injection site; a big, red, swollen, hard area about 4 inches in diameter at the injection site; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old female patient who ended up with a dispersed rash on her body (rash), a big, red, swollen, hard area about 4 inches in diameter at the injection site (vaccination site erythema), (vaccination site swelling), (vaccination site mass)  it was itchy all over (pruritus), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (QUADRACEL) and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  On 29-Oct-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT7065MA and expiration date- 30-Jun-2021] via unknown route in the right thigh for prophylactic vaccination.  On an unknown date, the patient ended up with a dispersed rash on her body (rash), a big, red, swollen, hard area about 4 inches in diameter at the injection site (vaccination site erythema), (vaccination site swelling), (vaccination site mass)  it was itchy all over (pruritus) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]).  The patient outcome was reported as Recovering for all events except unknown for pruritus.
Muscle tension and extreme pain in joints  Headache  Nausea  Vomiting  Confussion
Felt horibly sick; Low back pain like they were broken in two; Shaking and their teeth were chattering, they were freezing; Sick to their stomach, but vomiting only phlegm; Face was bright red; Felt extremely bad; Weak; Arm feels like it has been hit with a concrete block; Elbowand knee hurt; Fever of 102.2; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Felt horibly sick), BACK PAIN (Low back pain like they were broken in two), FEELING COLD (Shaking and their teeth were chattering, they were freezing), PRODUCTIVE COUGH (Sick to their stomach, but vomiting only phlegm) and ERYTHEMA (Face was bright red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diabetic since an unknown date. Concomitant products included HYDROCHLOROTHIAZIDE, METFORMIN, ATENOLOL, DILTIAZEM HYDROCHLORIDE (CARTIA XT), ATORVASTATIN, INSULIN ASPART (NOVOLOG) and INSULIN GLARGINE (BASAGLAR) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ILLNESS (Felt horibly sick), BACK PAIN (Low back pain like they were broken in two), FEELING COLD (Shaking and their teeth were chattering, they were freezing), PRODUCTIVE COUGH (Sick to their stomach, but vomiting only phlegm), ERYTHEMA (Face was bright red), ILLNESS (Felt extremely bad), ASTHENIA (Weak), PAIN IN EXTREMITY (Arm feels like it has been hit with a concrete block), ARTHRALGIA (Elbowand knee hurt), PYREXIA (Fever of 102.2) and HEADACHE (Headache). On 25-Feb-2021, ILLNESS (Felt horibly sick), BACK PAIN (Low back pain like they were broken in two), FEELING COLD (Shaking and their teeth were chattering, they were freezing), PRODUCTIVE COUGH (Sick to their stomach, but vomiting only phlegm), ERYTHEMA (Face was bright red), ARTHRALGIA (Elbowand knee hurt) and PYREXIA (Fever of 102.2) had resolved, ILLNESS (Felt extremely bad) outcome was unknown. At the time of the report, ASTHENIA (Weak), PAIN IN EXTREMITY (Arm feels like it has been hit with a concrete block) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information includes Tylenol
Felt fine during monitoring period.  Went to auto and started feeling palpitation and then lips felt numb.  Returned to building, sat for a few minutes and felt better.  Never had shortness of breath or any respiratory symptoms.  PSO@100% b/p 138/88 resp 18
Bruises on right side of arm and leg developed 3 days after the vaccine. Patient had wart-like looking  spots on the elbow that was itchy and burning. Patient experienced heavy breathing, but did not describe as "gasping for air" or an anaphylactic reaction.
Left arm became extremely sore with scar tissue build up with a 3 inch radius in the deltoid. It has been a month and there is still a small amount of scar tissue built up in the arm. Complete fatigue and no energy for 7 days after the first injection. Headache daily with severe nausea and diarrhea. Felt off for the entire time and very ill.
Pt developed right brachial neuritis due to tetanus toxoid. Rx'd physical therapy and neurological consultation.
Redness, swelling, induration, 16 mm x 16 mm irregularly shaped area (L) arm. At the time of the injection patient's muscle was very tight.
11/21 Pt presents to ER with c/o increasing SOB x2 days, report tested + at outpt clinic 3 days prior. CT shows multifocal airspace opacity.  11/22 Started on Decadron, remdesivir, vitamin C, vitamin D, and zinc.  11/23 CT shows worsening aeration. Baricitinib added. 12/02 The On high-flow oxygen.  On baricitinib at 4 mg. She is doing better. Resume Decadron at 10 mg IV  12/06 The patient finished treatment with baricitinib.  She remains on Decadron 10 mg IV every 24 hours.  The patient is doing much better.  She is now on 4 L oxygen.
Narrative:  Other Relevant Hx: Symptoms:  Headache & pain at unjection site, lethargy Treatment:
CHILLS; TIREDNESS; NAUSEA; DIFFICULTY BREATHING; HIVES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma, and allergy to grass and trees.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 13:00 to left arm for prophylactic vaccination. Concomitant medications included salbutamol for asthma. On MAR-2021, treatment medications included: diphenhydramine hydrochloride. On 20-MAR-2021, the subject experienced difficulty breathing. On 20-MAR-2021, the subject experienced hives. On 20-MAR-2021, the subject experienced tiredness. On 20-MAR-2021, the subject experienced nausea. On 20-MAR-2021 20:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and nausea on 23-MAR-2021, recovered with sequelae from hives on 21-MAR-2021, and had not recovered from difficulty breathing, and tiredness. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.