chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 65-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 on 22Jan2021 at 14:00 (at the age of 65-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Covid in Mar2020 during which the patient suffered with symptoms and fever for 17 days followed by several weeks of feeling weak. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021 at 19:00, after taking the first dose,  the patient experienced tiredness, joint pain, headache, muscle pain, chills, fever of 101.5, and nausea, which the patient stated were the same symptoms the patient had experienced when the patient was diagnosed with COVID-19 in Mar2020. The patient did not receive any treatment for the events. The patient sated these symptoms lasted 2 1/2 days until temp was normal and symptoms started to fade. The clinical outcome of fever was recovered on an unknown date in 2021.The clinical outcomes of tiredness, joint pain, headache, muscle pain, chills, nausea were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
REACTION TO COVID-19 VACCINATION; This spontaneous report received from a health care professional concerned a 43 year old male. The patient's weight was 77.3 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (form of admin unknown, oral, batch number: ZM021B0101 expiry: 30-NOV-2023) 10 mg, daily, and therapy dates were not reported for primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tadalafil. On MAR-2021, the patient experienced reaction to covid-19 vaccination. On 13-MAR-2021 to 14-MAR-2021, the patient was hospitalized. It was reported that patient was hospitalized one day after receiving covid vaccination due to reaction. patient could not recall exact date of vaccination or hospitalization but stated approximately 2.5 weeks ago. The patient was discharged on 14-MAR-2021.The patient was hospitalized for 1 day.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The outcome of reaction to covid-19 vaccination was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210408385-covid-19 vaccine ad26.cov2.s-reaction to covid-19 vaccination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  Patient also reported a  persistent headache for several days post vaccination
Information has been received from a medical assistant concerning an unknown number of pts who were vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine) at greater than 12 weeks of age. It was unknown if any medical attention was sought. The medical assistant indicated, via a telephone call, that she had no information with regards to specific identifiers for any of the pts involved. No further information is available.
flushing and redness of face, itching of arms & legs, a couple of hours after vaccine, family member gave her benadryl. He returned to pharmacy the next day to inform of the reaction.  He said she did not need to see her MD.
This spontaneous report was received from a pharmacist referring to a 90 year old female patient.  The patient's medical history and concurrent conditions were not provided. It was reported no drug reactions or allergies. On unknown date, the patient was vaccinated with PREVNAR 13 (formulation, strength, dose number, dose, administration route, indication, lot number and expiration date were not reported) and she was due to be vaccinated with PNEUMOVAX 23. On 17-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose number and dose were not reported) intramuscularly in the left arm, lot number M038216, expiration date 09-MAY-2019, for prophylaxis. Concomitant therapies included FLUZONE, which was administered in the right arm on the same date. Subsequently on 18-OCT-2017, the patient came into the pharmacy with swelling "the size of a golf ball" around the elbow area in the left arm. It was reported that it was nowhere near where PNEUMOVAX 23 was administered. The pharmacist stated that the area was also warm to touch. No treatment was given for the adverse event and lab diagnostics or studies were not performed. The outcome of skin warm and peripheral swelling was reported as not resolved. The causality assessment between PNEUMOVAX 23, skin warm and peripheral swelling was not provided.
Pt recv vax 3/10/98; 1 hr later pt exp swelling of R upper A for 7 dys, fever for 1 dy, soreness for 4 dys.
Patient felt lightheaded for 30 mins. No associated symptoms. Thinks he is just nervous. Monitored for 45 minute with resolution.
Soreness at the place of injection beginning around 12:10 pm, stomach ache beginning around 7:00 pm, followed almost immediately by tingly feeling in arms and legs. Lost movement below the elbow for 3-5 minutes around 7:15 pm. By loss of movement, I mean my fingers tensed up, fully extended, and I was unable to relax or move them at all.
dry portion (ActHIB) reconstituted with sterile water and separated from the liquid portion (DTAP-IPV) with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patients who was given dry portion (acthib) reconstituted with sterile water and separated from the liquid portion (dtap-ipv) with no reported adverse event after receiving DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection (strength, expiry date: unknown) (lot: UJ791AA) via unknown route in unknown administration site for Immunization.  On an unknown date the patients had an event of dry portion (acthib) reconstituted with sterile water and separated from the liquid portion (dtap-ipv) with no reported adverse event (product preparation error) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  Outcome: Unknown    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 the 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.
"Pain and weakness" in left bicept which gets better with movement; "weakness and stiffness" to both leg/calf muscles; "clicking" feeling to tendon/muscles in left leg and achilles tendons are tender.   Symptoms are intermittent and he reports that they are all improving over the last 4 months. It should be noted that he had an inlfuenza vaccine that same day.
Although I have tinnitus, it is now very high pitched constant squealing which has increased drastically after my 2nd injection
Administration of expired product (Medication error, medication error)(Med error) - not reported Vaccinee received 1ml of vaccine (Accidental overdose, Accidental overdose)(Overdose accid) - not reported A report was received from a health care professional on 24 October 2003 concerning three female vaccinees of unknown age who were inadvertently administered last years' vaccine (2002-2003) on an unknown date. On an unknown date three female vaccinees were inadvertently administered last years' vaccine (2002-2003). No adverse reactions had occurred at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1: 10 December 2003 Follow-up report was received from a health care professional on 10 December 2003 which indicated that a 35 year old female vaccinee inadvertently received 1ml of expired Fluvirin on 23 October 2003. No adverse events were reported to date. Follow-up pending. Cross reference to PJP-2003-00917 and PJP-2003-00028.
Persistent screaming for the next 3 days.  Acetaminophen, mylicon.
Numbness in tongue, mouth, eye. Watering in right eye. Unable to suck, blow, or spit. Headach on right back side of head.
This is a 84y.o. female with a PMHx that is significant for Hypertension, Hyperlipidemia, CKD, HFpEF/Cardiomyopathy with presevered EF and GIDD, Macrocytic anemia. Patient presented to the hospital today for Fatigue and decreased appetite for the past 3 days. Patient reports she is only short of breath with exertion. Patient tested positive for COVID 19 today (11/3/2021)- patient was vaccinated with J&J vaccine in July/2021. Patient denies and cough, chest pain, Headache, n/v/d. Patient lives at home alone and is able to ambulate with Walker and cane.
T 101.0-104.0 treated w/ TYLENOL and MOTRIN x 6 days. Redness/swelling/induration at site.
Information has been received from a nurse practitioner concerning a 32 year old female patient with no known drug reaction or allergies and a history in 2007, of papanicolaou smear abnormal with surgery and dislocated knee repair and a sister with multiple sclerosis who on 07-JAN-2010 was intramuscularly vaccinated with a 0.5 mL dose of GARDASIL (Lot # 0669Y) instead of H1N1 flu vaccine. Concomitant therapy included prenatal vitamins (unspecified), FLONASE, BENADRYL and SUDAFED prior to realizing that she was pregnant. It was reported that on 07-JAN-2010, the patient had 10 weeks of gestation, the patient LMP was on 27-OCT-2009 and the estimated date of delivery (EDD) is 03-AUG-2010. The patient had been followed since the vaccination by a maternal fetal medicine specialist. At 13 weeks of gestation, on approximately 26-JAN-2010 a routine First trimester screen blood test was performed, the result was normal. At 17 weeks of gestation, on approximately 23-JAN-2010, a sonogram was performed which showed echogenic foci in the left cardiac ventricle of the fetus. There were no adverse symptoms noted on the patient. Follow up information was received from the nurse practitioner which reported that the patient with allergy and a history of one previous pregnancy and one previous full term delivery and cryosurgery in 2000 due to abnormal papanicolaou smear who on 28-JAN-2010, had ultrasound done for screening which was within normal limits. On 25-FEB-2010, maternal serum alpha-fetoprotein (MSAFP) was within normal limits. There was no previous birth defect. At the time of reporting, the outcome was unknown. The baby's experience has been captured in WAES 1003USA00456B1. Additional information has been requested.
FEVERS 101 THEN 102 Narrative: Patient's wife called to report her husband has a fever. he received the Moderna vaccine yesterday he is only 2 months post covid infection. He had a fever of 101 this morning and she gave him 500mg of Tylenol at 2pm temp up to 102.6 so she gave him 2 more tylenol to equal 500mg. CONTINUED APA 650MG X'S 2 MORE DAYS THEN RESOLVED.
I had light headedness and queasy stomach immediately. 5 hours after the shot I had the same allergic reaction I have to foods that I am allergic to. My throat starts to swell, it?s hard to swallow. I start coughing profusely.  Later that evening came the chills, body aches, vomiting, diarrhea. That lasted 3 days. On day 8 I had severe pain down my arm. The same as the pain I had before I had my cervical spine fusion. On day 11 I had severe down my leg. Again the same type of pain I had before having lumbar spine surgery.  I?m on day 12 as I?m writing this.
Feeling warm tingling in face and feet seemed anxious. One dose of Benadryl 25 mg cap given plus water given
I received my 1st dose on 12/29/2020 after 3 weeks of the vaccine I woke up in the middle of the morning at around 2:00AM with severe pain on my right side including my breast area. I noticed a swollen lymph node because I was so curious about the pain. I went to a breast doctor for a breast exam on 01/25/2021. He did a mammogram, and it was fine. He found nothing. He said to take TYLENOL or ADVIL as needed for the pain. After the dose 1st dose every night, I experience hot and cold flashes. Sometimes I feel hot and sometimes I feel cold. I also feel pain in my breast it comes and goes. It  has become an ongoing issue for me now.
rec. immunizations 6/12/08 Td booster and meningitis vaccine. On 6/13/08 experienced shakiness and temp 102.7- seen in E.R. 6/14/08
leg cramping started on 10/11, one day after vaccination. patient presented to clinic for evaluation on 10/13. Ultrasound ordered and confirmed DVT
Pain under left breast; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: En6198), administered in left arm, on 27Feb2021 at 09:15 AM (at the age of 80-years-old) at 2nd dose, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included known allergies at bee stings, high blood pressure and high cholesterol. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced pain under left breast on 06Mar2021 at 23:00. No treatment was received for the event. The patient had not recovered from the event.   No follow-up attempts are possible. No further information is expected.
C/o headache + feeling like throat was closing  seen by EMT on site  BP: 126/84  P:105  Resp 16 Pulse Ox 100% Lungs clear no rash, no sob, no cp  Pt released at 17:25pm
Pt called back and stated he chose to have both injections in the RD. Pt then called back and stated he was having chills, achy and one episode of nausea. Pt did not call back for 2 day with this information. Pt was advised to use TYLENOL for fever and if worsening needs visit.
Patient received a 3rd dose of Shingrix from us on 8/4/2021. When she went to another pharmacy for her 4th dose, they notified us to let us know that she had already completed the course from a pharmacy 8/28/2020 and another pharmacy 12/02/2020. No issues that we are aware of that arose from the 3rd dose. Advised patient to contact MD if there is anything further that needs to be done.
Discharge Date: Aug 22, 2023 Discharge Provider: MD Primary Care Provider : MD    Admission Date: 8/17/2023 Details of Hospital Stay PRESENTING PROBLEM: COVID-19   HOSPITAL COURSE: 91 y.o. male who presents today with a past medical history of diabetes mellitus type 2, DVT on Coumadin, prostate cancer status post surgery, restless leg syndrome who presented from his independent living facility after a fall.  He slid out of his chair and then was too weak to walk.  He crawled to his alert button and then was brought to the ER.  He has not been feeling well for 2 days. He had fever, mild shortness of breath and a dry cough.  In the facility he was diagnosed with COVID-19 which was also confirmed with the ER.  He has been vaccinated.   In the ED, he had mild tachycardia, no hypoxia but was placed on 2L oxygen.  EKG with right bundle branch block, chest x-ray with left lower lobe opacity suspicious for pneumonia, knee x-ray with degenerative joint disease, CT head is negative.  Patient was admitted for further management and observation.  He was taken off of oxygen and did not have any episodes of hypoxia.  He was started on remdesivir and empiric antibiotics for possible superimposed bacterial pneumonia.  Patient had sundowning and episodes of confusion, impulsiveness, agitation at night times requiring into placed in a Posey bed.  During the severe was discontinued in case it is contributing to his confusion.  He worked with therapy who recommended discharge back to his living facility if 247 assist can be provided, and home health care.  Due to contact precaution policies in his current independent living facility, daughter opted to bring the patient home to live with her temporarily.  This was arranged and the patient discharged to daughter's home today.  He had finished 5 days of antibiotics.
No adverse event; 0.5 dose of the Moderna Bivalent instead of the 0.25mL; This spontaneous case was reported by an other health professional and describes the occurrence of ACCIDENTAL OVERDOSE (0.5 dose of the Moderna Bivalent instead of the 0.25mL) and NO ADVERSE EVENT (No adverse event) in an 11-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 12-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Dec-2022,  after starting , the patient experienced ACCIDENTAL OVERDOSE (0.5 dose of the Moderna Bivalent instead of the 0.25mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (0.5 dose of the Moderna Bivalent instead of the 0.25mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (0.5 dose of the Moderna Bivalent instead of the 0.25mL).    It was reported that this was the patients first dose with Moderna. Patient does not have any reactions to the vaccine. Patient previously had the primary series with Pfizer. No concomitant medication were reported. No treatment medication were reported
Injection pain and swelling at site of reaction, followed by redness and itch traveling down arm.  MD is a physician and when asked if she required further medical attention she said that it was not necessary.
1 day following: fever, body aches, chills, fatigue. Day 3 Covid arm.
Pt developed 105 fever and leukocytosis. 12/07/07-records received for DOS 10/24-10/26/07 DC DX: Right middle lobe pneumonia. Leukocytosis. Diaper rash. One day prior to admission seen in PCP office. C/O cold. Spike fever 105 seen in ED. Admitted next day.
Later that night she could not walk, had chills, had fever, and couldn't sleep and eat for two days, went to family doctor Dr.  still couldn't figure out what was going on still was having problems breathing and leg was having terrible shivering and is also having menstrual problems that she hasn't had in years; she also stated that she is having a hard time with moving .
54 Y FEMALE WITH HX ANXIETY, SYNCOPE/LOSS OF CONSCIOUSNESS, SX RESOLVED, REFUSED TRANSPORT, HOME WITH SON
I woke up with intense pain in my left upper shoulder in the general vicinity of where I received my shot.  I could not lift my arm.  It hurt to use my arm for driving, typing, for doing anything.  It was a dull, numb pain, and almost felt muscular in nature - or nerve related.  I have tried anti-inflammatories, ice, physical therapy, etc. all to no avail.  It has been 16 months and the pain still persists.  Saw a shoulder specialist and a general doctor.  Neither want to believe it is related to the vaccine.  Nothing else happened to the shoulder except the flu vaccination.  There seem to be a group of people that have similar adverse reactions to the flu shot.  I have had the shot virtually my whole life with no issues.
My sugar totally out of control 300 and above,  weight loss , dry mouth, light headed, dizziness, fatigue
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 17-AUG-2013, the patient was vaccinated with a dose of VARIVAX (Merck) (lot# J001179, expiration date 31-JAN-2015, dose, frequency, route and indication not reported). The vaccine was stored improperly at temperatures up to 21F from 01-JUL-2013 to 08-OCT-2013. On 08-OCT-2013, the vaccine was discarded. No adverse effects were reported. It was unspecified if the patient had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
severe chest pain, nausea... From Medical Report: Patient seen and examined.  I agree with the note and plan by NP, as documented in today's notes.  See additional findings below.   Coronary angiography showed normal left dominant coronary arteries.  A sending aortography performed at the time of this procedure showed no evidence of overt aortic dissection.  Left ventriculography showed no regional wall motion abnormalities.  This was followed by CT angiography showing no acute aortic pathology and no evidence of pulmonary embolus.  Constipation was noted.  The patient underwent serial troponin levels which were 0.  Echocardiography did not show significant abnormalities.  There was no pericardial effusion.  The patient had his pain treated with morphine.  It is unclear if given his aspirin allergy he can take nonsteroidal agents.  Ultimately, he requested hospital discharge which is reasonable given all life-threatening events have been excluded.  The etiology for the patient's chest pain is unclear but may be musculoskeletal given that he was performing unusual activities for him in the preceding days.  I have advised the patient return to the emergency department immediately should he develop recurrence of chest pain for additional work-up.
Few days after injection, noticed tingling sensation both sides of lower face, drooling when chewing. Recurrence diplopia, dysphagia, altered phonation.
sore arm within a few hours, then at 2 am, Temp 100.4-101.4, body aches, chills, Headache and slight nausea. Slept poorly all night. Symptoms continue today with fatigue, although somewhat improved