chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CALL TO ASSIST CLIENT WHILE IN OBSERVATION PERIOD. CLIENT PALE, DIAPHORETIC, LIGHTHEADED AND WEAK, STATES "I FEEL LIKE I'M GOING TO FAINT. TAKEN VIA WHEELCHAIR TO LAB, ASSISTED TO STRETCHER CHAIR WITH FEET UP. INITIAL VS: 112/66, HR 54, O2 ROOM AIR 99%. DEPARTURE: 129/74, HR 51, O2 95% RA AND KEPT UNDER DIRECT RN OBSERVATION FOR AN HOUR. AFTER STANDING AND WALKING DOWN THE HALL AT 2 P.M. WITH RN, CLIENT STATES THAT HIS LEGS FELT HEAVY AND HE FELT TIRED. O2 SAT WHILE WALKING 91%, HR 51. AFTER RETURNING FROM WALK, CLIENT STATES HE FELT "O.K" BUT "TIRED". BRIEFLY AFTER, O2 SAT DROPPED TO 87% AND HR TO 47 AND THEN BACK UP AFTER A FEW SECONDS TO 95%, HR 51. OXYGEN SATURATION AND HR FLUCTUATION BETWEEN 90-99% AND 50-54 BP BPM AFTER THIS OCCURENCE. ALTHOUGH , ALERT AND ORIENTED THROUGHOUT, EXPRESSED CONCERN TO WIFE REGARDING BRADYCARDIA AND ROOM AIR OXYGEN SATURATION AND OFFERED TO CALL EMS. BOTH DECLINED AND STATE WILL TAKE TO ACUTE CARE. V-SAFE BROCHURE WITH WIFE AND INSTRUCTED TO REPORT. ASSISTED CLIENT TO WHEELCHAIR AND TRASNPORTED TO PRIVATE VEHICLE.
On Sunday night I started to feel tired but I had been busy during the weekend so I thought it was just that. Also, I drove for 2 hours. I got home and I unpacked my bag. Later on I felt like I was having a headache. On Monday morning I went to work and I had a dry cough and I felt congested. I got off work and the next day the cough was better and my congestion was worse, I could not breathe okay. I made it through work. My coworker told me to get a Covid test. I called the doctor's office. When I went they took my tempt. They did the Covid taste and it was positive. They gave me 3 prescriptions.
Rapid Myoclonic muscle contractions at vaccine site. Please reach out to patient for video.
Information has been received from a registered nurse concerning an unspecified infant (gender not reported) who on 17-OCT-2014 was 16 weeks and 14 days and received the first dose of ROTATEQ 2ml oral and the second dose was given on 17-DEC-2014 at age 25 weeks and 2 days. No adverse effects were reported. No other information was provided. Additional information has been requested.
sore arm; feeling a little beat up the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; MALAISE (non-serious), outcome "unknown", described as "feeling a little beat up the next day".  Additional information: The patient had no side effects but only had minor side effects like a sore arm and feeling a little beat up the next day. He had 6 shots of the Pfizer Covid vaccine, two of the initial and 4 boosters.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300289406 Same patient/vaccine, different dose, similar event;
Contracted COVID-19 Virus after first shot; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Contracted COVID-19 Virus after first shot) 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.    In April 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 COVID-19 (Contracted COVID-19 Virus after first shot). At the time of the report, COVID-19 (Contracted COVID-19 Virus after first shot) 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 provided. No treatment medications were provided. This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred on unknown day and month after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable since only information about the first dose was disclosed. Very limited information regarding clinical course of the event has been provided at this time. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred on unknown day and month after the first dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was not applicable since only information about the first dose was disclosed. Very limited information regarding clinical course of the event has been provided at this time. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.
Acute onset of rash of the bilateral arms, biceps/forearms and left rib cage. Symptoms reportedly occurred at the time of initial injection on 17 November as well but were increased w/ 2nd dose
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot number M036294, expiry date 13-FEB-2018 (dose, frequency and route, were not provided) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Swelling and redness at injection site - increased to swelling, redness and very warm to touch, very painful for patient - this now extends entire length of upper arm (elbow to top of shoulder)
This case was considered medically important.  Information regarding PREVNAR 13 was received from a physician regarding a 4-year-old male patient who experienced idiopathic thrombocytopenic purpura.  The patient received a dose on an unspecified date in 2010.  The patient experienced idiopathic thrombocytopenic purpura on an unknown date in 2010.  The event has resolved.  No additional information was available at the time of this report.
Rash broke out on abdomen.  I treated with apple cider vinegar for itch.  After a week the rash went away.
PERIPHERAL NEUROPATHY ACUTE HYPERCAPNIC RESPIRATORY FAILURE 2/2/2023  --  RECURRENCE OF SAME SYMPTOMS
18FEB91 temp 104.8(R) sz type activity; ear infections on 20fEB91 w/fever & sz;  ear infection on 22FEB91
Information has been received from a medical assistant concerning a 74 old female with Meniere's disease, gastrooesophageal reflux disease, osteopenia and hypercholesterolaemia who was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23. There was no concomitant medication. Subsequently the patient developed "blotchy skin" and tongue swelling. Unspecified medical attention was sought. Subsequently, the patient recovered. Additional information has been requested.
I started having the worst sore throat I've ever had in my life and a fever; I didn't really have a cough or anything, but I had body aches and fatigue. I developed thrush to mouth sores/COVID-19 tongue. My jaws began locking up and swelling to where I couldn't open my mouth. I went to urgent care where I was tested and diagnosed with COVID-19 on 11/29/2022. The physician told me to remain active so it wouldn't progressively get worse and become pneumonia. The next day, my doctor prescribed me PAXLOVID to help with treatment and told me to let it run its course. They told me to gradually remain somewhat active to keep myself from getting sicker. I developed pain in the right side some time later, and doctors believed it was gallstones. After further diagnosis, they determined it was fatty liver that was later determined with the acid reflux I developed as well. Everything has progressed so fast over such a small period of time.
Pt received 1st Moderna covid vaccine at approx 10:25am with no apparent issue. He was sitting outside pharmacy in observation area playing on cell phone and approximately 10 minutes after receiving vaccine fell in the floor, hitting his head. EMTs were called immediately as a precaution. He was conscious when pharmacist reached his side. He reported remembering a buzzing in his ears and then woke up in floor. Pt reported no hx of seizures or fainting. He remained in floor for several minutes, reporting his head hurt, but was able to tell his name, location, and date with no issue.
Had to leave work with Fever, terrible muscle cramps,  couldn?t hold my head up, splitting headache
Sweats, chills, joint soreness, headache, fatigue and slightly short of breath lasted for 24hrs.
A physician reported via a company representative, that a 5 year old child received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the child tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The child developed a "high" fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers HQ0713214FEB2002, HQ1480025MAR2002, HQ1480225MAR2002 and HQ1480325MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.
Within 24 hours patient had complaints of migraine, body/muscle aches/pains, and cold sweats.
Nausea, fever, dizziness, widespread and severe muscular/joint pain, and weakness. Began approximately 4 hours after shot and lasted until approximately 6 AM the next day. Temperature still slightly elevated the next day (~99 degrees) and muscular/joint pain less severe but present. OTC pain meds ineffective in relieving body pain.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 11-AUG-2017 the patient was vaccinated with PROQUAD lot # M006107, .5 ml, subcutaneous for prophylaxis. Other suspect therapies included sterile diluent. On 11-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to PROQUAD and sterile diluent.
The initial case was missing the following minimum criteria: unspecified suspect drug. Upon receipt of follow-up information on 06Nov2018, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported for a female patient in her 70's received PREVNAR 13 (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swollen at injection and inflamed a couple of days, no restriction of movement with outcome of unknown. Information on lot number, batch number and expiration date has been requested.
24-48 hours fever 99-100, nausea, Headaches, dizzy, swelling below and above jaw on either side of mouth (thought mumps when saw), Tongue swollen also, Hard to swallow
Sore arm; Tired for a couple weeks; Headache; Nausea; Peripheral neuropathy went away after 10 years; Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021), FATIGUE (Tired for a couple weeks) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Peripheral neuropathy (for the past 10 years; it was progressively getting worse.).    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired for a couple weeks), HEADACHE (Headache) and NAUSEA (Nausea). On 10-Mar-2021, THERAPEUTIC RESPONSE UNEXPECTED (Peripheral neuropathy went away after 10 years) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received her first Moderna vaccine on 22Jan2021; received her second dose on 10March2021) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired for a couple weeks), HEADACHE (Headache) and NAUSEA (Nausea) had resolved.            No concomitant medications were reported.  The patient had the same side effects as with her first dose but a little worse.  No treatment information was provided.   This case was linked to MOD-2021-225639 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Event outcomes updated.
dizziness/dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 08Mar2021, outcome "not recovered", described as "dizziness/dizzy".  Upon Follow-up (12Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient that, The caller is calling on behalf of his wife about the Covid vaccine, Pfizer. The patient got the vaccine on Saturday and everything was fine, a couple of days later the patient was dizzy when she was working out. Today the patient woke up and she's so dizzy when she sat up in bed, it was pretty disruptive, The patient is so dizzy when she gets up she has to hold on to things. The patient drank 3 glasses of water and ate a bowl of oatmeal but now she is back in bed. The caller wants help with his wife and wants to know what they should do.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
muscle spasm at injection site, diffuse myalgias, headache, diaphoresis, nausea, gait instability, dizziness, fatigue, arthralgias, stiff neck- no treatments required
2hours post began with tingling in tip of tongue and bottom lip. Took otc benadryl.48hours later all right side of face became numb.Was sent for evaluation by employer  to hospital.dx with adverse reaction.bells palsy I was given Decadron IM and medrol dose pack.
07/03/22 presents to emergency room for "black stools x1 weeks". PMHx of "HTN, OSA, and restless leg syndrome"
Close contact with person with confirmed positive test for Covid19 on Saturday 6/18.  My test on 6/18 and 6/19 were negative.  Symptoms were sore scratchy throat and voice with occasional cough.  Test on 6/20 was positive for Covid19.  Doctor prescribed medication of Paxlovid for 5 days and Benzonatate for cough. Currently taking medication.
Dizziness, off balance, weakness, brain fog, fatigue, ringing in ears, feeling faint, heart palpitations. Side effects started the day after the second dose of Pfizer vaccine and have NOT gone away. It has been three weeks since it all started.
Developing shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Developing shingles) in a 30-year-old patient of an unknown 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (Developing shingles). At the time of the report, HERPES ZOSTER (Developing shingles) outcome was unknown.            It was reported that patient had developed shingles and got treated 72 hours after second Moderna vaccine     No concomitant medication was reported  No treatment medication was reported
Patient started feeling neck pain Wednesday morning that moved into her legs and arms.  She said her entire body felt like it had a Charlie horse by afternoon late.  She said the muscle pain was so bad that night.  She spent 2 hours in the bathroom because she could not get off the stool because of the . She said she had the worst headache of her life and it felt like her chest was on fire.  Patient was seen at the clinic for her symptoms and given an injection of steroids.  Not sure what day patient was seen at the clinic. She called on 11/20/06 to let us known she had been seen and was doing better.
A report was received from a health care professional on 31 October 2003 concerning a 61 year old female vaccine who inadvertently received a double dose of Fluvirin on 31 October 2003.  On 31 October 2003 the vaccine received a double dose of Fluvirin.  The vaccine had experienced no adverse reaction at the time of the report.  There was insufficient information to determine the reporter's causality assessment.  Update 1, 17 February 2004.  A follow-up report was received from a health care professional indicating that no adverse event had occurred at the time of reporting.  No follow-up pending, all information received.
Information has been received from a licensed practical nurse (LPN) concerning an 8 weeks old female patient with no drug reactions or allergies and no pertinent medical history who on 15-DEC-2011, was orally vaccinated with the first dose of ROTATEQ (lot # 669085/1659Z, exp. date 29-AUG-2012) (dose was not reported). There was no concomitant therapy. The nurse reported that on 22-DEC-2011 (reported as "seven days after her first dose of ROTAREQ"), the patient developed blood in her stool. The patient sought medical attention by visiting an unspecified physician's office. Non lab diagnostic tests were performed. Patient did not received treatment. At the time of the report, the patient had not recovered. Additional information has been requested.
Patient has experienced radiating left arm pain, and tingling to left fingers since the day of the COVID-19 vaccination on 12/23/2021. Pain occurs at rest or sleeping, and subsides with movements.
Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) 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 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced DIARRHOEA (Diarrhoea). At the time of the report, DIARRHOEA (Diarrhoea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided   This case was linked to MOD-2021-051502, MOD-2021-051502 (Patient Link).
a knot on arm; Tenderness; Can't sleep on it; Very very uncomfortable; now it is bright pink with dark lines through it; she can not even lay on it; having a fever/warm and feverish; injection site redness baseball size/big red circle developed at the site; warm and feverish/it burned like fire; This is a spontaneous report from a contactable consumer. This consumer (Patient) reported. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6204; Expiration Date: Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 between 12:00-2:00 (at the age of 72-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN5318; Expiration Date: May2021) via an unspecified route of administration, administered in Arm Left on 03Mar2021 between 12:00-2:00 (at the age of 72-years-old) as a single dose for covid-19 immunization and that 2 hours later she had tenderness, warmness and a presence there, like something was laying on her arm. It lasted for a few days. Did not bother her much. Caller did not even feel when she was given the shot, no pain with either shot. Medical history included oxygen therapy -stated Oxygen 24/7, illness: had all kinds of health conditions. No history of previous immunization with the Pfizer vaccine considered as suspect. No family medical history were reported. She received second dose of vaccine a week ago and on an unspecified date in Mar2021, having a fever and injection site redness baseball size, a knot on arm, having to place ice packs. It has been 1 week and its still there. She was on a daily Antihistamine but has not taken it. Caller stated she had her second vaccine on 24Mar2021. It was fine on the first day but on the second day, 26Mar2021 a knot developed. She said a big red circle developed at the site. She said she read it was called the Covid arm. She stated it was warm and feverish so she had to use ice packs because it burned like fire. She said it was very hot and very uncomfortable. She stated she also took Tylenol to keep the fever down. She said the knot is going down, now it is bright pink with dark lines through it, like a baseball size circle. She stated it is still tender, she cannot even lay on it. She developed tenderness, knot on arm warm feverish, big red circle, bright pink circle with dark lines in it, baseball size circle, felt like something was laying on it, tender can not sleep on it, very very uncomfortable, burn like fire. She has all kinds of health conditions but none that are relevant. Caller stated she is on Oxygen 24/7. No emergency room and physician office. Therapeutic measures were taken as a result of pyrexia. Outcome of the event vaccination site erythema, uncomfortable, feeling hot, hyperaesthesia was unknown; event knot on arm was recovering; while rest other events was not recovered. No follow-up attempts are needed. No further information is expected.
injection site edematous, red, painful, burning, stinging, warm to touch. Area has increased in size over the course of Tuesday afternoon, Wednesday, Thursday, Friday.