chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt a little weak; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheaded) and ASTHENIA (felt a little weak) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021 at 1:30 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (lightheaded). On 17-Mar-2021 at 6:30 PM, the patient experienced ASTHENIA (felt a little weak). On 17-Mar-2021 at 7:00 PM, DIZZINESS (lightheaded) and ASTHENIA (felt a little weak) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient went to lift weights later around 630-7PM and felt a little weak. He wants to know if he should take the second vaccine or not. He has not taken any medications for the side effects. He states that nothing was going within the first 15 minutes but then he felt lightheaded. He had a salad and water and then the lightheadedness went away. Consent given to Safety for follow-up.
1. "COVID Arm"- noticed vaccination site on left arm was red on 3/29/21, seven days after vaccination. The area was hot and tender to the touch.  Began treating with ice and acetaminophen. Today is day 9 after vaccination, and the red area has increased in size and is still hot and tender. Will continue treatment above and add an antihistamine. Appears to be an allergic reaction. I feel ok- energy level is normal and I continue to work, exercise and perform daily routine events as usual.   2. Left armpit area (lymph nodes) became swollen and tender to the touch on 3/23/21, one day after vaccination. Left untreated for a week, as I thought it was an exercise-related muscle strain. When I realized it may be vaccine-related on 3/29/21, I began icing the area and taking acetaminophen daily. Today is day 9 after vaccination. Swollen area remains same size, pain/tenderness has slightly increased. It has not stopped me from performing daily routine (work, exercise, household chores, etc.)
Started to feel weak, fainted-unable to see 5 sec lasted about 20 seconds. Has not eaten at all today. Only drank 16 oz seltzer water. Got up by self-sat/rested for 15 minutes.
Same day as injection, Headache; 3 days after injection, shingles outbreak (22 spots) on same side of abdomen as injection (left arm) but on opposite side from previous outbreak 2 mos ago.  Headache medicine only.
Gross swelling of left deltoid/upper arm to elbow. Mom did not notice until 07:00 AM on 6/19/00. Pt would not let mom keep cold rag on arm as she was instructed to do. Mother thinks he had a little fever.
received Moderna vaccine after the J&J vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna vaccine after the J&J vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: J&J Vaccine on 18-Nov-2020. Past adverse reactions to the above products included No adverse event with J&J Vaccine. Concurrent medical conditions included Type 1 diabetes mellitus.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna vaccine after the J&J vaccine). On 10-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna vaccine after the J&J vaccine) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient received J&J vaccine as part of the study.
pt noticed swelling lt side of neck in Am of 5SEP92; swelling noted along angle of mandible, mild tenderness, no erythema, no other nodes; TM clear; throat clear, lungs clear; dx parotitis; tx Motrin & heat;
Pt experienced numbness shortly after receiving the dose IM in RUE.  States that it feels "like her hand fell asleep".  at1515 pt escorted to clinic exam room and placed under observation.  Cold pack placed at injection site as well as back of neck.  Pt stated that she feels drunk and anxious.  Provider continued to provide comfort care to pt and at 1545, pt felt better.  Numbness resolved to right hand.    on 10/12/21 follow up with provider:  pt states she is having fatigue and headache which will not resolve and a cough/tickle in her throat.
I had very mild arm pain after receiving the vaccine for about a day. I had a regular doctor's appointment scheduled on 05/16/2023, I was diagnosed with atrial flutter. I have an appointment with a cardiologist tomorrow 05/25/2023.
Information has been received from a registered nurse concerning a 14 year old female with no pertinent medical history or drug reactions/allergies who in April 2007, was vaccinated with the first dose of Gardasil (lot # not reported), 0.5mL, intramuscularly in the deltoid.  In "early" June 2007, the patient received her second dose of Gardasil.  There were no concomitant medication.  In "late or early" July 2007, the patient became sick.  She had an increase in her liver enzymes during her illness.  As of 01-Nov-2007 the patient had not recovered.  The patient is under the care of the practice.  Additional information has been requested. In follow up information it was reported that in ??-OCT-2007 patient received a dose "number of previous dose 0" of GARDASIL lot #659437/1266U IM into left deltoid at 04:00 PM. It was mentioned that in November, 2007 her hepatic function tests (LFTs) was noted elevated and she complained of fatigue. She had complete blood count (CBC with diff) with differntial, complete metabolic panel, liver function test and thyroid function laboratory test was done. No result available except LFT being elevated. She recovered in December 2007. Additional information is not expected.
Fever; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) and PYREXIA (Fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (A total knee replacement in the left knee in 2015) in 2015.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ARTHRALGIA (Knee pain). On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, ARTHRALGIA (Knee pain) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) Fever of 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-114471 (Patient Link).
Swelling, left upper arm- site of DTaP immunization 6/7/04.
Patient noticed itchy red patch at injection site. Site is raised and about 2 inches long.
Very fussy, irritable p/shot awoke about 10PM w/loud, high pitched cry; temp was 103.4 R; p/less that 1min parent contacted MD who advised APAP immediately; site of inject was red & warmth w/small knot;
This is a spontaneous report from a contactable Nurse and physician. This Nurse reported similar events for 3 patients. This is the 1st of three reports. A patient of unspecified age and gender received Meningococcal Group B RLP2086, via an unspecified route of administration on 06Jun2018 at a single dose for immunization at the physician's office. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines with meningococcal group b rlp2086. The patient woke up with pain, chills, tired, nausea on 07Jun2018. The patient recovered from the events on an unspecified date in 2018. Pfizer is a Marketing Authorization Holder of Meningococcal Group B Rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of Meningococcal Group B Rlp2086 has submitted the same report to the regulatory authorities. Sender's Comments: Linked Report(s): US-PFIZER INC-2018288887; Same reporter/drugs/events different patients. US-PFIZER INC-2018288886 Same reporter/drugs/events different patients.
Patient waited 15 minutes and walked outside with caretaker, her legs felt heavy and she fell and broke her hip
temperature that product was out of range at 9 C time exposed to temperature was30 minutes or less/ NO AE; Initial information received on 26-May-2021 regarding an unsolicited valid non-serious case received from a other health professional via Medical Information.  This case involves a 6-years-old female patient who received 0.5 mL (VERO) [IPOL] (frequency: once, strength: standard, batch number: R1F801M and expiry date: 28-Sep-2021 via intramuscular route in left deltoid) which was exposed to 9 degree Celsius for 30 minutes and less was given post a temperature excursion that made the vaccine not useable  (product storage error) on 18-Mar-2021 for prophylactic vaccination  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  No other vaccines received by patient.  It was potential medication error case due to incorrect product storage.  Excursion occurred on 09-Mar-2021. that the excursion was spotted during an audit of temperatures from a data logger; that three consumers received the vaccine; and that with further verifying dates and times of vaccine administration only two consumers received the vaccine. The clinic calling the manufacturer for guidance. Caller is requesting temperature excursion information for the vaccine.  At the time of reporting, no adverse event was reported.  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 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.
Immediately, post vax, she developed an urticarial rash on her legs. Benadryl was given.
SYNCOPE, FELL TO THE GROUND, WOKE UP CONFUSED, PALE, SOB, CODE GREEN CALLED, PROVIDED GATORADE, TRANSPORTED TO HOSPITAL.
I experienced a stroke starting the early evening of 6/27/2022. However, it was not assessed and diagnosed until 6/28/2022.  This was because I had passed out onto my bed about 2.5 hours after the stroke started (which I did not realize the symptoms that I was suffering was a stroke). This is where my husband found me and surmised that I had simply gone to bed early (~7:30 PM). He was not aware of what was occurring, including any symptoms because he was at work at the time.  When he found me, to him, it appeared that I must have been very exhausted, went to bed early, and appeared to be sleeping. It was not until the next morning when I slept way past my usual arising time that my husband became concerned and realized that something may be wrong. The stroke was diagnosed after I went to the emergency room and it was observed via MRI analysis of my brain. It was an ischemic thalamic stroke.  This event was quite unexpected, as I have always been a very healthy and active person who values her health immensely. I do not fit the standard "checklist" of potential stroke patients - i.e., I do not have the usual underlying issues that are potential precursors to stroke.  Thank you for your consideration of my adverse event report.
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 details were reported as follows: Medical assistant reported that, the patient received an expired dose of Kinrix on the day of reporting, which led to expired  vaccine used. The reporter consented to follow up.
Hives developed on forearm of injected (right) arm, after 2nd injection more hives on left arm left thigh and hands (both)
I was just a little tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I was just a little tired.) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (I was just a little tired.). At the time of the report, FATIGUE (I was just a little tired.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported.
pt recvd vax 22AUG94 pt woke up 23AUG94 & found to have flat erythematous rash b ack of head, neck, back & buttocks; no fever well;
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: After using the arm during physical labor, injection site was very itchy. Then after her shower the next day, her deltoid was red and inflammed. No wound at the injection site, though the injection site is still visible.
Information has been received from a physician concerning his adult daughter who in 1995 was vaccinated with two doses of Varivax. In approximately July 2006, she broke out with a mild form of herpes zoster virus. It is unknown if medical attention was sought. No outcome was reported. No product quality complaint was involved. Additional information has been requested.
Left arm swelling x 7 days. Redness and pain reducing at 5 days. Sever itching.  No fever, respiratory distress, swallowing difficulties, dizziness or additional MSK symptoms
Vasovagal syncope in POD 10.  Lowered to ground, positioned supine w/ BLLE elevated on chair.  Pt reports resolving once supine and guided through breathing techniques.  Slight diaphoresis and pallor noted,  Skin color returned to baseline once transferred to MED OBS via WC and given 1 botttle water and 1 bag pretzels as pt reported eating "light today" with moderate caffeine intake and little other fluids.  Pt reports dizziness resolved completely @ 1647.   Released at 1655  VS 1640 SITTING  BP 116/78, HR 84, RR 16, 96%RA  1650 SITTING  BP 112/77, HR 82, RR 16, 95%RA 1652 STANDING  BP 128/89, HR 78, RR 16, 97%RA
night of 5/18 into early morning of 5/19: Pain in right arm, and upper right back, shoulder, and chest. Ultimately Vomiting violently. Could not lie down without the pain returning. 5/19 Day: Had light breakfast and dinner. No vomiting, but could not lie down without same pain. Morning of 5/20: Breakfast of cereal and fruit at 9am. And noon, I experienced pain again, vomiting at noon. Then to Urgent care, then, Emergency Room, then Hospital.
light headache lasting over 5 days, fatigue lasting over 5 days, initial back and chest pain 30 minutes after vaccine followed by dizziness and nausea. the back and chest pain come and go.
Redness and swelling on (R) deltoid where injection was given, complains of itchiness.
Pt recvd 3 doses of Engerix-B vax 19JUN90 & 17JUL90 & 13DEC90 & pt failed to convert to protected levels;
No AE's.  Follow up received on 1/5/2010. Patient 1 yr old. Given H1N1 for 3 yrs & older, on 12/21/09. No adverse effects.
* NOTE: CHILD MAY HAVE BEEN LIVING IN A SHELTER. HERPES ZOSTER DIAGNOSIS IN ONE DOSE VARICELLA VACCINE RECIPIENT. BLISTERS. Left upper extremity, spread to hand.
This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01Jul2021 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. Medical history and family history were none. There were no concomitant medications. No additional vaccines were administered on same date of BNT162B2. The patient did not receive any other vaccine within 4 weeks of BNT162B2. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported), on 06Jun2021 (at the age of 69-year-old) at single dose for COVID-19 immunisation and about two weeks following her first injection, she had typical reactions which included she was not feeling well for a day or two and needing to rest, her urine was dark and she got really sick/progressively ill. The patient had both shots. Approximately a week or two weeks following the second injection, the patient had extreme shortness of breath, was in afib, and very weak on 10Jul2021. She went to her family doctor she clarified as her internal medicine doctor to figure out what the problem was. She had multiple medical test. She received heart tests, lab tests, and ultrasound in 2021. When determining the problem of shortness of breath, it was found she had acute autoimmune hepatitis as a result of the chemical included in the vaccine in 2021. The outcome of the event extreme shortness of breath was recovering, of the other events was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
a 58 years old female patient received a 0.5 mL dose of Fluzone High Dose in error/No AE; a 58 years old female patient received a 0.5 mL dose of Fluzone High Dose in error/No AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 58 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] in error lot UJ232AA, expiry date: 10-Apr-2020 via intramuscular route in the left arm on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration and overdose.  At the time of report, no adverse event was reported.  Flu clinic visit 04-Oct-2019.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
Awoke night of vaccination with severe trembling for 1-2 minutes. Next I had body aches all over. Severe pain at site of shot - unable to sleep well. Tiredness, chills, headache.
Patient started experiencing tightness in throat and trouble swallowing approximately within 15 minutes after receiving second COVID-19 dose (Moderna). Patient was treated at vaccine event site with 0.3 mg of Epinephrine via auto-injector, and emergency services notified. Patient transported for further medical follow-up to a local hospital at which she reports receiving steroids and an  additional dose of epinephrine enroute. Patient kept for evaluation and was discharged home with a prescription for Medrol.
Red bumps/rash on back of both hands and left arm with a burning sensation. We are snowed in so could not leave home.  Took benadryl and rubbed down with coconut oil and lotion  spoke with nurse at local ER  she said common side effect of vaccine. Continue benadryl  If started having trouble breathing find way to ER    if not call Dr and report in AM.   Took another benadryl was better by morning but still hasnt gone away.
Mother called on 5/4/01 concerned due to large "knots" at the injection site. The largest is the size of an egg. Was told to call MD. On 5/9/01, spoke with the father and father states the swelling has gone down.
Client came into our office; left upper arm swollen, redden and warm to touch. No harden area. Instructed client to call her MD to be seen and to apply cool compress to area for relief. 12/9 Client saw MD; he prescribed antihistamine, prednisone and Keflex 500mg BID for 10 days. Spoke to client 12/13. She is doing well; no redness or swelling noted.
Report #2000028594-1 describes the inability to open the mouth of a child who rec'd Engerix-B. Allergies, medical history and concomitant medications are not specified. On an unspecified date the pt rec'd his first dose of Engerix-B. One day later, he experienced tingling in the jaw which became painful. The pt was unable to open his mouth for approximately one hr. As of 9/21/00, the inability to open the mouth resolved and the outcome of the tingling/ pain in the jaw is unknown.
I just took the booster dose; Fever; body aches; Headache; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH8030) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization; Bnt162b2 (Second dose), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "I just took the booster dose"; PYREXIA (non-serious) with onset 16Nov2021, outcome "unknown", described as "Fever"; PAIN (non-serious) with onset 16Nov2021, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 16Nov2021, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 16Nov2021, outcome "unknown", described as "Arm pain".  Additional Information: I didn't have any side effects from the 2nd dose but did from the booster.  Follow-up attempts are completed. No further information is expected.
Pt wife, reported pt had increased HR, fever, and chills. She states pt was admitted to hospital. DC DX: chest pain-noncardiac office note for DOS 3/30/06-chief complaint low back pain, hypertension, hyperlipidemia, obesity.