chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4JUN97 230AM insomnia, sweating, chills, malaise, weakness, sore throat, congestion (nasal), nausea, abd cramps, diarrhea, swollen lymph in neck, urticaria, pruritus, agitation, dizziness & felt like heart was racing;stayed home for work 4J
Patient called our office( family Dr)  and reported reaction of nausea continuing on Friday 1/8/2021 from Covid vaccine that she received on Tuesday - is a healthcare provider (patient supplied lot number today so provider could report reaction.) This was patients 2nd vaccine. States the afternoon that she received dose, had trouble breathing, itching. Took Benadryl and resolved. however nausea continued. MD prescribed Zofran for patient to resolve.
HIGH FEVER LESS THAN 24 HOURS OF IMMUNIZATION, TEMP 100.6 - 103.8 RECTAL
Arm sore next day with increased redness and knot under site. Tx with ice. 6/10/09 Pt was seen in office today with pain left arm, firm nodule at injection site, warm to touch - erythematous.
Fever of 101.9, chills, burning up, nausea, dizziness, headache, body soreness, diarrhea.
This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA587A, expiry date 20th August 2022) for prophylaxis. On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown. Additional details were provided as follows: The age at vaccination was not reported. The patient was administered the powder portion of Menveo (MenA component) reconstituted with sterile solution instead of using the correspondent liquid portion of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have information about patient's identifiers and was not sure if the administration might had occurred on 31th December 2021. The reporter did not consent to follow up.
rash and hives all over body; rash and hives all over body; This is a spontaneous report from a contactable healthcare professional (reported for herself). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EJ1685; expiry date: not known), intramuscular in the left arm on 17Jan2021 08:30 at single dose for COVID-19 immunization. There was no medical history. The patient is not pregnant. No known allergies. Concomitant medication included unspecified medication (other medication given in two weeks). No other vaccine in four weeks. No COVID prior to vaccination and not tested with COVID post vaccination. The patient experienced rash and hives all over body on 18Jan2021 11:00. These resulted in physician's clinic visit. Therapeutic measures were taken as a result of rash and hives all over body with prednisone, Benadryl, and Kenalog. The outcome of the events was recovered in Jan2021.
Site with 4cm area of redness and tenderness. Hot to touch; symptoms occurred with 24 hours of vaccine; reaction to Varicella
I noticed an abnormal growth in my left breast when doing my monthly self-examination. I mentioned it to my obgyn and she mentioned that it could be related to the site that I received the vaccine. She requested an ultrasound and the results showed that my breasts have denser tissue than average but nothing to be concerned about. The left breast was denser than the right breast.
Rash at injection site; Arm black/blue; Swelling from shoulder to elbow at the injection site; Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE BRUISING (Arm black/blue), VACCINATION SITE SWELLING (Swelling from shoulder to elbow at the injection site) and VACCINATION SITE RASH (Rash at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included Anemia.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 10-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Arm black/blue) and VACCINATION SITE SWELLING (Swelling from shoulder to elbow at the injection site). On 11-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site). On 10-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. At the time of the report, VACCINATION SITE BRUISING (Arm black/blue), VACCINATION SITE SWELLING (Swelling from shoulder to elbow at the injection site) and VACCINATION SITE RASH (Rash at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
9 days after shot developed a red, extremely itchy, scaly, raised rash at injection site. Warm to touch.
Meningococcal B vaccine given in error. Patient was due for Meningococcal Conjugate.
This spontaneous report was received from a Certified Medical Assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unknown dates, an unspecified number of patients received doses of VAQTA (lot # K005323, expiration date 10-FEB-2017; lot# L021361, expiration date 30-MAR-2017; dose, frequency, indication and route of administration were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt fell to floor; made moaning sounds; fluttered eye lids; twitched hands; feet x1 lasting less than 1 minute; pt stood up on own accord; Vss-neuro exam-neg color pale Vss;
FLUBLOK inadvertently administered to a 12 year old patient with no adverse event; Initial information received on 26-Oct-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves flublok inadvertently administered to a 12 year old patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrivalent recombinant vaccine lot QFAA23206, expiry date: 30-Jun-2024 via unknown route in the left arm for prophylactic vaccination (strength, formulation, route: unknown) was inadvertently administered to a 12 year old patient with no adverse event (product administered to patient of inappropriate age) (latency same day).  Action taken: not applicable.   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.
loss of hearing in my hearing impaired ear; sore arm; tinnitus; slight redness; This is a spontaneous report from a contactable consumer reporting for herself. A 55-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot #EW0153) via an unspecified route of administration in left arm on 15Apr2021 04:15PM for COVID-19 immunization. The patient took first dose of BNT162b2 (Lot number ER8730) on 25Mar2021 03:00PM in left arm. Relevant medical history included previous cancer history and two stem cell transplants. The patient had no known allergies. Concomitant medications included metoprolol, pravastatin, levothyroxine and cetirizine hydrochloride (ZYRTEC). On 16Mar2021 at 09:30PM the patient experienced loss of hearing in her hearing impaired ear, sore arm, tinnitus and slight redness. Clinical course was described as follows. Standard sore arm and slight redness, but the day after the second vaccine sudden onset tinnitus and loss of hearing in my hearing impaired ear. The patient noticed recent increase in tinnitus that may have started after the first vaccine, but this was very sudden after the second vaccine. Much better but tinnitus was ongoing. No treatment was given for the events. The patient had no COVID prior vaccination and was not tested for COVID post vaccination.
Headache Narrative:  Developed headache evening of vaccination, which persisted for another 4-5 days. Has h/o headaches (clarifies that she has not been d/w migraines) and is under the care of a neurologist. Headache mildly increased in intensity and noticeability (usually doesn't notice headache the entire day) than her typical. Took Tylenol with codeine and fioricet as prescribed by her neurologist. Was able to work and headache did not impinge on her daily activities. No atypical symptoms such as vision changes, mentation changes, aura, or amaurosis fugax described. Denies other adverse effects.
Vomiting 4/5/2018. Dehydration 4/5/2018. Irritability 3/25/2018. Diarrhea 4/5/2018. Fever 4/5/2018. Blood In stool 4/5/2018.
vaccine placed in refrigerator more than 30 days; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine placed in refrigerator more than 30 days) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine placed in refrigerator more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (vaccine placed in refrigerator more than 30 days) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. There was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. Date place in refrigerator was 29Sep2021. Patient did not experience temp excursion and any adverse event   No treatment medication was provided by reporter.
Swollen lymph nodes in neck on side of shot; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177), via an unspecified route of administration on 18May2021 at 14:30 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications included valsartan (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21May2021, the patient experienced swollen lymph nodes in neck on side of shot and tiredness. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph nodes in neck on side of shot and tiredness was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Vague symptoms; Cold type symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vague symptoms) and NASOPHARYNGITIS (Cold type symptoms) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vague symptoms) and NASOPHARYNGITIS (Cold type symptoms). At the time of the report, VACCINATION COMPLICATION (Vague symptoms) and NASOPHARYNGITIS (Cold type symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Liver function test increased: other (High) increased liver function tests. On an unknown date, SARS-CoV-2 antibody test: positive (Positive) IgG was positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Severe swollen glands. Started in lymph node near collarbone on the side where I got the injection.; Lymph nodes in neck were painful; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and asthma. The patient did not have any allergies to food, medications, or other products. Concomitant medications included metformin (MANUFACTURER UNKNOWN), dulaglutide (TRULICITY) and dapagliflozin propanediol monohydrate (FARXIGA) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Eng204) via an unspecified route of administration in the right arm on 07Mar2021 at 15:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021 at 16:00, 3 days after the vaccination, the patient experienced severe swollen glands started in the lymph node near the collarbone on the side where she got the injection and lymph nodes in the neck were painful in the next days. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the event severe swollen glands started in the lymph node near the collarbone and lymph nodes in the neck painful were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Developing a UTI; feeling tired and weakened; woozy and queasy; woozy and queasy; feeling tired and weakened; injection site muscular soreness for about a day and half; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Developing a UTI), ASTHENIA (feeling tired and weakened), DIZZINESS (woozy and queasy), VACCINATION SITE PAIN (injection site muscular soreness for about a day and half) and NAUSEA (woozy and queasy) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site muscular soreness for about a day and half). On an unknown date, the patient experienced URINARY TRACT INFECTION (Developing a UTI), ASTHENIA (feeling tired and weakened), DIZZINESS (woozy and queasy), NAUSEA (woozy and queasy) and FATIGUE (feeling tired and weakened). The patient was treated with CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]) ongoing since an unknown date for UTI, at a dose of UNK FOR 7 DAYS and Manual therapy (she used ice to help relieve the sore arm) for Vaccination site pain. On 26-Feb-2021, VACCINATION SITE PAIN (injection site muscular soreness for about a day and half) had resolved. At the time of the report, URINARY TRACT INFECTION (Developing a UTI), ASTHENIA (feeling tired and weakened), DIZZINESS (woozy and queasy), NAUSEA (woozy and queasy) and FATIGUE (feeling tired and weakened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
5 min after admin patient lost consciousness & fell to floor in lobby of the Health Department. Hit head & (L) inner arm. Unconscious 1-2 min - B/P 110/82 pale clammy. Pupils react to light. Alert. Provided with ginger ale. Family member was notified - here to drive patient - advised evaluation by physician today.
temperature excursion for vaccine that were administered to patient after excursion occurred; This spontaneous report was received from a nurse assistant referring to a patient of unknown age and gender. The patient´s pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 19-AUG-2020, after excursion occurred, patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # T002846, expiration date on 23-JAN-2022, for prophylaxis. The temperature was -10.2°C during a time frame of 1 hour and 53 minutes. There was no previous temperature excursions and the call was because of a data logger.        This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA014950: US-009507513-2008USA014951: US-009507513-2008USA014705: US-009507513-2008USA015018: US-009507513-2008USA014901: US-009507513-2008USA014937: US-009507513-2008USA014697: US-009507513-2008USA014767: US-009507513-2009USA000113: US-009507513-2008USA014757: US-009507513-2008USA014825: US-009507513-2008USA014888: US-009507513-2008USA014806: US-009507513-2008USA014798: US-009507513-2009USA000117: US-009507513-2008USA014803: US-009507513-2008USA015035: US-009507513-2008USA014820: US-009507513-2008USA014871: US-009507513-2009USA000112: US-009507513-2008USA014869:
Patient was given Moderna vaccine while an inpatient facility () .  Immunization record came through  clinic, it was Data from outside sources need reconciliation. Moderna vaccine was administered 6/16/21. This patient is not of age to receive the Moderna vaccine.  Pfizer was given as the second dose on 8/17/20.
3cm erythematous reaction L leg. Cold compresses, Advil, Benadryl.
The symptoms started on the morning of Tuesday Feb 16th with fevers and chills, a headache, pain in my joints especially my left hand. I've had extreme fatigued and slept 14 out of 24 hours on Tuesday into Wednesday. I took Wednesday and Thursday off from work. Currently (Thursday Feb 18 5:30pm) I am experiencing swelling in my face and numbness on the right  side. My breathing is fine but my head is foggy and my words are slurred.
Area of arm redness, induration, pain (several cm) in area surrounding inj site.
After client's Phizer immunization he c/o dizziness. Client was asked if he had eaten, he states, "I did not". Nurse offered apple juice and water. After drinking the fluids  he still c/o dizziness. Skin color pallor and was assisted to the floor and feet elevated. Applied ice pack to of neck.  Client taken via w/c to medical tent staff provided more care. Client was placed on cardiac monitor it showed sinus arrhythmia  w/ PACs . Both parents at client's side and agreed to have client sent to local hospital via EMS for further evaluation. Mom did report that client has had dizziness after receiving influenza vaccinations but did not report this at time of registration nor to vaccinator prior to receiving his 1st Phizer dose.
Progress Notes - Clinical MD at 4/15/2021  1:30 PM     HPI:  61 year old female with IBS presents with concerns about adverse reactions to vaccine which she got on 3/19/21.   Patient reports that she felt lightheaded after the vaccine when she was leaving. She got home and felt better but then that night woke up in a delirium which passed by the morning. She had some weakness in her extremities, brain fog, cold feeling, funny GI feeling and fatigue for 3 days and then was fine.   Two weeks ago she started to feel that the circulation in her lower legs was cut off with sensation of blood pooling in her legs with associated numbness and tingling. She describes it as what you feel when a tourniquet is applied to your arm.  No visible lower extremity swelling, redness and no pain.    One week ago she felt like her right hand was not working well and then left hand too. She then felt pooling in her arms like the sensation in her legs.No swelling, redness or pain.   She reports she did a hand stand and afterward felt pooling sensation in her lower abdomen which has since resolved but continues to have a prickling sensation that comes and goes.   Last night while lying on her back she felt the pooling sensation in her chest and this morning throbbing in head and chest and neck. That is when she decided to come in and be seen.    Patient denies severe headache, backache, abdominal pain, shortness of breath, bruises, unusual bleeding or rashes.   Patient has not had a physical exam with blood work since 11/9/17.
Fever 101.4, chills, body ache, head ache, extreme fatigue. All hit 24 hours after vaccination and gone after 48 hours