chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a other healthcare professional. This case is linked to case 2018SA320066 (same reporter). This case involves a 14 years old female patient who was vaccinated with 0.5 ml once dose of FLUBLOK (Batch number: QFAA1804 and expiration date: 01-Jun-2019) instead of FLUZONE QUADRIVALENT, on 17-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was unknown if any adverse event occurred following the vaccination.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. Documents held by sender: none.
pt awoke 4AM w/very sore arm, nausea, T101 (orally);states can't even lift arm;site described as sl red, sl swelling;
tingling; Numbness on right back shoulder, also started from hip down to toes; feels like ant crawling down my body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (tingling), HYPOAESTHESIA (Numbness on right back shoulder, also started from hip down to toes) and FORMICATION (feels like ant crawling down my body) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PARAESTHESIA (tingling), HYPOAESTHESIA (Numbness on right back shoulder, also started from hip down to toes) and FORMICATION (feels like ant crawling down my body). At the time of the report, PARAESTHESIA (tingling), HYPOAESTHESIA (Numbness on right back shoulder, also started from hip down to toes) and FORMICATION (feels like ant crawling down my body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was provided. No treatment was provided.
generalized aching, t102.8, rash behind knees & in armpits; sx lasted 48 hrs & then fully recovered;
1 1/2 cm redness at site, swelling. vomiting, Flushed but not febrile
soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 50-year-old male patient 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 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
The day after the vaccination, there was pain on my left side (my vaccine shot was in my right arm).  By Saturday 3/27/21 (day 4), a localized rash appeared on my left side (midriff area) which looked like herpes blisters.  The area was sensitive to touch and painful.  The pain had spread to my left back area.  Started 1000 mg Valacyclovir 3 times a day on 3/30/21, after I saw the doctor and she confirmed it was probably shingles.   The rash and sensitivity/pain are still present today, 4/2/21, on day 10 after the vaccine.
Admitted to ED with complaints of chest pain x 2-3 days.  Admitted for evaluation and subsequently found to have SARS-CoV-2 Antigen +, followed by PCR positive.
abdominal cramping; throat started hurting and started tightening; throat started hurting and started tightening; This is a spontaneous report from a contactable consumer(patient). A 13-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number not provided), via an unspecified route of administration on 20May2021(at the age of 13-years-old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.it was reported that Complainant hung up abruptly/transfer incomplete. Reporter stated that I am just reporting a reaction my daughter had to the shot. It was the Pfizer Covid vaccine. On 20May2021, she had abdominal cramping and then her throat started hurting and started tightening. Her weight is approximately 135 pounds and she's probably 5'5. Product details and pharmacy details could not be probed as the caller hung up abruptly. Call back was done to gather further information however it was unsuccessful. Hence limited information available over the call. The outcome of the events was unknown.  Information about lot/batch number has been requested.
PATIENT STATES THAT HER SHOULDER BLADE BEGAN TO HURT ABOUT 3 DAYS AFTER RECIEVING THE VACCINE. SHE REPORTS GOING TO A CHIROPRATOR AND TAKING OTC MEDICATION FOR PAIN. HER CHIROPRACTOR ADVISED HER TO SEE ORTHO. SHE STATES THAT ORTHO DIAGNOSED HER WITH BURSITIS WHICH HE FELT WAS REALATED TO GETTING THE COVID VACCINE.
little red part on her gums; Cough; This spontaneous case was reported by a patient and describes the occurrence of GINGIVAL DISORDER (little red part on her gums) and COUGH (Cough) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A, 00A21A and 005M21A) for COVID-19 prophylaxis.     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 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced GINGIVAL DISORDER (little red part on her gums) and COUGH (Cough). On 09-Feb-2021, GINGIVAL DISORDER (little red part on her gums) and COUGH (Cough) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Chest X-ray: diagnosed her with IOD (she thinks). In 2023, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered GINGIVAL DISORDER (little red part on her gums) to be related. No further causality assessment was provided for COUGH (Cough).    No relevant concomitant medications were reported.  She had not had any trouble. When she went to the doctor in September he told her it was early to get SPIKEVAX, flu shot or RSV vaccines. She recently went to urgent care and got tested for COVID-19 and was negative. They did a chest X-ray and diagnosed her with IOD (she thinks). She wont be able to get with a lung doctor for a while. Her doctor told her not to get the vaccine until her cough was better. Patient administered fourth vaccine of Moderna bivalent on 01 OCT 2022 with lot no. 055F22B. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747785 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747785:Bivalent Dose
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient had no relevant medical history. The patient's other relavant history information reported was no known allergies and no concomitant drugs taken.    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 03-Nov-2021, the patient experienced PYREXIA (Fever). On 03-Nov-2021, PYREXIA (Fever) had resolved.            Concomitant Drugs were not reported, as patient had no concomitant drugs taken.  No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
the third dose of Menactra was given in error, no adverse effects; 17 year old male had Menactra doses on 15Feb2016, 15Oct2018, and 26Dec2018, no adverse effects; patient had to recieve Gardasil HPV got Menactra instead, no adverse effects; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 17 years old male patient who received vaccines three doses of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 15-Feb-2016, 15-Oct-2018 and 26-Dec-2018 respectively.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose administered, inappropriate schedule of vaccine administered and wrong vaccine administered. The patient supposed to recieve GARDASIL HPV but got MENACTRA instead, (lot number and Exp. Date 26-AUG-2019) lot U5986AA via intramuscular route in the right deltoid, on 26-Dec-2018.  The patient did not had any signs of any adverse effect.  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.  Information on the batch number was requested for second and third dose of MENACTRA.  Documents held by sender: none.
headaches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and FATIGUE (fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches) and FATIGUE (fatigue). At the time of the report, HEADACHE (headaches) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up was received on 03-may-2021 contains an updated event
BRUISING OF ARM; CHILLS; HEADACHE; DIZZY; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The patient number not reported and has been requested. No concomitant medications were reported. On 21-MAY-2021, the subject experienced dizzy. On 21-MAY-2021, the subject experienced chills. On 21-MAY-2021, the subject experienced headache. On 22-MAY-2021, the subject experienced bruising of arm. The action taken with covid-19 vaccine was not applicable. The outcome of the headache, dizzy, chills and bruising of arm was not reported. This report was non-serious.
Pt reports itching and burning, describes it as a "jaggy" feeling, red rash on upper arm where vaccine was given.
Bleeding guns, swollen and painful axillary and cervical lymph nodes, body pain, sensitivity to fabric
I awakened the morning after the vaccine with blurry vision , flashing and a black spot with peppery background in my field of vision in my left eye.
New patient to Dr., stated never had pneumovax. Administered 10/9, patient called asking how long will be sick, arm red, swollen, feverish. Instruced to get ice pack on ASAP take Benadryl. Called later in afternoon, symptoms worse. Instructed to have someone take to WIC. 10/10 follow up phone call next morning, patient doing better.
Large area redness at site of shot 2x2 inches red, warm tender resolved in 72 hours.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2021 as dose 1, single (Lot number: Ex2405019), in left arm and on 05Jul2021 as dose 2, single (Lot number: Fe3064001) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Dec2021 as dose 3 (booster), single (Lot number: 041j21a), in left arm and on 07May2022 as dose 4 (booster), single (Lot number: 001MZ1a), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer maintenance Tamoxifen" (unspecified if ongoing), notes: Breast cancer maintenance Tamoxifen. Concomitant medication(s) included: TAMOXIFEN, start date: 31May2019; WEGOVY, start date: 01Mar2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 25Jul2022 to 29Jul2022.  No follow-up attempts are possible. No further information is expected.
Felt pain left shoulder after flu vaccine injected left deltoid.  Pain on-going from shoulder to neck to back; now also decreased mobility.  Saw MD 11/12/2003 and called MD 11/19/2003.  Pain felt immediately upon receiving vaccine.
Case number PHEH2016US024439, is an initial spontaneous report received from a pharmacist on 20 Sep 2016. This report refers to a 39 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: not reported) at a dose of 0.5 ml intramuscularly on 08 Sep 2016. On the same day after vaccination, the patient experienced arm discomfort. The patient also experienced stiffness of the arm and shooing pain for 2 weeks from an unknown date. The outcome of the event arm discomfort was reported as unknown and for the events stiffness of arm and shooting pain was not reported. The seriousness of the event arm discomfort was reported as non serious and for the events stiffness of arm and shooting pain was not reported. The causality of the events was not reported.
pt reported on 10DEC96 that on 26OCT96 about 8PM started getting blisters on inside of bottom lip;they were hot, red & itchy lasted about 1wk;cold air bothered them;used med on them which helped;did not seek med attention;pt ? if r/t vax;
Headache, nausea for next three days after vaccination. Treated with acetaminophen and cold compresses
Nausea/vomiting and chills 2 days after. Redness and swelling, warmth to the touch 4 days after injection
47 y/o female patient presents with cramping and paresthesia in her left upper extremity, immediately after vaccination.
I started have different period cycle. I been having severe pain, clotty and bleeding is much slower but more heavier. On Dec. 27th, I started having flu like symptoms. I had body ache, sore throat, chest congestive, and fatigue. I tested positive on Dec. 28th for Covid-19.
Flu like symptoms beginning about 8 hours after injection & lasting  about 36 hours. Also unable to lift arm used for injection which lasted about 16 hours.
tingling of tongue and feet, high spike in blood pressure (208/127), red flushed face and neck, dizziness and light headedness, increase in heart rate.
very very fatigued from losing all this fluid; Vomiting/ throwing up; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very very fatigued from losing all this fluid) and VOMITING (Vomiting/ throwing up) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VOMITING (Vomiting/ throwing up). On an unknown date, the patient experienced FATIGUE (very very fatigued from losing all this fluid). At the time of the report, FATIGUE (very very fatigued from losing all this fluid) and VOMITING (Vomiting/ throwing up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.
Difficulty to breath, pain in the lungs,  patient was rushed to the hospital and after addition, patient goes to cardiac arrest.
Patient and 2 other new hires in her group received the Tdap (Adacel-lot #UI543AA) and each deltoid of these persons were red/pink and raised, also warmer than surrounding skin.
Patient received expired vaccine. Pfizer recommend revaccination. Patient was contacted to schedule an appointment. Patient will contact us at a later time.
This spontaneous report as received from a pharmacist refers to a 62 years old female patient with diabetes, hypercholesterolemia, hypertension and anxiety. The patient was vaccinated with ZOSTAVAX (lot number 671780/0170AE; expired date as reported 06-MAR-2013 (0.65 ml, once, subcutaneously, left arm) on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-OCT-2012 the patient had been experiencing a headache since she received ZOSTAVAX. At the time of this report, the patient was still experiencing a headache, and she has not reported her experience to her physician. The reporter stated that the patient was "nervous about receiving ZOSTAVAX." Treatment TYLENOL was given for the adverse event. The patient was not recovered at the time of report. No laboratory diagnostics study performed. The patient had consulted pharmacist for medical attention. Additional information is not expected.
Incident details: Per Dr. email sent out on 9/1/22-"the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand." The patient was seen in office on 9/1/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (pfizer) in error as patients are now only supposed to receive the bivalent booster per Dr. email. Pt was due for booster at the time they received it, however the bivlalent booster was not yet stocked . Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation  of monovalent covid boosters receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also monovalent and bivalent are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS. Recommendation: I would recommend holding a meeting to notify Leads/Supervisors/Managers of any changes regarding COVID vaccine administration, rather than sending out an email that may not be read by all staff. If an email is needed to be sent, I recommend making it clear that a process is being changed.
On 6/5/06 parents noticed a blister type lesion on pts left shin close to the ankle. She saw Dr on 6/12/06. Dr diagnosed her with one focal area blister (Vesicle) and TX her with Benadryl cream. Mom said it never botherd her as in itching or hurting. It took 3-4 weeks to resolve and has left a small discoloration of the skin where the lesion was.
waited 20 minutes following immunization on way home child told mom he did not feel well child was bright red. fever 101-103 degrees F, during night decreased with Tylenol, but when 2-3 hours are up, fever increased again. child c/o no appetite.
brain fog; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jan2021 16:00 (Lot number: EN5318) at the age of 68 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (ongoing), notes: Got Pneumonia back in the 1980s, around 1983; and after that he had asthma. asthma is mild; "Pneumonia", start date: 1983 (unspecified if ongoing), notes: Got Pneumonia back in the 1980s, around 1983; and after that he had asthma.; "Concussions" (unspecified if ongoing), notes: States he has had three. The most severe was three years ago. States he was knocked completely unconscious and was unconscious for a while. The patient took concomitant medications.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovering", described as "brain fog"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "tired".  Additional Information: States he has had three. The most severe was three years ago. States he was knocked completely unconscious and was unconscious for a while. Caller states that he got his second dose of the vaccine at the end of February. Says after his first dose he had brain fog and other symptoms that dissipated rapidly. States his brain fog is persisting; it is better, but still there. He wanted to call because he has had three concussions in his life. The last one was three years ago and it was the most severe as he was knocked unconscious. States he was unconscious for a while. He states he is wondering whether Pfizer has any data or information regarding how the vaccine is tolerated in people with similar types of brain injuries. States with the millions of people getting the vaccine he thinks his question may be like looking for a needle in a haystack. Asks how long he will be on hold as he has already been on the phone for a while.  No follow-up attempts are possible. No further information is expected.