chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MARGINAL CORD INSERTION; MATERNAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a 32 year old female. The patient's weight was 63.49 kilograms, and height was not reported. The patient's past medical history included: miscarriage, and other pre-existing medical conditions included: The patient was pregnant at the time of vaccination. The patient had no history of tobacco, alcohol, or recreational drug use. Type of pregnancy was reported as singleton. The gestational age was four weeks and six days. The date of the patient's last menstrual period was 02-MAR-2021 and expected delivery date was 07-DEC-2021. The pregnancy was continuing. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose was not reported, administered on 05-APR-2021 for prevention of COVID-19. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included minerals nos/vitamins nos.  On unknown date during 2021, the patient had blood tests, such as cell-free DNA screening, alfa fetoprotein, or the quad screen and a nuchal translucency screen test. None of the tests showed any problem or concern.  On 05-APR-2021, the patient experienced maternal exposure during pregnancy. On 20-JUL-2021, the patient experienced marginal cord insertion. Laboratory data included: Diagnostic ultrasound (NR: not provided) which showed marginal cord insertion.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the maternal exposure during pregnancy and marginal cord insertion was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and marginal cord insertion as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy. Company causality between covid-19 vaccine ad26.cov2.s, and maternal exposure during pregnancy and marginal cord insertion was not related.  This report was serious (Other Medically Important Condition).  Additional information was received from patient on 06-Oct-2021. The following information was updated and incorporated into the case narrative: Event (marginal cord insertion added), lab (prenatal ultrasound added) and narrative.; Sender's Comments: V1: 20210763185-covid-19 vaccine ad26.cov2.s-Marginal cord insertion. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY .   20210763185-covid-19 vaccine ad26.cov2.s- Maternal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
inadvertently received a dose of quadracel, with no reported adverse event; 9 year old female patient inadvertently received a dose of QUADRACEL with no adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 9 years old female patient who advertently received a dose of quadracel, with no reported adverse event(Product administered to patient of inappropriate age, Accidental exposure to product) while receiving vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine (VARICELLA VACCINE) for Prophylactic vaccination.  On 03-Aug-2022, the patient received suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE at dose of 0.5 ml total (lot U7526AA, expiry date: 07-Sep-2024) via intramuscular route in the right deltoid for immunisation.  On 03-Aug-2022 the patient developed a non-serious 9 year old female patient inadvertently received a dose of quadracel with no adverse event (product administered to patient of inappropriate age), (accidental exposure to product) same day latency following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 22-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because facility was unable to download, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. They were filling out a temperature excursion assessment at that time. It was reported that no adverse reactions were reported by any patients. No treatment medications were reported.
Approximately 18 hours after the vaccine was administered, I started to feel cold and had chills. Also felt extremely fatigued.
Pt c/o fever and chills. Was given Advil. Next AM woke up with HA, arm was sore and swollen "she couldnt even put a shirt on." Was given Aleve twice that day. 8pm, took pt to urgent care and was told that was allergic reaction to vaccine.  Strep test was negative.
This case was reported by a healthcare professional and described the occurrence of incorrect storage of drug in a subject of unspecified age and gender who was vaccinated with (Flulaval, GlaxoSmithKline) for prophylaxis. The healthcare professional reported that multiple subjects (number unknown) were given Flulaval that was improperly stored, however, a specific number of subjects was not reported. The subject received no other immunizations on the date of receipt of Flulaval. In October 2007 the subject received unspecified dose of Flulaval (unknown) that had been stored incorrectly. The healthcare professional reported that according to the temperature log, on three separate occasions from 21 October 2007 to 24 October 2007, the temperature in the vaccine refrigerator got down to 33 degrees Fahrenheit. The healthcare professional considered the event was clinically significant (or requiring intervention) and could be jeoparding to the subjects. No clinical events were reported.
2 hrs post immun had high temp; episode of apnea & sz; Taken to ER temp @ hosp 103;
Complaints of high fever 102-102.3 with swelling to left arm arm hot to touch and painful.
I contracted COVID-19 4/20/22 with symptoms of cough, chest pain/tightness which was very short lived, chills, fatigue, sore throat, congestion, slight diarrhea, myalgia, and felt feverish. I was prescribed molnupiravir 4/21/22 and my symptoms resolved after the 5th day with only a lingering cough, which has resolved.
Bad cough; Chest still hurts; Heart beating fast and kind of hurt; Only got a couple hours of sleep; Heart beating fast and kind of hurt; Stuffy; Low temp; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 30-year-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Aug2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced heart beating fast and kind of hurt leading to angina pectoris, stuffy leading to nasal congestion, low temp leading to body temperature decreased, bad cough, chest still hurts leading to chest pain, heart beating fast and kind of hurt leading to heart rate increased and she only got a couple hours of sleep leading to insomnia on Aug2021. The patient underwent lab tests and procedures which included body temperature at 97.5 Fahrenheit, she is usually 97.5 but running 99.5 , sars-cov-2 test: negative on 26Aug2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Chest pain; This spontaneous case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) 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 reported. No treatment information was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Dec2020 as dose 1, single (Lot number: ej1686) and on 15Jan2021 as dose 2, single (Lot number: el3248) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Dec2021 as dose 3 (booster), single (Lot number: 030h21b) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown result; (30Jun2022) positive, notes: covid rebound. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not receive any other medications within 2 weeks of vaccination. The patient has no reported allergies. Reportedly rebound COVID. Felt fine on day 5 of Paxlovid (Day 6 of illness). Mild symptoms started day 10, more severe day 11.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
IT'S BEEN THIRTEEN DAYS SINCE MY SECOND VACCINE SHOT AND MY LEFT ARM IS STILL SORE AT THE INJECTION SITE AND SURROUNDING MUSCLES.
pt recv vax & w/in 30 to 60min devel a low grade fever & large swelling @ the inj site;pt recovered w/in 24hr w/o treatment;
Severe pain at site of injection, entire arm affected, fingers feel numb & tingling, breast painful, pain in neck & back.
Fatigue; Headache; Muscle Pain; Joint Pain; Nausea; Fever; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Was forced to stay in bed for 6 weeks with "all of the typical symptoms".).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (Vomiting). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain), NAUSEA (Nausea), PYREXIA (Fever) and VOMITING (Vomiting) had resolved.            Patient stated that he was "down for two days" and no side effects were present at that time.   This case was linked to MOD-2021-074454 (Patient Link).   Reporter did not allow further contact
headache; short pain and sharp pain in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (short pain and sharp pain in her arm) and HEADACHE (headache) 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 25-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (short pain and sharp pain in her arm). On 26-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (short pain and sharp pain in her arm) and HEADACHE (headache) had not resolved.            Concomitant medications were not provided. Treatment information was not reported.   Reporter did not allow further contact.
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 49 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Appendicitis; This is a spontaneous report from a contactable consumer (patient).   A 39-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 20Jun2021 (Batch/Lot number was not reported) as single dose (at the age of 39) for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient received the first dose on 30May2021 (at the age of 39), lot# unknown. Medical history was none. No known allergies. There were no concomitant medications.The patient experienced appendicitis on 12Jul2021. The patient was hospitalized for appendicitis for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 05Sep2021 Nasal Swab, sars-cov-2 test: negative on 24Sep2021 Nasal Swab. Appendix removed with surgery. The outcome was recovered in 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Initial report was received from a health care professional on 17 April 2012, which also involved a case of misuse (wrong route of administration). This reporter also reported another adverse event which was captured in case number 2012-04057. A 57-year-old female patient had received an intramuscular injection in the left deltoid of ADACEL, sanofi pasteur Ltd., lot number C4051AA, and an intramuscular injection in the left deltoid of TUBERSOL, sanofi pasteur Ltd., lot number C3763AA, on 14 April 2012. Within 24 hours, the patient complained of left upper arm redness and pain at the injection site. The patient also complained of tenderness in left axillary area with a large palpable nodule. The patient was diagnosed with cellulitis secondary to injection site. The patient denied any illness at the time of vaccination, any other vaccinations within four weeks of ADACEL and TUBERSOL and past medical history. The patient had no known allergies (NKA). The patient's outcome was recovered. Documents held by sender: None.
I just started bleeding after week one in March and it lasted 3 weeks. The same thing happened in April and then May I bleed the entire month all except one day. I had an appointment in May, but I couldn't go because of the cost. I went to the emergency room because I was having shortness of breath, chest pain and the bleeding made my blood count very low. The emergency doctor was saying the blood count was so low and referred me back to the OB doctor. I called my OB doctor, but he told me I needed to get surgery for birth control or ablation or a hysterectomy alt. to eliminate the amount of bleeding. I told the doctor that I really didn't want to go through surgery again since I just got a kidney transplant 3 years ago. I have started to eat foods that increase my platelets (B12 collagens, vitamin C).
Severe swelling and redness in injection site for 3 days. Swelling was painful and was the size of entire upper arm. Was advised to give antihistamine and cold compress to reduce swelling for 3 days or until swelling/redness went down.
Awoke with migraine symptoms.  I also experienced a migraine several hours after my 2nd Moderna vaccine in February.  While I have a history of migraines, I never awaken in the morning with a migraine and the occurrence of migraine after the 2nd vaccine and this booster is highly suggestive of a reportable adverse reaction.  The symptoms resolved and since it is a Sunday, my PCP is not available and I did not think it was necessary to go to the emergency room and risk COVID exposure with the current COVID rates rising and many hospitals at or near capacity.
lazy; exteremely hot; tired; This spontaneous case was reported by a consumer and describes the occurrence of LAZINESS (lazy), FEELING HOT (exteremely hot) and FATIGUE (tired) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006LZ1A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL for Hypertension, MELOXICAM for an unknown indication.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced LAZINESS (lazy), FEELING HOT (exteremely hot) and FATIGUE (tired). At the time of the report, LAZINESS (lazy), FEELING HOT (exteremely hot) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was unknown   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Significant follow up
still got a variant of the flu; Initial information received on 03-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age female patient who still got a variant of the flu while receiving vaccine INFLUENZA VACCINE  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (form, strength, dose, frequency, site, route: unknown, with an unknown batch number and expiry date: unknown) for prophylactic vaccination (Immunisation)  On an unknown date the patient  still got a variant of the flu(influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Reportedly "My daughter got hers but still got a variant of the flu"  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
I had a low grade fever, tightness in my chest, very stuffy and clogged head, and very congested. I had a dry cough, the first few nights I had sleeplessness. I was told by nurse to use my nebulizer 2 times a day. At end of virus was when my asthma acted up.
Client was seated in observation area and fell to floor, hitting face on floor. Client immediately jumped up with a disoriented expression to her face. Client was assisted to triage area by staff and assessed per this nurse. No visible injuries, bruising or discoloration noted. Client denied any pain or discomfort.  BP 128/74, HR 88. Client had a strong marijuana odor but denied any use prior to receiving vaccine. EMT was called and came and assessed patient. She was alert and oriented to self, place and time. Client had friend with her and was able to ambulate out of facility.
Pt appeared to have seizure while sitting down & fell face forward on floor. Laceration on forehead. Ambulance was called & arrived within 10 min. Pt transported to hospital Only health hx is Penicillin Allergy
w/in hrs of vax same day pt became very cranky & pt had noc screams for the 1st wk p/shot & has not slept all noc ever since; pt was sleeping all noc a/vax;
He is sleeping a lot of side effect, I mean all day; This is a spontaneous report from a contactable consumer (patient's wife). A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: AJ1685), via an unspecified route of administration on 17Dec2020 at single dose for covid-19 immunization.  Medical history was none. There were no concomitant medications.  The patient got his first shot on 17Dec2020 and he was sleeping a lot of side effect, all day. No treatment received and he just slept all day. Due date of next short was 08Jan2021 to 10Jan2021. The outcome of the event was unknown.
Fever 100, generalized aching, bilateral swelling posture cervical ncxecr el - cheelic el - complain of sore throat, malaise.