chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 5 days developed a sore throat and hard cough that would not go away. Went to a ready care clinic and was diagnosed with viral bronchitis. I was placed on a steroid inhaler for 6 weeks.
SLEEPLESSNESS SINCE INJECTION WAS GIVEN. SORE THROAT CONGESTION
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. The pharmacist reported that the patient had an unspecified allergy to neomycin and, on 09-DEC-2015, received a dose of ZOSTAVAX lot # L031271, expiration date: 19-NOV-2016 (dose and route were not provided), which was outside the recommendations per the prescribing information. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
vaccine was accidently administered intramuscularly instead of subcutaneously/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 25-Aug-2021 from an Other health care professional via Medical Information (MI) (Reference number- 00740843) and transmitted to Sanofi on 26-Aug-2021.  This case involves a 54-year-old female patient who accidently administered the YELLOW FEVER VACCINE [YF-VAX] intramuscularly instead of subcutaneously with no reported adverse event (incorrect route of product administration).  The patient's past medical history included Typhoid. The patient's past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. At the time of the event, the patient had ongoing Hepatitis A.   On 25-Aug-2021, the patient received 0.5 ml (total) dose (once) of suspect YELLOW FEVER VACCINE [lot UJ371AB and expiry date 21-Jul-2022] via intramuscular route in left deltoid for prophylactic vaccination.  It was reported, "She accidently administered the vaccine intramuscularly instead of subcutaneously".  It was a case of actual medication error due to inappropriate route of vaccination (latency was on the same day).  At the time of reporting, patient had no adverse event.  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.
felt like theres a hole in stomach; Throat and lips swollen; Throat and lips swollen; Hives bilaterally on body, puffy, outside of elbow, front and back of knees then all over body; Fever of 102.7F; Dermatographia; headache; heartburn; This spontaneous case was reported by a consumer and describes the occurrence of MECHANICAL URTICARIA (Dermatographia), PHARYNGEAL SWELLING (Throat and lips swollen), LIP SWELLING (Throat and lips swollen), URTICARIA (Hives bilaterally on body, puffy, outside of elbow, front and back of knees then all over body) and DYSPEPSIA (heartburn) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 026B21A and 001821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. In 2021, the patient experienced MECHANICAL URTICARIA (Dermatographia), DYSPEPSIA (heartburn) and HEADACHE (headache). On 02-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever of 102.7F). On 11-Dec-2021, the patient experienced URTICARIA (Hives bilaterally on body, puffy, outside of elbow, front and back of knees then all over body). On 13-Dec-2021, the patient experienced PHARYNGEAL SWELLING (Throat and lips swollen) and LIP SWELLING (Throat and lips swollen). On an unknown date, the patient experienced FEELING ABNORMAL (felt like theres a hole in stomach). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MECHANICAL URTICARIA (Dermatographia), PHARYNGEAL SWELLING (Throat and lips swollen), LIP SWELLING (Throat and lips swollen), URTICARIA (Hives bilaterally on body, puffy, outside of elbow, front and back of knees then all over body), DYSPEPSIA (heartburn), FEELING ABNORMAL (felt like theres a hole in stomach), HEADACHE (headache) and PYREXIA (Fever of 102.7F) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, Body temperature: 102.7 (High) Fever of 102.7 F.         No concomitant drug details were reported.  Patient stated that the symptoms were ongoing but controlled by medications.   This case was linked to MOD-2021-437080 (Patient Link).
Pulmonary endarterectomy; Flu like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4421646-00.  A 62-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY ENDARTERECTOMY (medically significant) with onset Feb2021, outcome "unknown"; INFLUENZA LIKE ILLNESS (medically significant) with onset 2021, outcome "unknown", described as "Flu like symptoms". The action taken for adalimumab was unknown.  The reporter considered "flu like symptoms" related to BNT162b2. The reporter's assessment of the causal relationship of "pulmonary endarterectomy" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter causality for the co suspect HUMIRA (ADALIMUMAB) for events Pulmonary thromboendarterectomy and flu like symptoms was not provided. Agency opinion is that there is no reasonable possibility that the event of Pulmonary thromboendarterectomy and flu like symptoms are related to  HUMIRA (ADALIMUMAB).  Clinical course: In Feb2021, the patient had Pulmonary thromboendarterectomy. He had covid vaccine issue which showed flu like symptoms. It was unknown if he was enrolled in a covid 19 vaccine trial.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events, influenza like illness and pulmonary endarterectomy cannot be totally excluded.
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018; dose and route unknown) for prophylaxis, which was exposed to temperature excursion of 33.2 degrees Fahrenheit (F) for 12 hours and 43 minutes and 54.3 F for 1 hour and 23 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effect had been reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004370: US-009507513-1612USA004371.
Severe headache/pale/diaphoretic weak but oriented. Oxygen give, after 15 min. color returned. Ambulate well.
fatigue, muscle pain, fever, fast heart beats taking pain-killer at 7:00pm and fever is gone at around 10:00pm still fatigue with some level of muscle pain
were allergic do it; Initial information was received on 12-Dec-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient) via social media.  This case involves a patient (age and gender unspecified) who were allergic do it (allergy to vaccine), while patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, family history and concomitant medication/therapy were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number, expiry date and other dosing details not reported] for prophylactic vaccination.  The patient developed allergic to do it (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for reported events.  There will be no information available on the batch number for this case.
Left thigh with 3 areas of raised pink sersiginous raiser border and flat center and left buttock with larger 2 inch confluent raised pink module; smaller raised pink papule her right shoulder and thigh. Started on BENADRYL 12.5mg/5ml syrup 5ml, 100q 6hrs for 2 days, follow up PRN. 9-11-09 per phone call pt much better.
I had a running nose, nasal congestion, cough, and sinus congestion. I tested positive for COVID-19 at home. I talked to my doctor through e-visit, and he prescribed me Paxlovid. I started to feel better after 2 or 3 days later.
Patient with localized allergic type reaction at injection site. Redness approx 5cm in diameter. Has improved with MOTRIN and cool compresses.
TINGLING FEELING ON RIGHT SIDE OF THE BODY; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced tingling feeling on right side of the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling feeling on right side of the body. This report was non-serious.
PATIENT MENTIONED THAT THE DAY AFTER THE SHOT HE GOT RASH ON HIS BACK AND ON THE OPPOSITE SHOULDER OF WHER HE GOT THE INJECTION.
haven't received the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter enquired should they start all over or just give her the second shot. The reporter consented to follow up. No further details provided on web form. This case had been linked with US2021213497, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021213497:same reporter
rash on the face; headache; Fever; couldn't move the arm at all; face swelling; body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), RASH (rash on the face) and HEADACHE (headache) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not available) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lupus erythematosus.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), HEADACHE (headache) and PYREXIA (Fever). On 04-Mar-2021, the patient experienced RASH (rash on the face). At the time of the report, MOBILITY DECREASED (couldn't move the arm at all), SWELLING FACE (face swelling), PAIN (body aches), HEADACHE (headache) and PYREXIA (Fever) outcome was unknown and RASH (rash on the face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
No additional ae; VARIVAX was administered following temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 03-MAY-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX), lot #W031815, expiration date: 05-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  The vaccine was stored in a temperature of 9 degree Fahrenheit (°F) for 2 hours and 6 minutes. There was no previous temperature excursion reported.
Tender; Sore/Arm was sore from elbow to shoulder; Very itchy; Rash; From elbow to wrist was tingly; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (Tender), INJECTION SITE PAIN (Sore/Arm was sore from elbow to shoulder), PRURITUS (Very itchy), RASH (Rash) and PARAESTHESIA (From elbow to wrist was tingly) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, PRAVASTATIN and ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced TENDERNESS (Tender), INJECTION SITE PAIN (Sore/Arm was sore from elbow to shoulder), PRURITUS (Very itchy), RASH (Rash) and PARAESTHESIA (From elbow to wrist was tingly). At the time of the report, TENDERNESS (Tender), INJECTION SITE PAIN (Sore/Arm was sore from elbow to shoulder), PRURITUS (Very itchy), RASH (Rash) and PARAESTHESIA (From elbow to wrist was tingly) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   Treatment includes Benadryl gel.
no additional adverse event; the patient was inadvertently administered a dose of Rotateq on 4/21/2020 that has been improperly stored; This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 21-APR-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot #1660947, expiration date 16-FEB-2021 for prophylaxis (exact dose, dose # and route of administration were not provided). The temperature excursion was 47.7 degrees Fahrenheit (F) for 12 minutes. The previous excursion was 58.3 F for 14 hours. The digital data logger was involved. No adverse effect was reported.
Five days later. March 2, I had a bout of diahrrea for about 90 minutes I also have the expected ones: Headache, some temperature, tireness. Today, March 15,, I had the same problem also about 90 minutes.
he can undergo a dental procedure for toothache before the second dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as a first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that caller wants to know if he can undergo a dental procedure for toothache before the second dose. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient has had a history of anxiety during vaccines in the past, and typically breaks out in hives. Because of this history with vaccines, it was determined by on-call nurses that patient should be given vaccine in private and held for 30 minutes with EMT assessment. After receiving vaccine, patient showed no symptoms of anxiety or hives, and was alert and oriented throughout entire encounter. Patient was calm and conversing with EMT during and after vaccine administration.
patient was given the Pfizer 5-11yo vaccine that was not diluted. the dosage of the vaccine given was equivalent to an adult Pfizer dose.
Laid out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Laid out) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced MALAISE (Laid out). At the time of the report, MALAISE (Laid out) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-072598 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-072598:
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Medium, Systemic: Headache-Severe, Systemic: Other- Itching-Severe
HPI: Patient presents with itchy rash, which is interrupting her sleep, on wrists and ventral forearms x 1 week. She has hx of eczema (specifically hand eczema). Has been rx'd triamcinolone 0.1% cream in past for this and has been using this regularly to right palm, which is not helping much. Had 2nd dose of COVID vaccine 2 weeks before onset of rash and thinks it may be r/t this. Also using hand cream regularly and tries to avoid hand sanitizer.
VERY SICK; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced very sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.
gestational high blood pressure; Live birth; Boostrix vaccine on 12/30/2019 at 33 weeks gestational age; This is a retrospective pregnancy case. This 31-year-old female subject was enrolled in an open label study titled.. The subject received Boostrix on 30th December 2019, for prophylaxis. The subject received Boostrix at week 33 of the pregnancy.   On 30th December 2019, unknown after receiving Boostrix, the subject developed vaccine exposure during pregnancy (Non-serious). Additional event(s) included gestational hypertension in January 2020 with serious criteria of hospitalization and live birth on 1st March 2020. The outcome of vaccine exposure during pregnancy was unknown. The outcome(s) of the additional event(s) included gestational hypertension (recovered/resolved) and live birth (unknown). The pregnancy resulted in a live neonate with no apparent congenital anomaly. On 1st March 2020 after [weeks gestation], the subject gave birth to a [male] neonate via vaginal delivery. The neonate weighed 3175 grams (7lbs) at birth.   It was unknown if the investigator considered the gestational hypertension to be related to Boostrix. Diagnostic results (unless otherwise stated, normal values were not provided):  In January 2020, Blood pressure measurement result was 130/81 mmHg.                                                                                                     See case US2020AMR173287 for details regarding the baby case.  Additional information was provided as follows: Two weeks after receiving the vaccine, the patient developed gestational high blood pressure. Her first high blood pressure reading was 130/81 but caller did not have the other blood pressure readings. At 37 weeks she was sent to the hospital for an induction due to continued high blood pressure. The patient had a normal delivery of a baby boy born on March 1, 2020 with a birth weight of 7lbs 3 oz. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR173287:same reporter
Swollen and bruised arm at injection site, fever (100.8), chills, nausea, headache, tired.
oozing from the injection site; This spontaneous report was received from a medical assistant and refers to a 67-year-old, non-pregnant female patient. No information regarding her pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscularly (exact dose, injection site, lot # and expiration date were not provided) for routine vaccination.  On 24-AUG-2020, she experienced oozing from the injection site. No treatment was given for the event. On the same date, the patient recovered (reported as no issue).  The relatedness between the event and the suspect vaccine was not provided.