chrisvoncsefalvay/vaers-outcomes huggingface dataset:
took Claritin, 2 or 3 tablets 200mg each of Motrin, and Lisinopril 20mg or 40mg prior to getting the vaccine; sore arm; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for a female patient of an unspecified age received bnt162b2 (Pfizer-BiNTech Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: EW0178), dose 1 via an unspecified route of administration on 19May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included loratadine (CLARITINE); ibuprofen (MOTRIN [IBUPROFEN]) and lisinopril for an unspecified indication. The patient experienced sore arm in May2021, took claritin, 2 or 3 tablets 200mg each of motrin, and lisinopril 20mg or 40mg prior to getting the vaccine on 19May2021. Patient stated that "Prior to taking the vaccine I had taken 5mg of Claritin, 2 tablets of 200mg each of Motrin, Lisinopril 20mg and my son took 1 Claritin 5mg and I would like to know if that is ok, will cause efficacy issues with the vaccine? I haven't taken any afterwards, even with the sore arm". Description of complaint: Caller took medication the same day as getting the COVID 19 vaccine on 19May2021. Caller stated that she had taken one 5mg tablet of Claritin, probably 2 but maybe 3 tablets 200mg each of Motrin, and Lisinopril 20mg prior to taking the vaccine that day. Caller stated she wants to make sure the medication did not impact the effectiveness of their vaccines? Caller stated she received the first dose on 19May2021, the lot number is EW0178 and unknown NDC number and expiry date.  Communication: Full details not obtained as caller declined to proceed with report at this time. Outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
COVID 19 VACCINE GIVEN 6 HOURS AND 23 MINUTES AFTER THE FIRST PUNCTURE OF THE VIAL; This spontaneous report received from a health care professional concerned a male of unspecified age. 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: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 22-SEP-2021 15:13 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced covid 19 vaccine given 6 hours and 23 minutes after the first puncture of the vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid 19 vaccine given 6 hours and 23 minutes after the first puncture of the vial was not reported. This report was non-serious.
PATIENT EXPERIENCE TINGLIN IN LEFT HAND 5 MINUTES AFTER VACCINATION AND TINGLINE IN RIGHT HAND 10 MINUTES AFTER VACCINATION. ONSITE EMS WAS REQUESTED. VITALS TAKEN 117/71 HR 86 AND O2 97% ON ROOM AIR. BLOOD GLUCOSE WAS 115. PATIENT BEGAN FEELING LIGHT HEADED. SHE HAD AN APPOINTMENT WITH  PRIMARY CARE PHYSICIAN YESTERDAY AND WAS GIVEN THE OK TO RECEIVE THE VACCINE. SHE ALSO START SHE HAS NOT HAD ANY VACCINE IN A LONG TIME. EMS TRANSPORTED HER TO E.R
This spontaneous report was received from the patient's mother, as part of a marketing research program and referred to two patients with unknown age and gender, who were currently 34 years old. The patient's concurrent conditions, medical history and allergies, as well as, concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (strength, dosage schedule, route, lot number and expiration date were not reported). On unknown dates, the patients had issues after the HPV vaccination. The outcome of adverse event was unknown. Additional information is not expected because the reporter refused to be contacted.
patient called the pharmacy manager complain about extremely nausea, joints pain, diarrhea, headache , pain and low rate fever 100.9 F.
COVID rash covering left arm. Severe itching. Started several hours after receiving vaccine and lasted several days
Pt started fussing about 2 hrs p/recvd vax; parents gave small dose of APAP; t100 r p/2-3 hrs of fussing, pt could not be comforted; phoned MD, said inc APAP; pt had restless night but was much better the next day & seemed OK 2 days later;
Years ago after accident had pinch nerve on back of neck and arthritis on neck. Next day after vax had facial pain and pressure headaches. Neck soreness. Pain especially left side above eye brow. On 8/9/16 called doctor and got ibuprofen 400mg. The ibuprofen helped. On 9/7/16 went to doctor. Still has symptoms now but they are more pronounced when lay down.
Booster shot @ 4om Saturday 11/20. Fever, chills, body aches began about 22hours post shot. These symptoms subsided by Monday morning. Also, swelling started in my left armpit about 20hours post shot and continued to intensify in pain and discomfort for two days. It is now Wednesday 11/24 and the pain has begun to decrease.
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 22-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N001530, expiration date 13-JAN-2019, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763 and expiration date 22-APR-2019. The temperature excursion was of 47°F to 50°F, during 35 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA003525: US-009507513-1801USA003520: US-009507513-1801USA003521: US-009507513-1801USA003522: US-009507513-1801USA003523: US-009507513-1801USA003524: US-009507513-1801USA003526: US-009507513-1712USA013991: US-009507513-1801USA003527.
herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On or about 16-DEC-2016, the pt was inoculated with zoster vaccine live (ZOSTAVAX) for the long term-term prevention of shingles and zoster-related conditions. Subsequent to inoculation, on an unknown date, the pt experienced shingles and was treated at a local health system. As a direct and proximate result of use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffering ongoing injuries, including but not limited to mental and physical pain, medical care and treatment. Also, had significant medical and related expenses including but not limited to medical losses, and costs included care for hospitalization, physician care, monitoring treatment, medications and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages. At the reporting time, the pt was not recovered from shingles and it was considered related to zoster vaccine live (ZOSTAVAX).
Since May 6, 2021, the day the second dose was administered, I have had a daily headache and tachycardia.
patient tested positive for COVID-19 by PCR on 3/23/21, >2 wks after fully vaccinated. Asymptomatic, tested due to exposure to COVID-19.
This spontaneous report as received from a healthcare professional refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored GARDASIL injection, lot # L004014 with expiration date 04-MAR-2017 and lot# L016428 with expiration date 03-JUL-2017 (dose and route of administration were not provided). No adverse effects were reported. Data logger was involved. The vaccine was exposed to a temperature of 22 Celsius (C), time frame for excursion was reported as 1104 hours total cumulative time. There was no previous excursion. This is one of several reports from the same reporter. Additional information has been requested.
PATIENT EXPERIENCED SYNCOPE POST IMMUNIZATION, INCLUDING "SYNCOPE INDUCED CONVUSIONS" AS DETERMINED BY EMT.
extremely heavy period/She is now filling adult diapers with blood; This spontaneous case was reported by an other health care professional and describes the occurrence of HEAVY MENSTRUAL BLEEDING (extremely heavy period/She is now filling adult diapers with blood) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021 at 1:00 PM, the patient experienced HEAVY MENSTRUAL BLEEDING (extremely heavy period/She is now filling adult diapers with blood). At the time of the report, HEAVY MENSTRUAL BLEEDING (extremely heavy period/She is now filling adult diapers with blood) 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.   Concomitant medication and treatment information were not reported.   Reporter did not allow further contact
One day after the 2 vaccinations (Nov 16, 2023 09:30EDT) I developed a lower right back pain. For 2 days after that I was in pain standing, with spasms developing after 15 minutes of standing. In bed I was fine, tight but no pain. Pain resolved after the two 2 days.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a adult female patient who received ENGERIX B pediatric. On an unknown date, the patient received the 1st dose of ENGERIX B pediatric. On an unknown date, an unknown time after receiving ENGERIX B pediatric, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.
Already have tinnitus and lose of hearing. After 2 days when I woke up the ringing is louder and I have additional hearing lose. It?s been  4 months and  it is not better. The ringing is almost unbearable.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (experienced itches crazy, so bad that the patient wants to take out her skin, every time in different parts of body, like arms, legs, back, hands) and HYPERSENSITIVITY (it was an allergic reaction) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031M20A and 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Anxiety and Blood pressure high. Concomitant products included DULOXETINE for Anxiety, AMLODIPINE for Blood pressure high, METFORMIN for Diabetes, MINERALS NOS, VITAMINS NOS (CENTRUM BALANCE) for Vitamin supplementation. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PRURITUS (experienced itches crazy, so bad that the patient wants to take out her skin, every time in different parts of body, like arms, legs, back, hands) and HYPERSENSITIVITY (it was an allergic reaction). The patient was treated with CORTISONE ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. At the time of the report, PRURITUS (experienced itches crazy, so bad that the patient wants to take out her skin, every time in different parts of body, like arms, legs, back, hands) and HYPERSENSITIVITY (it was an allergic reaction) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (experienced itches crazy, so bad that the patient wants to take out her skin, every time in different parts of body, like arms, legs, back, hands) to be related. No further causality assessment was provided for HYPERSENSITIVITY (it was an allergic reaction). The patient did not experience any symptom after the second dose. The itchiness happened several times during the day for the patient, and then it stopped for no apparent reason. The patient thought that it might be due to booster dose, because the patient did not make any change of the patient's diet or skin products, and went to see the physician, but the physician told the patient that it was an allergic reaction, and the physician did not prescribe any treatment. This case was linked to MOD-2022-456565 (Patient Link).
Patient called the pharmacy on 1/9/22 at 4:00pm, stating that on 1/8/22 she started to have swollen lymph node and knot in the underarm area of her left arm where she got the pfizer booster on 1/7/22
vomiting; This spontaneous report as received from a physician via a company representative concerning a 2-month-old patient of an unknown gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. In approximately July 2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, for prophylaxis(concentration, dose, frequency, lot # and expiry date were not reported). In approximately July 2019 (reported as a week after receiving the dose), the patient experienced vomiting. No product quality complaint (PQC) involved. The outcome of vomiting was unknown. The action taken was not applicable. The causality assessment between the vomiting and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was not provided.
p/vax pt exp a temp for 24hr & over 100 lesions;pt recovered;
This spontaneous report as received from a nurse practitioner via a field representative refers to a 3 year old male patient. The patient's medical history and current condition was not reported. On 06-MAY-2014 the patient was vaccinated with M-M-R II, single shot (lot number and expiry date unknown) via subcutaneous route (product lot number and expiry date was not reported). No concomitant medications were not reported. On 21-MAY-2014 the patient experienced high fever and became anemic and was referred to a hematologist. On 21-MAY-2014 the patient was diagnosed with leukemia and was currently in the hospital. The outcome of the events was reported as not recovered. A product quality complaint was not involved. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. Upon internal review, the event leukemia was considered to be medically significant and other seriousness criteria include hospitalization. Additional information has been requested.
redness of the site of the injection; a horrible, very large swelling of the injection site/swelling of the injection site, extending downwards, about 5 inches long.; fever for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness of the site of the injection), VACCINATION SITE SWELLING (a horrible, very large swelling of the injection site/swelling of the injection site, extending downwards, about 5 inches long.) and PYREXIA (fever for 48 hours) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 006D21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included IBUPROFEN for Rheumatoid arthritis.   On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Sep-2021, the patient experienced PYREXIA (fever for 48 hours). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness of the site of the injection) and VACCINATION SITE SWELLING (a horrible, very large swelling of the injection site/swelling of the injection site, extending downwards, about 5 inches long.). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of 1 dosage form and ACETAMINOPHEN for Fever, at a dose of 1 dosage form. On 05-Sep-2021, PYREXIA (fever for 48 hours) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (redness of the site of the injection) and VACCINATION SITE SWELLING (a horrible, very large swelling of the injection site/swelling of the injection site, extending downwards, about 5 inches long.) outcome was unknown.            Patient report no side effects after the first dose.
This spontaneous report as received from a registered nurse, who learned from their traveling nurse, refers to three patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patient were vaccinated with unknown doses of PNEUMOVAX 23 (lot # L024129, expiry date January 2017; route was not reported). The travelling nurse used pre-filled syringes for the first time. Concomitant medications were not reported. In January 2016 (reported as "within the last two weeks"), the patients experienced extreme swelling and redness in their entire upper arm area after receiving the PNEUMOVAX 23 vaccine from the pre-filled syringes. The patients sought medical attention. No lab diagnostics studies were performed. It was reported that the swelling lasted "longer than usual (3) days". The outcome of the events was reported as recovered on unknown dates in January 2016. The relatedness between the events and PNEUMOVAX 23 was not reported. The reporter requested for a lot check. Additional information has been requested.
High fever, stomach upset, bone pain, weak legs which progressed to not able to walk, delirious (partner was not able to understand what I was talking about, said I did not make sense).
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 1:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 53.13.  Concomitant products were not provided.    On 27-Apr-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 08 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  On 27-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 35, 10 AM: 36, 11 AM: 38, 12 AM: 43, 1PM: 43, 2 PM: 44, 3 PM: 43 and 4 PM: 43.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.    Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
improperly stored vaccine had been administered; late shipment; This spontaneous report as received from a medical assistant referring to a 44-year-old female patient. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.     The reporter complained about late shipment of product. It was supposed to come on 27-OCT-2020 but the product actually arrived 2 days late on 29-OCT-2020. The caller stated when she first received the vaccines, she for some reason thought the current date of receipt was actually 27-OCT-2020 and not 29-OCT-2020 and that the product was received on time. She immediately placed the product into the freezer. Since then, the caller was informed that the product was actually received 2 days late. On 03-NOV-2020, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T014309, expiration dare was 24-APR-2022 (conflicting information: also reported as 24-APR-2024), dose was 0.5 milliliter, single dose, route unknown) in the right upper arm (RUA) for prophylaxis. The operator was trained. The vaccine was used according to the instruction leaflet. The vaccine was not available for return/evaluation. The patient did not reported any additional adverse experiences as a result of receiving the improperly stored vaccine. The reporter stated that when she opened the package, the information and logger inside the package stated the product was "ok" but she does not have any of that paperwork at this time as when it was found "ok", she did not think twice and discarded the paperwork.  This is one of the six cases from the same reporter.; Sender's Comments:  US-009507513-2011USA013851: US-009507513-2011USA013379: US-009507513-2011USA013163: US-009507513-2011USA013200: US-009507513-2011USA013293:
Can I start feeling side effects an hour after the 2nd dose?; Can I get sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Can I start feeling side effects an hour after the 2nd dose?) and ILLNESS (Can I get sick) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Can I start feeling side effects an hour after the 2nd dose?) and ILLNESS (Can I get sick). At the time of the report, VACCINATION COMPLICATION (Can I start feeling side effects an hour after the 2nd dose?) and ILLNESS (Can I get sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported by reporter. Treatment information was not provided by reporter