chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 68-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: In 2018, the patient received SHINGRIX. The healthcare professional (HCP) stated that the patient had an unknown reaction to a dose of SHINGRIX. The HCP stated that they were not entirely sure of the details of the reaction. The reporter gave consent to follow up. No further details were provided.
Increased frequency of migraines  4/2 4/3 4/4 4/19  4/29 5/12  Migraines usually occured once annually in the years prior.
33wk preterm infant on apnea monitor & amino-phylline w/1 episode self-resolving apnea 1 day p/vax;significant inc in # apnea episodes for 24hr;Theophylline level OK & unchanged from prior result 1wk a/vax;
Arm is sore but I've had worse; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (001774). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 25Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "Arm is sore but I've had worse".  Additional Information: The report is from Pfizer Sponsored Program   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Arthralgia, NauseaVomiting, Fatigue, chills, injection site pain and swelling Narrative:
2wk p/vax broke out in diffuse pruritic, vesicular rash on trunk & upper extremities;over 30 lesions;cult positive for varicella zoster;
At the beginning of last month I went to the hospital and was told I had a upper respiratory infection with cold like symptoms.
A few bumps or rash appeared on fingers and elbows on day 8 after vaccine. By day 11 it had continually spread. It had spread to inside and outside of both hands,painful on thumbs. On my elbow there was a half dollar sized round circle with lots of hard little bumps. It is also on both my knee caps and top and bottom of both feet. On day 11 I went to Dr and two doctors couldn't diagnose rash. But they did give me a  cortisone shot.Today is day 12. Inflammation and pain in fingers and elbow has lessened but the deep itching still lingers. I've only had it on my extremities except for 3 bumps under 1 eye. They are small bumps interior of skin and no blisters. Bottom of feet hurt and make it sore to walk on.
Immediately following vaccination no adverse reactions occurred. Approximately 8 hours following, I began feeling sluggish & global muscle soreness. I slept that evening with Tylenol in my system(1000mg)  and then awakened the next morning with swollen & tender axillary nodes in my right upper extremity. I rested that day due I was still feeling bad(fatigue, muscle & joint pain, headache) with alternating 1000mg of Tylenol and 600mg Ibueprofen every 4 hours. January 31st morning I awoke and continued to have the swollen, tender axillary nodes with progression of swelling into my right breast and down into my right elbow area. I again alternated NSAIDs with no improvement except for lying supine with my RUE elevated toward the ceiling. Monday morning I continued to have the same above symptoms and Tuesday my RUE is swelling into my hand intermittently with continued tenderness & swollen axillary nodes. I see a physician on Thursday at 1330, Dr.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient felt lightheaded for about 20 seconds while sitting down in chair. Patient states she is afraid of needles and hates shots prior to vaccine. NO Anaphylaxis, no epi pen use, no benadryl use. Patient felt fine afterwards about 20 seconds.
Pt had palpitations immediately after first dose.  After 2nd dose, increased palpitations.
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for Prophylaxis of nausea and vomiting, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation, ONDANSETRON (ZOFRAN MELT) for Vomiting.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 24-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown. Not Provided          Patient called to be added to the Pregnancy Registry.
While driving home from school, this teacher who received H1N1 Vaccine at her school developed severe facial swelling- patient was almost unrecognizable. Went to ER and was treated with Benedryl and steroids. Still had swelling the next day. As of 12/21/09 continues to take Zyrtec for symptoms including cough and some facial swelling.Has returned to work.
This spontaneous report as received from a health care worker refers to a 2 month old patient (gender unspecified). On 01-APR-2014, the patient was vaccinated with first dose of ROTATEQ vial, oral, (dose and frequency unspecified) (lot number J001815 expiry date 06-JUN-2014) which had been exposed to 0 Celsius (C) for 102.25 hours. Concomitant therapy was unspecified. No adverse effects reported. No product quality complaint involved. The outcome of received first dose of ROTATEQ which had been exposed to 0 Celsius (C) for 102 hours was unknown. No further information reported. Additional information has been requested.
Information has been received from a physician concerning a 6 year old female who was vaccinated with a dose of varicella virus vaccine live. About a week later, the pt had a "breakthrough" with a rash that occurred on the buttocks area. Unspecified medical attention was sought and no prescription drug was required. It was reported that the pt was recovering. No product quality complaint was involved.  Additional information has been requested.
Pt received both doses of the Pfizer COVID-19 vaccine in January 2021 (1/2/2021 and 1/29/2021).   On 6/14/21, she began having mild symptoms of COVID (runny nose, congestion, fatigue, body aches) and was tested on 6/17.  This test returned positive.  Pt has reported already feeling much improved/recovered.
sick as a dog; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves patient (unknown demographics) who got sick (illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), past medical history, concomitant vaccination(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 [lot number and expired date not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick (illness) (non-serious), for 3 days (latency unknown), following the administration of INFLUENZA VACCINE.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the patient outcome was not reported.  There will be no information on the batch number to be requested for this case.
Patient was observed for 15 minutes and then left the building. She returned a few minutes later complaining about a neck and face rash, as well as throat swelling. She was given Benadryl 50 mg IM. O2 sats were 99-100% on RA, lungs clear . HR 105, B/P 158/80. She was taken t0 Treatment area of the clinic for further observation with Dr. .
This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: Expired dose possibly given, not confirmed.
5:45;upon arrival to the incident,patient was on the floor ,waking up seem disoriented at first but came back to self stated before passing out he had some numblings. Vital sign stable,pt stated he had this reaction when he was in high school when he received vaccine.Patient seem to vagal down. 5:50pm: reassess vital signs which was stable, no c/o numbness or tingling . water was given,patient was slowing assisted to chair.he stated he was feeling much better.
Vertigo that started on 09/03/21 and persisted daily until today, 10/06/21
event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 13-Nov-2021 and Low back pain. Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (Dose - 1, Batch/Lot no - J&J 1808609, ROA - IM, Arm and Volume - 0.5ml) on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26. Concurrent medical conditions included Drug allergy (Allergy to Codeine) and Sulfonamide allergy (Allergy to Sulfa).    On 24-Jan-2022 at 8:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jan-2022 at 8:56 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration date). On 24-Jan-2022 at 8:56 AM, EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant Medications were provided by the Reporter No treatment Information were provided by the Reporter   This case was linked to MOD-2022-473115 (Patient Link).   Reporter did not allow further contact
Heart palpitations, sudden heart fluttering and chest pain beginning about 12hrs after vaccination and lasting 3 days.
39 hours after I received 2nd injection, started with bad migraine (3x as bad as usual migraine), diarrhea, nausea, had temp of 99.5F for one day, fatigue.
PATIENT RECEIVED VACCINATION AND WAS THEN ASKED TO SIT IN LOBBY. AFTER BEING SEATED PATIENT PASSED OUT AND FELL OUT OF CHAIR, HITTING HIS HEAD AND BITING HIS LIP IN THE PROCESS. 911 WAS CALLED AND EPI PEN WAS RETRIEVED. PATIENT CAME TO AND WAS PALE, SWEATY, AND HAD CLAMMY HANDS. PATIENT REPORTED NO DIFFICULTY IN BREATHING OR FEELING OF THROAT SWELLING SO EPI PEN WAS NOT ADMINISTERED. BP WAS CHECK AND WAS EXTREMELY ELEVATED.  AMBULANCE ARRIVED A FEW MOMENTS LATER AND EMTS ASSESSED PATIENT. PATIENTS BP  HAD RETURNED TO NORMAL RANGE, COLOR WAS IMPROVED AND HE WAS NO LONGER SWEATING. EMTS ASKED PATIENT IF HE WANTED TO BE TAKEN TO THE ER FOR FURTHER EVALUATION AND PATIENT REFUSED. PATIENT SAT IN THE PHARMACY FOR A FEW MORE MINUTES AND WAS THEN DRIVEN BACK TO WORK.
NOT SURE OF EXACT REACTION. REACHED OUT TO CHECK UP ON PATIENT BUT DID NOT GET A WHOLE LOT OF INFORMATION ON THE SITUATION. I BELIEVE THAT THEY WERE HOSPITALIZED OVER REACTION AND HAVE BEEN RELEASED NOW.
Extreme shaking chills making it difficult to walk or function, profuse sweating, severe nausea , weak - all of above lasted 5 hours. Then headache, marked fatigue for 3 days, with episodes of weakness & "brain fog", lower than usual blood pressure despite being well hydrated (114/68 vs WNL 126/84 typical) I had ONLY mild headache and fatigue after 1st and 2nd doses of Moderns COVID vaccine
Some slight swelling at sight of flu shot. Increased swelling at sight of pneumonia shot eventually growing from size of golf ball in circumference to an orange. Difficulty in raising my arm due to some pain. Red rash covered area and although faded quite a bit, still remains. Both shots in right arm due to node dissection left arm (breast cancer). Saw internist on 10/31/2001. Diagnosis allergic reaction. 21 pack 4mg methylprednisone tabs;Benadryl and Levaquin due to shortness of breath.
ONSITE EMS WAS REQUESTED TO HER VEHICLE.  POSSIBLE ALLERGIC REACTION. BP 134/80  HR 99 PATIENT REFUSED ADDITIONAL EVALUATION AGAINST MEDICAL ADVISE AND ALLOWED TO GO HOME. She has since returned for her 2nd Covid-19 vaccination on 2/23/20201 and no reaction reported
Covid Positive; Covid Positive; This is a spontaneous report from a contactable other hcp.   A 43-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248), via intramuscular route, administered in left arm on 02Feb2021 15:30 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received other vaccine in four weeks. It was unknown if patient had covid prior vaccination. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE via intramuscular route, administered in left arm on 14Jan2021 15:30 as DOSE 1 single for covid-19. On 07Jul2021, the patient was covid positive. On 07Jul2021, the patient underwent sars-cov-2 nasal swab test which was positive. The outcome of the event was not recovered.; Sender's Comments: Based on the reported information, a causal association between the reported events of vaccination failure, covid-19 and suspect drug bnt162b2 cannot be excluded.
On the third day after the first shot my left knee start hurting very badly it was swollen  I cannot bend my Knee it?s feels like I have a fluid there. I tried  Motrin Tylenol Advil And Aleve nothing  helps . I cannot go to the doctor because I don?t have health insurance.I never had any health problem before  especially I never had any problem with joins or arthritis pain . So many weeks past and I still have a problem with my knee it?s not getting better.
Itchy red rash started on legs and spread to entire body day after shot was given.  Went to Dr?s was given steroids and rash Intensified each night.
COVID-19 Positive; Pain right arm; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (COVID-19 Positive) and PAIN IN EXTREMITY (Pain right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 Positive) and PAIN IN EXTREMITY (Pain right arm). At the time of the report, SARS-COV-2 TEST POSITIVE (COVID-19 Positive) and PAIN IN EXTREMITY (Pain right arm) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not included. Treatment information not provided.   Reporter did not allow further contact
Joint pain (elbow to hand)  Swollen right hand, unable to use and a lot of pain. Eventually, pain traveled to shoulder.  Treated with steroids(Prednisone). Also, was given some exercise to do and may prescribe physical therapy.
Woke up on 12/28/18 in A.M. with blotchy rash on forehead, runny nose and fever of 99.4- playing  normally and appetite decreased took nap and woke up around 2:30 and rash had spread to rest of face, upper arms and lower legs- rash blotchy and raised, no itching. Brought into office by Dad temp 98.1, runny nose and rash visibly raised and blotchy- treatment Tylenol as needed, call office if s/s worsen or other symptoms develop.
10-20 red, raised papules on upper chest and neck, and 20 accross back. Initial. Now Monthly non-viral psorisis with menstral cycle.
Vasovagal syncope. Fainting and seizures about 15 minutes after the dose was given
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 09-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "1", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 52 years old female patient who experienced shoulder injury, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. In January 2017 (unknown date), the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5686MA (reported as UT5686MA or UT5686NA) via unknown route (reported as intramuscular or intradermal) in the left deltoid. On an unknown date, the patient developed a non-serious shoulder injury (limb injury) within three weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Other relevant tests included No lab data. Final diagnosis was shoulder injury. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for shoulder injury. List of documents held by sender: none.
Information has been received from a LPN concerning a 39 month old female who on 08Apr03 was vaccinated in the left leg with a first dose of varicella virus vaccine live. Concomitant therapy that day included a first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot644584/1014M) administered in the right leg. Vesicles started to erupt on 17Jul05. On 20Jul05 at 9:10AM, the pt developed greater than 50 papules to her face, trunk and extremities. No other symptoms were noted. Follow up information indicated that there was no known adverse sequelae at this time. No additional information is expected.
This spontaneous report as received from a medical assistant refers to a 19 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 28-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1809USA002868:Original Case : 1809USA002868; US-009507513-1902USA009324:Original Case : 1902USA009323; US-009507513-1902USA009325:Original Case : 1902USA009323; US-009507513-1902USA009326:Original Case : 1902USA009323.
Rash under the arms in the armpits, severe skin allergic reaction, terrible and persistent itching all over the body, pain in the liver, swollen all over the body.
Sinus congestion, fluid build-up in left inner ear.  Treatment with Biaxin and OTC decongestants.  Visited primary health care provider on 11/12/2009.
sore arm after the first dose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after the first dose) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal) and Headache. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), ASPIRIN;BUTALBITAL;CAFFEINE for Headache, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm after the first dose) and HEADACHE (Headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm after the first dose) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-337879 (Patient Link).
Patient was sitting down after her vaccine waiting the 15 minutes.  About 5 minutes in she stated she was dizzy and losing her vision and then her head rolled backward.  The patient did NOT fall or hit her head, she was sitting down.  She woke up shortly thereafter and taken to a patient room and laid down.  While there she vomited a couple of times.  Pt states only had doritos for breakfast and her friend talked to her during the vaccination process about the time she fainted while getting a TB test.  Patient was evaluated by a PA who determined there was nothing clinically wrong with her, she was stable.  After 40 minutes patient was discharged to home and told to follow-up with any changes or concerns.