chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient came in for her first COVID vaccine. Before receiving the vaccine the patient told the pharmacist that she passes out every single time she has a vaccine or blood work due to a vasovagal reaction. She received the vaccine and sat for about 5 minutes, the patient and her father then went to sit in the chairs that patients wait in after getting the vaccine. About 5 more minutes later she passed out. She woke up immediately and the pharmacist gave her water. She sat for a few more minutes and was okay to leave.
Discomfort level of 7 on a scale of 1-10; pretty intense ear ringing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (Discomfort level of 7 on a scale of 1-10) and TINNITUS (pretty intense ear ringing) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Ear ringing.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Discomfort level of 7 on a scale of 1-10) and TINNITUS (pretty intense ear ringing). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Discomfort level of 7 on a scale of 1-10) outcome was unknown and TINNITUS (pretty intense ear ringing) had not resolved.            No concomitant product use was reported.  Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-092422 (E2B Linked Report).; Sender's Comments:  MOD-2021-092422:Same reporter
pt came to clinic for 2nd dose. described dev rash later that night after first dose on trunk and back, went away withi a few days on its own and reoccured 5 days after same area. c/o uticaria. also was sweaty with headahe and gen malaise 2 hrs after first dose
This spontaneous report was received from a consumer refers on behalf of herself as a female patient of 72 year old. No pertinent medical history was reported. Two weeks ago, approximately on 03-FEB-2015, the patient was vaccinated with ZOSTAVAX VIAL (strength, dose, lot# were not reported) at an unspecified store. The next day, approximately on 04-FEB-2015, the patient experienced itchiness around the injection site and low grade fever of 99F. The patient contacted the pharmacy and the pharmacist prescribed BENADRYL (manufacturer and dose unspecified) and ointment cream (manufacturer and dose unspecified). No specific diagnosis was communicated. A couple days later, on an unknown date approximately in February 2015, the patient experienced puffy bumps under her left arm and breast area. The patient did not contact the pharmacy to advise them of these new symptoms. The patient reported instead she applied a cream ointment and week later the bumps dissipated. No product Quality Complaint (PQC) was involved. Action taken was not applicable. On an unknown date approximately in February 2015, the outcome of events was reported as recovered/resolved. Causality was not assessed by the reporter. Additional information has been requested.
sharp pain in left armpit starting at 7pm on Wednesday 2/3. next day - Thursday 2/4 pain at injection site, baseball sized redness and swelling noted in area of injection. Both armpit pain and injection tenderness lasted until Saturday 2/6.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 29th March 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and injected limb mobility decreased. On an unknown date, the outcome of the pain in arm, swelling arm and injected limb mobility decreased were not recovered/not resolved. The reporter considered the pain in arm, swelling arm and injected limb mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine in the right deltoid. The patient then experienced soreness, swelling in the arm, and difficulty lifting the arm. The symptoms were improving on 2nd April 2018, but then worsened and were described as getting progressively worse at the time of the report. The patient did not require an emergency room or doctor visit prior to the report but the health care professional did state that he would refer the patient to their doctor. This case has been linked to the case US2018059362 and US2018059365 reported by the same reporter. The reported batch number 374KL for SHINGRIX did not exist and was updated to 3Z4KL as per the sales database.
Child developed Immune Thrombocytopenic Purpura with Bruising and platelets decreased to 14 8 weeks following MMR Vaccine-child has continued to have intermittent thrombocytopenia since ie chronic ITP. Requiring intermittent treatment with IVIG Followed by Hematology.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 9/2/2022 PNEUMONIA I21.4 ACUTE NON ST ELEVATION MI 9/2/2022 PNEUMONIA
not want to get out of bed; blood pressure increased; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (blood pressure increased) and FATIGUE (not want to get out of bed) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018L32A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Blood pressure (High blood pressure). Concomitant products included DILTIAZEM for Hypertension.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased). On an unknown date, the patient experienced FATIGUE (not want to get out of bed). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure increased) had not resolved and FATIGUE (not want to get out of bed) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement: (High) High.         Concomitant medication included high blood pressure medications.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-094869 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow-up added on 28-APR-2021, Vaccine date and batch no. added, concomitant medication added and event date updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-094869:Daughter's case
Starting in November 2022, I started getting a cold and I couldn't breath well. I started coughing and I got really sick with respiratory symptoms: coughing, trouble breathing, watery eyes. I made an appointment with my doctor who told me I had a cold which was triggering an asthma attack. He prescribed me medication for the nebulizer, steroid pack (prednisone) and antibiotic, and he told me to increase my asthma medication for awhile. I started getting better as time went on but it took awhile to get better. I've had trouble maintaining my asthma/breathing since.  In March 2023, I developed another respiratory illness that made me have trouble breathing. It was worse than the one in November. I had severe coughing and I saw my doctor who diagnosed me with bronchitis and a sinus infection. He put me on a 10 day prescription for antibiotics and cough medicine, and told me to double up on my NaC for 10 days to help thin the mucous. I just took my last dose of antibiotics this past Friday. I still have some residual congestion and my voice has not fully returned.    This was my first Moderna vaccine. All previous doses were Pfizer.
C/O flu like symptoms next day, fatigue, nausea, and HA x 4days. Reports HA went away for couple days and then returned. HA reported as constant, everyday all day. Reports high BP also as a new diagnosis, scheduled for tests on coratid arteries.
This spontaneous report as received from a nurse refers to a 15 weeks old male patient. On 11-MAR-2013, the patient was vaccinated (route not provided) with the first dose of ROTATEQ (lot number and expiry date not provided). The reporter called regarding the dosage schedule of ROTATEQ for an unspecified male patient that received his first dose of ROTATEQ on 11-MAR-2013. ROTATEQ was administered after age 15 weeks. The outcome of administered after 15 weeks of age is unknown. The reporter considered administered after 15 weeks of age to be not related to ROTATEQ. Additional information has been requested.
Information has been received from a physician concerning a 21 year old female patient with no pertinent medical history, no drug reactions/allergies, who on 03-JUN-2009 was vaccinated with the first dose of GARDASIL (Lot # 0162Y). On 04-AUG-2009 the patient was vaccinated with the second dose of GARDASIL (Lot # 0455Y). Concomitant therapy included hormonal contraceptives (unspecified). On approximately 11-AUG-2009, "1 week after the 2nd dose" the patient experienced a fever of 104 F, rash on the extremities that were mainly on the lower half, myalgia, fatigue and headache. There were unspecified emergency room test performed. The physician did not feel what the patient experienced was related to GARDASIL since the patient had no problems after the first dose. On an unspecified date, the patient recovered. No further information is available.
Potential hearing loss; Dizziness about one week after receiving which lasted about 3 hours; More intense tinnitus symptoms than usual; More intense tinnitus symptoms than usual; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9629), via an unspecified route of administration, administered in left arm on 08Mar2021 13:00 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a pharmacy/drug store. No other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Medical history included tinnitus, allergy to PCN and "Thygeson's Disease". Concomitant medication included ciclosporin (RESTASIS). The reported adverse events were dizziness about one week after receiving which lasted about 3 hours; more intense tinnitus symptoms than usual and potential hearing loss, all on 15Mar2021 at 17:00. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The outcome of the events was recovering.
24JAN94 TC recvd from mom reporting that lt leg where DTP vax recvd 18JAN94 was very red, swollen & hard to touch; states feels fine & running all over like usual;
Fatigue Lip Swelling (extremely chapped & painful, lips & skin surrounding lips flaked and painful for about a week now.  Sensitivity to any spicy or acidic foods.)
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 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 11:33 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 11:33 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, 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 76.66 Concomitant products were not provided. On 12-Jan-2021, Excursion time was 08 AM and 09 AM, temperature was 34, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021. Vial was stored on cooler 1 , on 12-Jan-2021, Excursion duration At 9 AM: 34, 10 AM: 34, 11 AM: 37, 12 PM: 40, 1PM : 40, 2 PM : 40, 3 PM: 41, 4 PM: 40.  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 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.
This 64 year old retired military family member received her yearly IM influenza vaccine on 19 October 2006. She reported being in "good and stable" health despite numerous medical conditions being able to function independently working 6 hours a day as a FNP at a health center. She would walk @ 2 times a week 3-4 blocks slowly due to requiring home oxygen use.Over the next few weeks her muscular aches worsened from a 1-2/10 onset to 2-3/10 without resolution. By the third week post vaccination her discomfort was now 5-6/10 with "increasing pains to all joints". She self adjusted her Relafen to 2 tablets twice a day for one week. She described this pain as a dull to spastic-sharp zap that was most searing to her lower back ... specifically the "right SI joint and sacral area". Over the Thanksgiving holiday her pain progressed to where she could not cook and was limited to sitting in a chair watching family events she use to participate in. She returned to work stating she "hurt" but it was not depilating".  By Tuesday 11/30/06 she complained of "being run over by a mack truck" with "searing pain all over her body...especially her back".  She saw MD December 1, 2006 for multiple myalgia/arthralgia and now new onset of right upper quadrant pain with decreasing appetite due to the pain.  He diagnosed her with arthralgia with normal labs ("3 WBC in us, neg culture, BS 140, H1AC 8.9, RUQ ultrasound wnl with chronic fatty liver").  She was placed on titrating Prednisone 60 mg decreasing 5 mg/day and Vicodin for pain.  She was re-evaluated by MD on 11 December 2006 where she reported being better but still in pain.  She can now ambulate @ 15 minutes before hurting and is receiving physical therapy TID.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
He got his vaccine, he started getting stiff where he could hardly lay on one side of his body, his right side.  It then got to where he was limping and went to the ER a month ago and they gave him something for pain.  It has gotten a little bit.  He was not able to move his right arm over his head, but it is improving.    They just treated him for arthritis.   He is improving, not at bad, said it's about a 2 on a scale of 1/10.
Within 24-48 hours following receiving the first series, and approximately 3 weeks after recent COVID infection, experienced a ?lump? to left breast with greenish nipple discharge and inverted nipple.  Nipple also had a decreased sensitivity to cold.   The lump decreased in size within 48-72 hours following the medical encounter
Patient contracted COVID after being fully vaccinated fatigue, sore throat, muscle aches, headaches, chills, fever, congestion, shortness of breath, loss of taste, loss of smell
FLU LIKE RESPONSE FOR A COUPLE OF DAYS.; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (FLU LIKE RESPONSE FOR A COUPLE OF DAYS.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. In September 2021, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE RESPONSE FOR A COUPLE OF DAYS.). At the time of the report, INFLUENZA LIKE ILLNESS (FLU LIKE RESPONSE FOR A COUPLE OF DAYS.) outcome was unknown.            No relevant concomitant medications were reported.   The reporter's causality for the events of flu like response for a couple of days was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Starting cough about 5 min post administration - face swelling about 15 min later, agitation allergic reaction.
Patient experienced swollen upper arm from shoulder to elbow as well as fever. Patient visited Dr's office and was given prescription for Keflex.
pt recv vax & exp pain @ inj site, entire arm hurt when it was moved, especially when it was moved up or down & devel lumps or a knot @ inj site; nurse could not locate the lumps; sx resolved spontaneously by 31JAN94
17 yr old patient received a 10 ug booster dose. Booster dose is not even approved in this age group Staff re-educated on booster eligibility and proper dosage for patients 12-17 who require a 3rd dose for immunocompromising conditions.
A spontaneous report was received from a consumer who is a Merck employee regarding her mother-in-law who is an 81 year old female who received ZOSTAVAX vaccine a few years ago (exact date unknown) (lot number and expiration date not reported). Medical history and concomitant medications were not provided. On an unspecified date, the patient developed shingles. The outcome of the shingles has been requested. Additional information has been requested.
Itching 48 hours on the Left rib area (under the breast) to Left upper side of the abdomen.  Red fine rash occurring and then to raised rash. Applied a mix of Neosporin and Hdyrocortizone and cream for psoriasis. Applied several times a day.  Slight pain at times, but I am 71! Heard on the news of possible shingles S E. went to the family clinic and report mad.  Called and they said I needed to report.
contracted HPV infection.; This spontaneous report was received from a pharmacist via company representative concerning a female patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unknown dates, the patient received 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Company unidentified HPV vaccine administered).   On an unspecified date, the patient contracted Human papillomavirus (HPV) infection. The outcome of the HPV infection was not reported.   The causal relationship between the Company unidentified HPV vaccine administered and the HPV infection was not reported.
Little Malaise; Mild symptoms; Tested positive for COVID one week after first dose; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose), MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose). On an unknown date, the patient experienced MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose) outcome was unknown and MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID 19.     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.
ON 14 JUN 05, PT RECEIVED A 2nd DOSE OF TWINRIX LOT # AHABA015BA. ON 20 JUN, HE EXPERIENCED FEVER, HEADACHE, FATIGUE, NO SOB, NO DIARRHEA, NO NAUSEA OR VOMITING. WENT TO ER ON 23 JUN 05. DIAGNOSED WITH FEBRILE ILLNESS AND ACUTE SERUM SICKNESS. TREATED WITH BENADRYL 25MG ONE EVERY 6 HOURS WHILE AWAKE, PREDNISONE FOR THE NEXT 3 DAYS. HE WAS ADVISED BY ER DOCTOR TO AVOID THIS IMMUNIZATION IN THE FUTURE. PT STATES THAT HE WAS FINE AND RETURNED TO WORK ON 24 JUN 05. HE WAS SEEN BY A MILITARY PHYSICIAN TODAY 27 JUN. MD CONCLUDED THAT THIS EPISODE HAS RESOLVED, PT RETURNED TO NORMAL.