chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Bled a little bit after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Bled a little bit after the first shot) and VACCINATION SITE PAIN (Sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroiditis NOS.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bled a little bit after the first shot). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). On 18-Jan-2021, VACCINATION SITE HAEMORRHAGE (Bled a little bit after the first shot) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood thinner, thyroid Medication. No treatment information was provided.
23DEC96 noticed tiny white lumps all over skin surrounded by red welt, c/o itching;pt scratched it burned like fire;saw MD put on reducing dosages Pred;p/1wk when completed med all came back;sent to MD;still c/o welts, itching;
Miscarriage at 8 weeks pregnant; Unevaluable event; This case was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20a and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) (seriousness criterion medically significant). 14-May-2021, the patient experienced UNEVALUABLE EVENT (Unevaluable event). At the time of the report, ABORTION SPONTANEOUS (Miscarriage at 8 weeks pregnant) and UNEVALUABLE EVENT (Unevaluable event) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   On  05/14/2021 and 05/17/2021 unknown lab tests were done ,results not provided. No Concomitant medications were  reported. No treatment information was provided.  This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified.   Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.; Sender's Comments: This is a RA report of pregnancy after vaccination and subsequent abortion. Date of LMP and pregnancy diagnosis are not specified.  Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.
compromised autoimmune hepatitis; shingles; hurts; blisters; This serious case was reported by a consumer via interactive digital media and described the occurrence of autoimmune hepatitis in a 81-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (The patient had shingles really bad lasted for 8 days). Concurrent medical conditions included nerve pain (The patient was left with nerve ending pain and there was no cure for this).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced autoimmune hepatitis (Verbatim: compromised autoimmune hepatitis) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pain (Verbatim: hurts) and blister (Verbatim: blisters). The outcome of the autoimmune hepatitis, shingles, pain and blister were not reported.   It was unknown if the reporter considered the autoimmune hepatitis, shingles, pain and blister to be related to Shingrix.     It was unknown if the company considered the autoimmune hepatitis, shingles, pain and blister to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-JUL-2023 This case was reported by a patient via interactive digital media. The patient got the Shingrix shot, when patient got the second shot that hurts, the patient did not think he/she would have shingles breakout.  15 days later, patient got shingles breakout. Not a lot of blisters but had them. Patient was told to isolate for 7 days. The patient mentioned all of them were different.  The patient had a compromised autoimmune hepatitis. The patient stated that vaccine did not keep you from getting shingles.  The patient reporter that if you get shingles they would not be as bad. So, guess we all deal with our situation the best way we could.  The follow-up could not be possible as no contact details were available.
p/pt recv vax devel rash + swelling @ eyes that continued to become progressively worse until pt took benadryl;24hr later sx resolving;
09/15/22 presents to Cardiac Cath Lab for "new cardiomyopathy". PMHx "moderate CAD per CCTA in 2015"
I have self diagnosed a large red rash,  warm,  itching and tenderness on my arm 8 days after my modern vaccine.
after patient received vaccine the next morning she noticed itching, swelling, erythema about 4 inches by 2 inches on arm.  No other symptoms.  She came so we at the clinic could check it out on 7/27.  pt given some zyrtec syrup.
I feel like I get zapped by an electric current on my arm,right above the hand along side the right side along a bone that is there, not on the upper arm.   I have no pain just the discomfort of having this strange feeling of like being hit by an electric volt. It lasts for a split second and then it goes away. In the beginning, it was more infrequent. Now it's more often. I don't feel it if I am resting my arm on the couch but if I get up to so something, there it is, again. I'm worried because I don't know what to do about it. I tried to massage the area a little bit but that's of no help. I never had anything like that in my life. It started shortly after I had the flu shot on my left upper arm.
Patient developed a "knot" on her left arm 3 days post vaccination. One week post vaccination the patient developed a pulmonary embolism.
Approx 1015 am, immediately following 4th vaccine injection (mening) pt. became pale, swayed to the side and fainted.  Nurse lowered her to the lfoor slowly, put legs up, by the time she was on the floor, she was awake.  She had not eaten breakfast prior to appointment and stated later she has fainted before with vaccination (x1).  This was not shared with nurse.  Felt completely fine after juice and a snack (15 minutes).
Information has been received from a pharmacist concerning an 81 year old female patient with a history of shingles on her trunk and no known drug allergies, who on 08-JAN-2009 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot # 66333/1555X) subcutaneously.  Concomitant therapy included CYMBALTA.  On 08-FEB-2009, one month later, the patient developed shingles with lesions in her ears and throat.  Patient sought medical attention by speaking with the pharmacists.  At the time of this report the patient had not recovered.  Additional information has been requested.
numb hands; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced numb hands on an unspecified date. Patient stated, "I had my first vaccination. I have numb hands. I have trouble writing." The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
2 mins after the vaccine I got a burning sensation in throat and chest area my heart beat elevated to 160 the burning sensation lasted about 5 mins elevated heat rate lasted about an hour but in 10 mins I was feeling better and heart rate went to 107 got cramping in stomach which lasted about an hour
Information has been received from a physician concerning a 17 year old female with childhood seizures from age 5-11 years old and had been seizure free since 11 years old and with no drug reactions/allergies.  On 05-AUG-2009  the patient was vaccinated IM with the first 0.5ml dose of GARDASIL.  The patient had been on DEPAKOTE (last dose was at age 13).  On 05-AUG-2009 three hours after she received GARDASIL the patient had a grand mal seizure with loss of consciousness.  The patient was seen in the emergency room at the hospital. There was no family history of seizure noted.  The lab diagnostics studies performed:  Genetic blood tests, "CBC", "CMP" urine analysis, "EKG" and all were negative.  The patient was scheduled for a 48 hours Electroencephalography (EEG) next week.  The physician requested to have WAES form faxed to him and he would provide all needed information.  At the time of report the patient's status was recovering.  Upon internal review, grand mal seizure was determined to be an other medical event.  Attempts to obtain follow-up information have been unsuccessful.  Additional information has been requested.
Prolonged deep, pervasive fatigue. After 2021 vaccines I retired and have not been able to return to work, extreme hardship.  Inlay lose my home due to much reduced income.
Information has been received from a physician concerning a 7 year old male patient with chronic sinusitis, asthma, low immunoglobulin and immunocompromized who on approximately 18-NOV-2009 (18-NOV-2009 or 19-NOV-2009) was vaccinated with PNEUMOVAX 23 (Lot # not provided). Concomitant therapy included montelukast sodium (MSD), SYMBICORT, FLONASE and BACTRIM. The physician reported that the patient received PNEUMOVAX 23 and on 19-NOV-2009 experienced an injection site reaction with cellulitis. The patient was treated with BENADRYL. The patient was admitted to the hospital on 23-NOV-2009 when there was no improvement. He has been treated with 2 doses of IV vancomycin but the area of the arm has increased in size with increased swelling, afebrile, White count was 8.3. It was not known if the patient received PNEUMOVAX 23 prior to this. Patient remained in the hospital. Chest x-rays were performed without results. Injection site reaction and cellulitis were considered to be an other important medical event by the physician. Additional information has been requested.
Migraine; chills; foggy head; muscle aches; tiredness; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: eln266), via an unspecified route of administration, administered in arm left on 15Feb2021 at 08:15 AM (at the age of 45-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included asthma, irritable bowel syndrome (IBS), high blood pressure, COVID-19 (If COVID prior vaccination: Yes), all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. Patient was diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. The patient previously took first dose of bnt162b2 for COVID-19 immunization. On 15Feb2021 at 20:00 (08:00 PM), the patient experienced migraine, chills, foggy head, muscle aches, tiredness, diarrhea. The patient did not receive treatment for the events. Outcome of all the events was recovered on an unspecified date in 2021.  Follow-up (PRD/SRD 11May2021): Follow-up attempts completed. No further information expected.
pt recvd vax;15dec94 checked by MD for rash;T 103 ax,malaise;20dec94 rechecked by MD, dx w/ AOM & t 104ax;pt dx w/ Rubella rash,was instructed to file VAERS; 3jan95 mom reports pt "OK" now;
1/31/2021 patient developed chills, cough, loss of taste/smell, nausea, vomiting, sore throat.  positive for COVID
Patient received her 1st dose of the COVID-19 Moderna vaccine at her employer's on-site vaccination clinic today, 1/8/21.  Patient was observed for 30 minutes following vaccine administration per recommendations, and did not report feeling any reaction.  Patient has a known bee sting allergy.  Approximately 1 hour following administration, patient began to experience "numbness and tingling in the tongue, and difficulty swallowing" but did not experience tongue swelling.  She contacted school nurse who immediately recommended patient go to the emergency department at Hospital for evaluation.  Hospital evaluated patient,  and prescribed Benadryl 50 mg every 6 hours for the reaction.  The emergency department at Hospital may be reached for additional information as needed.
Tested positive for COVID19 virus; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID19 virus) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID19 virus). At the time of the report, COVID-19 (Tested positive for COVID19 virus) outcome was unknown. Not Provided      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.   No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report as received from a physician refers to an 18 year old male patient. Medical history and concurrent conditions were none. Drug reactions or allergies was none. On an unspecified dates, the patient received the first and the second dose of GARDASIL 0.5 ml intramuscular. On 24-JUN-2015, the patient received the third dose of GARDASIL 9 (Lot# was reported as K026247, expiry date was 29-JAN-2017), intramuscular. On 24-JUN-2015, the patient experienced low grade fever after receiving GARDASIL 9. Patient sought medical attention (had called physician). None of the laboratory tests were performed. Patient was treated with TYLENOL for the low grade fever. Action taken was not applicable. The outcome of pyrexia was reported as not recovered/not resolved. The outcome of wrong drug administered was unknown. The causality for the event pyrexia was not reported. Additional information has been requested.
Patient developed some bruising on different sites of body (arms, legs) after getting the first shot.  Patient denied trauma to the sites of bruising. Did not state whether she was on any blood thinning medications or anticoagulants at the time. Didn't mention that she went to hospital for medical care. No other symptoms mentioned. Was reported to pharmacy when presenting for second shot. Second shot was deferred due to reaction to first dose and patient advised to follow-up with PCP to discuss candidacy for second dose.
Patient was sitting in observation for approximately 5 minutes , started feeling light headed and passed out. Patient was out for approximately 15 seconds before recovering. There were no seizure like symptoms or post-ictal state. Patient was helped onto a cot and a set of vitals was taken, BP 118/84, O2 98%, HR 84. Patient was advised to wait at least 15 more minutes and told not to leave until after the 15 minutes had passed and he was no longer having any symptoms. Patient was brought home by a family member.
Per call from mom, left thigh red swollen, temp of 101 degrees. Advised cold compress - ibuprofen. Call 4/3 a.m. if no improvement. Mom called 4/3 a.m. - swelling increased - child acts OK but mom is concerned. Scheduled appt to see Dr - Dr examined, reassurance given.
Information has been received from a pharmacist concerning a 62 year old female patient with no medical history who on 12-MAR-2011 was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck) (lot number not reported). There was no concomitant medication. On 12-MAR-2011, "the adverse events began on the day the vaccine was given", the patient experienced a very significant swelling that was very hot to the touch at the injection site. Approximately on 16-MAR-2011, "within 3-4 days of the adverse events starting", the patient recovered from a very significant swelling that was very hot to the touch at the injection site. No diagnostic laboratory tests performed. No treatment was given for the adverse events. The patient sought medical attention by calling the pharmacy the day after having received ZOSTAVAX (Merck). Follow-up information has been received from a registered pharmacist concerning the 67 year old patient who on 11-MAR-2011 at 18:15 pm (previously reported as 12-MAR-2011) was vaccinated subcutaneously into back of arm with ZOSTAVAX (Merck) (Lot number 669590/1507Z). Subsequently back of patient's arm became inflamed and hard. About the size, it looked like baseball on ""grape fruit" for 4-5 days. Patient was told to go to doctor. Patient called doctor and was told to wait a few days. Patient did wait and area returned to normal. The patient had recovered from the events within 4 to 5 days. No laboratory test was done. Additional information is not expected.
He presented to the ED with Bell's palsy on 5/12. He had left-sided facial drooping when he woke up at 6 am. He was hospitalized overnight for hospitalization and was started on prednisone.
Appr 3 hrs p/vax, pt devel apnea & cyanosis; required intubation & ICU stay; pertussis prep positive - so thought is this was likely due to pertussis & not vax;
Administered dose to 16 years old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 16 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 16 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Administered dose to 16 years old) had resolved.        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.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756486A, A0756488A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received from batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Few hours after flumist dev fever and itchy rash all over. SX resolved within one hour.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 at 12:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown", COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient treated with Paxlovid from 10Apr2023 to 15Apr2023. Known allergies and other medical history was not reported. Other medication in 2weeks: No.
IMMEDIATELY FOLLOWING SHOTS, PATIENT DEVELOPED URTICARIAL LESION LON BILATERAL LOWER EXTREMITIES, THEY RESOLVED WITHIN 15 MINUTES, THERE WAS NO BREATHING DISCOMFORT.
Redness, swelling, hot - 4x2 inches with numbness and tingling index in middle finger.  Nausea, vomiting, diarrhea for 24 hours after vaccine.  Symptoms are resolving.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 66-year-old female patient who received SHINGRIX (batch number T73K2, expiry date unknown) for prophylaxis. On 6th March 2019 18:10, the patient received SHINGRIX. On 6th March 2019 22:00, 3 hrs 50 min after receiving SHINGRIX, the patient experienced fever, chills, nausea and injection site pain. In March 2019, the outcome of the fever, chills, nausea and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever, chills, nausea and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine into the left deltoid. The pharmacist stated that the side effects resolved late the night before the day of reporting.
About April 17th I woke up with my right sinus plugged up with nasal drip and sore throat.  I had a fever of 102. The next day it had affected both sides.  I went to the urgent care.  I have had a bit of a cough and was given a prescription for my cough. As of today I am feeling much better.