chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wife had tinnitus 1 month after had Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (wife had tinnitus 1 month after had Moderna Covid-19 Vaccine) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced TINNITUS (wife had tinnitus 1 month after had Moderna Covid-19 Vaccine). At the time of the report, TINNITUS (wife had tinnitus 1 month after had Moderna Covid-19 Vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.  On 10-Mar-2021 patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) in unknown route with batch no. 031M20A.  Patient reported that she developed tinnitus 1 month and a half after getting the vaccine and that she's still having it. she first noticed it between 18 Mar 2021 - 21 Mar 2021.   Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received contains Vaccine information.
Got pretty sick with Covid like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got pretty sick with Covid like symptoms) 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 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced ILLNESS (Got pretty sick with Covid like symptoms). At the time of the report, ILLNESS (Got pretty sick with Covid like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test: negative (Negative) Tested negative on day 2 for COVID. On 26-Aug-2021, SARS-CoV-2 test: negative (Negative) Tested negative on day 9 for COVID.         No concomitant medications were reported. Treatment information was not provided. Patient reported that she had the second dose of Moderna 08FEB2021.  On 16AUG2021 patient got pretty sick with Covid like symptoms.  She tested negative on day 2 and day 9 for Covid.  Patient and his son were traveling together and he had the J&J vaccine.  He tested positive for Covid on his day 6.    Reporter did not allow further contact
Gradual increasing severe pain and Severe Left arm pain gradually increasing over 36h period, as well fatigue, night sweats, all over muscle pain, severe left temporal headache, cold shivers, upset bowels
shingles outbreaks were on the face and arm; not yet received the second dose in the series; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included meningitis and shingles.   In February 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter stated that the got the first shot of the Shingrix series but  did not know for sure that the injection was given intramuscularly but she assumes that the person administering it gave it correctly. The patient after vaccination got shingles. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter stated that the patient gets shingles 2 to 3 times per year. The reporter stated that the shingles outbreaks were on the face and arm, not always the chest. The reporter did not have the patient's MD information.
nightmare; sleeps all the time, for 5-6 hours each day; fever; chills; Initial information received on 26-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves an elderly female patient (age not reported) who experienced nightmare (nightmare), sleeps all the time (somnolence), fever (pyrexia) and chills (chills), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Past vaccination included Fluzone High-Dose and Pneumovax 23 on 23-AUG-2018.  Past medical history, medical treatment and family history were not provided.  Concomitant medications included ROSUVASTATIN CALCIUM (CRESTOR).  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ280AA) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious nightmare (nightmare), sleeps all the time (somnolence), fever (pyrexia) and chills (chills) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis were nightmare, chills, pyrexia and somnolence.   It was not reported if the patient received any corrective treatment.  On an unknown date, the event outcome was not reported from the all events.
On 1-8-21, I rec Pfizer Covid shot #1 on 1-28-21 I rec Pfizer #2, Pfizer Booster 12-16-2021. On 12-23-21 I developed a slight head cold which treat & relieved with OTC Sudafed. Sometime before 12-27-21 I noticed what appeared to be a ring worm on the Rt side of my rib cage. Treated with OTC antifungal cream with NO improvement. I spread to 90% of my torso. After seeking medical attention, from Numerous physicians a biopsy was performed & diagnosed as Granuloma Annulare. Please NOTE I AM NOT A diabetic. Due to the time frame of the Covid shots, I am convinced there is a correlation between the shots & the Dx. I have read several articles that suggest that my situation is NOT the first of it's kind & that has been associated with vaccinations/immunizations. Do You have any info that suggest this reaction related to Pfizer Covid shots/Booster
Red raised welt/hive at injection site. Itching. Sore. Rash about 1 inch in diameter. Lasted 2 days. Then reoccured the next week about 10 days after injection in a larger welt/hive with larger spread and more intense itching. Rash spread beyond injection site along upper arm in more than one area.
She got her vaccine, she had redness, swelling, the area was very hard, warm to touch.  Today she is saying after coming into the office she said that it is about 1/2 the size at it was yesterday, but improving, but still hard, warm to touch and very itchy.  She has been using Benadryl ointment and ice on the area.  The NP wanted her to continue icing, and to use the Benadryl ointment.  She was also instructed to take Benadryl at night and Zyrtec during the day and Ibuprofen or Tylenol for the discomfort if needed.  She is suggesting that she continue with the 2nd vaccine and premedicate prior to that vaccine. She has also been instructed to call back on Monday with an update and to check for spreading of the redness down to the arm and to seek medical attention if that happened.  The area of erythema was 7"x6", about the size of a fist.
This spontaneous report was received from a nurse and refers to unspecified number of male patients of unknown age. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, reported as within the last 1-2 years, the patients were vaccinated intramuscularly with doses of GARDASIL injection (dose, frequency, lot # and expiration date were not provided). No concomitant therapy was reported. The patients complained about stinging at the site of injection immediately after vaccination (dates unspecified). The stinging only lasted for a few seconds and all of the patients recovered from the event (dates unspecified). No treatment was given for the events. No product quality complaint (PQC) was involved. The relatedness between GARDASIL and the events was not reported. Follow up information has been received on 13-AUG-2015. All telephone attempts to obtain follow up information has been unsuccessful. Follow up information has been received from a nurse on 18-AUG-2015. The nurse clarified that she was referring to 12 year old males. She was not able to provide identifiers, lot number and expiration date and dates of vaccination. She stated that this was a few years ago at another location. This is one of the several reports from the same reporter. Additional information has been requested. Patient details, event tab and narrative were updated.
"Covid Arm" a week after shot.  Rash with redness, swelling, pain, & bumps within rash.  It has grown from a 1x1 inch circle to 4x6 inches in 3 days.
I had two vaccines and then the 1st booster in the month of May. Afterwards, i had a stroke which a aeare of in August 2021. However, after realizing and assessing myself, the first stroke, which told i had one before, it had to happen in th month of July 2021.
12/18/2020 I HAD A LOT OF BODY, MUSCLE AND JOINT PAIN. THIS LASTED ALL DAY 9:00 AM - 9PM. I WENT HOME AT 5 AND WENT TO SLEEP FOR 90 MINUTES. SYMPTOMS WERE MILDER. I STARTED TO NOTICE L UNDER ARM PAIN, INTENSIFIED OVER THE WEEKEND.  12/21/2020 CONTACTED PCP; LYMPHNODES SWELLING. PAIN LASTED UNTIL  12/22/2020, LATER EVENING THRU 12/23/2020 12/25-/12/26 NO  PAIN TELECHAT WITH PCP NOT VISIT; DR PRESCRIBED TYLENOL
Case was hospitalized for Covid after completing the Covid vaccine series.  He presented with sepsis physiology including fevers and tachycardia as well as shortness of breath and cough. Initiated on broad-spectrum antibiotics given risk for complex catheter related urinary tract infection and pneumonia. Covid test was positive. Chest x-ray did not show significant infiltrate initially.   Started aggressive treatment for Covid with remdesivir and then steroids started shortly thereafter because hypoxia rapidly developed and he required significant respiratory support. CT chest 10/12 showed no PE. Some perihilar infiltrate and bibasilar infiltrate noted as well. CT abdomen/pelvis did not show any acute problems. Baricitinib started on 10/13 as well because of significant hypoxia likely related to Covid. By 10/14 oxygen requirements had markedly improved. For several days prior to discharge, he was on room air during the day and 8 L of oxygen overnight, which is his home dose. Sputum production was not increased over baseline for several days prior to discharge.
Patient received influenza vaccine on 10-13-06 from unknown site. Approximately 2 days later she developed diarrhea and body aches, these symptoms progressed to respiratory distress and decreased oxygenation and she was subsequently admitted to Hospital on 10-18-06. The patient has suffered similar reactions to vaccines in the past. 3/16/07 Received medical records from hospital which reveal patient experienced difficulty breathing, SOB, fever, cough, malaise/fatigue, diarrhea & wheezing.  Developed diarrhea & myalgia 2 days s/p flu vax w/increased SOB & productive cough on day of admit.  Sats in ER were 40s w/copious secretions.  Admitted on 10/18 & tx w/IV antibiotics, nebs, CPAP & progressed well.  D/C to home on 10/20 on oral antibiotics, nebs & nightime BIPAP. FINAL DX: pneumonia & respiratory distress.
This spontaneous report as received from a physician refers to an 1 year old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-JUL-2015, the patient was vaccinated with PNEUMOVAX23 injection (dose, strength and lot number or batch number unspecified) intramuscular, in error. No concomitant medications were reported. No known adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Spoke with patient's mother on 12/7/2021.  She reported that had not experienced any adverse effects.
This is a spontaneous report from a contactable consumer based on information received by Pfizer from Amgen (manufacturer control number US-AMGEN-USASP2016132248), license partner for ENBREL. Initial Receipt Date = 26-SEP-2016. This spontaneous report (USASP2016132248) was reported to Amgen on 26/SEP/2016 by a consumer and involves a 63 years old female patient who took Prevnar 13 about a year ago and felt like crap, she moved both medications doses to Sunday this week, coughed all winter, last winter, she had infections, mostly all viral, and SureClick Autoinjectors, but they became very painful and unbearable/7 or 8 seconds of pure agony while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included ongoing Rheumatoid Arthritis. Concomitant medication included methotrexate. Co-suspect medication included Prevnar 13. The patient began Enbrel on an unknown date. The patient used to use Sureclick autoinjectors but they became very painful and unbearable. It was seven or eight seconds of pure agony. On an unknown date, the patient switched to a prefilled syringe. In 2015, the patient took Prevnar 13 and felt like crap. Last winter in 2015, the patient had infections, mostly all viral, all winter long. Subsequently, the patient had to be off of Enbrel for three months from November until spring. On an unknown date, the patient stated that she coughed all winter, could not isolate herself anymore and stated that she stayed home mostly. On an unknown date in SEP/2016, the patient stated that she moved both medications doses (methotrexate and Enbrel) to Sunday this week and was planning on adjusting next week's dose of these medications if she goes through with the Pneumovax 23 on Thursday. No treatment information was provided. The outcome of the events feeling abnormal, intentional product misuse, cough, viral infection and injection site pain were reported as unknown. Action taken with Enbrel was reported as unknown for the events feeling abnormal, intentional product misuse, cough and injection site pain. Action taken with Enbrel was temporarily withheld for the event viral infection. The causal relationship between the events feeling abnormal, intentional product misuse, cough, viral infection and injection site pain and the product Enbrel was not provided by the consumer. Amgen's assessment: The events were considered to be non-serious.
Patient fainted, was unconscious for 30 to 40 seconds. We called 911. Patient was brought from chair to floor. patient had a pulse and was having shallow breaths. After around thirty seconds patient regained consciousness and became alert. patient correctly responded to questions of date and place.
About a month after the vaccine, I experienced headaches that lasted until one week ago. The only relief that I had was lying flat on my back. It was a constant headache that happened everyday. Sonogram of eyes, checked sinuses with endoscopic procedure, and x-rays on neck. I had physical therapy. I also went to a neurosurgeon and was prescribed Amitriptyline and Robaxin that did not work and made my headaches worse. I have stopped the meds and still continued physical therapy. I do have surgery on my vertebra which was an infusion. That did not help my headaches and my doctor and I feel that was not due to my headaches. I have tried dry needling that has helped and the headaches has resided. I did have an MRI to rule out anything else. I did have COVID-19 in 2020 and I have not felt the same since then especially with energy. Then on 2/2/2022, I got COVID-19 after 3 vaccines. My surgery was scheduled and then I tested positive for COVID-19 which delayed my surgery by a month. I had symptoms of a different headache, dry cough, runny nose, loss of sleep, low grade fever of 99, brain fog, and fatigue. My symptoms lasted for 7-10 days.
Administration of an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 5397f, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. On the day of reporting an expired dose of Engerix-B was inadvertently administrated to a patient, which led to expired vaccine used. At the moment of the call the reporter had no information regarding the patient but agreed to be contacted follow-up and give further detail.  No further events were reported. The reporter agreed to follow-up.
Patient felt light-headed after the injection. By about 2:00 PM he complained of having an upset-stomach and feeling like he may throw-up.  He did not eat dinner, but finally threw-up at 8:15 PM.
Paresthesias in armpit upon injection in upper arm. Headache and nausea within hours of injection  Night pain with body aches, 3:00 am first 2 nights then to a lesser degree for 4 add'l nights. Fatigue for 4 days. Upper arm pain with redness,swelling and itching lasted 5 days.
flu like symptoms lasted only a day; body aches lasted only a day; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms lasted only a day) and MYALGIA (body aches lasted only a day) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006N20A and 042L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms lasted only a day) and MYALGIA (body aches lasted only a day). On 18-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms lasted only a day) and MYALGIA (body aches lasted only a day) had resolved.            Patient is taking Several medications and vitamins did not provide further details.  No treatment medication was provided by reporter.   This case was linked to MOD-2021-396401 (Patient Link).
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 at 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 - A0756535A, A0756537A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A. With a possibility of 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 for 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.
Pulse rate increasing eventually 122-136-145-156; Blood pressure was 176 over 110; Had fever on second day 102 Temp; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp). At the time of the report, HEART RATE INCREASED (Pulse rate increasing eventually 122-136-145-156), HYPERTENSION (Blood pressure was 176 over 110) and PYREXIA (Had fever on second day 102 Temp) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: 176/110 (High) High. In 2021, Body temperature: 102 (High) High. In 2021, Fibrin D dimer: high (High) elevated. In 2021, Heart rate: 122 (High) Increasing 122-136-145-156..         Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-006816 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Warmth, erythema, and swelling to a half dollar on right arm where vaccine was administered occurred x4 days after injection, By day 8 (15 Jan 2021)  swelling resolved to a quarter size but had accompanying itching.  Itching is still ongoing as of today 20 Jan 2021.  Used betamethasone cream which helps somewhat with itching
(L) deltoid redness, swelling, soreness, with some "streaking" as described by patient.