chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Confusion-Mild, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: patient eyes rolled back started shaking or jerking-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Patient was moved to floor as she was passing out. She had jerking movements possible seizure. Lasted 2 seconds. Vitals were assessed. 911 was called and patient was assessed. Patient lost feeling in right cheek immediately. Shot was administered in let arm. EMS assessed. She had a HR of 48 and BP of 80/36. She appeared fine after 20 minutes. EMS recommended she go to hospital but patient refused.
Beginning Saturday 2/13/21 5:00 pm began with the rash. Prior to that had  malaise,  chills, joint pain &fever which started 2/12/21 evening. No rash after first dose-only had fever and malaise after first dose which subsided after 7 hours.
Right deltoid (site of Tdap and MCV 4) redness/swelling tender warm skin/pain - large local reaction.
Arm turned bright red, the size of my hand from wrist to fingertips, at the site of injection. Within an hour it was spreading both upwards and downwards. My face turned red. I went to the Emergency Room at Hospital where I was given steroids and a prescription for same.  By morning the site was a faded red at the initial "hand-sized" oval area. The remainder of the redness was gone.
Information has been received from a consumer concerning her 13 month old daughter who on 25-NOV-2009 was vaccinated with the first dose of VARIVAX (Merck) (lot# not reported). There was no concomitant medication. On 25-NOV-2009, within seconds after receiving VARIVAX (Merck), the patient developed a hive on her leg less than an inch below injection site. The hive was red raised area with a white spot in middle. She was treated with an antihistamine. The area cleared in about 5 to 8 hours. A few weeks later she developed a red raised circle about the size of a pickle jar lid at the site of injection. She was treated with an antiviral. At the time of this report, the patient had recovered. This is one of several reports from the same source. No further information is available.
Initially, upper arm was stiff and a bit sore. This has continued since 10/2/16 when shot was administered. When upper arm is still, there is no pain, but I no longer have a full range of motion without pain. This does not disable me but I keep hoping pain will go away.
5 inch welt at injection site, itching, feverish to touch, lump in arm, pain in arm
useless arm syndrome / my lifting capacity would drop in the arm (by about 30% to 50%, or more.) that it was given in for 3-4 days after day 2 of the vaccine being in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "useless arm syndrome / my lifting capacity would drop in the arm (by about 30% to 50%, or more.) that it was given in for 3-4 days after day 2 of the vaccine being in the arm".  Additional information: The reported that every time they had a vaccine or booster, they would get useless arm syndrome; their lifting capacity would drop in the arm (by about 30% to 50%, or more) that it was given in for 3-4 days after day 2 of the vaccine being in the arm. It got so bad their shoulder took over for lifting to the point where the patient nearly hurt their shoulder. They had to actually stop doing hard work, sawing branches, because their left arm could not handle a 50-pound log by itself, which was really, really sad. The patient said it was awful to get this, to feel that 25 pounds up and down was heavy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt erroneously received expired Pfizer dose on 12/1/21. Staff contacted Pfizer to inquire if this lot batch were still viable at the time of vaccination provided.  Following discussion with Mfr,  pt did not need to be revaccinated as Pfizer Mfr had stability data to support this excursion for 1 day post expiry from manufacturing data
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 17May2023 to 21May2023.  Clinical course: Patient received vaccine and also other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient tested positive for COVID on 6/14.  He was seen in the ED on 6/15 for worsening shortness of breath and cough. He was provided supplemental oxygen in the ED, and ultimately admitted to the hospital from 6/15-6/29. This meets criteria for vaccine breakthrough case review.
Immunization given Friday, pt c/o Saturday of jaw pain, different pattern of breathing, heart racing "didn't feel good" Saturday/Sunday.
Joint pain in the 5th finger (pinky) of the left arm, swelling present along the finger and left wrist. Symptom began the next day after vaccination. Vaccine administered 11/24/21. Symptom present on 11/25 & 11/26, unknown if it will be present for the next few days or resolution of symptoms.
Person woke up on Sept 17 & was very shaky and could not get out of lift chair. Walked finally to bathroom (took very long time to walk) could not get off toilet. Very weak. EMS came & wanted him to go to hospital. He was okay & coherent in ER & Sunday - after being admitted, on Monday incoherent!
This spontaneous report was received from a nurse practitioner referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # M007764, expiry date: 30-JAN-2018 (strength, dose number, route and anatomical location were not provided). Concomitant therapies were not provided. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient received vaccination for Hep B about 12pm in office. Around 2pm that same day she began to experience extreme dizziness followed by a h/a. Symptom relieved by going to bed. Symptoms resolved the next morning.
Pain at injection site, fever, tired, diarrhea. Headache, shivering, upset stomach.
Pt states development of rash/bumps over injection site. States she is not allergic to band-aid used or any adhesives.
immed ( by 15min) urticaria onset angioedema/arthralgia;tx w/zyrtec & pred;
Rash/hives appeared on evening of 5th day, covering a large area from nearly shoulder to elbow. Rash was raised, fiery red, and warm to touch.  Injection site itself had been mildly itchy for a day or two prior and mildly sore. Took Xyzal and applied topical hydrocortisone cream to the rash. In the morning, the rash had spread more so tried to use virtual visit. Gave up after an hour because I had to go to work. Took 2 Xyzal and applied hydrocortisone cream again. After work, I tried virtual visit again - gave up after 4 hrs of waiting! Did the Xyzal and hydrocortisone again. That night and again yesterday (Thanksgiving). Rash is less vibrant now, but still somewhat itchy. It is shaped and slightly larger than the print of a steam iron.
Stomach cramps in her stomach; Usual sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramps in her stomach) and PAIN IN EXTREMITY (Usual sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps in her stomach) and PAIN IN EXTREMITY (Usual sore arm). At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramps in her stomach) and PAIN IN EXTREMITY (Usual sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-032103 (Linked Report).; Sender's Comments:  MOD-2021-032103:MOD21-042287- cross linked case
covid vaccine breakthrough case  dose 1 1/14/21 025J20A dose 2 2/11/21 012L20
Bruising next day at injection site.  Significant pain started 9/8.  Decreased ROM 9/9 and persisting since then.  Vaccine was administered fairly high on deltoid.
2hrs p/vax deep soreness, redness, swelling-temp occurred-pain seems to move to rt arm-loss of muscle strength (21 days later still aching)
Significant muscle and joint pain, particularly in legs, mostly in right but varies.  Feelings of cramping right calf.  Went to ER, ultrasound negative, bloodwork unremarkable, MD visit later, was told to reduce inflammation via diet and moderation of activity.    Symptoms have continued until present and have affected ADLs
feeling freezing cold; weakness; headache; neck pain; hurting all over, body aches; 100 degree fever; chills; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Jan-2021, CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
fainting after administration of vaccines; instructed patient to put head between the knees, applied a cold compress to the back of the neck, gave patient water, symptoms improved after nursing interventions were implemented; obtained BP reading (114/92).
3hrs following injection severe headache 12 hours following injection 102- 105 fever lasting 24 hours. Tylenol dropped the fever from 105 to 102. Accompanying fatigue, weakness. Unable to get out of bed for 24 hours. Fatigue continued for additional 24-48 hours. No lasting fever past 24 hours of onset.
With  five minutes of  vaccine Increased heart rate shot up to 198 bpm. Regular resting heart rate for me is in the 50s. Left pupil dilated completely, right people constricted to pin size. Extremities went numb and ice cold. Went to emergency room Per request of EMTs at vaccination center. Was given high-dose Benadryl and  Saline IV. Heart rate return to normal and all other symptoms disappeared after treatment.
Debilitating illness.  Cannot sleep, Fever of 103.  Body aches, nausea and vomiting. Cannot work.  Feel awful
11AM h/a, sore arm (lt) lt side of neck sore lightheaded, BP inc  150/90; 1140AM BP 140/90 c/o nausea; sent home to rest;
Achiness; Diarrhea; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Achiness) and DIARRHOEA (Diarrhea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 032M20A, 032F21A and 057M21A) for COVID-19 vaccination. Concurrent medical conditions included Irritable bowel syndrome (Diagnosed many years ago). Concomitant products included LOPERAMIDE HYDROCHLORIDE (IMODIUM) and LOPERAMIDE HYDROCHLORIDE (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) for Irritable bowel syndrome.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Achiness) and DIARRHOEA (Diarrhea). At the time of the report, PAIN (Achiness) and DIARRHOEA (Diarrhea) outcome was unknown. The patient called and reported that she received 5 doses of Moderna COVID-19 vaccine, 4 Monovalent and 1 Bivalent. the patient always had the same reaction after all Moderna COVID19, Diarrhea and Achiness. No treatment medications were reported.   This case was linked to MOD-2022-649195 (Patient Link).
Sore arm evening of vaccination. Woke up 4am, vomiting, chills, fever. Lasted 12 hours and symptoms subsided. No treatment neccessary
Patient was tired and not feeling very well; Patient was tired and not feeling very well; Initial information was received on 10-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a male patient who was tired (fatigue) and not feeling very well (malaise), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was tired (fatigue) and not feeling very well (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that he did, will see how he does. So far, not so good.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
I received the injection mid morning. By mid afternoon I experienced light-headedness. Nothing alarming. I went to bed around 9:00PM. At 11:00PM I was awakened by rather violent, uncontrollable shaking of my arms and legs. It was not unlike shivering from the cold, but much worse. That lasted approximately 15 minutes, then it subsided. For the next 5 hours, I alternated being extremely hot, then freezing cold. This was intense enough to keep me awake the entire time. Perhaps some of the awake time was the upset from how  I was awakened in the first place. I can assure you that is NOT the way one wants to awaken! It took 48 hours to begin to feel normal.
Patient received a vaccine from a vial that was exposed to room temperature for 19 hours; This case was received via a Regulatory Authority (Reference number: US-irms-MOD21-125183) on 30-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine from a vial that was exposed to room temperature for 19 hours) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine from a vial that was exposed to room temperature for 19 hours). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine from a vial that was exposed to room temperature for 19 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.   No treatment medication was reported.
that's why you have nerve pain the vaccine your the 3rd person; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: that's why you have nerve pain the vaccine your the 3rd person ). The outcome of the nerve pain was not reported.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported via consumer interactive digital media. The reorter reported that, the why patient had nerve pain, the vaccine, patient was the 3rd person reporter had heard this from and one was reporter friend, it keeps reoccurring in one spot after vaccinated. The reporter had it because of medication side effects and never got it since. Follow up was not possible, as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter US-GSK-US2023AMR057502:Same reporter US-GSK-US2023AMR057506:Same reporter US-GLAXOSMITHKLINE-US2023AMR056691:Same reporter
This spontaneous report as received from a 51 year old female registered dietitian with no pertinent medical history and no drug reaction allergies, refers to herself. On 04-SEP-2013 the patient was vaccinated with ZOSTAVAX lot# J002865, expiring 07-JUN-2014, 0.65 ml, subcutaneous. There was no concomitant medication. 4 days after the injection, on 08-SEP-2013, the patient experienced a rash, pain at the injection site, her left knee was in absolute pain, inflammation of her joints which she described as squishy and excruciating inflammation affected her left knee, right shoulder and right wrist bone and finger joints, after receiving ZOSTAVAX. She stated she also had sore throat. She stated that discomfort resolved in all joints (and her throat) after two weeks, with the exception of the right knee with increased in inflammation and pain, and had not resolved. She stated that her large muscle groups felt "full of lactic acid". The patients outcome was reported as recovering. The patient stated that she had never had any joint problems in the past. The patient saw a doctor for medical attention. She stated at an unspecified physician was performing blood tests for rheumatoid arthritis, C-reactive proteins, inflammatory markers and had performed x-ray (results not provided). The casual relationship was not provided. Additional information has been requested.
2 hours after injection upper arm  blew  up and became red and itchy and painful to touch.  Not at injection site was the whole upper arm.  Next day arm was more swollen and red and placed circle around area redness.  Throughout the day the swelling and redness spread out beyond the circles.  Was approximately 3inch x 4 inch area on front of arm and back of arm.  By bedtime was about 5inch x 5 inch on both front and back of upper left arm.(Same side as where injection was).  Next am and through out today the swelling and redness was moving to where it was below the elbow and moving down the arm throughout the day..
at almost exactly 36 hours from the inoculation, I had uncontrollable chills, lasting hours- I was wearing 5 layers of clothes, under 3 blankets, with no fans on, and still violently shaking from chills...I could not get warm!!  I drank cups of HOT water, took a burning hot shower for 45 minutes, and finally chills lessened.  I had an insane migraine about 46 hours after the vaccine administration - I thought that my head was going to explode.  I took 2 Aleve gel caps and 3 Extra Strength Tylenols for the migraine to ease up, but I still have a headache.  I
Received flu vaccine 10/30/02 at 12PM. Went home feeling ill with chills by 14:00. At 16:00, developed hives, posterior and anterior chest, axilla, and bilateral legs. Experienced generalized burning and stinging in area of rash.
I have a previous diagnosis of COVID 01/19/2021 which I experienced long hauler symptoms with long recover time. Next day went to Hospital - Research Medical Center. to received the antibody infusion and 01/20/2021. August 2021, I had flu, body aches and fatigue, no appetite and taste and I was declining in health unable to stand and study and cognition  function was deciding and was not eating and decided it was time to go the the hospital. Overnight stay for a specialist diagnosis of Hep A and thought thought a liver transplant was needed and they also discovered issue with liver. New hospital, the diagnosis the heart palpitation and advised of the order to get image of the heart, see how COVID impacted the heart. To monitor it. Clinical Depress with 05/2021 Rheubutrian, Lexapro and was removed.
Itching; Hives on her forehead and ear; This is a spontaneous report from a Contactable consumer. A 63-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Lot number, expiry date not reported) via intramuscular on left arm on 19Jan2021 at 24:00 as Single dose for COVID-19 Immunization. Patient medical history included she stated that she had hives on and off since her 30s and adds she was menopausal, allergy, Blood pressure from unspecified date. No prior vaccination taken within 4weeks. Patient concomitant medication included Zyrtec (CETIRIZINE HYDROCHLORIDE) 10mg one twice daily by mouth, taking a year and half; Aldactone (PIRONOLACTONE) taking for over a year, Singulair (MONTELUKAST SODIUM) 10mg; take once daily by mouth at night for allergy,taking for a year and half from unspecified date and still ongoing. On 22Jan2021, patient experienced broke out in hives; came on her forehead and right ear after receiving first dose of vaccine. She experienced itching from unspecified date. Hive came three days later on her forehead and right ear. Six days visited clinic. Treatment was given by Pepcia and Atarax for the itching and it worked definitely; All of her hive cleared up the next day. She was scheduled for the second dose on 09Feb2021. The Outcome of events was recovered on 30Jan2021.  Follow-up attempts are completed. No further information is expected.
I broke out in hives on my entire torso on 9-16, and 17. I suffered high fever, and a seizure on 9-17. I continue to have tightness in the chest, shortness of breath, and sweating.