chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested for Covid antibodies.The result was negative; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (tested for Covid antibodies.The result was negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukaemia. Concomitant products included VENETOCLAX for Chronic lymphocytic leukaemia.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (tested for Covid antibodies.The result was negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (tested for Covid antibodies.The result was negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 antibody test: negative (Negative) Negative.         No treatment information was provided.
Pain/swelling in left arm. Sent for venous duplex doppler. Results show: DVT in LUE
Patient experienced nausea, diarrhea, pain in site area, swollen, itchy.
itching was incredible; Had a full body rash, rash didn't clear on the first regimen, covered in the rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Had a full body rash,rash didn't clear on the first regimen,covered in the rash) and PRURITUS (itching was incredible) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced RASH (Had a full body rash,rash didn't clear on the first regimen,covered in the rash). On an unknown date, the patient experienced PRURITUS (itching was incredible). The patient was treated with PREDNISONE for Rash, at a dose of 10 day rounds of prednisone each. At the time of the report, RASH (Had a full body rash,rash didn't clear on the first regimen,covered in the rash) and PRURITUS (itching was incredible) outcome was unknown.        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.   No concomitant medications provided. No treatment medications provided.
I am an RN & received the H1N1 Flumist vaccine while at work.  Approx. 1 1/2 hrs after receiving vaccine, vision in my rt. eye was affected (wavy lines, loss of peripheral vision, pieces of field of vision "missing").  This lasted for approx. 30 minutes.  I went to the ER because I felt like I was going to lose vision in my rt. eye.  Approx. an hour after vision issues resolved, my lips & rt. arm became completely numb; this lasted for several minutes then resolved.  A head CT was done, which was normal, but no other treatment was necessary. In 2004, I was diagnosed with atypical migraine (no headache but had temporary stroke-like symptoms similar to this episode) but had had no issues in the last 5 years.  I followed up with a neurologist on 10/20/09 & he believes I just had another atypical migraine, but with the length of time since the last episode & the timing of this episode so soon after receiving the vaccine, we felt it should be reported, just in case.  I typically receive the injectable seasonal flu vaccine & haven't had any issues.
Burning and itching sensation when feet are warm/sweating. 2/14 toes became red and swollen, . Light chest cough previous week, possibly unrelated.
Patient developed local reaction at site of injection consisting of slight swelling, redness and soreness.  Patient was treated with tylenol and benadryl.
Information has been received from a registered nurse concerning a 16 year old female with a "history of syncope after injections" and no known drug allergies who on 17-AUG-2009, was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number 658271/0558X). There was no concomitant medication. On the same day, the patient fainted and exhibited tonic-clonic movements lasting one minute immediately after receiving GARDASIL. The patient experienced fatigue and headache after returning home. The symptoms resolved in two days without requiring treatment. No lab tests were performed. The patient sought unspecified medical attention. Follow up information was received from the registered nurse via phone call. She stated that the patient did not receive any concomitant vaccinations when the first dose of GARDASIL was administered. Right after the GARDASIL vaccination was given to the patient she state, "I am going to pass out". The patient was seated at that time and placed in a reclining position. The patient had loss of consciousness (LOC) with tonic-clonic movements for about 45 seconds. The patient regained loss of consciousness and was at first disoriented. The patient became oriented and stated that she had a headache. The patient went home accompanied by her mother. The patient's mother called the office to state that the patient had extreme fatigue and a headache. The patient went to bed and slept for about six hours. The registered nurse stated that the patient's mother was contacted (date not reported) and the patient had recovered. Follow up information was received from the registered nurse regarding a 16 year old female who was vaccinated intramuscularly in the right deltoid with first 0.5mL dose of GARDASIL (lot number 658271/0558X). The registered nurse reported that after vaccination the patient promptly passed out, ammonia salts were passed under her nose, and then the patient went into tonic-clonic movements of extremities that lasted 30-45 seconds, the patient came to with a headache on top of head and was disoriented for a few seconds, patient's vital signs were stable. It was reported that the patient's mom reported that patient went straight home and could barely make it up to her bed because of extreme fatigue and slept for three hours (previously reported as about six hours). The patient headache lasted for three days (previously reported as two days). The patient was eating, drinking and going about her usual activities of daily living by the day after the injection. At the time of the report the patient had recovered. No further information is available.
pt recv vax & exp lethargy & drowsiness & fell asleep in class; nurse noted that pt was possibly overtired, but there was no way of being sure;
This spontaneous report was received from a registered nurse and refers to a 31 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown), lot # M015735 with expiration date of 30-MAR-2018 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 78 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1705USA014053:
breathing issues, lightheadedness. Pt did not eat breakfast. V/S: SpO2 @ 98% in RA, PR: 75 bpm
I had the second vaccine on February 13 in afternoon.  I had a stroke causing expressive aphasia on the evening of February 14.   I had no side effects from the first vaccine and just soreness in arm of injection after the second vaccine.  I realize that the stroke could coincidental but thought I should report it just in case for information in the event others had similar event.
Information has been received from a 33 yr old female with no drug reactions/allergies who never had chickenpox who on 09Nov04 was vaccinated SC with a dose of varicella virus vaccine live. There was no concomitant medication. On 18Apr05 the pt had a titer test that showed she did not develop antibodies. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/12/2006. Information has been received from a 33 year old female with an allergy to sulfa drugs and no pertinent medical history who on 09-NOV-2004 was vaccinated subcutaneous with a first dose of VARIVAX (Merck). There was no concomitant medication. On 18-APR-2005 the patient had a first test that showed she did not develop antibodies. In November 2005 the patient was vaccinated with a second dose of VARIVAX (Merck) and a titer test was performed a short time later. It showed that the patient did not have immunity to chickenpox. The outcome was reported as not recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information is available.
Very painful mouth ulcers (5) on lip and in mouth. Swollen around jaw line. Sore mouth.   Treatment: I am swishing orajel and mylanta with lidocaine to relieve pain.
Febrile/vomited x1 staring- would not respond to parents. Had seizure and turned blue x15 seconds-Was pos ictal x2-3"
I am reporting this event as *possibly* being related to my 2nd Moderna shot. No one knows for sure either way. I feel, however, that if you have received other, similar reports, then this problem may need to be looked into. Beginning two days after my 2nd Moderna injection, I developed constant, severe pain in my buttocks, thigh, calf & foot. When it did not diminish after a couple of weeks, I made an appointment with my doctor, whom I saw on April 22, 2021. She diagnosed my condition as piriformis syndrome, an inflammation of the piriformis muscle that causes it to pinch the sciatic nerve. Nothing showed on an X-ray of my lower back and hips that could account for this. I began a regimen of physical therapy, finally, on May 17, 2021. Although there has been some improvement in the level of my pain, the pain persists. It is particularly unpleasant during the night and often keeps me awake.
I had a terrible headache which started about an hour after the injection and lasted for 3 days.  I had a  sore arm for two weeks which was hard to move.  I started having a brain fogginess and vertigo (that leads to nausea), and fatigue within 24 hours after the vaccine and it has continued to this day which is 21 days ago.  It comes and goes especially when I look up or down/ side to side quickly.  I have not seen my doctor yet (appointment upcoming)  but I am not planning on getting the second vaccine d/t these reactions.
pt recv vax;arm swelled up about 4x nl w/ erythema, warmth & pain; lasted for 3 days then went away;
I woke up on 22Apr2021 at around 2 a.m. with very severe pain in my chest region; I also had some difficulty breathing as this tended to make the pain worse; I was not able to go back to sleep; I still feel pain in that area of my body and extending to my back.; thought I was suffering from pericarditis; This is a spontaneous report from a contactable other Hcp(patient). A 52-year-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EW0150), via an unspecified route of administration on 09Apr2021 at 11:00 am (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EP7534), via an unspecified route of administration on 19Mar2021 at 11:00 am (at the age of 52-year-old) into left arm as a single dose for COVID-19 immunization at Public Health Clinic. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin taken for diabetes mellitus, start and stop date were not reported. The patient had no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Apr2021 at around 2:00 a.m, the patient experienced very severe pain in my chest region. He was not able to go back to sleep and had some difficulty breathing as this tended to make the pain worse. He literally stayed up until daybreak when he went in to see my doctor. The doctor performed electrocardiogram test and found my heart to be functioning well despite the severe pain that he was experiencing. She thought he was suffering from pericarditis. She decided to go the nearest ER for further tests. He stayed in the ER for about 5 hours during which I was subjected to a bunch of tests which turned out negative, patients primary care doctor then prescribed for me colchicine BID and ibuprofen 600 mg TID for 3 months. He still feels pain in that area of my body and extending to my back. The patient was visited to Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care for the events. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unspecified date 2021 found my heart to be functioning well. The outcome of the events were not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event pericarditis and the suspect drug BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Heart pain constant for about six months, hives right after vaccine. Heart pain intermittent since vaccine.
24OCT red blotchy rash on back -1 mark on face no fever;eating normally;25OCT rash redder;26OCT rash more pronounced, over entire trunk & face, no fever, nl appetite;
Initial report was received on 20 November 2013 from a health care professional. A physician (gender, age and date of birth not reported) had received an injection of FLUZONE (lot number, route, site and date of administration not reported) and an unspecified amount of time later, was diagnosed with drug induced Sweets syndrome. No further information available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
My arm was sore on same day as shot was given (5/5/2021), and I followed instruction to do arm movements to mitigate pain. However, I did not notice a rash until 5/16/2021. It started itching and then when I touched the area hurt.  The pain is traveling now and my shoulder area, under armpits (lymph node area) are tender and sore. The rash is red and circular and seems to be fading, larger than a silver dollar. I also notice that I have an itchy throat, metal taste at times, etc.
One day after recvng the vARIVAX VAC (SUB Q IN RIGHT TRICEPS AREA)pt developed redness swelling.Was examined 2 days after recvng the immun and had redness and swelling(15 x 12cm)over injection site with a 2 x 4 cm area of intact fluid filled vesicles with some confluence of vesicles within the area of redness
Patient states that she has tingling under her feet at night, sharp twitch jerk in body and GI upset.
First Pfizer covid 19 vaccine on 12/22/20 lot# EH9899. I had known RA very mild state at time abd had been off immune meds for prior year. About two weeks later I got a rash in my abdomen similar to prior RA related rashes, very mild sandpaper like.  Then around  my Jan vaccine I noticed a very minimal irritation at urethra.  I drank more water. 2 days after vaccine I started having severe urethral pain rapidly progressing and could not sleep.  I looked with a mirror and saw linear and circular ulcers on a deep red base with some pus- like edges on some lesions in the vulvar area.  The next morning I was seen by a gynecologist who did biopsy.  The ulcers progressed rapidly over the next few days to the point that many went through the entire mucosal layer and I could see the underlying tissue.  It was extremely painful and all I could do was stand in order not to be in pain. Gyn determined on exam lesions did not go in to vaginale canal. I also started getting smaller but similar lesions in my Buccal mucosa.  The rash on my abdomen became a much larger, modular and painful rash over my abd/ chest/ legs abd a few in hands abd arms but spared head/ palms/soles. On 1/19/21 the pathologist determined biopsy was c/ w likely autoimmune process.  Same day my rheumatologist suspected a new bechets +/- skin vasculitis syndrome and  started me on prednisone and arava. The skin and mouth sores rapidly improved on prednisone.  Mouth sores resolved in a few days.  Skin became non painful and flat red dots within a few days.  The vulvar mucosal lesions started healing but much slower over about 2 weeks then resolved completely.  A few weeks later I developed a moderate RA joint flare and fatigue syndrome.  I was treated with Prednisone twice more fir that.
swelling; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SWELLING (swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced SWELLING (swelling). At the time of the report, SWELLING (swelling) outcome was unknown.        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.   No concomitant medications was provided
I am having vaginal bleeding.; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (I am having vaginal bleeding.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy (Patient had a hysterectomy over 20 years ago).   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 05-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (I am having vaginal bleeding.). At the time of the report, VAGINAL HAEMORRHAGE (I am having vaginal bleeding.) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
One day post vax pt felt warm and was given Tylenol. The next day pt broke out in rash on front of calf and small area on chest. No fever. The next day the rash was better but fever of 101. Treated with Tylenol for fever, hydrocortisone cream for rash.
Got really sick and sore; Got really sick and sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick and sore) and MYALGIA (Got really sick and sore) 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 Arthritis.    No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free pen. In May 2021, the patient experienced ILLNESS (Got really sick and sore) and MYALGIA (Got really sick and sore). In May 2021, ILLNESS (Got really sick and sore) and MYALGIA (Got really sick and sore) had resolved.            Action taken with mRNA-1273 in response to the events was not applicable   This case was linked to MOD-2021-185994 (Patient Link).
Started with aches, chills, and mild cold symptoms. By 9:00PM 10/21/2009, I was unable to care for my children. I was could barely move my arms or legs due to severe weakness. I was also acting as if I had been sedated. I was unable to stay awake and confused.   As of morning of 10/22/2009, I was able to get dressed and come to work, but I am still weak and shaky, and still am experiencing minor cold symptoms. I reported these symptoms to my PCP. I have been taking Ibuprofen and Tylenol as needed.
Suspected vaccination failure; had it terrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's spouse. The age at vaccination was not reported. The reporter stated they (reporter and patient) were vaccinated years ago so the reporter had to get it soon. The reporter stated that his/her husband just had terrible shingles. The reporter urged not to wait. This case was considered as suspected vaccination failure as the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were not available. The follow-up would not be possible as no contact details were available.
Itchy, warm rash developed on upper left arm approximately 9 days after receiving vaccine. Rash is a 7? x 3? area on day 11. Light pink on the inside with a darker ring around the edge.
Pt received Hep B Aelurt dose #1.  No dyspnea.  Reports hives (generalized), lightheadedness, and cramps several hours later.  Questions allergic reaction to Hep B: To take Benadryl.
DT vaccine administered 05/01/03 in left deltoid. Pt complained of allergic reaction 05/04/03 with fever, body aches and chills. Left arm swollen with heat in it. Tx with Prednisone 40 mg PO x1, Benadryl 50 mg PO x1 and MD appt in AM.
Fever and diarrhea, lasting several hours. Treated with Tylenol, per recommended dose. Pt dx'd as being Autistic (2/6/01).