chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had third covid Pfizer vaccine; COVID-19 antibody test negative; Heart flutter; Blood pressure shoot up; MC-2015-135  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4157183-00 (AbbVie).  A 69 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; ibrutinib (IMBRUVICA), oral since Jan2021 (ongoing) (Batch/Lot number: unknown) at 420 mg for chronic lymphocytic leukaemia. Relevant medical history included: "Cll" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose, Route of Admin:1)Intra-muscular), for COVID-19 Immunization; Bnt162b2 (Second dose, Route of Admin:2)Intra-muscular), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "had third covid Pfizer vaccine"; CARDIAC FLUTTER (medically significant) with onset Oct2021, outcome "unknown", described as "Heart flutter"; BLOOD PRESSURE INCREASED (non-serious) with onset Oct2021, outcome "unknown", described as "Blood pressure shoot up". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (Oct2021) shoot up; heart rate: (Oct2021) 136 bpm; sars-cov-2 antibody test: (unspecified date) negative. The action taken for ibrutinib was dosage not changed.The reporter considered "had third covid pfizer vaccine" not related to COVID-19 antibody test negative .The reporter causality for the events Cardiac flutter, Blood pressure increased, COVID-19 antibody test negative was not reported for the co-suspect IMBRUVICA.  Additional information: The patient did not have antibodies with imbruvica (ibrutinib). The patient had no known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available in narrative the reported  events of  Booster, Antibody test negative  cardiac flutter and BP increased are assessed as related to suspected vaccine 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.
Hives developed on left side 3 days after Dose 1 of the Moderna COVID vaccine.  Left side torso, left arm, left side of neck.  Vaccine was given in right arm.   Patient is breastfeeding.  She is taking a second gen antihistamine to see if this helps.
pt recv vax in late OCT96 & devel inj site rxn w/a quarter-sized welt w/redness & induration;pt recovered;This is 1 of 5 pt;
Patient was given vaccination at the health Center.  He was observed and waited for 15 minutes prior to leaving.  Drove home.  Close to his home, he began to feel lightheaded.  However continued to try to make it home and passed out.  Crashed car into a tree.  Was taken to a local hospital where he had a head CT, hand Xray, CXR and "blood work."  He was advised that all testing was normal and that he had a mild concussion.  Evening of event, he had a mild headache.  Day after the event, the only complaint was tenderness around the vaccine site.  He has not had prior reactions to vaccines but states "I work construction and have noticed that I have had vasovagal symptoms with pain in the past."
Minor pain after vaccination shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor pain after vaccination shot) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PAIN (Minor pain after vaccination shot). At the time of the report, VACCINATION SITE PAIN (Minor pain after vaccination shot) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
Received Pfizer vaccine, L arm. 1 week later, developed progressively worsening L chest abscsses, complicated bacteremia with staph aureus and requiring repeat debridements in operating room including now new abscesses that are abutting sternoclavicular joint concerning for osteomyelitis. Pt also has diabetic foot ulcer R side w/ osteomyelitis discovered after he came in for chest abscesses, cultured to have MSSA/MRSA. Chest abscesses also w/ MRSA and MSSA.
About one hour after receiving the influenza vaccine, the patient's left arm began tingling and burning from the site of injection down to the elbow. About 30 minutes later, the patient began to feel "spacy". These symptoms progressed and the patient began to feel nauseous and broke out into a sweat. The patient stated that she basically felt drunk. She also describes experiencing "flashes" in her peripheral vision while driving home as well as GI distress and diarrhea which occurred 5-6 hours after vaccination. The patient stated that her "spaciness" had resolved by that same evening and the next morning she felt normal again. The patient stated that she did not take any medications for relief of these symptoms.
After receiving  Pfizer COVID-19 vaccine on 12/18/20, patient c/o nausea.
Patient said injection site was itchy the night of the vaccine.  She then got sores in her mouth and around her mouth. Pt visited an urgent care clinic and received Valacyclovir for 10 days and lidocaine for her mouth.
Pt reports worsening vision and visual snow after receiving vaccine, "compression of vision"/skewed vision. Notably pt has macular degeneration and had vision changes prior to vaccine so not clear that worsening vision changes are related
I started feeling exhausted on 10/22/22. Then, on 10/23/22, I woke up in the middle of the night to vomit and I ran into the glass slider and cut up my face. I went to the Emergency Room, and they ended up giving me a COVID-19 test and I tested positive. I was fatigued, nausea, congestion, and a sore throat. I was prescribed Paxlovid. I was sick up until 11/05/22.  All the symptoms were gone at this point except for fatigue. Then, in January, I got sick two more times. I had a sore throat, fatigue, and congestion. I took Sudafed and Mucinex. I got well for about a week and then got sick again and had all the same symptoms. I kept testing negative for COVID-19 at this time. Then, I got sick again on 2/26/23. I was throwing up and had severe diarrhea. I was sick until 3/2/23. In March, I had chest congestion again and took Sudafed and Mucinex. This lasted until 3/20/23. Then, it happened again, and I went to the Emergency Room. I had fatigue, congestion, headache, and chest congestion.  Then, in April, I was sick again with the same symptoms. Then, on 4/20/23, I got a what I thought was a stye in my eye, but it was a cyst.
My arm was sore the same night.  I had trouble sleeping on it for days. I was icing it.  It got worse and I had sharp pain when I tried to lift my arm. It would not go up     I assumed it was going to go away with time.   I saw Dr  (my PCP) a month later  He said it should not be still in pain and unable to be raised.  He said my shoulder was frozen.   I saw Dr. who said it was one of two things.   The shot was given into the bursa or the needle hit a vein which bled into the bursa which caused the impingement.  He has  me going  to therapy.   It is not helping at all
Pain and stiffness in left arm that evening applied hot compress 10/13 pain continued. 10/14 feverish and increased pain in arm and axilla.
Fatigue for 12 hours after receiving vaccination at 9:15 am.  Went to bed at 10:00 pm, slept all night, and felt fine the next morning. Slight discomfort (1 on a scale of 10) at injection site the next morning, which dissipated by noon.
severe diarrhea lasted 2weeks and 2 days. Self treatment with Brac diet, stayed hydrated. reduced stress. Lots of chicken soup broth. called physician  and assured her would follow up.
1. Nipple on L breast became dark purple; Nipple on left breast became dark raspberry color 2 days following vaccination. Cold to touch. No pain. No treatment. Subsided spontaneously after 2-3 days duration.  2. Chronic fatigue.  Energy levels still  have not returned to pre-vaccination levels.  Acute fatigue immediately following vaccination. Slept greater than 12 hours straight following each vaccination.  Constant acute exhaustion lasting  2-3 days following vaccination. Chronic fatigue persists. 3. Feeling of tightness around entire thoracic cavity is chronic and intermittent in intensity. No cardiac pain or symptoms. Lung function same as baseline.
Before having the vaccines patient also had had a nebulizer treatment which caused blood pressure to rise and made patient light headed.  Was feeling better before leaving the office about 2:30.  By 3:00 was feeling very tired and uneasy which got worse and continued into the evening. Took a 2 1/2 hour nap about 5:30 and woke up around 8:00 PM and had trouble speaking.  Patient had slurred speaking and stayed home from work because was very sluggish and couldn't speak clearly. Friday was fine. Saturday was very tired and right arm was warm and swollen when shot was given. Had a bad headache and was vey nauseous. Sunday was fine. Monday was broken out on back with insect bite hives mostly on the right side.  Same side as swollen arm.  Took Benadryl for three days and all symptoms disappeared.
An hour after 2nd Moderna vaccine, I had pain in the back of my neck. Swollen lymph node/nodes by collarbone and on neck - left side - same as injection site. Now two weeks later, still not going away.
At 1:33pm, nurse notified Lead Nurse about Pfizer Pediatric Monovalent vial lot#: FT1551 expiration date 11/30/2022 not being diluted with normal saline. At 1:21pm, client received his second Pfizer Pediatric Monovalent dose, administered in his left arm by nurse.  At 1:36pm, Lead Nurse notified Clinical Project Coordinator (CPC), about incident. CPC instructed Lead Nurse to notify on-call physician about incident.  On-call physician was notified at 1:41pm and provided Lead Nurse with the CDC Clinical Interim Clinical Considerations, "No diluent, resulting in higher than authorized dose.  With a recommendation:  Do not repeat dose. Inform the recipient of the potential for local and systemic adverse events." Lead Nurse spoke to client?s mother at 2:31pm and explained that client's received today?s vaccine at a higher concentration.  Client?s mother denied that client was experiencing any reactions or adverse symptoms or localized skin reactions. Client?s mother was given emergency precautions and verbalized understanding information that was explained.
About 3am the next morning I woke up to a loud ringing in both my ear.  When I sat up I was very very dizzy.  I got up and showered and my feet swelled very bad.  I did not feel well but I went to work but the feelings never got better.  So on 1/10 Sunday I went to the medical center because I jjust didnt not feel well.  The swelling in the lower legs was still there so I was prescribed 20 mg of presnisone for 5 days.  The sound changed during the time of the antibotics but after I stopped taking the prednisone the ringing sound came back, my left foot is still numb and my eyes are constantly red and burning even after putting drops in my eyes, I still suffer from headaches and if I turn my head too far left or right I get dizzy still to date.  On 1/14 I was given a 60 mg dose of tapered predinosone for 2 week to help elevate the symptoms but it did not work.  On 2/12 I saw an ENT specialist who performed a hearing test which did produce minor hearing loss and was diagnosed with having Tinnitis.
No adverse effects were noted; A HCP called to report that an expired dose of VAQTA was inadvertently administered to a patient on 4/10/2023 with an expiration date of 3/6/2023. No adverse effects were noted. No additional AE reported. No PQC.; This spontaneous report was received from an unspecified health care professional and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 10-APR-2023, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL (lot # W002894, expiration date: 06-MAR-2023) once (route of administration, anatomical location not provided) for prophylaxis.  No adverse effects were noted.
pt exp bilat conjunctivitis & scleritis p/vax;An ophthalmologist believes this to be r/t immune phenomena;eye cult yielded no growth;
This spontaneous report was received from a health care professional regarding a patient of unknown gender and age (reported as 1-year old child). The patient's relevant medical history, concurrent conditions, concomitant medication and drug/allergies were not reported. On 08-MAR-2019, the patient (reported as 1-year old child ) was vaccinated with 1 dose of GARDASIL 9 (strength, route not reported) lot # N035955 and expiry date: 09-OCT-2020, for prophylaxis (product administered to patient of inappropriate age and product use issue). No adverse effects were reported. The outcome of product administered to patient of inappropriate age, no adverse event and product use issue was unknown.
approx 2hr p/vax pt had sudden onset of dizziness w/spinning & light-headed & nausea w/o emesis & h/a; complete recovery w/in 48hr;
Exposed to pt with C pox during his incubation period. Pt now has 15-20 little red spots in face and arms x 24 hrs; denies fever, rash or other symptoms.
1 hour after #3 GARDASIL, developed facial and L arm erythema, slightly raised rash (cheeks, nose, forehead, behind ears). Tx'd with BENADRYL, Medrol Dose Pk.
nausea; vomiting; chills; headache; muscle aches; Pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle aches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (Pyrexia). At the time of the report, NAUSEA (nausea), VOMITING (vomiting), CHILLS (chills), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (Pyrexia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Body temperature: 100.2 (High) 100.2 fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Medications: medicines for diabetes and blood pressure.
sore left arm within 2 hours; rash on both arms within 8 hours; chills, headache, tiredness following day
This is a spontaneous report received from a noncontactable other HCP (patient). A 30-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 30, intramuscularly, in left arm, on Aug 30, 2021, at 10:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed hypoesthesia (more numbness in arms when sleep after the first dose), onset 2021, with outcome of recovering. No therapeutic measures taken as a result of hypoesthesia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
On May 13, 2021, approximately 4 weeks after second dose of the vaccine, I developed a very severe stabbing ice pick headache on the left side of my head behind my eye. By May 17, 2021, the pain was so severe that I went to the emergency room but did not receive a clear diagnosis. On May 18, 2021, I began to notice a prickly sensation on my forehead and rash forming. Urgent care confirmed diagnosis of shingles on evening of May 18, I was prescribed Valtrex, Gabapentin, and an oral steroid. As of today (May 21), the shingles rash is blistering on my left forehead, eyelid, and scalp and is mildly painful, and I have a few swollen lymph nodes, but the shooting nerve headache comes back intermittently and is still very uncomfortable. I feel that this should be reported because if people could be more susceptible to shingles after the vaccine, there should be public information about this. My case was very scary with the terrible shooting nerve pain in my head and I have learned that it is very important to get treatment for shingles started as early as possible to prevent long term effects, so I think this is something people should be made aware of.
Initially light soreness at injection site.  24 hours after injection significant soreness at injection site, chills, body aches, head ache, and fatigue.
Very dry eyes, more so than usual. Sometimes I have dry eyes due to contacts but this felt very unusual.  It occurred the next day after receiving Covid vaccine. It only lasted a few hours then went away.
Pt developed mild swelling, erythema and tenderness with some warmth to LUE. Seen in clinic 8/4/17 and recommended ice, motrin and benadryl PRN. Mom to f/u if needed. F/u call on 8/8/17 with no answer, mom to call back for any concerns.
Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of UNDERDOSE (Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patients may have received a Moderna bivalent booster dose of 0.25ml instead of 0.5ml).    Concomitant drugs were not reported. Treatment medications were not provided. This case was reported for patient 7 out of 17.   This case was linked to US-MODERNATX, INC.-MOD-2023-707980 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707980:Case for patient 1
Vaccines administered 06/28/02 pt went to ER 06/29/02 with seizures, undetermined cause of seizure-? vaccine, possible UTI with fever. First seizure began 06/28/02-went to ER with second 06/29/02.
Large red swollen area, warm to touch, approx 40mm circumference on L upper arm
On August 18, I was at work and my noses started to run. I took a test around 4PM and I knew my manager had COVID-19. My manager was home with it, but we all knew she had tested positive. It ran through our entire office. I went home and wasn't feeling the greatest tested for COVD-19 and it was positive. I then contacted the doctor through telehealth and was given PAXLOVID. Within 24 hours I was starting to recover. I felt bad all the way until Tuesday, and I was able to return on Thursday, August 25.
This spontaneous report as received from a healthcare worker, a Certified Medical Assistant (CMA), refers to a 24 year old female patient. The healthcare worker reported that the patient had received first and second dose of GARDASIL on unspecified dates, and the patient should have received her third dose in February 2013. The healthcare worker also reported that the patient was scheduled to receive the third dose " in the next few days". Additional information is not expected.
Case number PHEH2012US012755, is an initial spontaneous report received from a nurse on 25 Jun 2012: This report refers to 13-year-old male patient. He was vaccinated with MENVEO (batch number: M11073), intramuscularly, ten-days ago (unknown date). After vaccination, he experienced headaches. The event outcome and causality was not reported.
Within 3 hours post vaccination:- Conjunctivitis uterine contractions and start of menstruation on day 15 of cycle. fatigue;pain at injection site. Within 6 hours post vaccination:fever;chills;congestion;disorientation;severe bone and joint pain (systemic);muscle pain (systemic).
Fever 102 to 103 w/APAP from 13MAR92 to 17MAR92; On 16MAR92 began screaming, shaking, not sleeping, not performing developmental tasks, listless, leg quivering; Seen by MD 16MAR92 & given meds; MD felt was rxn to DTP;
I have recent had bowel and acid reflux issues. I am also very depressed. I consulted my primary doctor on these. My tummy is better now, and I am working with my doctor on depression / stress management. I have NOT been diagnosed with nor think I have had COVID since my vaccination, and my doctor did not suggest there was a direct relationship between my vaccine and these current health concerns. When the check-in app asked if I have had any recent medical issues, I answered generally and truthfully.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site scab in a 68-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th January 2020) for prophylaxis. On 9th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day after receiving SHINGRIX, the patient experienced injection site scab and injection site itching. On an unknown date, the outcome of the injection site scab and injection site itching were recovered/resolved. The reporter considered the injection site scab and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional reported that a patient developed small scabs around the injection site 1 to 2 days after receiving the SHINGRIX. The scabs were itchy.