chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate severity headache lasting about 4-6 hours. This occurred both ~24 h + ~48 h after dose administration. Eventually resolves with Ibuprofen 800 mg + Acetaminophen 1000 mg.
Patient experiencing what we consider to be a local site reaction (severe). 6 inch diameter swelling and tenderness over 48 hours post-injection. Little redness or warmth.
EMPLOYEE BECAME TIRED, RESTED IN CHAIR FOR > 10 MINUTES. Offered water. Resting and drinking water. After 15 minutes, she started screaming and clawing at her throat saying she can't breathe., She flopped herself onto the floor. Her extremities became rigid, seizure like.  (No hx. of seizures)  A code was called, Code team came assessed her and she was taken to the ED for further assessments.
From initial info received on 10/18/02, seven female employees were vaccinated on 10/15/02 and 10/17/02 with Fluzone. They experienced local reactions of redness, swelling and itching 24 hrs post vaccination. The facility physician prescribed Tylenol. From additional info received on 11/4/02 via fax from the reporter, four of the seven employees have been identified. Pt two is a 48 year old female who received a Fluzone (U0968AA), administered IM in the left deltoid on 10/15/02 at 2 pm. Reportedly two hours later the pt experienced an edematous left arm, red from top to elbow, hot to the touch and painful; chills with headache that lasted 24 hrs. The pt reportedly recovered from these events.
her friend was tested positive for COVID-19 about 2 months after received the full 2 doses of the Pfizer COVID-19 vaccine; her friend was tested positive for COVID-19 about 2 months after received the full 2 doses of the Pfizer COVID-19 vaccine; Her friend thought she had a cold but turns out she had COVID-19.; This is a spontaneous report from a contactable consumer via Pfizer. This consumer reported for a female patient that A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. It was unknown if the patient was pregnant. The patient medical history and concomitant medications were not reported. It is unknown if patient had COVID prior vaccination. It was unknown whether the patient received other vaccine in four weeks or not. Reporter's friend informed her that her friend was tested positive for COVID-19. About 2 months after she received the full 2 doses of the Pfizer COVID-19 vaccine. Her friend thought that she had a cold but turns out she had COVID-19. It was unknown if the AE required treatment. The patient was tested COVID post vaccination. The patient underwent lab test SARS-CoV-2 test which showed positive result. The outcome was all events were unknown.  Follow-up attempts are needed; Information about lot/batch number has been requested. .
itchiness of face and upper boy(abdomen, back, arms, neck);; redness on the face; itchy throat; headache; swelling of the face (eyes,nose, lips); This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: EN6208), via an unspecified route of administration in the left arm on 21Mar2021 at 10:30 (at the age of 53-year-old) as single dose for COVID-19 immunisation. Medical history included sickle cell, fibromyalgia, asthma. The patient was allergic to sulfa drugs. The patient had not received any medications in two weeks prior vaccination. The patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, the patient experienced minor itchiness of face and upper body (abdomen, back, arms, neck), slight redness on the face, itchy throat, headache and swelling of the face (eyes, nose, lips). The clinical outcome of the events itching, redness of face, itchy throat, headache and swelling of the face were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
She got her vaccine, she had no initial reaction.  A couple of days later she had a real bad pain on the left side of her breast, too painful to touch due to the tenderness.  on 10/31/22 she had a mammogram and everything came out all right, and felt that she was fine.  She went to have her get the COVID 19 vaccine today and the nurse told her to call us and report the previous vaccine issues.  The symptoms of her breast did go away and by the time she had her mammogram it was not hurting anymore.
noted that the moderna booster was not the bivalent booster but the original moderna. called the pt and informed her and she voiced no problems. provider was informed and office manager
This spontaneous report was received from an unknown woman via a company representative and refers to eight female patients of unknown age. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with GARDASIL (Lot#, expiration date and dose were not reported) intramuscularly to prevent HPV disease. Concomitant medications were not reported. The reporter stated that she heard that GARDASIL caused "thyroid issues". The outcome of thyroid disorder was unknown. The reporter considered thyroid disorder to be related to GARDASIL. Additional information is not expected as no contact details were provided.
itchiness on scalp; itchiness on back; appearance of hives on the back; back appeared red; nausea; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (itchiness on scalp), PRURITUS (itchiness on back), URTICARIA (appearance of hives on the back), ERYTHEMA (back appeared red) and NAUSEA (nausea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter. .     On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced SKIN IRRITATION (itchiness on scalp), PRURITUS (itchiness on back), URTICARIA (appearance of hives on the back), ERYTHEMA (back appeared red) and NAUSEA (nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, SKIN IRRITATION (itchiness on scalp), PRURITUS (itchiness on back), URTICARIA (appearance of hives on the back), ERYTHEMA (back appeared red) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.
Flat red rash approximately 3 inches in diameter surrounding injection site  (looked like petechiae) with extreme itching for 2-3  days.  Notified appropriate local site to report reaction. No more symptoms after 3 days.  Unknown if caused by the Covid vaccine as it occurred 8 days after injection.
PT devolved occulsive DVT to left femoral vein; This is a spontaneous report received from a contactable physician. A 77-year-old male patient received second dose of BNT162B2 (Batch/Lot number and expiry date was not reported), via an unspecified route of administration on 24Mar2021 at single dose in the left arm for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included azithromycin (Z-PAK) taken for an unspecified indication, start and stop date were not reported. The patient experienced "devolved occulsive DVT to left femoral vein" on 24Mar2021 with outcome of unknown. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of occulsive dvt to left femoral vein which included apixaban (ELIQUIS). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event "occlusive DVT to left femoral pain" with BNT162b2 can not be fully excluded.  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.
Gave vaccine at 10 AM. By 3 PM symptoms (muscle weakness and tingling in hands) started. Pt. wife called me, I referred to ER to r/o Guillain Barre. ER physician didn't think it was G-B.
Developed blood clot in superior Mesenteric Vein; This is a spontaneous report received from a contactable consumer other non-health care professional (the patient).   A 57-year-old male consumer received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: EN6203; Batch no: not reported) via an unspecified route of administration in left Arm on 16Mar2021 02:00PM (at the age of 57-years-old) as dose 1 and BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot Number: ER8233; Batch no: not reported) via an unspecified route of administration in left Arm on 06Apr2021 11:00 AM (at the age of 57-years-old) both as single for covid-19 immunization at hospital. The patient medical history was not reported. The patient concomitant medication included medications received within 2 weeks of vaccination Omeprazole (PPI) and Atorvastatin both for unspecified indication from unknown date and unknown if ongoing. The patient Known allergies was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On an unspecified date in 2021, patient developed blood clot in superior Mesenteric Vein. Adverse event result in Emergency room/department or urgent care. Patient was hospitalized for 3 days. Seriousness was reported as serious with hospitalization. The outcome of event was unknown.   Follow-Up (09Aug2021): Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a healthcare worker (also reported as secretary) regarding a 25 year old female patient. The patient had a medical history of osteomyelitis of the hip at four years of age (approximately in 2002). The patient had a history of local reaction (unspecified) while on prior therapy with VARIVAX (Merck) (reported in MARRS # 1407USA000891). On 27-JUN-2014, the patient was vaccinated at the camp check up with GARDASIL (dose, frequency, route, product lot/ expiry date unknown) and shortly after passed out (Hospitalization). The secretary stated the patient "eventually came to but then she had a terrible headache and we had to keep the lights off". The secretary stated Emergency Medical Team (EMT) was called and the patient was taken Emergency Room. The secretary stated she did not know how the patient was currently doing or if she has been admitted to Medical Center. When asked if the patient had any drug reactions or allergies the secretary reported that the patient had an unspecified local reaction after receiving VARIVAX, on an unspecified date (reported in MARRS # 1407USA000891). No treatment was given. No lab diagnostic studies were performed. The patient's present status was unspecified by reporter. The outcome of event was unknown. No product quality complaint (PQC) was reported. Additional information has been requested.
Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was 92 and a resident at facility when he passed away. Patient has been LTC resident since 2/15/2019 and received hospice services prior to receiving first Pfizer vaccine dose. Patient receiving hospice care for terminal colon cancer.
45 mins post inject fell asleep to the following afternoon (12PM) & again until 530PM; 530PM on 27OCT93 noticed: redness, swelling & tenderness @ the inject site achiness, over entire body; ice applied to inject site, APAP given;
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 3/31/2021 and 4/29/2021. Patient presented to outside facility ED on 9/30/2021 with chief complaint of feeling ill and fever of 2-3 days duration. Patient also had slight dry cough, diagnosed with COVID, and discharged home. On 10/2/2021 patient presented to ED with c/o SOB, chills, and generalized weakness that had been ongoing for 3 days PTA.  Pt had also had hematuria and increased urinary frequency. ED workup revealed BUN 24, sCr 1.4 and thrombocytopenia, While in ED, following the Regen-COV infusion  He became hypoxic requiring  15L/min O2 and syncopal episode lasting <30 seconds. He was admitted to med-surg for acute respiratory failure.  On 10/10, his clinical course was complicated by worsening respiratory distress and he was transferred to ICU for further management. On 10/14/2021 patient required intubation and mechanical ventilation support. On 10/23 patient required multiple vasopressor support. On 10/24 family decided to transition to comfort care and patient expired on 10/24/2021.
Severe vomiting (at least 8 times) and diarrhea in the evening. Elevated temperature (99.2-99.5°F) with chills and other fever-like symptoms. Muscle ache around injection site, but no redness or swelling. The morning after, experienced mild fever (temperature 100.3°F) and fatigue.
Fever 101.5 for 3 days chest pain SOB heaviness in chest upon exertion since 02/19/2021 to present
red-raised rash on face, neck & chest as reported by mom; DPH given;MD recommends no flu shot d/t allerg rxn (rash)
This Case was reported by the mother of a consumer and described the occurrence of skin reactions (dermatological reaction) in an 8-year-old male subject who was vaccinated with influenza virus vaccine (flu vaccine, Glaxosmithkline). A physician or other health care professional has not verified this report. Concurrent medications included multivitamins. On 30 October 2006, in the afternoon, the subject received unspecified dose of flu vaccine at .25ml in an unknown arm. Two to four weeks after vaccination with flu vaccine, the subject developed what the mother referred to as a Dermatological reaction (skin reactions). A systemic reaction. He developed lesions (described as a nummular) on his hand, wrist, arms and the back of the ankles. It had been called eczema as well as some other Unidentifiable term (spongia). The condition responds to steroids, but when they are stopped the symptoms return. The subject has also been treated with Mupirocin and this worsened the lesions. The child has reportedly seen several dermatologists as well as allergists. He was tested for everything and it all comes back negative. The first flu vaccine the subject ever received was by Aventis and he ended up with over 300 lesions. At the time of reporting the outcome of the events was was unspecified. This was also considered to be a medication error as Glaxosmithkline flu vaccine in not indicated for use in pediatric subjects. These events occurred again in this subject in 2007 following vaccination with a Glaxosmithkline flu vaccine. Refer to case number A0739862A for details surrounding the second report.
Pain in legs and back after 15 days/30 days. Shortness of breath 45 days. Pulmonary Embolisms 45 days. Chest pains-45 days. 9 months treatment-DOVENOX and WARFARIN.
almost immediately after recieving the shot I noticed pain in my arm and shoulder, not stiffness...pain. Throughout the afternoon it worsened, coming in waves and throbbing.  I took extra strength Tylenol. No relief. About 5:00 I began to feel slightly feverish, congested with a headache. After having had these shots every year, I did not relate these symptoms to the shot. The painful arm was an obvious reaction. Later in the evening, I became nauseated, pale and clammy. I did vomit once. Applied a cool compress and went to bed. Today, the arm pain is still evident, however not as severe. The nausea is faint and I have a nasty taste in my mouth.    I wanted to make you aware of the reaction in the event that I was not alone and this could possibly be related to the batch that was asministered. Please contact me if necessary.
Face cheeks and chin had a rash, burning, red, and bumpy. This started the next day after my second vaccine. I went to my dermatologist later that day and got a topical prescription steroid cream. Most things cleared up within a week but I still have pink cheeks.
I experienced the following side effects for both SHINGRIX shots: Tiredness, headache, shivering, fever, no appetite, flu-like symptoms. After the second SHINGRIX shot I also had a pain down the right left from my knee to my toes. The pain started three days after the shot and lasted three days. It was so severe that I went to Urgent Care on the third day and the doctor could not identify what caused the pain. I was referred to a osteopathic specialist on the fourth day (since the shot) but by that morning, all the pain was virtually gone. I went to the appointment anyway and the doctor could not identify the cause of the pain. By the fifth day after the shot, the pain was completely gone. I would also like to note that I had my second SHINGRIX shot in my right arm and the pain was also on my right side (down the outer side of my right leg). I did not injure my leg in any way leading up to this event. The pain came suddenly and left as quickly with no other lingering effects.
Swelling in left arm size of a baseball very red and sore. After not  even one hour of receiving vaccinations body felt weak had chills and fever. Next day had no energy body aches and no taste.  Headache and nausea.  Lasted for about 4 days.
Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 called. Had right arm pain and loss of consciousness. EMS got 180/104 BP and blood glucose was 122. Was transported to hospital. Returned to the facility the next day with no complications,  was just fatigued.
Pt given rabies vaccine Friday, Nov 12, presented today 11/18/99 with headache and nausea.
Dysmenorrhea and menorrhagia since 7/07.  Her 1st HPV was 4/07, 2nd 6/07 and last 10/07.
no adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 55-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    No concomitant medications were reported. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not provided.
Mon. 8/2 in the evening unusual heaviness in my chest, shallow breathing.  Tue. 8/3 in the evening about 10pm panic attack. First ever panic attack. Recorded temp in the ambulance was 100.6. Resting heat rate of 165. Involuntary leg convulsions starting at my hip flexors. Almost like repeated Charley horses that stopped and started at random.  According to ER nurse I had a panic attack related to marijuana consumption and preexisting anxiety.  I think it's worth noting that I've had anxiety for 15 years and I've smoked weed for 10. I have never had a panic attack. I have never had trouble breathing. I have never suddenly out of the blue had a resting heart rate of 165.   Since the "panic attack" I haven't been able to breathe normally. My chest has a constant heaviness. I am gasping for air and yawning all day, and not because I'm tired, it seems to be my body's effort to get adequate oxygen into my lungs.
Give in wrong site. Swollen, red and hot. On right arm. Treatment was cephalexin. We talk to nurse and give her paper with what site to give shots in.
PATIENT IS 17 YEARS AND 3 MONTHS OLD AND WAS GIVE A PFIZER BOOSTER SHOT-( NO UNUSUAL SIDE EFFECTS WERE REPORTED)
Presented to ED w/AMS; admitted for COVID-10 pna; did not require O2 therapy; tx w/abx, melatonin, zinc. Regarding the patient's COVID infection, the patient's clinical course was mild. He was not hypoxic and did not require supplemental oxygen throughout his hospitalization. He completed a course of intravenous ceftriaxone and intravenous azithromycin. No further isolation is required post-hospitalization as he is greater than 10 day from date of diagnosis.
This was my first Covid-19 Vaccine. Within about 3 hours of the injection I began to experience numbness and tingling in my hands and in the left side of my face.  It lasted for about 24 hours.  It was significant enough that I had to move my hands continually to be able to use them to grip something firmly.
Pt felt right sided nasal congestion after flu vaccine, followed by fell lousy, emesis x1, chest tightness. HX of same when dry weather/winds. Uses inhaler PRN.
Sore throat; swollen lymph glands; joint pain; low grade fevers; high blood count 12.5; neuralgia, h/a, lethargic; all w/in 1 wk to 3 yrs p/vax; alot of viral infections & viruses till today;
shortness of breath, pain in legs specifically hip and knee joints. fever of 103. cold sweats, body aches. extreme headache. hallucinations