chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 3 am on the 23 of April I woke with chills, headache, and a large red welt at the injection site. Between then and the end of the week I was alerted by my Apple watch that my heart rate was elevated (above 100bpm) when at rest. The highest I remember was 125. My arm remained red and swollen at the injection site for several days and then became itchy. The redness finally faded, but the vaccination site is still visible. I did see my cardiologist later in the week, but this was a previously scheduled appointment and by then my blood pressure was back to my normal.
Information has been received from a registered nurse concerning a 5 year old female who on 3/16/01 was vaccinated SC with a 0.5ml dose of varicella virus vaccine live. On 7/8/04, it was reported to the physician's office that the patient developed breakthrough varicella. Unspecified medical attention was sought. It was noted that therapy with varicella virus vaccine live was discontinued. A product quality complaint was not involved. No further information was available. The nurse also reported that the patient's female sibling had a similar experience after therapy with varicella virus vaccine live (WAES0408USA00470).
Had TDAP on 02/14/11. Pt's father states on 2/15 the site became red and swollen site became more red and swollen and hard on 2/16 and 2/17. Dr. recommended warm compresses, antibiotic, TYLENOL & Ibuprofen for treatment. If isn't improving after 2-3 doses of antibiotic to come back for further treatment.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that 5 had received FLULAVAL and had experienced injection site pain. This is case 2 of 5 (see case IDs A0949586A, A0949594A-A0949596A for details of the other reports).
Within an hour or so, became severely congested; was like sinuses filled with cement. Could only breathe through mouth, and felt short of breath as result. Later developed cough which lasted for several days. Felt as though my seasonal allergies had been turbo-charged. Some fatigue. The next night had low fever (99F; but I usually run a little over 97F).  Injection site hurt upon movement for 48 hours. Resolved, but several nights later (day 4 or 5) had tingly pain at injection site that woke me from sleep, and persisted into next day.
erythematous patch that is 8x8cm in largest diameter with smaller areas of extension of the erythema beyond the main rash on right thigh where PCV was injected.  Rash began approximately 15 min after vaccine administration, while she was still in the exam room.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician).  An 80-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 04Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 17Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 80 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: other medical history: hypertension controlled with meds; "atrial fibrillation" (unspecified if ongoing), notes: other medical history: atrial fibrillation controlled after 2 ablations. Concomitant medication(s) included: LISINOPRIL; ATORVASTATIN, start date: May1985; HYDROCHLOROTHIAZIDE; TAMSULOSIN; ASPIRIN [ACETYLSALICYLIC ACID]; GAVISCON [ALGELDRATE;ALGINIC ACID;MAGNESIUM TRISILICATE;SODIUM BICARBONATE]; CHOLECALCIFEROL; VITAMIN D3; CRANBERRY; GLUCOSAMINE SULFATE; REFRESH TEARS. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jun2022) Positive; (16Jun2022) Negative; (20Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course: Yes the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. Yes the patient previously receive a COVID-19 Vaccine. There is no known allergies. Positive test on 09Jun2022 with mild URI symptoms. Paxlovid 09Jun-13Jun, resolution of symptoms after 3 days. Negative test 16Jun. Recurrent symptoms, worse, 20Jun. Positive test 20Jun. Other medical history: hypertension controlled with meds; atrial fibrillation controlled after 2 ablations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The company cannot completely exclude the possible causality between the reported COVID-19, which is considered as failure of vaccine BNT162B2, and the administration of BNT162B2, as the efficacy of a vaccine varies individually and may be affected by different factors including drug potency.
Information has been received from a RN concerning a 56 year old healthy female who was vaccinated with a first and second dose of hep b virus vaccine rHBsAg (yeast). Subsequently, several days after vaccination with the first dose the pt developed fever and headache. The pt experienced fever and headache 5 days after the second dose. Unspecified medical attention was sought. No product quality complaint involved. No additional information is expected.
This study case was received from the investigator on 12 September 2012. A female subject experienced chest pain and palpitations on 27 August 2012, five days after the subject had received on 22 August 2012 the following vaccines: ACAM2000 (lot number and route of administration not reported), an injection of TYPHOID VACCINE (lot number, route and site of administration not reported), an injection of INFLUENZA VACCINE (lot number, route and site not reported) and an injection of ANTHRAX VACCINE (lot number, route and site of administration not reported). The subject experienced palpitations, chest pain and pressure after physical training (PT) /exercise that was relieved by sitting down. The one time episode lasted approximately 2 hours. According to the investigator, it was unlikely to be cardiac in nature. The subject had an ECG done on 30 August 2012 which was normal. Rapid troponin on 30 August 2012 was also normal. The subject had no past medical history and no cardiac history. Concomitant therapy included BURN 60 once daily. No further information was available at the time of the report. The subject's outcome was recovered on 27 August 2012. According to the investigator, chest pain and palpitations were remotely related to the trial product. Documents held by sender: none.
11/04/2021 Patient reported to ED after experiencing altered mental status, weakness, fatigue, loss of appetite, nausea, vomiting, body aches, and chills approximately 10 hours after receiving her 3rd COVID-19 booster. Patient stated she experienced similar symptoms after receiving her second COVID-19 vaccine. Patient was admitted to the hospital 11/5/2021 2:09am Patients symptoms improved and she was discharged 11/5/2021  5/13/2022 Patient experienced fever, shortness of breath, and drowsiness after 4th COVID booster.
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. Pertinent medical history and drug reactions/allergies were unspecified. Concomitant medications were reported as none. In 2008, the patient was vaccinated with ZOSTAVAX, (lot #, strength, dose and frequency not reported). On an unknown date (also reported as recently), the patient experienced an episode of shingles. The outcome of an episode of shingles was reported as recovered. Causality assessment was not provided. The patient sought medical attention. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Diagnosed with sixth nerve palsy; Diarrhea; Headache; Nausea; This is a spontaneous report from a contactable consumer. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686 and expiry date: Mar2021), via an unspecified route of administration on 02Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included hypertension.  Concomitant medication included cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), calcium (CALCIUM), rosuvastatin (ROSUVASTATIN). The patient experienced double vision and diagnosed with sixth nerve palsy on Jan2021, diarrhea and headache and nausea on 2021. The reporter stated "I am calling in reference to reporting possible side effect or adverse reaction to the vaccine. It is in reference to my mother, she had the first dose on 02Jan2021 and 14 days later, she started with double vision, ended up in the hospital. She was in the hospital 4 days (4 nights), diagnosed with sixth nerve palsy." The patient was hospitalization from 18Jan2021 to 22Jan2021. Reporter stated, "She was in hospital, she has visiting nurse now for physical therapy that comes to house and they going to redraw her labs tomorrow Wednesday. They were basically normal, all the lab results were normal." Therapeutic measures were taken as a result of double vision, diagnosed with sixth nerve palsy. Outcome of the events was unknown.
Chills - lasted 16 hours  Bad Headache - still have Nausea - lasted 14 hours Vomiting - lasted 13 hours  muscle aches - still have exhaustion - still have
Still feel awful most days not myself; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Still feel awful most days not myself) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Still feel awful most days not myself). At the time of the report, FEELING ABNORMAL (Still feel awful most days not myself) 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.  No treatment information was provided.
About 2 hours after receiving my first Pfizer Covid 19 vaccine, I started getting pins and needles in my hands and feet, It was constant for about 72 hours, and then became off and on since then. It is not 2 1/2 weeks later and I still have the off and on pins and needles daily. I'm concerned about getting my second dose, as I am afraid the pins and needles will get worse. I'm also afraid the pins and needles won't go away. Other side effects were a fever the day after my vaccine, that lasted 24 hours. Headache for 4 days, and body aches for 2 days.
Pt. developed fever and chills. Myalgias, severe pain and swelling in arm at injection site. Feels like he has the flu. Never had a reaction like this before following vaccinations. Painful to move arm.
TIA; Slurred speech; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Apr-2021 to 07-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 07-Apr-2021, TRANSIENT ISCHAEMIC ATTACK (TIA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications and treatment information was not provided by the reporter.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD21-087942 (E2B Linked Report). This case was linked to MOD-2021-114502 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD21-087942:2nd dose
stroke; Paralysis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and PARALYSIS (Paralysis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and PARALYSIS (Paralysis) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) and PARALYSIS (Paralysis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Caller reported that her father had Stroke and Paralysis after taking the vaccine. No treatment medications were reported. COMPANY COMMENT: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) events of Cerebrovascular accident (AESI) and paralysis, which occurred after dose mRNA-1273 administration, which was unknown dose in COVID-19 vaccination schedule. Latency cannot be assessed as date of vaccination and events onset dates are not known. No further clinical information or details about course of the event was provided for medical review. The outcome of the events was not known at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per the  Medicines Agency list of important medical events.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected, serious (medically significant) events of Cerebrovascular accident (AESI) and paralysis, which occurred after dose mRNA-1273 administration, which was unknown dose in COVID-19 vaccination schedule. Latency cannot be assessed as date of vaccination and events onset dates are not known. No further clinical information or details about course of the event was provided for medical review. The outcome of the events was not known at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events' seriousness was assessed as per the Agency list of important medical events.
neuropathy in my hands and feet; had an old Lyme disease infection(probably a year old); general ache and pain; joint stiffness; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Apr2021 (at age of 52 years old, Lot Number: ER8729) as a single dose for covid-19 immunization. The patient medical history was not reported. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously took the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), on 19Mar2021 (at age of 52 years old, Lot Number: ER6201) for covid-19 immunization. After getting the second dose of the COVID-19 vaccine, on 10Apr2021 the patient experienced general ache and pain, joint stiffness, fatigue, headache, and neuropathy in his hands and feet, which, per the guidelines, were normal side effects of the vaccine. However, when these symptoms still did not disappear after two weeks, he went to the Urgent Care on 26Apr2021. Blood test taken at the Urgent Care showed that he had an old Lyme disease infection (probably a year old). He was treated with Doxycycline for 3 weeks, but his condition never improved and the symptoms persists to this day. Since the Urgent Care visit, he had been evaluated by a neurologist, a hematologist/oncologist, an infectious disease specialist, a rheumatologist; none of them found any problem. He had done numerous blood tests and a full MRI of the spinal column and the brain. All of the tests came back normal. The patient underwent lab tests and procedures which included covid test type post vaccination, Blood test on 26Jul2021: Negative, Nasal Swab PCR on 26Aug2021: Negative. The patient was not received treatment (except Doxycycline for Lyme disease infection). The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The outcome of the events was not recovered.
Approx 3 hrs after vaccine was given the infant developed a red raised linear warm area across the area of the thigh in site where the Hib vaccine was administered. The area remained red and warm for 2 days and then appeared bruised with no other residual effects.
patient did not feel well 2 minutes after vaccine and started to lose consciousness.  Called 911 and administered 1 dose of epipen 0.3mg's.  Was feeling better after the epipen, however we do not think it was an allergic reaction
nonSTEMI (heart attack) required angiogram, in hospital for 3 days
The patient is 17 years old, underage to receive this vaccine product. When realized, the patient had left. Calls were made to the patient on 1/28/2021 with a voicemail to return this call. Parents were called on 1/28 with a voicemail left for. COnversation on 1/29 with the (father) and they were aware, his mother took him and are OK with the fact that he received the vaccination.  The second dose administered on 2/25/2021, per Dr. and parental consent.
12/14 around 3 after napping my 1 year old woke up a high fever 102 and cheeks tomato red.  The rest of the day he refused to eat or nurse. Day 2 fever and red cheeks still refused food, would nurse and have bottle. He refused to be put down, unlike his usual active self. Day 3 fever goes to 101.7 rash on cheeks lighten a little. Day 4 no fever. Rash on cheeks and now body, little appetite and clingy. Day 5-7 mirror day 4.
Received first vaccine, Moderna, on 01/28 . Received 2nd vaccine, Pfizer, on 02/25.
Apprx. 1-2 hours after vaccines, pt became very white, lips turned blue, and he almost passed out. I gave him juice and took him to the doctor's office. Seems okay, but it has happened 2 x's since.
My husband was scheduled to receive the first Shingrix vaccination and was given the Pfizer COVID-19 vaccination instead (in error).  He had already received both doses of the COVID-19 vaccination.
Swelling in my knee that require physio therapy, severe pain in my right wrist with ganglion, and left elbow area.
Nausea and vomiting daily for six months, muscle weakness, joint pain, sharp stomach pains, dizziness, loss of appetite, migraines, subconjunctival hemorrhaging, chronic fatigue syndrome, arthritis.
Patient was given an expired PCV23. Patient held in office for approximately 10 minutes. No adverse reaction noted.
5 hours after shot, fatigue set in and a warm feeling in head. About 1 a.m. that night, now Sunday morning I was awoken with a massive migraine. Felt heavy pressure in head, thought I had a blood clot in paranoia.  Ate 4 Tylenol to soothe the massive throbbing headache (one I have never had in my life before, comparable to the worst hangover you could ever have x10). I was well hydrated drinking water and Gatorade through the night. If the Tylenol did not subside the pressure in my brain I would have gone to the Emergency Room that night, that is how severe and unworldy it was for me. Sunday awoke at 10 to see my daughter for my weekly visit. About 1 hour in I call it short and proceed to go home and rest as I had felt extremely exhausted and a massive mental fog over my mind. I hydrated again that a.m. with pedialyte and water. Slept close to 20 hours on Sunday. Monday I woke up feeling a bit off mentally, still with persistent body aches, joints I don't normally ever feel aches in were sore  but i took it slow and did not really complete anything that day, called out of work to try to fully recuperate. Tuesday, I wake up feeling no brain fog not really fatigued mentally atleast. I walk into work notice a bit of physical exhaustion from ordinary walk into work, felt warm in a.m. My lunch break began now I had to ascend 4 flights of steps in parking garage which I normally do with ease, except this time I was winded like I did a mild workout. As I'm driving in my car with a.c on I notice I still feel warm, I go home and take my temperature to discover it was at 101.1 f.. I subsequently called out of work for rest of day, took Tylenol and temperature slowly subsiding. Note: I am a 31 year old male (life time of exercise through sports/military/hobby, I currently exercise 4 to 5 times a week. Run on average 4 to 5 miles a week with 30 min weight training. I have no underlying health conditions. Days before vaccine I was feeling healthy as can be, as of right now muscle aches and mild fever persists close to 72 hours post second dose vaccine .
ACHING BONE PAIN IN LEFT FOREARM, NOT JOINT PAIN - COMES AND GOES.   SEEMS TO BE FURTHER APART AS TIME GOES BY.  ALSO HAD THE NORMAL TIRED, CHILLS AND PAIN IN ARM FROM INJECTION AS THE FIRST ONE DID.
Pt received the 1st dose of Moderna and developed severe onset of vertigo 3 days later along with chest pain and shortness of breath. Shortness of breath and chest pain resolved but vertigo persisted until improved 7/21/21.  Follow up visit 7/21/21 with his PCP. Vertigo has gradually improved.
Client came to clinic for zoster vaccine had prescription from doctor on 1-26-16 stated she felt some soreness that evening on the 1-27-16. Had small area quarter size redness and swelling - 1-28-16 - large area of redness noted - warm to touch may use cool compress.
patient's caregiver reported patient "hot"! took off coat + hat + mask. Face appeared red around nose, upper lip + cheeks. Inspected full upper body (back, neck, stomach, arm, inj. site) - no rash or abnormalities, Redness gone after 10 minutes. Treated anyway w/25 mg Benedry, 40 mg Pepcid AC. Monitored for 45 mins + released.
Shortly after shot, my arm started to swell and get red and itched a lot -hives (pneumonia shot). Pt. does not have and cannot get the info req.