chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke up at five a.m. nauseous, migraine. Tried to eat something. Felt like morning sickness. (No way I'm preggo- tubes removed). Vomit 6:45am, chills, joint pain, muscle ache fatigue, headache, nausea all day. Bridge of nose hurts, ears hurt throat hurts feels like drainage. No fever. Greenish color to my face. Heating pad, rest, water, Advil 4:30 pm and hot bath.
This is a spontaneous report from contactable consumer (patient). A male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported, expiry date: unknown), via an unspecified route of administration on an unspecified date, in Feb 2021, single dose, for COVID-19 immunization. Patient's medical history included inflammation from tumors in his neck (receiving chemotherapy and often gets congestion that interferes with breathing). Concomitant medications not reported. The patient reported, he had both shots. The last was 13 days ago. He wants to take an antibiotic but wanted to make sure it won't hamper with the vaccine. He reports these symptoms as normal for him but reports his only side effects from the vaccine was "it felt like someone took a baseball bat to my arm afterwards," on an unspecified date. Outcome of the event: unknown. Follow-up attempts completed. No further information expected.
Shaking uncontrollably, accelerated heart rate up to 110, crying, sudden pain in right leg, feeling cold
patient received  1.0 ml  of Fluzone Quadrivalenton, no AE; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA297927, 2019SA317307, 2019SA317358, 2019SA317359, 2019SA317360, 2019SA317361, 2019SA317363, 2019SA317364, 2019SA317365, 2019SA317366, 2019SA317367, 2019SA317368, 2019SA317369, 2019SA317370, 2019SA317371, 2019SA317372, 2019SA317373, 2019SA317374, 2019SA317375, 2019SA317376 (same reporter).  This case involves a 33 years old patient (gender not reported) who received a 1.0 ml of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [Fluzone Quadrivalent] (lot UJ223AB, expiry date not reported) via unknown route in unknown administration site (side reported as right) on 22-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of overdose.   At the time of reporting, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I woke up early at 5AM, realizing my heart was racing, and I had irregular pulse. I took my blood pressure, and it was really high and pulse rate was over 170. I called 911 and an ambulance took me to ER. They gave meds in an IV and couldn't stop it. I got a cardio shock under a sedative and more meds. Then they just kept pumping in more meds. I was there about seven hours. I finally got to a normal sinus rhythm, and they gave me meds to take. ELIQUIS and amiodarone to prevent blood clots and stop the AFIB. Also, the referral to see the Cardiologist, that agreed for me to stay on the medications prescribed from the ER. Sometime in January 2022, I will have a catheter ablation of the left atrium.
This case was reported by a consumer and described the occurrence of lung infection in a 47-year-old male subject who was vaccinated with Influenza vaccine (manufacturer unspecified) and FLOVENT 44 mcg hfa-cfc inhaler for asthma. A physician or other health care professional has not verified this report. Concurrent medical conditions included asthma, lung infection, muscle pain in back and neck pain. Historic medications included Prednisone and AUGMENTIN. On an unspecified date in 2013 the subject received unspecified dose of Influenza vaccine (unknown). In 2013, at an unspecified time after vaccination with Influenza vaccine, the subject experienced "getting worse quickly" with lung infection, muscle pain in back, neck pain exacerbation. The subject was hospitalised. The subject was treated with prednisone. In March 2013 the subject was re-hospitalized because he continued to be sick. He started Fluticasone propionate at 2 puff (s) twice per day and also received prednisone. In 2013, at an unspecified time after reducing Fluticasone propionate, the subject experienced withdrawal symptoms, the return of muscle back pain and neck pain. At the time of reporting, the outcome of the aggravated lung condition and sick were unknown; the aggravated muscle pain in back, neck pain exacerbation and withdrawal symptoms were unresolved. Patient stated that he's always had asthma. He had a bad lung infection in November 2012 with pain in his muscles in the back and the back of his neck. He went to the physician's office and he had prednisone and AUGMENTIN to try to kill his infection. He got better with this treatment, but the symptoms came back when he went off these medications. At an unknown date, he was still sick with the same symptoms and patient stated that he should not have had the flu shot under those conditions. However, at an unknown date he received the flu shot, he got worse quickly and was hospitalized. At the hospital he was given prednisone. He continued being sick and was hospitalized again in March 2013. At the hospital he got more prednisone as well as FLOVENT HFA prescriptions. He was also seeing by some respiratory physicians and was asked to cough up to take a culture and examine it. He has to make an appointment with the clinic to find out the results. Patient said that he discontinued taking prednisone in March 2013 after being on prednisone for three months. He weaned off the prednisone well and did not have any side effects from taking prednisone. Patient said that FLOVENT helped him with his symptoms. However, he's been trying to wean off the medication since it's so expensive and he has no insurance. At an unknown date patient has been taking one puff once a day. Patient said that every time he skips the medication his symptoms of having pain in the muscles of his back and the back of his neck come back. As soon as he takes one puff of FLOVENT, these symptoms go away. Patient believes he is having symptoms from withdrawing the FLOVENT treatment.
Numbness/Tingly/Pins and Needles sensation for over 24 hours starting two hours after shot.  Sensation was felt in face, lips, arms, hands and legs.  Took Benadryl at hour 18 and feeling finally subsided.
Patient admitted as observation on 8/9 due to Sepsis (*) 2/2 CAP. Patient was tested for COVID-19 and was positive on 8/9.
Tired for last couple of days after the vaccine; Heart racing; Panic attack; concerning because it seems something that can cause like inflammation of my heart muscle or inflammation below outside of my heart.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: SE3592), via an unspecified route of administration on 14Sep2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date in Sep2021, after second vaccination, the patient experienced tired for last couple of days after the vaccine, heart racing, panic attack and was concerning because it seems something that can cause like inflammation of heart muscle or inflammation below outside of heart. Clinical course included: patient had the Pfizer vaccine on Tuesday and didn't have any really side effect or anything. The patient doesn't know if the patient was having any side effect now; was not exactly sure what was going on. When probed for the side effects, it was reported that like the patient was just really tired for last couple of days and has been getting heart racing, was that means like a panic attack it just happened for about 20 minutes ago as well and the patient doesn't know if maybe like doing something or if it was the vaccine does something to heart or vaccine making it; the patient was not exactly sure what's going on, don't know if that was like the side effect or not. When paraphrased the concern, it was reported that the patient was concerning because it seems something that can cause like inflammation of heart muscle or inflammation below outside of heart. It was with the second dose of the vaccine. It was reported that the patient was ok right now. The outcome of events was resolved on an unspecified date in Sep2021.  Follow-up attempts are completed. No further information is expected.
Information has been received from a 61 year old female patient who in October 2008, was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not provided). The patient stated that she received the vaccine and 24 hours later she became very ill and was hospitalized. She was very disoriented and sick. Health Care Professional at hospital determined it was ZOSTAVAX (Merck) that caused her to become ill. The patient has sought medical attention. At the time of this report, the patient was recovered. Additional information has been requested.
Information has been received from a pharmacist referring to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date the patients was vaccinated with RECOMBIVAX HB. The pharmacist stated that the patients received the second dose in the series of three doses of RECOMBIVAX HB later than the recommended dosing schedule interval on unknown dates, resulting in negative titers on unknown dates. It was unspecified if the patients sought medical attention. The outcome of hepatitis B surface antibody negative was unknown. Additional information has been requested.
A male consumer reported that he received an injection of smallpox vaccine on 2/22/1972 at 17 years of age while in the military. On 3/2/72, he experienced a low grade fever and back pain. He was seen at the base clinic where a diagnosis of suspected kidney infection was made. He was treated with ampicillin. A urine culture showed no growth; however, he continued to become very sick. He was admitted to the base hospital on 3/5/72 with a temperature of 102 degrees F. An IV pyleogram showed right kidney damage. A radiocystogram performed on 3/10/72 showed no reflux and he was released on 3/10/72 without further treatment. He reported that he continued to experience pain and inflammation of the right kidney, without infection, over the next 30 years. He also noted that he developed heart problems over the years. A thallium stress test on 10/02, showed blocked arteries. A computerized tomography was performed. Results of the scan showed no lower gastrointestinal problems; however, did show an incidental finding of a mass on the right kidney. A biopsy showed a T1 cancerous mass on the right kidney with no nodes or metastases. The right kidney was surgically removed on 4/2/02.
Shortness of breath, especially with exertion. Dizziness and elevated sugar levels (A1C)
first shot 18 months ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 91-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 18 months before reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-May-2022 Reporter's Comments: The patient self-reported this case. The patient had first shot of Shingrix 18 months before reporting and wanted to know if he/she needed to start all over with 2 shots or would 2nd shot only still be effective. Additional Supportive Information: The patient did not receive the 2nd dose of Shingrix till the day of reporting, which led to incomplete course of vaccination.
Pt experienced induration & tenderness in a 12X12cm area at site of injection in lt upper arm after receiving Typhoid vax. Red, tender streaks radiating to the lt axilla, dx as lymphangitis. Vac administered other pts w/out adverse effects.
there was a bump and bubble on his arm and it started to get hard; there was a bump and bubble on his arm and it started to get hard; the needle bent/it went into the fat of the arm and not the muscle; This is a spontaneous report from a contactable consumer (patient) and a non-contactable consumer (patient's girlfriend).   A 29-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on arm on 27May2021 as second dose, single for COVID-19 immunisation (at the age of 29-year-old). The patient medical history and concomitant medications were not reported. Previous, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as first dose, single for COVID-19 immunisation. The patient was a 29-year-old male patient who received his second dose of the Pfizer BioNTech COVID-19 vaccine on 27May2021 at a vaccination site and when he was being administered the Pfizer BioNTech COVID-19 vaccine, the needle bent. The nurse and pharmacist both said it was ok and that it went into the fat of the arm and not the muscle (start date: 27May2021). The patient also mentioned that there was a bump and bubble on his arm, and it started to get hard (start date: 27May2021). Patient would like to know if there was any guidance about what he experienced, if he received the right dose and if it will affect the efficacy. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
Patient stated had tingling in arm and finger approximately 45 min to 1 hour after vaccine
dizziness; weak; diarrhea; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weak), DIARRHOEA (diarrhea) and DECREASED APPETITE (no appetite) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weak), DIARRHOEA (diarrhea) and DECREASED APPETITE (no appetite). The patient was treated with ACETAMINOPHEN for Symptomatic treatment, at an unspecified dose and frequency and NAPROXEN ongoing from 22-May-2021 for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), ASTHENIA (weak), DIARRHOEA (diarrhea) and DECREASED APPETITE (no appetite) outcome was unknown. Not Provided
Very sensitive now to regular meds; lower back felt really heavy; pounding sensation up and down my torso; feeling of muscle heaviness that I almost felt paralyzed; extreme body ache; chills; I had a bad headache; stinging on both sides of my head and on hands and feet; was very lethargic; arm became real sore and was painful; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiry date not reported), via an unspecified route of administration on the left arm on 27Jan2021 10:30 at single dose for covid-19 immunisation. Medical history included mild lupus, post concussion syndrome (PPCs) and allergies: sulfur (very sensitive to large doses) from an unknown date and unknown if ongoing.  Concomitant medication included esomeprazole magnesium (NEXIUM), tramadol, alprazolam and acetylsalicylic acid (ALKA SELTZER). The patient reported that after just a few hours on 27Jan2021, their arm became real sore and was painful to use until next morning, was sore for 2 days. Hurt after much normal use. Woke up on the morning of 28Jan2021 (3 am) with chills, extreme body ache and feeling of muscle heaviness that they almost felt paralyzed. They could still move. They had a bad headache and stinging on both sides of their head and on hands and feet. They took aspirin and went back to sleep. When they got up they felt some better, but did not feel well and was very lethargic. That night they took another aspirin before bed. On the morning of 29Jan2021 (second day ) they again woke up at 3 AM to extreme body ache, the same heavy paralyzing feeling, but this time their lower back felt really heavy and there was a pounding sensation up and down their torso. They repeated the aspirin dose and went back to bed but did not sleep anymore that day. They did feel some better but still very lethargic. Next day better, but took 5 days to feel some normal w/o fatigue. The patient is very sensitive now to regular meds. Therapeutic measures were taken which included aspirin. The patient was recovering from feeling of muscle heaviness that I almost felt paralyzed, extreme body ache, chills, headache, stinging on both sides of my head and on hands and feet, lethargy recovered from arm became real sore and was painful on an unspecified date, while the outcome of the other events was unknown. The patient was not diagnosed with COVID prior to vaccination and has not been tested for COVID since vaccination.
Nausea followed by vomiting , light headed, digestive issues and constipation.
UTI right before second shot; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI right before second shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI right before second shot). At the time of the report, URINARY TRACT INFECTION (UTI right before second shot) outcome was unknown.            No concomitant medications were reported.  Treatment  include antibiotics for UTI .  Action taken with mRNA-1273 in response to the events were not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14-APR-2021 contains significant information of Extra event (UTI right before second shot) . On 02-Jul-2021: Follow up received on 02-Jul-2021 contains Non-Significant information.
Cough, runny nose congestion sneezing fever off and on x 3wks. Albuterol solution 0.083%.
Patient has a history of anxiety and anaphylaxis to latex. She started feeling weird in head, nauseated, and dizzy a few minutes after her vaccine. BP 153/96 with pulse of 101 5 minutes post vaccine. We continued to monitor her. 20 minutes post vaccination bp 136/89 with pulse 97. 30 minutes post vaccine we tried to sit her up. She was very nauseated. bp 144/99 pulse 85. 35 minutes post vaccination bp 140/108 and pulse 83. She felt sick with her IBS, and we got her into the bathroom via wheelchair. 50 minutes post vaccination, bp was 129/93 with pulse of 83.  We called her husband to pick her up because she was exhausted after all of this.
Patient states that at 9am on 3/27/15 she noticed that the site of injection was red, swollen and hot about the size of a quarter. By the afternoon when she presented to the pharmacy the injection site to larger to about an inch wide. Patient followed up with primary care doctor.
Initial and follow-up information has been received from a nurse practitioner and a 44 year old white disabled male smoker with hyperlipidemia, chronic back pain, disk disease L5 in 2006, dyslipidemia, Human Papilloma viral infection, human immunodeficiency virus, occasional alcohol use, fatigue, insomnia, and no known drug allergies, who on 21-SEP-2007 at approximately 10:00 was vaccinated IM in the right arm with a second dose of pneumococcal 23v polysaccharide vaccine. At the time of the vaccination the patient was ill with HIV, HPV, fatigue dyslipidemia and insomnia. The patient's temperature was normal at the time of the vaccination. Concomitant therapies included cyclobenzaprine hydrochloride (MSD), TRUVADA, VICODIN, LEXIVA, gemfibrozil, loperamide hydrochloride. On 21-SEP-2007 at 11:30 (also reported as between 13:00 and15:00) the patient developed a high fever of 104.6, chills, and contacted his physician (also reported to be 101.3 at noon and Friday night, then Saturday morning it was 104.6). The patient denied chest pain, nausea, vomiting, dyspnea, and dysphagia. The patient took 100mg of ADVIL as advised by his physician. The physician advised the patient to take ADVIL 600 mg, three times a day "push" fluids, and go to the emergency room if the symptoms worsened. It was reported that the patient had recently had his CD-4 count taken and it was 387. The patient denied ever having pneumocystis carinii pneumonia. The patient had no complaint of abdominal pain, no lightheadedness, or dizziness. The patient's symptoms had worsened and he went to the emergency room on 24-SEP-2007. The patient's main complaint was body aches. It was reported that the patient was awake, alert, and oriented. The patient pulse oximetry was 97% on room air, respiratory rate was 16, pulse 120, the initial blood pressure was 147/88, temperature was 100.6, re-check temperature was 100.1, the patient's skin was hot and flushed, and subtle right upper lobe infiltrate on a chest x-ray. The patient was hydrated intravascularly, given unspecified antibiotics intravenously, and given the first dose of AVELOX, intravenously. The patient was given AVELOX oral for a 10-day course of treatment. The patient was also given a albuterol/ATROVENT aerosol. The patient was diagnosed with community-acquired pneumonia in the right upper lobe, and human immunodeficiency virus by history. The follow-up plan of care was reviewed with the patient and the patient voiced an understanding of the plan. The patient was discharged from the emergency room with a family member/friend and with prescriptions for AVELOX 400 mg, hydrocodone/homatropine syrup 5/1.5mg/5mL, and albuterol inhaler 17 gm. Subsequently, on an unspecified date, the patient recovered from fever and chills. The patient recovered from pneumonia on 17-OCT-2007 and was prescribed Z-PAK. No product quality complaint was involved. Additional information has been requested.
The night  after the COVID vaccine had fever 101.4, feeling cold, until the follow day.  Went to the Emergency Department the following night because I noticed that I was drooling, feeling very dizzy and weak.
Eight days after the injection the left arm became itchy, red and hard at the injection site . No treatment done, I just kept an eye on the site