chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine at approximately 09:50 am, waited for observation 15 minutes, then returned to work. At approximately, 12 noon started to notice blurry vision from left eye and severe headache behind eyes. Sat for a minute or so but not improving so returned to vaccinating pharmacist. At that time patient also felt flushed and overheated. Patient laid flat on back, applied cold compresses to forehead and back of neck.  After 20 minutes patient?s vision and flushing has improved but still had a headache. Patient then moved to a seated position. Still had the headache, but vision and flushing completely resolved.
Patient states that the following day she had a full body rash. which itched like crazy. Denies fever, redness at site, difficulty with breathing, Patient states this is the first time she had a reaction like this. No previous problem with flu vaccinations. Patient did not check in with her Primary Care Doctor. I had encouraged to do so even after 2 weeks. So that she can update her provider of the situation.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On 23-JUN-2015, the patient was vaccinated with both VARIVAX (Merck) subcutaneously (lot #, expiration date, dose and anatomical location were not reported) and PROQUAD (Merck) subcutaneously (lot #, expiration date, dose and anatomical location were not reported). No product confusion was specified. No known adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Was at a wedding and then started getting a cold and bad headache a few days later. Took a home test for COVID and tested positive. Saw Dr. on 7/18/2022, she took a chest x-ray and found that a Translucent area on Right Lung was the start of Pneumonia. Was given doxycycline, and it's slowly getting better. Have started taking DELSYM, and taking cough drops. My coughing is worse at night and having to sleep propped up. Having another chest x-ray in 3 weeks.
body aches; Fatigue; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2 reported as Pfizer-Biontech Covid-19 Vaccine; unknown lot numbers and expiration dates), first dose was via an unspecified route of administration on an unspecified date at a single dose and the second dose was via an unspecified route of administration on an unspecified date at a single dose for covid-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose of the vaccine and is experiencing fatigue and body aches on an unspecified date. The reporter inquired for the information as to how long this will last. The events was considered as non-serious. The outcome of the events was unknown.  Information on the Batch/Lot number has been requested.
approx 2 hrs p/vax pt cried for several hrs inconsolably until cried self to sleep; cont to cry on & off throughout the evening; 48 hrs later had 2 szs-body went limp & eyes rolled up in head; dx hyps arrhythimia; poss brain damage;
I received the Pfizer Bivalent booster for COVID-19 on 11/7/2022. On the evening of 11/27/2022, I went to dinner with my husband. We parked a block away from the restaurant where we planned to eat, but I was really tired at that point, so I asked if we could park somewhere closer. I'm usually not so tired, though. When I went to bed that night, I had a sore throat. I woke up at 1 AM on 11/28/2022 with a fever. I took a home antigen test and very quickly got a positive result. I developed a headache, nausea, and tightness in the chest for the first couple of nights. I also had nasal congestion at night that was so bad that I couldn't breathe out of my nose. It was so bad that I would sit in the bathroom with a hot shower running, because I hoped the steam would clear my sinuses. I also used a humidifier, an asthma inhaler twice a day, a NETI POT, and fluticasone nasal spray. After a few days, the extreme nasal congestion was gone, but it was replaced by a severe headache. It wasn't a sinus headache, though. It was more like a severe migraine-tension headache. I switched between ADVIL and TYLENOL at different intervals, but they didn't work. However, when I finally tried naproxen, it did the trick. Altogether, the headache lasted 3-4 days. During the headache, I was nauseous. I never threw up, but I was afraid of throwing up. I was too nauseous to eat, but I managed to take in a little soup. The nausea was intermittent and would come and go over the course of a week; sometimes, the nausea was more or less intense than at other times. At the time of this writing, I have an upset stomach that has come and gone for about a week now. I have had diarrhea. I have also experienced an overall feeling of queasiness and the feeling that something isn't right; it's similar to the feeling you might get with food poisoning, but not as intense. I also still have an intermittent cough, and at night, it feels like I have an upper chest cold. I get a scratchy throat that gives me the urge to cough. Ever since I've had the virus, I've been colder than usual. Whenever I go outside, I'm more sensitive to the cold air, and it irritates my asthma. A couple of days after I tested positive, I had a telehealth visit with a doctor. I was offered PAXLOVID, but I declined, because I know two people who experienced rebound infections and a bad aftertaste when they took it. I was prescribed ondansetron for the nausea and benzonatate for the cough. I only took the benzonatate twice, because I wanted to cough up any mucus that was present, because I feared that suppressing the cough would irritate my asthma and possibly lead to pneumonia. I also got a burning rash on one side of my right arm and had to go to urgent care. I was prescribed VALTREX to keep on hand in case the rash turned out to be shingles. Thankfully, it did not and it went away after less than 24 hours, so I didn't have to use the VALTREX. I took another home antigen test on the tenth day and got a positive result. When I took it again 1-2 days later, the result was negative.
Information has been received from a registered nurse concerning a 33 year old male with no pertinent medical history and no drug reaction/allergies who on 26-JAN-2006 was vaccinated SC with a 0.5 mL dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot#0615P). There was no concomitant medication. On 26-JAN-2006, about 18 hours post vaccination, the patient developed a swollen and tender elbow near the injection site. No other information was available. The outcome was reported as recovering. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
The night of my vaccination I spiked a fever of 104.  It stayed high for three days - even with Tylenol and Ibuprofen I could not get it below 100.  It finally broke on the fourth day.  My other symptoms lasted longer.  I had terrible muscle pain and joint pain, fatigue, headaches, swollen glands, swelling and a rash at the injection site, strange bruising on my other arm, and a sore throat that made swallowing difficult.  I am now nine days post-vaccine, and my only lingering symptoms are a sore throat, laryngitis, and a cough.  I am healthy and have never before reacted to a vaccine.  This was a terrifying and *lengthy* reaction.
patient has 20x10cm red area on right arm. following vaccinations.  She experienced mild itching and swelling but condition has not worsened for 5 days.  Patient returned to the clinic 8 days following vaccinations and was examined by medical doctor.  Patient allergy profile was updated to include pneumococcal conjugate vaccine. (No reaction in the left arm where the Shingrix was administered)
Lungs filled with blood clots; Lungs filled with blood clots; heart was strained trying to pump blood through the clots; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 16-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, lot number: unknown at this time in the left arm), for COVID-19 Immunization. The following information was reported: PULMONARY EMBOLISM (hospitalization, disability, medically significant, life threatening), PULMONARY THROMBOSIS (hospitalization, disability, medically significant, life threatening) all with onset 28Jul2021, outcome "not recovered" and all described as "Lungs filled with blood clots"; MYOCARDIAL INJURY (hospitalization, disability, medically significant, life threatening) with onset 28Jul2021, outcome "not recovered", described as "heart was strained trying to pump blood through the clots". The patient was hospitalized for pulmonary embolism, myocardial injury, pulmonary thrombosis (hospitalization duration: 6 day(s)). The events "lungs filled with blood clots" and "heart was strained trying to pump blood through the clots" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: (03Aug2021) Negative; SARS-CoV-2 test: (03Aug2021) Negative. Therapeutic measures were taken as a result of pulmonary embolism, myocardial injury, pulmonary thrombosis. Additional information: It was reported that the patient lungs filled with blood clots and heart was strained trying to pump blood through the clots. Still having problems. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not received any other medications the patient received within 2 weeks of vaccination. The patient was admitted to intensive care and was given blood thinners. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient been tested for COVID 19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
All-over full body ache; Nausea; Headache; Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (All-over full body ache), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Low grade temperature) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (All-over full body ache), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Low grade temperature). At the time of the report, PAIN (All-over full body ache) and HEADACHE (Headache) outcome was unknown and NAUSEA (Nausea) and PYREXIA (Low grade temperature) had worsened.            No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 08-jul-2021 contains No new information
red, itchy, and a rash at the injection site; rash at the injection site; itchy, and a rash at the injection site.; fever; sweats; This case was reported by a consumer and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received the 1st dose of Shingrix. On 20th December 2020, 2 days after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced fever and sweating. On 22nd December 2020, the patient experienced injection site erythema, injection site rash and injection site itching. The patient was treated with ibuprofen. On 21st December 2020, the outcome of the fever and sweating were recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site rash and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site itching, fever and sweating to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient states he received 1st dose of Shingrix and developed fever and sweats. The patient was treated with ibuprofen for fever and sweats. On 22nd December 2020,4 days after vaccination the patient stated that he had red, itchy, and a rash at the injection site. The reporter declined for any other information for Adverse event. The reporter did not consented to follow up.
PATIENT REPORTED NUMBNESS IN ARM, TIP OF MIDDLE, THUMB AND RING FINGER. ALSO REPORTING JOINT PAIN IN FINGERS
Patient had immediate pain to sight of shot. She stated that it turned black and blue and warm to touch. She stated that she has a bit of redness as well.
xanthelasma; This case was reported by a consumer via call center representative and described the occurrence of xanthelasma in a 30-year-old patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Twinrix at an unknown dose. On an unknown date, unknown after receiving Twinrix, the patient experienced xanthelasma. On an unknown date, the outcome of the xanthelasma was unknown.   It was unknown if the reporter considered the xanthelasma to be related to Twinrix.  Additional case details were reported as follows: The patient received Twinrix and had xanthelassma.
(L) thigh - pink, small hematoma 2cm at injection site. Area previously red in color - now resolved to light pink. Denies pain, no warmth, no edema, no discharge.
her pregnant daughter was recently prescribed AREXVY by her doctor; This non-serious case was reported by a consumer via call center representative and described the occurrence of intercepted drug prescribing error in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient  did not receive Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced intercepted drug prescribing error (Verbatim: her pregnant daughter was recently prescribed AREXVY by her doctor). The outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2023 Reporter was the patient's mother. The reporter stated that her pregnant daughter was recently prescribed Arexvy by her doctor, which led to intercepted drug prescribing error. As per prescribing information, Arexvy was only indicated in patients who were 60 years and older. The patient has not received a dose of Arexvy yet. The reporter did not consent to follow-up.
Chronic hives beginning about a week after vaccine and continuing to date. Hives appear every evening and if scratched will quickly expand and spread. Always on legs, arms or buttocks. Benadryl and zyrtec make them go away until the next evening.
Pain behind right ear and in shoulder and necke; AM 10/24/14 right side face drooping and some loss of taste. Sensitive hearing right hear loud noises hurt must drink through a straw cannot close eye right.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 30-SEP-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405, 1310USA008406 and 1310USA008407 (same reporter link). Additional information has been requested.
Injection sight tenderness; Fatigue; Severe headache; This is a spontaneous report from a contactable other HCP report for self. This 30-year-old not pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) intramuscular at left arm on 30Dec2020 at single dose for COVID-19 immunization. Medical history included Asthma, anxiety, allergies to Acetaminophen (seizure like activity and fainting). No COVID prior vaccination. No other vaccine in four weeks. Concomitant medications include Fluoxetine, lorazepam, and Ibuprofen. Patient experienced injection sight tenderness, severe headache for 5 days, fatigue for 7-10 days after first dose. The outcome of events was unknown.
Throat tightness/numbness; Throat tightness/numbness; Shortness of breath w/min exertion; Dull chest pain; Right calf pain/cramping; Right calf pain/cramping; Fever; Chill; Body aches; Severe headache; Left arm swelling; left arm swelling, redness, knot; left arm swelling, redness, knot; Pain at injection site; Fatigue; This is a spontaneous report received from a contactable nurse (who is also the patient). A 59-year-old female patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), intramuscular in the left arm, on 11Jan2021 07:30, at single dose, for COVID-19 immunization, in the hospital. Medical history included COVID-19 (COVID prior vaccination: Yes) and known allergies to penicillin and erythromycin. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: unknown), intramuscular in the left arm, on 23Dec2020 07:15, for COVID-19 immunization. The patient experienced shortness of breath w/min exertion, right calf pain/cramping, fever, chill, body aches, severe headache, left arm swelling, redness, knot and pain at injection site, dull chest pain, fatigue, throat tightness/numbness on 11Jan2021. The events resulted to emergency room/department or urgent care visit. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: The 59-year-old patient received the second dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021, and experienced shortness of breath w/min exertion, dull chest pain, throat tightness/numbness and other symptoms on the same day.  Considering plausible temporal relationship, the events were probably related to the second dose of BNT162B2.  The case will be reassessed should additional information become available.  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.
Patient went to medical center ER on 8-1-11. She states swelling started on 7-29-11. Symptoms were facial swelling, itching hand, tongue numb. Pt was treated with VISTARIL 25 mg.
Patient received shot on 11/7/17. Patient presented to pharmacy on 11/9 claiming cellulitis in arm with an antibiotic for KEFLEX.
No reaction: Missed dose.  Vaccine leaked from the hub of the syringe. This was pt 2nd dose
within a few minutes  I became  overly warm and feeling  dizzy, my blood pressure went up to 189/80 and my pulse elevated to 99.  My normal levels are usually 120/70 and pulse 54-60.  I had acute anxious feeling and overall body shaking. I was taken down to the ED by stretcher, I received the vaccine in the hospital setting,  I stayed in the ED for 3 hours and was discharged home.  I felt fatigued and weak for 24 hours after.
Chills, nausea, sweating, dry heaving, injection site pain, muscle aches.
Painfull Red Hot Hard Knot at injection site, under left arm out is in painful when moving arm of just being still. Fever/chills and a red hive rash on upper chest.
Angioedema in my lips the next day; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 15Dec2021 10:00 (Lot number: FJ1620) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER2613, Vaccine Administration Time: 11:00 AM), administration date: 01Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6206, Vaccine Administration Time: 11:00 AM), administration date: 11Mar2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 15Dec2021 10:00, outcome "unknown", described as "Booster"; ANGIOEDEMA (medically significant) with onset 16Dec2021 18:00, outcome "recovering", described as "Angioedema in my lips the next day". The event "angioedema in my lips the next day" was evaluated at the physician office visit. Therapeutic measures were taken as a result of angioedema  Patient had no receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no any other medications the patient received within 2 weeks of vaccination. Patient received Solumedrol shot and medrol dose pack for the adverse event. Patient had no diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. Patient had no known allergies.  No follow up attempts needed no further information expected..; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the reported events Immunisation, Angioedema and suspect drug BNT162B2 cannot be 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.
Patient called and emailed HD regarding a concern about a possible reaction to Moderna Covid19 vaccine. Patient received vaccine on January 12, 2021. On January 20, 2021, she emailed the HD and reported the following: "... this morning I notice a 1.5 inch diameter raised circle around injection site. It itches and is hot to the touch".