chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain/swelling/redness spreading around spot where shot was given. Swelling size of golf ball and hard to touch. Redness radiating down arm. Also started coughing morning of 7/6/2016.  Went back to doctor on morning of 7/9/2016. Diagnose was reaction to shot. Prescribed to take Tylenol or Aleve for pain, ice pack for swelling & Predisone 10 mg for inflammation. Take 5 pills @ once for next 3 days then 3 pills @ once for next 3 days.
transient (1-2 minutes) flushing; chest tightness (on the same side as vaccine); lightheadedness; This is a spontaneous report from a contactable consumer (the patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), via an unspecified route of administration in the left arm on 18Dec2020 at 08:45 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history included Hodgkin's lymphoma from Nov2019 (treated for cure Nov2019 through Feb2020). The patient did not have any allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had received unspecified concomitant medications within 2 weeks of the vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 18Dec2020 at 08:45 (as reported), the patient stated that 5-10 minutes after vaccine administration, she experienced transient (1-2 minutes) flushing, chest tightness (on the same side as vaccine), and lightheadedness. The patient was treated for flushing, chest tightness, and lightheadedness with BP measurements (as reported) and oral hydration. The clinical outcome of flushing was recovered on 18Dec2020, while chest tightness and lightheadedness were recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Rash & cellulitis CEFTRIAXONE 1 GM ONCE ,LIDOCAINE 2.1 ML ONCE
OUT OF SPECIFICATION PRODUCT USAGE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 207A21A expiry: 07-AUG-2021) dose was not reported, administered on 24-JUL-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the subject experienced out of specification product usage. On 24-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product usage and incorrect product storage was not reported. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 76-year-old male patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX .5 ml. In September 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue, headache and lack of motivation. On an unknown date, the outcome of the fatigue, headache and lack of motivation were unknown. It was unknown if the reporter considered the fatigue, headache and lack of motivation to be related to SHINGRIX. Additional information received as follows: The patient received SHINGRIX sometime in August 2018. The patient received SHINGRIX on the left arm. The patient reported that during the past 2 weeks before from the reporting date, he had experienced fatigue, no motivation and slight headaches. The patient stated that he was a widower and had not been eating well either and recently added Ensure and Boost to his diet.
Information has been received from a physician concerning an 11 yr old male who was vaccinated with a dose of varicella virus vaccine live. On 13Jun05 the pt presented with breakthrough varicella, with less than 50 lesions, mostly crusted and scattered on the body. The pt had no fever, and no treatment was necessary. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
my husband, an hour after, got a really bad headache; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient (husband) got a really bad headache an hour after, got a really bad headache and still cannot get rid of the headache The outcome the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Day after had low fever, nausea, and felt drunk and/or drugged for about 7-8 hours. When the drugged feeling stopped I developed a bad migraine for about 24 hours. 6 days after shot, injection site became swollen, itchy and warm.
Patient wife reports begn feeling achy  last evening ; this monsring began with severe nausea , followd by voimiting  and unable to keep fluids down for several hours.  Reported  to Oncolosgist ( who cleared  patient for  vaccine injection ) .  Patent /wife advised to go to ER for assessment / IV fluids  ( 5pm Friday 15Jan 2021)
Pt began to experience pain in arm soon after administration of Prevnar-20 vaccine.Pain radiated from shoulder down to hand.Pt states she could not lift arm for three days after. As of 1/18/23 pt still has some pain in arm although it has lessened in severity.
bacteria on her stomach; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly into the right arm on 15Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing cholesterol and ongoing high blood pressure. Concomitant medication included losartan (LOSARTAN) for high blood pressure and atorvastatin (ATORVASTATIN) for cholesterol. It was reported that the patient had colonoscopy on 21Jan2021 and had found bacteria on her stomach. The patient was treated with 10 days antibiotic regimen of amoxicillin and clarithromycin. The patient's second dose was scheduled on 04Feb2021 and she was inquiring if she could still have the shot and if the antibiotic will affect the effectiveness of that shot. Outcome of event was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No medical history was reported. On 11-SEP-2013 the patient was vaccinated with ZOSTAVAX lot # 672556/1602AA, subcutaneous. No co-suspected or concomitant medications were reported. The vaccine that the patient received on 11-SEP-2013 had expired on 13-JAN-2013. No adverse effects were reported. Additional information has been requested.
Pt recvd vax in the PM following vax exp itching around inject site; pt indicated sx have not fully abated; however does still itch only on occasion;
Red blotch ~ 2 inches in length and 1 inch in width down back of arm at injection site.  Patient said that is appeared slightly red shortly after injection, however today (7/27/2009) 6 days after, the site is inflammed and brighter in color.  Patient also stated that it has started to itch today (7/27/2009)
spike protein was negative; Doesn't think the vaccine is working if his spike protein is negative.; Doesn't think the vaccine is working if his spike protein is negative; This is a spontaneous report from a contactable nurse (patient). A 46-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered on the right deltoid on 18Dec2020 12:00 (at the age of 45-year-old) as dose 1, single (lot: EH9899, expiry: 18Dec2020) and intramuscular, administered on the right deltoid on 08Jan2021 12:00 (at the age of 45-year-old) as dose 2, single (lot number: EL1284, Expiration Date: 08Jan2021) for COVID-19 immunisation. Medical history included donate his blood in May2021. There were no concomitant medications. Patient has been monitoring his spike protein to donate blood. His spike protein level has been positive around late Feb and in early Mar, he was able to donate his blood. He donated again in May and his spike protein was negative. At the end of Jun or early Jul, he donated again his blood and has not received the results for his spike protein. He imagined it would be positive since it was negative on May or end of Apr. His last spike protein was negative, and he was tested around May2021. Five months after the vaccine. Spike protein was previously positive. Reporter seriousness for Negative Spike Protein: Medically significant, Life threatening. Doesn't think the vaccine is working if his spike protein was negative. Stated he was moderately to severely physically active. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. Relatedness of drug to the event Negative Spike Protein was considered Related by the primary Source Reporter (Method of assessment: Global Introspection).; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Pt lost sense of smell and taste and felt ill within several days of 2nd Moderna vaccine and developed elevated LFTS and autoimmune hepatitis.
Pt presents with arm discomfort and redness after receiving the flu vaccine. Unsure of exact vaccine. Pt reports high dose.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
Fatigue lasting at least one week, fever, chills, extreme hot, lack of sleep, sweating, increased heart rate, brain fog, headache last at least a week, decreased lung capacity, shallow breathing, wheezing with activity (where there was none before), out of breath doing mundane tasks (where there was no issue before), lasting tiredness.
Nausea, vomiting, and stomachache, joint pain, headache, tiredness, chills. Lasted over 24 hours. Pain was a 9 on a scale of 1-10, I was really sick!  I called physician and he prescribed benadryl, phenergine, and tylenol.
Patient received a Pfizer bivalent booster for 12+ and patient should have received the Pfizer bivalent for ages 5-11.
24 hours after administration of vaccine, child began having dizziness, weakness, disorientation, and a fast, irregular heartbeat.
Rash on arm near injection site.  No treatment.  Still slightly visible after two weeks.
w/in 30 min of vax, exp dizziness x 3-4 hr; double vision x 2 hr; tingling in extremities for approx 1 hr; exp numbness after tingling lasting approx 3 hr; lost motor skills and disoriented;
This spontaneous report as received from a licensed practical nurse refers to a 12 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that on 15-AUG-2014 the patient was vaccinated with a dose (unspecified in series) of VAQTA INJ (lot # J016216; expiration date 18-AUG-2014), 0.5 ml, once, intramuscularly, that had been exposed to 1 deg. C for 4 hours. The patient did not seek medical attention. No adverse effects reported. This case is linked to cases MARRS # 1409USA002596 and MARRS # 1409USA002597 (same reporter link). Additional information has been requested.
severe pain in my spine all down my neck.; I had severe pain in my chest; confusion really bad; I also had heart palpitations for 2 days; This is a spontaneous report from a contactable consumer (patient).  A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0177 and expiry date was not reported), via an unspecified route of administration into right arm on 30May2021 at 16:45 (at the age of vaccination: 42-year-old) as Dose 1, single for COVID-19 immunization. Medical history included: Known allergies to chili peppers and chimoy, bells palsy and vasovogal condition of BP. The patient did not had any other vaccine in four weeks of first dose. Concomitant medications included: thyroid meds (within two weeks of BNT162B2). The patient was neither diagnosed with covid prior vaccination nor tested for Covid post vaccination. On an unspecified date at 09: 00 am, the patient stated that she had all the normal effects but severe pain in her spine all down neck. The patient also had severe pain in chest and confusion really bad and also had heart palpitations for 2 days. The patient did not receive any treatment for adverse events. Outcome of all events got recovered on an unspecified date with lasting effects (sequelae).  Follow-up attempts are completed. No further information is expected.
throat was closing and itchy had to take Benadryl for two days. Vomiting the whole weekend after the vaccine.
Pt recvd 2-1cc injects of Recombivax 12DEC90 & 14JAN91; 13JUN91 recvd Engerix-B; pt "did not develop immunity";
Starting at 11 pm, I developed a high fever, which continued through the night.  I also have severe arm discomfort, limiting mobility.
Administration of vaccines that may have undergone temperature excursion; Administration of vaccines that may have undergone temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccines that may have undergone temperature excursion) and PRODUCT STORAGE ERROR (Administration of vaccines that may have undergone temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccines that may have undergone temperature excursion) and PRODUCT STORAGE ERROR (Administration of vaccines that may have undergone temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccines that may have undergone temperature excursion) and PRODUCT STORAGE ERROR (Administration of vaccines that may have undergone temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.   No treatment details were provided.; Reporter's Comments: This report refers to a case of temperature excursion       ( 37 days in refrigerator) and in appropriate storage of product with no associated AEs
Stroke confirmed with MRI brain scan.  Placed on blood thinner medication and evaluated by primary care physician and neurologist. Symptoms included dizziness and disorientation for 30 minutes and vision issues for two days.  Some light headedness continued for a couple of months.  No other symptoms or issues since about December 2022.
Patient was not 16 years of age.  Patient was 15 yrs at time of vaccine.
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients was reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. Follow-up information as received from office manager refers to a 19 months old patient. On 05-APR-2014 the patient was vaccinated with a dose of improperly stored (Oka/Merck) (lot # J012818, expiration date 10-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional information has been requested.
The pt experienced a rash, and hives on arm with swelling the diameter of a small orange. Now swelling is gone and it appears to be a dry occasionally itchy rash. (As stated by mom.)
Information has been received from a physician concerning a female who was vaccinated with one dose of varicella virus vaccine live. Subsequently the patient failed to seroconvert. Unspecified medical attention was sought. Additional information has been requested.
phone call from mom of pt 13SEP96 reported that pt whole arm et all fingers swelled up w/in 4hr of vax on19AUG96;whole arm hot to touch;mom gave Ibuprofen, swelling lasted x 3days;pt had pain & c/o not being able to lift anything;
4/23/22 patient was admitted to the facility from Hospital. Discharge labs were normal, platelets at this time were 193. 4/25/22 resident patient received COVID-19 Moderna booster shot. Patient tolerated well, no signs or symptoms of reaction to the vaccine. 5/3 routine labs were collected. Platelets at this time on CBC were 9. Patient was transferred to the hospital where he revived 1 unit of platelets, started on IVIG x 2 doses, and dexamethasone 40mg po x 4. On 5/10/2022 patient was transferred back to hospital and on 5/12/22 platelets were 65. The hospital ruled out many causes of thrombocytopenia (such as DIC, hemolysis, production issue, infection, or sequestration) and deemed that the acute thrombocytopenia was likely due to ITP from Vaccine-Induced Thrombotic. thrombocytopenia. No skin findings other than a bruise at the injection site. Patient was not on heparin.
7 - 4 pm Redness & swelling at site of injection & spread to within an inch of shoulder & elbow. Hot & tight. Pruritis - scratching.
Within 2 days of receiving the shot, she began to have muscle contractions in her right bicep/tricep, causing severe tremors in that arm. They started intermittently and then progressed to constantly, even while she slept. A week later it moved to her right leg and now has progressed to her face. She has also had 2 episodes of her chest tightening, having difficulty breathing and being dizzy. Our pediatrician's office saw her 5 days after the shot when the contractions were only in her arm. They brought in 3 doctors, none of which knew what was happening, but all said, "its not the GARDASIL" They referred us to neurology that day. The neurologist performed an exam and ordered tests, all of which came back normal. She said she is not ready to rule out the GARDASIL but she 98% sure it is "conversion syndrome" That is a disorder caused by the brain's reaction to some stressor and according to the neurologist, often sexual abuse. Our daughter adamantly denies any form of sexual abuse, but we did start her in therapy to try and find a cause. She has seen the therapist 6 times and the therapist says there is absolutely no evidence of any trauma or stressor. This girl was a healthy, active 14 year old student. She has a great group of friends, makes straight A's and has good family support. She is a dancer and had to take a medical leave from the studio due to her issues.
temp 101.5 following day following day 99.; Body aches; soreness of arm; This case was reported by a nurse via sales rep and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced fever. In October 2020, the patient experienced pain in arm and general body pain. On an unknown date, the outcome of the fever, pain in arm and general body pain were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm and general body pain to be related to Shingrix.  Additional details were provided as follows: The patient received her first dose of Shingrix and on the following day experienced fever. The Patient also developed soreness of arm for 5 days. On the same day of vaccination the patient experienced body aches. Due to this the patient underwent Flu and covid-19 tests which were negative. The Full blood count was also reported to be normal. The reporter consented to follow up.
I had the expected things like body aches, cold sweats/chills, crazy headache, little bit of  nausea. But my heart rate is all over the place. Every-time I stand up it jumps to 116. My resting heart rate was 113 for 8hours straight Monday night. So the j&j website lists that as an allergic reaction. The urgent care basically said wait it out and be careful cuz if I move like too fast I could pass out again cuz of the blood pressure
Developed painful raised hard  knot at injection site. bright red, itchy, approximately 3 x 4 inches on left deltoid
Fever:  began 03/07/2021, did not take temp. Pushed fluids. Fever spiked 03/09/2021 to 102 degrees F. Continued pushing fluids. Gave 2mls of ibuprofen and a detox bath.  Rash:  began on 03/09/2021 around 1300. irregular borders. red, swollen, itchy. After detox bath redness is visibly reduced.
Pain at injection site, pinched nerve sensation, radiating between shoulder, elbow and wrist lasted 2 days.  Treated with Aleve and resolved 48 hours after onset.
Tight throat developed within minutes of shot. When eating later in the day, chest pain as food might have been having difficulty going down. Both symptoms lasted all day but were better the next day.
Hospitalization - acute hypoxemic respiratory failure due to COVID-19, pnuemonia due to COVID-19 virus