chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to office x2 days after receiving vaccines with red, swollen area site approximately equal to 2-3 inches. Child was put on Augmentin, continue to do warm compress and to return if worsening
Immediately after second dose of Pfizer Covid-19 vaccine given, patient developed a yellow bruise at injection site. She reports feeling like a foreign body in injection site and reports feelings of tightness, pressure, and heat at site. Patient developed swelling of right arm over the next 3 weeks. Patient saw her PCP on 2/12/21 and an ultrasound was done to R arm. Results were negative. Five to six weeks post vaccine administration, patient is reporting weight loss over 10 pounds, possible hair loss, loose stools, and sweaty palms and feet. She also reports the right arm pressure and tightness is now radiating to her upper back.
Information has been received from a physician concerning a 59 year old female with no pertinent medical history who in the end of June 2006 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (Yeast). There was no concomitant medication. A month later, at the end of July 2006, the patient developed conjunctivitis and redness on her neck and shoulder. Unspecified medical attention was sought and the patient recovered from the symptoms. At the time of this report. it was noted that the patient was still experiencing tinnitus and a burning sensation on her face and shoulder. The physician reported that medical attention was sought and laboratory test were performed, including a complete blood cell count and liver function test (no results were reported). The patient's present status was reported as recovering. No product quality complaint was involved.
Injection site swelling; Injection site redness; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site swelling and injection site redness. On an unknown date, the outcome of the injection site swelling and injection site redness were unknown.   It was unknown if the reporter considered the injection site swelling and injection site redness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 30-Jun-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that could put ice on the injection site for the swelling and redness. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Severe debilitating pain in arm starting at 6hrs post dosing, then dizziness. Unable to stand or walk due to weakness 8 hours post injection. Severe chills in a room where everyone else was extremely hot due to temperatures outside, collapsed in home. Fever reached ~101F prior to dose of MOTRIN. 2 hours later excessive sweating as fever "broke". Next morning (~16hrs post shot) still with pain in arm making it unable to use or grasp anything, headache and general malaise. Breathing was slightly shallow at 8 hours but did improve. Not at the point of requiring emergency care.
Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: pt states his arm is numb since the shot and he is unable to use it. he was advised to seek medical attention
Initial information was received on 17 November 2008 from a health care professional. A 47 year old female patient with allergies to penicillin, codeine, DEMEROL, iodine, and bee venom received an intramuscular right deltoid injection of FLUZONE SV 2008-2009 (lot number U2771AA) on 07 November 2008. Three hours post vaccination the patient experienced shortness of breath (SOB), swollen tongue and throat, headache and itching. The patient self treated with EPIPEN and BENADRYL 25 mg. The patient went to the ER and was treated with Prednisone, BENADRYL and a "pain medication" for her headache. The patient had an EKG completed (results not reported). The patient was recovered at the time of the report. List of Documents held by Sender: None.
This is a spontaneous report from a contactable consumer, the patient. A 79-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 12Mar2021 at 12:00 (at the age of 79-years-old)  (Batch/Lot number was not reported) as a single dose and dose 2 via an unspecified route of administration on 14Apr2021 (at the age of 79-years-old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included ongoing asthma, ongoing rheumatoid arthritis and allergies (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. With both vaccine inoculations, the next day and for at least 8 days afterwards, the patient's asthma was very much increased. The patient had constant coughing and wheezing. In addition, for 3 days their RA pain was much increased. The events started on 12 Mar2021. No treatment was given. The outcome of asthma increased, coughing, wheezing and RA pain increased was recovering.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Red, swollen and warm to touch hip to below knee, limp with walk.  BENADRYL and ice pack to leg.
No additional adverse effect reported.; a male Patient received improperly stored VAQTA; vaccine expiration date: 05-MAY-2019; This spontaneous report has been received from a medical assistant referring to a 20 months old male patient. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.      On 14-NOV-2019, the patient was vaccinated with impeoperly stored hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (unit unknown) (lot # S009562, expiration date reported as 26-JUL-2020 but upon internal validation established as 05-MAY-2019; route, frequency and dose details were unknown) for prophylaxis (product storage error and expired product administered).   The vaccine was stored above 47 degrees Fahrenheit (52.09 degrees Fahrenheit) for 1.39 hours. The previous temperature excursion included above 47 degrees Fahrenheit (64.83 degrees Fahrenheit) for 13.35 hours. The digital data logger was involved. No additional adverse effect reported.
Swollen eyelids on day 2 to day 4 post the first vaccination of Pfizer/BioNTech.
Within an hour I had a Slight headache and sore injection site. This lasted for 2 days. On Sunday, I started to experience shortness of breath after doing small tasks. Monday was worse. Shortness of breath, light headedness, chills, nausea,  dizziness, weak, and tired. I?m experiencing the same symptoms when walking or doing movement.
1/7/97: fever and vomit, crabby, congestion, not sleeping. 1/13/97: crabby, fever, congestion, not sleeping. 1/21/97: ear-fluid. 1/30/97: fever, not sleeping, bad breath. 2/3/97: rash on abdomen-red dots spread to the rest of the body over the week.
Pt had a witnessed  syncopal episode approx. four minutes after receiving her first dose of the Pfizer vaccine. Pt was assisted to the ground in a supine position. Pt regained consciousness approx. 20-30 seconds after fainting. After coming to, pt complained of abdominal pain to the RLQ. All vital signs stable and within normal limits. No signs of allergic reaction noted. Pt treated on site by paramedics. Pt transported to a local hospital ER for follow up.
Immunization received at 3pm no reaction immediately.  Next morning I woke up with acne type lesions on my face and a large elongated swollen area on my back.  My face cleared up but I had to go to the MD and have the back wound incision and drainage.
This spontaneous report was received from a physician via a company representative and refers to a male patient who was reported to be 11 or 12 years old. There was no information concerning the patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (exact dose, route of administration, lot# and expiration date were not provided). On an unknown date, reported as after being administered a dose of GARDASIL 9, the patient experienced fainting. The outcome of the event was unknown. The causality assessment was not provided. Upon internal review the event of fainting was considered to be medically significant. This is one of several reports received form the same reporter. Sender's Comments: US-009507513-1905USA011304: US-009507513-1905USA011106: US-009507513-1905USA011790.
Suffered from convulsions accompanied with low grade fever. Convulsions began on 09/08/07 lasting 1-2 min, no reported pattern, happened roughly 4 times in the following weeks. 4/28/08-records received-evaluation 3/31/08 13 months of age-Assessment: not eligible for early intervention services.  Per family patient screamed after 2, 4 and 6 month immunizations and experienced convulsions.
client under 18 was given moderna as their first shot so per protocol gave moderna as their second injection
Developed hives, itching on 11/4/02, occurring over sporadic areas: started top of his head, varying in duration. Reports ankle furion surgery on 10/28/02 by MD, described as a repeated surgery after a curshing ankle injury 7/99 and history of treatment for osteophlebitis.
Headache, Arthralgia, NauseaVomiging, hot flashes, runny nose, fatigue, arm soreness, muscle stiffness Narrative:
Left thigh numbness, patient said relieved with chiropractor adjustment. I suggested rule out blood clot.
Inappropriate formulation of vaccine administered; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Inappropriate formulation of vaccine administered) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Inappropriate formulation of vaccine administered) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Aug-2021, INCORRECT PRODUCT FORMULATION ADMINISTERED (Inappropriate formulation of vaccine administered) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patients were given Moderna vaccine as though it had preservative and dose administered after 7 days from  punctured vial. No Concomitant medications were reported.  No Treatment medication was reported.   This case was linked to MOD-2021-332833, MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information received on 29 Sep 2021 contains non significant information.
Started having symptoms the next morning with nausea, then that same night had soreness at injection site with rash (red) around the injection site and warm to touch, vomiting,  diarrhea,  fever (102), chills, severe muscle and joint pain, fatigue.  Just took tylenol and rest as much as I can. Felt better 3/12, just have the sore arm, redness, and warm to touch around the injection site.
Went to sleep around noon; Woke up w/t104R, taken to MD office; given APAP;
Information has been received from an RN concerning a female pt who was vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent. Subsequently, the pt developed a local injection site reaction consisting of a red "band-like" induration on the arm where the injection was given. Within 72 hours, the induration resolved. Unspecified medical attention was sought. The reporter expressed a concern with the lot number. Additional information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 24-JUN-2016, the patient was treated by a physician/MD at a clinic for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
VARlVAX was improperly stored and administered; This spontaneous report was received from a medical assistant concerning to a 4-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 04-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not provided); lot number T021824 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported and validated as 25-JUN-2022.   The administered vaccine had a temperature excursion of 16.1 degrees Fahrenheit (°F) for a time frame of 1 hours and 45 minutes, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2101USA000920: US-009507513-2101USA000953: US-009507513-2101USA000954: US-009507513-2101USA001042:
I woke up at three in the morning the general tightness and soreness from my arm had spread across my upper back and it caused me to twist and contort in pain.
Vaginal bleeding/spotting within 72hrs of second vaccine, two weeks before my normal menstrual cycle. Menstrual cycle was heavier, lasted a couple days longer, and cramps were more intense.   Second menstrual cycle came at the normal time, lasted a day or two longer than usual, bleeding was a little heavier. However, it is now two weeks after that period I started spotting again yesterday along with breast tenderness. No pregnancy, and no other symptoms.
Case number PHEH2016US028508, is an initial spontaneous report received from a health care professional on 26 Oct 2016. This report refers to a female patient of an unknown age. Medical history and concomitant medication was not reported. The patient was vaccinated with one single dose FLUCELVAX (batch number: 185887, expiry Apr 2017) at a dose of 0.5 ml intramuscular on 24 Oct 2016. On 25 Oct 2016 the patient experienced 7 cm patch of erythema around the injection site. It began on 25 Oct 2016. The patient was using cold compresses and ice for the erythema. It was unknown if the erythema was improving. Final outcome of the event was unknown. Seriousness of the event was reported as non-serious. Causality of the event was not reported.
Case number PHEH2014US025107, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 80-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscular at a dose of 0.5 ml on 24 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Information has been received from a physician's assistant concerning a 9 year old black male with no known allergies or pertinent medical history who on 03-SEP-1999 was vaccinated with a dose of Varivax (lot# 630675/0424J). There was no concomitant medication. On 07-AUG-2006 a titer was 0.98 for IgG and IgM was less than 0.90, the patient failed to convert. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. The patient's brother (WAES # 0608USA03595) also experienced a failure to convert. Additional information is not expected.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/30/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  HYPOXIA 4/30/2022 ACUTE HYPOXEMIC RESPIRATORY FAILURE  ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/30/2022 CANCER METASTATIC TO PLEURA  HYPOXIA 4/30/2022 CANCER METASTATIC TO PLEURA
Vaccination site reaction; Swollen arm; Itchy rash; blister; Rash; Pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Pain in arm), RASH PRURITIC (Itchy rash ) and BLISTER (blister) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, the patient experienced VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), RASH PRURITIC (Itchy rash ), BLISTER (blister) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE REACTION (Vaccination site reaction), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Pain in arm), RASH PRURITIC (Itchy rash ), BLISTER (blister) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided. Patient received (Something like zerotax) prescribed by her HCP as treatment medication.
Information has been received from a registered nurse concerning a 9 year old male who was vaccinated with his second dose of Varivax (Oka/Merck). Subsequently, two days post vaccination, the patient developed a fever and cold symptoms. The patient was taken to an emergency room and blood was drawn. The patient's white blood cell count was "low, but was still within normal limits." The patient was not hospitalized. The registered nurse indicated that the patient had never experienced an adverse event post vaccination with any vaccines prior to this vaccination. The product quality complaint unit was not involved. Additional information has been requested.
Information has been received from a certificated medical assistant referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 09-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). On 09-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K006117, expiration date 14-JAN-2017, dose and route were not reported). Concomitant drug was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
Right earlobe turned purple and left earlobe was red; Not warm to the touch, no pain associated with discoloration.
It was reported that the occurrence of generalized aching in a pt who was vaccinated with hepatitis A vaccine inactivated and hepatitis B vaccine recombinant (Twinrix) for prophylaxis. The pt had no relevant medical history or concurrent conditions. he experienced no adverse events following previous immunizations. On 1/6/03 at 8:30, the pt rec'd his second injection of Twinrix. At approximately 16:30, the pt began experiencing generalized aching, mid epigastric pain, weakness, decreased appetite, difficulty sleeping,elevated heart rate and a fever of 99.1F. The pt's heart rate on 11/7/02 was 64 beats per minute. On 01/07/03, his heart rate was 97 BPM. The reporting person considered the events to be probably related to Twinrix administration. As of 1/7/03, the events persisted.
I did not have an adverse reaction to the vaccine. In 11/2022, I developed tinnitus in my ears. I was really busy at work and hoped it would go away. My immune symptom is out of whack. I tried to get better rest and better diet to help with my symptoms.
itching; pink in color; slightly puffy; mild rash on legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), ERYTHEMA (pink in color), SWELLING (slightly puffy) and RASH (mild rash on legs) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PRURITUS (itching), ERYTHEMA (pink in color), SWELLING (slightly puffy) and RASH (mild rash on legs). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 25 mg. At the time of the report, PRURITUS (itching), ERYTHEMA (pink in color), SWELLING (slightly puffy) and RASH (mild rash on legs) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: event outcome updated.
This spontaneous report was received from a medical assistant refers to a 14 year old female patient. On 26-JUN-2014 the patient was vaccinated with LIQUID PEDVAXHIB (dose, route, lot # and dosage schedule were not reported). The reporter did not mention if the patient received LIQUID PEDVAXHIB prior to this dose. No adverse symptoms reported. Additional information has been requested.