chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient. The patient's age, medical history and concurrent conditions were not provided. On or about 27-OCT-2013 the patient was vaccinated with ZOSTAVAX, (route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of Herpes Zoster. On or about 30-AUG-2016 the patient was treated by a health professional in the Emergency Department for Ophthalmic Herpes Zoster. The patient has been prescribed oxycodone hcl/acetaminophen (PERCOCET) to attempt to manage and relieve her painful symptoms. 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, pain and suffering, and other damages. Upon internal review Ophthalmic Herpes Zoster was considered to be medically significant.  Additional information has been requested.
PAIN; This spontaneous report received from a patient via company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported,1 total administered for prophylactic vaccination. No adverse events were reported following vaccination. (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s booster (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 03-NOV-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 03-NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s booster, the patient experienced pain (Dose number in series 2). Treatment medications included: Naproxen sodium for pain but was not effective per patient. The patient had enquired about the administration of the Tylenol chewable tablet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain. This report was non-serious.
After the first shot I began having a "pin point" pain in my lower left leg; a tightness in my left calf area/left leg feels heavy while walking; tightness sometimes extends to my upper thigh; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left (Lot number: EW0161) as dose 1, single and administered in arm left (Lot number: EW0173) as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Eggplant" (unspecified if ongoing), notes: known allergies: Eggplant. Concomitant medication(s) included: DOXYCYCLINE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Apr2021, outcome "not recovered", described as "After the first shot I began having a "pin point" pain in my lower left leg"; LIMB DISCOMFORT (non-serious) with onset 17Apr2021, outcome "not recovered", described as "a tightness in my left calf area/left leg feels heavy while walking"; MUSCLE TIGHTNESS (non-serious) with onset 17Apr2021, outcome "not recovered", described as "tightness sometimes extends to my upper thigh". The events "after the first shot i began having a "pin point" pain in my lower left leg", "a tightness in my left calf area/left leg feels heavy while walking" and "tightness sometimes extends to my upper thigh" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, limb discomfort, muscle tightness.  Additional information: No other vaccine in four weeks and Doxycycline Other medications in two weeks. No covid prior vaccination and no covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 53-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a day after receiving SHINGRIX, the patient experienced shoulder pain. On an unknown date, the patient experienced tiredness and fever. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved and the outcome of the tiredness and fever were recovered/resolved. It was unknown if the reporter considered the shoulder pain, tiredness and fever to be related to SHINGRIX. Additional details were provided as follows: The patient reported that he experienced right shoulder soreness ever since receiving his 1st dose of SHINGRIX in October 2018. The patient also had tiredness and fever that began within the 2 days after the vaccination but those had resolved. The patient's doctor had advised him that he should wait a while before receiving the 2nd shot, he was not sure he would get the 2nd shot. The patient provided the consent to follow up.
Father of patient states, about one hour after receiving the Flumist, patient's eyes became puffy and swollen. This lasted for three to four hours, then eyes returned to normal state.
pt was admitted to hosp ER w/elevated temp;exp dehydration, sepsis presumed-cult negative;gastroenteritis, urinary tract infect, upper resp infect;some cough & vomit;pt congested;
got the initial series in 2021 and I got Moderna/  I was told to Pfizer has a lower dose so I tried that; I get the terrible like extremally headache like, worse than anything; I was not able to keep anything down and then I spent whole day like vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization; Moderna (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunization, reaction(s): " have the absolutely terrible time with the second Moderna shot". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "got the initial series in 2021 and I got Moderna/  I was told to Pfizer has a lower dose so I tried that"; HEADACHE (non-serious), outcome "unknown", described as "I get the terrible like extremally headache like, worse then anything"; VOMITING (non-serious), outcome "unknown", described as "I was not able to keep anything down and then I spent whole day like vomiting".  Additional Information: The patient was calling about the Pfizer Covid vaccine Bivalent. The patient had the initial series in 2021, got Moderna and had the absolutely terrible time with the second Moderna shot and so, patient didn't get booster until now. The patient was told that Pfizer has a lower dose so patient tried that. Patient had really exactly the same of course that patient had with Moderna but was slightly milder but still really awful. Unlike most people the patient know who have got no symptoms and discomfort for about a day and they were okay, patient had three days of "hell". The patient meant that for about 36 hours of "what is being to give really bad for me", patient get the "terrible extremally headache like, worse then anything I know I used to have it" and at about 36 hours, patient was not able "to keep anything down and then I spent whole day like vomiting."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a 72 years old male physician regarding himself. The patient had an allergy to suture that was used in surgery many years ago but was no longer being used. The patient's medical history included a couple of hernia operations at least 10 years ago. On an unknown date 15 years ago (approximately October 1997), the patient was vaccinated with 3 doses of RECOMBIVAX HB (lot# and route not reported). No concomitant medications were reported. In the past week on an unknown date in approximately September 2012, the patient had 2 titers done by 2 different laboratories that were negative for hepatitis B. He had titers done 5-6 years ago and the titers were fine. No treatment information was reported. The patient sought medical attention (unspecified). The outcome of the event was unknown. The relatedness for the event was unknown for RECOMBIVAX HB. Additional information has been requested.
SHAKY, JUST FEELS STRANGE. NO DIZZINESS, NO DOUBLE VISION, NO SYNCOPE. COOL PACK TO CHEST. BP 10:41 134/61 HR 55, 10:43 AM 120/75 HR 56, 10:46 AM 126/65 HR 56. WENT HOME 11:05 AM. FOLLOW UP PHONE CALL 4:40 PM, DOING WELL HER MOM, NO PROBLEMS.
PATIENT WAS SCREENED FOR ILLNESS, AE, ALLERGIES,  15-20 minutes after vaccination I was alerted that Patient fainted and hit her head against a shelf, no injuries noticeable.  she was helped up on a bench given orange juice and she mentioned she did not eat anything all day.
COVID 19/ Positive Covid on 08Feb2022; COVID 19/ Positive Covid on 08Feb2022; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: SINGULAIR, start date: Aug2018; BREO ELLIPTA, start date: Aug2018. Past drug history included: Bactrim, reaction(s): "Drug Allergy"; Asa, reaction(s): "Drug Allergy"; Advil, reaction(s): "Drug Allergy"; Tylenol, reaction(s): "Drug Allergy". The following information was reported: COVID-19 (medically significant) with onset 08Feb2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 08Feb2022, outcome "unknown" and all described as "COVID 19/ Positive Covid on 08Feb2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Feb2022) Positive, notes: Positive COVID on 08Feb2022; (17Apr2022) Positive, notes: Positive COVID on 17Apr2022. Therapeutic measures were taken as a result of covid-19, vaccination failure included Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA lot # M021124, expiration date 02-FEB-2018; lot # M022531, expiration date 23-FEB-2018 (dose and route of administration were not reported). None of the patients reported adverse effects. Administered doses of the vaccine experienced a temperature excursion of 32.4 degrees Fahrenheit for 3 hours 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Started with itchy rash at nap of neck then had itchy rash to inside of elbows,then itchy rash to upper outer thighs then to both buttocks and upper and lower back.
lymph nodes were swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FJ8762) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "other medical history: Heart palpitations (SVT)" (unspecified if ongoing); "other medical history: Heart palpitations (SVT)" (unspecified if ongoing); "known allergies:Shellfish" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; NAPROXEN; AMBEREN; BIOTIN. Vaccination history included: BNT162b2 (Dose 1, single, lot number: EW0150, at left arm), administration date: 10Apr2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "For the first 2 shots the swollen lymph nodes lasted 3 weeks"; BNT162b2 (Dose 2, single, lot number: EW0170, at left arm), administration date: 02May2021, when the patient was 52-year-old, for COVID-19 immunization, reaction(s): "For the first 2 shots the swollen lymph nodes lasted 3 weeks". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "lymph nodes were swollen".  Additional information: No other vaccine in four weeks. Facility type vaccine was pharmacy or drug Store. No covid prior vaccination and not tested for covid post vaccination. Swollen painful lymph nodes-both under-arms and neck, lower back pain, joint pain. For the first 2 shots the swollen lymph nodes lasted 3 weeks but almost all lymph nodes were swollen for the first few days, then only her neck and left underarm. The 3rd shot, the lymph nodes were swollen for less than a week.  Follow-up attempts are completed. No further information is expected.
pt developed a partial small bowel obstruction which required surgical intervention. He was found to have an adhesive band compressing the small intestine. There was no other signs of pathology in the abdomen. The pts only other surgical procedure was a right inguinal hernia repair which was distant from the site of the band.  The pt began with persistent nausea, crampy pain and vomiting 5 days after his first dose of the Pfizer vaccine.
moderate headache; a bit tired; This is a spontaneous report from a contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 31Jan2021 at single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, it has been unknown if the patient has been tested for COVID-19. It was unknown if the patient had allergies to medications, food, or other products. On 01Feb2021, the patient experienced moderate headache and was a bit tired. It was unknown if treatment was given as a result of the events. Clinical outcome of the events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23 (dose, route unknown, lot # J006242 and expiry date 03-AUG-2014). On an unknown date the patient had a reaction that considered of red hot swollen skin the day after the vaccination. The outcome of events was unknown. Additional information has been requested.
racing heart, tight throat, lightheaded.  Advised to take benadryl and wait to see if change.  Approx 30 minutes later symptoms stopped
On 2/13/2021 I noticed a red rash, it is about 2 inches, it is almost a circle around where the shot was given. It is itching. It is still there as of 2/18/2021. I is starting to fade some.
Patient had no signs and symptoms after having injections of any reactions during time of course when patient walked out side she fell to ground and ambulance was called.
Redness and soreness noted day after, then 1 week later severe redness, soreness, and slight swelling at injection site.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 59-year-old female patient who received SHINGRIX for prophylaxis. On 4th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, headache, stomach pain, nausea, injection site pain and feeling unwell. In May 2018, the patient experienced fatigue. On 7th May 2018, the outcome of the feeling unwell was recovered/resolved. On an unknown date, the outcome of the shivering, headache, fatigue, stomach pain, nausea and injection site pain were recovered/resolved. It was unknown if the reporter considered the shivering, headache, fatigue, stomach pain, nausea, injection site pain and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: On 4th May 2018 in morning, the patient was vaccinated with her 1st dose of SHINGRIX. The patient experienced soreness at the injection site after the dose was administered. On the same day of the vaccination later, she was not feeling well, she had nausea, terrible stomach, headache and shivering. The patient stayed in bed all over the weekend, and did not feel better until 7th May 2018, Monday. She was not sure, whether she would get vaccinated with the 2nd dose of SHINGRIX.
My stomach is full of I want to say hives, it's red, it's burning, it's full of rash; My stomach is full of I want to say hives, it's red, it's burning, it's full of rash; My stomach is full of I want to say hives, it's red, it's burning, it's full of rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 07Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after vaccination, the patient experienced stomach was full of, the patient wants to say hives, it's red, it's burning, it's full of rash. It was reported that the patient was calling with a question and a concern that the patient took 1st dose of the Pfizer shot yesterday and stomach was full of, the patient wants to say hives, it's red, it's burning, it's full of rash. The patient wanted to know is that normal or any recommendations that the patient can use to take away that symptom or is it a normal 'allergy'. Consumer was unwilling to share further information hence product details and other details were unknown. Limited information was available over the call. The outcome of events was unknown.  Information about batch/lot number cannot be obtained. No further information is expected
5/1/19 (about a week) after 2nd shot, pt got blister rash between her breast & under left breast, very itchy. pt wash with soap & apply bactroban oint. - got little better.
LITTLE TIRED; This spontaneous report received from a patient concerned a female of unspecified age. 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, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced little tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from little tired. This report was non-serious. This case, from the same reporter is linked to 20211210246.
CURRENTLY PREGNANT, FOLLOWS WITH OB, DUE DATE UNKNOWN. NASAL CONGEST, COUGH
administered the Diluent and not the HIB lyophilzed with no AE; Initial information received on 16-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old male patient who was administered the diluent and not the HIB lyophilzed (product preparation issue), while he received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  On 15-Oct-2019, the patient received 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ124AAA via intramuscular route in the right vastus lateralis.  On an unknown date, it was reported that they were busy and in a hurry and did not grab both vials when preparing the Pentacel. They administered the diluent and not the HIB lyophilized (product preparation issue) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It was an actual medication error due to product preparation issue.  No lab data was provided.  Final diagnosis was not applicable administered the diluent and not the hib lyophilzed with no ae.   It was not reported if the patient received a corrective treatment.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Employee had a Hepatitis B vaccination on 01/27/21 to her left deltoid.  On 01/29/21, the employee reported itching, pain/soreness, rash, and tenderness to her left arm.  The employee was offered Benadryl but declined.  Vital signs were monitored.  Ice pack was applied to injection site.  Employee then began to complain of nausea and weakness.  She was sent for evaluation and treatment but due to COVID, she was not able to get in.  She was seen the following day, 01/30/21.  Employee returned to work on 02/02/21.
Information has been received from a health professional concerning a 15-month-old female with no medical history who at a well check up on 12-MAR-2008 was vaccinated at 11:30 in the left leg with the first dose of VARIVAX (Merck). There was no illness at the time of vaccination. On 21-MAR-2008 the patient experienced a 2 cm red maculo-papular rash at injection site. Medical attention was not sought. At the time of this report, the outcome was unknown. Additional information has been requested.