chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of allergic reaction in a 36-year-old female patient who received TWINRIX adult. Concomitant products included contraceptive nos and amitriptyline. On 12th January 2015, the patient received the 1st dose of TWINRIX adult. On 12th January 2015, an unknown time after receiving TWINRIX adult, the patient experienced allergic reaction (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required), throat swelling (serious criteria hospitalization, disability, life threatening, clinically significant/intervention required and other) and tingling (serious criteria hospitalization, disability, life threatening and clinically significant/intervention required). The patient was treated with BENADRYL and SOLU-MEDROL. On 13th January 2015, the outcome of the allergic reaction and tingling were not recovered/not resolved and the outcome of the throat swelling was recovered/resolved. The reporter considered the allergic reaction, throat swelling and tingling to be almost certainly related to TWINRIX adult. Additional details provided: The patient received TWINRIX adult at her doctor's office yesterday as 2 shots in 2 separate arms (for unknown reason) and began having allergic reaction described as throat swelling and tingling all over the body. The patient took BENADRYL at home without effect and came to emergency room 4 hours after the dose was administered. The outcome of the events did not worsen to a life threatening/disabling condition since she was smart to take BENADRYL and go to emergency room. Her symptoms especially the tingling was still continuing. The patient was kept in the observation in hospital at least 1 day. The patient was not sure if she took other medications. The reporter was questioning if the patient really received TWINRIX or single antigen hepatitis A and B vaccines.
Red rash on neck, just right if center; apx 3-4 ? in verticals length and 2-3? wide. Treated with Aquaphor topically.. rash lasted about 6-7 days. ( this also occurred when 2nd dose of same vaccine was received 3/11/21.
Patient presented for 2nd vaccine, patient is 8 years old and received Pfizer grey top vaccine for age 12 and up.
Patient developed local reaction to ZOSTAVAX. Welt formed at site of injection about the size of a quarter and flat redness developed around the area. No other signs of allergic reaction developed. She did also note a reaction to the adhesive on the bandage.
shooting pain in the head; brain fog; fatigue; clammy feet; hollow sound in the stomach; clotting platelet elevated after she got the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a 87-years-old female patient (reporter's mother) that:  A 87 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at an (Age at the vaccination 87years old) dose number unknown, single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date, the patient had experienced strange side effects - shooting pain in the head, brain fog, fatigue, clammy feet , hollow sound in the stomach (you can hear its amplification) - Her mother takes chemotherapy every night for 5 years now because of lung cancer - She is 115 pounds and asking if the booster dose will be the same amount as the initial 2 doses- Asking if the booster dose is highly advised for her mother and if she needs it - She confirmed that her mother is not immunocompromised according to her doctor. Patient mentioned that she had a normal platelet count in February and all of a sudden her clotting platelet elevated after she got the vaccine. At the time of reporting, the outcome of the events were unknown.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. There was no pertinent medical history, drug reactions or allergies and concomitant therapies reported. On an unknown date, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (Lot number L003775 and expiry date 04-FEB-2017) (dose and route were unknown). There were no adverse effects reported. Lot number L003775 with expiry date 04-FEB-2017 has been verified to be a valid lot number for (Oka/Merck) VARIVAX. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patient's identifiers, lot numbers and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015, regarding a 1 year old patient of unknown gender. On 04-AUG-2015, the patient was vaccinated with improperly stored dose of (Oka/Merck) VARIVAX (lot # L003775). This is one of several reports received from the same source. Additional information has been requested. Patient's details, event information and narrative were upgraded.
Injection site pain  reoccurs 7 days after vaccine; 5 days after arm pain had already stopped hurting.  Maybe ?Covid arm?.
2 weeks after first covid shot, left arm is still itching. Also I?ve developed this warming sensation in my left heel that comes and goes all day. I?ve had this for 4 days now and it has not gone away. I?m not doing any physical activity either. This started the same after I developed the covid arm rash. As soon as the rash started to go away, the warming sensation in my heel started. I have never felt this feeling before in my life. This feels really strange. It?s more annoying than anything. But I?m wondering when it will go away. It just feels like a heat sensation running down my left heel. Just the left heel.
Narrative: 1ft increase, likely due to other cause ie chemotherapy for NSCLC
Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vial initially stored in refrigerator on 04-Jun-2022 and administered on 20-Jul-2022).    Concomitant medication information was not provided by the reporter.  Patient received half dose.  Vial was initially stored in the refrigerator on 04-Jun-2022.  Vaccine administered to 346 patients after the 30 day by used involved 35 vials. Vial did not undergone any temperature excursions.  Treatment information was not provided by the reporter.
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. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 08-JUL-2011, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-FEB-2012, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster shingles. On or about 24-FEB-2012, the patient sought subsequent treatment for ongoing pain and new zoster infections. On or about 15-MAR-2012, the patient was treated for continued and uncontrolled herpes zoster outbreaks. On or about 26-MAR-2012, the patient was treated for continued suffering, at which time she was diagnosed with shingles and post-herpetic neuralgia. On or about the dates of 12-JUL-2012 and 10-AUG-2012, the patient sought treatment for her continued neuralgia symptoms that was resistant to treatment attempts. On or about the dates of 29-AUG-2012 and 17-OCT-2012, the patient was treated again for ongoing and worsening symptoms of post-herpetic neuralgia. The patient was prescribed TEGRETOL, TOPAMAX, TRILEPTAL, VALTREX, amitriptyline, gabapentin, and hydrocodone for management of her painful and persistent 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, and pain and suffering, and other damages. Additional information has been requested.
About 5-6 hours after the injection on Thursday, I first noticed some aching and  fatigue.  Soon, that same evening, I noticed I was getting some cold symptoms, including stuffy sinuses, slight headache, and a bit of a sore throat. Not having a fever,  I managed to go to work the next day, Friday, but had a lot of post nasal mucus and felt tired and weak with again a slight headache from sinus pressure. Over the weekend my symptoms have gotten worse, with much thicker mucus.  It's now Sunday night, and I have a slight fever and feel chilled. My sinus congestion has not alleviated, and I have sinus pain in my face , head, and ears. I have not had any coughing.
12/16/2020 - woke up at 2 in the afternoon with a sore left arm at the site of injection. (She works nights.) She also had a headache and her stomach felt bloated. She developed a temperature of 101.4 on 12/18 and it went down on Sat to 99.6. H/A, body aches and low grade temperature lingered through 12/20. She woke up feeling normal on 12/21.
LPN inadvertently administered half of the ordered dose of Menveo when she used a generic sterile diluent to reconstitute the Men A lyophilized conjugate vaccine component (vial 2) instead of the Men CYW-135 liquid conjugate vaccine component (vial 1) that is meant to serve as the diluent for the Menveo vaccine. Provider was notified of the error. Provider contacted the patient's guardian and explained the error along with her recommendation that the patient receive the full dose at the patient's next visit scheduled in one month.   The error was discovered the next day during vaccine inventory when there was an extra bottle of Menveo liquid conjugate vaccine.   No adverse reaction noted by patient/family.  We will be ordering Menquadfi moving forward to avoid the need for reconstitution.
Two days after receiving booster, my headaches began, and have not stopped.  Also, this negative side effect is also affecting my labido.
presents to the ED with SOA that began at midnight tonight while getting ready for bed. Following the onset of the SOA she began to have diaphoresis, lightheadedness, and a burning sensation in her chest that radiates to her back. No nausea or vomiting. She reports checking her heart rate and was tachycardic. She tried to bare down and walk off the tachycardia, with no relief. While she was driving to the ED, her symptoms gradually resolved
no additional AEs; expired dose of VARIVAX was administered; This spontaneous report was received from a medical assistant, referring to a 16-year-old male patient. The patient's concomitant therapy, concurrent condition, medical history and drug reactions/allergies were not reported.  On 25-MAY-2023, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose was 0.5 milliliter (ml), lot number was reported as U016063, expiration date was reported as 20-MAY-2023, route and anatomical location were not provided) for prophylaxis (expired product administered), 5 days past expiration date of 20-MAY-2023. No additional adverse event (AE) reported (no adverse event).
very tip of tongue was tingly; little bit dizzy; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 39 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Apr2021 11:02 (Lot number: ER8729) at the age of 39 years as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Scoliosis", start date: 2018 (ongoing), notes: Diagnosed around 2018; "slipped disk in her back" (unspecified if ongoing), notes: diagnosed around last year; "Allergic to Windex" (unspecified if ongoing), notes: Caller stated, what windows are cleaned with, and that it is very weird. Concomitant medication included: IBUPROFEN taken for back disorder (ongoing). The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 19Apr2021, outcome "not recovered", described as "very tip of tongue was tingly"; DIZZINESS (non-serious) with onset 19Apr2021, outcome "not recovered", described as "little bit dizzy".  Additional information: Caller stated she was calling about the Pfizer-BioNTech COVID-19 Vaccine.  She received it this morning. A few minutes after she received her vaccine, the very tip of her tongue was tingly. She received the vaccination at 11:02 am and the tingling is not getting worse, but it has not gotten any better. This started a few minutes after receiving her vaccine, maybe 5 minutes after.  Caller added that she was a little bit dizzy.  It was not like the room was spinning and it started kind of around the time that she got home from getting the vaccine and was about the same as it was. Treatment received was none, except laying down. Caller also clarified that her vaccine was received in her right arm, like up by her shoulder. She had not received any other vaccine within 4 weeks.  No follow-up attempts are possible. No further information is expected.
pt recv vax 23AUG96 & 4DEC96 pt devel approx 100 pox;it was reported that the pt did not feel bad;
Arm got puffy; Didn't feel well; Arm got red; Arm got hot; Horrible headache; Didn't want to do anything other than lay down or sit,tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot) and HEADACHE (Horrible headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot), HEADACHE (Horrible headache) and FATIGUE (Didn't want to do anything other than lay down or sit,tired). At the time of the report, PERIPHERAL SWELLING (Arm got puffy), MALAISE (Didn't feel well), ERYTHEMA (Arm got red), FEELING HOT (Arm got hot), HEADACHE (Horrible headache) and FATIGUE (Didn't want to do anything other than lay down or sit,tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment was reported for the events.
9 days after,  Reaction occurred. Went  to Urgent care; with  rash & redness, & itchiness below the injection. Next  day, Inflammation spread almost  to elbow. Given prednisone 10mg oral tablet.
Erythema and swelling at injection site began day of vaccination and continuing 3 days later, although they have subsided greatly.
herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions or concomitant medications. On or about January 2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose # and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient inoculation, the patient was treated for herpes zoster or shingles. As a direct and proximate result of the patient's use of the ZOSTAVAX vaccine, the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; significant medical and related expenses as a result of these injuries, including but not limited to costs for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
DIED FROM HEART ATTACK WITHING 24 HRS OF TAKING SHOT; This spontaneous report received from a consumer via social media via a 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry- Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Dose number in series-1. No concomitant medications were reported.  On an unspecified date, as reporter stated, "his dad's coworker (patient) died from a heart attack within 24 hours of taking the Johnson & Johnson COVID shot". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20211165280-Covid-19 vaccine ad26.cov2.s- died from heart attack. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
Dull aching pain in injection site.  Sporadic but over a long peroid.
Initial report received from a patient/consumer on 27 SEPTEMBER 2012. A 53-year-old female patient, with reported medical history of allergy to E Erythromycin and nickel, received a dose of FLUZONE intradermal (dose no. was not reported) in her deltoid region on 04 SEPTEMBER 2012 (lot number: UT4463BA). Concomitant medications were not reported. The patient reported that on 05 SEPTEMBER 2012 i.e. 01 day after receiving FLUZONE ID she developed itchy knot which was oozing clear fluid. She also felt very tired on the same day i.e. on 05 SEPTEMBER 2013. On 21 SEPTEMBER 2012 i.e. 17 days after receiving vaccine administration itchy knot have become blister in size of nickel and also nex6t day (18 September 2012) i.e. 18 days after vaccine administration the blister size of knot have become increased in size to half dollar and the blister area looked like a cluster of bumps and was still itchy and clear drainage surroundings to skin which was warm to touch. Lab investigations were none. Corrective measures were not reported. At the time of this report, the outcome of events was reported as not resolved. Documents held by sender: none.
pt recv vax 1APR96 & on 7NOV96 pt devel vaccine failure & chicken pox on chest, neck, & face consisting of greater than 50 lesions;another pt was reported as well (WAES96121484);
11/02/2021, 4 days post vaccine- when I woke up, there was no swelling of any kind. It was really painful, and I could not bend my left knee. I had to call my girlfriend over to get out of bed. It took 30 minutes to try to bend my left knee. I tried to do exercises to get it to start working. I am not sure if I have an autoimmune disease that started to attack my joints, but it hurt. My wrists and the joints on my fingers also became painful after the 1st dose of Pfizer. And the pain became worse after the 2nd dose. My doctor diagnosed it as arthritis. I have never had arthritis and I feel I am too young for it to have developed that quickly. The aches, pain, and stiffness in my joints are specifically in my wrists, fingers, and my left knee, where I can't move them.
Information has been received from the VAERS database via a journalist. This spontaneous report refers to a patient of unknown age. The patient was vaccinated with lot # (657676/0619U) ZOSTAVAX on 25-JUL-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.