chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Licensed Practical Nurse regarding multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant therapies  were provided. The patients were vaccinate on multiple unspecified dates between 14-JAN-2018 and 24-JAN-2018 with improperly stored doses of ROTATEQ, (lot # N013504, expiry date 08-DEC-2018 and N011647 expiry date 17-NOV-2018) for prophylaxis (dosage schedule, route and anatomical location were not reported); and improperly stored doses of LIQUID PEDVAXHIB, (lot # N022167 expiry date 08-FEB-2020 and N012119 expiry date 06-FEB-2020) for prophylaxis (dosage schedule, route and anatomical location were not reported). The temperature excursion for the vaccines were reported as 47 Fahrenheit degrees  to 77 Fahrenheit degrees during a time frame of 1 hour and 10 minutes. No previous temperature excursions were reported and the call was made because a data logger. No adverse effects were reported.
This is a spontaneous report from a contactable consumer (patient) via a Pfizer sales representative. A 16-year-old patient of unspecified race/ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain and redness/rash on an unspecified date with outcome of unknown.
Information has been received from a licensed visiting nurse concerning a 17 year old female who in February 2007 was vaccinated with the first dose of Gardasil. A second dose of Gardasil was received on an unspecified date. Concomitant medication was not reported. In 2007, the patient experienced injection site redness. The patient sought unspecified medical attention. The outcome of the event was not reported. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Hashimoto" (unspecified if ongoing), notes: I have Hashimoto, Treatment: Consumer stated, "No. I do not have to, just I have the disease". The patient's concomitant medications were not reported. The following information was reported: BLISTER (non-serious) with onset 10Dec2021, outcome "unknown", described as "I have on my left shoulder, I have this blister. Might be, it look like a burned, like I burned by something, which like, which is 4.3 inches, like 6-7 centimeter long."; BURNS SECOND DEGREE (non-serious) with onset 10Dec2021, outcome "unknown", described as "Its a burn like, you know blister on it like 7 centimeter long, 3 inches may be 7-8 centimeter long and may be 1-2 centimeter wide". Therapeutic measures were taken as a result of blister, burns second degree. Additional information: Consumer stated, saying that, Pfizer has a deal that it doesn't matter what happen to us due to the vaccine is nothing we can do about. They don't treat us, they don't get of us and I said, you and I realize, no you are one of us, you are not one of them because they don't care about you either so, I will be frustrated (further not clarified) and I shouldn't be frustrated to you too. It's not your fault, you just work for them. I am just a bit frustrated, and I know, nothing I can do because of them, finding this and then they push us, they obligate us, it's mandate for us to have the vaccine, when they do not take any responsibility for anything so it's fair enough to be frustrated, alright that's all. Consumer was informed about Pfizer medical information department and contact number was provided. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient received his first dose of Moderna COVID 19 Vaccine on 23Apr2021 and the second dose on 06May2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID 19 Vaccine on 23Apr2021 and the second dose on 06May2021) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID 19 Vaccine on 23Apr2021 and the second dose on 06May2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID 19 Vaccine on 23Apr2021 and the second dose on 06May2021) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information were reported.
I noticed increased joint pain around 4/17. I was having trouble walking and riding my bike due to pain in my hip. I saw my dr. on 4/29. Started regimen to help w/ hip pain that consisted of pain relievers. I started physical therapy which has helped but still have fatigue and joint pain. Still feeling extreme joint pain as of 5/16.
Patient fainted shortly after receiving second dose of Moderna Covid vaccine. When I approached the patient he was laying on the ground and very pale but still breathing. I rolled him onto his back and elevated his feet and asked him to keep breathing and try to stay calm. I asked someone to grab him some water and someone else to run to the pharmacy and grab the pharmacy manager while I monitored the patient. I asked if I could help him sit up to drink some water and he accepted. After sitting up I asked if he had eaten and if I could get him something to eat. He stated he hadn't eaten all day and that he had a panic disorder and felt like he was having a panic attack. I asked if he had medicine he needed to take to help him feel better, he stated no, he needed to just wait it out. Then he told me he felt like he was going to throw up and I got him a waste basket that he threw up in right away. I asked the patient if he hit his head or if he wanted us to call an ambulance; he stated no to both questions. The pharmacy manager arrived and sat with the patient for the next half hour or more until he felt better. He stated that his dad was going to take him home now that he felt better. Some store staff had us fill out an incident report and the pharmacy manager walked the customer out to his car where he said he would call and find his dad.
Multiple patients were administered doses of MMR-II or VAQTA after they were involved in a temperature excursion; No additional AEs were reported; This spontaneous report has been received from a medical assistant, concerning an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II) subcutaneous injection (lot number W029789 with expiration date reported as 23-SEP-2023, was not valid for M-M-R II) (lot number W009107 has been verified to be valid for measles, mumps, and rubella [wistar ra 27-3] virus vaccine, live, rHA [M-M-R II], expiration date reported and confirmed as 04-DEC-2023), or hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (lot number W028555 has been verified to be valid for hepatitis a vaccine, inactivated [VAQTA], expiration date reported and confirmed as 10-JUL-2024), administered as prophylaxis (exact doses, routes of administration, and anatomical locations were not provided). The vaccine doses were administered after they were involved in a temperature excursion of 9.2 degree Celsius during a time frame of 40 minutes and they did not suffer previous temperature excursions. No additional adverse events (AEs) were reported.  Follow up information was received from the medical assistant on 23-MAY-2023. It was reported that one of the patients was a 13-month-old male patient. On an unknown date, the patient received an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, (rHA) (M-M-R II) (lot # 4029789, expiration date not reported, Lot # 4029789 is an invalid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant human albumin) (M-M-R II))  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2305USA002471:
8/30/2008 Awoke from nap and appeared fatigue, whole body began shaking and convulsing lasted 5 min total. POC took to ED. ED course IV NS Bolus, CBC and BMP drawn, more alert after fluid bolus and patient discharged home with parents.
Child was seen in our office 10-16-08 and received the flu vaccine that evening. Mom states that she left our office and went to Wal-Mart. As she pulled into driveway @ home, less than 2 hrs later, child was staring and lips were blue, his O2 sat was 95. Ambulance was called and child taken to ER, dx - post-ictal. With febrile illness/child had low grade fever 101.4 degrees. No wheezing.
Immediate onset of pain, myalgia.  Went to Dr. on 10/26/2010 for extreme pain.  Had MRI (negative), Saw Orthopedist who did EMG (showed slight neuritis), numerous blood work showed only elevated Sed Rate.  Currently complaining of increasing discomfort.  Currently taking Steroids.
ANXIETY; HEART RACING; STRANGE FEELING IN LEGS; RESTLESS LEG SYNDROME; NUMBNESS AND TINGLING IN LEFT ARM; This spontaneous report received from a patient concerned a 63 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and 205A221A expiry: 01-JUN-2023) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced strange feeling in legs. On 07-APR-2021, the subject experienced restless leg syndrome. On 07-APR-2021, the subject experienced numbness and tingling in left arm. On 13-APR-2021, the subject experienced anxiety. On 13-APR-2021, the subject experienced heart racing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from strange feeling in legs, restless leg syndrome, numbness and tingling in left arm, anxiety, and heart racing. This report was non-serious.
Still sneezes sometimes; Feels tired all the time; Severe coughing; coughing ever since for the last two weeks; tickling cough; coughing up blood; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Severe coughing; coughing ever since for the last two weeks; tickling cough), SNEEZING (Still sneezes sometimes), HAEMOPTYSIS (coughing up blood) and FATIGUE (Feels tired all the time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Pulmonary arterial hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT) for an unknown indication.   On 26-Dec-2017, the patient TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to UNK, Inhalation. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TREPROSTINIL SODIUM (TYVASO) (unknown route) 18-54 µg (3-9 breaths), four times a day (QID) via inhalation. On an unknown date, TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to UNK, Inhalation. In February 2022, the patient experienced COUGH (Severe coughing; coughing ever since for the last two weeks; tickling cough) and HAEMOPTYSIS (coughing up blood). On an unknown date, the patient experienced SNEEZING (Still sneezes sometimes) and FATIGUE (Feels tired all the time). At the time of the report, COUGH (Severe coughing; coughing ever since for the last two weeks; tickling cough) and SNEEZING (Still sneezes sometimes) had not resolved and HAEMOPTYSIS (coughing up blood) and FATIGUE (Feels tired all the time) outcome was unknown.            No medical history was reported.  Action taken with IH Tyvaso was not reported for the events of cough, haemoptysis, fatigue and sneezing. After COVID booster shot, patient went to urgent care.  Treatment information was not provided by the reporter.
Initial report received from a healthcare professional on 03 October 2013. This is an invalid case of several patients. Several patients of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID intramuscularly in deltoid, batch number: UH899AC (dose number not reported) on an unspecified date. It was reported that, multiple patients received vaccination from FLUZONE MDVs and after vaccination when needle removed from patients' arm there was a "gray spot" at needle injection site. Stated gray spot "easily wiped off" and no other symptoms or reactions occurred. Product complaint also filed for this situation as PR 236930. The laboratory tests and corrective treatments were not reported. The event was event recovered. Documents held by sender were none.
Patient received 1st Pfizer vaccine and second dose moderna vaccine. Patient provided education. department of health and welfare do not recommend repeating series at this time.
Constipation; Felt awful; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful). At the time of the report, CONSTIPATION (Constipation) and FEELING ABNORMAL (Felt awful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment products reported.   It was reported that the patient received the vaccine about 10 days before the date of reporting.  Treatment information was not provided.
Vomiting, fever persistent with medicine. Chills, joint pain. X  2 days at this point.
I have no side effects from my 1st Moderna shot. The 2nd Mondena shot, about an hour after getting it I had an huge burst of energy come over me that lasted for a good 6 to 8 hours.  The following day around 2:30pm  I begin having Flu like symptoms, chills, body ache, skin tenderness, extreme tiredness, minor head and weakness that lasted about 15 hours.
one week post injection, injection site became red, swollen and itchy.  Rash last approx 24 hours.
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. Pertinent medical history and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # L013068, expiry date 14-APR-2017, dose and route of administration not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient started having chills Sat. night. Arm was swollen with a large knot. Skin around site was warm. Patient had a fever of 102 degrees for 2 days. Went to urgent care Sunday morning - given Rx for ATARAX.
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a patient (age and gender unknown) who received an expired dose of vaccine MENACTRA. The patient's past medical history, concomitant medication and family history were not provided. On 13-Mar-2019, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA, expiry date: 11-Mar-2019, via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
She was given a PNEUMOVAX .5 IM in her left deltoid IM on 4-27-10 at approx 3:15 PM.  She returned to the clinic at 2 PM on 4-28-10 - her left deltoid was red, warm to touch - T98.2.  She was started on BACTRIM DS BID X 10 days and she will return to the clinic on 4-30-10 for a recheck.  She was instructed to return sooner if the arm is getting worse.
A-typical spotting mid-menstrual cycle; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 19:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included herbal remedies (MANUFACTURER UNKNOWN) from an acupuncturist, taken for an unspecified indication from an unknown date and unknown if ongoing. On 13Apr2021, beginning 3 to 4 days after first dose, the patient experienced a-typical spotting mid-menstrual cycle and the spotting was continuing until 15Apr2021, the sixth day and had not stopped at the time of this report. The patient typically had regular periods with no spotting and the period had just ended 7 days prior to the spotting (4 days before the shot). The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event spotting mid-menstrual cycle was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Hives, Itching, Redness and Aching to bilateral legs, bilateral arm pits, sides of torso. Started on inner thighs late afternoon 6/30, as small areas of redness and rash. More extensive coverage of raised hives, itching and redness by 7/1, given BENADRYL 25 mg at home. Was not getting any better and started to spread up torso to arm puts. Went to Emergency Room on 7/1 received double dose of Prednisolone and presciption for 4 days of Prednisolone and instructed to give BENADRYL 3-4 times a day.
tachycardia; This is a spontaneous report from a contactable consumer. This 35-year-old non-pregnant female consumer (patient) had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EWO191) via an unspecified route of administration on 14Jun2021 into right arm; 12:15 PM as DOSE 1, SINGLE for covid-19 immunization (at the age of 35 years) at Pharmacy or Drug Store. The patient medical history included allergic to avocado. The patients concomitant medications were not reported. It was reported that patient did not take any vaccination in four weeks and did not take other medications in two weeks. The patient was not diagnosed with COVID-19 prior to the vaccine. It was also reported that since the vaccination the patient had not been tested for COVID-19. On 18Jun2021 at 12:00 AM the patient had experienced tachycardia. Therapeutic measures were taken as a result of tachycardia and included treatment with Beta blocker. The patient had visited Emergency room/physician office/department or urgent care. The outcome of the event was recovering  Follow-up attempts are completed. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of rash in a 15-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included otitis media. Previous and/or concurrent vaccination included DT and IPV; manufacturer unspecified given on an unspecified date. Concurrent medications included TRIPEDIA and Amoxicillin trihydrate (Amoxicillin). On 24 February 2008, the subject received 1st dose of HAVRIX (intramuscular, right thigh). On 26 January 2008, at an unspecified time after vaccination with HAVRIX, the subject experienced rash on his groin, trunk and legs. The subject was seen in the emergency department but not treated. The subject was treated with BENADRYL after consulting his physician. At the time of reporting, the outcome of the event was unspecified. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. Follow-up information received via the original reporter and an allergist on 22 April 2008 indicated that the events may have started within one day of receiving HAVRIX and DT and IPV. The dates still reveal a two day onset. The child was an allergist on 28 March 2008 at the age of 17 months following the onset of generalized urticaria and hives beginning at the injection sites on both sides and spreading to cover his entire body on 26 January 2008. He did not have systemic symptoms and the hives resolved with BENADRYL treatment after about three days. Since that time, the child remained well. A skin test with DPT, DT and tetanus toxoid and the hepatitis A vaccine performed on 28 March 2008 gave negative reactions by prick and intradermal testing with a good positive histamine control. There was no evidence of an allergic reaction to any of the vaccine components. The subject has just finished a course of amoxicillin (date not specified) just before he received his vaccines and it was suggested that the events may have been a delayed reaction to the amoxicillin. It was also suggested that the events my have been the result of a viral infection. The events remained resolved at the time of reporting.