chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a Licensed Practical Nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with improperly stored ROTATEQ, lot# L008996, expiration date- 01-DEC-2016 and lot # K011948, expiration date- 07-JUN-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Site of injection became very sore. Within 24 hours, there was significant swelling and hardness at injection site. This subsided over the next few days. Then on 1/27/21, the swelling returned, the injection site was hard and hot to the touch. It is very itchy. This has been ongoing for 24 hours now. Nurses have been monitoring the injection site and are concerned that it might be cellulitis. They have circled the injection area to monitor spread of rash/swelling/heat to check in 24 hours.
Patient dis not have any reaction to vaccine. She wa administered an expired vaccine punctured the day before and was left in the fridge.
Mother called to report hives after dose of PENTACEL #2 & Hepatitis B #2. Child behind in all vaccines. Mother refused all other vaccines. Developed hives within 8 hrs of vaccines on abd. Hives resolved without any medical care. Mother had given child a dose of liquid TYLENOL after vaccines.
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient presents to the emergency department with redness, induration, pain, warmth, and tenderness in right arm where vaccinated one day earlier. Patient prescribed antibiotics and advised to take acetaminophen, ibuprofen, and diphenhydramine as needed. Patient discharged stable to home.
Kinrix given to patient age 2 when indicated for ages 4-6 yrs old. No adverse reactions noted.
Diagnosed with Shingles on May 4--shingles rash started April 29th.
Narrative: Experienced symptoms consistent with hypersensitivity reaction 5 days after receipt of dose#1 of the Pfizer COVID-19 vaccine. Subsequently received a dose of the J&J COVID-19 vaccine without reaction.
Patient received vaccine around 9 am. She came by pharmacy around 4:30 reporting severe abdominal pain.
Pt called 1/16/19 stating she woke up 1/15/14 with (R) sided numbness in face and drooping of face. Immediately sent to urgent care clinic. Pt given steroid shot and PO steroids.
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), on 31Oct2021 as dose 3 (booster), single (Lot number: f48028) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 1, single (Lot number: 036a21a) and on 31Mar2021 as dose 2, single (Lot number: 038a21a) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPIRONE, start date: 02May2021; ADDERALL, start date: 04Jul2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 22Aug2022, outcome "not recovered", described as "first positive test 11Aug; first negative test 16Aug, continued negative tested until 22Aug when I started testing positive again". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Aug2022) Positive, notes: first positive test; (16Aug2022) Negative, notes: first negative test; (22Aug2022) Positive, notes: until 22Aug when I started testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Caught COVID. Symptom onset 09Aug, first positive test 11Aug; first negative test 16Aug, continued negative tested until 22Aug when I started testing positive again. Patient treated with Paxlovid, treatment start date was 11Aug2022 and stop date was 15Aug2022, Patient took other medication in two weeks. No known allergies.
Five days of flu like symptoms. I had bone chilling cold. I was freezing and could not stay warm. I had a high fever, sore throat, head aches, body aches, and fatigue
Patient returned to vaccine clinic 1 hour and 45  min after Covid 19 vaccine reporting dizziness and blood in sputum. Pulse Ox was 99%, Pulse was 113. No SOB. Per Protocol called 911 for transport to ED for evaluation
Intense shoulder pain, limited range of motion. Intensity lessened with time, but a year later I still do not have full range of motion and there is pain (ranging from 4-8 on a 10 point scale) daily.
This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), MYALGIA (Body ache), FATIGUE (Fatigue) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A /017B21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PREDNISONE, DEXAMETHASONE ACETATE (DECADRON A), METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]), CYANOCOBALAMIN, FOLIC ACID, IRON PENTACARBONYL, ZINC (ZENFER Z) and CIPROFLOXACIN HYDROCHLORIDE (CIPRO [CIPROFLOXACIN HYDROCHLORIDE]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), MYALGIA (Body ache), FATIGUE (Fatigue), HEADACHE (Headache), PAIN OF SKIN (Skin pain) and PYREXIA (Low grade fever). At the time of the report, HYPERHIDROSIS (Sweating), LETHARGY (Lethargic), FATIGUE (Fatigue), HEADACHE (Headache), PAIN OF SKIN (Skin pain) and PYREXIA (Low grade fever) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication include Prednisone, Decadron, Medrol, Zenefrax and Cipro. Concomitant product use was not provided.   This case was linked to MOD-2021-082902 (Patient Link).
24 hours following the DTaP injection, pt was noted to have increased edema and slight warmth surrounding the injection site. Over the last 24 hours edema and erythema has proceeded to include the entire thigh extending from the front to ? thigh. Pt occasionally shows signs of discomfort, but his playing and walking with limp. No fever. Injection site is mildly erythematous. No drainage or induration.
Information has been received from a registered nurse concerning a 37 month old female who on 23-JUL-2007 was vaccinated with a dose of MERUVAX II vaccine (lot # 654402/1188F). The patient developed hives all over her body within 24 hours of administration. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. Follow up information has been received a registered nurse concerning a 37 month old female with no illness at time of vaccination and no drug allergies, who on 23-JUL-2007 was vaccinated with the first dose of MERUVAX II vaccine (lot # 654402/1188F) in the left arm. The patient's mother stated that the patient developed hives after injection within 24 hours. There were no labs or diagnostic tests performed. The patient recovered at the time of the report. No further information is available. The patient had a history of hives all over body while on prior therapy with MERUVAX II (MSD, WAES 0912USA01534).
pt devel abdo pain & pancreatitis p/ea of 2 vax w/Hep B; No further details were provided;
PERIPHERAL NEUROPATHY ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ACUTE HYPERCAPNIC RESPIRATORY FAILURE DUE TO OBSTRUCTIVE SLEEP APNEA
Facility did not report any adverse reaction. Recipient received an additional bivalent booster--after having received on in September
Armpit is still a bit swollen; Entire body was achy; Armpit is still a bit swollen and have pain sometimes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Armpit is still a bit swollen), MYALGIA (Entire body was achy) and AXILLARY PAIN (Armpit is still a bit swollen and have pain sometimes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Armpit is still a bit swollen), MYALGIA (Entire body was achy) and AXILLARY PAIN (Armpit is still a bit swollen and have pain sometimes). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Armpit is still a bit swollen) had not resolved and MYALGIA (Entire body was achy) and AXILLARY PAIN (Armpit is still a bit swollen and have pain sometimes) outcome was unknown. Not Provided          Patient was on antibiotics for the HCG done for infertility.  No concomitant medications were reported.  No treatment medication was reported by reporter.   This case was linked to MOD-2021-248035 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: upgraded to valid case- patient demographics added, suspect drug details added, events added.
10/21 Arm pain shoulder to hand requiring narcotic to sleep.  I have a very high pain tolerance.  I have never needed narcotic after orthopedic or dental surgery (2 weeks ago) or after c-section.  . 10/22 arm pain slightly better but nauseated, no vomiting.  Experiencing vertigo to point need to lay down frequently.  ringing in ears and severe general malaise,. (I am a nurse)
Felt extremely ill for 4 days. Temp, headache, nausea,  Kidney stones 4/28/2021
pc from mom stated pt cried all noc p/receiving first 2 sets of immun & nothing mom did would make pt stop crying;
Employee was at Employer sponsored Mass flu clinic where Covid-19 boosters were being offered.  Employee went through 2 influenza lines and did not communicate clearly with staff thinking she received the Covid-19 bivalent booster and ended up receiving a 2nd influenza vaccine.  Both vaccines with same lot number and expiration.  This was realized after the 2nd influenza vaccination had already been administered to the Employee.
Flu vaccine was administered to employee at 1210 on 10/30/20. Agency was contacted by employee at 1220 to report feeling GI discomfort, tingling sensation in mouth that lasted approximately 5 minutes, chest pressure that lasted approximately 5 minutes, and dizziness which lasted approximately 2 minutes. As per employee GI discomfort and acid reflux s/s remain but all other s/s subsided. Employee was given oral fluids (Gatorade 360 mL), employee tolerated well. First set of vitals taken at 1230 BP 125/80 P 84. Vitals retaken at 1248 BP 118/80 P 80. Last set of vitals taken at 1300 BP 116/78 P 88. Agency was contacted by Agency for further guidance. Agency was advised to provided employee with phone number in case s/s returned. Employee was released home in stable condition.
Patient developed hives after 5 minutes post immunization. No other signs of allergic reaction. Given BENADRYL 12.5 mg/5ml immediately. Hives resolved in 15 minutes approx.
This spontaneous report as received from a other health professional refers to a 6 year old patient. On 03-JUL-2014 the patient was vaccinated with VARIVAX (Merck) (lot # J009728, expiration date: 07-AUG-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Relapse tested positive 15Sep2022; Relapse tested positive 15Sep2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Jan2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 84 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Sulfur" (unspecified if ongoing); "Known allergies: Contrast dye" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, latency 8 days after the suspect product(s) administration, outcome "not recovered" and all described as "Relapse tested positive 15Sep2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (15Sep2022) Positive. Therapeutic measures were taken as a result of covid-19 which include from 07Sep2022 to 11Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Site: Pain at Injection Site-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: PATIENT VACCINE WAS GIVEN TOO HIGH ON ARM AND CAUSED SHOULDER PAIN AND SORE ARM
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA 1/9/2023 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
She states that she does not know for sure if a Pentacel was reconstituted with a Merck sterile water and then given to a patient with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00723451) and transmitted to Sanofi on 13-Aug-2021.  This case involved (unknown age and gender) patient it was reported that she does not know for sure if a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] was reconstituted with a merck sterile water and then given to a patient (product preparation issue)  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, it was reported that she does not know for sure if a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: lot UJ543AAA and expiry date: 10-Jul-2022) (dosing details unknown) via unknown route in unknown administration site for prophylactic vaccination was reconstituted with a merck sterile water and then given to a patient (product preparation issue)  It was reported that,"Caller stated that it comes with the 2 vials, (Powder, Diluent). Stated that in the box was an extra diluent in the box, and she thinks it was mixed likely with sterile water. What are the recommendations. She would also like to know what the safety concerns are of a patient getting a second Pentacel vaccine. She states that they will try and figure out which of the four kids this happen to and maybe they can narrow it down to two patients. She was asked for the initials and dates of birth of the potential patient, but she states that she does not have that available at this time".  This was an actual medication error case due to inappropriate reconstitution technique (latency same day)  At the time of reporting, no adverse event    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 the 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.
On 3/10/00, the pt experienced right wrist pain and left wrist swelling. It was noted that the right wrist was positive for effusion, however, the left wrist was negative. The pain and swelling were worse in the morning. The effusion was not aspirated. The events required a visit to the doctor's office.
I am 15 years post menopausal. 5 days after 2nd vaccine listed above, I got a light period for 2-3 days, month later another for 2-3 days and July had one for 5 days. Called Dr she sent me for ultrasound then on to gyno who performed a uterine biopsy. Results were no cancer. Since end of July, no period. Had booster shot Dec 3, no issues since
21-year-old female received her first dose of Janssen at 2:33 pm and it begins with symptoms of emesis, nausea, dizziness and weakness. She was taken to the incident observation area to evaluate her and her vital signs were: 71 for Pulse, 36 for Temperature, 100/60 B/P, 19 Resp, and 98 Dextro. Nurse communicates with Dr. and refers to placing the patient in the Trendelenburg position and giving her a GATORADE and then keeping her under observation for 30 minutes. After re-evaluating her, the patient continues with the same vital signs, but the patient refers to having severe abdominal pelvic pain and Dr. is notified again and refers to transfer her to the Hospital by the Medical Ambulance and was treated by the EMT.
Immediate feeling unwell: diaphoretic, nausea, profound weakness. He had the same reaction with the second oral tablet.
Heart pounding, anxiety, hot flashes, vaginal bleeding w/ clots. Bleding lasted a week. Still having heart pounding and hot flashes. Not sexual active prior to incident.
The adverse reaction is not for myself but my daughter who I was pregnant with at the time. I became pregnant with my daughter between my vaccine doses. (First dose was on 04/07/21 and second dose was on 05/12/21. My estimated due date was 01/03/22 and my daughter was born on 01/10/22. She weighed 8 lbs 6 oz and it was natural, vaginal delivery. However, a ultrasound in November of 2021 showed a cyst had developed on one of my daughter?s ovaries. The doctors were shocked by this as they had never seen an ovarian cyst in a baby in utero. We monitored the cyst until I delivered her in January. Some time in December the cyst popped and they kept an eye on the fluid from the cyst. Most of it was absorbed. In April of 2022, at a routine wellness visit for my daughter, the pediatrician discovered she had a fused labia. After researching the possible cause of both the cyst and the fused labia, it came down to hormonal imbalance (excessive estrogen). I may believe this is related to the COVID-19 vaccine because of the research that shows vaccine affects women?s menstrual cycle.
Approximately 12 hours after given IM injections in R deltoid of Menactra and Boostrix, pt. developed urticarial lesions on R upper back and RUE.  The urticaria spread to all extremities within 2 days of injections.  + itching
Stated developed slight dizziness, "the feeling you get before you become severely sick".  Then developed a hoarse voice for 3.5 days & slight cough to clear throat often.
Site noticed by mom on 7/14.  Red about 10 cm.  Not painful, no treatment.  Noted to the side of the injection site.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included one previous pregnancy resulting in normal birth of a full-term live infant with no defect.  The subject had not been using contraception before becoming pregnant.  On 7 September 2011 at 13:48 the subject received a booster dose of Boostrix (.5 mL, intramuscular, right deltoid), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 34 weeks pregnant at the time of vaccination.  Date of last menstrual period was 12 January 2011 and estimated date of delivery was 19 October 2011.  Ultrasound on 18 May 2011 had revealed no evidence of a defect.  Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasound on 18 May 2011 had revealed no evidence of a defect.
UNDERDOSE; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies and did not have drug abuse or illicit drug. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-MAY-2021, the subject experienced underdose. The action taken with covid-19 vaccine  was not applicable. The outcome of underdose was not reported. This report was non-serious.